Spain

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Most operators have the necessary knowledge and motivation to ensure proper animal welfare at slaughter. Improvements in animal welfare at slaughter are driven by that, supported by effective official control activities with adequate follow-up actions from operators. However, administratively burdensome and lengthy sanctioning process reduce the dissuasive effect of enforcement when operators are reluctant to comply. Sanctioning procedures are not dissuasive, risking repeated or prolonged animal suffering.

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All official laboratories designated for the analysis of samples for PWN are exempt from mandatory accreditation under Article 40(1)(b) of Regulation (EU) 2017/625. The CA also indicated that all designated laboratories are under the official supervision of the NRL and will participate in proficiency tests for PWN in 2025. Data provided by the CA show that some laboratories have participated in proficiency tests in the past, such as the Centro de Sanidad Forestal Calabazanos in 2010. Additionally, some laboratories have organized inter-laboratory collaborative studies on PWN, including the Laboratorio Agrario y Fitopatológico de Galicia and Centro de Sanidad Forestal Calabazanos in 5 April 2025. The audit team noted that while laboratories designated by the AC authorities for the analysis of PWN samples in the three PWN affected ACs have quality assurance systems in place (either accreditation to EN ISO/IEC 17025 or ISO 9001:2015) as required by Article 40(1)(b)(iv) of Regulation (EU) 2017/625, there is no information available to MAPA regarding the compliance of other designated laboratories with this requirement.

Authorisation is required prior to the movement of specified wood outside the DA in the AC Extremadura. This process also includes official sampling of the wood. In the AC Galicia, official samples for PWN are taken during the annual official control visits to operators authorised to issue plant passports. Additionally, an official sample was taken at a suspended operator to confirm his compliance with requirements to issue the ISPM mark (see details in section 5.8, point 61). Article 2(1) of Regulation (EU) 2017/625 defines that official control means activities in order to verify compliance by operators and goods with plant health legislation. Therefore, the samples described above were taken in the context of official controls. The testing of these samples in designated laboratories using methods which are not accredited to ISO 17025 is not in line with Article 37(4) of Regulation (EU) 2017/625. The derogation from mandatory accreditation under Article 40(1)(b) of Regulation (EU) 2017/625 applies only to laboratories conducting analyses in the context of other official activities. 5.1.4 Public awareness campaigns

There is sufficient testing capacity in the network of designated laboratories under supervision of the NRL. Most samples tested are taken for surveys. A small number of samples are taken for official controls, and the testing of these samples in laboratories, which are not accredited to ISO 17025, does not provide the level of quality assurance required by EU legislation.

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With regard to the risk-based planning criteria the programme requires the regional CAs to choose a number of risk criteria from a list. For agricultural holdings, it contains the following: the result of previous control, whether checks have been carried out in the last 4 years, the size of the holding, the toxicity and the overall quantity of the PPPs used, the reliability of own controls, the type of crops cultivated (from a food safety perspective), the location of the holding (proximity to source of contamination for the crops) and other criteria which may be added by the autonomous communities11. For PPP service provid- ers, the risk criteria are the following: the result of previous control, the toxicity of the PPPs used, the overall quantity of the PPPs used and the size of the treated areas, and oth- er criteria which may be added by the Autonomous communities. The audit team noted that among the afore-mentioned risk criteria, the results of monitoring activities of PPP residues carried out for the purpose of Article 8 of Directive 2000/60/EC of the European Parliament and of the Council12 are not mentioned in the national programme. This is not 10 The Decree establishes and regulates also the Digital Agricultural Farm Notebook 11 In its response to the draft report, the competent authority stated that: `The SIEX database, which includes the REAs of all Autonomous Communities, includes information on the operator, the location of the holdings and the crops, and whether the operator sells directly to consumers or carries out own checks. This application au- tomatically generates a first risk categorisation for each holding, taking into account the risk categorisation of each crop (based on several criteria such as iRASFF alerts, results of controls on hygiene control programmes for agricultural primary production and use of plant protection products, non-compliances detected under AE- SAN's Pesticide Residues Control Programme and other combinations of factors) and the area under cultivation. Operators are required to update information once a year to reflect the crops they have'. 12 Also called the `Water Framework Directive' 14 in line with article 24(2)(a) of Regulation (EU) 2017/625.

In CLM, the regional control programmes for 2022 and 2023 reviewed by the audit team included annual controls of 550 agricultural holdings. In both programmes, they were planned across risk categories in line with the percentages specified in the national pro- gramme. The criteria used to classify agricultural holdings were essentially the crops cul- tivated and the size of the holding, therefore, in line, as well, with the indications provid- ed in the national programme, although not in line with Article 24 (2)(a) of Regulation (EU) 2017/625 (see paragraph 53).

In VC, the 2022 and 2023 regional control programmes on agricultural holdings set a target of 314 annual controls and the specific number for each province. In both pro- grammes, the controls were planned across risk categories in line with the percentages specified in the national programme. The main criteria to classify agricultural holdings were the crops cultivated, the size of the holding and its location with respect to the risk of nitrate loss, therefore, in line, as well, with the indications provided in the national programme, although not in line with article 24 (2)(a) of Regulation (EU) 2017/625 (see paragraph 53).

Comprehensive national control programmes on the marketing and use of PPPs are in place and are updated at central level regularly, in agreement with the various autono- mous communities. These control programmes, which include risk-based plans for PPP formulation analyses and are underpinned by advanced IT databases, provide good guid- ance and support for the regional CAs to plan their controls on a risk basis. The autono- mous communities reviewed follow in general these national programmes and plan their controls, prioritising operators with higher risk, and this helps a better functioning of the system of official controls. Nonetheless, the results from the monitoring of PPP residues in water bodies are not taking into account, which is not in line with EU requirements and reduces to an extent the efficacy of the programme. Delegation of certain tasks Findings

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Samples for PPP formulations are analysed by three accredited laboratories all designed by the relevant CAs. The main one is in Madrid, which is the national reference laborato- ry for PPP formulation. Catalunya and Andalusia avail of their own laboratories. These laboratories carry out analyses of a wide range active substances, more than 240, which are included in the scope of accreditation. However, the audit team noted that neither im- purities nor co-formulants are analysed. Consequently, the CAs are unable to verify the absence of unacceptable co-formulants in PPPs set out in Annex III to Regulation (EC) No 1107/2009 and cannot determine whether certain impurities do not exceed the maxi- mum content permitted in the approval of the relevant active substances as provided in Article 6(b) of Regulation (EC) No 1107/2009. This is also not in line with Article 24(1) of Regulation (EU) 2017/625. Representatives from the central CAs stated that this is a general problem in the EU because there are no validated methods at EU level for the de- tection of these substances14. 14 In its response to the draft report, the competent authority stated that: `During the audit process, the Spanish central authorities repeatedly pointed out the need to set up a European reference laboratory and thus to comply with Article 92 of Regulation (EC) No 2017/635 on official controls. The aim of this request when setting up this European laboratory is to respond to the need of the various national laboratories to develop master tech- niques for this subject, as well as the possibility of sending samples for analyses'. 17 Conclusions on laboratories used for formulation analysis of plant protection products as part of official controls

There are designated and accredited laboratories for PPP formulation analyses. This pro- vides solid basis for ensuring reliable results of tests and analyses. Nonetheless, the lack of analyses for unacceptable co-formulants and regulated impurities in the sampling pro- gramme together with the limited controls on the source of active substances (see conclu- sion 81) partly undermines the capability of the system of official control to ensure the safety of the PPPs placed on the market.

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Disease control measures on suspected cases were generally adequate. However, the lack of routine sampling and testing in suspected cases may have delayed outbreak confirmation, and potentially increased the viral load in the farm, or weakened the basis for ruling out suspected cases.

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For confirmed cases, the authorities implemented appropriate control measures, except they fail to trace animal products dispatched from infected farms. Although the oversight is unknown, it could have led to the unintentional spread of sheep pox 4 https://food.ec.europa.eu/horizontal-topics/official-controls-and-enforcement/legislation-official-controls/better- training-safer-food_en. 4 to other farms and regions, presenting inconsistent risk-mitigation measures and hampering the assurance provided by the disease containment measures.

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The audit team identified some establishments packing and placing in the market seeds for sprouting for the final consumer which were not found in the existing registers. This type of companies might be registered as operators selling seeds for sowing, but there were not registered as food producers. This is not in line with Article 6(2) of Regulation (EC) No 852/2004. Therefore, these operators are not subject to control by the competent authorities. Approval of sprout-producing establishments

In the case of post-primary production operators, there is a system for registration that covers all type of activities with the exception of operators placing seeds for sprouting to the final consumer. This prevents the CA to conduct the appropriate official controls to verify compliance with the applicable rules in the latter area of controls.

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However, the inspectors did not properly cover the suitability of the seeds of EU origin to be used for sprouting. In all visited establishments, there were bags of seeds of different species stored which were labelled as seeds for sowing, with no indication of suitability for sprouting, neither in the labels, nor in the associated documentation such as invoices or delivery notes. Inspectors did not require evidence that the seeds were appropriate for producing sprouts, and that had been obtained in compliance with the requirements of Annex I to Regulation (EC) No 852/2004.

The competent authorities carried out official controls to sprout producers with overall an adequate scope. However, the verification of compliance that seeds produced in the EU stored and used in these establishments are suitable for production of sprout has been systematically overlooked during official controls. This undermines the effectiveness of such official controls.

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As part of the official control, inspectors verify the operator's sampling plans (final products and surfaces) and analyses carried out for testing pathogens. Operators visited were using used both non-accredited and accredited laboratories for the analyses of their samples. In general, the analytical methods used were not the reference methods of Commission Regulation (EC) No 2073/2005. Inspectors did not verify that the used alternative methods had been validated in accordance with ISO 16140-2 or no evidence was presented that the competent authority had formally authorised the operator to use other analytical methods. This is not in line with Article 5(5) of Commission Regulation (EC) No 2073/2005.

The CAs do verify that operators carry out microbiological testing as set out in Regulation (EC) 2073/2005. However, there is no control of whether the methods used are in line with Article 5(5) of Regulation (EC) No 2073/2005. This lack of assessment to challenge the reliability of the own controls carried out by operators weakens the effectiveness of the official controls.

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The audit team identified serious deficiencies in the establishment visited in the AC of Madrid. These deficiencies included structural issues, such as the location of crates washing facilities within the production area of high-risk products, the deficient separation of clean and dirty areas, lacking appropriate changing facilities for personnel accessing to "clean" areas and the inadequate crossing flows of raw material, packing material and finish products. These are not in line with the requirements set out in Chapter I, II, V, IX of Annex II to Regulation (EC) No 852/2004. In addition, food safety culture was deficient and risk practices were identified which include, among others, peeling and de-rooting onions in the same area than packing ready to eat products (RTE); the placement of a floor brush over the water basin for cleaning tools; use of cutting tools without observing internal colour code to avoid cross contamination with allergens (celery); lacking system to identify clean/dirty crates for raw material and final product. These are not in line with the requirements set out in Chapter XIa on Food Safety Culture of Annex II to Regulation (EC) No 852/2004.

The audit team reviewed previous inspection reports, and some non-compliances had been documented. However, the CA had failed to identify serious structural and operational shortcomings despite inspecting that operator for more than 10 years.

To address the serious deficiencies identified during this audit, the Health Department of Madrid informed the audit team of actions taken: · Regarding the operator, the CA has drafted a comprehensive report indicating all identified shortcomings and activity suspended until deficiencies are corrected. · Regarding the official control system, in the last quarter of 2024 an official control to all establishments in the region producing cut fruits and vegetables. These official controls will be carried out by two inspectors. The responsible for the technical unit of FNAO will carry out one supervision on the performance of the inspector on the spot in that type of establishments. · Changes in the planning of official controls for 2025 programme. The inspection criteria will prioritise establishments producing RTE with higher frequency of controls. The annual programme will be adjusted to consider the workload due to non-programmed activities to ensure that all operators are subject to an annual complete control. The official control procedure has been changed to require that inspections are carried out by a team of two inspectors in the high-risk establishments. A new supervision procedure will be adopted requiring supervision on-site to be carried out in high-risk establishments. · The internal audit unit will include for the 2025 plan, one audit to the programme of official control of FNAO and specifically of RTE operators. 16 Other control systems

The serious structural and food safety culture shortcomings identified in a producer of 17 RTE cut fruit and vegetable calls into question the effectiveness of the official controls associated to this type of high-risk production. Consequently, the deficiencies in the enforcement measures compromises the effectiveness of the system of official controls.

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The audit team checked reports of such supervision activities to official controls within the scope of this audit. In some cases, the number of on-site supervision controls were not in compliance with the planned ones. In Murcia, the department of Health indicated that in 2022, where more than 10 500 official controls were carried out in all areas related to food, 8 supervision on-site inspections were conducted. In 2023, out of more than 11 000 official controls, 11 on-site supervision inspections were carried out. The on-site supervision inspections were not related to FNAO. In Madrid, no in-situ supervision inspections were carried out in 2022, 2023 and 2024. As seen in paragraphs 6 66 and 68 below, these supervision arrangements have not been effective to identify deviations or deficiencies in the performance of official controls in the area of FNAO, and therefore has not fulfilled the requirement sets out in Article 5(1)(a) of Regulation (EU) 2017/625. Conclusions on competent authorities.

The lack or ineffective supervision activities prevent the competent authority to identify, correct and therefore improve the system of official controls.

The Madrid Health Department informed the audit team that the reorganisation will be accompanied with a change of the supervision system to be implemented from 2025. 15 Before 2021, supervision activities consisted in a documentary revision by the line manager. In 2021, one supervision on site was performed, in a sector different than FNAO, and from 2022 to 2024 no supervision activities were conducted, neither documentary nor on the spot. This is not in line with the guidance agreed between AESAN and the ACs.

The audit team reviewed previous inspection reports, and some non-compliances had been documented. However, the CA had failed to identify serious structural and operational shortcomings despite inspecting that operator for more than 10 years.

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For one of the ACs, the system for internal audits has not been implemented yet by the competent authority. This means that corrective actions to address recommendation No.1 of audit report 2019-6678 have not been fully implemented. Resources

However, the audit team noted that one region has not yet developed and implemented an internal audit system.

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For certain information not included in these three documents and in the national coordinated plan for alerts on animal health, MAPA requires the authorities of the regions to elaborate any necessary instructions reflecting their regional information and needs in case of an emergency (i.e., regional communication protocols in case of crisis, human resources available and their deployment in case of a crisis, protocol for the slaughter of birds of establishments in the restricted zones, resolutions on burial, exceptional movements, restocking procedures and compensations). It also requires the national disease crisis centre to approve the regional contingency plans. Six Autonomous Communities out of 17 hold such a document.

The audit team noticed some examples of missing information in the contingency plans at Autonomous Community level: a. Contact emergency telephone numbers for the general public and operators to notify any suspicion (including holidays and weekends). b. Framework of cooperative communications with veterinary services at regional level, designated bodies or natural persons, relevant stakeholders, and local designated laboratories. c. Human resources and specific roles of all animal health professionals who should be involved in the implementation of the control and eradication measures. d. Location of local disease crisis centres, list of facilities and equipment required in case of an emergency. Responsibilities for keeping this equipment up to date. 6 Arrangements for the deployment of equipment and personnel from other provinces or Autonomous Communities. e. Specific depopulation and disposal arrangements in each Autonomous Community. f. Emergency funds at Autonomous Community level. Due to the unavailability of contingency plans or their incompleteness at regional level, in most cases there were no records of some of the necessary information to ensure a high level of disease awareness and preparedness and the ability to launch a rapid response to an emergency of HPAI. This is not in line with Article 43 of Regulation (EU) 2016/429.

Since 2019, the authorities conducted several simulation exercises concerning responses to epizootic outbreaks. No simulation exercises specifically relating to HPAI have been carried out. Some of the Autonomous Communities most affected by the last HPAI epidemic in 2022, did not have a written contingency plan with the regional information necessary for rapid response in case of emergency. The audit team did not see any evidence that this last epidemic led to any updates on their contingency plans' procedures. The competent authorities do not sufficiently ensure that simulation exercises concerning the contingency plans are carried out regularly or at appropriate intervals to verify their functionality. All this is not in line with Article 45 of Regulation (EU) 2016/429. Early detection

In the event of suspicion of HPAI in poultry, the competent authority set restrictions on the suspected establishments without delay. However, the initial veterinary investigation and sampling was delayed in several cases. Although in most cases, informal communications with the national disease crisis centre occurred immediately, there were delays in the regional authorities conducting the required investigation to confirm or rule out the presence of HPAI. This is not in line with Article 54 of Regulation (EU) 2016/429.

Epidemiological investigations were generally done at the time of sampling. They were regularly incomplete. In most cases, the official veterinarians did not include in the investigation report the likely time that the infection was already present in the establishment, the likely origin of the infection or the full list of direct and indirect contacts. This is not in line with Art 54(1)(g) and 57(1) Regulation (EU) 2016/429.

Identification of epidemiological contacts (tracings back and forth) were regularly delegated to the private sector. However, the audit team rarely saw any evidence that the authorities followed up on those tracings and applied control measures on possible contact establishments. This is not in line with Articles 57(1) and 62 of Regulation (EU) 2016/429 and Articles 17, 18 and 19 of the Commission Delegated Regulation (EU) 2020/687.

The standard procedure does not include, within the minimum information required during the preparation process, the need to plan such depopulation in such a way as to avoid any risk of spreading the relevant category A disease agent during and after killing. The audit team saw strong evidence that some of the secondary cases, could be due to airborne transmission of virus during depopulation of the nearby primary case. The dates on which the secondary case could have been infected, coincided with the dates when the depopulation of the primary case was carried out.5 This is not in line with Article 12(1)(a) and (b) of Delegated regulation (EU) 2020/687.

The authorities ordered the depopulation of suspect cases during the epidemic, sometimes without waiting for their confirmation. The competent authority had already identified that they had an important shortage of resources and personnel during the epidemic to timely implement the depopulation of cases. Nine of the 38 outbreaks (24%) did not need depopulations measures because all birds were already dead due to the disease by the time the depopulation could be implemented6 (Table C). This is not in line with Articles 13(1)(a) and 61(1)(b) of Regulation (EU) 2016/429. Table C Days from suspicion to depopulation (source- ADIS) Days Number of outbreaks (%) <5 12 (32) 5-7 9 (24) >7 8 (21) No depopulation 9 (24) 5 In its response to the draft report, the competent authority stated that "use of additional slaughter techniques that prevent or reduce that dispersion route has been studied and is being assessed, in particular gas killing within production houses." 6 In its response to the draft report, the competent authority stated that this "was due to the high mortality rate among the species present on the farm given the strain circulating. 14 Total 38 (100)

The authorities identified logistics as the main difficulties for the disposal of dead birds and products, due to the concentration -in a short period of time- of outbreaks with a high number of birds. The authorities encountered lack of processing plant capacity, shortage of trucks for the transfer of manure and dead birds and big difficulties for establishing dedicated burial sites for mass disposal of birds (lack of machinery and sometimes rain). This is not in line with Articles 3(1)(a) and 61(1)(b) of Regulation (EU) 2016/429.

The audit team noted significant delays between depopulation or disposal of infected birds and products and the subsequent implementation of preliminary cleaning and disinfection measures. In 38% (14) of the outbreaks, the preliminary cleaning and disinfection was carried out 10 to 47 days after the disposal of dead birds. This is not in line with 62(1) and 65 of Regulation (EU) 2016/429 and Article 15 and points A and B of Annex IV of the Delegated regulation (EU) 2020/687 2020/687.

The EU reference laboratory provided the authorities with a phylogenetic analysis that helped understand from which areas in Europe the virus was introduced. The competent authority did not provide any evidence to the audit team of other epidemiological analysis that has been carried out on the 2022 epidemic to identify possible risk factors that contributed to the introduction and the spread of diseases and thus, to develop and implement better informed policies on prevention and early detection accordingly. The authorities have not identified and addressed their gaps in the response to the HPAI epidemic in 2022 and thus they have not used the lessons learnt during the epizootic, to improve the national and regional contingency plans. This is not in line with Article 43 of Regulation (EU) 2016/429.

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To ensure that each Autonomous Community has a contingency plan adapted to its reality, services and needs, which is regularly validated and tested (e.g., simulation exercises, recent epidemics, etc) and allows: - The quick identification, contact details and responsibilities of the services (including delegated bodies) which would be involved during an emergency. - The performance of complete epidemiological investigations, including the identification and investigation of epidemiological contacts, the timely veterinary visits and sampling. - The adequate and timely depopulation and disposal of infected birds. Article 29 of Regulation (EU) 2017/625; Articles 3(1)(a), 13, 43, 45, 54, 57, 61(1)(b), 62, 65(1)(a) and (b) of Regulation (EU) 2016/429; and Articles12(1)(a) and (b),15, 17, 18, 19, 25, 26 and points A and B of Annex IV of the Commission Delegated Regulation (EU) 2020/687. Recommendation based on main conclusions No. 36, and 80 and associated findings No. 16,17, 18, 48, 50, 51, 52, 53, 54, 57,59, 64, 65, 69 and 70.

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For the early detection in wild birds, the veterinary authorities also worked closely with the environmental departments and conservation agencies and stakeholders. The audit 7 team considered the number and location of samples taken, both for active and passive surveillance of wild birds adequate and in line with high-risk areas and high-risk periods of introduction of the infection. In 2021, the NRL in Spain processed 1,225 samples from wild birds, of which two were positive. In 2022, there were 3,040 such samples of which 144 were positives.

There were major delays in confirming the infection (Table A) for the positive samples taken either by active or passive surveillance of wild birds (172 from September 2020 to April 2023). Nearly 99% of all cases were confirmed more than three days after sampling, and 50% of them were confirmed two weeks after sampling. The timescales were due to the involvement of two laboratories in the diagnosis of the disease ­ the Autonomous Community laboratory where the generic Polymerase chain reaction (PCR) test is carried out and the national reference laboratory where the virus is subtyped and its pathogenicity determined. The authorities explained that in many of those cases, confirmation was not considered urgent because cases in wild birds had already been confirmed in the same areas. Table A Days from Suspicion to Confirmation of avian influenza in wild birds -Sep 2020 to April 23- source ADIS Days Number of positives (%) 0 to 3 2 (1.2) 4 to 7 26 (15) 8 to 10 24 (14) 11 to 14 32 (19) >15 up to 75 86 (50) no date 1 (0.6) Total 172 (100)

The authorities took samples of dead and sick wild birds reported under passive surveillance in the same areas where the first cases of poultry were confirmed a few days after (January and February 2022). However, the fact that those wild birds' samples were processed and confirmed several days after the poultry cases were detected, prevented the competent authority from implementing the enhanced surveillance in poultry, that should have been triggered after confirmation of the infection in wild birds. This is not in line with Section 2, paragraph 2(a)of Annex II of Delegated Regulation (EU) 2021/689.

During passive and active surveillance, the NRL detected six positives to avian influenza virus other than H5 or H7 in 2020, 43 positives to other than H5 or H7 avian influenza virus in 2021 and, 67 non H5 and no H7 avian influenza virus in 2022. All these were detected in wild birds. Laboratory capacity- Diagnostics used for general early detection.

In the event of suspicion of HPAI in poultry, the competent authority set restrictions on the suspected establishments without delay. However, the initial veterinary investigation and sampling was delayed in several cases. Although in most cases, informal communications with the national disease crisis centre occurred immediately, there were delays in the regional authorities conducting the required investigation to confirm or rule out the presence of HPAI. This is not in line with Article 54 of Regulation (EU) 2016/429.

Medlemsstatens svar

Page: 1 dations has been received. Please check back again later to see this f. DG(SANTE) 2023-7757 of the audit carried out from 03 May 2023 to ghly pathogenic avian influenza ction Proposed by the competent authority

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The authorities granted a total of 752 movement derogations from restricted zones to free areas. The great majority (740) were direct movements to slaughter. The remaining 12 movements were granted from hatcheries in the restricted zone to other neighbouring areas outside the restricted zone. 12

These movements were carried out in line with the majority of requirements, e.g., clinical inspections, testing, sealed transports, best available routes to avoid cross contamination, and they were all under official supervision. But the audit team saw evidence that the authorities did not carry out an adequate risk assessment before they authorised those movements considering all relevant EU requirements. There is no protocol or instructions to carry out this risk assessment taking into account relevant legislation. This is not in line with Article 28(1) and 43(1) of the Commission Delegated Regulation (EU) 2020/687. E.g. during this epidemic in Spain, there was evidence that some neighbouring establishments to a confirmed case, were likely infected during the time of the depopulation and disposal of infected animals. However, one of the movements' derogations to slaughterhouse was from a turkey establishment located near an infected premises (approximately 500m). The authorities allowed this movement to take place just one day after suspicion and three days after depopulation of the close-by infected establishment. This was a high-risk movement, and the authorities did not provide evidence of a risk assessment before granted this movement derogation (see finding 64)4. Laboratory capacity in emergency situations

Medlemsstatens svar

To ensure that an effective risk assessment is carried out before granting movement derogations from restricted zones due to cases of HPAI. Article 28(1) and 43(1) of Commission Delegated Regulation 2020/687. Recommendation based on main conclusion No. 81 and associated finding No. 57.

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The two exceptions concerned the MS protocol for performing physical checks on food of animal origin and the protocol for sampling on food of animal origin for laboratory testing, which were issued in 2011 and 2015 respectively, which had not been updated in line with Article 12(2) of the OCR.

The audit team also noted that the guidance for the selection of items or packages provided in those two protocols was not in line with the percentage of items or packages in a consignment of products of animal origin and the maximum number of items or packages specified in point 4 (b) of Annex II to Commission Implementing Regulation (EU) 2019/2130. Similarly, the guidance for the selection of items or packages for the performance of identity checks of products of animal origin, was not in line with Article 3(3) of the same Regulation (See also finding 64).

However, the lack of updated documented procedures for performing physical checks and sampling of consignments of goods of animal origin, internal audits and lack of deadlines for completion of corrective actions have an adverse impact on the overall effectiveness of the organisation of official controls on animals and goods entering the EU, and its compliance with Union legislation.

The audit team observed official controls of consignments of food of animal origin during their visits to the BCPs of Madrid Airport and Bilbao Port and noted that the documentary checks were carried out in line with Article 2 of Regulation 2019/2130. The selection of the items or packages for identity checks and the samples for examination was based on the documented procedures detailed in section 5.1.4 above. One percent of the number of items of a consignment was selected for checks, however the selected number of items or packages was less than the minimum specified by Article 3(3) and point 4 (b) of Annex II to Regulation 2019/2130. 5.2.4.3 Checks on consignments of goods of non-animal origin

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The MS informed the audit team that certain BCPs, which that had been designated and listed for categories of goods referred to in Article 47(1), (d), (e) or (f), had been designated for the performance of documentary checks only. At such BCPs, consignments are subsequently transferred to a designated control point when identity and physical checks are required. The seven BCPs and 10 inspection centres concerned, which are indicated in the published list (18) do not have the required minimum facilities for the performance of identity checks and physical checks, including sampling of the categories of goods for which they have been designated, which is not in line with Article 64(3) of the OCR and Article 3 of Regulation (EU) 2019/1014. As indicated in the above table, BCP A Coruña is one such BCP.

The audit team noted during their initial assessment of the BCP Bilbao port, and confirmed during the visit to the BCP, that the cold storage facilities for food of non- animal origin were restricted to a single room for both frozen and chilled goods, which is not in line with Article 3(1)(c) of Regulation (EU) 2019/1014.

The audit team also found during the visit to the BCP Bilbao port that the unloading rooms and storage rooms were not fitted with the walls and floors that are easy to clean and disinfected, and that the unloading room did not have adequate drainage, which is not in line with Article 3(2) of that Regulation. Some storage rooms, and part of the (18) See: https://www.sanidad.gob.es/profesionales/saludPublica/sanidadExterior/controlesSanitarios/instaAlmacen/ home.htm [in Spanish] 17 unloading area, were not clean, with presence of dust, mould, spider webs and dirt. In addition, during a period of heavy rainfall, rainwater flooded into one part of the unloading area. The competent authorities' verification control reports had identified the poor maintenance of the facilities, however a deadline for corrective actions to address those issues had not been provided. The reports had also not identified the lack of cleaning and disinfection of the facilities.

The audit team noted that at the BCP Madrid airport, there are no storage facilities for chilled and frozen categories of products of non-animal origin for which it is designated, which is not in line with Article 3(1)(c) of Regulation (EU) 2019/1014. In addition, the competent authorities informed the audit team that, in exceptional cases, it permits physical checks on consignments of products of non-animal origin to be carried out at commercial storage facilities. However, the audit team noted that those facilities did not have the required inspection rooms or areas, which is not in line with Article 3(11) of Regulation (EU) 2019/1014.

The audit team visited the facilities at the inspection centre Iberia as part of the BCP Madrid airport, and noted a number of shortcomings that were similar to findings identified by MAPA and the MS as a result of their audits and verification checks, detailed in section 5.1.6 above, and which therefore, had not been appropriately addressed by the operator. Those shortcomings concerned: a. the cross-flow of movements of animals and goods due to the unloading area being shared for certain categories of animals and goods, and the facilities for products of animal origin, category POA-NHC listed in 6(1) of Regulation (EU) 2019/1014 not forming one integrated and whole working unit, which is not in line with Articles 5(3), 5(5) and 6(2) of that Regulation, nor Article 64(3)(h) of the OCR; b. the housing of consignments of live insects transported at chilled temperatures in the storage rooms for chilled products of animal origin, category POA-NHC; which is not in line with Article 64(3)(b) of the OCR; c. the use of storage rooms dedicated for products of animal origin not intended for human consumption for the storage of other goods and animals including live insects intended for export, Union origin goods and medical devices and medicines, which is not in line with Article 6(3) of Regulation (EU) 2019/1014; and d. the poor maintenance and cleaning of the facilities throughout the inspection centre, which is not in line with Article 4(4) of Regulation (EU) 2019/1014 and Article 64(3)(i) of the OCR. 18

The MS informed the audit team that an action plan was received following their supervision check of the inspection centre Iberia carried out in June 2021, which had identified shortcomings in the facilities for products of animal origin for human consumption, including the flooring of the inspection rooms and refrigerated storage room. The MS confirmed that their assessment of the plan was sent to the inspection centre on 14 June 2022, requiring that the planned action be completed within one month.

The audit team assessed the facilities at the inspection centre Progeco as part of the BCP Vigo port based on the completed assessment table and supporting documents provided by the MS and noted that the although the inspection centre is designated for products of non-animal origin intended for human consumption with three temperature regimes (ambient, chilled and frozen), it has only storage rooms for chilled and frozen products respectively, which is not in line with Article 64(3)(b) of the OCR nor Article 3(1)(c) of Regulation (EU) 2019/1014.

During the audit, the MS provided an updated assessment table and supporting documents, indicating that an additional temperature-controlled container would be installed on-site, with a deadline for completion by October 2022. 19 Conclusions on the compliance of border control posts with minimum requirements

The majority of the BCPs and inspection centres thereof evaluated during the audit were not fully compliant with the minimum requirements for BCPs, for one or more of the categories of animals and goods for which they had been designated. The lack of minimum facilities for controls on consignments of food of non-animal origin is a systemic deficiency in certain BCPs.

The competent authorities have taken immediate action to address deficiencies identified at certain BCPs and inspection centres, however in the remaining BCPs, the competent authorities cannot guarantee the appropriate handling of animals and goods, the proper verification of compliance of those animals and goods and the prevention of the risk of cross-contamination.

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However, shortcomings in their implementation, in particular the performance of documentary and certain identity and physical controls, the recording of the outcome of those in the CHED, and occasional significant delays in implementing measures required by the competent authority, collectively weaken the overall effectiveness of the official controls.

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Natural caves used for cheese maturation may receive more than one approval when used by several FBOs, contrary to the requirements of EU legislation.

Medlemsstatens svar

To ensure that approvals of FBOs at all stages of production only cover one physical location, as required by Article 6(2) of Regulation (EC) No 852/2004, Article 4 of Regulation (EC) No 853/2004 and Article 148 of Regulation (EU) 2017/625. Recommendation based on conclusion No 47. Associated finding No 39.

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The system of official controls covers the entire dairy sector and is based on procedures and instructions aimed to ensure consistency and uniformity of official controls. Their implementation ensure in general that operators comply with the national and EU provisions and that non-compliances are timely corrected and appropriately followed- up. Some weaknesses were noted in respect of controls on HACCP-based programmes (verification of pasteurisation processes) and on handling of ABPs.

Medlemsstatens svar

To ensure that effective audits of HACCP-based procedures cover the verification of parameters of heat-treatment, as required by Article 3.2 of Commission Implementing Regulation (EU) 2019/627 and in line with the requirements laid down in Article 5 of Regulation (EC) No 852/2004. Recommendation based on conclusion No 115. Associated finding No 105.

Medlemsstatens svar

Page: 1 DG(SANTE) 2022-7440 of the audit carried out from 31 January 2022 of milk and dairy products Action Proposed by the competent authority

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The 2019 and 2020 national residue monitoring plans included relevant species and commodities except for farmed game and crustaceans. They covered all of the substance groups required and complied with the sampling levels and frequencies laid down in EU law (13). The number of samples planned to be taken in each of the 17 Autonomous Communities is largely based on their respective production volumes for all commodities and animal species, which is in line with EU requirements (14), with the exception of farmed game where only five samples were planned for in 2019 and 2020, respectively, and none in 2021 and 2022. In addition, for farmed crustaceans, no samples were planned to be taken during those years, which is contrary to EU law (15) (16).

With regards to farmed game, there is no clear overview at national level on the number of farms producing farmed game and what the production volumes per species may be in order to guide the planning of the residue monitoring plan for this commodity. The audit team identified several farms in Spain where farmed game, as (8) Programa nacional de control de investigación de residuos de medicamentos veterinarios y otras sustancias (PNIR) en producción primaria. (9) Programme 15 of the national multi-annual official control plan (2021-26) for the food chain, about residues of veterinary medicinal products and other substances in food of animal origin. (10) Article 12 of Regulation (EU) 2017/625. (11) Article 9(1) of Regulation (EU) 2017/625. (12) Royal Decree 1749/1998. (13) Annexes I, II and IV to Directive 96/23/EC, Article 1 and Annex to Decision 97/747/EC. (14) Article 9(1a) of Regulation (EU) 2017/625, Annex IV to Directive 96/23/EC, Annex to Commission Decision 97/747/EC. (15) Article 1 and Point 2 in Chapter 3 of the Annex to Commission Decision 97/747/EC. (16) Point 2 in Chapter 3 of Annex IV to Directive 96/23/EC. 3 defined in EU legislation (17), is produced. The animals (deer) on these farms are kept in large enclosures, are individually identified, fed, treated with veterinary medicinal products, such as vaccines or anthelmintics, and are sent for slaughter to commercial slaughterhouses or are slaughtered in on-farm slaughter facilities. The audit team also identified two farms keeping ostriches, batches of which are sent regularly to a slaughterhouse. The competent authority stated during the audit that they intend to include farmed game in the 2023 residue monitoring plan (see finding 21).

With regard to farmed crustaceans, the audit team found that several species are being produced for human consumption, albeit with small production volumes: common ditch shrimp (Palaemon varians) ­ estimated production 240 tonnes in 2018 and 180 tonnes in 2019), white leg shrimp (Penaeus vannamei) ­ estimated production 7 tonnes in 2018 and 2019), tiger shrimp (Penaeus japonicas) and freshwater shrimp (Macrobrachium carcinus).

For aquaculture finfish, both the national annual residue monitoring plan (18) and the residue monitoring plan sampling instructions of the multi-annual control plan (8) stipulated that samples which are to be analysed for Group A substances, should not be taken from juvenile fish (alevines). This is not in line with the EU requirements (19), as samples for Group A substances should be taken at all stages of farming. The MAPA representatives sent during the audit an e-mail to all Autonomous Communities a message to the effect that aquaculture samples, to be tested for Group A substances, shall be collected at all stages of farming and that this change should be implemented as soon as possible. Existing instructions in Catalonia provided the option to collect samples for the analysis of substances from Group A at different stages of the animal production cycle. Equally evidence was received that the Autonomous Communities of Galicia and Valencia plan to implement this change already in 2022 and the Autonomous Communities of Navarra and Aragón in 2023.

With the exception of farmed game, aquacultured crustaceans and Group A substances in aquaculture, the planning of residue monitoring is comprehensive, timely and takes relevant risk factors into account, thus contributing to the effectiveness of controls on residues. (17) Points 1.5, 1.8 and 1.6 of Annex 1 to Regulation (EC) 853/2004. (18) Point 8.2 of the "Programa nacional de control de investigación de residuos de medicamentos veterinarios y otras sustancias (PNIR) en producción primaria". (19) Chapter 3 of Annex IV to Directive 96/23/EC. (20) Article 9(1) of Regulation (EU) 2017/625. 4 5.1.3. Implementation of the residue monitoring plan

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The 2019 and 2020 national residue monitoring plans were implemented as foreseen, with the exception of farmed game (no samples taken, see finding 8) and under-sampling of aquaculture finfish (80 % and 78 % of minimum required samples were taken, respectively) thus not fulfilling the number of samples required by EU law (26)(27). Furthermore, aquaculture samples for Group A substances were not taken at all stages of production (see finding 11), contrary to EU requirements (28). The audit team identified during the audit that residue monitoring samples could be taken at 207 fattening farms for 34 finfish species, 22 nurseries for 11 species and 27 hatcheries for 8 species. Furthermore, for aquacultured crustaceans, there were 43 farms in the Autonomous Community of Andalucía producing common ditch shrimp and 3 for tiger shrimp (29) and other species of crustaceans. In the Autonomous Community of Castilla y Leon there are 2 farms producing white-leg shrimp (see finding 10).

The residue monitoring plan was, with the exception of farmed game and aquaculture, implemented in accordance with planned arrangements and thus contributes to the effectiveness of official controls on residues. 5.1.4. Other residue monitoring programmes Findings

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The national programme established as the main risk factors for animal welfare, firstly the transport of unweaned (and cull animals), secondly the transport over long journeys (and by sea) and thirdly transport during adverse weather conditions. Therefore, the ACCAs' risk-based checks should consider, and prioritised for official controls, the transport of unweaned calves over long journeys. However, this was not always the case and some autonomous communities failed to consider them within their control programme, resulting in the implementation of an official control system which was not aligned with the identified risk factors. This was not in line with the Article 9, point 1(a) of the Regulation (EU) 2017/625. 2 https://www.mapa.gob.es/ca/ministerio/planes-estrategias/plan-nacional-de-control-de-la-cadena- alimentaria/12pnco_tcm34-585346.pdf 8

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ACCAs performed the minimum checks established for control posts checks for (twice a year) and assembly centres (once a year). If transport operations verifying took place during those checks, the ACCA's procedures established that a welfare check on transport would be carried out. However, the compliance with transport operations within the scope of this audit usually took place approval outside normal working hours (e.g. night-time arrivals), thus they were not observed during those checks and, as a result, no welfare checks on requirements of transport were performed at those establishments. control posts and assembly 18. When ACCAs performed the checks on transport of other type of centres. animals, they did them in accordance to documented procedures and kept written records for them. A designated body conducted 19. The designated body by one ACCA for delivering roadside checks roadside checks performed several of them on vehicles transporting unweaned calves over long journeys and identified some non-compliances. However, they on vehicles did not transcend into sanctions, legal actions nor notification to other transporting Member States. Although, according to the inspection records, they were related to documentary requirements (e.g. journey logs) with no unweaned appreciable impact in the welfare of the calves at the time of the calves over long inspection, the absence or delay on taking enforcement action or/and notification to other Member States reduced the effectiveness of the journey, but they did not transcend into any action on non-compliance. Communication with other 9 Member States official controls. in relation to the

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The authorities had control verification procedures for their animal welfare checks on transport including supervision procedures and internal audits. The authorities implemented them and used them for the continuous improvement of their control systems.

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At the control post, a veterinarian designated for that purpose checked the fitness of the 1 https://ec.europa.eu/food/audits-analysis/audit_reports/details.cfm?rep_id=2340 4 calves for continuing the journey and at the assembly centres, authorised veterinarians conducted equivalent checks on calves destined to other autonomous communities, including those calves that had previously arrived from long journeys. The authorities conducted the required regular checks at approved control posts and assembly centres for verifying compliance with their approval requirements.

There was no national guidance for supporting consistency in the approval of vehicles particularly in relation to the definition of the type of animals covered by such approval and for the assessment of the design and positioning of the watering devices for unweaned calves. This led to the approval of vehicles for transporting bovine animals, including unweaned calves without considering their special needs. This creates uncertainty about the adequacy of the approval of vehicles during checks conducted at different stages of the journeys particularly when they rely on documentation and databases (e.g. approval of journey logs, retrospective checks). 6 FINDINGS ON FRAMEWORK FOR OFFICIAL CONTROLS AND OTHER OFFICIAL ACTIVITIES The key strengths the official control system were the identification of the risk of transporting of unweaned calves over long journeys, the established minimum number of checks and its control verification procedures (i.e. supervision and internal audits). Its key weaknesses were firstly, the lack of regional coherence in the consideration of such risks, resulting in the implementation of insufficient number of checks. Secondly, the lack of guidance on the special needs of unweaned calves led to uncertainty about the suitability of approved vehicles and on the effectiveness of checks. And, thirdly, the delegation of some official tasks to a delegated body without the required accreditation jeopardised the validity of their checks and associated enforcement.

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There is a good system to minimise the risk of livestock vehicles having to wait long times at the port. However, when delays happen, the authorities do not unload, water and feed the animals after 4 hours, as the ports lack facilities for it and officials do not send them to the nearby facilities identified for this purpose unless the loading is delayed to the next day. This, together with the fact that drivers ignore the use of shaded parking leaving vehicles with animals in the sun, creates a risk of animals suffering when there are delays and/or temperatures are high.

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The procedures of communication regarding animal welfare issues between the Health and Agriculture departments in one of the ACs were not satisfactory, resulting in a lack of feedback from Agriculture of the impact of the actions taken by the OVs working for the Health department at slaughterhouse level. This does not allow the OVs to understand how effective their work is or, potentially, to learn from mistakes. 5.2.2 Impartiality, freedom from conflict of interest,

The cooperation and coordination arrangements between and within the CA(s) are satisfactory for the performance of official controls and enforcement, apart from the provision of feedback information to slaughterhouse OVs that report welfare-related 10 issues to the department dealing with farms and primary production, and which in one of the ACs was not in place.

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Neither of the two CAs have a specific and structured training procedure for those veterinarians that work for them occasionally, covering absences of permanent OVs. The audit found evidence of some problems related to PMI in two out of six establishments, in both ACs, where the resident OV was not present and a locum one was in charge.

Equally, private veterinarians doing AMI on farm for ES are not included in these training activities. As mentioned in paragraph 15, one of the CAs has already taken steps to resolve this. 9 5.2.5 Supervision and audits

The two ACs have a system of internal audits and checks to monitor the performance of their OVs and ensure they deliver official controls adequately.

Both CAs have procedures to train, support and control the OVs delivering official controls on a regular basis, but neither have a specific and structured procedure for those veterinarians that work for them occasionally.

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In one of the ACs, for establishments other than slaughterhouses, there is no set procedure to regulate when the first inspection or audit of the establishment has to take place after approval and once the activity has started. As a result, the CA might not inspect a new establishment for a long period of time and cannot assess compliance with legislation and FBO's own checks.

Both CAs have procedures to review the approval status of the establishments in their territory on a regular basis, in order to ensure that it reflects the activities that the FBO carries out. However, one of the slaughterhouses reviewed by the audit team was still approved to slaughter a species that had not been processed for the last five years. The controls did not review if this slaughterhouse still met the conditions for this species. Conclusions on approval of establishments

In one of the ACs, there are no arrangements to ensure that, following the approval process, a suitably short period of time for newly approved establishments other than slaughterhouses is established in which to carry out an FBO's audit or an operational inspection.

The system for review of approvals does not currently ensure, in one of the ACs, that the establishments maintain the approval for only those activities that are relevant or that the approval conditions for activities not carried out, continue to be met.

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According to the OVs' explanations and descriptions of the activities, in two of the six slaughterhouses audited (one in each AC), the PMI was not carried out in accordance with the legislation.

In one of them, the OV stated to have passed as fit for human consumption the carcase of an ES bovine without having inspected the lungs and green offal, as the FBO staff did not present them for inspection.

In the other slaughterhouse, where only one veterinarian is normally present, the OV explained that they would not be able to inspect the green offal (which would go directly to the gut room) of the carcases processed during the time they would spend in the lairage for AMI reasons as the slaughtering line would not stop. Nevertheless, those carcases would be health marked and passed as fit for human consumption. This is not in line with Article 19 of Regulation (EU) 2019/627.

In both cases, the OVs explained that, if any doubt, the slaughterhouse staff know what is fit and unfit for human consumption and would save for them any offal with signs of being unfit.

It has to be noted that, in the second AC and in order to address the fact that the PMI was not carried out in accordance with the EU requirements, management at central level took immediate action and arranged for a second and more experienced OV to be deployed to the slaughterhouse as a support mechanism.

Also in two of the six slaughterhouses, the FBO staff carried out the removal of the spinal cord, which is classed as a specified risk material, after the carcases had been inspected and health marked as fit for human consumption. This is not in line with Article 45 (q) to Regulation (EU) 2019/627. Procedures for poultry

The implementation of the official controls does not ensure that PMI of all carcases and offal takes place in accordance with Article 19 of Regulation (EU) 2019/627.

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The monitoring programme indicates that biotoxins monitoring results that exceed the limits established in in Annex III, Section VII, Chapter V Point 2 to Regulation (EC) No 853/2004, trigger an immediate closure of production areas and, in one autonomous community, an increased sampling of water and bivalve molluscs in the adjacent production areas. Only one of the autonomous communities had a closure in the last two years due to exceedance of biotoxins. Closure of the production area, and withdrawal and recall of bivalve molluscs already placed on the market, was correctly implemented but there was a significant delay (7 days from the date of sampling) in the availability of test results (see also paragraph 60).

Significant delays in obtaining laboratory test results for some biotoxins lower the effectiveness of weekly monitoring, delays area closures and can increase the risk of placing unsafe product on the market.

The audit team noted significant delays in the issuing of laboratory test results to both autonomous communities, requiring often four to six days for ASP and lipophilic toxins and seven to ten working days in the case of PSP, instead of the three days commonly needed. The legally required, Art. 37(4)(d) of Regulation (EU) 2017/625, timely delivery of test results is not achieved. Conclusions on laboratories

Medlemsstatens svar

To ensure that laboratories involved in official controls for biotoxins provide timely results, as required by Article 34(d) of Regulation 2017/625, so that competent authorities can act promptly to impose closures when needed, as required by Article 65(1) of Regulation (EU) 2019/627. Recommendation based on conclusion No 42. Associated findings Nos 31 and 60.

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The audit team was informed that in Spain these controls are performed by food safety/public health authorities at auction halls, dispatch centres and processing 9 establishment. The controls are documental, on identity, and on results of sampling performed by operators. However, some autonomous communities do not take official samples to verify compliance with the health standards laid down in Chapter V of Section VII of Annex III to Regulation (EC) No 853/2004. 5.1.6 Movement of live bivalve molluscs and registration document accompanying batches

The gap on official verification sampling of marine gastropods, in some autonomous 10 communities, could pose a risk of marine gastropods being placed on the market without meeting the health standards.

Medlemsstatens svar

To ensure that marine gastropods harvested outside classified production areas are subject to official sampling to ensure compliance with the health standards laid down in Chapter V of Section VII of Annex III to Regulation (EC) No 853/2004, as required by Article 11 of Regulation (EU) 2019/624. Recommendation based on conclusion No 43. Associated finding No 35.

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The competent authority has not designated National Reference Laboratories either for E. coli or for biotoxins testing of live bivalve molluscs sampled at primary production level for the monitoring of production areas, contrary to the requirements of Article 100(1) of Regulation (EU) 2017/625.

Due to the above currently there is no coordination of activities of the official laboratories involved in testing of live bivalve molluscs sampled at primary production level. Nor organisation of proficiency testing and respective follow up for those laboratories or of any of the other tasks under the responsibility of a national reference laboratory, contrary to the required by Article 101 of Regulation (EU) 2017/625.

The absence of national reference laboratories for biotoxins and E.coli at primary production, with the consequent gap on their tasks and responsibilities, is an important shortcoming in a control system for which laboratory performance has high impact.

Medlemsstatens svar

To ensure designation of national reference laboratories for biotoxins and E.coli, as required by Article 100 of Regulation (EU) 2017/625, covering primary production and that this designation includes the tasks and responsibilities of Article 101 of that same Regulation. Recommendation based on conclusion No 61. Associated findings Nos 44 and 45.

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Both autonomous communities started designating official control laboratories, as required by Article 37(1) of Regulation (EU) 2017/625, in 2021. Not all involved laboratories are designated yet, namely for one autonomous community in relation to chemical contaminants (see also paragraph 52).

Nevertheless, in both autonomous communities the official designations and/or contractual obligations do not include sufficient details to fulfil the requirement in Article 37(3)(c) of Regulation (EU) 2017/625 (and in the MAPA procedure) for `arrangements necessary to ensure efficient and effective coordination between the laboratory and the competent authorities'. For example none of those designations include: a maximum response time for any of the different analysis performed, failing to address the requirement in Article 37(4)(d) of Regulation (EU) 2017/625 to deliver results in a timely manner (see also paragraph 60); an indication of any supervisory activities (beyond maintaining accreditation) and right of access by the competent authority, as required by Article 5(1)(g) and (h) of Regulation (EU) 2017/625.

With regard to supervision of the designated laboratories, both autonomous communities decided that audits by the national accreditation body (Entidad Nacional de Acreditación, ENAC) address all the supervisory needs for that designation. However: accreditation audits cover exclusively accreditation requirements from EN ISO/IEC 17025 or from the accredited testing methodology. Official designation requirements (Article 38 of Regulation (EU) 2017/625) or contractual obligations, such as a defined maximum response time and official access to documents would not be covered; the competent authorities plan to verify the accreditation status of the designated laboratories but not to obtain the accreditation assessments produced by ENAC, contrary to the required in Article 39(1) of Regulation (EU) 2017/625; in one autonomous community the internal audits programme can include laboratories but the criteria indicated for such audits would not address the points above. These gaps can result in the inability of the competent authorities to detect failures from the designated laboratories and immediately withdraw that designation, completely or partially, contrary to the required by Article 39(2) of Regulation (EU) 2017/625. 5.2.1 Laboratories for microbiology and chemical contaminants

Claiming confidentiality concerns, the laboratory that analyses monitoring samples for PSP, and part of the samples for ASP and lipophilic toxins, refused to provide several documents to the audit team (such as standard operating procedures) even after receiving 13 precise legal details of the confidentiality obligations of the audit team. This raises doubts on the competent authorities legal powers, and procedures, to perform official controls and have access to documents, required by Article 5(1)(g) and (h) of Regulation (EU) 2017/625. The analyses are performed using the EU reference methods, established in Article 60 of Regulation (EU) 2019/627, and are all accredited by ENAC, as required in Article 37(5)(a) of Regulation (EU) 2017/625. The laboratory has in principle appropriate equipment for the analyses performed. The laboratory has validated the analytical methods. The audit team assessed the validation process of one of these methods and noted that the laboratory concluded to a successful validation even for the non-complying criteria. It analyses all the legislated compounds, but the very limited number of documents that the laboratory agreed to provide had insufficient information to allow the audit team to assess the performance of the method. The assessment of the documents provided generated certain doubts that the procedures followed produce accurate results. This laboratory participates in proficiency testing once every five years for each group of marine biotoxin (most recently for lipophilic toxins in 2016 and for PSP and ASP in 2018). Results seem in general to be satisfactory for lipophilic toxins and ASP. However, for PSP there is a significant number of questionable results, for which a repetition was carried out but not an investigation that led to a conclusive explanation of these results, which raise doubts on the accuracy, and therefore reliability of PSP testing results.

The designation of official control laboratories does not yet include all relevant laboratories, and is lacking in details to ensure timely provision of results, and efficient and effective coordination and supervision. As a consequence laboratory underperformance or failures may be detected with delay, or go undetected, negatively impacting on the quality of official controls.

One of the laboratories for biotoxins could be evaluated and was determined to be providing reliable results for the ASP and lipophilic toxins testing it performs. The other laboratory could not be fully evaluated and the data received causes doubts on PSP method validation and accuracy, and on PSP proficiency testing. Therefore, quality and reliability of the testing it performs is doubtful.

Medlemsstatens svar

Page: 1 endations has been received. Please check back again later to see ref. DG(SANTE) 2021-7254 of the audit carried out from 14 June 2021 to olluscs Action Proposed by the competent authority

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Sample collection and handling, and E. coli testing procedures as described in the laboratory procedures are generally satisfactory (see also paragraph 50). However, the number of dilutions made during the analyses of samples is not enough to provide an exact E.coli most probable number when results are > 18 000 per 100 g of flesh and intravalvular liquid. Therefore, in the limited cases this happened it was not possible to determine if these areas exceeded the limit of 46 000 per 100 g of flesh and intravalvular liquid established in Articles 54(3) and 55(2) of Regulation (EU) 2019/627 for class B and C areas (although there were no class C production areas in the autonomous communities visited). Therefore, decisions made in these cases about reclassification and/or closure of production areas were not adequately informed. b) For the presence of toxin-producing plankton in water

The few cases where the results of the microbiological monitoring of class B production areas do not provide an exact result (number) pose a challenge to the decisions for reclassification and/or closure of these production areas.

Both laboratories involved in microbiological testing met during the audit provided documentation showing that the testing methods used for: E. coli and Salmonella are the required EU reference methods (respectively, EN/ISO 16649-3 and EN ISO 6579-1), and are accredited and their correct performance is supported by participation in proficiency testing with satisfactory results; the standard operating procedures for E. coli testing are in line with requirements but the number of dilutions made during the analyses is not enough to provide an exact 12 number when results are > 18 000 per 100 g of flesh and intravalvular liquid (see also paragraph 12); one of the laboratories has two E. coli testing acceptance criteria that are not in line with those of ISO 16649-3 (namely, sample temperature > 10ºC and start of testing beyond 24h from time of sampling). Nevertheless, it has also performed the required validation studies that satisfactorily demonstrate this divergence in acceptance criteria has no negative impact on test results.

Laboratories for microbiology and for chemical contaminants perform the required methods and provide timely results. However, in a few cases, E.coli testing provides insufficient detail to allow the competent authorities to decide correctly if a production area requires a downgrade of classification, or even closure, to prevent unsafe product from entering the market.

Medlemsstatens svar

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The National Contingency Plan for Xf (see section 5.3) includes the survey protocol. It describes in detail the procedures for risk based surveys, including the survey period, sampling priorities and practice, laboratory tests and communication of the results. The protocol is based on the guidance provided by the Xf Survey Card of the European Food Safety Authority (EFSA), which are adapted to the specific Spanish conditions. The following priorities are set for inspections and sampling: · Nurseries and garden centres in general; · Areas surrounding nurseries, garden centres and DAs, routes from DAs; · Valencia coastline; · A minimum number of samples from Citrus, Vitis, Olea, Prunus and Quercus sp. plantations in relation to their total surface area in the region; · Plantations which were established recently (2-4 years) with material originating from areas considered as risky; · Places/areas with favourable climate for Xf; · Collection sites for vectors.

The survey protocol of the National Contingency Plan provides comprehensive guidance for the ACs for Xf surveys outside the DAs. However, no mechanism exists to verify whether the surveys are risk based and whether they are implemented consistently and effectively.

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En el Plan Nacional de Contingencia (adjunto a este Plan de Acción, "Xylella fastidiosa_contingencia_Diciembre 2021.pdf") f se han identificado todos los lugares de realización de prospecciones, en los que se contempla la vigilancia en todos los ámbitos: Viveros y Garden Center, plantaciones agrícolas y forestales, y zonas situadas en el entorno de lugares de riesgo (zonas demarcadas, vías de comunicación con zonas demarcadas, o lugares que hayan recibido material vegetal de zonas demarcadas o terceros países con presencia de la plaga). Además, se contempla la intensificación de las prospecciones en zonas con condiciones ecoclimáticas favorables para el establecimiento de la plaga (Andalucía, C. Valenciana, Baleares, Extremadura y Cataluña). - En las prospecciones realizadas en los Viveros y Garden Center, además se aplican criterios de riesgo en cuanto a la selección de especies vegetales a inspeccionar: vegetales de alto riesgo; especies vegetales hospedantes que han sufrido un gran impacto por la presencia de X. fastidiosa en otros países, como son los cítricos, la vid o el olivo; especies vegetales hospedantes a varias subespecies y especies vegetales hospedantes sobre las que

In the National Contingency Plan (attached to this Action Plan, "Xylella fastidiosa_contingencia_Diciembre 2021.pdf") all f survey sites have been identified, in which surveillance is contemplated in all areas: Nurseries and Garden Center, agricultural and forestry plantations, and areas located in the vicinity of places of risk (demarcated areas, routes of communication with demarcated areas, or places that have received plant material from demarcated areas or third countries with the presence of the pest). In addition, intensified surveys are contemplated in areas with favourable ecoclimatic conditions for the establishment of the pest (Andalusia, Valencia, Balearic Islands, Extremadura and Catalonia). - In the surveys carried out in the Nurseries and Garden Center, risk criteria are also applied in terms of the selection of plant species to be inspected: high-risk plants; host plant species that have suffered a great impact due to the presence of X. fastidiosa in other countries, such as citrus fruits, vines or olive trees; host plant species to several subspecies and host plant species over which P. spumarius has a special preference (P. myrtifolia and A. saligna, for example).

In the National Contingency Plan (attached to this Action Plan, "Xylella fastidiosa_contingencia_Diciembre 2021.pdf") all survey sites have been identified, in which surveillance is contemplated in all areas: Nurseries and Garden Center, agricultural and forestry plantations, and areas located in the vicinity of places of risk (demarcated areas, routes of communication with demarcated areas, or places that have received plant material from demarcated areas or third countries with the presence of the pest). In addition, intensified surveys are contemplated in areas with favourable ecoclimatic conditions for the establishment of the pest (Andalusia, Valencia, Balearic Islands, Extremadura and Catalonia). - In the surveys carried out in the Nurseries and Garden Center, risk criteria are also applied in terms of the selection of plant species to be inspected: high-risk plants; host plant species that have suffered a great impact due to the presence of X. fastidiosa in other countries, such as citrus fruits, vines or olive trees; host plant species to several subspecies and host plant species over which P. spumarius has a special preference (P. myrtifolia and A. saligna, for example). A

In the National Contingency Plan (attached to this Action Plan, "Xylella fastidiosa_contingencia_Diciembre 2021.pdf") all survey sites have been identified, in which surveillance is contemplated in all areas: Nurseries and Garden Center, agricultural and forestry plantations, and areas located in the vicinity of places of risk (demarcated areas, routes of communication with demarcated areas, or places that have received plant material from demarcated areas or third countries with the presence of the pest). In addition, intensified surveys are contemplated in areas with favourable ecoclimatic conditions for the establishment of the pest (Andalusia, Valencia, Balearic Islands, Extremadura and Catalonia). - In the surveys carried out in the Nurseries and Garden Center, risk criteria are also applied in terms of the selection of plant species to be inspected: high-risk plants; host plant species that have suffered a great impact due to the presence of X. fastidiosa in other countries, such as citrus fruits, vines or olive trees; host plant species to several subspecies and host plant species over which P. spumarius has a special preference (P. myrtifolia and A. saligna, for example). A

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The regional autonomy established in the Spanish Constitution means that the National Contingency Plan cannot specify the minimum resources for controls that each AC shall make available, including procedures for making additional resources available as necessary. Similarly, it cannot specify rules detailing how to identify the owners of plants subject to measures or how to notify the order of removal and powers to access private properties. These are specifically required by Article 3 of Regulation (EU) 2020/1201. These issues may be dealt at AC level and annexed to the national contingency plan. However, in the absence of appropriate regional measures, compliance with EU rules may not be ensured.

The National Contingency Plan was prepared and updated according to the provisions of the EU legislation and provides a general framework for the implementation of the necessary actions in the case of an outbreak. However, it does not contain specific provisions required by the EU legislation, which are within the competency of the 12 ACCAs. The absence of information on how these provisions are addressed by the regions calls into question the ability of ACs to control any future outbreaks.

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Se adjunta el Plan nacional de contingencia, que recoge la ligatoriedad de contar con líneas presupuestarias específicas a vel nacional y autonómico para la lucha y prevención de agas. (página 18) Page: 3 arch 2022 ort ref. DG(SANTE) 2021-7282 of the audit carried out from 20 September Xylella fastidiosa Action Proposed by the competent authority

The National Contingency Plan is attached, which includes the obligation to have specific budget lines at the national and regional level for the control and prevention of pests. (page 18)

The National Contingency Plan is attached, which includes the ll obligation to have specific budget lines at the national and regional level for the control and prevention of pests. (page 18) Page: 3 recommendations (ES updated) received 16/6/2022 lan submitted by the competent authorities of Spain in response to Report ref. DG(SANTE) 2021-7282 of the October 2021 in order to evaluate the situation and controls for Xylella fastidiosa Action Proposed by the competent authority Información adicional de la autoridad competente en respuesta a la evaluación de los servicios de la comisión 3.2 (a) Se incluye el siguiente apartado dentro del Plan Nacional de Contingencia de Xylella fastidiosa. Recursos y procedimientos para poner a disposición recursos adicionales de acuerdo al artículo 3.2 del Reglamento 2020/1201 Los presupuestos de las autoridades competentes en materia de Sanidad Vegetal de las Comunidades autónomas, dotarán de recursos suficientes para hacer frente a las prospecciones y controles recogidos en el presente Plan de Contingencia. Además, en caso de ser necesario, para hacer frente a los costes derivados de la aplicación de medidas que deban adoptarse en caso de confirmac

National Contingency Plan is attached, which includes the obligation to have specific budget lines at the national and 3 regional level for the control and prevention of pests. (page 18) Page: 3 e report's recommendations received 16/6/2022 plan submitted by the competent authorities of Spain in response to Report ref. DG(SANTE) 2021-7282 of the October 2021 in order to evaluate the situation and controls for Xylella fastidiosa tion Proposed by the competent authority ditional information from the competent authority in response the evaluation of the commission's services 2 (a) The following section is being included within the National ntingency Plan for Xylella fastidiosa sources and procedures for making additional resources ailable in accordance with Article 3.2 of Regulation 20/1201. e budgets of the competent plant health authorities of the tonomous Communities shall provide sufficient resources to pe with the surveys and controls set out in this Contingency Plan. addition, if necessary, to meet the costs arising from the plication of measures to be adopted in the event of confirmation suspicion of the presence of the disease in the territories of the tonomous Communities, th

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The audit team noted that the laboratories of the ACs Balearic Islands and Madrid have sufficient capacity to test all official plant and insect samples collected in the AC. Although the capacity of the official laboratory of AC Valencia has increased since the last audit, it is still not sufficient for testing all official samples within the timeframe technically necessary. In particular, in 2020, there were substantial delays during testing plant samples from the DA. The ACCAs stated that requirements for personal distancing in the laboratory during the COVID-19 pandemic and a shortage of PCR reagents contributed to the delay. For 2021 the delays decreased, however the laboratory still needed on average 18 days to complete the tests. The ACCAs, met by the audit team did not have defined testing deadlines or arrangement to prioritise high-risk samples. In 8 particular, in AC Valencia these issues contributed to the long delays between sampling and the removal of plants (see section 5.5.2) Conclusions on the organisational aspects of the plant health controls

The ACCA stated that in the DA Alicante : · Since 2017, 4,694 plants were tested positive. After the establishment of a new IZ, the first priority is the removal of the positive tested plant as it is the proven source of any further spread by the vector. Until the time of the audit, 97.7% of the positives (4,588 plants) have been removed. In 2021, the average time elapsed between the test result and the removal of plants was 89 days. · For the removal of plants listed in Article 7(1)(a)to(e) of Regulation (EU) 2020/1201 (i.e. specified plants other than the positive), priorities are applied. The DA, where numerous overlapping IZs are surrounded by a common BZ of 2.5 km radius, was divided into priority zones (see figure VI). To achieve the best level of protection against the spread of the disease out of the DA with the resources allocated to the ACCA; · The 2.5 km "outer" part is drawn around the IZs, which are located closest to the border of the DA (green stripe ­ see figure VI), has the highest priority. If any positive is found there, a new IZ is established, and the eradication measures are completed as soon as technically possible; · The rest of the BZ is divided into sections of 5 km (red, orange and yellow stripes). The further the zone is from the border of the DA, the lower priority it has, and consequently the longer delays in the completion of the plant removal. In 2021, the average time needed for the plant removal was 94 days for the priority 1 IZs, 120 days for the priority 2 and 150 days for the priority 3. These figures relate only to IZs where the removal of plants was completed by the time the audit (see table III); · The removal of specified plants was completed in 43.7% of the territory of the IZs, established since 2017, covering an area of 1,150 ha. Even in the highest priority area 77% of the plants to be felled had been removed at the time of the audit, while it was only 18% in the lowest priority parts of the DA. Although in the IZs established in 2020 in the highest priority area the level of completion is satisfactory, the non- completion of the work in the IZs established earlier significantly reduces the impact of those efforts (see table III). In the areas of second and third priority the works were completed in a low or very low percentage of the IZs and in the vast majority of the cases with significant delays; · At least 771 IZs were revisited, in order to identify and remove the plants, which were qualified as specified plant for Xf subspecies multiplex after the plant removals in those IZs was completed. 18 Figure VI. Prioritisation of the plant removal of plants other than the positive tested ones in the DA Alicante Source: ACCA Valencia Table III. Plant removal in the IZs of DA Alicante (as of September 2021) Implementation of plant Total area of Plant removal Removal completed removal priorities the IZs (ha) completed (ha) (%) of area Grand total: IZs established since 2017 1st priority 966 744 77.0% 2nd priority 813 251 30.9% 3rd priority 853 155 18.1% Total 2,632 1,150 43.7% From the grand total: IZs established in 2020 1st priority (red) 411.3 392.5 95.4% 2nd priority (orange) 257.9 61.6 23.9% 3rd priority (yellow) 286.5 5.27 1.8% Total 955.6 459.3 48.1% From the grand total: IZs established in 2021 1st priority (red) 250.1 27.1 10.8% 2nd priority (orange) 228.6 19.9 8.7% 3rd priority (yellow) 157.1 0.36 0.2% Total 635.8 47.4 7.5% Source: ACCA Valencia

In the IZs of the DA Alicante, only a part of the specified plants were removed and in the vast majority of the cases with substantial delays. The delayed completion of the works and the system of prioritisation of the removals are not in line with the EU legislation. The applied measures do not sufficiently control the spread of the disease and cannot result in eradication. There is a pronounced risk that the bacterium continues to spread within the DA and a there is a risk of further natural spread from the DA into the neighbouring areas. 21

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Se ha procedido a un cambio en el proceso de notificación de positivos mediante resoluciones individuales, lo cual supondrá una agilización de las notificaciones, y una reducción de los retrasos en la erradicación. es t También se están comenzando los trámites para modificar la Ley 43/2002 de Sanidad Vegetal con el objetivo de agilizar la entrada en las parcelas afectadas por Xylella fastidiosa (positivos + área de erradicación), y de esta forma reducir el nº de parcelas que actualmente requieren autorización judicial previa para su destrucción. Este procedimiento se encuentra en una fase preliminar de la tramitación y por tanto se desconoce la redacción final del texto. Con respecto al laboratorio, se está procediendo a una reorganización de los recursos destinados para el análisis con el objetivo de reducir el tiempo transcurrido entre la entrada de la muestra en el laboratorio, y el boletín de resultados

A change has been made to the process of notification of positives through individual resolutions, which will mean an acceleration of notifications, and a reduction in delays in eradication. es t Procedures are also being begun to amend Law 43/2002 on Plant Health with the aim of speeding up the entry into the plots affected by Xylella fastidiosa (positive + eradication area), and thus reduce the number of plots that currently require prior judicial authorization for their destruction. This procedure is at a preliminary stage of the process and therefore the final wording of the text is unknown. With regard to the laboratory, a reorganization of the resources allocated for the analysis is under way with the aim of reducing Page: 4 nslation) received 15 March 2022 ort ref. DG(SANTE) 2021-7282 of the audit carried out from 20 September Xylella fastidiosa Action Proposed by the competent authority the time elapsed between the entry of the sample into the laboratory and the results bulletin.

e A change has been made to the process of notification of positives hrough individual resolutions, which will mean an acceleration of ifications, and a reduction in delays in eradication. el que se dictan disposiciones para la aplicación en España de la normativa de la Unión Europea relativa a las medidas de protección contra las actividades oficiales en dicha materia. Page: 9 recommendations (ES updated) received 16/6/2022 lan submitted by the competent authorities of Spain in response to Report ref. DG(SANTE) 2021-7282 of the October 2021 in order to evaluate the situation and controls for Xylella fastidiosa Action Proposed by the competent authority Procedures are also being begun to amend Law 43/2002 on Plant Health with the aim of speeding up the entry into the plots affected by Xylella fastidiosa (positive + eradication area), and thus reduce the number of plots that currently require prior judicial authorization for their destruction. This procedure is at a preliminary stage of the process and therefore the final wording of the text is unknown. With regard to the laboratory, a reorganization of the resources located for the analysis is under way with the aim of reducing the

le A change has been made to the process of notification of positives through individual resolutions, which will mean an acceleration notifications, and a reduction in delays in eradication. Procedures are also being begun to amend Law 43/2002 on Plant Health with the aim of speeding up the entry into the plots affected by Xylella fastidiosa (positive + eradication area), and thus reduce the number of plots that currently require prior judicial authorization for their destruction. This procedure is at a Page: 9 e report's recommendations received 16/6/2022 plan submitted by the competent authorities of Spain in response to Report ref. DG(SANTE) 2021-7282 of the October 2021 in order to evaluate the situation and controls for Xylella fastidiosa Action Proposed by the competent authority preliminary stage of the process and therefore the final wording of the text is unknown. With regard to the laboratory, a reorganization of the resources allocated for the analysis is under way with the aim of reducing the time elapsed between the entry. Additional information from the competent authority in response to the evaluation of the commission's services - What are the exact changes in the n

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Although in the DA Alicante the vector controls prior to and during the removal of plants were in line with the EU rules, the measures recommended by the ACCA for controlling the juvenile and adult stages of the vector in orchards are applied only by certain farmers. Therefore, they do not provide sufficient protection against the spread of Xf by vectors.

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are Se han adoptado medidas para hacer obligatorios los tratamientos the contra los vectores, en todas sus fases, en la zona demarcada. of the of Se procederá a controlar la adopción de las medidas obligatorias frente a los vectores de Xylella fastidiosa en la zona demarcada de Alicante mediante la comprobación y el control de los cuadernos de campo. Se incluyó la obligatoriedad de estos tratamientos en toda la ZD en la Resolución de 16 actualización de la situación que se publicó en el DOGV (adjunta a este plan de acción, Page: 4 arch 2022 ort ref. DG(SANTE) 2021-7282 of the audit carried out from 20 September Xylella fastidiosa rá para ón con el olítica demarcada cionado cada uno de os fitosanitarios etal obligatorios de realiza un os avisos en -fastidiosa Page: 5

e Measures have been taken to make vector processing mandatory, in all its phases, in the demarcated area. the The adoption of the mandatory measures against the vectors of Xylella fastidiosa in the demarcated area of Alicante will be controlled by checking and controlling the field notebooks. The obligatory nature of these treatments throughout the DZ was included in the Resolution of 16 update of the situation that was published in the DOGV (attached to this action plan, "publicacion DOGV 16 actualización.pdf ") and will be maintained for the following. This action will be carried out in collaboration with the Control and Technical Support Service of the D.G. of Common Agricultural Policy. Likewise, the municipalities of the demarcated area will be required to list the farmers to whom the phytosanitary product has been provided, and the amount supplied to each of them, to verify the application of phytosanitary treatments against vectors in the demarcated area. Different warning notes have been published on the website of the Plant Health Service to carry out the mandatory work of eliminating vectors from their nymph phase, and the vector cycle is monitored to continue with the w

e Measures have been taken to make vector processing mandatory, in all its phases, in the demarcated area. r The adoption of the mandatory measures against the vectors of Xylella fastidiosa in the demarcated area of Alicante will be controlled by checking and controlling the field notebooks. The obligatory nature of these treatments throughout the DA was included in the Resolution of 16 update of the situation that was published in the DOGV (attached to this action plan, "publicacion DOGV 16 actualización.pdf ") and will be maintained for the following. This action will be carried out in collaboration with the Control and Technical Support Service of the D.G. of Common Agricultural Policy. Likewise, the municipalities of the demarcated area will be required to list the farmers to whom the phytosanitary product has been provided, and the amount supplied to each of them, to verify the application of phytosanitary treatments against vectors in the Page: 15 recommendations (ES updated) received 16/6/2022 lan submitted by the competent authorities of Spain in response to Report ref. DG(SANTE) 2021-7282 of the October 2021 in order to evaluate the situation and controls for Xylella fasti

easures have been taken to make vector processing mandatory, all its phases, in the demarcated area. he adoption of the mandatory measures against the vectors of ylella fastidiosa in the demarcated area of Alicante will be ontrolled by checking and controlling the field notebooks. The bligatory nature of these treatments throughout the DA was ncluded in the Resolution of 16 update of the situation that was ublished in the DOGV (attached to this action plan, "publicacion OGV 16 actualización.pdf ") and will be maintained for the ollowing. This action will be carried out in collaboration with the ontrol and Technical Support Service of the D.G. of Common gricultural Policy. ikewise, the municipalities of the demarcated area will be equired to list the farmers to whom the phytosanitary product has een provided, and the amount supplied to each of them, to verify he application of phytosanitary treatments against vectors in the emarcated area. ifferent warning notes have been published on the website of the lant Health Service to carry out the mandatory work of liminating vectors from their nymph phase, and the vector cycle s monitored to continue with the warnings in the important hase

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order to establish more effective coordination ls between the various CAs (competent authorities), the following measures will be or have been taken: · MAPA/SOIVRE: in relation to finding 6, the ommunication procedures between SOIVRE and the RESPUESTA SGCCALA in the event of the detection of non- Además de la información facilitada anteriormente, f compliances in controls of imported organic products es preciso actualizar lo siguiente: ave been included in document DI-III-ECO (see the attached document approved by MECOECO (the Coordination Board for Organic Farming) on 3 December 2020). Deadline: already implemented. · MAPA/SOIVRE/ACs: in relation to finding 6, a working group was set up to discuss issues MAPA/SOIVRE/MS: Se ha formado un nuevo surrounding imports, with the participation of the CAs Grupo de Trabajo para el control oficial de las of the ACs, a number of control authorities, SOIVRE importaciones de productos ecológicos para and the SGCCALA, using a remote tool called FORO- abordar las futuras implicaciones en frontera del SOIVRE. Deadline: already implemented. denominado "paquete COI-BCP" (derivado de los · MAPA/ACs: in relation to finding 6, the actos secundarios del

n de establecer una coordinación más eficaz entre las distintas AC (Autoridades Competentes), las uientes actuaciones se van a acometer o se han acometido: APA/SOIVRE: en relación con la constatación 6 se han incluido los procedimientos de comunicación entre SOIVRE y la SGCCALA en caso de detección de incumplimientos en los controles en los productos ecológicos importados en el documento DI-III-ECO (se adjunta el documento aprobado en MECOECO el 3 de diciembre de 2020). Plazo: ya ejecutado. MAPA/SOIVRE/CC.AA.: en relación con la constatación 6 se ha puesto en marcha un grupo de trabajo para debatir cuestiones relativas a las importaciones en el que participan tanto AC de las CC.AA., algunas ACtrl, SOIVRE y la SGCCALA a través de una herramienta telemática denominada FORO-SOIVRE. Plazo: ya ejecutado. MAPA/CC.AA.: en relación con la constatación 6 durante la MECOECO de 18/03/2021 se abordó el asunto de la posible modificación del documento CATIN-ECO. Se acordó modificarlo para adecuarlo al nuevo Reglamento 2021/279 con la intención de establecerlo en línea con el Anexo I en cuanto a la nueva categorización de los incumplimientos y las medidas a implementar de forma coordinada por tod

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nd · MAPA: in relation to finding 19 and conclusion 24: at the end of 2020, during the he preparations for the new National Programme for the Official Control of Organic Production (PNCOPE) for 2021, under the National Plan for the Official Control d of the Food Chain (PNCOCA) for 2021-2025, three Page: 3 the action plan submitted by the competent authorities of Spain in response to Report ref. DG(SANTE) 2020-7042 of the tober 2020 in order to evaluate the control systems for organic production and labelling of organic products Action Proposed by the competent authority Updated Action Proposed by the competent authority ch alternatives were proposed to the CAs for dealing with RESPUESTA: a change in the criterion relating to the type and d frequency of supervision. It was not possible for all the MAPA: En la MECOECO celebrada el 4 de octubre de ry, ACs to agree on a new criterion, and since the 2021 se presentó una nueva propuesta relativa a la c programme had to be approved by the deadline, a supervisión anual de los Organismos de Control por No decision was made to extend the previous programme parte de las Autoridades Competentes de las f by one more year. The PNCOPE was approve

MAPA: en relación con la constatación 19 y la conclusión 24, informar que a finales de 2020 durante la elaboración del nuevo Programa Nacional de Control Oficial de la producción ecológica (PNCOPE) para 2021, dentro del PNCOCA 2021-2025, se propusieron tres alternativas e a las AC para afrontar un cambio de criterio en cuanto a la naturaleza y frecuencia de las supervisiones. No fue posible consensuar un nuevo criterio con todas las CC.AA., y ante la ol necesidad de aprobar el Programa en plazo, se optó por prorrogar un año más lo establecido en el anterior Programa. El PNCOPE fue aprobado y ratificado en la MECOECO de 03/12/2021, quedando pendiente para 2021 la revisión del asunto relativo a las supervisiones, entre otros (se adjunta el acta). En consecuencia, se ha seguido trabajando ofreciendo nuevas alternativas, que fueron planteadas y debatidas en en el punto 4 "Programa de Control Oficial de la Producción Ecológica y documento VERIFICA-ECO. Revisión" de la MECOECO de 18/03/2021 (se adjunta convocatoria con orden del día, ya que el acta es aprobada en la siguiente MECOECO). Esta nueva propuesta afectaría tanto a los criterios para determinar el número de supervisiones anuales

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rs After the audit, remote contact has been maintained aid between the CCAs (central competent authorities) of the MC and MAPA, and also between the CAs of the ACs for organic production and market control. ic · MAPA: This recommendation was set out during the MECOECO meeting held on 18 March RESPUESTA: 2021, in which the CCA for Consumer Affairs also participated, during which the case was made for the need for cooperation at Autonomous Community level. After this, another meeting was held on 24 March between MAPA and the ACs, at the level of the Directors-General, at which various important matters were discussed such as enhancing coordination between the CAs of the ACs for the performance of MAPA: se adjunta el Acta de la MECOECO controls of retailers exempt pursuant to Article 28(2) de 18/03/2021. Además, informar que con of Regulation (EU) No 834/2007. fecha 9 de julio se ha aprobado en el seno de la On the other hand, the document drafted by the MECOECO un documento de Directrices para Working Group on Distributors provides for the la coordinación de las Autoridades inclusion of a reference to the monitoring of competentes de Producción ecológica en la Page: 7 the action plan

la auditoría se ha mantenido contacto telemático entre las ACC del MC y del MAPA, así como entre las AC de las CC.AA. de producción ecológica y de control en mercado. : Esta recomendación fue expuesta durante la MECOECO celebrada el 18 de marzo de 2021, en la que también participó la ACC de Consumo, durante la que se abogó por la necesidad de cooperar y colaborar a nivel de Comunidad Autónoma. Tras la misma, se mantuvo el 24 de marzo una reunión entre el MAPA y las CC.AA., a nivel de Directores Generales, en la que se trataron diversos asuntos importantes, como el de potenciar la coordinación entre las AC de las CC.AA. para la realización de controles sobre los minoristas exceptuados en base al artículo 28 apartado 2 del Reglamento 834/2007. Por otra parte, en el documento resultante del Grupo de Trabajo sobre Comercializadores está previsto incluir una referencia al control del cumplimiento de las condiciones establecidas para aquellos minoristas exceptuados por la normativa comunitaria. Plazo previsto: antes de finales de 2021. Page: 4 pain to the recommendations of report ref. DG(SANTE) 2020-7042 of the audit carried out from 05 October 2020 e control systems for organic product

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4 a) MAPA: At present, and with a view to the rs public list of organic operators in Spain having all the elds set out in Annex XII to Regulation (EC) No 889/2008, adaptations are being made to the public RESPUESTA: EC) databases held by MAPA, which are generated by the En relación con este punto, se actualiza la información n databases of the ACs as competent authorities for the de la siguiente manera: ficial control of organic production. This adaptation involves removal from the current list of operators line together with the modification and full implementation of the REGOE (General Register for Organic erators) set out in Royal Decree 833/2014 of 3 tober 2014 establishing and regulating the General gister of Organic Operators and creating the Organic 4 a) MAPA: Con el fin de cumplir con la oduction Coordination Table. obligatoriedad de publicar los datos contenidos en and In relation to the REGOE, on the one hand the changes los certificados de los operadores ecológicos, tanto e being made at present to include not only the fields en el Reglamento (EC) No 889/2008 como en el Annex XII to Regulation (EC) No 889/2008, but Reglamento (UE) No 2018/848, el MAPA ha so the fields of

4 a) MAPA: Actualmente, y con objeto de que el listado público de operadores ecológicos en spaña disponga de todos los campos que figuran en el Anexo XII del Reglamento (CE) nº tán adaptando las bases de datos públicas que dispone el MAPA y que se alimentan bases de datos de las CC.AA. como autoridades competentes en materia de control oficial a producción ecológica. Dicha adaptación consiste en la eliminación del actual listado de ores junto con la modificación y puesta en marcha completa del REGOE (Registro General e Operadores Ecológicos) recogido en el Real Decreto 833/2014, de 3 de octubre, por el que se stablece y regula el Registro General de Operadores Ecológicos y se crea la Mesa de oordinación de la producción ecológica. n relación al REGOE, por un lado la modificación del mismo se está realizando actualmente para ncluir ya no solo los campos del Anexo XII del Reglamento (CE) nº 889/2008, sino también los ampos del nuevo modelo de certificado que impondrá la legislación delegada del Reglamento UE) 2018/848. Por otro lado la puesta en marcha completa del REGOE, que ya está en uncionamiento y en donde las CC.AA. pueden actualizar la lista de operadores con todos los ampos r

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nd · Extremadura: with regard to this ied recommendation and in particular to the points own highlighted in findings 38 and 41, the Control n Authority of the Autonomous Community of Extremadura has set out below a series of improvements and adjustments made to guarantee mpliance with the regulatory provision. Deadline: mpleted ­ In relation to findings 38-41: For the 2021 rketing year, efforts will be made to complete the additional and unannounced inspections which were itially scheduled on the basis of the already tablished risk criteria. With regard to finding 39. Instructions have en drafted for the classification of risks in cordance with Article 27(3) of Regulation (EC) No Page: 14 the action plan submitted by the competent authorities of Spain in response to Report ref. DG(SANTE) 2020-7042 of the tober 2020 in order to evaluate the control systems for organic production and labelling of organic products osed by the competent authority Updated Action Proposed by the competent authority d operators have been classified in line instructions. ds finding 40. A meeting was recently th all the technical experts in order to concept of the additional and unannounced to be carried ou

Extremadura: en lo que concierne a esta recomendación y especialmente a los hallazgos destacados en los constataciones 38 a 41, la Autoridad de Control de la Comunidad Autónoma de Extremadura dispone a continuación una serie de mejoras y matices desarrollados para garantizar el cumplimiento de lo dispuesto normativamente. Plazo: ya realizado - En relación a la constatación 38-41. Se procurará para la campaña 2021, llegar a completar las inspecciones adicionales y sin previo aviso, que se hayan programado inicialmente basadas en los criterios de riesgo ya establecidos. - En lo que respecta al a constatación 39. Se ha diseñado unas instrucciones para la clasificación de riesgos en consonancia con lo dispuesto en el artículo 27, apartado 3, del , Reglamento (CE) nº 834/2007 y se han clasificado a los operadores e función de estas instrucciones. - En lo que atañe a la constatación 40. Se ha organizado recientemente una convocatoria de reunión con todos los técnicos para aclarar el concepto de las inspecciones adicionales y Page: 9 pain to the recommendations of report ref. DG(SANTE) 2020-7042 of the audit carried out from 05 October 2020 e control systems for organic production and lab

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· Extremadura: with regard to this recommendation and in particular to the incidents tors, highlighted in finding 61 and conclusion 66, the 2) Control Authority of the Autonomous Community of Extremadura has set out below a series of e improvements and adjustments made to guarantee compliance with the regulatory provisions. Deadline: completed ­ As regards finding 61: In addition to there being a guaranteed sample number depending on the risk analysis, the aim is to cover suspicions and non- compliances outside the 5% initially established, and based on the risk analysis. ­ With regard to conclusion 66 and the effectiveness of the sampling programme. We have drafted the Instruction (Evaluation of risk criteria. Version 1/2021), attached to this report, which contains a number of risk-based criteria for the selection of operators to be subject to sample controls.

Extremadura: en lo que concierne a esta recomendación y especialmente a las incidencias destacadas en la constatación 61 y conclusion 66, la Autoridad de Control de la Comunidad Autónoma de Extremadura dispone a continuación una serie de mejoras y matices desarrollados para garantizar el cumplimiento de lo dispuesto normativamente. Plazo: ya realizado - En relación a la constatación 61. Se garantizará no solo el nº de muestras tomadas en función del análisis de riesgo, además se pretende alcanzar las sospechas y no conformidades que estén fuera del 5% establecido inicialmente, y basado en el análisis de riesgo. - En lo que respecta a la conclusión 66 y a la eficacia del programa de muestreo. Se ha desarrollado en la Instrucción (Evaluación de criterios de riesgo. Versión 1/2021) que se 2, adjunta a este informe, que contiene unos criterios basados en el riesgo para la selección de los operadores que vayan a ser sometidos a control de toma de muestra. Page: 10 pain to the recommendations of report ref. DG(SANTE) 2020-7042 of the audit carried out from 05 October 2020 e control systems for organic production and labelling of organic products Action Proposed by the competent authority

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that MAPA. Since the end of the audit and until the in publication of the latest revised list on the MAPA web page (15 April 2021), the CAs continued with the process of appointing specific laboratories for organic RESPUESTA: aid production, in accordance with document DE-LAB- ECO v1. . Some of the ACs which had already designated laboratories specifically for organic production have updated their designations with the appointment of Page: 16 the action plan submitted by the competent authorities of Spain in response to Report ref. DG(SANTE) 2020-7042 of the tober 2020 in order to evaluate the control systems for organic production and labelling of organic products Action Proposed by the competent authority Updated Action Proposed by the competent authority new laboratories in line with document DE-LAB-ECO MAPA. Desde la finalización de la auditoría y hasta la publicación de la última revisión del listado en la v1: Castile-La Mancha: Analytica Alimentaria GmbH página web del MAPA (11/10/2021) las AC han continuado con el proceso de designación de (branch in Spain), Catalonia: Eurofins Institut Dr laboratorios específicos para producción ecológica conforme al documento DE-LAB-ECO v1

PA. Desde la finalización de la auditoría y hasta la publicación de la última revisión del listado en la página web del MAPA (15/04/2021) las AC han continuado con el proceso de designación de e laboratorios específicos para producción ecológica conforme al documento DE-LAB-ECO v1. de las CC.AA que ya habían designado laboratorios especificamente para la producción ecológica han actualizado sus designaciones, designando nuevos laboratorios conforme al documento DE-LAB-ECO v1: Castilla-La Mancha: * La Rioja: * s Además, en esta última actualización del listado también se incluyen las designaciones realizadas por s seis CC.AA conforme al mencionado documento DE-LAB-ECO: Aragón: * Cantabria: * illa y León: * Galicia: *.Navarra: * enlace a la página web del MAPA en el que se puede consultar el listado de laboratorios designados especificamente en el ámbito del control oficial de la producción ecológica es el siguiente: * Link removed Algunas de las CC.AA. anteriores tienen en marcha procesos de designación de otros laboratorios, además de los incluidos en el listado, que está previsto que se completen a lo largo de 2021. Como se ha indicado anteriormente, la SGCCALA actualizará el list

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IVRE: The following actions will be taken: In the upcoming weeks, an instruction will be issued g to inspectors, recalling the importance of the na, Commission Guidelines and recommending an Page: 19 the action plan submitted by the competent authorities of Spain in response to Report ref. DG(SANTE) 2020-7042 of the tober 2020 in order to evaluate the control systems for organic production and labelling of organic products Action Proposed by the competent authority Updated Action Proposed by the competent authority a increase in samples, while maintaining the re proportionality, coherence and appropriateness of the RESPUESTA: et, as control measures. Deadline: 1 July 2021 ­ the Subdirectorate-General for Inspection will SOIVRE: Los reglamentos comunitarios, en que se nalyse the measures taken fortnightly, monitoring the enmarca el control, obligan a aplicar un análisis de s on balanced application of the guideline. Deadline: riesgo para determinar los controles físicos con toma aid ongoing de muestra a realizar, indicando que los controles oficiales se efectuarán en la medida de lo posible de tal manera que se reduzcan al mínimo las cargas administrativas y las perturbaciones opera

SOIVRE: Al respecto se van a realizar las siguientes actuaciones: g as próximas semanas se emitirá instrucción a los inspectores recordando la importancia las Guías de la Comisión y recomendando el aumento de la toma de muestras, siempre teniendo la proporcionalidad, coherencia y adecuación de las actuaciones de control. Plazo: d 01/07/2021 - Desde la Subdirección General de Inspección se analizará las actuaciones realizadas incenalmente monitorizando la equilibrada aplicación de la directriz. Plazo: en ejecución

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d This recommendation was expressed under point 5 of the agenda during the MECOECO meeting held on 18 Page: 20 the action plan submitted by the competent authorities of Spain in response to Report ref. DG(SANTE) 2020-7042 of the tober 2020 in order to evaluate the control systems for organic production and labelling of organic products Action Proposed by the competent authority Updated Action Proposed by the competent authority nt March 2021 (invitation with agenda attached). It was RESPUESTA: lt concluded that all the ACs with delegated control bodies had to amend their deadlines in line with Article Con el objetivo de mejorar y clarificar la respuesta a of a 27(5)(d) of Regulation (EC) No 834/2007. A new esta recomendación, este asunto se trató en la última approach with the CAs with CBs was later studied, and MECOECO del 4/10/2021 y con posterioridad se ha by the following agreement was reached: celebrado una reunión específica con las Autoridades ion When the result of a control indicates the presence of a Competentes que han delegado el control en OC en serious irregularity or infringement affecting the España. condition of the product or operator, the delegated Durante la mis

l Esta recomendación fue expuesta durante la MECOECO celebrada el 18 de marzo de 2021 en el punto adjunta convocatoria con orden del día). Se llegó a la conclusión de que todas aquellas AACC con smos de control delegados debían modificar sus plazos en línea con lo establecido en el artículo , apartado 5, letra d), del Reglamento (CE) n.º 834/2007. Con posterioridad se ha estudiado un nuevo amiento con las AC con OC, y se ha llegado al siguiente acuerdo: ando el resultado de un control indique la presencia de una irregularidad o infracción grave que afecte a la condición del producto o del operador, los organismos de control delegados informarán inmediatamente, y en cualquier caso antes de 48 horas a contar desde el momento en que se tome la decisión por el órgano de certificación, a su autoridad competente. Así mismo, ante la sospecha de un Page: 14 pain to the recommendations of report ref. DG(SANTE) 2020-7042 of the audit carried out from 05 October 2020 e control systems for organic production and labelling of organic products Action Proposed by the competent authority cumplimiento grave, los organismos de control delegados también informarán inmediatamente, y en r caso antes de

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The National Reference Laboratory (NRL) for the viruses of non-woody plants is the Laboratory for Virology of the Polytechnic University of Valencia. Their activity is based on an agreement with the MAPA. The laboratory is responsible for the confirmatory tests of the positive and undefined results on ToBRFV obtained by the ACCA laboratories. Until the time of the audit, this practically meant the confirmation of tests results carried out with enzyme linked immunosorbent assay method (ELISA) and with real-time polymerase chain reaction method (RT-PCR). In the case the ACCA laboratory tested the sample with a molecular method the same RNA extract was used for the confirmation. The laboratory stated that since 1 October they carry out ToBRFV tests with RT-PCR methods, listed in the Annex of Regulation (EU) 2020/1191.

An appropriate laboratory network assists the implementation of the official controls. However, the lack of effective and coordinated proficiency tests on the use of the RT- PCR method for the detection of ToBRFV by the numerous ACCA laboratories could influence negatively the effectiveness of the controls. The staff of certain official laboratories have experience in testing with molecular methods; however, this experience is not evident for the detection of ToBRFV using the method described by Regulation (EU) 2020/1191. Therefore, proficiency tests are necessary to assess the performance of the ACCA laboratories.

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samples In relation to this recommendation, following the audit, a training the test course for the regional laboratories of the Autonomous the Communities together with a Proficiency Test was planned for the first quarter of 2021. Both activities are given and organised by 625. the National Reference Laboratory for non-woody viruses with the supervision of MAPA. The training of laboratories took place on 4 March while the Proficiency Test is ongoing (the planned chronology is as follows: Samples sent from 8 to 10 March 2021 Deadline for the submission of results by the laboratories of the Autonomous Regions: 31 March 2021 Sending of the final report by the organiser: 14 April 2021)

Following the audit, a training course for the - At least 1 laboratory per Autonomous regional laboratories of the Autonomous Community has participated in the ommunities together with a Proficiency Test proficiency test, and there are even was planned for the first quarter of 2021. Autonomous Communities where up to 2 oth activities are given and organised by the laboratories have participated. Of the 19 ational Reference Laboratory for non- laboratories that attended the test, 12 of them woody viruses with the supervision of are considered to have obtained an adequate MAPA. The training of laboratories took result. Following the requests of the regional on 4 March while the Proficiency Test laboratories themselves, as well as the is ongoing (the planned chronology is as criteria of the Ministry, it has been decided follows: Samples sent from 8 to 10 March that another proficiency test, as well as 2021 Deadline for the submission of results another training session, will be carried out by the laboratories of the Autonomous as a correctives measures, the dates for Regions: 31 March 2021 Sending of the final which will be set shortly. report by the organiser: 14 April 2021

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The ACCA initially considered this case as a finding and therefore the outbreak was only reported to EUROPHYT-Outbreaks on 29 October 2020. This considerable delay is not in line with requirements of Article 32 of Regulation (EU) 2019/1715, which requests the reporting within eight working days after the confirmed presence of a pest subject to EU emergency measures.

The late reporting of an outbreak not fully in line with the provisions of the EU legislation could have a negative effect on the coordinated controls at EU level.

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fruit This recommendation indicates that the provisions of Article 32 s of Regulation (EU) 2019/1715 should be complied with, in e 30 particular in relation to the notification deadline. In this matter, ne for regarding the delay in the notification of the second outbreak recorded in a pepper seed research centre, it is indicated that from the Autonomous Community of Andalusia it was included in the third update of the initial outbreak (Outbreak No.958). That communication was carried out on 1 June 2020 to the MAPA, being notified in EUROPHYT-Outbreaks on 04 June 2020. The delay from the date of confirmation of the laboratory result was aggravated by the emergency caused by the declaration of the State of Alarm in the Spanish State in order to manage the health crisis caused by COVID- 19. The date of communication of 29 October reflected in finding No. 32 corresponds to the notification that was made as an independent outbreak (Outbreak No. 1207), after considering that it was appropriate to notify it as a separate Page: 1 ed 13 March 2021 of report ref. DG(SANTE) 2020-7104 of the audit carried out from 26 October 2020 Tomato brown rugose fruit virus Action Proposed by the competen

This recommendation indicates that the provisions of Article 32 of Regulation (EU) 15 should be complied with, in particular in relation to the notification deadline. In this matter, regarding the delay in the notification of the second outbreak recorded in a pepper seed research centre, it is ated that from the Autonomous Community of Andalusia it was included in the third update of the initial outbreak (Outbreak No.958). That communication was Page: 1 ndations (updated), received 21 May 2021 mitted by the competent authorities of Spain in response to Report ref. DG(SANTE) 2020-7104 of the 020 in order to evaluate the situation and control for Tomato brown rugose fruit virus t authority Updated Action Proposed by the Competent Authority he MAPA, reaks on e date of result was sed by the rm in the e the health date of lected in he notification outbreak idering that it a separate eak (Outbreak g. this is a one-off inary delay in tive effect on isk of spreading ccurred in a eties, where, nement of the nd, these lines which made ead. sence of this fected breeding equent Page: 2 ndations (updated), received 21 May 2021 mitted by the competent authorities of Spain in response to Report r

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The CAs confirmed that they do not have comprehensive information about the number of lots/batches, quantities and test status of specified seeds, produced before 15 August 2020 and subject to provisions of Article 7(2) of Regulation (EU) 2020/1191. Therefore the implementation of those provisions has not started. The MAPA and the ACCAs have recently requested in writing that the registered seed companies and traders provide updated information about the stocks in question. The inspection and official sampling or the official supervision of the sampling and tests carried out by the business operator will be planned and implemented, when comprehensive information about the stocks is available. 15 5.5.3 . Official controls on plant passport issuance

The inspections at the places of production of tomato and pepper seeds, the necessary tracing back and forward of seed lots are carried out in line with the EU legislation. However, the plant health risk of the spread of ToBRFV on seeds is not managed appropriately as the seed lots in stock are currently not tested although it is required by Regulation (EU) 2020/1191. 5.6 CONTROLS ON THE INTRODUCTION INTO THE EU OF SPECIFIED PLANTS FOR PLANTING Legal requirements Article 8 of Regulation (EU) 2020/1191. ISPM 31 Findings

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ich Currently, the provisions of Regulation 2020/1191 are being tested for applied in relation to seed stocks stored prior to 15 August 2020. by MAPA urged compliance by requesting information on the tent existence of stocks of specified seeds to ensure that the first icle 7(2) movement of these seeds within the Union does not take place without having been previously analysed in accordance with the Annex to Regulation 2020/1191. To date the: The seeds have been tested in accordance with the Annex to that Regulation: 448 tomato seed lots. 155 pepper seed lots. and 98.50 kg of Tomato seeds 538.85 kg of pepper seeds Page: 2 ed 13 March 2021 of report ref. DG(SANTE) 2020-7104 of the audit carried out from 26 October 2020 Tomato brown rugose fruit virus 3

urrently, the provisions of Regulation (EU) to 2020/1191 are being applied in relation to Number of analyses performed seed stocks stored prior to 15 August 2020. t MAPA urged compliance by requesting The total number of analyses performed on information on the existence of stocks of tomato seeds is: , specified seeds to ensure that the first movement of these seeds within the Union 750 analyses in official laboratories. does not take place without having been 413 analyses in seed company laboratories. eviously analysed in accordance with the Annex to Regulation (EU) 2020/1191. To The total number of analyses performed on date the: bell pepper seeds is: The seeds have been tested in accordance with the Annex to that Regulation: 84 analyses in official laboratories. 448 tomato seed lots (98.50 kg). 155 pepper 252 analyses in seed company laboratories. seed lots (538.85 kg) Pending results of laboratory analysis 155 tomato seed lots 543 lots of pepper seeds. - No ToBRFV positive detection has been recorded in the stocks of tomato and pepper seeds stored before August 15th 2020. Therefore, it has not been necessary the application of measures by Competent Authorities of the Autonomous

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In the two Regions visited some transporters transported ABP to processing plants authorised for the production of PAP for feeding aquaculture animals. These transporters were registered for transport of Category 3 ABP from all kind of species including ruminant and non-ruminant animals. In accordance with point (b) Section D, Chapter IV, Annex IV of Regulation (EC) No 999/2001 the animal by-products of non- ruminant origin intended for production of PAP for feeding aquaculture animals should not be transported in vehicles and containers used for the transport of ABP of ruminant origin unless these vehicles and containers have been cleaned beforehand in order to avoid cross-contamination in accordance with a documented procedure which has been given prior authorisation by the competent authority. Whenever such a cleaning procedure is used, a documented trace of its use should be kept available to the competent authority for a period of at least two years. At the transporters visited, no evidence was available that the vehicles and containers were not being used for transport of ABP of ruminant origin. In addition, the two regional competent authorities visited had never given prior authorisation for a cleaning procedure that would allow derogating from the ban on the use of the same containers and vehicles for the transport of ruminant and non-ruminant ABP. Verification of compliance with point (b) Section D, Chapter IV, Annex IV of Regulation (EC) No 999/2001 is not specifically indicated in the checklists used by inspectors during the official inspections. The auditor was informed of a case of ruminant cross-contamination in one processing plant visited authorised for 1 After the audit the competent authority carried out a comprehensive official investigation. Based on this investigation they excluded that the source of the ruminant contamination was Category 1 or 2 ABP. 11 the production of PAP for aquaculture animals whose likely source was an ABP transporter (see finding 35).

However, problems identified regarding the official inspection of commercial documents, limited controls of transporters transporting ABP for the production of PAP for aquaculture, and the authorisation of validation of processing method 7 weaken the effectiveness of these official inspections.

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Two processing plants visited were using processing method 7, which had been authorised by the competent authority. In one processing plant, during the 30 day validation period microbiological samples had been taken (Salmonella, Enterobacteriaceae, Clostridium perfringens) by the operator. The local inspector was not present during this sampling. The operator could not demonstrate that there was a sampling procedure in place at the time of the validation and the operator also could not demonstrate the place of the sampling. The operator sent these samples to a laboratory which was not accredited for testing Clostridium perfringens. The operator stated that the sampling protocol did not accompany the samples. This is not in line with the requirements of point G, Chapter III of Annex IV to Regulation (EU) No 142/2011. The local inspector collected official samples once (see finding 24) during the validation period; the samples were sent to an official laboratory and the results were compliant for all microbiological criteria. However, official laboratory results for Clostridium perfringens were communicated as 'less than 10/g', not as 'absent/g'. This is not in line with the requirements of point G(c)(i) of Chapter III of Annex IV to Regulation (EU) No 142/2011. The competent authority authorised the validation of processing method 7.

In the other processing plant the whole validation procedure was well documented, and the microbiological results were adequate. The official inspector was not present when the samples were taken. The operator had a written sampling procedure in the HACCP plan following the legal instructions. When the operator explained to the auditor his sampling procedure during validation, he stated that the samples were taken at the border of the end of the processing line and the place of storage. The samples for Salmonella and Enterobacteriaceae were taken only 3-4 hours later than the end of the production. This very short time after a relatively high temperature (80 C) heat treatment does not give sufficient time for aerobic microbes which survived to start growing. This sampling practice significantly reduces the chance of finding potential Salmonella and/or Enterobacteriaceae contamination in the produced PAP whose shelf-life is one year. Based on the laboratory results these samples were sent for analysis only when all 30 samples had been taken, thus approximately half of the samples were sent to the laboratory one month later than the date of the collection. Since the validation procedure had been authorised, the operator took samples for microbiological control from each produced batch using the same method. Salmonella and/or Enterobacteriaceae 10 contamination had thus never been identified. Official controls did not identify this shortcoming in the HACCP plan.

However, problems identified regarding the official inspection of commercial documents, limited controls of transporters transporting ABP for the production of PAP for aquaculture, and the authorisation of validation of processing method 7 weaken the effectiveness of these official inspections.

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Checks on commercial documents accompanying consignments of raw ABP and derived products is part of the routine official inspections and these checks should be recorded in the relevant checklists. The auditor identified a significant number of commercial documents at processing plants, transporters, and storage plants visited that did not contain information on the sub-category of ABP, contrary to the requirement of Article 10 of Regulation (EC) No 1069/2009, and/or without information on the species despite the fact that these consignments of ABP were sent for the production of feed. Several commercial documents of intra-EU trade of Category 3 ABP originating from Spain did not contain information on "commodities certified for" and also on the requirement of Article 10 of Regulation (EC) No 1069/2009 despite the fact that the destination of these 12 consignments was a pet food producer. These practices are not in line with the requirements of Chapter III, Annex VIII of Regulation (EU) No 142/2011. These non- compliances were not noted in official control reports.

In some cases local inspectors stated that they orally communicated non-compliances relating to commercial documents to the operators or they sent emails informing the operators on these non-compliances, however these were not recorded in official inspection reports. This is not in line with the requirements of Article 9 of Regulation (EC) No 882/2204. The auditor saw evidence of email notifications. A similar problem was identified by an internal audit in 2016 (see finding 8).

However, problems identified regarding the official inspection of commercial documents, limited controls of transporters transporting ABP for the production of PAP for aquaculture, and the authorisation of validation of processing method 7 weaken the effectiveness of these official inspections.

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The central competent authority has prepared a procedure for the notification of intra- EU trade of PAP and MBM in the Trade Control and Expert System (TRACES). Point 3 of this procedure describes the obligation of the Spanish competent authorities to inform the competent authority of Member State of origin of the arrival of each consignment. Based on this procedure the Spanish competent authorities have two options of how to inform the competent authority of origin. The first is via TRACES, which is the requirement of Article 48 of Regulation (EC) No 1069/2009; the second is to send back the fourth copy of the commercial document from the receiver business to the producer business based on point 2 of Chapter III, Annex VIII of Regulation (EU) No 142/2011. With the second option the information exchange is carried out between business operators which cannot replace the obligatory information exchange between competent authorities as required by Article 48 of Regulation (EC) No 1069/2009.

The auditor noted that the Spanish competent authorities did not systematically inform via TRACES the competent authorities of the Member State of origin of the arrival of consignments of PAP, contrary to Article 48(3) of Regulation (EC) No 1069/2009. In 2017 and 2018, no information was sent to the Member State of origin in relation to around 80% of such arrivals. The auditor also noted that most of the operators visited used the second option of the procedure described in finding 23.

Inadequate implementation of requirements concerning information to be transmitted back to the competent authority of the Member State of origin via TRACES relating to intra-EU trade of PAP negatively affect the reliability of the flow of information on the intra-EU trade of such products. 14

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The CAs met reported certain human resources challenges over recent years, which in some cases - together with organisational changes, information technology (IT) systems changes and resources allocation - were highlighted by the CAs met as the cause for reduced implementation of certain controls (e.g. on FBOs HACCP based procedures in Navarra, and supervisory controls in both regions visited).

However, some recommendations dating from 2015 such as putting in place audits of FBOs and an internal (CA) verification/supervisory system had not been closed to date. This is not in line with Article 4, Paragraph 6 of Regulation (EC) No 882/2004. The ACCA took some actions to address them, though limited for the RTE sector. The CA cited IT - and staffing issues (see paragraph 14), but indicated that these recommendations would be addressed this year.

Challenges were identified in particular in relation to aspects of training, efficient cooperation and coordination in practice, and the verification of effectiveness of controls. These challenges, together with delays in effectively addressing audit findings, may and sometimes do impact on the controls over the production of RTE foods.

In Navarra, the risk-based criteria are used for establishing the frequency for general hygiene controls for new FBOs and new activities. For other cases, the frequency is every five years. The risk- based criteria are not used for establishing the frequency of controls over FBOs own controls including HACCP- based procedures, nor for controls on specific sector requirements (e.g. raw milk criteria). In Cataluña, the frequency of all types of controls is established on a risk basis.

In Navarra, CAs are required to carry out controls over FBOs HACCP-based procedures at approval, for expansion of activity, and in the case of alerts. Individual inspectors decide when to carry out controls on specific sector requirements. In the dairy establishment visited in Navarra the last control for specific requirements was carried out in 2014. In the same establishment, the last control related to FBOs HACCP- based procedures took place at the time of approval (in 2007) despite expansion works and changes in production.

The CA prioritisation of the controls for an FBO with multiple-activities and more establishments with the same approval (in Cataluña) did not allow an adequate focus on the risk areas. Consequently, the high-risk area visited by the audit team was not subject to recent controls. This prevented the CA from detecting several non-compliances noted during the audit team's visit, some of them long-standing. 4.4.1.2 Procedures for official controls

Each CA has procedures and instructions for staff performing official controls that apply to RTE food production. To the extent assessed by the audit team, these procedures are facilitating the official controls and are in general known and used by the staff met during this audit. The inspectors met considered them as supportive to their work. The procedures cover inspections and sampling, and in Cataluña also audits. Navarra does not have procedures for audits of FBOs' practices and procedures as required by Article 4, Paragraph 3 of Regulation (EC) No 854/2004.

In Navarra the procedures are under review to ensure that a frequency for certain controls (e.g. on routine controls for FBOs HACCP based procedures and on sector 13 specific requirements) and for the use of related checklists is defined. Certain aspects (e.g. some provisions of Regulation (EC) No 2073/2005, the use of identification marks) that are mandatory for official controls, were not included in the checklists. This led to a lack of related controls. The regional CA undertook to include them during the revision of the checklists.

The CAs produce reports on the official controls carried out. In line with Article 9 of Regulation (EC) No 882/2004, these reports include a description of the purpose of official controls, the methods applied, the results obtained and action to be taken by the FBO concerned. The FBOs receive a copy of the report. The audit team noted, in some of the reports in both AC, limited evidence that all aspects included in the scope of the control were covered, as required in the ACCAs control procedures. 4.4.1.3 Scope/coverage of official controls

Official controls are performed in Programmes that are grouped together in blocks. The following Programmes, particularly relevant for the scope of this audit, and the related implementation data provided by the CCA are summarised below: a. Programme 1 - general control of food establishments - include hygiene inspections. The MANCP data indicate that this Programme is applied yearly in all ACs and that the ACCAs implemented approximately 85% of the 435 809 scheduled controls under this Programme for the country in 2017 and detected non-compliances in 26 % of these controls. b. In establishments (excluding retail) in the meat, dairy, fishery and composite products/prepared dishes sectors - i.e. those most likely to produce RTE food, Programme 1 controls took place with a national average of just under two of such controls per establishment in 2017. The variations are between controls in 42% of the establishments in Islas Baleares up to 12 controls per establishment in Castilla la Mancha on average, in 2017. c. Programme 2 covers FBO's own controls, including HACCP based procedures and FBO's compliance with the provisions of Regulation (EC) No 2073/2005. Overall, the ACCAs implemented approximately of 85% of the 96 136 scheduled controls under this Programme for the country in 2017. CA detected non- compliances in 15.8 % of these controls (highest in the dairy sector). d. In establishments (excluding retail) in the meat, dairy, fishery and composite products/prepared dishes sectors - i.e. those most likely to produce RTE food, Programme 2 controls took place in 32% of the establishments in the country in 2017. The variations noted are between 2% of the establishments in Navarra to 121% of the establishments in Comunidad Valenciana. The frequency of controls, according to these figures, varied considerably between other AC, e.g. 3% in Cataluña, 5% in Galicia, 10% in Castilla la Mancha, 11% Pais Vasco, 14% in Andalucia). e. Programme 5 covers official controls over FBOs compliance with the legislation on food labelling and food contact materials (see paragraph 65). 14 f. Programme 11 covers official sampling and testing for microbiological criteria (see chapter 4.4.1.4). g. Programme 12 covers official controls over FBOs controls for Anisakis (see paragraph 64).

Both CAs have put in place a system of routine risk-based official controls over production of RTE foods, supported by procedures and a comprehensive network of accredited laboratories under national coordination. Inspections, official sampling and in the Cataluña also audits cover relevant aspects of the legislation. The procedures for organisation of controls are currently under review in Navarra for further fine-tuning the risk determination for the RTE sector, for deciding the frequency for controls over FBOs HACCP based procedures, currently limited, and specific sector requirements and for starting to implement audits of FBOs' procedures and practices.

The controls cover satisfactorily a range of aspects of the "Hygiene Package", although there is scope for improvement in the controls over FBO's measures for prevention of cross-contamination and verification within the HACCP-based procedures, including the requirements of Regulation (EC) No 2073/2005 and of the EURL guidelines. The CAs' ability to detect relevant non-compliances and require adequate corrective actions is hindered by the fact that the control focus does not or not necessarily target (all) the areas relevant for food safety, whether by design or at the time of their implementation, and by some gaps in the knowledge of control staff.

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While an overall good number of inspectors receive yearly relevant training, there are differences between the AC in the array of training topics offered to their staff, and in the percentage of inspectors participating to training. Limited training was offered for controls over microbiological criteria in some AC.

The official control staff met was in general trained and knowledgeable for some parts of their work within the scope of this audit. The audit team identified training needs, mainly in relation to: a. the approval of establishments in Cataluña (see paragraphs 31-35). A new training session on this topic was ongoing at the time of the audit; 7 b. the focus and depth of the controls, and the assessment of the flexibility options and HACCP-based procedures implemented by FBOs, including compliance with Regulation (EC) No 2073/2005 in both AC visited (see paragraphs 53-62, 66, 88.e, f and g); c. the evaluation of the gravity of certain non-compliances in both AC and taking the required actions in case of non-compliance (see paragraphs 75-79, 81-83).

The findings above suggest that while a wide range of training is offered to staff, the systems in place for identifying and addressing training needs do not adequately capture the individual needs that arise, in particular considering the wide area of official controls over production of RTE food, in order to ensure that staff is kept up-to date in their area of competence as required by Article 6 of Regulation (EC) No 882/2004.

Challenges were identified in particular in relation to aspects of training, efficient cooperation and coordination in practice, and the verification of effectiveness of controls. These challenges, together with delays in effectively addressing audit findings, may and sometimes do impact on the controls over the production of RTE foods.

The procedure for adding new approved activities in Cataluña emphasised that the official controls should not verify FBOs HACCP based procedures, but focus on infrastructure. The ACCA explained that this approach was intended for particular situations. However, its wording led to some confusion amongst control staff on the requirements in the case reviewed by the audit team. The ACCA swiftly modified this procedure during the audit and provided examples of reports of approval visits demonstrating that the approval visits check FBOs' compliance with all relevant requirements of the applicable legislation.

These reports indicated delays of days or months for the approval visits in five out of eight cases (e.g. nine months conditional approval; five months between the first and second approval visit). The district team carrying out controls in the newly approved 10 establishment visited during the audit considered that six months between the first and second approval visit complies with the rules in place. These examples are contrary to the provisions of Article 31, paragraph 2(d) of Regulation (EC) No 882/2004, and of the regional procedures.

In the case of a recent approval assessed by the audit team, the district CA evaluated FBOs HACCP-based procedure solely during the visit for full approval contrary to the regional procedures. The duration of the full approval visit did not allow a thorough check of FBOs HACCP-based procedures. Consequently, the inspector had not evaluated certain elements thereof, like its validation and verification, as required by the regional procedures.

The CA acknowledged that the extent to which FBO's own procedures are evaluated depends on the background of the inspectors, and some aspects may be overlooked. The inspectors met had not received training in relation to the approval of establishments. A new training session on this topic was ongoing at the time of the audit.

The audit team noted during another visit that more establishments of the same group, located over a few km radius, with public roads between them, have the same approval number. The CCA clarified this is not in line with the legislation. The ACCA indicated this as a particular case due to historical reasons and that work was ongoing to address it. The ACCA started an investigation during the audit to confirm that this was not the case with other establishments in the AC.

The inspectors were in general able to detect non-compliances during the visits carried out as part of the current audit, in particular as regards the general hygiene requirements. While several aspects were adequately covered by the official controls, some aspects were missed and/or not addressed: a. In three establishments (two dairies and a fishery) CA challenges concerning the implementation of flexibility measures led to acceptance of cross-flows in the absence of adequate mitigating measures, as well as to under-detection of some unhygienic practices (e.g. in relation to unpacking, cleaning during production) with potential for cross contamination; b. In one of these establishments (in Cataluña), long standing maintenance and design issues as well as some operational hygiene non-compliances detected during the visit by the inspector were not noticed in the report of the previous recent official control (see paragraph 81.e). c. In another multi-activities establishment, the CA did not detect the potential for contamination coming from the practice of handling raw materials and packed final products in the same room where condensation was noted on the ceiling, followed by unpacking in a way that involved product touching of outer packaging prior to slicing.

The CAs met required the FBOs to take corrective action once they understood the potential impact on the safety of the product and provided the audit team with official control reports of swift follow-up controls. In an establishment producing RTE fishery involved in several alerts in another AC, not visited by the audit team, the official control report immediately prior to the alert suggested a fully compliant FBO. The control reports related to the alerts indicate several non-compliances including structural, hygiene, temperature controls and shelf-life studies. The ACCA reported to have replaced the inspector in the meantime (see paragraph 80).

The approach to controls over FBOs HACCP-based procedures differs between the ACCAs. In Navarra, these controls are comprehensive at the time of approval (except for validation and verification of HACCP based procedures), but they are limited afterwards (see paragraphs 49 and 51d). In Cataluña these controls are part of the routine controls carried out within the risk-based frequency, but limited as regards certain elements of FBOs' HACCP-based procedures. In particular: 15 a. in a multi-activity establishment, FBOs' practical implementation of the critical control point cooking validation and the reprocessing activity had not been part of CA controls for one of the production lines considered as "high risk" by both FBO and CA; b. in a dairy establishment, the critical limit used by the FBO differed from the values in different documents of the HACCP-based procedures, although previous controls had detected this non-compliance and reported it as having been addressed by the FBO. In addition, the controls did not check whether the alternative methods used by the dairy FBOs for alkaline phosphatase testing are validated against the ISO method in Regulation (EC) No 2074/2005, as the CA was not aware of the requirement.

The official controls over FBOs' compliance with Regulation (EC) No 2073/2005 are part of Programmes 1 and 2. In Cataluña, these controls are part of the routine risk-based controls. In Navarra, these controls check if the FBOs implement the sampling plans described in their HACCP based procedures (evaluated before starting operation). Nonetheless, FBOs further changed the procedures after approval, as noted in the establishments visited, and the CA did not evaluate if the changes ensure continued compliance with the above Regulation.

In the cases assessed by the audit team, the CAs checked whether FBOs implement their sampling and testing plans for food safety criteria. In one case, the CA accepted the limit of 100cfu/g Listeria monocytogenes at the end of production for RTE sushi with a shelf- life of five days, in the absence of adequate FBO demonstration that this value would not be exceeded throughout the shelf-life of the product. This is not in line with Chapter 1, Annex I to Regulation (EC) No 2073/2005. The CA acknowledged challenges with the controls over FBOs' compliance with this Regulation and the lack of related training.

As regards process hygiene criteria, the controls had not been satisfactory in one of the three cases evaluated by the audit team. The CA considered the process hygiene criteria in Chapter 2, Annex II of Regulation (EC) No 2073/2005 as a FBO's choice and did not require the FBO to include in their procedures the compliance limits for these criteria and the action to be taken in case of non-compliance, as required by Article 7 of Regulation (EC) No 2073/2005.

The controls as regards the number of sampling units were in most cases satisfactory. In the relatively recently approved establishment visited, the CA accepted the FBO's reduction of sampling units from five to one in the absence of historical documentation proving effective HACCP-based procedures, contrary to the requirements of Article 5.3 of Regulation (EC) No 2073/2005. FBOs' testing methods had not been subject to official controls in the cases assessed. This is not required by the procedures in Navarra.

FBOs' shelf-life studies for RTE food able to support the growth of Listeria are required to be verified by the CAs routinely in Cataluña, but not in Navarra. The cases assessed by the audit team, both in Cataluña and in Comunidad Valenciana, revealed that in 16 general the CA asks for FBO shelf-life studies for Listeria monocytogenes or checks them thoroughly at the time of alerts, but not beforehand or routinely otherwise.

The provisions of the EURL Guidance on sampling the food processing area and equipment for the detection of Listeria monocytogenes and of the EURL Technical Guidance Document for conducting shelf-life studies on Listeria monocytogenes in RTE foods were in general not known, and not taken into account by CAs met which had not dealt with Listeria alerts.

Consequently, CA accepted that FBOs sampling only after cleaning and disinfection, which makes the detection of the pathogen difficult leading to a false sense of security. In one case where the CA evaluated the FBOs studies as satisfactory, the studies did not demonstrate that the food safety criteria applicable throughout the shelf-life of the products can be met under reasonably foreseeable conditions of distribution, storage and use as required by Article 3 of Regulation (EC) No 2073/2005. Also, the CA did not detect the lack of shelf-life studies for some product classes. In other cases, the CA accepted shelf-life studies based solely on organoleptic properties.

The CAs met during the audit highlighted different challenges in the organisation and performance of controls over the production of RTE food: a. assessing FBOs decisions to classify different types of food as RTE or not considering production product characteristics, heating/cooking instructions, national or regional consumption habits; assessing FBOs shelf-life studies and the limit applied for Listeria monocytogenes, in the absence of more specific guidance and reference persons/experts; b. limited knowledge of some FBOs producing high risk RTE food, especially small ones challenge CAs in their work with these FBOs, in particular in relation to the implementation of own controls including HACCP based procedures; c. resources limitations in some districts (e.g. insufficient number of calibrated thermometers for official controls; sometimes lack of clear indication of the date where re-calibration would be due as well; inspectors' excessive workload); some of these operators are remotely located adding an additional travel burden to CAs for swift follow-up visits; certain district inspectors need to travel for training was mentioned also a challenge; d. the multitude of tasks for individual CAs not supporting the thoroughness of the controls-the same official control staff carries out controls in different types of establishments and sectors and has responsibilities for checking FBOs' compliance with several parts of the legislation, not only food hygiene; CAs in Navarra highlighted inspectors' difficulty to adapt to different types of establishments. e. in the districts and provinces where the inspection tasks are distributed per geographical area, some inspectors carry out controls in a limited number of establishments of one sector (e.g. one fishery establishment in the area). In one of the cases assessed during the audit, the limited practical experience and the lack of specialised training in the specific sector undermined the inspector' confidence in challenging FBOs in their decisions; f. the inspectors met mentioned the need for specialised training mainly on food technologies/production process including for new foods and new production technologies, technical requirements for high risk areas, equipment measurement uncertainty, controlling hazards in RTE foods, the provisions of Regulation (EC) No. 2073/2005, weighing non-compliances and deadlines to implement corrective actions, administrative procedures and legal and technical content of the reports; 23 g. The practical implementation of certain requirements, for example in relation to flexibility in small establishments as well as in the implementation of the information received during training for example for the evaluation of FBOs' shelf-life studies; h. The lack of a clear definition for high risk food as regards other dangers than Listeria. Some outdated procedures or rather large procedures for which one of the inspectors met welcomed the possibility to highlight the most relevant parts for inspectors. 4.4.4 Suggestions and measures put in place to address the identified challenges aiming to facilitate compliance with the EU food hygiene requirements in this area and reducing food borne outbreaks related to RTE foods

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Nonetheless, Navarra AC grants full approval after the first on-site visit, without seeing the FBO in operation and without being able to check the FBOs' validation and verification of its HACPP-based procedures. In addition, limited controls on FBO's HACCP-based procedures are implemented in this AC (2% of the establishments in 2017), and the audit team found that some aspects of FBOs validation and verification of HACCP based procedures are missed by these controls.

The procedure for adding new approved activities in Cataluña emphasised that the official controls should not verify FBOs HACCP based procedures, but focus on infrastructure. The ACCA explained that this approach was intended for particular situations. However, its wording led to some confusion amongst control staff on the requirements in the case reviewed by the audit team. The ACCA swiftly modified this procedure during the audit and provided examples of reports of approval visits demonstrating that the approval visits check FBOs' compliance with all relevant requirements of the applicable legislation.

These reports indicated delays of days or months for the approval visits in five out of eight cases (e.g. nine months conditional approval; five months between the first and second approval visit). The district team carrying out controls in the newly approved 10 establishment visited during the audit considered that six months between the first and second approval visit complies with the rules in place. These examples are contrary to the provisions of Article 31, paragraph 2(d) of Regulation (EC) No 882/2004, and of the regional procedures.

In the case of a recent approval assessed by the audit team, the district CA evaluated FBOs HACCP-based procedure solely during the visit for full approval contrary to the regional procedures. The duration of the full approval visit did not allow a thorough check of FBOs HACCP-based procedures. Consequently, the inspector had not evaluated certain elements thereof, like its validation and verification, as required by the regional procedures.

The CA acknowledged that the extent to which FBO's own procedures are evaluated depends on the background of the inspectors, and some aspects may be overlooked. The inspectors met had not received training in relation to the approval of establishments. A new training session on this topic was ongoing at the time of the audit.

The audit team noted during another visit that more establishments of the same group, located over a few km radius, with public roads between them, have the same approval number. The CCA clarified this is not in line with the legislation. The ACCA indicated this as a particular case due to historical reasons and that work was ongoing to address it. The ACCA started an investigation during the audit to confirm that this was not the case with other establishments in the AC.

The audit team noted difficulties with ensuring that approvals are kept updated in relation to activities no longer carried out by FBOs. In Navarra, one of the 11 establishments visited had approval for an activity not performed in ten years. In Pais Vasco, a dairy FBO informed the CA that the production ceased and the business was intended to be sold or rented. This type of information does not trigger temporary suspension of activity. The CA became aware that production restarted with a new owner due to an alert caused by detection of 100 000cfu/g Listeria monocytogenes in a RTE food produced in the establishment. The CA's visit on-the-spot identified serious non-compliances and the establishment had been closed since. Conclusions on registration and approval of food business operators

The ACCAs have systems in place for registration and approval of establishments producing RTE foods which for several aspects are supportive of achieving compliance. The ACCAs visited in general apply the related procedures, to a larger extent in Navarra. However, the procedure in Navarra and the implementation of the procedure in Cataluña, connected with training needs, do not ensure full and consistent compliance with the provisions of establishments' approval as provided for in Article 31 of Regulation (EC) No 882/2004.

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The regional guidelines for dairy production in Cataluña do not require FBOs to ensure the alternative methods used for alkaline phosphatase testing to verify the effectiveness of the pasteurisation process, are validated against the ISO method provided in Regulation (EC) No 2074/2005. As the guidance is used by both FBOs and CA staff, this aspect was not checked by FBO and not subject to official controls in the case assessed by the audit team. Conclusions on national measures

The national measures in place support both FBOs in addressing the microbiological hazards and control the production process of RTE foods, as well as CAs in performing the related official controls. Advice for consumers aiming to prevent food borne outbreaks is also available. There is scope for reviewing the regional measures to support a harmonised and correct implementation by the dairy industry of the measures for verifying the effectiveness of pasteurisation and related official controls.

In the cases assessed by the audit team, the CAs checked whether FBOs implement their sampling and testing plans for food safety criteria. In one case, the CA accepted the limit of 100cfu/g Listeria monocytogenes at the end of production for RTE sushi with a shelf- life of five days, in the absence of adequate FBO demonstration that this value would not be exceeded throughout the shelf-life of the product. This is not in line with Chapter 1, Annex I to Regulation (EC) No 2073/2005. The CA acknowledged challenges with the controls over FBOs' compliance with this Regulation and the lack of related training.

As regards process hygiene criteria, the controls had not been satisfactory in one of the three cases evaluated by the audit team. The CA considered the process hygiene criteria in Chapter 2, Annex II of Regulation (EC) No 2073/2005 as a FBO's choice and did not require the FBO to include in their procedures the compliance limits for these criteria and the action to be taken in case of non-compliance, as required by Article 7 of Regulation (EC) No 2073/2005.

The controls as regards the number of sampling units were in most cases satisfactory. In the relatively recently approved establishment visited, the CA accepted the FBO's reduction of sampling units from five to one in the absence of historical documentation proving effective HACCP-based procedures, contrary to the requirements of Article 5.3 of Regulation (EC) No 2073/2005. FBOs' testing methods had not been subject to official controls in the cases assessed. This is not required by the procedures in Navarra.

FBOs' shelf-life studies for RTE food able to support the growth of Listeria are required to be verified by the CAs routinely in Cataluña, but not in Navarra. The cases assessed by the audit team, both in Cataluña and in Comunidad Valenciana, revealed that in 16 general the CA asks for FBO shelf-life studies for Listeria monocytogenes or checks them thoroughly at the time of alerts, but not beforehand or routinely otherwise.

The provisions of the EURL Guidance on sampling the food processing area and equipment for the detection of Listeria monocytogenes and of the EURL Technical Guidance Document for conducting shelf-life studies on Listeria monocytogenes in RTE foods were in general not known, and not taken into account by CAs met which had not dealt with Listeria alerts.

Consequently, CA accepted that FBOs sampling only after cleaning and disinfection, which makes the detection of the pathogen difficult leading to a false sense of security. In one case where the CA evaluated the FBOs studies as satisfactory, the studies did not demonstrate that the food safety criteria applicable throughout the shelf-life of the products can be met under reasonably foreseeable conditions of distribution, storage and use as required by Article 3 of Regulation (EC) No 2073/2005. Also, the CA did not detect the lack of shelf-life studies for some product classes. In other cases, the CA accepted shelf-life studies based solely on organoleptic properties.

The controls cover satisfactorily a range of aspects of the "Hygiene Package", although there is scope for improvement in the controls over FBO's measures for prevention of cross-contamination and verification within the HACCP-based procedures, including the requirements of Regulation (EC) No 2073/2005 and of the EURL guidelines. The CAs' ability to detect relevant non-compliances and require adequate corrective actions is hindered by the fact that the control focus does not or not necessarily target (all) the areas relevant for food safety, whether by design or at the time of their implementation, and by some gaps in the knowledge of control staff.

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The actions taken in the cases of alerts related to RTE food assessed by the audit team showed a mixed picture. In Navarra, the CA carried out a swift visit on-the-spot and had verified and documented, in subsequent visits, a rapid tracing back, recall and destruction of the merchandise. Contrary to the national procedure for alerts, an official control to ascertain that the measures put in place by the FBO adequately address the cause(s) and prevent its(their) reoccurrence, does not take place. In Cataluña, the CAs carried out on-site visit and investigated the possible causes of RASFF alerts in the cases assessed by the audit team. 19

In Cataluña, the CA releases the detained product involved in a RASFF alert following detection of Salmonella by a molecular method in an outbreak investigation in the absence of apparent causes at establishment level, according to the official control reports carried out at the time and with negative official test results, Subsequently, the confirmation for Salmonella presence using the ISO method and information that the same strain had been involved in an outbreak was received via the RASFF network.

The new information received resulted in the CA questioning the FBO's food safety management system, called for more thorough official controls and CA requests for adequate shelf-life studies. Nonetheless, the CA had accepted that the FBO uses Salmonella-positive ingredients, in the absence of an indication of the level of contamination, provided 15 samples of the final products were negative. According to the FBO demonstration made available to the CA, the respective production process ensures one log reduction.

The ACCA stated the approach taken by the district CA in managing the RASFF alert above is not the routine one. In addition, following the audit team's visit, the CA requested the FBO to review their HACCP based procedures and to demonstrate that the processing is eliminating the hazard in question as required by Article 7 of Regulation (EC) No 2073/2005.

The action taken by the CA in Comunidad Valenciana in relation to several alerts concerning the same establishment producing RTE fishery products revealed also difficulties in ensuring that the contaminated foods are traced and recalled in a timely fashion, and that the actions put in place by the FBOs prevent recurrence. a. Some of the CA on-the-spot visits took place with one and two weeks delay that could not be justified. The control reports indicate delays in tracing back the product until the product had expired and a recall was not needed, and delays in addressing the root cause (sanctioned with 1000 penalty). b. Seven months after the first alert of these series, based on the outcome the shelf- life study, the shelf-life of the RTE products had been significantly shortened, for some RTE category by half. For non-compliances related to hygiene and lost traceability, the report indicate repeated request for immediate action in three consecutive reports, the third one with a 30 days deadline.

The ACCAs stated to have realised that the case could have been handled better, and to have taken action to address the control weaknesses. As a result, and for the year following this series of alerts, the monitoring system for on-the-spot visits following food incidents indicated a rapid response (see paragraph 54).

When the inspectors do not consider the non-compliances to be serious, the measures taken do not ensure that these are corrected routinely and in a timely fashion. In most of such cases seen by the audit team, the potential for product contamination was not adequately assessed, and CAs in general did not request action in relation to exposed products: 20 a. the CAs had given the same importance and same deadline (e.g. between seven days and 3 months) to maintenance non-compliances like peeling rust and peeling paint, irrespective of whether they could impact on exposed product or not (e.g. in the establishments producing composite products in Navarra, and in the fishery establishments in Cataluña). b. For action in relation to equipment in contact with food (inadequate cleaning of the slicer in a dairy establishment, peeling slicer in a composite products establishment), the CA in Navarra had given the same deadline as for addressing holes in the floor, while the FBO continued to use the former in production. c. In two of the three establishments visited where condensation was noted above exposed ingredients or intermediate products, the CA did not require FBO action in relation to the products or otherwise (Navarra). One of these was an establishment where Listeria had previously been detected in final products. In another establishment, CA accepted inadequate mitigating measures, considering that condensation was difficult to manage in the relevant area. d. In a third establishment, in Cataluña, the control reports documented repeated findings, including of ceiling condensation. Non-compliances considered minor had in general not been followed-up. At the time of the audit, the detection of ceiling condensation in the vicinity of exposed ingredients led to inadequate FBO action suggesting that the food safety management system in place was not able to effectively address this repeated failure. This did not trigger stronger enforcement action. e. In Cataluña, in an establishment producing different high risk RTE fishery products, the CA had not recorded in previous controls several and extended long standing maintenance and design issues as well as some operational hygiene ones noted by the same inspector during the audit. The inspector considered as minor non-compliance all maintenance issues, including when present above or in contact with exposed product, and stated to be reluctant to challenge the FBO whom he considered to have greater expertise. f. In the absence of adequate supervisory controls, the head of the district team did not detect the above mentioned situation. The report of a new reinforced district CA control in the same establishment identifying numerous shortcomings with short deadlines for remedy was submitted to the audit team at a later stage. g. Nonetheless, the approach to consider all maintenance issues minor, regardless of the potential for contaminating the product was in general shared by the control staff met in the ACs visited. This impacted on the corrective actions required by the CA and their effective follow-up. 21

In Cataluña, the CAs met by the audit team explained that they are not required to give a deadline for the FBO to rectify minor non-compliances. The CA is required to request action from FBO only in case of serious non-compliances5. This resulted in either non- compliances repeatedly recorded in control reports (e.g. meat establishment) without adequate action (this was the case also for the fishery establishment Comunidad Valenciana) or lack of recording of non-compliances considered to be of minor nature (e.g. fishery establishment).

In those cases where the potential risk associated with non-compliances considered as "minor" is not adequately assessed, this impacts on both the necessary requests for corrective action, as well as on the timeliness of their implementation. The action in case of non-compliance differs between the regions visited and the action in relation to the products is in general limited to instances of confirmed non-compliant official test results. 5 In their comments to the draft report the CA noted that under the procedures corrective measures must always be taken in case of non-compliance, whether minor, serious or very serious. The procedures do not set deadlines for the corrective measures to be implemented in the event of non-compliance; rather they establish, on the basis of the severity of the non-compliance, whether the corrective measure should be immediate or a timetable be set for their implementation. Hence, in Catalonia, non-compliances of this nature detected in the control reports can be attributed to incorrect application of the established procedures. 22

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The measures targeting a specific pathogen are more developed as regards Listeria monocytogenes. National or regional measures aiming to support FBOs and CAs in addressing the main cause of outbreaks, human cases and hospitalised persons 5 (Staphylococcus in dairy products) according to the national data (see chapter 3) have to date not been adopted.

Cataluña was implementing an initiative to address the main cause of food alerts due to pathogenic microorganisms (Salmonella detection in meat products) at the time of the audit. This initiative includes relevant guidance for official control staff, based on expert advice. Relevant information of this initiative, from which the control staff in other AC might benefit, has not been shared between ACs.

National guidelines to support FBOs in implementing HACCP based procedures and good hygiene practices are available for the production of RTE milk, egg products and fruit juices. Each AC may have other guidelines in place. In Cataluña such guidance documents are available as regards Listeria control in the food industry, and concerning hygiene requirements for raw milk cheese production. The production of increasingly popular types of foods considered as potentially presenting a higher risk, like raw products or composite RTE food, does not benefit yet from industry guides.

The regional guidelines for dairy production in Cataluña do not require FBOs to ensure the alternative methods used for alkaline phosphatase testing to verify the effectiveness of the pasteurisation process, are validated against the ISO method provided in Regulation (EC) No 2074/2005. As the guidance is used by both FBOs and CA staff, this aspect was not checked by FBO and not subject to official controls in the case assessed by the audit team. Conclusions on national measures

The national measures in place support both FBOs in addressing the microbiological hazards and control the production process of RTE foods, as well as CAs in performing the related official controls. Advice for consumers aiming to prevent food borne outbreaks is also available. There is scope for reviewing the regional measures to support a harmonised and correct implementation by the dairy industry of the measures for verifying the effectiveness of pasteurisation and related official controls.

There is scope for further exploring in the national or regional measures the options to address the hazards stemming from the highest number of outbreaks, human cases and hospitalised persons following consumption of RTE food in recent years, according to the national data, and for sharing relevant regional measures where available.

Coordination and cooperation mechanisms within and between the ACCAs and by AESAN are in place (e.g. inter-territorial and inter-sectoral coordination bodies, including a permanent working group for applying Hygiene Regulations, in tools for sharing good practices and problems). Examples of coordination and cooperation relevant for the RTE sector were presented to the audit team. While, in all cases assessed, the CA acted upon receipt of notification or request, the audit team noted that these actions are not necessarily swift: a. In the example of inter-AC coordination provided by the audit team (a complaint from a consumer with medical symptoms upon consumption of RTE food produced in a different AC), the local CA carried out the investigation two weeks after receiving the notification. The regional CA submitted the feedback to the other AC within one month from the initial communication as the suspicion had not been confirmed. b. AESAN informed the audit team that for production of unpasteurised dairy products, a coordination system is in place to ensure that CA carrying out controls in such establishments are informed when the animal health status of the herd providing the milk, changes. The deadline provided by the national legislation for communicating this information is maximum seven days. c. In the example provided to the audit team (i.e. the detection of tuberculosis at farm level), and while the public health CA received the notification from the animal health team promptly, an on­the-spot visit was organised four months after receiving the information. During this visit the official controls found raw milk cheese production using the milk from the herd where TB was detected.

Challenges were identified in particular in relation to aspects of training, efficient cooperation and coordination in practice, and the verification of effectiveness of controls. These challenges, together with delays in effectively addressing audit findings, may and sometimes do impact on the controls over the production of RTE foods.

The ACs visited have different procedures in place for approval of establishments. Some elements thereof support compliance with the provisions of Article 31, paragraph 2 of Regulation (EC) No 882/2004. a. In Navarra, an ACCA group of experts carries out an "in depth" initial evaluation of the written HACCP-based procedures before the FBO may start production. When the outcomes of this evaluation and of the on-site visit by the district CA are satisfactory, the ACCA grants the approval. The audit team received examples demonstrating the correct implementation of the regional procedure. b. In Cataluña, the district CAs issue conditional approval for three months when the outcome of the on-site visit, carried out upon receipt of an application for approval and before FBO starts operations, is satisfactory. Before issuing a full approval, another on-site visit within three months is required to establish compliance with the EU law while the establishment is in operation. The same procedure requires district CA to evaluate FBOs' compliance with infrastructures and own controls during these visits.

Different approaches are in place between ACs. Whether the product is RTE or not, and the risk data identified by the CA (see chapter 3) -for example, manipulation potentially introducing a hazard (e.g. slicing), lack of pasteurisation, the history of non-compliance- impact differently on the attributed the risk category, depending on the AC. The same RTE meat products are considered as medium risk by some ACs, but as low risk by others, while raw meat is considered high risk. In Navarra, the procedure allocates more points (i.e. a higher risk category) if FBOs do not have own controls/procedures than if 12 these controls/procedures are not implemented.

The data on the control frequency for RTE producing establishments (e.g. dairy, meat, fishery, composite products) assessed by the audit team indicate that the minimum frequency of controls in establishments of the same sector varies between once per year to four times per year, depending on the AC. Some AC did not provide information on their minimum frequency of controls. Certain controls are limited (see paragraph 51).

In Navarra, the risk-based criteria are used for establishing the frequency for general hygiene controls for new FBOs and new activities. For other cases, the frequency is every five years. The risk- based criteria are not used for establishing the frequency of controls over FBOs own controls including HACCP- based procedures, nor for controls on specific sector requirements (e.g. raw milk criteria). In Cataluña, the frequency of all types of controls is established on a risk basis.

Official controls are performed in Programmes that are grouped together in blocks. The following Programmes, particularly relevant for the scope of this audit, and the related implementation data provided by the CCA are summarised below: a. Programme 1 - general control of food establishments - include hygiene inspections. The MANCP data indicate that this Programme is applied yearly in all ACs and that the ACCAs implemented approximately 85% of the 435 809 scheduled controls under this Programme for the country in 2017 and detected non-compliances in 26 % of these controls. b. In establishments (excluding retail) in the meat, dairy, fishery and composite products/prepared dishes sectors - i.e. those most likely to produce RTE food, Programme 1 controls took place with a national average of just under two of such controls per establishment in 2017. The variations are between controls in 42% of the establishments in Islas Baleares up to 12 controls per establishment in Castilla la Mancha on average, in 2017. c. Programme 2 covers FBO's own controls, including HACCP based procedures and FBO's compliance with the provisions of Regulation (EC) No 2073/2005. Overall, the ACCAs implemented approximately of 85% of the 96 136 scheduled controls under this Programme for the country in 2017. CA detected non- compliances in 15.8 % of these controls (highest in the dairy sector). d. In establishments (excluding retail) in the meat, dairy, fishery and composite products/prepared dishes sectors - i.e. those most likely to produce RTE food, Programme 2 controls took place in 32% of the establishments in the country in 2017. The variations noted are between 2% of the establishments in Navarra to 121% of the establishments in Comunidad Valenciana. The frequency of controls, according to these figures, varied considerably between other AC, e.g. 3% in Cataluña, 5% in Galicia, 10% in Castilla la Mancha, 11% Pais Vasco, 14% in Andalucia). e. Programme 5 covers official controls over FBOs compliance with the legislation on food labelling and food contact materials (see paragraph 65). 14 f. Programme 11 covers official sampling and testing for microbiological criteria (see chapter 4.4.1.4). g. Programme 12 covers official controls over FBOs controls for Anisakis (see paragraph 64).

The differences in the approach between ACCAs towards various aspects of the organisation and implementation of the controls suggest a missed opportunity for sharing good practices and exploiting synergies between ACCAs with a view to providing comparable support for staff carrying out controls in establishments with similar risks, further strengthening the control systems and their consistency, as well as ensuring a uniform control approach towards all FBOs. 4.4.3 Challenges encountered by the CA in the organisation and performance of controls over the production of RTE foods

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However, some recommendations dating from 2015 such as putting in place audits of FBOs and an internal (CA) verification/supervisory system had not been closed to date. This is not in line with Article 4, Paragraph 6 of Regulation (EC) No 882/2004. The ACCA took some actions to address them, though limited for the RTE sector. The CA cited IT - and staffing issues (see paragraph 14), but indicated that these recommendations would be addressed this year.

In 2016 the supervisory system's objective was changed aiming for the yearly supervision of all inspectors. This objective was not met in 2016. Between 2016 and 2018 the system required documental supervision, including the possibility of on-site verification at the monitoring team's request. The later was used to a limited extent, mainly in relation to exports. The ACCA highlighted that from 2019 onwards each inspector has to be supervised on-the-spot.. In the absence of adequate verification of effectiveness of the controls, required by Article 8, Paragraph 3, point (b) of Regulation (EC) No 882/2004, the training needs affecting the performance of the controls had not been identified. Conclusions on competent authority

Challenges were identified in particular in relation to aspects of training, efficient cooperation and coordination in practice, and the verification of effectiveness of controls. These challenges, together with delays in effectively addressing audit findings, may and sometimes do impact on the controls over the production of RTE foods.

The actions taken in the cases of alerts related to RTE food assessed by the audit team showed a mixed picture. In Navarra, the CA carried out a swift visit on-the-spot and had verified and documented, in subsequent visits, a rapid tracing back, recall and destruction of the merchandise. Contrary to the national procedure for alerts, an official control to ascertain that the measures put in place by the FBO adequately address the cause(s) and prevent its(their) reoccurrence, does not take place. In Cataluña, the CAs carried out on-site visit and investigated the possible causes of RASFF alerts in the cases assessed by the audit team. 19

In Cataluña, the CA releases the detained product involved in a RASFF alert following detection of Salmonella by a molecular method in an outbreak investigation in the absence of apparent causes at establishment level, according to the official control reports carried out at the time and with negative official test results, Subsequently, the confirmation for Salmonella presence using the ISO method and information that the same strain had been involved in an outbreak was received via the RASFF network.

The new information received resulted in the CA questioning the FBO's food safety management system, called for more thorough official controls and CA requests for adequate shelf-life studies. Nonetheless, the CA had accepted that the FBO uses Salmonella-positive ingredients, in the absence of an indication of the level of contamination, provided 15 samples of the final products were negative. According to the FBO demonstration made available to the CA, the respective production process ensures one log reduction.

The ACCA stated the approach taken by the district CA in managing the RASFF alert above is not the routine one. In addition, following the audit team's visit, the CA requested the FBO to review their HACCP based procedures and to demonstrate that the processing is eliminating the hazard in question as required by Article 7 of Regulation (EC) No 2073/2005.

The action taken by the CA in Comunidad Valenciana in relation to several alerts concerning the same establishment producing RTE fishery products revealed also difficulties in ensuring that the contaminated foods are traced and recalled in a timely fashion, and that the actions put in place by the FBOs prevent recurrence. a. Some of the CA on-the-spot visits took place with one and two weeks delay that could not be justified. The control reports indicate delays in tracing back the product until the product had expired and a recall was not needed, and delays in addressing the root cause (sanctioned with 1000 penalty). b. Seven months after the first alert of these series, based on the outcome the shelf- life study, the shelf-life of the RTE products had been significantly shortened, for some RTE category by half. For non-compliances related to hygiene and lost traceability, the report indicate repeated request for immediate action in three consecutive reports, the third one with a 30 days deadline.

The ACCAs stated to have realised that the case could have been handled better, and to have taken action to address the control weaknesses. As a result, and for the year following this series of alerts, the monitoring system for on-the-spot visits following food incidents indicated a rapid response (see paragraph 54).

When the inspectors do not consider the non-compliances to be serious, the measures taken do not ensure that these are corrected routinely and in a timely fashion. In most of such cases seen by the audit team, the potential for product contamination was not adequately assessed, and CAs in general did not request action in relation to exposed products: 20 a. the CAs had given the same importance and same deadline (e.g. between seven days and 3 months) to maintenance non-compliances like peeling rust and peeling paint, irrespective of whether they could impact on exposed product or not (e.g. in the establishments producing composite products in Navarra, and in the fishery establishments in Cataluña). b. For action in relation to equipment in contact with food (inadequate cleaning of the slicer in a dairy establishment, peeling slicer in a composite products establishment), the CA in Navarra had given the same deadline as for addressing holes in the floor, while the FBO continued to use the former in production. c. In two of the three establishments visited where condensation was noted above exposed ingredients or intermediate products, the CA did not require FBO action in relation to the products or otherwise (Navarra). One of these was an establishment where Listeria had previously been detected in final products. In another establishment, CA accepted inadequate mitigating measures, considering that condensation was difficult to manage in the relevant area. d. In a third establishment, in Cataluña, the control reports documented repeated findings, including of ceiling condensation. Non-compliances considered minor had in general not been followed-up. At the time of the audit, the detection of ceiling condensation in the vicinity of exposed ingredients led to inadequate FBO action suggesting that the food safety management system in place was not able to effectively address this repeated failure. This did not trigger stronger enforcement action. e. In Cataluña, in an establishment producing different high risk RTE fishery products, the CA had not recorded in previous controls several and extended long standing maintenance and design issues as well as some operational hygiene ones noted by the same inspector during the audit. The inspector considered as minor non-compliance all maintenance issues, including when present above or in contact with exposed product, and stated to be reluctant to challenge the FBO whom he considered to have greater expertise. f. In the absence of adequate supervisory controls, the head of the district team did not detect the above mentioned situation. The report of a new reinforced district CA control in the same establishment identifying numerous shortcomings with short deadlines for remedy was submitted to the audit team at a later stage. g. Nonetheless, the approach to consider all maintenance issues minor, regardless of the potential for contaminating the product was in general shared by the control staff met in the ACs visited. This impacted on the corrective actions required by the CA and their effective follow-up. 21

In Cataluña, the CAs met by the audit team explained that they are not required to give a deadline for the FBO to rectify minor non-compliances. The CA is required to request action from FBO only in case of serious non-compliances5. This resulted in either non- compliances repeatedly recorded in control reports (e.g. meat establishment) without adequate action (this was the case also for the fishery establishment Comunidad Valenciana) or lack of recording of non-compliances considered to be of minor nature (e.g. fishery establishment).

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The provisions of the EURL Guidance on sampling the food processing area and equipment for the detection of Listeria monocytogenes and of the EURL Technical Guidance Document for conducting shelf-life studies on Listeria monocytogenes in RTE foods were in general not known, and not taken into account by CAs met which had not dealt with Listeria alerts.

Consequently, CA accepted that FBOs sampling only after cleaning and disinfection, which makes the detection of the pathogen difficult leading to a false sense of security. In one case where the CA evaluated the FBOs studies as satisfactory, the studies did not demonstrate that the food safety criteria applicable throughout the shelf-life of the products can be met under reasonably foreseeable conditions of distribution, storage and use as required by Article 3 of Regulation (EC) No 2073/2005. Also, the CA did not detect the lack of shelf-life studies for some product classes. In other cases, the CA accepted shelf-life studies based solely on organoleptic properties.

The controls cover satisfactorily a range of aspects of the "Hygiene Package", although there is scope for improvement in the controls over FBO's measures for prevention of cross-contamination and verification within the HACCP-based procedures, including the requirements of Regulation (EC) No 2073/2005 and of the EURL guidelines. The CAs' ability to detect relevant non-compliances and require adequate corrective actions is hindered by the fact that the control focus does not or not necessarily target (all) the areas relevant for food safety, whether by design or at the time of their implementation, and by some gaps in the knowledge of control staff.

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Parts 1 and 2 of PNCOCA include national guidance for the drafting and implementation of procedures to verify the effectiveness of the controls carried out. This guidance covers amongst others supervision mechanisms, and internal audits.

However, the audit team noted flaws in the supervision arrangements (not effective or not implemented) and internal audits. This weakens the overall effectiveness of the official control system with regard to the approval of, and the official control of establishments (see sections 5.2 and 5.3.1 of this report). 10

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The competent authorities should carry out internal audits and implement the verification procedures defined either in the multi-annual national control plan or in the autonomous community control plan, as required by articles 4(6) and 8(3)(a) of Regulation (EC) no 882/2004. Recommendation based on conclusion No 37. Associated findings Nos 10 to 15.

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In the case of an approval granted in 2015, the approval procedure had not been correctly followed. The audit team was informed that, at that time, the assessment of the HACCP plan was not part of the approval procedure and that, during the on-site approval visit, the HACCP had not been audited.

However, the adequate and effective implementation of the control procedures by the authorities with a view to maintain up-to-date the lists of approved establishments is hindered by the non-respect of both FBOs and competent authorities' obligations, as required respectively by Article 6(2) of Regulation (EC) No 852/2004 and of Article 31(2)(c) and (e) of Regulation (EC) No 882/2004. 12

Medlemsstatens svar

The competent authorities should, in accordance with Article 31(2)(c) of Regulation (EC) No 882/2004, ensure that only approve establishments for which the food business operator has demonstrated that it complies with the relevant requirements of food law, in particular, the requirements of Article 5 of Regulation (EC) No 852/2004 concerning the HACCP. Recommendation based on conclusion No 53. Associated findings Nos 43 to 46.

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In two cases the audit team noted that FBOs had considerably changed their manufacturing process without communicating these to the competent authorities. In one of the cases the changes consisted of the displacement of equipment and modification of the production flow; the other concerned the introduction of a new production line for manufacture a new product, in an area not designed for that purpose.

However, the adequate and effective implementation of the control procedures by the authorities with a view to maintain up-to-date the lists of approved establishments is hindered by the non-respect of both FBOs and competent authorities' obligations, as required respectively by Article 6(2) of Regulation (EC) No 852/2004 and of Article 31(2)(c) and (e) of Regulation (EC) No 882/2004. 12

Medlemsstatens svar

The competent authorities should, in accordance with Article 31(2)(e) of Regulation (EC) No 882/2004 and Chapter I(1)(b)(i) of Annex III to Regulation (EC) No 854/2004, ensure that when carrying out official controls the approval of establishment is kept under review also in order to detected possible changes made by the FBOs that have not been communicated as per their legal obligations of Article 6(2) of Regulation (EC) No 852/2004. Recommendation based on conclusion No 53. Associated findings Nos 48 to 51.

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Page: 1 f. DG(SANTE) 2019-6678 of the audit carried out from 07 May 2019 to tion of fishery products derived from tuna species Action Proposed by the competent authority

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The CAs of the AC Valencia decided to check the possible presence of Xf with a grid- based survey beyond the borders of the DA of 5 km radius, established in 2017. The 10km area surrounding the borders of the BZ was divided into 1km x 1km grid. In 2018, the majority of the squares were visually inspected and the symptomatic plants were sampled. This surveillance resulted in 18 positives, each of those was found close to the border of the BZ established after the 2017 surveys.

Although significant efforts were made in 2018 to monitor the presence of Xf in the DA, due to incomplete surveys, the proper extent of the spread and the full host range of the pathogen in the DA is not known.

Medlemsstatens svar

in Se ha contratado más personal para la realización de las ctividades de prospección para la campaña 2019. Se incrementarán las prospecciones en la zona demarcada, prioritariamente en la zona del límite exterior de la ZD para poder delimitar con mayor precisión la extensión de la ZD, pero también para aumentar la prospección en el primer Km de la Zona Tampón

in More staff have been recruited to carry out surveying activities for he 2019 campaign. The surveys in the demarcated area will be increased, primarily in the outer boundary area of the ZD in order to be able to delimit with greater precision the extent of the ZD, but also to increase prospecting in the first km of the Buffer Zone.

e staff have been recruited to carry out surveying activities for the 2019 campaign. Respuesta de Comunidad Valenciana: El The surveys in the demarcated area will be plan de acción no prevé CONCENTRAR las increased, primarily in the outer boundary actividades de prospección en los area of the demarcated area in order to be alrededores de la ZD, las prospecciones se able to delimit with greater precision the CONCENTRAN en la zona demarcada, y se extent of the area, but also to increase prevén unas prospecciones DE MENOR INTENSIDAD en la envolvente de 10Km prospecting in the first km of the Buffer alrededor de la ZD, de hecho se han Zone. muestreado el 22% de las cuadrículas de la envolvente exterior de la ZD, pero se han muestreado el 99% de las cuadrículas de 1Km de la Zona Tampón.

e staff have been recruited to carry out surveying activities for the 2019 campaign. Response from Comunidad Valenciana: The The surveys in the demarcated area will be action plan does not foresee increased, primarily in the outer boundary CONCENTRING the surveying activities in area of the demarcated area in order to be the surroundings of the DZ, the surveys are able to delimit with greater precision the CONCENTRATED in the demarcated zone, extent of the area, but also to increase and some LESS INTENSITY surveys are foreseen in the 10Km envelope around the prospecting in the first km of the Buffer DZ, in fact 22% of the grids of the external Zone. envelope of the DZ have been sampled, but 99% of the 1Km grids of the Buffer Zone have been sampled.

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The CA of the AC Valencia stated that until end of March 2019: From the 440 plants, which tested positive during the 2017 monitoring, 370 have been felled. The remaining 70 positives are located in parcels where the owners refused to grant access to the CAs' for eradication; The removal of host plants was completed only in 11 IZs, although more than 50% of the 75,000 host plants (mainly almond trees) which were found in the zones have already been felled (see Table VI). The completion of the work in the IZs with felling activities was hindered or not possible due to legal issues (see paragraph 49); As in the DA of the AC Valencia Xf was not detected on olive trees, Olea europaea is not considered as a host of the type of the bacterium present in the area, and therefore, olive trees have not been removed in any of the IZs. Table V. Eradication activities in the DA of the AC Valencia in 2018 Number of IZs Number of host plants (in all IZs) Total Removals Positive At least one Clear-cut Tested Positives Identified Removed established started plants positive completed positive removed in total in total removed tested plant 11 440 370 70,949 37,740 removed 157 145 102 27 Source:CA of the AC Valencia

Although numerous host plants were removed in the IZs established in 2017, due to the partial and delayed removal of the positives and the host plants in their 100m vicinity, the conditions remained favourable for the spread of the disease within and from the DA. The same conditions are valid for the high number of new positives identified during 2018 and for the host plants in their 100m vicinity.

Medlemsstatens svar

Se han mantenido varias reuniones con los Alcaldes de los municipios incluidos en la ZD solicitando su colabaración para ons acelerar la eliminación de los positivos. Uno de los tribunales de Alicante ha dictado la primera sentencia, siendo ésta a favor de la Conselleria de Agricultura en lo referente a la adopción de medidas frente a Xylella fastidiosa, por lo que esperamos dicha sentencia sirva de precedente para las sentencias de otros recursos interpuestos por los afectados, así como en lo referente a las autorizaciones de acceso a parcelas valladas para la eliminación de positivos. Todas las plantas hospedadoras a X.f. multiplex (excepcto el olivo) se están eliminando en las Zonas Infectadas. Los ensayos de patogenicidad que se están llevando a cabo en el IVIA siguen sin poder demostrar que el Olivo sea una planta hospedante de X.f. multiplex ST6 Page: 1 3 August 2019 report ref. DG(SANTE)/2019-6730-MR of the audit carried out from 01 April trols for Xylella fastidiosa on Proposed by the competent authority

Several meetings have been held with the Mayors of the municipalities included in the ZD requesting their collaboration to ons accelerate the elimination of the positives. One of the courts of Alicante has issued the first ruling, this being in favour of the Conselleria de Agricultura regarding the adoption of measures against Xylella fastidiosa, so we hope that this ruling will serve as a precedent for the judgments of other appeals filed by those affected, as well as in relation to authorisations for access to fenced plots for the elimination of the positives. All host plants of X.f. multiplex (except the olive tree) are being eliminated in the Infected Zones. The pathogenicity tests that are being carried out in the IVIA still cannot demonstrate that the Olive tree is a host plant of X.f. multiplex ST6.

ral meetings have been held with the Respuesta de Comunidad Valenciana: Mayors of the municipalities included in the con datos actualizados, se puede decir demarcated area requesting their que SI se están aplicando medidas de collaboration to accelerate the removal of the erradicación, que van más allá de las positive plants. plantas positivas. De hecho hay declaradas 1.547 plantas positivas, de las One of the courts of Alicante has issued the cuales se han eliminado hasta la fecha first ruling, this being in favour of the 1.403; si se tiene en cuenta todos los vegetales hospedantes eliminados se tienen más de 62.500... por lo que se Conselleria de Agricultura regarding the puede deducir que SI se está adoption of measures against Xylella destruyendo en el entorno de 100m no Page: 1 tions (updated) received 20/12/2019 ted by the competent authorities of Spain in response to Report ref. DG(SANTE)/2019-6730-MR 019 in order to evaluate the situation and official controls for Xylella fastidiosa Action Proposed by the competent authority Updated Action Proposed by the Competent Authority fastidiosa, so we hope that this ruling will sólo las plantas positivas, sino también serve as a pre

ral meetings have been held with the Mayors of the municipalities included in the demarcated area requesting their Response from Comunidad Valenciana: collaboration to accelerate the removal of the with updated data, it can be said that the positive plants. eradication measures are being applied, which go beyond positive plants. In fact, One of the courts of Alicante has issued the 1,547 positive plants have been declared, first ruling, this being in favour of the of which 1,403 have been eliminated to Conselleria de Agricultura regarding the date; if all the eliminated host plants are taken into account, there are more than 62,500... so it can be deduced that YES adoption of measures against Xylella Comunidad Valenciana is destroying not Page: 1 e to the report's recommendations (updated) received 20/12/2019 Spain in response to Report ref. DG(SANTE)/2019-6730-MR of the audit carried out from 01 April and official controls for Xylella fastidiosa Action Proposed by the competent authority Updated Action Proposed by the competent authority fastidiosa, so we hope that this ruling will only the positive plants in the 100m serve as a precedent for the judgments of environment, but also

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Since the 2018 audit, the CAs of the AC Valencia carried out movement controls as detailed in Table VI. Non-compliance was found only in one case at a control in a port. Table VI. Movement controls in the DA of the AC Valencia since the 2018 audit Nurseries/garden Roads Ports/ferries Airports centres 2,302 147 154 576 Source: CA of the AC Valencia

The movement controls implemented in the DA of the AC Valencia, in particular the system of inspections in the nurseries, cannot guarantee that specified plants do not leave that area.

Medlemsstatens svar

ts Se realizarán más controles aleatorios y programados en el lugar estino de la zona tampón a los viveros y Garden Centers que recibido vegetales especificados procedentes de otros viveros GC de la ZD. olicitará a la Guardia Civil que ajuste sus controles de etera en función del riesgo (épocas de mayor movimiento de rial vegetal, proximidad a viveros, ...) para evitar la agación de la enfermedad. : 2

ts Further random and scheduled checks at the destination of the buffer zone will be carried out on nurseries and Garden Centers that have received specified plants from other nurseries and/or GC in the ZD. The Guardia Civil will be asked to adjust its roadblocks according to the risk (times of increased movement of plant material, proximity to nurseries, ...) to prevent the spread of the disease. Page: 1

Further random and scheduled checks at the destination of the buffer zone will be carried Respuesta de Comunidad valenciana: se e out on nurseries and Garden Centers that have están realizando al menos 2 inspecciones received specified plants from other nurseries anuales en los Viveros y Garden Centers and/or GC in the demarcated area. de la Zona Demarcada. Tanto en las inspecciones de los viveros, como en los controles de carretera se tienen en cuenta factores de riesgo como especie vegetal Page: 2 tions (updated) received 20/12/2019 ted by the competent authorities of Spain in response to Report ref. DG(SANTE)/2019-6730-MR 019 in order to evaluate the situation and official controls for Xylella fastidiosa uthority Updated Action Proposed by the Competent Authority adjust its (controles centrados en plantas de times of almendro, Polygala, otras especies de al, Prunus), periodos de mayor movimiento event the de planta (de abril a octubre), y periodos de mayor presencia de adultos de los insectos vectores (de abril a diciembre). Page: 3

Further random and scheduled checks at the destination of the buffer zone will be carried Response from Comunidad Valenciana: At e out on nurseries and Garden Centers that have least 2 annual inspections are being received specified plants from other nurseries conducted in the Nurseries and Garden and/or GC in the demarcated area. Centers of the Demarcated Area. Both nursery inspections and roadblocks take into account risk factors such as plant species (controls focused on almond plants, Polygala, other Prunus species), Page: 2 e to the report's recommendations (updated) received 20/12/2019 Spain in response to Report ref. DG(SANTE)/2019-6730-MR of the audit carried out from 01 April and official controls for Xylella fastidiosa uthority Updated Action Proposed by the competent authority adjust its times of periods of increased plant movement al, (April to October), and periods of event the increased adult presence of vector insects (April to December). Page: 3

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MAPA and the ACPHS for Galicia confirmed that no further notifications had been provided since 2016, although the T. erytreae had since continued to spread in Galicia, including into the Province of Lugo. The distribution of T. erytreae in Galicia is illustrated in Figure 1 below, which also indicates the year in which the pest was first found in each municipality. Figure 1: Distribution of T. erytreae in Galicia in 2019 10

The data in Figure 1 above indicates that T. erytreae was found in a number of new areas only in 2019 or 2018, in particular in the Province of Lugo and eastern parts of the Province of A Coruña. Neither the new information concerning the spread of the pest into a new area, nor the change of control strategy for T. erytreae detailed in section 5.3 below, were notified to the Commission and other Member States, as required by Article 2(5) of Decision 2014/917/EU.

The initial outbreaks of T. erytreae were notified to the European Commission and other Member States, however, the pests' continued spread into new areas of Galicia was not notified, which hinders the ability of other areas of Spain and the other Member States, in adapting their official controls as necessary.

Medlemsstatens svar

a La actualización de la zona demarca se realiza periódicamente de acuerdo a los resultados de las prospecciones y de una forma flexible debido al avance de la plaga. s En cualquier caso, se realizarán notificaciones sobre la extensión n de la plaga cuando se confirme la presencia de la misma en nuevas zonas distintas de las infestadas de acuerdo a la tiva vigente.

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As noted in section 5.2.2 above, the ACPHS has not legally revised the demarcated areas for T. erytreae since 2016. Instead, the ACPHS stated that it implements a 'flexible demarcation' in the event that T. erytreae is found in a new area. In practice, this means that the movement of host plants from nurseries in areas, or even places, where T. erytreae has been found is not prohibited. The infested plants identified in the places must either be destroyed or heavily pruned and treated with a plant protection product, but other (un-infested) host plants on the site may be moved within the demarcated area. The audit team noted that the flexibly demarcated areas are not recorded, and the ACPHS inspectors performing checks did not appear to be aware, or concerned, whether a nursery or retailer of host plants was situated in such a flexibly demarcated area or not.

However, such an approach is not in line with EU requirements for the production and movement of host plants in item 10.1 of Annex IV Part A Section II to Directive 2000/29/EC, nor is in line with the national or regional legislation for the pest, which undermines confidence in the guarantees, and pest free status of host plants, that are intended to be provided by that legislation. Conclusion on control measures for T. erytreae, D. citri and HLB

The control measures have also not been fully applied in Galicia, in particular in those areas in which T. erytreae occurs, but that have not been demarcated, as required. That undermines confidence in the guarantees, and pest-free status of host plants, which are intended to be provided by the national and regional legislation and EU legislation, and poses a risk for the further spread of the pest in trade.

Medlemsstatens svar

Como ya se indicó durante la auditoría, en Galicia, la presencia de plantas hospedantes de Trioza erytreae es muy dispersa pués está fundamentalmente localizada en pequeños huertos y jardines de propietarios particulares. ismo, no hay producción de planta y, en general, la disponible en viveros procede de zonas de fuera de Galicia que están libres de la plaga. Los viveros de zonas libres que venden planta, restringen su comercialización a su entorno local por lo que los movimientos son muy reducidos. Nuestra experiencia parece indicar que la infección no se produce por el movimiento de planta, sino por la dispersión de la plaga de una zona infestada a otra próxima debido al vuelo de los adultos. En cualquier caso, está previsto publicar breve una resolución que actualice las zonas infectadas por Trioza eritreae. Así mismo se notificará, a todos los viveros y comercializadores de cítricos, las restricciones existentes en el movimiento de plantas hospedantes. Los interesados también podrán consultar las zonas infestadas, y las medidas a aplicar para evitar la extensión de la plaga a través de una página WEB. Page: 1 /02/2020 eport ref. DG(SANTE) 2019-6732 of the audit carried out fro

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The National Contingency Plans establish the means for implementing the measures required by the Royal Decree. MAPA confirmed that there have been no changes to those plans since the previous audit, and the plans have not been reviewed or tested through test-exercises.

MAPA and the ACPHS of the Canary Islands and Galicia provided details of their experience with the use of plant protection products as part of their control measures for the eradication or containment of T. erytreae, which were initiated following the first findings of the pest in those Autonomous Communities. The report of the previous audit provides a detailed description of the area-wide pesticide applications by TRAGSA in Galicia at that time, which were based on the initial experience in the Canary Islands. Although the treatments had proved effective at protecting individual host plants, the ACPHS stated that they had proved ineffective at preventing the spread of the pest or even in suppressing it, in infested areas.

MAPA highlighted the continued withdrawal of authorisation of a number of the plant protection products since the previous audit, including for neonicotinoides14. MAPA stated that they would not grant emergency authorisation under Article 53(1) of Regulation (EU) No 1107/2009, for the use of such plant protection products.

MAPA and the ACPHS also highlighted the problem with false-positives in the initial laboratory screening tests for HLB. That can lead to a significant number of results, which must subsequently be confirmed, or refuted by further laboratory analysis. MAPA stated that the additional tests may take a long period of time and are resource intensive and that this complicates the surveys and means that it is legally difficult for the authorities to take action, based on a possibly false preliminary positive result for HLB.

There were no requirements for the establishment or review of contingency plans in the EU legislation applicable at the time of the audit. MAPA informed the audit team that National Contingency Plans had not been reviewed or evaluated in light of experience, as recommended by point 12 of EPPO Standard PM9/10(1).

However, the legislation and contingency plans have not been reviewed in light of experience, in particular the proven ineffectiveness of plant protection products, which play a key role in the control measures, which undermines confidence in the ability of the proposed control measures to ensure the prompt and effective eradication of new outbreaks of those pests.

Medlemsstatens svar

ency La revisión del Plan de Contingencia de Trioza es competencia el MAPA y, de acuerdo a las recomendaciones, se está revisando ity and para su actualización. t of En relación a la disponibilidad de insecticidas en Trioza eritreae, rovided como ya se ha indicado durante el desarrollo de la auditoría, desde el 9 de septiembre de 2019 se ha ampliado la autorización being de insecticidas para su uso en cítricos a efectos de prevenir la extensión del organismo nocivo en plantas huéspedes. Indicar e también se utilizan insecticidas autorizados para insectos chupadores que además actúan sobre Trioza erytreae. Adicionalmente, informamos que vistos los buenos resultados obtenidos por la utilización de Tamarixia ssp. en Canarias, se están realizado ensayos de utilización de este parasitoide para combatir Trioza erytreae en Galicia. Estos ensayos incluyen el seguimiento de la evolución de Tamarixia para analizar su comportamiento en las condiciones de Galicia y establecer las condiciones de su utilización. Page: 2

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The demarcated area of As Neves was established following the first finding of PWN in the area in 2010. The situation up until November 2016 was evaluated in detail by the previous audit. The demarcation was revised following the seven new findings in the demarcated area in August 2018 after a significant delay, by the Resolution of 28 December 2018 of the Directorate-General of Livestock, Agriculture and Agri-Food Industries (14). The revised demarcated area is illustrated in Figure 1 below (Annex IV of the Resolution), and is in line with the provisions of Article 5(2) of Decision 2012/535/EU.

The ACPHS indicated that there were no particular reasons why the demarcated area was not revised `without delay' as required by Article 5(3) of Decision 2012/535/EU. The audit team noted during visits to wood processing industry and heat-treatment facility in Galicia, that susceptible material continued to move from the area, pending its demarcation. Figure 1: Situation of PWN in Galicia ­ As Neves demarcated area

The significant delay in establishing a new demarcated area following the finding of seven new infested trees in As Neves, did not hinder the felling and removal of those trees. However, it did delay the application of controls on the movement of susceptible material from the area, necessary to limit the potential of the pest to spread through such movements. 13

Medlemsstatens svar

The identification of the new outbreaks in 2018 meant the e immediate elimination of the affected trees and their destruction, following the protocol established in the national contingency plan for the Pine Wood Nematode and the Galicia Action Plan. However, the resolution establishing the elimination of a 100 m buffer zone around the affected trees could not be published immediately. It should be pointed out that during all this time all the symptomatic trees around the affected points were eliminated and a very exhaustive follow-up was carried out to avoid the movement of sensitive material. In any case, we expect that, in the event of new detections of infected trees, a resolution will be made immediately to be able to carry out the actions required to establish the buffer and demarcated zones, so that they can implement the measures established in Decision 2012/535/EU.

La identificación de los nuevos focos del año 2018 supuso la e inmediata eliminación de los árboles afectados y su destrucción, siguiendo el protocolo establecido en el plan de contingencia nacional para el Nematodo de la Madera del Pino y el Plan de Acción de Galicia. Pero no se pudo publicar de forma inmediata la resolución que establecía la eliminación de una zona buffer de 100 m entorno a los árboles afectados. Se debe indicar que durante todo este tiempo se eliminaron todos los árboles sintomáticos entorno a los puntos afectados y se realizó un seguimiento muy exaustivo para evitar movimiento de material sensible. En todo caso, esperamos que, en el caso de que se produzcan nuevas detecciones de árboles infectados, se realizará de forma inmediata una resolución para poder realizar las acciones requeridas para establecer la zona buffer y demarcada, con lo que de este modo se puedan implantar las medidas establecidas en la Decisión 2012/535/UE.

he identification of the new outbreaks in La situación que se dió en el año 2018 fue 2018 meant the immediate elimination of the excepcional motivada por un periodo de affected trees and their destruction, following tiempo en el que hubo cambios en el the protocol established in the national gobierno que dilataron la publicación de contingency plan for the Pine Wood la Resolución en el Boletín Oficial hasta Nematode and the Galicia Action Plan. que un nuevo responsable estuviera However, the resolution establishing the nombrado al efecto de firmarla. elimination of a 100 m buffer zone around the Esta situación no debe de volver a affected trees could not be published repetirse y en todo caso para evitarlo se va immediately. It should be pointed out that a incluir en el Plan de Acción. Se incluirá during all this time all the symptomatic trees en el plan de acción unas instrucciones around the affected points were eliminated firmadas por el director general para que and a very exhaustive follow-up was carried en cuanto se detecte y notifique un nuevo brote de la plaga solo sea necesaria la out to avoid the movement of sensitive comunicación a los propietarios afectados material. de

he identification of the new outbreaks in 2018 meant the immediate elimination of the The situation in 2018 was exceptional due affected trees and their destruction, following to a period of time in which there were the protocol established in the national changes in the government that delayed contingency plan for the Pine Wood the publication of the Resolution in the Nematode and the Galicia Action Plan. Official Bulletin until a new official was However, the resolution establishing the appointed to sign it. elimination of a 100 m buffer zone around the This situation must not be repeated and in affected trees could not be published any case, to avoid it, it will be included in immediately. It should be pointed out that the Action Plan. Instructions signed by the during all this time all the symptomatic trees Director General will be included in the around the affected points were eliminated Action Plan so that as soon as a new and a very exhaustive follow-up was carried outbreak of the pest is detected and reported, only the communication to the out to avoid the movement of sensitive affected owners of the removal of trees in material. the 100 m area will be necessary. Communica

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In every establishment visited, the audit team checked the feed inspectors' assessment of the operators' hazard analysis and critical control points (HACCP) plans. In many cases, the inspectors' assessment was sufficient. However, in 6 out of 11 establishments visited, the audit team noted shortcomings in relation to the adequacy of the risk assessment for some ingredients used for the production of feed additives (predominantly contaminants of chemical origin, e.g., heavy metals, dioxins/polychlorinated biphenyls (PCBs), etc.). The failure of the operators to identify relevant hazards, as required by Article 6(2)(a) of Regulation (EC) No 183/2005, was neither spotted by the inspectors met during the audit nor had these issues been identified in any of the previous inspection reports.

The system of planning of inspections is based on appropriate risk-related factors and thus ensures that the official controls are carried out regularly, on a risk-basis and with appropriate frequency. The effectiveness of the inspections is weakened by deficient assessment of the operators' HACCP-plans, and incomplete verification of completeness of the operators' record-keeping and of appropriateness of the retained samples. Infrequent verification of the correctness of labelling reduces the competent authorities' possibility to adequately verify that labelling requirements have been met by FeBOs. 5.2.2 Sampling 5.2.2.1 PLANNING OF OFFICIAL SAMPLING

The audit team examined two RASFF notifications (one originated from Spain and one sent to Spain due to the distribution of the affected product) and actions taken by relevant competent authorities. While the immediate actions taken to ensure withdrawal of the products affected from the market were sufficient and timely, the audit team noted that no specific actions were taken to ensure that the FeBOs revised their HACCP-plans with the aim to make sure that the same situation did not occur again. In both cases, the operators' own checks were not designed to identify the deficiencies which had eventually triggered the RASFF notifications. The situation thus cannot be considered as completely remedied as required by Article 54(1) of Regulation (EC) No 882/2004.

Medlemsstatens svar

Formación: Para autoridades competentes:

ormación: utoridades competentes: Organización de cursos de formación para inspectores en los que se incluya la identificación de los peligros más frecuentes en materias primas y aditivos y la verificación de los sistemas APPCC. Fecha prevista: octubre 2019 Para los operadores: Volver a difundir el listado de peligros más frecuentes en función del tipo de pienso (materia prima, aditivo o premezcla). Fecha prevista: marzo de 2019 Documentos para el control oficial Incluir la verificación del cumplimiento/adecuación del APPCC en los documentos de verificación utilizados en el control oficial de establecimientos Incluir en las actas de inspección o informes posteriores las modificaciones recomendadas en el APPCC y los plazos de subsanación establecidos. Se incluirán también este tipo de medidas en el seguimiento de las notificaciones RASFF- Fecha prevista: diciembre 2019

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In general, the feed inspectors met demonstrated good knowledge of the relevant legislative provisions laid down by Article 18 of Regulation (EC) No 178/2002 and in the section "Record-keeping" in Annex II to Regulation (EC) No 183/2005. 6 Nonetheless, in 2 of the 11 establishments visited, traceability was undermined by deficient record-keeping by the operators (namely absence of the batch number of the incoming materials used for production of feed additives/premixtures). This is not in line with the requirements laid down in the section on "Record-keeping" (1 and 2(b)) in Annex II to Regulation (EC) No 183/2005. These shortcomings were not spotted by the inspectors met during the visits of the two establishments, nor had they been reflected in the previous inspection reports.

As for the operators' obligation to take samples of ingredients and of each batch of products manufactured and placed on the market, or of each specific portion of production (in the case of continuous production) in sufficient quantities using a procedure pre-established by the manufacturer (hereinafter: retained samples), the audit team checked several samples in all of the establishments visited and noted that in many cases they could not be considered as adequate due to the absence of a pre-established written procedure (on taking of retained samples) by the operators, absence of sealing, and/or insufficient quantity. The audit team noted that samples of ingredients are rarely taken in the majority of the FeBOs visited. This is not in line with the requirements laid down in the section "Quality control"(4) of Annex II to Regulation (EC) No 183/2005. The audit team noted that this issue was not identified as a non-compliance in the available inspection reports. 5.2.1.4 LABELLING

The system of planning of inspections is based on appropriate risk-related factors and thus ensures that the official controls are carried out regularly, on a risk-basis and with appropriate frequency. The effectiveness of the inspections is weakened by deficient assessment of the operators' HACCP-plans, and incomplete verification of completeness of the operators' record-keeping and of appropriateness of the retained samples. Infrequent verification of the correctness of labelling reduces the competent authorities' possibility to adequately verify that labelling requirements have been met by FeBOs. 5.2.2 Sampling 5.2.2.1 PLANNING OF OFFICIAL SAMPLING

Medlemsstatens svar

Organización de cursos de formación para inspectores en los que se incluya la identificación de los peligros más frecuentes en materias primas y aditivos y la verificación de los sistemas APPCC. Fecha prevista: octubre 2019 Para los operadores: Volver a difundir el listado de peligros más frecuentes en función del tipo de pienso (materia prima, aditivo o premezcla). Fecha prevista: marzo de 2019 Documentos para el control oficial Incluir la verificación del cumplimiento/adecuación del APPCC en los documentos de verificación utilizados en el control oficial de establecimientos. Incluir en las actas de inspección o informes posteriores las modificaciones recomendadas en el APPCC y los plazos de subsanación establecidos. Se incluirán también este tipo de medidas en el seguimiento de las notificaciones RASFF Para las Autoridades Competentes: Formación sobre control de la trazabilidad. Fecha prevista: octubre 2019 Incluir un número mínimo de inspecciones sobre la muestroteca, comprobando que existe un procedimiento escrito sobre la toma de muestras por el operador, que las Page: 1 DG(SANTE)/2018-6316-MR of the audit carried out from 16 October ir ingredients and traceability n Proposed

Para las Autoridades Competentes: Formación sobre control de la trazabilidad. r un número mínimo de inspecciones sobre la Page: 1 f. DG(SANTE)/2018-6316-MR of the audit carried out from 16 October their ingredients and traceability Proposed by the competent authority teca, comprobando que existe un procedimiento sobre la toma de muestras por el operador, que las s están precintadas correctamente, que la cantidad que en es suficiente, que se toman muestras de todos los entes. ación de un documento (check-list) de la CNCAA re verificación de trazabilidad. ar a las actas de inspección los registros umentales del operador que acrediten la trazabilidad ificada en el control oficial. Se ha añadido una casilla ecífica de trazabilidad en la tabla 5 (incumplimientos control documental) del documento de comunicación resultados de controles oficiales. apartado de APPCC del mencionado listado de ificación, se incluye la comprobación de la existencia prerrequisitos, entre ellos, el de toma de muestras. revista: Final de 2019 das a los operadores de piensos: Información al sector crito y en reuniones sectoriales) sobre: s requisitos del muestreo (procedimiento escrito) ndiciones de mantenimiento

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The audit team noted that the majority of the inspectors met possessed good knowledge of the relevant labelling requirements. However, only in a few cases did they consult the relevant authorisation acts to identify any additional labelling requirements.

For the vast majority of the labels examined by the audit team, the inspectors interviewed could identify the numerous deficiencies present (primarily absence of the name of the functional group, the directions for use and/or safety recommendations, the identification number (including one of the International Union of Biochemistry for enzymes), the batch reference number and/or the date of manufacture, the correct classification of the product, the active substance concentration/inclusion rate, the name of other substance(s) contained in the preparation, etc.). Notwithstanding their capability to identify such shortcomings, labelling shortcomings were only clearly noted as a non- compliance in one of the previous inspection reports seen.

The audit team noted three labels where the products checked were incorrectly labelled as "complementary feed" due to levels of feed additives being higher than 100 times the relevant fixed maximum content in complete feed. This contradicts the requirements laid down by Article 8(1) of Regulation (EC) No 767/2009 and was not spotted by the inspectors met. Conclusion on the planning and implementation of inspections

The system of planning of inspections is based on appropriate risk-related factors and thus ensures that the official controls are carried out regularly, on a risk-basis and with appropriate frequency. The effectiveness of the inspections is weakened by deficient assessment of the operators' HACCP-plans, and incomplete verification of completeness of the operators' record-keeping and of appropriateness of the retained samples. Infrequent verification of the correctness of labelling reduces the competent authorities' possibility to adequately verify that labelling requirements have been met by FeBOs. 5.2.2 Sampling 5.2.2.1 PLANNING OF OFFICIAL SAMPLING

Medlemsstatens svar

ación en materia de etiquetado de aditivos, Page: 2 DG(SANTE)/2018-6316-MR of the audit carried out from 16 October ir ingredients and traceability ction Proposed by the competent authority ncidiendo en la necesidad de revisar las disposiciones de os actos de autorización del aditivo, y de dejar constancia n el informe que se entregue al operador (acta de nspección o informe posterior) de todas las deficiencias. echa prevista: octubre 2019 Se pondrá a disposición de todos los inspectores y del ector un resumen de estos contenidos, con el fin de lograr a máxima difusión de esta información. En el check-list de etiquetado se ha incluido la omprobación del reglamento de autorización de los ditivos implicados en el control de etiquetado.

Formación en materia de etiquetado de aditivos, ncidiendo en la necesidad de revisar las disposiciones de os actos de autorización del aditivo, y de dejar constancia n el informe que se entregue al operador (acta de inspección o informe posterior) de todas las deficiencias. Se pondrá a disposición de todos los inspectores y del sector un resumen de estos contenidos, con el fin de lograr a máxima difusión de esta información. En el check-list de etiquetado se ha incluido la comprobación del reglamento de autorización de los aditivos implicados en el control de etiquetado. echa prevista final 2019

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In the autonomous communities visited, the feed inspectors interviewed could in general demonstrate good knowledge and implementation of the respective requirements laid down by Annex I to Regulation (EC) No 152/2009. However, in four out of eight cases observed by the audit team, the samplers could not correctly identify the minimum number of incremental samples to be taken due to erroneous identification of the size of the sampled portion, which resulted in fewer incremental samples than required by part 5 of Annex I to Regulation (EC) No 152/2009.

The audit team noted that only in two cases out of eight the correct size of the sampled portion was documented in the sampling record, which is a mandatory parameter according to part 10 of Annex I to Regulation (EC) No 152/2009.

A systemic shortcoming was noted by the audit team in terms of the preparation of final samples from the aggregate ones for control of substances where non-uniform 9 distribution is presumed. The inspectors would normally use simple manual mixing to ensure the appropriate homogenisation rather than special equipment (mechanical or automatic dividers) required by part 9(4) of Annex I to Regulation (EC) No 152/2009. For substances with non-uniform distribution, simple manual mixing cannot ensure complete homogenisation of the aggregate sample. In one autonomous community visited, the respective ACCA informed the audit team that dividers had been purchased and were planned to be put to use in 2019 after relevant training. Conclusion on the planning and implementation of official sampling

The system in place for planning of official sampling is effective and risk-based. However, the effectiveness of the sampling is weakened by the fact that the representativeness of the sampling, and thus the samples' legal and analytical validity, is not ensured for control of substances with non-uniform distribution. 5.2.3 Actions taken on non-compliances

Medlemsstatens svar

Formación en materia de toma de muestras (R152/09), en articular en el caso de distribución no homogénea. ncidir en los requisitos del acta de muestreo (parte 10, nexo I R152/09). Elaboración de un documento consensuado en la NCAA, que se pondrá a disposición de todos los nspectores, con el fin de lograr su máxima difusión. En el check-list que se está elaborando para la inspección e ha incluido una hoja relativa al muestreo oficial y el cta de muestreo. echa prevista para las dos acciones: finales de 2019

Formación en materia de toma de muestras (R152/09), en articular en el caso de distribución no homogénea. ncidir en los requisitos del acta de muestreo (parte 10, nexo I R152/09). Elaboración de un documento consensuado en la NCAA, que se pondrá a disposición de todos los nspectores, con el fin de lograr su máxima difusión. En el check-list que se está elaborando para la inspección e ha incluido una hoja relativa al muestreo oficial y el cta de muestreo. echa prevista: Final de 2019

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The audit team examined two RASFF notifications (one originated from Spain and one sent to Spain due to the distribution of the affected product) and actions taken by relevant competent authorities. While the immediate actions taken to ensure withdrawal of the products affected from the market were sufficient and timely, the audit team noted that no specific actions were taken to ensure that the FeBOs revised their HACCP-plans with the aim to make sure that the same situation did not occur again. In both cases, the operators' own checks were not designed to identify the deficiencies which had eventually triggered the RASFF notifications. The situation thus cannot be considered as completely remedied as required by Article 54(1) of Regulation (EC) No 882/2004.

In the autonomous communities visited, the audit team studied several cases of non- compliances (deficient labelling, HACCP-related deficiencies, etc.). The audit team noted that in many cases the inspection reports did not contain an unambiguous request for corrective action and consequently no timeframe was specified to remedy the deficiency(ies). A dedicated follow-up is very rarely carried out, especially for labelling deficiencies. In two cases where a timeframe to remedy the deficiency(ies) was given, it was not respected by the operators and there was no further action from the authorities' side. The situation observed is not in line with the requirements laid down by Article 54 (1) of Regulation (EC) No 882/2004.

The audit team noted that in one autonomous community, there is no guidance on how to deal with non-compliances and what relevant actions to take. This does not facilitate 10 consistency in the approach taken by different feed inspectors when dealing with non- compliances. Conclusion on the actions taken on non-compliances

Corrective measures to address non-compliances are weakened by inadequate action to ensure that operators remedy the situation and subsequent official verification of same. 5.2.4 Establishments producing/trading non-authorised (in the EU) feed additives but are exporting or re-exporting them from the EU to a third country

Medlemsstatens svar

Elaborar un documento orientativo sobre plazos límite rientativos para que el operador comunique la resolución e incumplimientos a la autoridad de control. Este ocumento se pondrá a disposición de todos los nspectores, con el fin de lograr su maxima difusión. Incluir en los planes y procedimientos de control la bligatoriedad de verificar que el operador ha Page: 3 DG(SANTE)/2018-6316-MR of the audit carried out from 16 October ir ingredients and traceability s a a ión de

Elaborar un documento orientativo sobre plazos límite rientativos para que el operador comunique la resolución e incumplimientos a la autoridad de control. Este ocumento se pondrá a disposición de todos los nspectores, con el fin de lograr su maxima difusión. Incluir en los planes y procedimientos de control la Page: 3 f. DG(SANTE)/2018-6316-MR of the audit carried out from 16 October their ingredients and traceability s a a ión de

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The audit team noted the following shortcomings: In several cases of transit of fishery products for human consumption from one BIP destined directly to a ship the net and gross weight declared in both CVED and veterinary certificate issued in accordance with Article 1(3) of Commission Decision 2000/571/EC was the same. The competent authority stated that they had noticed this noncompliance during documentary checks. It had (in the opinion of the audit team, incorrectly) decided not to take any further action considering that there was no risk. In one case of direct transit of fishery products for human consumption where the consignment was loaded in two containers, the competent authority acknowledged that whilst the first container was correctly checked at the entry BIP (Cartagena) and exit BIP (Valencia), the second container was not checked at either the entry or exit BIPs. In a case of import of animal by-products (ABP) category 3 destined for the production of pet food, the operator had incorrectly declared the ABP as raw pet food in Part I of CVED (raw pet food). This error had not been identified by the competent authority during the documentary check, which had implications for the way in which the consignment was handled (see finding 66). In another case an operator had tried to import buffalo horns from India as decorative items. The competent authority correctly rejected the consignment 10 due to a mismatch between the health certificate and other documents, and the fact that the operator did not respond to the request of the competent authority to provide supporting documents. The operator tried to re-import the same product three weeks later in the same container with the same certificate number and the same date of signature as the first certificate. According to Customs' information the container had left Spain (with both these certificates). The local competent authority acknowledged that the lack of identity check undermined the identification of this commodity. No evidence was provided to the audit team to confirm that the consignment was re-dispatched to the third country of origin within the period of 60 days as required by Article 21(2) of Regulation (EC) No.882/2004 or even beyond this period (see finding 72). 5.2.3.3 Implementation of controls on food and feed of non-animal origin

The audit team noted several non-compliances in relation to the confirmation of re- dispatch of rejected consignments (see finding 72). 5.2.4 Safeguard measures, re-enforced checks regime, reduced checks regime and procedures for channelled and re-imported consignments

The audit team checked some files where the documentary, identity or physical checks had resulted in the consignments being rejected. Evidence was available that rejected consignments had been adequately destroyed or re-dispatched to the country of origin in line with Articles 19 and 21 of Regulation (EC) No 882/2004 and Article 17 of Directive 97/78/EC with the following exceptions identified by the audit team in two out of three BIPs/DPEs visited: In the cases of correctly rejected consignments of washed wool, game trophies (see finding 59), fishery products and peanuts and capsicum (pepper) destined for human consumption, there was no evidence that the consignments in question had been re-dispatched to the third countries of origin as required by Article 21 of Regulation (EC) No 882/2004; At all BIPs visited, samples (that were no longer intended for human consumption for commercial reasons and classified as category 3 ABP) taken from products of animal origin or foodstuffs containing products of animal origin were disposed as part of general waste if the sampling results were satisfactory and as category 1 or 2 ABP only if the results were unsatisfactory. This practice does not ensure that the provisions of Article 14 of Regulation (EC) No 1069/2009 are adhered to. 12

Official controls on imports of live animals and feed and food of both animal and non- animal origin were, for the most part, carried out properly by the competent authority. The national monitoring plan for imports of products of animal origin did not reach all of the planned sampling targets, undermining the objective of the monitoring plan. In the cases where the confirmation of re-dispatch of rejected products was absent or inconclusive there is a risk that these products may not have left the EU territory. Furthermore, the absence of confirmation that temporarily admitted horses had left the EU territory does not comply with EU requirements. Some minor shortcomings were found in relation to the implementation of documentary checks but these were not considered by the audit team to have a negative impact on public or animal health.

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The sampling programmes of MSCBS comprised two phases covering different parameters. The targets of the 2016 sampling plan of phase I (heavy metals and sulphur dioxide), histamine, biotoxins and pathogenic micro-organisms) were not reached (64.6% of the planned samples were taken (824 samples taken/1276 samples planned). The sampling level was particularly low for Listeria (7.5% of the planned samples were taken (80 samples allocated of which only 6 were taken)). The targets of phase II (antibiotic and pesticide residues and aflatoxins) were not reached (73,2% of the planned samples were taken (109 samples taken/149 samples planned)). Likewise not all targets of the 2017 sampling and monitoring programme were reached. The 2017 results are reported in a different format: compliance percentage/parameter/BIP, which makes the comparison between the two years impossible. The competent authorities were aware of 9 this and stated it was due to a compatibility problem with the computer database they had used. The competent authorities stated that the discrepancy between the sampling targets at BIPs and the sampling level reached was partly due to lack of staff and partly due to low number of consignments received.

Official controls on imports of live animals and feed and food of both animal and non- animal origin were, for the most part, carried out properly by the competent authority. The national monitoring plan for imports of products of animal origin did not reach all of the planned sampling targets, undermining the objective of the monitoring plan. In the cases where the confirmation of re-dispatch of rejected products was absent or inconclusive there is a risk that these products may not have left the EU territory. Furthermore, the absence of confirmation that temporarily admitted horses had left the EU territory does not comply with EU requirements. Some minor shortcomings were found in relation to the implementation of documentary checks but these were not considered by the audit team to have a negative impact on public or animal health.

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The audit team checked in total 11 files related to import of live animals (horses, circus animals such as lions, pumas, tigers and reptiles) and noted that the documentary checks had been performed correctly. However, in all five cases of horses temporarily admitted and checked by the audit team, there was no evidence indicating that these animals had left the EU territory (see finding 73). The competent authority declared that since there is no legal obligation requiring the owner of the temporarily admitted horses to notify the competent authority and the customs of the arrival of the horses at the exit BIP it makes it difficult for the BIP staff to confirm whether the horses have left the EU territory.

At one exit BIP which is approved for live animals in several cases of temporarily admitted live equidae from Morocco no evidence was provided to the audit team confirming that the horses had left the EU territory in the period of time (90 days) required in Annex II(E) to Commission Decision 92/260/EEC. Conclusions on implementation of official controls on imported goods

Official controls on imports of live animals and feed and food of both animal and non- animal origin were, for the most part, carried out properly by the competent authority. The national monitoring plan for imports of products of animal origin did not reach all of the planned sampling targets, undermining the objective of the monitoring plan. In the cases where the confirmation of re-dispatch of rejected products was absent or inconclusive there is a risk that these products may not have left the EU territory. Furthermore, the absence of confirmation that temporarily admitted horses had left the EU territory does not comply with EU requirements. Some minor shortcomings were found in relation to the implementation of documentary checks but these were not considered by the audit team to have a negative impact on public or animal health.

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r Article PAN carece de un objetivo general cuantitativo PPPs, El PAN 2018-2022 cumple lo dispuesto en el artículo 4.1 de la irectiva, al establecer objetivos cuantitativos, metas, medidas y calendarios para cada una de sus medidas, a fin de reducir los riesgos y efectos del uso de plaguicidas. En ningún momento la Directiva habla de que los PAN deban definir un único objetivo consensuado entre todas sus medidas, sino que el objetivo subyacente del PAN debe satisfacer el objetivo general de la Directiva, mediante los distintos ámbitos de interés en el uso de productos fitosanitarios. La postura de algún estado miembro puede haber sido establecer un objetivo general, por ejemplo de la mano de la reducción del volumen total de productos fitosanitarios consumidos, pero este enfoque no ha sido compartido en España. En España el PAN es un instrumento que, por una parte, plasma todas las actuaciones que ya se están haciendo en materia de uso sostenible; y, por otra, que sirve de lanzadera para algunas de las actividades venideras. Si la Comisión entiende que los PAN deben fijar un único objetivo global, debería cambiarse la redacción de la actual DUS y avanzar todo lo posible en el desar

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PPP · Legislación para la formación adicional de los asesores for En el Real Decreto 1311/2012 se dispone que el asesor en GIP eda ejercer su actividad cuando haya acreditado su condición y haya inscrito en el Registro Oficial de Productores y Operadores OPO). acreditación se realiza mediante la "titulación habilitante", que desarrolla en el Anexo II de la citada norma. Su exigencia es y alta para todos los aspirantes, ya que han de acreditar un nimo de 40 ECTS (European Credit Transfer System) en terias relacionadas directamente con la producción vegetal, de s cuales, al menos 12 corresponderán a materias que estén lacionadas directamente con la protección vegetal. instalación de la obligación de una formación continua que tualizara la formación curricular implicaría una limitación de las Page: 2 eport ref. DG(SANTE)/2018-6362-MR of the audit carried out from 23 January es to achieve the sustainable use of pesticides onal de las por el artículo certificación de desde 1990. stema de s de carnés iante manuales n dos, a través dos y una guía un compendio IV del Real a los declaraciones, uir una dicamente, olicitud para la interesado onibilidad de onocimientos, o IV del Real (artículo

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ote and El MAPA está muy comprometido con la difusión pública sobre el ide uso sostenible de productos fitosanitarios y participa activamente neral en campañas de concienciación en materia de uso sostenible de forma directa, mediante ponencias y divulgación del conocimiento, como a través de la página web: El número mensual de visitas a la Web es de más de 700.000. Las descargas de las guías de gestión integrada de plagas sólo en 2015 alcanzaron las 500.000. El video sobre "Gestión Integrada de Plagas ­GIP" disponible en Youtube, tiene 18.850 visualizaciones siendo el 8º video más visto en el canal que tiene el MAPA. Por su parte, otros organismos regionales competentes realizan actividades propias de formación e información, tanto para usos profesionales como no profesionales. La prevista revisión intermedia del PAN permitirá a los organismos competentes establecer sus propias estrategias de difusión del conocimiento y campañas de concienciación relacionadas con el uso de fitosanitarios.

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cide El Sistema de recogida de información de intoxicaciones agudas bidas a plaguicidas se encuentra consolidado. Si se reconoce la dificultad, sobre todo ante intoxicaciones en el ámbito no profesional y por motivos de urgencia de salvar la vida del afectado frente a la recogida exhaustiva de datos, en poder diferenciar por parte de los profesionales sanitarios (clínicos asistenciales) si el productos desencadenante de la intoxicación se trata de un plaguicida de uso agrícola (fitosanitario) o de un plaguicida de uso Page: 4 eport ref. DG(SANTE)/2018-6362-MR of the audit carried out from 23 January es to achieve the sustainable use of pesticides tion Proposed by the competent authority agrícola (biocida) obstante, se considera que se responde a las exigencias tablecidas en el Reglamento CLP (Reglamento (CE) nº 72/2008 del Parlamento Europeo y del Consejo, de 16 de ciembre de 2008, sobre clasificación, etiquetado y envasado de stancias y mezclas, y por el que se modifican y derogan las rectivas 67/548/CEE y 1999/45/CE y se modifica el Reglamento E) nº 1907/2006)

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f PAE to · Andalucía los últimos meses se han autorizado dos instalaciones para la visión de equipos de aplicación aérea de productos fitosanitarios Andalucía y una tercera se encuentra en trámite. En Andalucía, tualmente, hay censados 34 equipos de aplicación aérea de oductos fitosanitarios, de los cuales 25 ya han sido speccionados, lo que supone un 73,5 %. imismo, ha sido modificado el Manual de procedimiento para la torización de aplicaciones aéreas de productos fitosanitarios en comunidad autónoma de Andalucía, requiriéndose al presentar la licitud que acompaña al Plan de Aplicación Aérea, certificado de visión de los equipos de aplicación de las aeronaves implicadas. Comunidad valenciana la " constatación nº 36" se dice que en Valencia, en el momento la auditoria no había un cuerpo de inspectores (ITEAF) para speccionar los equipos de tratamientos aéreos y que las specciones en instalaciones fijas no se pueden transmitir por no ner un formato adecuado. Además dice que los sistemas de gistro no cubren el equipo de aplicación utilizado en ferrocarriles otras unidades específicas para las aplicaciones no agrícolas. specto a la primera parte del párrafo, en la Comunitat Page: 5 e

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et out Requisitos conservación de registros sobre el control de las ls as plagas y enfermedades ticle La GIP es obligatoria en virtud del artículo 10 del RD 1311/2012, donde se especifica que `la gestión de las plagas se realizará mediante la aplicación de prácticas con bajo consumo de productos fitosanitarios, dando prioridad, cuando sea posible, a los métodos no químicos, de manera que los asesores y usuarios opten por las prácticas y los productos con menores riesgos para la salud humana y el medio ambiente'; y, además, `se llevará a cabo teniendo en cuenta los principios generales de la gestión integrada de plagas establecidos en el anexo I'. Para satisfacer esta correcta gestión de las plagas, las explotaciones están obligadas a la contratación de los servicios de un asesor, según lo dispuesto en el artículo 10 del RD. De nuevo el artículo 11 del RD es claro en cuanto a la necesidad de considerar los principios de GIP: `el asesoramiento [...] se efectuará siguiendo los principios generales de la gestión integrada de plagas establecidos en el anexo I que sean aplicables en cada momento o tipo de producción'. Y en el artículo 11 se especifica que `deberá quedar reflejado documen

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The CCA stated that roughly 95% of primary producers are registered in REGEPA. However, the respective AC visited estimated that approximately 95% in Galicia, Catalonia and Andalucía, 70% in Comunitat Valenciana and 60% in Murcia of farmers were registered in REGEPA at the time of the audit. The number of unregistered farms was mainly linked to the farm size and farms not receiving CAP subsidies. According to the CA a significant number of these unregistered farms could be involved in the production of very high risk products.

Representatives of the AC of Galicia informed the audit team that for the planning of official controls information from additional databases were used to capture the majority of farms in the AC. The Comunitat Valenciana initiated awareness campaigns among farmers to increase the registration rates in the database. In the Autonomous Community of Catalonia, information on REGEPA was circulated in order to increase registrations. 6 Approval of Food Establishments

However, although REGEPA is in operation since 2015 a substantial number of farms were not yet registered in several of the AC visited. This is not in line with Article 6 of Regulation (EC) No 852/2004 and could result in numerous farms, producing high risk produce, not considered for official controls. 5.2.3 Organisation and Scope of Official Controls Legal requirements Article 17 of Regulation (EC) No 178/2002 and Article 3 of Regulation (EC) No 882/2004 Findings

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line with the COMUNIDAD AUTÓNOMA DE ANDALUCÍA En los próximos meses se va a elaborar material divulgativo en relación a las obligaciones de las explotaciones agrícolas sobre producción primaria agrícola. roducen Este folleto se colgará en la página web de la Consejería de l artículo 6 del Agricultura, Pesca y Desarrollo Rural, y se remitirá a Delegaciones Territoriales y Oficinas Comarcales Agrarias en las que los productores tendrán acceso al mismo. Además, se tiene intención de remitirlo a todas las explotaciones de riesgo muy alto y alto inscritas en REGEPA y a Organizaciones Profesionales Agrarias para su distribución entre sus asociados. Asimismo, como complemento a la campaña de divulgación expuesta, a lo largo del año 2019 se realizará una sesión informativa dirigida a Organización Profesionales Agrarias y público en general en la que se informará sobre los requisitos de obligado cumplimiento en materia de higiene de la producción primaria agrícola, entre los que se encuentra la inscripción en REGEPA. Por otra parte, periódicamente, a través de los perfiles en redes sociales de la Red de Alerta e Información Fitosanitaria se lanzan campañas de divulgación sobre diferentes te

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The large majority of consignments arriving at the port are accompanied by a national movement document instead of a journey log (see also finding 18). This movement document is not nationally harmonised. In the different versions seen by the audit team, the declaration of fitness for transport was always signed by either the transporter or the farmer at the place of departure.

For the few trucks that arrived after long road journeys, the official checks do not detect the absence of a transporter for the sea journey on the journey log (which should have been indicated in box 6.4 of Section 1). Copies of tachographs are not collected, as required by Article 21(2) of the Regulation, to verify journey times from the place of departure to the port.

The competent authorities follow the instructions of the national protocol and do not request journey logs for animals travelling short road journeys before reaching the port. This is not in line with the Zuchtvieh judgement4, which indicates that these should also be considered as long journeys since it takes more than 8 hours to reach the destination in the non-EU country. In 2015 the Spanish authorities asked the Commission in writing about this issue and they proposed means of addressing it (see also finding 22); they have received no reply to date.

The fact that the authorities do not request journey logs for most consignments, as these start mostly in Spain, prevents them from ensuring that journeys are realistic and have been planned in line with the requirements, in particular to avoid unnecessary waiting times at the port and the identification of a person or entity responsible for the sea leg of the journey.

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The national protocol: Does not indicate the need to identify a transporter for the sea leg of the journey, required by Article 6(1) of the Regulation, nor their responsibilities (see also findings 17 and 35); Indicates that a journey log is only required if the time taken to reach the exit point is more than 8 hours.

The national protocol also includes sections indicating legal requirements and additional instructions. They both go into more detail than that the Regulation for both the approval of livestock vessels and their inspection prior to loading. It also includes relevant checklists. The pre-loading inspection checklist (Annex 5D) is incomplete, e.g. it does not include checks that the equipment listed in Chapter IV of Annex I of the Regulation is in good working order.

The competent authority indicated that the above-mentioned national protocol has not yet been fully implemented. Namely, the central competent authority has not yet verified how the measures prescribed in the protocol translate into practice, and how they are being applied. Article 4(2)(a) of Regulation (EC) No 882/2004 requires the competent authority to ensure the effectiveness and appropriateness of official controls.

During the audit, the competent authorities at the two ports exporting animals could not provide annual data on the number of animals for which they had refused loading due to the animals being unfit or having arrived dead at the ports.

The new documented procedures could ensure ­ when fully implemented ­ that in general, animals are spared unnecessary suffering during the journey.

The lack of appropriate facilities at ports for checking the animals in the trucks and of no permanent veterinary presence during loading of the livestock vessels, combined with the absence of an official veterinarian at the place of departure to certify fitness for transport5 create a risk of unfit animals being transported. The system is further weakened by the lack of registers at the ports about the animals' fitness for transport.

The national protocol procedures are in general sufficient for inspections to livestock vessels, but have not yet been fully implemented. These procedures include many of the criteria contained in the Network Document on livestock vessels agreed by the National Contact Points' network, and were well-known by the personnel met by the audit team.

The competent authority provided the information in the table below. This shows the total number and outcome of livestock vessel inspections at the time of loading (Article 20 of the Regulation) between January 2015 and June 2018. The type of deficiencies detected included: non-operational drinkers, presence of rust, lack of identified "hospital/isolation pens", dirty or poorly maintained feeders, no first-aid kits/supplies for the animals, lack of alarms at the wheelhouse for the systems for ventilation, light and water production, and lack of stunning equipment. The competent authority informed the audit team that all deficiencies could be corrected prior to loading and there was no need to cancel any livestock vessel loading during this time period. Year Total number of Complied with With inspections Regulation 1/2005 deficiencies 2015 158 2016 150 143 15 2017 143 7 2018 (until June) 187 182 5 79 76 3 A livestock vessel which was seen during a DG Health and Food Safety audit in another Member State at the end of April 2018 had loaded animals at one of the Spanish ports in March and April 2018 (see also finding 34). This vessel, which was seen during the audit at the end of April, had long standing deficiencies, was in a poor state of repair and lacked several essential systems. Nevertheless it had been allowed to load animals in the Spanish port twice in 2018. It was deficient regarding Points 2(a), 4, 5, 6 and 7 of Section 1 of Chapter IV of Annex I to the Regulation, i.e.: ventilation, the fresh water system, drainage, lighting, no alarms for these systems and no fire alarms in the decks accommodating animals. 9

The competent authorities at both ports are not using the pre-loading checklist that is included in the national protocol.

During the audit, the officials described and demonstrated pre-loading animal welfare controls of livestock vessels carried out at the port visited. They were correct and well- performed. Regarding documentation: Records indicate that controls are carried out on ventilation (Point 2 Section 1 Chapter IV Annex I of the Regulation), cleaning and disinfection, watering equipment (Point 4 Section 1 Chapter IV Annex I of the Regulation) and ramps; Records also indicate that calculation is made to evaluate the stocking density (Chapter VII Annex I of the Regulation) and the amount of water and feed necessary for the animals (Section 2 Chapter IV Annex I of the Regulation); There are no records indicating that the other requirements of Section 1 Chapter IV Annex I of the Regulation had been checked, in particular that drainage, lighting and fire-fighting systems and the monitoring and alarm systems remain in good working order.

The available documentation of those controls in the port which was not visited was very poor, indicating only that a control according to Article 20 of the Regulation had been carried out but without giving details on what had been checked.

The official veterinarians seen carrying out pre-loading inspections of livestock vessels were competent in this task and this provides a good level of assurance that livestock vessels inspected in this way are suitable to prevent unnecessary animal welfare problems notwithstanding the poor quality of records kept. However, the poor conditions on a livestock vessel which was allowed to load at one of the Spanish ports earlier in 2018 indicates that some pre-loading inspections are insufficient and do not ensure that essential systems for animal welfare are in place.

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Both ports lack appropriate facilities to rest, feed and water the animals outside the means of transport. This would not allow the authorities to fulfil the requirements in Annex I, Chapter III, Point 1.2(a) of the Regulation in the case, for instance, where unloading and loading of the animals from each truck requires more than four hours. The competent authorities require organisers to plan the arrival of trucks at the port in a way that avoids unnecessary waiting.

In one port there are no plans to add such facilities. In the other, there is a project to build a facility, with an estimated capacity for 600 cattle and a covered area with a capacity to park 40 trucks in the shade. The authorities will discuss this project for its approval in November 2018.

The competent authorities require organisers to submit contingency plans for each shipment, which must include providing for a situation where the loading of animals is not authorised. At the port visited, the operator, as part of its contingency plan, has an agreement with a holding, located 60 km from the port, to use it for unloading the animals in case of need. According to the operator, the holding has capacity for 5600 cattle or 15000 sheep. The competent authorities have not visited this holding to confirm whether it would be feasible to use it at short notice, and its suitability.

The other port has not identified nearby facilities in which to unload the animals in case of need. Conclusions on welfare of the animals arriving at the port

The absence of facilities to unload the animals at the port might lead to welfare problems, particularly if a delay occurs with the loading of the animals. Although this is 5 In their response to the draft report the Competent Authority noted that at the place of departure there is an official veterinarian who issues health attestations, although these do not always include an attestation of fitness for transport. 8 mitigated by provisions in the contingency plans, the feasibility and suitability of the arrangements have not been fully verified by the relevant authorities.

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Both the Balearic Islands and Valencia have produced their own Regional Contingency and Action Plans. The regional contingency plan for the Balearic Islands was updated on 1 February 2018, although it was noted by the audit team that the Valencian regional contingency plan had not been updated since 2016.

The Valencian Contingency Plan does not take into account modifications to the National Contingency Plan and latest technical advances.

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Appropriate control measures are in place to verify that EU requirements regarding GMO presence in seeds are implemented. However, the implemented threshold for traces of GMOs in conventional seed is not in line with EU requirements. 5.3.5 Controls of GMOs in food and feed Legal requirements Articles 4(2), 12, 13, 16(2), 24 and 25 of Regulation (EC) No 1829/2003. Articles 4, 5 and 9(1) of Regulation (EC) No 1830/2003. Articles 2, 4, 5 and 6 of Commission Regulation (EU) No 619/2011. Findings

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The implementation of the controls of GMOs in food and feed is generally appropriate. However, the absence of any sampling for food controls is not in line with the EU requirements.

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Central CAs and CAs of ACs generally have access to appropriate analytical capacity. In certain cases, the scope of laboratory analysis is limited and does not cover all pending and known unauthorised GMOs (see also section 5.3.7 below). Otherwise, the audit team did not identify any cases where facilities or equipment necessary for official controls were inadequate. Conclusions on resources for performance controls

The CA stated that these types of samples ("prospective samples") are sent for analysis to the regional laboratory in another AC for screening of two elements (p35S and 14 tNOS). According to their workflow, in the case of a positive screening, they would repeat sampling and would take an official sample, in three repetitions and send these for analysis to an accredited GMO laboratory. So far, they have not used that option for additional sampling.

The audit team noted that the scope of accreditation for some of the regional official laboratories is very narrow. For example, the public laboratory in Cantabria, authorised for GMO analysis of food and feed samples, is accredited only for two screening elements, p35S and tNOS and for three event-specific qualitative methods; and in Aragon only two screening elements, p35S and tNOS were used which means that only certain relevant GM events can be detected (e.g. in soya bean some 50 % of events cannot be detected).

Furthermore, in cases of positive screening results, a limited number of EU validated event-specific detection methods were applied to identify GM events which were potentially present. For example, one food sample (snack) tested positive for both p35S and tNOS and tested negative for Roundup Ready soya bean, maize Bt11 and MON810. No further testing was carried out to identify the GM event present. The laboratory explained the result was due to traces of soya bean in the product. In another case, a conventional maize seed sample tested positive for p35S and negative for tNOS. To identify the GM events, only five common GM events were tested and MON810 tested positive below 0.1%. No further tests were conducted to exclude other events which might be present in the sample (result was explained by MON810 presence only).

The limited analytical screening scope, particularly at official laboratories designated by competent authorities of ACs, means that analytical methods used for official controls do not comply with relevant EU rules. This is not in line with Article 11(1) of Regulation (EC) No 882/2004 which requires that sampling and analytical methods used in the context of official controls shall comply with relevant Community rules. 18 Furthermore, Article 9(1) of Regulation (EC) No 1830/2003 requires that member states implement control measures including testing to ensure compliance with placing on the market GM products. NRL

At the central level, the CAs have access to a broad scope of accredited analytical capability for GM events. However, the limited analytical scope at regional level is not compliant with the EU rules and poses a risk that some GM events which might be present in food, feed and seed are not detected and thus placed on the market. 19 5.3.8 Enforcement measures Legal requirements Articles 4(5) and 33 of Directive 2001/18/EC. Articles 45 of Regulation (EC) No 1829/2003. Article 11 of Regulation (EC) No 1830/2003. Findings

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The BIPs visited had no access to the ship, boat and aircraft manifests or other sources of information required to ensure that all consignments of live animals are presented for veterinary control. This is not in line with Article 5 of Regulation (EC) No 282/2004 (see finding 23).

The BIPs visited had no access to the ship, boat and aircraft manifests or other sources of information required to ensure that all relevant consignments are presented for veterinary control. This is not in line with Article 6 of Commission Regulation (EC) 136/2004 (see finding 17). For ports, access to manifests was terminated after the introduction of the new "Customs One-Stop Shop" system.

In general, the documentary checks are performed correctly in order to ensure compliance with the requirements of the legislation. However, as none of the BIPs visited have access to the ship and aircraft manifests and other sources of information, this impairs the ability of the competent authority to correctly identify consignments which have not been presented and should be subject to official controls.

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tro de la información se limita a aquellas partidas procedentes de escartando los movimientos de mercancías entre partes del territorio Europea) que son objeto de inspección por parte del MSSSI y e hayan transcurrido más de 7 días desde la fecha de activación de la neral esta se activa cuando se produce la llegada efectiva de la ritorio de la Unión). con objeto de dar respuesta a la recomendación recogida en el informe de la ciembre de 2017 el MSSSI y MAGRAMA solicitaron a la AEAT el acceso del PIF y PED a la información de las declaraciones sumarias de todas las ntes de terceros países que llegan al territorio español, sin aplicar ningún tipo ción temporal. de la carta conjunta enviada a la AEAT (Documento PA1). Page: 1 ons of report ref. DG(SANTE)/2017-6045-MR of the audit carried out from 12 June 2017 cks at the Union borders Action Proposed by the competent authority B (Asociación Española de Consignatarios de Buques) se ha consignatarias su colaboración de cara a garantizar que los a la información contenida en los manifiestos. a de que se materialice el alta de los inspectores en la base de datos la integración de la información dentro del Sistema Informático de , se ha solic

información se limita a aquellas partidas procedentes de países movimientos de mercancías entre partes del territorio aduanero de e inspección por parte del MSSSI o MAPAMA y siempre que hayan desde la fecha de activación de la sumaria (por regla general esta la llegada efectiva de la mercancía al territorio de la Unión). eto de dar respuesta a la recomendación recogida en el informe de la de 2017 el MSSSI y MAPAMA solicitaron a la AEAT el acceso del ED a la información de las declaraciones sumarias de todas las partidas países que llegan al territorio español, sin aplicar ningún tipo filtro o carta conjunta enviada a la AEAT (Documento PA1). Page: 1 report ref. DG(SANTE)/2017-6045-MR of the audit carried out from 12 June 2017 the Union borders Proposed by the competent authority Asociación Española de Consignatarios de Buques) se ha nsignatarias su colaboración de cara a garantizar que los la información contenida en los manifiestos. e que se materialice el alta de los inspectores en la base de datos integración de la información dentro del Sistema Informático de e ha solicitado a los consignatarios faciliten una copia de todos formato de fácil manejo, tipo pdf o similar. esto de q

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nión de coordinación entre MAPAMA, AECOSAN y autoridades competentes de las CCAA celebrada el 1 de febrero de 2018, se acordó la creación de una Mesa de prevención del raboteo sistemático. Esta mesa estará integrada por representantes de las CCAA, MAPAMA, AECOSAN y sector productor para la discusión y aprobación de documentos de trabajo comunes en relación a la ión a los ganaderos, las listas de comprobación que sirven de apoyo a los inspectores en la realización de los controles de bienestar anímales en las explotaciones de cerdos, y las medidas a llevar a cabo en caso de detección de incumplimientos. La primera reunión de la Mesa de prevención del raboteo sistemático se realizará el 13 de marzo de 2018. l marco de la Mesa de prevención del raboteo sistemático se elaborará una Hoja de ruta que propondrá la elaboración y adopción de elementos tales como: - elaboración de fichas descriptivas de cada explotación, - orientaciones para la cuantificación del nivel de canibalismo en las explotaciones, - análisis de riesgos de canibalismo - plan de acción elaborado por los productores para minimizar ese riesgo de canibalismo. 1 Action Proposed by the competent authority La difusión de las

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In the national registration database of producers of seed and nursery plants there are currently 11,655 entries of registered potato operators. A substantial increase from 280 in 2016 to 398 in 2017 was observed in potato operators registered in Andalucía. Similarly the registered potato operators have been increased in Comunidad Valenciana from 19 in 2016 to 25 in 2017. Additional information provided by the single authority indicated that eight potato operators have been registered in Islas Baleares and one operator in Madrid. During 2016, operators in Extremadura and Castilla la Mancha moved ca. 9,300 t of ware potatoes to other EU Member States. However, at the time of the audit registration of certain potato operators had not been completed. Despite substantial professional potato production and trade taking place from these regions to Spain and to other EU Member States certain potato producers still remain without having been registered. This is not in line with Article 1 of Commission Directive 93/50/EEC.

There is a clear division of responsibilities and good communication between the single authority and the regional competent authorities. Due to the non-complete registration of professional potato operators in certain autonomous communities, there is risk of uncontrolled potato movement.

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En fecha de 16 de junio de 2016, una vez finalizada la primera auditoría sobre Epitrix sp, el Subdirector General de Sanidad e Higiene Vegetal y Forestal envió un oficio específico recordando, a los responsables de sanidad vegetal de las diferentes Comunidades Autónomas, la necesidad de cumplir con esta obligación. Asimismo, como consecuencia de la reiteración en la observación en esta nueva auditoría, el Subdirector volvió a recordar mediante oficio esta obligación y solicitó información detallada de los avances realizados durante este periodo de tiempo. El avance realizado en este sentido ha sido muy notable y se sigue trabajando en ello. Las principales dificultades como es el registro de los productores de autoconsumo, que no tienen ninguna obligación legal de inscribirse puesto que no comercializan su cosecha se ha logrado vencer utilizando los mecanismos adecuados. Prueba de ello es el ejemplo de la Comunidad Autónoma de Asturias donde se han registrado 4666 agricultores de autoconsumo los cuales corresponden a 5387 parcelas declaradas cuando tan sólo existen 31 almacenes y productores profesionales de patata. Los datos facilitados por las Comunidades Autónomas son los siguie

To ensure that all commercial producers, collective warehouses and potato dispatching centres are registered in a comprehensive and up-to- date register in all autonomous communities of Spain in line with Commission Directive 93/50/EEC. Recommendation based on conclusion 18 Associated finding 16

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The audit team visited one field found infested during 2016 within a recently demarcated area in the province of Cadiz and two fields within the buffer zones of areas already demarcated since 2015 in the province of Seville prior to the latest amendment of Decision 2012/270/EU and noted that: the demarcation of the infested zone was limited only to the surface where there is a crop (or "plantación") of potatoes or other E. papa hosts. This could be considered to be in line with the Spanish language version of Decision 2012/270/EU, where the term "plantación" is used, but is not in line with the English1 version, which uses the term "field", i.e. a plot of land with defined boundaries according to ISPM No.5; 1This text was initially drafted in English and then later translated into other languages. 11 the same also applies for fields within the outer border of the 500 m width buffer zone. Demarcation is not carried out in line with Annex II section 1(1b) of the same Decision because only the part of the fields within the 500 radius is included and not the entire fields. The RCA stated that, in the notification letters sent to producers, they require that any potatoes grown in parcels located the outer limits of the buffer zones to be considered, treated and handled as produce grown within the demarcated area.

The audit team also noted that a 500 m width buffer zone beyond the edge of the infested fields is only applied to new outbreak sites; areas which have already been demarcated prior to the adoption of the provisions of Decision EU 2016/1359 remain with a buffer zone of 100 m beyond the infested area; infested zones are not reviewed and buffer zones are not expanded.

As already stated in the previous audit report, merging of four geographically close demarcated areas in a larger demarcated area in the province of Seville did not take place. Instead, an "intensive surveillance zone" composed of the demarcated areas and the areas between them had been established. The RCA stated that possible expansion and further merge of the demarcated areas in line with Article 6 of Decision 2012/270/EC, is not considered to be necessary as monitoring carried out within the demarcated areas had not revealed the actual presence of E. papa but only cases of tubers with signs of Epitrix sp. infestation.

The entire autonomous community of Asturias has now been demarcated whilst in Andalucía the infested area continues to increase. Andalucía has implemented precautionary measures to prevent the further spread of the pest. However, area demarcation is not carried out in line with the provisions of Decision 2012/270/EU, which may reduce the effectiveness of the control measures in place. 13

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ndalucía on ta Comunidad Autónoma ha concluido el proceso de revisión de todas las zonas demarcadas de Andalucía para lo que ha tenido en cuenta la recomendación realizada por la auditoría Prueba de esto, es que las 9 zonas demarcadas que se establecieron en el año 2016 ya se hicieron conforme a la Decisión de Ejecución (UE) 2016/1359 de la Comisión de 8 de agosto de 2016 por la que se modifica la Decisión de Ejecución 2012/270/UE. Éstas, están formadas por una zona infestada (donde se ha detectado la presencia Epitrix papa) y una zona tampón (área de 500 metros más allá del límite de una zona infestada). En 2017 las nuevas zonas demarcadas establecida también se ha realizado conforme la decisión de Ejecución (UE) 2016/1359. En estas zonas demarcadas se considera como zonas infestadas los campos de cultivos completos, igual que las fincas que se encuentran incluidas en las zonas tampón. Page: 4 ber 2017 rt ref. DG(SANTE)/2017-6169-MR of the audit carried out from 15 May 2017 Action Proposed by the competent authority Las zonas demarcadas del año 2015 que se mantienen en Andalucía, también han sido revisadas y ampliadas conforme a la última modificación de la decisión. Asturias El P

on respecto a la información solicitada sobre la fusión de las on zonas tampón de los brotes 942 y 280, se aporta la siguiente ormación: En el brote Nº942, la CCAA de Andalucía ha tenido en cuenta las recomendaciones del equipo auditor en la visita de mayo de 2017, de tal manera que las zonas demarcadas (ZD) declaradas en 2016 (Coria del Río ZD Nº 16 y Puebla del Río ZD Nº 17) y la ZD Nº18 de Coria del Río declarada en 2017, han sido fusionadas en la ZD XVI, que incluye la zona cubierta por las 3 ZD así como los espacios entre ellas, siguiendo así lo definido en el punto 2 de la Sección 1 del Anexo II de la Decisión 2012/270/UE. Para justificar dicha actuación se adjuntan los mapas iniciales de las ZD 16,17 y 18, así como el mapa de la nueva ZD XVI y el listado de parcelas incluidas en la citada ZD. El brote Nº 280 ha dado lugar a la ZD Nº XXI en 2017, a partir de 3 brotes distintos y muy próximos, que incluye la zona cubierta por las 3 ZD así como los espacios entre ellas, siguiendo así lo definido en el punto 2 de la Page: 1 12 December 2017 rt ref. DG(SANTE)/2017-6169-MR of the audit carried out from 15 May 2017 Action Proposed by the competent authority Sección 1 del Anexo II d

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The plan includes survey, diagnostic and eradication protocols. The survey protocol takes into account the 2015 Commission guidelines for Xf surveys. It defines the following areas, which are considered as national priorities during the surveys: Nurseries and garden centres in general; Areas (fruit, horticultural plantations, forests, parks, gardens, public roads etc.) established 2-4 years ago with plants from DAs and from non-EU countries, where Xf is present; Nurseries and garden centres on transport routes from DAs; The Valencia coastline; Agricultural crops of particular economic importance for Spain with the following minimum annual inspection rates: olives, citrus, almonds, plums and cherries - 1 per 10,000 ha; vines, apricots, peaches, nectarines - 1 per 15,000 ha and oaks 1 - per 5 50,000 ha with at least one sample per inspection. However, the audit team is not convinced that these minimum annual inspection rates are sufficient for the detection of a possible infection, taking into account the presence of these crops in different parts of Spain; Vector insects collected from the main agricultural crops. Sweeping and direct catch is recommended but not the use of sticky traps. The survey protocol also describes the main symptoms, defines the method and timing of the visual inspections and sampling of symptomatic and asymptomatic plants.

The legislative tools, the national and regional contingency and action plans provide an appropriate framework for the implementation of the control measures. Nevertheless these plans need to be reviewed in the light of the latest information about the presence of Xf and in particular concerning the intensity of surveys in agricultural crops of particular economic importance.

The audit team reviewed the details of Xf surveys in Andalusia and Valencia and noted that: The vast majority of the surveys were carried out in the period of late spring/early autumn, which is suitable for the observation of symptoms and sampling. Nurseries and garden centres were checked during the annual plant passport inspections; Both ACCAs generally followed the priorities of the national contingency plan and adjusted these according to the specificities of the region; There were significant differences in survey intensity of the crops of specific economic interest; Valencia largely implemented the national priorities and especially in the main agricultural crops the survey density was higher that it was recommended nationally. However, even this intensity might be not be high enough for detecting possible outbreaks; Andalusia implemented generally also the national priorities. However, the survey density of olives groves in that AC was only the half of that, which is recommended nationally (one inspection per year per 20,000ha). As Andalusia is the main olive production region, the audit team considers that this survey intensity is not sufficient for the early detection of a possible outbreak and it is not in line with the requirements of Article 3 of the Decision; In Andalusia, the majority of the surveys were carried out by the plant health service and the forestry authorities, while Valencia successfully attempted to involve other organisations, including producer groups into the surveillance and to combine the Xf checks with other plant health activities; Valencia considered that large scale trapping and analysis of insect vectors for the presence of Xf is an effective way of surveying the pathogen. Therefore checks for the presence of Xf were carried out with thousands of sticky yellow traps placed in crops and other areas for monitoring other harmful insects. 5.2.2 Surveys in the Buffer Zone

Xf surveys outside the DA are generally risk based and follow the national guidelines. However, the intensity of these surveys, especially in olive trees in Andalusia, is not high enough to comply with requirements of Article 3 of the Decision.

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rcated area are MAPAMA he presence of Teniendo en cuenta la información más reciente sobre la presencia he pathogen, as de Xylella fastidiosa en nuestro país (252 positivos en Prunus r concerning dulcis, 68 positivos de Olea europaea var europea, 179 positivos de Olea europaea var sylvestris y los 28 positivos de Vitis vinefera), El MAPAMA propondrá a las comunidades autónomas un aumento de las prospecciones en los cultivo del almendro, del olivo y del cultivo de la vid. Según datos oficiales del MAPAMA, en España actualmente hay 2.526.496 ha de olivar, 941.951 ha de viña y 548.604 ha de Almendros. La intensidad de prospección en estos cultivos fijada por el Plan de contingencia fue: Almendro y Olivo: 1 prospección por cada 10.000 ha. Vid: 1 prospección por cada 15.000 ha. Se está modificando el Plan Nacional de Contingencia para incrementar la intensidad de prospección según la representación territorial de los principales cultivos sensibles a Xylella fastidiosa, en particular a almendro, olivo, vid y cítricos. Dicha modificación se reflejará en el Plan de Acción para el año 2018, que se remitirá a la Comisión antes del 31 de diciembre de 2017. ANDALUCÍA Andalucía, según lo establ

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Directly after the presence of Xf was confirmed in a nursery in Mallorca the ACCA the ACCA established a BZ of 10km radius and commenced surveying it, based on a 100m x 100m grid as required by the Decision. As this survey quickly resulted in numerous positive findings the CA decided to extend the BZ to the entire territory of the Balearic Islands (see chapter 5.3.1). Due to the available limited human resources and laboratory capacities, it was then decided to carry out surveys in the BZ, based on a 1km x 1km grid. The work started in parallel on each of the four islands. The main aim was to swiftly obtain comprehensive information about the outbreak situation.

The audit team observed inspections carried out by inspectors of the Plant Health Service and by employees of a public company specialised in providing emergency services in agriculture, rural development and nature conservation (TRAGSA) in the DA and noted that the survey teams: Identified the position of the 1km x 1km grid square to be checked with the help of GPS data and with a specific application on their computer tablets, which used satellite pictures indicating the already inspected squares; 13 Attempted to check visually at least 50% of the surface of the square. In order to achieve this goal they drove along all available roads in the square and walked into the fields where possible. However, checking the majority of the area visually was not always possible, due to the lack of roads, accessibility of some parts of the square, including natural areas, abandoned agricultural land and private properties. The survey teams did not report any problems with accessing private properties, as until now they could obtain the consent of the proprietor practically in each case; Checked visually the host and specified plants in the square and tried to identify symptoms, possibly caused by Xf. numerous host plants, especially wild and cultivated olives and almonds, showed some symptoms of a certain decay in the form of dried or scorched leaves and twigs. However, as the region had been suffering from drought for a period it was not obvious which of the symptoms could have been caused by Xf. Due to the limited laboratory capacities only those host plants, which showed severe and typical symptoms, were sampled. Practically no samples were taken from asymptomatic hosts; The sampling for laboratory analysis was carried out according to the method described in the regional action plan and was in line with provisions of the Commission guidelines and the EPPO laboratory protocol; In the case of olive and fruit trees, incremental samples were taken from the different parts of the canopy. The laboratory sample represented a single plant, no composite samples were prepared. The sampled plant was clearly marked for possible follow-up; The results of the survey, including the proper GPS coordinates of the sampled plants were duly recorded on a computer tablet and the data were later uploaded to a regional database.

The ACCA informed the audit team that, at the time of the audit overall 62% of the squares had been surveyed; the coverage was higher in Mallorca and Ibiza. Samples for laboratory analysis were taken from only 15% of the inspected squares (see table III.). Table III. Surveys in the BZ (as of 9 June 2017) Balearic Total number Number % of Number of % of % of Islands of grids (1km x of grids total grids with inspected total inspected sampling squares squares 1km) 66% 2,598 68% 289 11% 7% Mallorca 3,935 485 43% 183 38% 26% 354 42% 52 15% 6% Ibiza 710 56 62% 15 27% 11% 3,493 539 15% 10% Menorca 820 Formentera 135 Total 5,600 Source: ACCA Balearic Islands

The audit team noted that the intensity and territorial coverage of the surveys in the BZ is not in line with provisions of Article 6(7) of the Decision and consequently cannot provide a comprehensive picture about the territorial spread and extent of the Xf infection. The number of positives and their territorial distribution (see figure I in chapter 4.2) already indicate that Xf is widespread throughout the three islands, in cultivated and abandoned agricultural land, natural and urban areas.

The audit team considers that the current survey results do not provide a comprehensive picture of the host range of Xf in the BZ. 5.2.3 Surveys in the Infected zones

Surveys in the BZ and IZs are not in line with the provisions of the Decision and do not provide a comprehensive picture of the territorial spread and extent of the infection and of the host range. This seriously compromises the eradication measures and has a negative impact on the implementation of other measures, required by the Decision.

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infected zones and MAPAMA 6(3) and 6(7) of Como es conocido por la auditoria una vez detectado el primer uffer zone are positivo y sin haber podido determinar el origen de la infección se aron a detectar nuevos positivos en plantas distantes de las demarcada establecidas. Ante esta situación y con el ivo de optimizar adecuadamente los recursos disponibles y ar el mayor territorio posible, se optó por prospectar almente con una malla de 1 × 1 km. Hasta octubre del 2017 res ha prospectado el 21,8 % del total de las cuadrículas lecidas con la malla 1 × 1 m (5.600 cuadrículas). as a la utilización de esta malla se ha podido realizar una a detección de otros brotes, se ha podido declarar todo el Page: 2 ived 31 October 2017 ations of report ref. DG(SANTE)/2017-6216-MR of the audit carried out from 12 June 2017 controls for Xylella fastidiosa Action Proposed by the competent authority territorio de Baleares como zona demarcada y se ha podido prohibir la salida de plantas de las islas. Esta rápida actuación se considera efectiva a la hora de gestionar el riesgo y consolidar el principal objetivo de la decisión, que es evitar la propagación. Sin embargo, si las acciones se hubieran dirigid

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After numerous positives were identified in the Balearic Islands in the period December 2016 ­ January 2017, Spain decided not to eradicate the outbreaks fully in line with the provisions of Article 6(2) of the Decision. In the vast majority of the IZs only the host plants, which were tested positive, were removed or intended to be removed. All host plants in the 100m radius of the positive plants, regardless of their health status and other specified plants, showing symptoms were not considered subject to eradication measures. Table VI and VII show details of the eradication work. Table VI. Eradication measures in the Balearic Islands (as of 9 June 2017) Island Positives Positives Positives- Plants removed removed removal pending total Mallorca 156 78 78 2,135* Ibiza 68 42 26 42 Menorca 28 16 12 16 Formentera 0 0 0 0 Total 252 136 116 2,193 Source: MAPAMA * Including host plants removed in the nursery, where the first outbreak was detected Table VII. Removed positive plants per species (as of 9June 2017) Positives removed Mallorca Ibiza Menorca 1 1 Acacia saligna 1 12 Cistus monspeliensis 1 3 1 Lavandula dentata 3 3 Nerium oleander 22 11 Olea europaea var. sylvestris 5 22 16 Olea eruropaea var. europaea 13 1 Polygala myrtifolia 3 Prunus avium 26 1 Prunus dulcis 5 Rosmarinus officinalis 1 42 Vitis vinifera 78 Positives with removal pending Source: MAPAMA

At the time of the audit, about half of the positive plants had been removed. Felling orders were issued in general two-to-three weeks after the final laboratory result was available. None of the proprietors has appealed against the official decision. 18 Thereafter, it usually took two-to-three weeks to complete the felling. Nevertheless, there were significant delays in certain cases due to difficulties in identifying the owner (e.g. holiday homes, abandoned land). (see table VI).

The audit team visited IZs in Mallorca and Ibiza, where positive plants had been removed and noted that: In the 100m area of the removed plants, there were numerous host plants, which were not removed (olives, almonds etc.). Many of them showed symptoms of decay to varying degrees. Only some of them had been sampled and found negative; In the IZs, an inventory was not made to identify the (non-host) specified plants and no samples were taken from those plants present; The IZs were not revisited to remove newly identified host plants.

The audit team considers that the current measures are not in line with the Decision regarding eradication, as some of the plants tested positive were removed with delay and the host plants regardless to their health status and other plants showing symptoms were not removed in the IZs. The CAs did not express a clear position about their future intention regarding the removal of host plants other than those tested positive in the IZs. 5.3.3 Agricultural practices

The currently applied measures do not ensure the eradication of the pathogen. Given that Xf is widespread on three of the Balearic Islands on a wide range of host plants and different subspecies of the pathogen are present in the infected area, eradication will be very difficult to achieve.

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ng the MAPAMA ne with Article El MAPAMA entiende que a consecuencia de la amplia he immediate distribución de la enfermedad en las islas y la amplia gama de plantas hospedadoras identificadas, las medidas de erradicación establecidas por la decisión causarían un gran impacto ambiental y económico en todo el territorio de la comunidad autónoma de Baleares. Por este motivo, España solicitó oficialmente a la Comisión Europea, la estrategia de contención en las islas Baleares. Posteriormente en la última reunión del SCOPAFF realizada en octubre, se votó favorablemente por unanimidad la nueva Page: 3 ived 31 October 2017 ations of report ref. DG(SANTE)/2017-6216-MR of the audit carried out from 12 June 2017 controls for Xylella fastidiosa Action Proposed by the competent authority modificación de la decisión en la que se autoriza a la comunidad autónoma de Baleares a realizar una estrategia de contención. Actualmente, se está esperando la publicación de este documento. Debido a todos estos acontecimientos el MAPAMA comprende que las Islas Baleares actualmente sigan realizando la estrategia de contención en todo su territorio. BALEARES Las autoridades regionales de Baleares estiman que e

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The audit team visited nurseries, both producers and traders with outlets in the BZs and noted that: The majority of the establishments are wholesalers or retailers of plants for planting imported from mainland Spain or from other MS. There are some producing nurseries who propagate a narrow range of specified plants; The main professional clients are other nurseries on the island and companies dealing with landscaping or gardening; Each nursery visited stated to the audit team that they do not market specified plants outside the island where they are located. They are fully aware of the measures implemented after the outbreak and they duly inform their professional and private customers about the existing ban; In each nursery, posters and flyers clearly displayed the movement restrictions in force and the list of specified plants; The nurseries keep detailed records on production, incoming stock and sales to professional clients of specified plants; They do not keep records on sales to private clients, however they do inform them about the export ban of specified plants; The ACCA inspects the nurseries at least once a year in order to authorise them for issuing plant passports. Controls related to Xf always form part of these inspections. Since the first outbreak was detected, the ACCA carried out numerous additional inspections in the nurseries; Plant passport and Xf related inspections in the nurseries and garden centres are carried out according to an annual schedule. Therefore the timing may not be ideal to find possible symptoms of Xf and the stock present at the time of inspection do not always represent the annual trading activity of the establishment; ACCA inspectors take samples from each symptomatic plant and randomly from the asymptomatic plants as well. However, due to limited laboratory capacity, the extent of random sampling is not in line with requirements of ISPM 31 and therefore it could not be representative of the stock of specified plants present in the nursery. 5.4.4 Movement control of specified plants at airports, ports

The resolution of the regional minister, which bans the movement of specified plants out of the territory of the Balearic Islands is implemented through a wide set of measures. There is multichannel awareness raising at airports, ports, in the form of posters, flyers informing both arriving and departing passengers. There are controls at airports and sea ports. The relevant authorities or security services reports any findings to the Civil Guard for enforcement.

The audit team noted that: 22 The Agriculture Department of the Balearic Islands maintains close working relations with the airport and seaport authorities, the security services responsible for controlling the exiting passengers and with the Civil Guard. These organisations are members of the recently established regional steering and coordination group for Xf issues; At the international airports, both in the arrival and departure halls, posters and even electronic displays inform passengers about the restrictions in force. At check-in desk there is information material about the ban including the list of specified plants; The airport security services check the presence of living plants during the scanning of cabin bags and check-in luggage. Any plant detected is confiscated and stored in a separate container until it is destroyed. The Civil Guard is informed about each case, however no further enforcement measures are applied. In April-May 2017 the ACCA received reports of 17 cases from Ibiza airport and 11 cases from Mallorca airport concerning plants in personal luggage. Usually lavender, rosemary, rose and geranium plants were detected; Representatives of the port authorities and security services confirmed that they provide information about the existing restrictions to ferry operators and passengers and to staff and passengers of other vessels leaving the islands; At the ferry ports there are practically no exit controls on trucks neither in the traffic between the islands nor to the mainland. There are occasional checks on exiting cars, but there are no controls on the luggage of passengers leaving the islands by ferries or by other type of vessels. 5.4.5 Road controls

The controls in the nurseries provide a level of guarantees that specified plants are not leaving the demarcated area and also that a possible outbreak is quickly detected. However, despite the wide-ranging information campaign it cannot be excluded that tourists or other individuals intend to export specified plants bought in the nurseries. Therefore there is a pronounced plant health risk related to the possible transport of specified plants in the luggage of private persons leaving the islands.

The current measures implemented at the airports provide for a reasonable level of guarantee for containing the infection on the territories of the Balearic Islands. However, at the sea ports the same level of guarantees is not ensured. 23

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t least part of BALEARES rea, as required Las autoridades regionales de las Islas Baleares mantienen reuniones de coordinación con las autoridades portuarias para intensificar los controles en los puertos marítimos con el objetivo de prohibir cualquier movimiento de vegetales especificados fuera del territorio. El Gobierno de las Islas Baleares ya ha publicado un nuevo póster, Page: 4 ived 31 October 2017 ations of report ref. DG(SANTE)/2017-6216-MR of the audit carried out from 12 June 2017 controls for Xylella fastidiosa Action Proposed by the competent authority que simplifica la información aportada por el anterior. Ya está a disposición de las autoridades portuarias y de los aeropuertos. También tiene previsto elaborar trípticos informativos que van a ser distribuidos por los puertos con el objeto de recordar a los pasajeros la prohibición de salida de material vegetal de las Islas Baleares. En la reunión de coordinación mantenida en el mes de octubre con Guardia Civil (Puertos del Estado - TOTAL 5 puertos) y Autoridad Portuaria (Ports de les IIBB - TOTAL 42 puertos), se acordó repartir 300 de los nuevos pósters, donde queda detallada la prohibición de salida. Las autoridades

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The audit team noted that the laboratory: Was able to cope quickly with the challenges resulting from the outbreak and gained experience in routine real-time PCR testing; Efficiently uses the relatively limited facilities at its disposal; Maintains close working relations with the NRL and with the laboratory responsible for subspecies identification; Participated in an international proficiency test for Xf detection, which had recently been organised within the framework of an EU research project, and was assessed as highly proficient; Applies a serial DNA extract dilution in order to control PCR inhibition caused by substances present in some host plants. However, these inhibition control steps are not elaborated and validated for each host plant, therefore, there is a chance of false- negative results due to the inhibition of DNA amplification; Sends only a proportion of the positive and undetermined samples for confirmatory tests to the NRL (at the time of the audit only in the case of positives from a new area or from a new plant species) (see chapter 5.2.2). LOSVIB usually sends both the plant and DNA extract for confirmation. None of the negatives are re-tested for quality control purpose by a different laboratory. The audit team considers that although it is not a requirement, re-testing would provide additional assurance.

The current system of confirmatory testing on samples originally tested by the LOSVIB laboratory could undermine the effectiveness of the implementation of the control measures.

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testing Xylella MAPAMA e and on a Respecto a la recomendación número 5 el MAPAMA entiende additional que Baleares durante los años 2016 y 2017 ha tenido que procesar un número importante de muestras y ha tenido que afrontar con rapidez la realización de un número importante de análisis. Específicamente el Laboratorio oficial de las Islas Baleares (LOSVIB) durante estos 2 últimos años, ha recibido 1776 muestras de la isla de Mallorca, de las cuales han sido analizadas 1755 y se han obtenido 321 positivos. De la isla de IBIZA ha recibido 825 muestras, de las cuales se han analizado 806 muestras, y se han obtenido 100 positivos. De Menorca el LOSVIB ha tenido que procesar 423 muestras, de las cuales se Page: 5 ived 31 October 2017 ations of report ref. DG(SANTE)/2017-6216-MR of the audit carried out from 12 June 2017 controls for Xylella fastidiosa ty nido 69 positivos. De la muestras lo que ha s que no se han obtenido zados se han podido mizado sus recursos para entemente realizar omentarios realizados por objetivo prioritario del muestras positivas eal posible de la y no tanto la confirmación . teniendo en cuenta las itor. Por este motivo el tes vegetales enviando muchas plantas ido

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The audit team noted that: Although the staff of these laboratories had experience in detection of pathogenic bacteria in plant samples, only some had participated in any specific training for Xf analysis organised by the NRL; Except the Official Plant Health Laboratory of the Balearic Islands (LOSVIB) the AC laboratories did not have the opportunity to participate in a proficiency test on Xf analysis with molecular or serological methods, organised in the framework of an EU research project. The NRL has not organised any proficiency test for them. The satisfactory performance in the proficiency tests could provide additional assurance and could mitigate the risk of false test results; The NRL advised AC laboratories to use two different real-time PCRs for Xf detection. However, the audit team could not receive confirmation from the CA that this was actually the case in each laboratory. Some laboratories use enzyme linked immunosorbent assay (ELISA) tests, which is not recommended by the EPPO protocol PM 7/24(2) for testing samples from pest-free areas. 8

Due to the lack of regular proficiency tests on Xf analysis for the ACCA laboratories sufficient assurance cannot be provided that the official test results reflect entirely the infection status of the samples.

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ls with Laboratorio Nacional de referencia mples taken in El laboratorio Nacional de Referencia, de acuerdo con las o provide additional autoridades del ministerio y para evaluar la fiabilidad de las pruebas realizadas por los laboratorios regionales de diagnóstico, está ultimando la preparación de diferentes muestras vegetales y con diferentes concentraciones de Xylella fastidiosa. (Proficiency Test, ensayo interlaboratorios). El envío de dichas muestras a los laboratorios de diagnóstico de las distintas CC. AA está planeado para la semana del 20-24 de noviembre, dando un plazo razonable para que las analicen y antes de final de año tener un informe del ensayo. Page: 7

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Considering the high incidence of CLs, several of the non-sampled 19 places of production in Valderredible are likely to be infected. The ACCA declared that it did not have the resources to take samples at all places. Lacking the evidence of the presence of CLs, the ACCA did not impose measures on those producers. However, given the epidemiological situation there is reason to impose similar measures on producers with an, as of yet, unknown status. Moreover, since potato stocks would be eliminated by the start of the new growing season, the sampling opportunity was lost.

Given the fact that the ACCA of Castilla y León had not been aware of the presence of an infected plot on their territory, it had not been in the position to take measures to address the situation. 5.2.4 Surveillance

The MAPAMA and the ACCAs have not substantiated that the surveys planned and those already carried out in some of the ACs, are representative for the concerned ACs, together representative for Spain, and designed and executed in a way to provide an adequate statistical confidence necessary for the results to be meaningful for regulatory purposes, as advised by ISPM9. 5.2.5 Communication with stakeholders

Whilst the ACCAs are responsible for the control of CLs within their territories, whose activities mainly focus on surveillance, the audit team did not observe a coordinated research effort concerning above questions which are pertinent to ISPM 9 section 2.4.1and 3.2.3. Conclusions on pest control

The initial investigation of the finding of zebra chip symptoms in potatoes in Cantabria has been effective in identifying infected places of production and potato lots. Measures have been taken to contain the infection at those places of production. However, potentially infected farms have not been investigated and communication of important findings has on occasion been delayed due to staff shortages. Current surveillance plans have not been fully elaborated and are insufficient for obtaining essential information concerning the pathology, epidemiology and potential economic impact. Altogether this can undermine the decision making on subsequent control measures and the overall effectiveness of the pest control.

The risk of the disease spreading to other EU Member States is small considering the structure of the production and supply chain of potatoes in the infected area and the current knowledge about the disease. Although containment measures provide additional assurances, these can only be fully effective if applied on all places of production likely to be infected.

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Cantabria: El día 1 de agosto ha reiniciado la actividad de su laboratorio y ha contratado personal externo para las labores de inspección. Por lo tanto, Cantabria espera realizar las actuaciones detalladas en el plan de Acción de la presente campaña. (Conclusión 12). Durante la presente campaña, tiene previsto tomar muestras en las explotaciones afectadas, para determinar el grado de diseminación de la enfermedad, así como de la presencia de potenciales vectores. En función de los datos del seguimiento de la enfermedad que se obtengan en la presente campaña se decidirá si deben tomarse las medidas en todo el municipio de Valderredible o solo en las explotaciones en las que se ha detectado CLso. Los planes de Vigilancia, tal como se indica en el plan de acción, se irán revisando y modificando constantemente, para adaptarlo a los cambios que se puedan originar. (Conclusión 43). Los comentarios basados en la conclusión número 44 se especifican en el documento denominado "Comments on the draft report". Page: 1

Cantabria Esta Comunidad ha tenido en cuenta las recomendaciones establecidas por la auditoria y en consecuencia ha modificado su plan de acción. Tal como especifica este documento, Clso es una enfermedad de reciente detección en Cantabria, de la que todavía no se conoce en todo detalle tanto su forma de transmisión como el grado de afectación en el cultivo. Teniendo en cuenta que la auditoría recomienda que se planteen acciones concretas para determinar la presencia real de la enfermedad, se expone en el plan de acción de Cantabria que en Valderredible se realizarán prospecciones y se tomarán muestras en todas las explotaciones productoras de patata, independientemente de que estén o no afectadas por la enfermedad. Las muestras serán recogidas siguiendo el protocolo de prospecciones establecido en el Plan de Contingencia. En total se recogerá como mínimo 1 muestra por cada explotación. En la zona de Valderredible hay 32 explotaciones, ya se prospectaron 13 explotaciones, 10 de las cuales dieron positivo a la bacteria. Las prospecciones previstas, en la modificación del Plan de Acción de Cantabria, se desarrollarán en las explotaciones que dieron positivo a la bacteria (10), para c

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El Plan Nacional de Control Oficial de la Cadena Alimentaria ery (PNCOCA) establece en el programa 1 el control general de los es, in establecimientos alimentarios y en el programa 2 el control de los ntation autocontroles en los establecimientos alimentarios. Estos controles se hacen en todos los sectores y fases contemplados en el plan, entre los que se encuentran los establecimientos del sector 2 de "pescados, moluscos bivalvos y derivados". La ejecución de dichos controles es llevado a cabo por las diferentes CCAA, para lo que todas ellas tienen y aplican procedimientos operativos. En relación al programa 2, con estos procedimientos operativos verifican que los operadores de empresa alimentaria disponen de procedimientos basados en los principios del APPCC y los aplican y mantienen actualizados. Asimismo, disponen de mecanismos de supervisión para comprobar que las acciones realizadas se llevan a cabo convenientemente. Acciones propuestas: Establecimientos fabricantes de lomos de atún descongelados, lonjas y mercados mayoristas: 1. 1. Revisar, y en caso necesario modificar, los sistemas de planificación de los controles en base al riesgo de las inspecciones y auditorías a los e

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During the audit, the audit team confirmed that under the Spanish legal framework the competent authorities have adequate powers to take the necessary samples for AMR monitoring. However, the personnel from the designated laboratory are not considered part of the competent authority and therefore can only access slaughterhouses if the operators voluntarily agree to grant this access. In 2014, staff from this laboratory were not allowed to enter a significant number of broiler slaughterhouses initially included in the work plan. In one particular case, this problem was overcome through the intervention of MAGRAMA, which resulted in the operator of the largest turkey slaughterhouse in the country finally granting access to staff members of the concerned laboratory. Although the situation has improved in 2016, some large broiler slaughterhouses are still denying access to these staff to perform the sampling.

The competent authorities responsible for the monitoring of AMR in food producing animals and food are clearly designated, well-structured and organised, and have the necessary powers and resources, which is a prerequisite for the adequate implementation of the harmonised monitoring of AMR. The lack of powers of the designated laboratory staff for accessing slaughterhouses and perform sampling has an impact on fulfilling the Decision requirements regarding the poultry population to be covered by the sampling design.

Regarding the broiler slaughterhouses the following was noted by the audit team: In 2014 the broiler slaughterhouses included in the sampling plan, contrary to point 2.3.1 of Part A of the Annex to Decision 2013/652/EU, processed only 40% of the domestic production while for 2016 the figure improved and has reached 54% (see point 6). The figures on slaughter production used for the sample allocation corresponded to two years before the sampling year and not to the previous year as recommended in EFSA 2014 guidance document. These data were obtained from an industry publication that does not include all the national slaughterhouses. As a consequence, in the case of slaughtered broilers the designated laboratory calculations of the population covered by the sampling plan were overestimated. The audit team noted that in the autonomous communities visited the slaughter volumes per slaughterhouse were readily available while at central level this information was not compiled.

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In 2014, the minimum required 170 Campylobacter jejuni isolates were not achieved for broilers and turkeys. Only 80 and 37 isolates were tested for AST and reported to EFSA for these populations respectively. According to the data provided by the competent authority in Spain C. coli is more prevalent than C. jejuni. The competent authority stated that for this reason they have difficulties to achieve the minimum required 170 isolates for the latter, especially in the turkey population. However, the amount of caecal samples to be taken for both populations of broilers and turkeys in the 2016 sampling plan (500 each), has been unchanged from 2014 despite the minimum number of isolates not being achieved. EFSA 2014 guidance document recommends that the number of samples to be taken should be established depending on the prevalence. MAGRAMA stated that it would be very cumbersome to increase significantly the number of samples to be taken.

The requirement set out in point 2.3.1 of Part A of the Annex to Decision 2013/652/EU that caecal samples collected at slaughterhouses shall be distributed evenly over each month of the year was not adhered to in 2014, 2015 and 2016. The designated laboratory stated that this was due to delays in the public tender approval and to the fact that submission of the AST results to MAGRAMA has to take place by December. In 2014 caecal samples were gathered from May to November while in 2015 sampling took place from March to October and in 2016 it started in April.

AECOSAN has designed the collection of samples at retail outlets distributing the samples to be taken proportionally in the 13 provinces (NUTS-3 areas) more populated representing 60% of the total population. This approach to ensure the representativeness of sampling at this level is detailed in EFSA 2014 guidance document, where it is highlighted that NUTS-3 areas selected should cover at least 80% of the population (see section on Closing Meeting). In Catalonia, the authorities allocate the requested number of samples proportionally to the population to the three administrative areas of the province of Barcelona, which is the only Catalan province included in the sampling plan. In Murcia the authorities allocate the samples to the metropolitan area which is the most populated and also logistically allows the samples to be submitted to the laboratory within the required timeframes. In both autonomous communities, and to ensure the representativeness of the samples taken, the authorities took samples mainly obtained in the supermarket chains that have the biggest market share and are widely represented in the region. 7 Isolates from samples collected at poultry primary production

The overall bovine slaughter data were used for the sampling design of caeca from bovine under one year of age. As a consequence, the sampling allocations were not proportional to the slaughter of eligible animals as required by point 2.3.1 of Part A of the Annex to Decision 2013/652/EU and detailed in EFSA 2014 guidance document.

Regarding the broiler slaughterhouses the following was noted by the audit team: In 2014 the broiler slaughterhouses included in the sampling plan, contrary to point 2.3.1 of Part A of the Annex to Decision 2013/652/EU, processed only 40% of the domestic production while for 2016 the figure improved and has reached 54% (see point 6). The figures on slaughter production used for the sample allocation corresponded to two years before the sampling year and not to the previous year as recommended in EFSA 2014 guidance document. These data were obtained from an industry publication that does not include all the national slaughterhouses. As a consequence, in the case of slaughtered broilers the designated laboratory calculations of the population covered by the sampling plan were overestimated. The audit team noted that in the autonomous communities visited the slaughter volumes per slaughterhouse were readily available while at central level this information was not compiled.

The documented procedures and instructions in place could ensure adequate implementation of most of the provisions laid down in the legislation. However, there are deficiencies in the design and implementation of the sampling plan that call into question the representativeness of sampling. These concern notably the information available to exclude the sampling of repeated epidemiological units, the amount of samples taken for C. jejuni in relation to the prevalence, the exclusion of some months of the year, the type of samples taken at retail and, notably, the sample allocation to slaughterhouses and retail, These issues could lead to the gathering of AMR monitoring data not fully comparable with those obtained by other Member States.

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As required, individual standardised forms accompany the samples with all the relevant information. The audit team noted that the information requested by the CNA did not allow for the exclusion of repeated epidemiological units from reporting, as required by point 2.3 of Part A of the Annex to Decision 2013/652/EU. In the two autonomous communities visited this information was available (see section on Closing Meeting). Isolates gathered from caecal samples collected at slaughter

In Murcia it was noted that, in 2014 and 2015, in several cases the samples forwarded to the CNA belonged to the same lot. According to EFSA 2014 guidance document, each sample should be sourced from different lots. This problem was not identified by the CNA or AECOSAN (see section on Closing Meeting). The instructions given by this autonomous community to the samplers requested that samples should be taken from bovine meat from bovines under 1 year of age, which is contrary to point 2.3.3 of Part A of the Annex to Decision 2013/652/EU that specifies that samples should be taken from bovine meat. The Catalonian competent authority also requested that bovine meat samples should comprise only meat from bovines under 1 year of age. In both autonomous communities this issue was rectified. The audit team also noted that, contrary to point 2.3.3 of Part A of the Annex to Decision 2013/652/EU, several retail samples tested in 2015 were not taken from fresh meat.

The documented procedures and instructions in place could ensure adequate implementation of most of the provisions laid down in the legislation. However, there are deficiencies in the design and implementation of the sampling plan that call into question the representativeness of sampling. These concern notably the information available to exclude the sampling of repeated epidemiological units, the amount of samples taken for C. jejuni in relation to the prevalence, the exclusion of some months of the year, the type of samples taken at retail and, notably, the sample allocation to slaughterhouses and retail, These issues could lead to the gathering of AMR monitoring data not fully comparable with those obtained by other Member States.

The selection of the isolates to be tested for susceptibility and reported on is done by the laboratories performing these tests. In the case of the isolates reported by AECOSAN the information available did not allow officials to ascertain if repeated epidemiological units were reported (see points 33 and 46). INFORMATION INCLUDED IN THE REPORT

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In 2014, the number of isolates tested and reported for Salmonella for testing and verification of compliance with Chapter 2 of Annex I to Regulation (EC) No 2073/2005 at slaughterhouse level was 130 for broilers and 1 for turkeys. For the year 2015, 128 isolates were tested and reported under the same category for pigs and 9 for bovines under 1 year of age. The audit team noted that, even though the minimum 170 isolates had not been achieved for 2014 and 2015, isolates available from official samples at autonomous community level were not always gathered and tested for AST by the CNA. In Catalonia this issue has been solved and for the year 2016 all relevant isolates have been submitted so far. At the time of the audit and for the year 2016, 68 and 35 Salmonella isolates obtained from official samples from broiler and turkey carcasses respectively were gathered by the CNA. This represents an improvement from the 2014 data. 5

Despite the minimum required number of Salmonella isolates at slaughterhouses not being achieved, the competent authority did not systematically make use of the food business operators' isolates for AST, as set out by Article 3 of Decision 2013/652/EU (see point 31). AECOSAN and Catalonia presented evidence that, in 2015, the slaughterhouse industry representatives were encouraged to submit Salmonella carcass isolates with only four isolates provided altogether. In addition, and in relation to this point, the audit team noted that relevant Salmonella isolates originating from samples collected by food business operators in the context of Regulation (EC) No 2073/2005 were obtained in two out of the three private laboratories performing laboratory tests for the food business operators visited. These isolates were not used for AST testing in the context of Decision 2013/652/EU.

Despite the minimum 170 isolates for each species not being achieved the gathering of food business operators' isolates amounted only to 4. 8

As a consequence of the competent authority not gathering a sufficient number of Salmonella isolates (for the purpose of antimicrobial susceptibility testing), obtained by food business operators from carcass samples taken in the context of Regulation (EC) No 2073/2005, the minimum 170 Salmonella isolates had not been achieved for the relevant species since the introduction of Decision 2013/652/EU.

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The audit team noted that the CVL did not carry out any oversight, as NRL, over the designated laboratory and was not aware of the performance in the relevant proficiency tests to ensure that adequate follow up of such tests as required by point 2(c) of Article 33 of Regulation (EC) No 882/2004.

Laboratory procedures were available on the spot and generally followed the relevant international standards. However, the following was noted by the audit team: In the designated laboratory the procedures and records for sample acceptance and ESBL testing did not include verification of the temperature and time requirements set in the EURL Laboratory protocol for isolation of ESBL-, AmpC- and carbapenemases-producing E. coli for ceacal samples. In the NRLs, adequate quality controls with reference strains were run for each batch of plates tested and adequate records were kept. In the designated laboratory the reference strain was run weekly and not for every batch. The laboratory was able to present ample information regarding past satisfactory results using this reference strain. Nevertheless, there was no documented procedure in place, in line with Clinical and Laboratory Standards Institute (CLSI) standard M07-A10, as required by point 3 of Part A of the Annex to Decision 2013/652/EU, in order to describe the rationale behind the reduced frequency of the use of the reference strain and describing in which cases the laboratory must revert to use the strain for every AST batch. In all three laboratories, the procedures as explained dealt generally with out of range or unusual results and prevented the exposition to light of microdilution trays. Nevertheless, these procedures were not documented and for some unusual combinations of resistance no investigation was performed. Likewise, the procedures as explained dealt correctly with skips but the procedure was not documented. The laboratory procedures for Campylobacter minimum inhibitory concentration determination in the CVL and the designated laboratory were not based on the M45 13 CLSI standard as required by point 3 of Part A of the Annex to Decision 2013/652/EU. In particular, the time defined for incubation was not in line with the relevant standard and included deviations of up to eight hours. With regard to the detection of ESBL- or AmpC-producing E. coli, the audit team noted that reference strains were regularly used to validate the preparation of the McConkey agar when the media was prepared in the laboratory and the positive and negative controls were used weekly as recommended. Nevertheless, this was not described in the documented procedures. In the three laboratories when performing the second panel for AST (Table 4 of Decision 2013/652/EU) the reference strain E. coli ATCC 25922 was used. CLSI protocol M100S latest edition recommends using both reference E. coli ATCC 25922 and Klebsiella pneumonia ATCC 700603 strains. The latter is more suitable for ESBL profiles in order to verify more effectively that the test performance is satisfactory. 5.2.2.4 Storage of the isolates

Both NRLs have the necessary equipment to freeze isolates at temperatures below -80°C and to store them for at least 5 years. Nevertheless, the audit team noted that in the designated laboratory only Campylobacter isolates were stored at -80°C while other isolates were stored at -40°C without any validation to ensure viability and absence of changes in strain properties as required by point 5 of Part A of the Annex to Decision 2013/652/EU. The designated laboratory stated that relevant isolates will be moved to -80°C storage. Back-up equipment and emergency plans in case of equipment malfunction were available. Conclusions on official laboratories

An appropriate laboratory network for official monitoring of AMR is in place. Laboratories are properly designated and operate in accordance with the EU requirements. Some weaknesses have been identified during this audit mainly in relation to documented procedures and the use of reference strains. Further weaknesses in the coordination role of the NRL for AMR over the designated laboratory were noted. These weaknesses could affect the ability of the laboratories to obtain harmonised and comparable results. 14

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The collection form used for reporting the "generic description of the implementation of the AMR monitoring" was also submitted to EFSA as required in Part B (2) of the Annex to Decision 2013/652/EU. The description of the sampling designs, stratification and randomisation per animal population and food was not complete enough and mainly included the following text "according to EFSA technical specifications and Commission implementing Decisions 2013/652/EU and 2013/653/EU". The competent authorities stated that the information provided was incomplete due to the difficulties they encounter when introducing text in the reporting excel text forms.

The annual report includes all the mandatory information for each individual isolate reported under harmonised monitoring, and some information reported on a voluntary basis exceeds the current mandatory monitoring under EU legislation. There are though some weaknesses in the overall description of the implementation of AMR monitoring that partially undermine the reliability of the data submitted. 15

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Spain complies with the EU legal requirement for the number of samples taken and analysed on an annual basis (the number must correspond to at least 5% of the number of organic operators). In 2015, a total of 1 220 samples were taken by the designated CBs in Andalusia, compared to 13 296 organic operators (9.2 %). This is fully compliant with Article 65 of Regulation (EC) No 889/2008. Both CBs visited complied with this requirement. The authorities in Andalusia stated that 118 of the samples taken in 2015 contained pesticide residues. At the two CBs, samples were taken across the production and processing chain, based on the identified risks. In addition to food and feed, a substantial number of samples were taken from leaves and soil. The audit team considered this sampling approach as good practice.

Both CBs visited had included a Standard Operating Procedure (SOP) in their Manual of Procedures regarding the risk assessment for prioritising samples for pesticide residue analyses. There were also sampling instructions in place. They were very detailed at one CB, but the other CB only referred to the Royal Decrees stated above. A sample of leaves with a weight of 290 grams had been taken at one of the CBs, but it was unclear whether the amount was sufficient to qualify as a representative sample, and where in the field the sample was taken. At one of the laboratories visited, a sampling record for a grape sample 5 of 500 grams was accepted, whereas Royal Decree 291 of 2003 and Directive 63/2002/EC require a weight of at least one kilogram for the laboratory sample.

At the two CBs visited, multi-residue analyses combining both liquid chromatography (LC) and gas chromatography (GC) techniques were not requested from the laboratory, except in particular cases of higher risk. One of the CBs requested only GC analyses for samples of lower risk. The other CB requested, for such samples, analyses alternating between LC and GC techniques, so that individual samples were not analysed with both techniques. One laboratory confirmed, in respect of six examples chosen by the laboratory, that requests for analysis by a third CB related to GC only. In this context it should be noted that analysis by GC techniques is not suitable to detect modern polar (watersoluble) pesticides, which are widely used by conventional farmers. Neither is an LC technique alone suitable to detect many of the relevant pesticides.

The lack of clear official criteria on sampling procedures for products other than those of plant and animal origin covered by Royal Decree No 290/2003 poses a risk that the interpretation of laboratory results is affected by a sampling procedure which is not representative for its purpose.

The lack of clear official CA criteria for the scope of analyses to be carried out (in particular, as to gas and liquid chromatographic techniques) impacts negatively on the control system: as gas chromatography is used as the only laboratory detection technique in many cases, the data on pesticide detections is likely to represent an underestimation of the true presence of pesticide residues in organic produce.

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The Spanish multi-annual National Control Plan for the Food Chain (2016 ­ 2020) specifies that the CAs may refer to the lists of laboratories that have already been previously designated by other competent authorities in order to select a laboratory to carry out analyses for pesticide residues in organic production. The SGCDAE stated that a representative of the ministry unit, with competence in the corresponding laboratories or agri-food laboratories, will be invited to the next Organic Production Coordination Group meeting, and the implementation of this provision would be discussed, as would the scope of pesticide residue analyses in Organic Production.

The two laboratories visited by the audit team are listed by the Andalusian CA for Organic Production, the CAPDR, however they had not been formally designated by the CA to carry out official analyses (the CAPDR informed the audit team that the process for designation has started). The laboratories conduct analyses for pesticide residues in different plant products. The laboratories had an adequate level of qualified staff. The equipment in the laboratories was state of the art. 7

The process for official designation of laboratories for pesticide residue analysis in organic production is being developed. The official designation is expected to facilitate co-ordination and supervision of these laboratories.

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The organic section of the Spanish 2014 Annual Report submitted under Article 44 of Regulation (EC) No 882/2004 shows that both CBs visited met the minimum requirements in terms of the number of samples taken. One CB was reported to have detected one sample that indicated a breach of Regulation (EC) No 834/2007. However, the audit team found that in 2014 at least 8 samples taken by this CB actually tested positive, often showing residues of non-authorised substances, leading to measures and sanctions issued by the CB against the organic operators. The CAPDR investigated this anomaly at the CB and confirmed the discrepancy of communicated results after the audit. The CAPDR have informed the audit team that administrative sanctions have been imposed on the CB in question for inaccurate reporting to the CA. Conclusions on measures in cases of pesticide residue detections

A discrepancy in reported data for non-compliant results raises questions as to the accuracy of the organic control data reported by Andalusia in the 2014 Annual Report.

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Tal y como se establece en el Plan de Acción sobre el control de la mplementación del programa nacional de erradicación de la n tuberculosis bovina 2015-2016, desde la Subdirección General de nidad e Higiene Animal y Trazabilidad del MAGRAMA se d in solicita el mes siguiente a cada trimestre los informes de ejecución de los diferentes tipos de controles sobre los veterinarios de das las Comunidades Autónomas con el fin de comprobar que se han cumplido los objetivos propuestos o se han plicado las medidas correctoras necesarias para su cumplimiento y que se contemplan en dicho Plan de Acción. En la actualidad se han solicitado los informes de los dos primeros trimestres del año marzo y abril junio) y se está comprobando el mplimiento de los objetivos o solicitando a las CCAA las el medidas correctoras necesarios en el caso de que existan iaciones. El control adicional de verificación mediante la ueba de ELISA ya se encuentra implantado en todas las CCAA.

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Con el fin de obtener datos comparables en todos los mataderos de todas las CCAA que permitan establecer unos objetivos mínimos de detección de granulomas, se ha incluido en el Programa e Erradicación de la Tuberculosis bovina 2017 el procedimiento de obtención y evaluación de dichos datos: Para cada matadero que sacrifique ganado bovino los SVO de sanidad animal de las CCAA, conjuntamente con sus homólogos de salud pública, recogerán anualmente los siguientes datos, diferenciando si son animales de campaña o sacrificios de rutina: Page: 1 ref. DG(SANTE)/2016-8771-MR of the audit carried out from 01 February ress made by the programme co-financed by the European Union to eradicate nº de animales sacrificados entre el 1 de enero y el 31 de diciembre; nº de animales con lesiones sospechosas (granulomas) a la inspección post-mortem; nº de animales en que se ha procedido a la toma de muestras y remitidas al laboratorio para su análisis; resultados de los análisis realizados (cultivo, PCR, histo- patología). Esta información será remitida por las CCAA al M.A.G.R.A.M.A., dentro de la información complementaria a remitir para el informe final del año de ejecución del programa nacional. Lo

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El Programa Nacional de Erradicación de la Tuberculosis Bovina 2017 establece, en su apartado de "Sistema de Vigilancia en mataderos y Salud Pública", las pautas generales de coordinación y cooperación entre las of autoridades competentes de sanidad animal y seguridad alimentaria a este respecto. Para informar a los veterinarios de los mataderos de los resultados de sus actuaciones, se ha incluido en dicho programa que de los resultados de las pruebas diagnósticas se informará a los SVO de Sanidad Animal responsables del rebaño de origen de los animales y a los SVO de Salud Pública donde radique el matadero donde se efectuó la toma de muestras, para su traslado a los de salud pública de dicho matadero. Estas pautas generales serán detalladas en un protocolo Page: 2 ref. DG(SANTE)/2016-8771-MR of the audit carried out from 01 February ress made by the programme co-financed by the European Union to eradicate conjunto elaborado por MAGRAMA y AECOSAN en consenso con las CCAA. La fecha de finalización y puesta en marcha de este protocolo se estima en el primer semestre de 2017. También se ha incluido en el programa nacional que en el caso delos establecimientos de manipulación de caza ,

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En el Programa Nacional de Erradicación de la Tuberculosis Bovina 2017 ha sido incluido el Plan de Acción en Fauna Silvestre 2017 (PATUBES), que comprende propuestas de medidas concretas a aplicar en función de la clasificación de las distintas regiones de acuerdo a su situación epidemiológica de riesgo (retirada de subproductos de la caza, limitación de densidades por distintos métodos, asesoramiento en materia de bioseguridad en explotaciones ganaderas, formación...). Este Plan, que constituye la propuesta de actuación por parte de las autoridades competentes en sanidad animal, se encuentra en fase consulta y acuerdo con el resto de autoridades competentes r (caza y medio ambiente, sanidad y seguridad alimentaria) y e complementará, una vez acordado, con iniciativas legales que posibiliten su cumplimiento, en caso necesario. Se adjunta el borrador del Plan que está en fase de consulta, en Page: 3 ref. DG(SANTE)/2016-8771-MR of the audit carried out from 01 February ress made by the programme co-financed by the European Union to eradicate yo apartado 3, "Opciones de intervención en TB en lación con la fauna silvestre", se incluye un punto pecífico (3.2.2) relativo a la mejora de l

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mo ya se ha indicado en la respuesta a la Recomendación nº4, el Plan de Acción en fauna silvestre, cuyo borrador ha do elaborado por un grupo de trabajo compuesto por las toridades competentes en Sanidad animal junto con pertos en la materia, está en fase de consulta para su uerdo con el resto de autoridades competentes volucradas y otras partes interesadas. icionalmente en las Comunidades Autónomas afectadas han constituido o están en fase de constitución las ominadas Mesas de Sanidad Animal, en la que participan s partes interesadas claves en el programa de erradicación, en la que se informan y discuten las medidas más ecuadas. Page: 4

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The notifications provided the information required by Decision 2014/917/EU, however the long delay, between confirmation of the presence of the pest and its notification to the Commission and other Member States in both cases, is not in line with Article 2 of Decision 2014/917/EU, which provides for a maximum of eight working days for the provision of at least a preliminary notification. 5.2.2 Surveys for Trioza erytreae and Ca. Liberibacter spp

The outbreaks of T. erytreae have been notified to the European Commission and other Member States, but after a significant delay. That is not in line with Article 16(1) of Directive 2000/29/EC nor Article 2 of Decision 2014/917/EU; it also hinders the response of other Member States, in particular in adapting their official controls as necessary.

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The audit team observed the application of a pesticide treatment to a recently identified infested tree, on the boundary of the infested zone close to Santiago de Compestela, within the area targeted by the official pesticide treatment programme. It was noted that the treatments were applied by specially trained staff from TRAGSA using appropriate equipment. The active ingredient applied was chlorpyriphos, which was chosen primarily on the basis of cost.

However, the application of authorised plant protection products, which is the only measure aimed at inhibiting the further natural spread of the pest, is not carried out systematically, particular in those areas bordering the remaining free areas of the AC of Galicia. The further spread of T. erytreae is therefore inevitable. It cannot therefore be concluded that all necessary measures have been taken to inhibit the spread of the pest, at least in those areas, as required by Article 16(1) of Directive 2000/29/EC.

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The control measures taken following a finding of T. solanivora focus on infected tubers or the field or store in which the trap on which the moths were caught was placed, which is not necessarily their source. This means that the measures are unlikely to result in the eradication of the pest from the infected area, however they should at least inhibit its spread in line with Article 16(1) of Directive 2000/29/EC. 5.6.2 Control measures for Tecia solanivora in Asturias

The objective of the control measures for T. solanivora in both Galicia and Asturias, is its eradication, however the measures, as applied, are unlikely to achieve this.

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However, despite of the fact that the demarcated area had been in place since the end of 2010, the regional service had not set up a system ensuring the timely implementation of PWN control measures as required in Decision 2012/535/EU, the Regional legislation and the Action plan for the demarcated area. In particular, In 2016, the resources allocated to the surveys, identification of dead trees or trees in decline and sampling activities were insufficient for the work to be completed in the whole demarcated area at the frequency and within the required deadlines; (see also section 5.4.1) In 2015 and 2016, the work of felling and removal of identified dead or declining trees in the demarcated area did not start before May 2015 and mid-July 2016 despite the requirements of point 7 of Annex I to Decision 2012/535/EU to have the work completed before the start of the flight season of the vector (1 April each year) and to be done immediately from 1 April until 31 October. The delays in felling and removing the infested tree entail a further risk of spread of PWN (see also section 5.4.2). 5.1.2 National and regional provisions 5.1.2.1 National Contingency Plan

The audit team noted that the sample taken from the symptomatic tree in Salvaterra do Mino on 18 February 2016 was confirmed to be infested with PWN by the regional laboratory on 2 May 2016 i.e. 2,5 months after the sample was taken. Although the symptomatic tree was in a demarcated area where there was a requirement to fell and remove identified dead or declining trees before the 1 April, the tree was not felled until the diagnostic was confirmed. Although the confirmation by the National Laboratory is a prerequisite for taking official measures, the handing of the infested wood sample by the Regional laboratory was not done so as to minimise the delays in getting the results confirmed: the first testing took six weeks instead of the three weeks normally required and the Regional laboratory then retested the sample before requesting a confirmation by the National Reference Laboratory. 5.1.4 Communication to the Commission and other Member States

There is a clear organisation of the controls related to PWN and there is a good cooperation and communication between the entities involved. However, in Galicia, this organisation did not ensure the timely and appropriate implementation of surveys, testing of samples and control measures in the demarcated area of As Neves.

The current Action plan for the demarcated area of As Neves is not fully in line with Decision 2012/535/EU as it limits the intensive survey to the surroundings of the new finding although such an intensive survey was still required around the initial outbreak.

The audit team noted that the surveys of trees in the 20 km zone along the border with Portugal and the demarcated area are performed by the same two people from Tragsatec. The map above shows that the work is conducted starting from the border with Portugal and progressing Northward in accordance with the regional service's assessment of the highest risk for PWN infestation. The results of the intensive surveys conducted in this 20 km zone along Portugal since 2010 have demonstrated that PWN is not present outside the existing demarcated area of As Neves. This is confirmed by the preliminary results of the surveys conducted in 2016. Conclusions on annual surveys of the territory outside demarcated areas

The audit team noted that Tragsatec staff involved in these felling and sampling activities did not check for the presence of signs of vectors' activity either in the infested tree or in the dead or declining trees and branches surrounding it. There was no assessment of the risk of further spread from this site before the felling and removal of the susceptible trees. Based on the interviews held by the audit teams, staff involved in these activities and in their supervision had a limited knowledge of the biology of the vector and ways of spreading PWN and could not explain the signs of vector activity.

The audit team noted that there was no investigation of the possible origin of the PWN infestation. The regional service considered that this new finding was a new incursion from Portugal, either by dispersal flight of the vector or human assisted dispersal. However, they had not identified any particular risk in the surroundings or any evidence for two such incursions at short distance despite intensive surveys showing that the 20 km zone along the border with Portugal is free from PWN (see section 5.2). The audit team noted that while there was no evidence of a new incursion from Portugal, the following facts points towards an extension of the outbreak detected in 2010: The two infested trees were three km apart; Significant shortcomings were identified during the three previous DG Health and Food Safety audits which questioned the effectiveness of measures implemented; Based on data provided by the regional service, the level of sampling of dead or declining trees in the demarcated area of As Neves were every year was below 17% in each year from 2011 to 2014 and reached only 38% in 2015. This is not in line with point 7 of Annex I to Decision 2012/535/EU. It cannot therefore be excluded that infested trees were eliminated without being detected; Samples are generally taken at chest height which reduces the probability of finding PWN in trees which died or declined for reasons other than PWN and were infested by oviposition; The possibility of latent PWN infestations in Galicia (see also section 4.1) which could explain that infested trees show wilting symptoms a few years after the first infestation. 5.3.2 Establishment of a demarcated area

The action plan dated May 2016 further specifies the different zones comprising the Buffer Zone and control measures to be implemented in each of these: Zone A: clear-cut zone of 100 m radius around the new infested tree; Zone B: a 100 m to 3 km zone around the new infested tree where intensified surveys of susceptible trees and vectors are conducted; Zone C: the remaining part of the buffer zone also referred to as 3-20 km zone.

The audit team noted that the order delegating the work of felling and removing trees to Tragsa was signed mid-July i.e. at the end of the period given to private owners to organise their sales of wood. Consequently the clear-cut zone was implemented from end-July to September, which is after most of the vectors would already have emerged from trees and branches. These measures were therefore implemented too late to be effective in preventing PWN spread and are therefore not in line with point 2 of Annex I to Decision 2012/535/EU.

According to the regional service, 1,282 susceptible trees were felled in the clear-cut zone. A total of 17 samples were taken from symptomatic trees which were sampled. Only one sample was taken from asymptomatic trees without this being justified based on the risk of spread of PWN which is not in line with point 2 of Annex I. This requires that a number of asymptomatic trees be sampled selected based on the risk of spreading of PWN. All samples tested negative for PWN.

The audit team visited the infested site and the clear-cut zone and noted that the stump of the infested tree was marked with a red ring and was located in an uneven and rocky terrain on a steep slope. The representative of the regional service who had supervised the work stated that after the felling and removal of trees, the branches and cutting remains had been crushed on-site by a tractor and that the result had been judged satisfactory given the characteristics of the area. The audit team noted that on such terrain the method implemented could not be effective and indeed spotted the presence of some branches big enough to contain pupae of the vector. This is not in line with point 2 of Annex I to Decision 2012/535/EU. 11 Conclusions on measures taken following the suspicion of the new detection of PWN

Control measures have been taken to address the new detection of PWN based on the assumption that this is a new outbreak linked to a new incursion from Portugal. However, this is not based on evidence and the extension of the outbreak of 2010 cannot be excluded. This risk is not addressed by control measures taken so far.

The delays in felling and removing the infested symptomatic tree and the absence of preventative measures resulted in a risk of further spread of PWN. These risks would have been significantly less if control measures had been implemented in accordance with Point 7 of Annex I to Decision 2012/535/EU. The inadequate implementation of the clear-cut following the finding of PWN further adds to this risk.

The competent authority reported that at the time of the audit, the survey was completed in zone B while work was still on-going in zone C, as shown in table 1. The audit team noted that the level of samples taken from asymptomatic trees in zone B in 2016 is not consistent with requirements laid down in point 4(a) of Annex I. The regional service confirmed that the asymptomatic trees sampled were those present at the grid points surveyed (see also 5.3.3). Table 1: Samples taken in the demarcated area from 1 January until mid-October 2016 Zone B (100 m-3 km) Zone C (3-20 km) Number of samples planned 548 911 in 2016 (348 at grid points + 200 of (61 at grid points + 850 of Samples taken from symptomatic trees) symptomatic trees) symptomatic trees 239 316 Samples taken from asymptomatic trees 366 13 Total 605 329

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En la zona de corta de 100 m se tomaron 17 muestras de es sintomáticos y una muestra constituida por 7 pies asintomáticos, cantidad que consideramos suficiente dentro ese rango para poder delimitar la extensión del foco. También se tomó un elevado uce número de muestras en el radio de 3 km desde el punto positivo. La detección de este positivo se realizó durante los trabajos de inspección permanente dentro del área demarcada para identificar sks y muestrear todos los árboles sintomáticos. En el entorno del árbol positivo se tomaron un elevad número de muestras, tanto antes como después de la detección, de forma que pudo realizarse una delimitación clara de la extensión del foco. Dentro del plan de acción para 2017 se incluye un programa de inspecciones y toma de muestras que se considera adecuado para mitigar los riesgos de expansión de la plaga.

The surveillance and early detection is guaranteed in the arcated Zone, based on the monthly survey of the area between 100 and 500 meters around a theorical focus, every two months between 500 meters and 3 km and in the flight period between 3 km and the outer limit of the Demarcated Zone as stipulated in the new Action Plan, to which must be added two more annual surveys based on the monitoring grid. cause latency is not possible due to the temperatures in the zone, each tree with symptoms is killed as soon as possible and a composite sample is taken, which is immediately analyzed, which guarantees early detection. Point 3.2 of the new action plan summarizes and fixes the calendar of all these actions, both monitoring and sampling, with a sufficient level of intensity to guarantee that if a new source of NMP appeared in the demarcated area, this would be identified and eradicated in a fast and safe way.

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All RCAs consulted use the CAP register as a basis for their respective official records of professional potato producers. Typically this is further supplemented with industry information on an on-going basis. However, the team noted that in certain ACs registration is incomplete.

The Valencian RCA stated that registration of pack houses only started there in 2015. So far 19 premises have been registered, but the total number remains unknown. There is no single register. This also applies in the case of growers. In Andalucía, the previous audit reported 91 ware potato wholesalers/packing stations and 195 seed potato wholesalers. The Andalucía RCA reported there are now 280 registered ware potato wholesalers. However, despite the progress observed regarding increased registration of ware potato wholesalers in Andalucía, recent interceptions of potato consignments from this autonomous community in two Member States and follow up investigation during this audit (see also paragraph 69), indicates compliance with the registration requirements requires further improvements.

All RCAs acknowledged difficulties in dealing with the generic issue of small private growers. As there are no legal requirements, small non-professional growers are not registered, and normally produce for private consumption within the immediate locality of production. RCA inspections are largely conducted at random or guided by local knowledge. 5.2.2 Surveillance strategy

Variability in the comprehensiveness of registration of both producers and pack houses exists between the various RCAs visited/consulted. Registration is particularly incomplete in two ACs where considerable surface areas of ware potatoes are grown but the growers are not registered or known to the relevant RCAs. This undermines fundamentally the overall effectiveness and reliability of surveillance efforts and ultimately any control measures in place.

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Galicia: Ya existe un registro de todos los almacenes que comercializan patata producida dentro de la CCAA. -También existe un registro bastante completo de productores de patata. -En este sentido, se están mejorando estos registros, de forma que se tenga constancia de todos aquellos productores cuya producción vaya destinada a la comercialización, diferenciándolos así de los productores de autoconsumo. Andalucía: en la actualidad existen 280 operadores de patata de siembra inscritos y 87 operadores de patata de consumo. -Por otro lado, la comercialización de la patata de consumo producida en esta CCAA, especialmente la extratemprana y temprana, se realiza en su mayoría, directamente desde el campo al mercado, mediante operadores profesionales inscritos en el ROPCIV (Directiva 93/50/CEE de la Comisión). -Estos operadores mantienen un registro de los agricultores y las explotaciones de patata con los que trabajan, así como del destino de la producción, pudiendo aplicar en todo momento una trazabilidad completa del origen y destino de los tubérculos. Los citados operadores y sus datos son la base de la planificación y ejecución de los trabajos de prospección fitosanitaria. -Se van a

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Whilst some largely administrative issues with respect to plant passports were identified with respect to the movement of potatoes from the DA in Galicia, gaps in the registration and export of infested potatoes from unregistered premises and/or traders from Andalucía result in a high risk of international dissemination from infested, uncontrolled lots.

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Galicia: Aunque se es consciente de que se ha debido a un problema meramente Page: 1 017 ref. DG(SANTE)/2016-8979-MR of the audit carried out from 06 June 2016 administrativo y puntual se ha distribuido un oficio a todas las Autoridades Competentes recordando la necesidad de uso del pasaporte fitosanitario de sustitución en estos casos. Andalucía: el operador ya se ha inscrito y autorizado para expedir pasaporte fitosanitario en caso de manipular y comercializar tubérculos procedentes de zonas demarcadas de Epitrix.

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However, with respect to other hosts, very little practical guidance is provided in the NCP.

In all RCAs visited, sampling was largely focused on the surface crop. Less systematic and comprehensive attention was paid to borders and hedgerows, or other areas in the immediate vicinity or adjoining potato fields under survey, populated by other host plants, such as weeds. This is not fully in line with Article 4(1) of Decision 2012/270/EU. Such areas, when included, were typically subject to visual inspection only.

No entomological nets were employed in any of the RCAs visited as part of Epitrix surveys. Similarly, insect traps, where used, were deployed in low numbers. 12 Conclusions on Epitrix sp. surveillance strategy and results

However, the sampling approach retains a very high level of focus on crop surfaces, with insufficient attention given to other hosts and/or weeds in neighbouring fields and/or boundaries (hedgerows), which present a natural reservoir of potato flea beetles and function as sources of re-infestation.

However, irrespective of the legal approach, monitoring around and in the vicinity of fields remains unsatisfactory, in particular with respect to other hosts and weed hosts (see also paragraphs 41 and 42).

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s Andalucía: Siguiendo las recomendaciones de la auditoria de septiembre de 2015 se han aumentado las prospecciones de Epitrix, tanto en patata como en otros hospedantes. h -Las malas hierbas hospedantes situadas en las explotaciones de patata o en sus lindes fueron incluidas en los trabajos de prospección de la plaga, al igual que otros cultivos huésped distintos de la patata, como el tomate u otras solanáceas y que fueron incluidos siguiendo lo contemplado en el análisis de riesgos de la plaga (PRA) de EPPO. -Se procederá a la revisión de los manuales de trabajo, y de cara a las prospecciones de 2017, se hará especial hincapié en malas hierbas hospedantes u otras especies situadas en bordes, setos y lindes de explotaciones de patata, incluyendo además de observaciones visuales, técnicas de mangueo para la captura de adultos. Galicia: Durante las inspecciones realizadas en parcelas de patatas, se controlan también los lindes, setos y malas hierbas e incluso otros cultivos próximos. -Se ha establecido en estas zonas un plan de prospecciones muy completo, prestando especial atención a las zonas libres de plaga, para poder realizar una detección precoz de la plaga y establecer exacta

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At the time of the audit, the regional resolution necessary to deal with this new situation was still in draft format. Consequently, a precautionary approach, based on prohibition orders on the harvest and movement of infested potato crops, was adopted. However, this approach did not include demarcation, or the associated risk management obligations, as required by Decision 2012/270/EU.

The four closely located DAs, of the eight DAs originally established under Decision 2012/270/EU had not been merged within the scope of Annex II section 1 point (2). The RCA of Andalucía does not consider that the distance of approximately 2 km from one another is sufficiently close to merit such action. These four DAs have been merged under a parallel regional "vigilance zone" concept, which is identical to the requirements of a DA as outlined in Annex II Section1, with the exception that potatoes can be moved without washing or brushing. On a visit to one such original DA (now part of this "vigilance zone"), which was claimed to have been intensively surveyed by the RCA, the audit team noted mature and flowering plants of Solanum nigrum (a major weed host) were easily found, reflecting concerns regarding the efficacy of intensive surveillance and monitoring, particularly at this location.

In Andalucía, the recognition of E. papa as the causal organism has led to the emergence of a parallel risk management approach. Management of existing DAs established under Decision 2012/270/EU are only partially compliant with the Decision, whilst new outbreak sites, notified under Article 16.2 were, at the time of the audit, neither demarcated, nor, in the absence of the anticipated regional 17 Resolution, subject to any further measures. Orders prohibiting harvest and movement of two potato fields from the eight new outbreak sites in the province of Seville had been violated.

Merging of geographically close DAs, in line with Annex II section 1 (2) of Decision 2012/270/EU, has not taken place (see section 5.4) with risk(s) as regards the further spread remaining as movement of potatoes from the area between them is not restricted.

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España considera que las constataciones recogidas en la Auditoría en base a esta recomendación no se corresponden con la realidad observada por los auditores, por lo que debe tratarse de algún mal entendido. En todo momento se ha cumplido con lo n. establecido en el artículo 5 y en el Anexo II de la Decisión 2012/270/UE. Una vez modificada la citada Decisión mediante la publicación de la Decisión 2016/1359/UE se han declarado las nuevas zonas demarcadas de Epitrix papa

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However, with respect to other hosts, very little practical guidance is provided in the NCP.

In all RCAs visited, sampling was largely focused on the surface crop. Less systematic and comprehensive attention was paid to borders and hedgerows, or other areas in the immediate vicinity or adjoining potato fields under survey, populated by other host plants, such as weeds. This is not fully in line with Article 4(1) of Decision 2012/270/EU. Such areas, when included, were typically subject to visual inspection only.

However, the sampling approach retains a very high level of focus on crop surfaces, with insufficient attention given to other hosts and/or weeds in neighbouring fields and/or boundaries (hedgerows), which present a natural reservoir of potato flea beetles and function as sources of re-infestation.

However, irrespective of the legal approach, monitoring around and in the vicinity of fields remains unsatisfactory, in particular with respect to other hosts and weed hosts (see also paragraphs 41 and 42).

As reported in the previous audit report, Andalucían farmers are not prohibited from planting host plants, including potatoes, in infected fields during the next growing season. Nevertheless, in such cases farmers have to apply regular insecticide 15 treatments and implement additional measures, including destruction of crop debris and weeds and brushing and washing of harvested potatoes. The common rotation is to grow potatoes every second year with cereals or Brassica crops in between. Maize is part of the rotation cycle, however, information as to its role as a host plant was not known in Andalucía (see also paragraph 56).

In Andalucía, the recognition of E. papa as the causal organism has led to the emergence of a parallel risk management approach. Management of existing DAs established under Decision 2012/270/EU are only partially compliant with the Decision, whilst new outbreak sites, notified under Article 16.2 were, at the time of the audit, neither demarcated, nor, in the absence of the anticipated regional 17 Resolution, subject to any further measures. Orders prohibiting harvest and movement of two potato fields from the eight new outbreak sites in the province of Seville had been violated.

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Andalucía: Se ha comprobado el cumplimiento de los requisitos para el traslado de patata fuera de las parcelas. -Al productor que incumplió la orden de prohibición se le ha aplicado un procedimiento infractor. nts -Se procederá a la revisión de los manuales de trabajo, y de cara a las prospecciones de 2017, se hará especial hincapié en malas hierbas hospedantes u otras especies situadas en Page: 2 017 ref. DG(SANTE)/2016-8979-MR of the audit carried out from 06 June 2016 bordes, setos y lindes de explotaciones de patata, incluyendo además de observaciones visuales, técnicas de mangueo para la captura de adultos. Galicia: Durante las inspecciones realizadas en parcelas de patatas, se controlan también los lindes, setos y malas hierbas e incluso otros cultivos próximos.

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With respect to decontamination of machinery and vehicles it was reported that, particularly in Andalucía, growers tend not to share machinery outside their own commercial collective.

Transport vehicles, normally refrigerated articulated trucks, are typically rented (at the discretion and expense of the client, not the grower or trader). The audit team noted that there was no system to ensure that such vehicles are cleaned and decontaminated in an appropriate way (for movements from either from the DA in Galicia or DAs in Andalucía). This is not consistent with the Decision. Conclusions on control measures for Epitrix sp.

Machinery, in particular transport vehicles for export purposes, both from DAs in Galicia and Andalucía, are not subject to any controls or system of regulation and therefore present a further source or risk. This is not compliant with the Decision (Article 3a).

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A nivel nacional, se han dado instrucciones a los almacenes de patata que manipulan tubérculos de zonas demarcadas para que realicen la descontaminación de los embalajes, aquinaria y vehículos de transporte. Se ha elaborado un protocolo de higiene que se anexará al PNC en el que se especifica claramente todas las medidas en cumplimiento del Artículo 3 bis de la Decisión 2012/270/UE (Artículo 3a de la Decisión 2014/679/UE) Page: 3

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In one AC, the FVO audit team noted that most inspection visits in one establishment visited were planned instead of being unannounced. The CA of the AC stated that visits in large-scale establishments are usually announced in advance. Provided the nature of the control permits and the inspector knows that the presence of a particular member of the business is advisable, visits to large-scale establishments may be arranged according to the CA, at the shortest notice possible.

The system of official controls is in place as described in the Country Profile for Spain. Within the scope of the audit, the official control plans are implemented as foreseen and official controls are carried out in accordance with documented procedures. Despite systems being in place, there are some shortcomings in their thoroughness and follow-up. Systems for training varied between ACs, with no training on the use of additives being provided in one etc. Some of the deficiencies identified could directly be contributed to insufficient training. 5.2.2 Implementation of official controls

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The official staff use checklists for inspections and for the HACCP audits and more detailed explanatory documented control procedures are available for the staff. The checklists used for official controls included amongst other topics, labelling and traceability of food. The controls on labelling should comprise checking labelling at FBOs' premises, checking of commercial documents and controls on health and identification marks. In three of the four ACs visited, the CA did not have a special checklist or instructions for checking of additives. Evidence for official sampling on 5 additives was available in the ACs visited and for some other ACs. Checklists were completed and, where applicable, more detailed information was reported in annexed reports. Results of official controls are signed off by and are made available to the FBOs. The results are thereafter entered in the official database. In the establishments visited examples were seen of reduced or increased frequency of controls and ad-hoc inspections. The instructions do not require quantitative traceability of foodstuff. In-depth verification of traceability and controls on maximum permissible limits of additives was not performed often. With a view to justifying the use of certain additives in meat preparations such as chorizo, one AC informed the FVO audit team that in co-operation with the University, a quick test is being developed to determine if certain meat preparations keep the characteristics of fresh meat or not.

The system of official controls is in place as described in the Country Profile for Spain. Within the scope of the audit, the official control plans are implemented as foreseen and official controls are carried out in accordance with documented procedures. Despite systems being in place, there are some shortcomings in their thoroughness and follow-up. Systems for training varied between ACs, with no training on the use of additives being provided in one etc. Some of the deficiencies identified could directly be contributed to insufficient training. 5.2.2 Implementation of official controls

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The official staff use checklists for inspections and for the HACCP audits and more detailed explanatory documented control procedures are available for the staff. The checklists used for official controls included amongst other topics, labelling and traceability of food. The controls on labelling should comprise checking labelling at FBOs' premises, checking of commercial documents and controls on health and identification marks. In three of the four ACs visited, the CA did not have a special checklist or instructions for checking of additives. Evidence for official sampling on 5 additives was available in the ACs visited and for some other ACs. Checklists were completed and, where applicable, more detailed information was reported in annexed reports. Results of official controls are signed off by and are made available to the FBOs. The results are thereafter entered in the official database. In the establishments visited examples were seen of reduced or increased frequency of controls and ad-hoc inspections. The instructions do not require quantitative traceability of foodstuff. In-depth verification of traceability and controls on maximum permissible limits of additives was not performed often. With a view to justifying the use of certain additives in meat preparations such as chorizo, one AC informed the FVO audit team that in co-operation with the University, a quick test is being developed to determine if certain meat preparations keep the characteristics of fresh meat or not.

The system of official controls is in place as described in the Country Profile for Spain. Within the scope of the audit, the official control plans are implemented as foreseen and official controls are carried out in accordance with documented procedures. Despite systems being in place, there are some shortcomings in their thoroughness and follow-up. Systems for training varied between ACs, with no training on the use of additives being provided in one etc. Some of the deficiencies identified could directly be contributed to insufficient training. 5.2.2 Implementation of official controls

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The CA identified eight samples as compliant with the labelling requirements. The non- compliances identified by the CA were mainly related to ingredients (not corresponding to the actual use), and missing or wrong information on the use of allergens. For one sample, the CA considered their findings on labelling as inconclusive. The FVO audit team made some additional observations: The label of a sample of burger meat did not mention the name of the species used. The label indicated only "lean" (magro) and "fat" (tocino). One sample of rabbit meat contained voluntary labelling information on feeding and the animal welfare conditions of the rabbits. This information was not verified by the CA. Following the provision of additional information by the CA, it was possible to trace the rabbit meat cuts to the slaughterhouse of origin. This was also the case for another sample of cut lamb meat.

The results of the traceability exercises conducted indicate that the official controls are partially effective, with the results that some serious and/or systemic deficiencies are not detected and acted upon.

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The CAs of the ACs informed the FVO audit team that training covering meat traceability and labelling (for example, on general labelling requirements and on health claims) had been organised at AC level. One AC visited had not organised training on additives. Most of the local CAs met during the audit had participated in training on traceability and labelling. Some of the local CA personnel met who were responsible for the controls in the establishments visited, had not participated in any training on additives, which was, for example, the case in one establishment where significant 6 non-compliances were identified during this audit on the FBO traceability system in place (see chapter 5.2.2.1). Conclusions on organisation of official controls

The system of official controls is in place as described in the Country Profile for Spain. Within the scope of the audit, the official control plans are implemented as foreseen and official controls are carried out in accordance with documented procedures. Despite systems being in place, there are some shortcomings in their thoroughness and follow-up. Systems for training varied between ACs, with no training on the use of additives being provided in one etc. Some of the deficiencies identified could directly be contributed to insufficient training. 5.2.2 Implementation of official controls

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CAs are designated for the official controls of PDO/PGI/TSG for the verification of compliance with the product specification and are adequately staffed. However, ACCAs are not designated in all Autonomous Communities to carry out checks for the surveillance of the use of the names in the market place. and therefore it cannot be ensured that controls based on risk analysis are carried out in all Autonomous Communities. This lack of designation is not in line with Article 36 of Regulation (EC) No 1151/2012. 5.2.2 Control Bodies Legal Requirements Articles 39(1) and (2) of Regulation (EU) No 1151/2012. Articles 5(2) (e) and (f) and 5(3) of Regulation (EC) No 882/2004. Findings

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nities, in Se ha solicitado a las CCAA la designación de la autoridad to guarantee competente de acuerdo con lo previsto en el artículo 36(1). d on the market to Se adoptarán las medidas que sean precisas para que estos es 36(3)(b) and 38 controles sean considerados en el futuro PNCOCA 2016-2020, si bien ya se ha enviado información a las CCAA sobre las conclusiones de la auditoria, para que puedan avanzar en la organización de los controles en base a datos objetivos de riesgo de incumplimientos en la oferta al consumidor en su territorio de acuerdo con la recomendación Page: 1

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t MSSSI En adelante se va a documentar por escrito el análisis del riesgo realizado así como los diferentes criterios tenidos en cuenta a la hora de confeccionar el plan anual de vigilancia. En concreto, para el plan del año 2016, se han tenido en cuenta los siguientes aspectos: el volumen de partidas de los diferentes productos importadas de terceros países durante el año previo; los resultados de los controles oficiales y de los análisis llevados a cabo durante 2015 en los diferentes PIF; el historial de rechazos y, en especial, las notificaciones RASFF y los controles reforzados activados por la Comisión durante el año 2015; y las combinaciones de plaguicidas y productos que se establecen para el año 2016 en el Reglamento de Ejecución (UE) 2015/595 de la Comisión, de 15 de abril de 2015, relativo a un programa plurianual coordinado de control de la Unión para 2016, 2017 y 2018 destinado a garantizar el respeto de los límites máximos de residuos de plaguicidas en los alimentos de origen vegetal y animal y a evaluar el grado de exposición de los consumidores a estos residuos. Por otra parte, el reparto de las muestras por productos, países y puntos de entrada se ha establecido ate

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The CA stated that the right delta is considered free of Pomacea sp., despite on-going reports of small, isolated incidences (approximately 10 per annum) which the CA considers as intentional introductions. The CA qualified this view based on both the 8 isolated sporadic pattern of incidences and physiological age of individual snails found (which tend to be mature adults (commonly estimated at 3-4 years old minimum)).

During the course of the current audit; The audit team received technical information and an explanation of survey approaches, including river surveys as conducted from boats (normally out-sourced contractors with training) as co-ordinated by the DALFF, as well as those conducted by the DGNEB. The audit team observed the presence of snails and egg clutches across various sites and locations in the left delta area, both in fields and irrigation/drainage channels, as well as clutches, and remnants of clutches, in lower parts of the Ebro river (downstream from the town of Amposta at the location of the river mooring facility as mentioned in Finding 16). The CA stated that incidences of random, sporadic intentional introductions to various rice fields in the right delta have each been eradicated following the application of intense measures (with the audit team taking the opportunity to visit several such locations as part of the audit). The CA stated that some 520 rural agents, under the control of DGNEB are responsible for surveillance, law enforcement and control activities of the natural environment. In addition to regular, on-going field inspections, the CA stated that 600 Km of irrigation/drainage channels were surveyed in 2014 with the aim of inspecting the entire irrigation/drainage network of the right delta by the end of 2015. 9 The CA stated that the distribution of the pest in the Ebro delta has not extended beyond that as reported during the previous audit in 2013. The demarcated area remains much larger than required under the Implementing Decision 2012/697/EC. 5.3.2.2 Pals municipality

Following this recommendation as a general guide throughout this follow-up audit, the audit team noted; A high technical understanding of the organism and management/eradication solution(s), with a well-developed range of technical measures for control and eradication purposes e.g. salination (via an integrated water management approach), drying and phytosanitary approaches (saponins, cyanamides, lime), as well physical containment measures. All measures are well documented under the eradication action plan. 14 Overall strengthened involvement of stakeholders towards successful application of the eradication action plan (e.g. via the ''Technical commission for Island apple snail'', including a similar committee at Pals). Persistent and on-going illegal intentional introductions in the right delta buffer zone and possibly Pals. However, the audit team found that, despite routine patrols and spot checks, as evidenced through documentation provided to the auditors, the authorities have been unable to deal effectively with this intentional element of spread in the right delta. Furthermore, the CA stated that no sanctions had been made to date. With regards to the Pals outbreak site, irrigation to the site, via two irrigation pipes (with the source quoted as the river Ter some 7-8 Km distant) was immediately closed (and officially sealed) with open ditch drainage channels plugged with compacted earth (approximately 2 m long, and to a height equal to that of the field) at various strategic locations to effectively seal off any drainage from and to the site. The site, as well as drainage channels, was treated with saponins (evidence of which was apparent from the presence of numerous dead crayfish carcasses). 5.4.2.2 Containment measures

Furthermore, with regards to illegal intentional introductions, although routine patrols and spot checks are carried out, given the frequency of such outbreaks in the right delta, there is an absence of legal enforcement to effectively tackle this worrisome situation. No sanctions have been established to date. This is not consistent with Article 5 (1) of Decision 2012/697/EC, and represents a further impediment to fully satisfying Recommendation 1.

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However, although the location of the designated place where agricultural machinery is cleaned has improved significantly, the modifications made in response to Recommendation 2 from the previous audit cannot exclude all risks of spreading the organism, and as such remains not in line with the Section 2 (c) of Annex II of Commission Decision 2012/697/EU. Ensuring physical containment as well as introduction of standard operating procedures for general site management of the facility and process(es) were considered necessary. Based on this assessment, it was concluded that Recommendation 2 remained partially addressed.

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On visits to various rice production field sites during the audit, particularly within the left delta, the audit team noted/observed; Presence of incorrect, as well as absence of maintenance and official control, of mesh screen installations (physical barriers), especially in the left delta fields, to prevent snail movement via infested irrigation river water between fields. Despite 15 effectively undermining eradication efforts, and being subject to legal controls, no sanctions have been made. Limited progress with the installation of physical barriers/traps to prevent physical movement of snails direct from the river into fields. Use of sluice gates to prevent the access of infested waters to the river or to other channels. Issues with regards to machinery and boat cleaning. Conclusions

However, issues regarding the effectiveness of physical containment installations (which lacks official enforcement and controls despite regional legislation requiring mandatory compliance with official measures at farm level) are not consistent with Article 5 (1) of Decision 2012/697/EC. Furthermore, no sanctions have been established for cases of non- compliance with regards physical containment. In view of this, Recommendation 1 remains only partially addressed.

Subsequently, based on Recommendation 3 as a guide, the audit team noted that; Of the 280 drainage outlets to the river which were considered a pathway for the physical movement of Pomacea sp. directly from the river to fields, only 40 had been repaired (including 13 of the most important breaches), or amended in such a way to prevent such movement (elevated in relation to the river waterline to prevent snail movement direct for the river) The installation of mesh netting in open ditches and field level channels, to prevent the movement of Pomacea sp. in and around fields is often substandard, or inappropriately installed. Furthermore, control and quality checks on the installations and maintenance of such mesh barriers, despite a legal requirement, are not enforced. 17 Conclusions

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During the audit, the auditors noted that: To date, no successful measures have been found to eradicate the pest in the river which is seen as a critical element in the overall eradication and maintenance of pest free status across the delta. 16 Until now, the eradication treatments implemented are manual collection of adults and egg clutches and elimination of the vegetation in the river banks for egg clutches destruction. The aim of such actions is to maintain levels of the snail in the river below the threshold of population explosion. Tracts of river bank vegetation had been removed the previous year, and periodic surveys continue. The audit team visited one such site on the right part of the Ebro river, below Amposta.

Although measures have been taken to reduce the level of infestation, no overall successful measures have been found to effectively eradicate the pest from the river. This is inconsistent with Decision 2012/697/EU which requires that all measures to eradicate Pomacea sp. should be taken and an integrated eradication approach for rice fields, channel network and river, should be in place.

Subsequently, the audit team noted; Evidence of clutches along the edges of the Ebro river, particularly around the mooring facility as mentioned in Finding 15. Based on discussions with some leisure boat owners, Pomacea sp. egg clutches have been known from boat hulls that navigate the Ebro river course. A prohibition exists on the movement of boats from saltwater to freshwater in the absence of a specific authorisation, in particular beyond Tortosa. It was unclear to the audit team who issued this authorisation or how it was controlled. The Harbour Master Authority has, since 2013, incorporated Pomacea sp. inspections as part of, and in parallel to, their hull checks, but do not issue any documentation or certification for this. 20 An absence of restrictions to transfer boats from the Ebro river or delta complex to outside the demarcated area (e.g. to other parts of Spain, especially where rice may be grown). Although unable to witness on this follow-up audit, the CA stated that the boat hull cleaning facility is a mobile service that operates very much as the machinery cleaning service did as reported in the previous audit, i.e. as a mobile call out service, operating on unsealed ground (with no general fixed location) and without any controlled waste water/soil management, etc. Conclusions

A designated biosecure hull washing facility is not available and no certification procedure for the movement of boats exists (as is now the case for machinery). No biosecurity controls exist for the movement of boats outside the demarcated area

With respect to boats, although now recognized as a potential source of spread, given the level of uncertainty and concern over the biosecurity issues and level of risk management of further spread of Pomacea sp. in and along the river Ebro water course, and potentially beyond the demarcated area, it was concluded that Recommendation 4 remained partially addressed. 5.4.5 Follow-up The table below summarizes the follow-up to the relevant recommendation(s) made in report DG(SANCO)2013-6803-MR Final. No Previous recommendation Assessment 21 No Previous recommendation Assessment Ensure that all measures necessary for the Partially addressed. eradication of Pomacea sp. are taken, and 1 in particular that the measures required at See finding(s) No 57. Art. 5 (1) of Decision 2012/697/EU, are fully implemented and sanctions are See recommendation Nos 1 and 3 of the established in cases of no compliance. current audit report. Ensure that appropriate biosecurity Partially addressed. 2 measures, in line with Art. 5 (1) of See finding No. 78. Decision 2012/697/EU, are implemented in places where agriculture machinery is See recommendation No 2 of the current cleaned. audit report. Ensure that all the measures necessary for Partially addressed. the eradication of Pomacea sp. in line 3 with Art. 5 (1) of Decision 2012/697/EU See finding(s) Nos 60 and 69. are taken, and they are implemented in such a way that further risks of Pomacea See recommendation No 3 of the current sp. spreading to new areas is prevented. audit report. Ensure that investigations are carried out to determine if there is a risk of spreading Partially addressed. 4 Pomacea sp. through the movement of See finding(s) Nos 79 and 83. boats in the Ebro river and if needed, measures are taken to address such risk, See recommendation No 4 of the current in line with Art. 5 (1) of Decision audit report. 2012/697/EU. Ensure that the awareness programme is Partially addressed. extended and covers information to be 5 provided to the general public and See finding(s) No 16. tourists visiting the river Ebro delta, in line with Art. 5 (2) of Decision See recommendation No 5 of the current 2012/697/EU. audit report. 22

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There is a good awareness of the pest amongst central competent and regional official staff with the message of the risks and impacts reaching the general public and those directly involved in rice production. However, the situation with respect to informing specific, high risk Ebro river users, such as leisure boat owners and anglers, is inadequate which could inadvertently contribute to the spreading the pest to new area. Furthermore, public signs aimed at raising the awareness and alerting other growers, as well as the general public, to the presence of the pest in or around the demarcated areas remain absent. This is not fully in line with point 2 of Article 5 of Commission Decision 2012/697/EU, and as such Recommendation 5 of the previous audit remains partially addressed.

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Three out of the six approvals seen had only recently been updated to correctly reflect the activities carried out in the establishment. For example, one large-scale milk processing establishment had ceased to produce milk powder in 2009 but the activity was only removed from the approval in 2014. Another milk processing establishment had been approved in 2011 to produce meat products but had according to the FBO, never produced these products. The meat products were removed from the approval in September 2015. A small scale cheese and butter producer visited, had been portioning and repacking butter for some years but the activity had only been added to the approved activities on the day of the audit. Conclusion on registration/approval of Food Business Operators

The system in place for registration and approval of establishments including milk collection centres was in general well implemented. However, some shortcomings were noted in relation to keeping the approvals updated regarding the actual production activities. 5.1.5 Prioritisation of official controls Legal requirements Article 3 of Regulation (EC) No 882/2004 Findings

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Data in Tables 2 and 3 indicate that for the vast majority of the ACs, there was practically the same overall level of implementation of the surveillance in 2013 and 2014. However, there was a significant increase in the area inspected and the number of inspections carried out in Galicia in 2014. In addition to potatoes, 40 ha of tomato crops were also inspected in 2013 and 20 ha in 2014. The average inspected area of the total ware potato production in 2013 represented 4.8 % and in 2014 3.8 %, which is in accordance with the required 3 % in the National Contingency Plan. However, there was very significant variance between the ACs from 0.5 % to 100 % of fields inspected. In Andalucía the proportion of potato production inspected in 2013 and 2014 was similar to the national average with 3.2 % and 4.1 % respectively. In Asturias the proportion of potato production inspected was significantly lower (0.7 % and 0.5 % respectively) than the national average and in Galicia the proportion was very low with 0.7% in 2013, increased to 2.0 % in 2014. Concerning other regions in Spain, the area inspected in the main ware potato producing AC Castilla y Leon was significantly lower than the national average and targeted level from the National Contingency Plan with 0.6 % of the area inspected in 2013 and 0.5 % in 2014.

Another way of evaluating the inspection data is looking at the number of fields inspected compared with the total production area which gives an indication of the 8 inspection density. As shown in the last column of Tables 2 and 3 above, the average inspection density in Spain was 96 ha and 48 ha of potato production per inspection in 2013 and 2014 respectively and varies very much between the ACs. In Andalucía there were 311 ha of potatoes per one inspection in 2013 and 339 ha in 2014 which is significantly below the national density average. It indicates that large but few potato plots were inspected there and consequently a very low density of inspection. The inspection density in Asturias and in Galicia was in both years similar or higher than the national average. However, taking into account the fragmented potato production with very small plots in Asturias, the proportion of fields inspected there was very low as well.

Seed production in Spain is concentrated in three ACs, namely in Castilla y Leon with the largest share of production of around 68 %, followed by Basque Country and Navarra. In 2013 and 2014 on average some 30 % plots of seed potatoes were surveyed for PFB with some 1,300 visual inspections of seed potato fields per year. However, in the largest seed producing, AC Castilla y Leon, there were only 56 visual inspections carried out and 7 plots inspected each year covering an area of 12 ha in in 2013 and 13 ha in 2014. Furthermore, in the same AC there were no lot inspections carried out in 2014, although in total 515 lot inspections were carried for domestic seed produced in Spain. The intensity of survey for PFB in seed potatoes in AC Castilla y Leon is significantly lower compared to other ACs and does not reflect the potential risk related to the neighbouring affected ACs Galicia and Asturias.

Taking into account the high proportion of inspected fields found infested in Asturias and Andalucía, the high proportion of unregistered producers of potatoes, the lack of systematic surveys of other cultivated host plants and vegetable hobby growers, the intensity of survey is not considered sufficient to determine the actual distribution and spread of the pest. Furthermore there is a very low intensity of surveys for PFB carried out in some other key potato producing ACs in Spain which does not provide sufficient information of the presence of the organism. This is not in line with Article 4 of Commission Decision 2012/270/EU. Conclusions on Epitrix sp. surveillance strategy and results

A detailed surveillance protocol and good inspection guidelines have been elaborated in Spain for the detection and identification of PFB. However, the percentage of ware and seed potato producing areas inspected and sampled in annual official surveys varies widely between the ACs and is, in many cases, significantly lower than required in the National Contingency Plan and is insufficient to reliably identify or rule out the actual presence of PFB.

The suspected occurrence of PFBs triggered increased surveying activities in both recently affected ACs. However, the implemented intensity of surveillance does not provide sufficient information about the actual distribution of the harmful organism in these ACs.

Medlemsstatens svar

lan Nacional de Contingencia (PNC) para Epitrix sp. establece mínimo a inspeccionar del 3% de la superficie de patata de consumo declarada, el cual se aprobó en agosto de 2015. En 2013 4 la Decisión comunitaria, y el Protocolo de Prospecciones do por el MAGRAMA en julio de 2013, no establecían una superficie mínima a inspeccionar. En 2016 se extremará la vigilancia en las Zonas Demarcadas y sus alrededores, tanto en campos de cultivo de patata como de otras especies hospedantes, de tal forma que se establecen unas estimaciones de porcentaje de inspección y densidad de inspección según la tabla anexa (ver tabla 1). En cualquier caso estos datos serás superiores a los establecidos en años anteriores, tal y como se ve en el documento anexo "tablas". Asimismo, dentro del plan de prospecciones se van a incluir parcelas de otras especies huésped a Epitrix spp que se encuentren próximas a parcelas de cultivo de patata. Ademas, para controlar a los pequeños productores con consumo local o autoconsumo se han establecido muestreos aleatorios. De tal forma se realizan dos tipos de prospecciones: Muestreos dirigidos (se realizan sobre la superficie y propietarios registrados): Muestreos aleato

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The representative of Asturias also stated that they establish a demarcated area and designate an infested zone and a buffer zone around each infested plot according to the minimum required by Decision 2012/270/EU of a 100 m width from the infested plot. The geographically close demarcated areas were merged. However, where the 100 m radius intersects plots, the entire plot is not added to the demarcated area, which is not in line with Decision 2012/270/EU, Annex II, Section 1, point 1.

When delimiting the size of the buffer zone, the minimum required by Decision 2012/270/EU was always applied in Andalucía and Asturias. There was a very high proportion of inspected fields found infested in Asturias (some 50 %) with a high level of infestation, fragmented cultivation of host plants and presence of host weeds. Due to the recency of the outbreaks in Andalucía and insufficient intensity of surveillance, there was uncertainty about the actual spread of the pest. Thus the plant health services in both ACs did not take into consideration other elements for delimitation, such as, the presence of other cultivated or wild PFB hosts in the area and the capacity of the pest to spread naturally, the distribution of other potato crops or other host plants between two or more demarcated areas that have not been selected for sampling during the official surveillance. Consequently the establishment of infested zones and buffer zones was not carried out taking into consideration the sound scientific principles required by Decision 2012/270/EU, Annex II, Section 1, point 3.

The establishment of demarcated areas in Asturias and Andalucía were notified immediately in line with EU requirements. However, due to uncertainty regarding the actual spread of PFB, the establishment of infested zones and buffer zones was not carried out taking into consideration the sound scientific principles required by Decision 2012/270/EU. In particular, geographically close demarcated areas were not merged. This is not in line with Decision 2012/270/EU, Annex II, Section 1, points 2 and 3.

Medlemsstatens svar

amos de acuerdo con la fusión de Zonas demarcadas, pero siderando aquellos casos en los que exista una distancia erior a 500 metros entre Zonas Demarcadas próximas (5 veces a mínima de la Zonas Tampon), a la vista de los trabajos gilancia de la plaga y teniendo en cuenta la capacidad de el insecto vector. más, en 2015 Epitrix sp. fué buscado y encontrado en otros pedantes distintos a la patata (Berenjena, Judía, Malas hierbas) ara el establecimiento de zonas demarcadas se tuvieron en nta dichos hospedantes. Page: 2 f. DG(SANTE)/2015-8661-MR of theauditcarried out from14 September rix

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The FVO team visited five demarcated areas in Andalucía and met plant health inspectors, owners of the infested fields and of fields in the buffer zone and noted that: All the fields visited were tilled and without any potato debris left and clean of weeds, including along the field's borders. Owners of the infested fields and of the fields in the buffer zone confirmed the receipt of the official demarcation notice and were aware of the harmful organism and imposed control measures. They intended to plant other crops in the next growing season. Professional farmers have their own technical staff responsible for the management of the crop production and protection. They confirmed regular and intensive insecticide treatments (clorpyrifos and pyrethroid) during the growing season for other potato harmful organisms like potato tuber moth and Colorado beetle. The insecticides used for these organisms are also effective against PFBs. Inspectors were knowledgeable about the harmful organism and inspection techniques. However, when they inspected suspected potato fields they generally had not inspected neighbouring potato plots, plots of other cultivated PFB hosts or wild host plants in the vicinity of the potato fields. Inspectors stated that they performed follow-up visits to the infested fields in demarcated areas to verify the implementation of control measures like destruction of the crop debris and weeds in the field and along the field border. However, during the follow-up monitoring they were not inspecting other plots in the buffer zone with cultivated host plants or in the vicinity of the demarcated area. In one demarcated area there was an urban area included in the buffer zone with many home gardens producing potatoes and vegetables. Monitoring was not carried out there and the residents had not been informed about the pest. 14 5.3.3 Movement of potato tubers, decontamination and issuance of plant passports Legal requirements Article 3 of Decision 2012/270/EU. Findings

The representative of Galicia stated that five warehouses in the demarcated areas comply with the requirements for the marketing of potatoes outside demarcated area, including the management of waste. Potatoes are inspected in the warehouses after washing. In Asturias all infested plots identified by the regional authorities so far were intended for own-consumption or at most for local market and surveillance of the movement of potato tubers out of the demarcated areas was not carried out. Thus, the control activities in Asturias do not ensure that all potatoes produced in the demarcated areas comply with the requirements for movement laid down in Annex I to Decision 2012/270/EU.

Official control measures put in place in demarcated areas were generally in line with Decision 2012/270/EU, however, confirmation of the outbreak did not trigger intensive monitoring or additional investigation in the demarcated area or its vicinity. Not all necessary measures were put in place like prohibition of planting of host plants and alternative measures are not equally effective to achieve eradication. This is not in line with Article 5 of Decision 2012/270/EU and the requirements for official measures to be taken within demarcated areas as laid down in Section 2 of Annex II to the same Decision.

Control measures in place for commercial scale movement of potato tubers outside demarcated areas are adequate, however, surveillance is not carried out for non- commercial movement of potatoes.

Medlemsstatens svar

o de asegurar que todo el conjunto de la zona demarcada rea adecuadamente se va a proceder a un control vo en las zonas demarcadas, procediendo al establecimiento de control en en todas las parcelas de cultivo de patata plantas huésped que existan en las mismas, para detectar la osible presencia de Epitrix. erá a la identificación de las parcelas de cultivo de de plantas huésped en todas las zonas demarcadas comunicación a la autoridad fitosanitaria y posterior ficial mediante prospecciones y control del movimiento ulos desde la zona de producción al almacén autorizado avado y/o cepillado de los tubérculos y verificación de las es de traslado de los tubérculos dentro y fuera de las arcadas conforme a lo establecido en la Decisión, tal y e ha comunicado a los agricultores situados en ZD Resolución. , se anotaran e identificaran en una base de datos, previa ión y registro por parte de la autoridad competente, especies sensibles en las zonas demarcadas y se efectuará is o seguimiento especial de esas parcelas e se permitirá el plantar especies hospedantes en las arcadas, previa solicitud por parte de los agricultores, rol oficial, una vez el riesgo haya sido valorado, y se que no es v

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Designation of authorities (e.g. regional animal health and public health authorities and BIPs) are well defined. BIPs and regional animal health authorities have proper access to TRACES and use it with regards to imports and intra-Union trade of live animals and animal by-products. However, not all regional public health authorities have access to TRACES, thus they can not exchange information with other Member States in relation to animals sent for slaughter and re-imports.

The competent authorities have experienced staff with the exception of the regional public health authorities, who have not been using the system, do not have access to it and have not received training. Therefore, the minimum prerequisites for the use of TRACES by the regional public health authorities are not in place.

Medlemsstatens svar

OMUNITARIO (SALUD PÚBLICA) de la Administración General de Estado (AGE): n monográfica con las Autoridades competentes en materia de Salud pública de las es Autónomas para informarles de los resultados de la Auditoría y de las actuaciones as a cabo a raíz de la misma.(03.nov.14) ción en la Comisión Institucional del pasado 26.11.14 (órgano colegiado de AECOSAN en que participan representantes de las CCAA y de otros Departamentos Ministeriales de la Administración General del Estado) de los resultados de la auditoría, de la necesidad de antar el sistema a nivel nacional, así como instar a llevar a cabo la introducción de los datos correspondientes a los controles oficiales en los mataderos de partidas de animales vivos destinados al sacrificio y el seguimiento de las partidas reimportadas o canalizadas de productos de nimal en el sistema TRACES. (26.11.14) Se propone la realización de actividades de carácter informativo/ formativo para las Autoridades competentes de materia de salud pública tanto a nivel central como de las Comunidades a través de: o Jornadas monográficas específicas a llevar a cabo en el primer semestre de 2015: La primera de ellas será impartida por representantes

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There is a system of verifying that TRACES modules are used correctly by the BIPs. However, it does not detect and correct on time repeated errors due to focusing on the implementation of control procedures. Therefore it is not ensured that official controls are effective, deficiencies in TRACES are detected and corrective actions are implemented when required.

There is no system of verifying that TRACES modules used by regional animal health authorities are used correctly (control of DOCOMs, channelled consignments or consignments sent for destruction) and LVUs (control of INTRA-CERTs). Therefore, the deficiencies are not detected and corrected on time. A system to verify that the TRACES control module is used by regional public health competent authorities is not developed since they have no access to TRACES or only have recently received access. Therefore, Spain does not comply with the minimum requirements of the use of TRACES for the recording of controls in abattoirs and re- imported consignments of products of animal origin).

Medlemsstatens svar

NITARIO (SANIDAD ANIMAL): l fin de garantizar que de forma uniforme y en todo el territorio nacional, se cumplan los quisitos establecidos de la Decisión de la Comisión 2004/292/CE de 30 de marzo de 2004, la aplicación del sistema Traces y del Reglamento (CE) nº 882/2004, en lo relativo a la y adecuación de los controles oficiales de los animales vivos, los alimentos y los piensos todas las fases de la producción, se ha desarrollado el "Protocolo para la verificación de la ificación TRACES en movimientos intracomunitarios" (documento II): Protocolo de erificación TRACES intra OMUNITARIO (SALUD PÚBLICA): ara hacer frente a esta recomendación, las comunidades autónomas (CCAA) realizarán las iguientes actuaciones: ncluir la verificación de la utilización del sistema TRACES por parte de los diferentes usuarios en a programación de control oficial a partir del año 2016 MPORTACIONES (SANIDAD ANIMAL): n las próximas supervisiones que se realicen por parte de la SGASCF, se hará especial hincapié n comprobar si se corrigen las deficiencias encontradas en la Auditoria de la FVO. MPORTACIONES (SANIDAD EXTERIOR): eforzar la verificación de la utilización del sistema TRACES en las supervisiones

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According to representatives of the National Reference Laboratory met, they have not been able to complete the validation of the PCR method for detecting the presence of ruminant DNA in feed put in place by the European Reference Laboratory owing to a number of technical difficulties. However, the laboratory achieved satisfactory results in the proficiency tests conducted by the European Reference Laboratory in 2013 and 2014. The official regional laboratories have experienced similar difficulties and so the method is not included in the scope of accreditation of any of the official laboratories conducting this PCR analysis in Spain. As a result, representatives from the Autonomous Community where the compound feed producers visited are located stated that it was decided not to take official samples from these establishments. The audit team noted that no other laboratory has been designated by the Spanish competent authorities to perform these tests in the meantime. The lack of appropriate laboratory facilities does not satisfy the requirements of Article 12 of Regulation (EC) No 882/2004 and has resulted in no routine 4 official samples being taken in any of the producers of compound feed for aquaculture in 2013 and 2014. Conclusions on official control systems

There are largely adequate arrangements in place to enable the organisation and planning of regular official controls to monitor and verify that operators comply with the requirements related to the use of eligible PAP for the production of compound feed for aquaculture animals. However, the effectiveness of these measures is currently undermined by the lack of appropriate means to analyse official samples to verify the absence of ruminant DNA in such feed.

Medlemsstatens svar

El Laboratorio Arbitral Agroalimentario (LAA) está acreditado bajo la Norma UNE-EN ISO/IEC 17025, para el análisis de ) alimentos y piensos y está designado como Laboratorio Nacional de Referencia (LNR) para el control de la presencia de restos o productos de animales, incluidas harinas de carne y huesos, en sustancias destinadas a la alimentación de animales de producción (PAT´s). Actualmente la determinación de PAT´s por microscopía óptica se encuentra bajo el alcance de acreditación, no así la técnica de PCR, que está en proceso de validación. Es importante destacar que, el LAA participó en el ensayo de validación de este método por PCR, organizado por el EURL-AP en 2012. Además, interviene sistemáticamente, en todos los ensayos de aptitud organizados por dicho Laboratorio, obteniendo buenos resultados en 2012, 2013 y 2014. Por este motivo y con vistas a la acreditación del método de PCR mediante el análisis de ADN de rumiante en piensos, el LAA está llevando a cabo las pruebas necesarias para verificar el funcionamiento correcto de dicho método, al haber participado ya en su validación. Se espera tener completada la verificación antes del mes de septiembre del año en curso para

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According to representatives of the National Reference Laboratory met, they have not been able to complete the validation of the PCR method for detecting the presence of ruminant DNA in feed put in place by the European Reference Laboratory owing to a number of technical difficulties. However, the laboratory achieved satisfactory results in the proficiency tests conducted by the European Reference Laboratory in 2013 and 2014. The official regional laboratories have experienced similar difficulties and so the method is not included in the scope of accreditation of any of the official laboratories conducting this PCR analysis in Spain. As a result, representatives from the Autonomous Community where the compound feed producers visited are located stated that it was decided not to take official samples from these establishments. The audit team noted that no other laboratory has been designated by the Spanish competent authorities to perform these tests in the meantime. The lack of appropriate laboratory facilities does not satisfy the requirements of Article 12 of Regulation (EC) No 882/2004 and has resulted in no routine 4 official samples being taken in any of the producers of compound feed for aquaculture in 2013 and 2014. Conclusions on official control systems

The compound feed producers visited had comprehensive own controls systems in place; the risk that the PAP received could be contaminated with ruminant material had been identified and a number of measures taken to prevent this from happening. These included a specific procedure to approve suppliers, laboratory certificates from suppliers showing an absence of ruminant DNA in the PAP (the frequency depended on each supplier) and incompatibility charts for road hauliers showing that ruminant material could not be transported before non-ruminant PAP. In addition, one of the feed producers periodically tested the final product for the absence of ruminant DNA. The results of the tests checked by the audit team were negative for ruminant DNA. Official controls in both plants were extensive and included checks on the operators' measures put in place to ensure the absence of ruminant material. However, no routine official samples for the detection of PAP of ruminant origin were taken in any of these establishments during 2013 and 2014 (see point 7). This is not in line with Article 7 and Section F, Chapter V of Annex IV to Regulation (EC) No 999/2001.

Although there is no routine sampling at compound feed producers and aquaculture farms, competent authorities perform adequate documentary and other verification checks along the chain and this, coupled with the robust measures put in place by the operators, allows them to largely ensure that only eligible PAP is used for the production of aquaculture feed.

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tilla y León: La sección F del capítulo V del Anexo IV del Reglamento 999/2001 especifica que los análisis de PAT se realicen de Page: 1 uthority on 15 May 2015 ref. DG(SANTE)/2014-7041-MR of an Audit carried out from 17 f certain proteins of animal origin in feed for aquaculture animals en el anexo VI del nto (152/2009) se l análisis de PCR. e han realizado conforme n realizado análisis: rario Regional de ía acreditada conforme ANFACO-CECOPESCA, de ADN acreditada s de muestras oficiales ito de ANFACO sobre para el 2015 se ha de pruebas para detectar técnicas detectan la pero no se cuantifica, s hallazgos son ulta en gran medida las Page: 2

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yecto de Real Decreto por el que se modifica el Real Decreto 1881/1994, de 16 de septiembre, por el que se establecen las condiciones de policía sanitaria aplicables a los intercambios intracomunitarios y las importaciones procedentes de países terceros de

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Se seguirán realizando prospecciones de acuerdo al protocolo to, para detectar la presencia de PSA.. se producen nuevas detecciones de PSA en zonas en las que riormente se desconocía su presencia, se notificará inmediatamente a la Comisión, de conformidad con el artículo 4, apartado 2, de la Decisión 2012/756/UE, y de conformidad con la legislación nacional ( articulo16.1 del Real Decreto 58/2005)

ing to detect the presence of PSA in ordance with the proposed protocol will . If PSA is detected in areas where its presence was previously unknown the Commission will be notified immediately in accordance with Article 4(2) of Decision 2012/756/EU and with national legislation (Article 16.1 of Royal Decree 58/2005).

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nuevo protocolo de prospecciones de PSA se recoge un iento de prospección adecuado de cara a poder confirmar suficiente certeza la ausencia del organismo en todas las áreas sideradas libres. También incluye procedimiento de inspección huertos, Gardens Centers y jardines privados.

ew PSA survey protocol includes a g procedure that should be sufficient to confirm, with adequate certainty, the absence of the organism in all areas claimed to be free. It also includes a procedure for inspections of orchards, garden centres and private gardens. (updated) received 30/04/2015 t Authorities of Spain on 09 February 2015 in response to Report ref. DG(SANTE)/2014-7194 October 2014 in order to evaluate the situation and control for Pseudomonas syringae pv.

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evo protocolo de prospecciones de PSA recoge los cedimientos necesarios para cumplir los requisitos que e la Decisión en cuanto al movimiento de plantas.

The new PSA survey protocol includes the procedures necessary to meet the A los viveros localizados fuera de áreas requirements laid down in the Decision with libres de plaga se les retiró la autorización de regard to movements of plants. emisión de pasaporte fitosanitario y de comercialización de plantas para plantación de Actinidia spp. Además se procedió a la destrucción de toda la planta sensible presente en los mismos. Tal y como se establece en el Plan de Acción no podrán volver a producir y comercializar planta de kiwi hasta que cumplan con las condiciones establecidas en la Decisión.

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Las medidas de erradicación llevadas a cabo por la Administración son ejecutadas por la empresa pública TRAGSA. Los trabajos son siempre coordinados y controlados por personal de la Administración con competencias en sanidad vegetal. Se establecerá un procedimiento más eficaz para la transmisión de la ormación sobre identificación y corta de árboles secos o sintomáticos entre los distintos organismos implicados. En cuanto a las cortas por parte de propietarios privados son autorizadas y controladas por parte de las autoridades forestales. En Castilla y León la planificación y dirección de los trabajos la realiza la Administración Regional, a través de su personal técnico especializado, al igual que ocurre con la redacción de las propuestas y las certificaciones y controles de los trabajos. La ejecución se realiza por empresas adjudicatarias bajo una supervisión continua ejercida por el personal técnico de la Administración de los servicios forestales competentes de carácter regional y provincial. Como ejemplo la eliminación de los árboles de especies sensibles se realiza bajo supervisión de la Administración mediante autorizaciones específicas a empresas para su eliminación, y con

Answer of the Autonomous Community of Galicia: The eradication measures taken by the authorities are Este tipo de acciones de aplicación carried out by the public company TRAGSA. The directa sobre el terreno no son work is always coordinated and supervised by the competencia de la Autoridad personnel from the official bodies with responsibility Nacional, son las autoridades for plant health. A more effective procedure will be regionales las competentes en el put into place for transmitting information on the diseño y ejecución de las actividades, identification and cutting of dried or symptomatic siempre en línea con la con el artículo trees between the various bodies involved. 6 (2) de la Decisión 2012/535/EU. Cutting by private owners is approved and supervised Comunidad Autónoma de Galicia: La by the forest authorities. tala de árboles por parte de los propietarios sólo está permitida en el Answer of the Autonomous Community of Castile- período de bajo riesgo, entre Leon: noviembre y abril. Para ello deben presentar una ante la autoridad In Castile-Leon, the work is planned and supervised forestal de la zona en la que se vaya a by the specialised technical officers of the region

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4 of Castilla y León elaboraró su plan de contingencia y lo ha actualizado según los comentarios y recomendaciones que la FVO realizó durante su inspección del 19 al 23 de mayo de 2014. estro plan de contingencia está en consonancia con el plan de contingencia nacional, también actualizado, elaborado por el MAGRAMA, y siempre cumpliendo los preceptos del artículo 4 de la Decisión 2012/535/UE . Esta actualización está basada también en las experiencias del pasado, para asegurar la adopción rápida de medidas en el caso de que se detecte un nuevo brote. El nuevo Plan de Acción y su Anexo se adjunta como ficheros separados a esta respuesta

astile-Leon had already drawn up contingency plans El Plan Nacional de Contingencia así and has now updated them to take into account the como el Protocolo de Higiene anexo remarks and recommendations made by the FVO al mismo, fueron actualizados, during its inspection of 19-23 May 2014. Our analizados y aprobados en el marco contingency plans are in line with the national del Comité Fitosanitario Nacional, en contingency plans, which have also been updated and Julio del 2014. Cualquier nueva were drawn up by the Ministry of Agriculture, Food and Environment (MAGRAMA) in accordance with revisión que fuera necesaria se haría en el marco de este Comité, que como Article 4 of Decision 2012/535/EU. The recent changes also took account of past experience and órgano de coordinación entre las were aimed at ensuring that measures are taken Autoridades Nacional y Autonómicas rapidly in the event of a fresh outbreak. se reúne con una periodicidad bimestral. The new action plan and its annex are attached to this response as separate files.

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the La ZD de As Neves se ajusta a lo establecido en la Decisión 2012/535/UE. En las zonas afectadas por incendios se talaban y eliminaban todos los árboles con un nivel de afectación que ion impedía su supervivencia, pero se dejaban en pie aquellos árboles l a los que el incendio no había afectado significativamente, es decir, que sólo presentaban algo quemada la corteza en la parte inferior, pero que no habían sido afectados en la copa y que por lo tanto, presentaban un aspecto saludable y sin síntomas de que fueran a secar. Se han dado instrucciones para que todos los árboles afectados por incendio sean retirados. Una vez solventados los atrasos en la tala de árboles se están realizando inspecciones visuales continuadas para la detección de nuevos árboles sintomáticos. Estos son talados y muestreados inmediatamente. Los planes de Acción de Castilla y León se elaboran según la normativa vigente y se ajustan a los apartados 1 y 2 del artículo 9 de la Decisión 2012/535/UE. Page: 2 t ref. DG(SANCO)/2014-7195 -MR of a/an audit carried out from 13 May elenchus xylophilus. La zona demarcada de Sancti-Spiritus se ha ampliado, para mayor seguridad en la erradicación del brote, siguiendo l

Answer of the Autonomous Community of Galicia: Comunidad Autónoma de Castilla y The demarcated area of As Neves complies with León: Se ha revisado nuevamente el Decision 2012/535/EU. In fire-affected areas, all trees Plan de Acción de Sancti-Spiritus that had been affected to such an extent that they donde se establece la Zona demarcada de 14 km de radio, razonando y ns (updated) received 23/01/2015 tent Authorities of Spain on N/A in response to Report ref. DG(SANCO)/2014-7195 -MR of a/an er to evaluate the situation and control for Bursaphelenchus xylophilus. could not survive were felled and eliminated, but justificando las razones para those not significantly affected (i.e. trees with establecer este nuevo radio. También scorched lower bark, but an unaffected crown, which se ha incluido el calendario para looked healthy and did not show symptoms of drying) eliminar los árboles con decaimiento, were left standing. que coincide con el establecido en la Decisión 2012/535/UE y los Planes Instructions have been given for all fire-affected trees de Contingencia nacional y to be cleared. autonómico de Castilla y León. Se adjunta el Plan de Acción de Sancti- Now that the delays in fell

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Los organismos oficiales de las Comunidades Autónomas siempre r que realizan una interceptación de material sensible que pudiera ser sospechoso de contener nematodo realizan de forma inmediata el análisis en sus laboratorios, que son periódicamente calibrados y están en coordinación con el laboratorio Nacional de Referencia (CSIC). En el caso de un posible positivo, se remite con carácter urgente una muestra al laboratorio nacional de referencia para su contraanálisis, y se establece una comunicación inmediata, directa y permanente con ell MAGRAMA para su traslado a la Comisión Europea si se confirmase. A modo de ejemplo, en el último positivo detectado, en Sancti- Spiritus (Castilla y León) se hizo la comunicación oficial tras la confirmación por el Laboratorio Nacional de Referencia por ser la Page: 3 t ref. DG(SANCO)/2014-7195 -MR of a/an audit carried out from 13 May elenchus xylophilus. primera vez que se detectaba el NMP en una masa forestal susceptible en esta Comunidad Autónoma. En el caso de posibles detecciones de positivos de la presencia de Nematodo de la Madera del Pino ésta se comunica tras el análisis morfológico por el laboratorio de la región, todo ello en cumplimi

never they intercept susceptible material spected of containing nematodes, the official dies of the Autonomous Communities always have analysis carried out immediately in their boratories, which are calibrated periodically and are ordinated with the national reference laboratory SIC). the event of a possible positive, a sample is mediately sent to the national reference laboratory r counter-analysis, and immediate, direct and rmanent communication is set up with GRAMA so that the European Commission can notified if the positive is confirmed. r example, in the last positive case in Sancti- iritus (Castile-Leon), the official notification was de once the outbreak had been confirmed by the tional reference laboratory, as this was the first me PWN had been found in a susceptible forest and in this Autonomous Community. a suspected positive case of pine wood nematode is tected, it is notified following morphological alysis by the regional laboratory, in accordance ns (updated) received 23/01/2015 tent Authorities of Spain on N/A in response to Report ref. DG(SANCO)/2014-7195 -MR of a/an er to evaluate the situation and control for Bursaphelenchus xylophilus. with Article 16 of Directive

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risk En la Comunidad Autónoma de Galicia se cumple con lo nce establecido en el apartado 1 del artículo 2 de la Decisión n 2012/535/UE y en el Plan de Contingencia, y se realiza un muestreo completo para la detección del NMP en las zonas de riesgo que existen a lo largo de todo el territorio de la CA. El plan de Contingencia de Castilla y León y los Planes de Acción de las zonas demarcadas de Castilla y León se adaptan permanentemente a las nuevas situaciones de riesgo del nematodo, especialmente en las Zonas Demarcadas por el mismo, para cumplir las exigencias del apartado 1 del artículo 2 de la Decisión 2012/535/UE. Se establecen adecuadamente el tipo de inspecciones a realizar en cada parte del territorio según su nivel de riesgo y la intensidad de muestreo tanto de las especies sensibles como del vector. Éstos resultados se comunican anualmente, en forma y plazo, a la Comisión a través del MAGRAMA.

Answer of the Autonomous Community of Galicia: Galicia complies with Article 2(1) of Decision A nivel nacional el Plan Nacional de 2012/535/EU and the contingency plans, and full Contingencia es un elemento sampling is carried out in order to detect PWN in the dinámico que puede ser adecuado a areas at risk, which are found throughout the un supuesto nuevo escenario si este Autonomous Community's territory. ocurriera, de forma inmediata en el marco del Comité Fitosanitario Nacional en sus reuniones bimensuales, no hay por tanto riesgo Answer of the Autonomous Community of Castile- en el marco actual de seguimiento Leon: determinado por el Plan Nacional de The contingency plans of Castile-Leon and the action Contingencia (última versión) de plans for the demarcated areas of Castile-Leon are infravalorar el seguimiento de las continually updated to take account of new nematode zonas forestales susceptibles y en risk situations, particularly in the demarcated areas, in riesgo. Cada Comunidad Autónoma order to comply with Article 2(1) of Decision en el marco de sus competencias 2012/535/EU. desarrolla el Plan Nacional de Contingencia adecuándolo a la su The type of inspection to be car

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En un principio consideramos que la Zona Demarcada de Sancti- is Spiritus definida por Castilla y León de 6 km cumplía legalmente ex I con el apartado 2 del artículo 5 de la Decisión 2012/535/UE, al ne haberse tomado todas las medidas de erradicación de acuerdo con el artículo 6. Pero teniendo en cuenta el riesgo del NMP, el principio de seguridad básico en esta actuación de erradicación, las recomendaciones de este informe, las indicaciones de los Inspectores de la FVO, y considerando además la capacidad de vuelo del vector, hemos procedido a ampliar la Zona Demarcada Page: 4 t ref. DG(SANCO)/2014-7195 -MR of a/an audit carried out from 13 May elenchus xylophilus. de Sancti-Spiritus a 14 km de anchura, en ella se inventariarán además de las masas forestales, todos los pies aislados y en bosquetes que puedan existir, para su inspección, muestreo y eliminación en caso de síntomas de decaimiento, así como para su posterior inspección anual. En esta franja actual de 14 km se incluyen las masas forestales con especies sensibles limítrofes al noroeste con la antigua zona demarcada de 6 km, donde ya se estaba prospectando con la misma intensidad que en la Zona Demarcada el estar en la zo

er of the Autonomous Community of Castile- eon: nitially, we were of the opinion that the demarcated rea of Sancti-Spiritus of 6 km defined by Castile- eon complied legally with Article 5(2) of Decision 012/535/EU, since all eradication measures had been n in accordance with Article 6. However, after ing into account the risk of PWN, the basic ecurity principle in these eradication measures, the ecommendations in this report, the suggestions made y the FVO inspectors, and also the vector's flight apacity, we have extended the demarcated area of ancti-Spiritus to a width of 14 km; we have also ade an inventory in this area of the forest stands, nd all isolated bases or bases in woods, so that they ns (updated) received 23/01/2015 tent Authorities of Spain on N/A in response to Report ref. DG(SANCO)/2014-7195 -MR of a/an er to evaluate the situation and control for Bursaphelenchus xylophilus. can be inspected, sampled and eliminated if they show signs of decline, as well as in their subsequent annual inspection. This current strip of 14 km includes the forest stands with susceptible species bordering the old demarcated area of 6 km in the north-east, where explorations are being carr

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En la Comunidad Autónoma de Galicia se realiza un muestreo completo en toda la zona demarcada de As Neves, tanto de árboles ble sintomáticos como asintomáticos, tomando un elevado número de muestras en las zonas afectadas por incendios. Por otra parte, existe una completa red de trampeo para captura del insecto vector, tanto en toda la zona demarcada como en la zona que la rodea.

Answer of the Autonomous Community of Galicia: In the Autonomous Community of Galicia, Comunidad Autónoma de Galicia: comprehensive sampling is carried out throughout the Según lo establecido en el Plan de demarcated area of As Neves, including both Acción, en la Zona Demarcada y en la symptomatic and non-symptomatic trees, and taking a Zona Tampón se ha establecido un large number of samples in fire-affected areas. completo plan de prospecciones, basado en muestreos sistemáticos There is a complete network of traps for catching the establecidos a través de mallas de vector insect, both throughout the demarcated area muestreo, y los muestreos de todos and in the surrounding area. los árboles secos o sintomáticos detectados y eliminados dentro de la misma. ns (updated) received 23/01/2015 tent Authorities of Spain on N/A in response to Report ref. DG(SANCO)/2014-7195 -MR of a/an er to evaluate the situation and control for Bursaphelenchus xylophilus.

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for En estos momentos se está realizando una labor continuada de identificación y eliminación de árboles secos y sintomáticos, uld be incluidos los afectados por incendios. Se prestará una mayor atención en las zonas de incendios para eliminar todos los Page: 6 t ref. DG(SANCO)/2014-7195 -MR of a/an audit carried out from 13 May elenchus xylophilus. árboles que hayan sido afectados por el mismo, aunque sólo presenten la corteza quemada en la base del tronco. Se ha garantizado el cumplimiento del punto 7 del anexo I de la Decisión 2012/535/UE ya que se han eliminado todos los árboles, tanto con presencia de NMP, como los sanos en la zona infestada y de corta de 500 m, además en el resto de la zona demarcada todos los árboles con decaimiento son identificados, muestreados, analizados y eliminados, asegurándonos de que todos los árboles de especies sensibles apeados con síntomas de decaimiento son analizados por nuestro sistema de muestreo.

wer of the Autonomous Community of Galicia: k on identifying and eliminating dried and Comunidad Autónoma de Galicia: ptomatic trees, including those affected by fire, is Una vez finalizados los trabajos de rently ongoing. Greater attention will be paid in corta y eliminación de árboles secos y fire areas to eliminate all fire-affected trees, even sintomáticos pendientes de they have only suffered scorched bark at the base of eliminación de años anteriores, trunk. durante el 2014 se ha realizado una prospección continuada para la detección de árboles secos o wer of the Autonomous Community of Castile- sintomáticos, tanto afectados por n: incendios como por otras causas, y se pliance with point 7 of Annex I to Decision ha procedido a su tala y destrucción 2/535/EU has been fulfilled by eliminating all inmediata. es with PWN present and all healthy trees both in infested area and in a clear-cut zone of 500 m, by ntifying, sampling, analysing and eliminating all es showing signs of decline in the remaining arcated area, and by ensuring that all trees of ceptible species with symptoms of decline are lysed by our sampling system.

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Los árboles secos o sintomáticos identificados dentro de la ZD son eliminados en cumplimiento del período establecido por el punto 7 (a) del Anexo I; donde se hace referencia específica a la "temporada de vuelo del vector" , tal como lo define el artículo 1-f de la Decisión de Ejecución de la Comisión 2012/535. Este artículo define como genérico el comprendido entre el 1 de abril y el 31 de octubre, salvo en el caso de que exista una justificación técnica-científica para una duración diferente". Los procesos de corta y eliminación se hacen en cumplimiento de la Decisión, en este caso en el periodo referido, o en un periodo diferente si se justifica de una forma técnico-científica adecuada. Esto se aplica a todos los focos activos de nematodo existentes en España y sus entornos. Además, en el caso específico de la zona tampón del foco de Valverde del Fresno existente en el territorio de Castilla y León, y siguiendo lo preceptuado en el apartado a) del punto 7 del anexo I de la Decisión 2012/535/UE, se está tramitando una propuesta en Castilla y León, cuyo plazo de ejecución será del 1 de noviembre de 2014 al 31 de marzo de 2015 en la zona demarcada de Santi-Spíritus y en la de Valve

ed or symptomatic trees identified inside the arcated area are eliminated within the period set Comunidad Autónoma de Galicia: in point 7(a) of Annex I, which refers specifically Los árboles identificados en el the `flight season of the vector', as defined in período desde el 1 de noviembre al 31 icle 1(f) of Commission Implementing Decision de marzo se cortarán y eliminarán en 2/535, i.e. `the period from 1 April to 31 October, ese período. ept where there is technical-scientific justification a different duration'. The cutting and elimination cesses comply with the Decision, being carried out hin the defined period or a different period where Comunidad Autónoma de Castilla y re is technical-scientific justification. León: En Castilla y León los árboles con decaimientos identificados, ns (updated) received 23/01/2015 tent Authorities of Spain on N/A in response to Report ref. DG(SANCO)/2014-7195 -MR of a/an er to evaluate the situation and control for Bursaphelenchus xylophilus. de outbreak sites talados y analizados en el período desde el 1 de noviembre al 31 de marzo se eliminarán dentro de este Castile- período. the buffer zone del Fresno on s underway in ) of Annex I to Castil

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l Al igual que en la respuesta anterior, ya que son de aplicación los mismos artículos (1-f, y 7-b del Anexo I) los árboles secos o sintomáticos identificados dentro de la ZD son eliminados en cumplimiento del período establecido por la "temporada de vuelo Page: 8 t ref. DG(SANCO)/2014-7195 -MR of a/an audit carried out from 13 May elenchus xylophilus. del vector" , tal como lo define la Decisión de Ejecución de la Comisión 2012/535. Este artículo, que define como genérico el comprendido entre el 1 de abril y el 31 de octubre, establece la salvedad referida del caso de que exista una justificación técnica- científica para una duración diferente. Los procesos de corta y eliminación se hacen en cumplimiento de la Decisión, en respuesta a esta recomendación en el periodo referido, o en un periodo diferente si se justificase de una forma técnico-científica adecuada. Esto se aplica a todos los focos activos de nematodo existentes en España y sus entornos. En el caso específico de As Neves, los árboles secos o sintomáticos identificados en la ZD en el período comprendido entre el 1 de abril y el 31 de octubre se talarán inmediatamente y, o bien se destruirán in situ, o bien se separará l

As indicated in the answer above, which also relates Comunidad Autónoma de Galicia: to the same articles (1(f) and 7(b) of Annex I), dried Una vez terminados los trabajos of and symptomatic trees identified within the atrasados en abril de 2014, desde esa demarcated area are eliminated within the `flight fecha se han realizado controles season of the vector', as defined by Commission continuados para detección de árboles Implementing Decision 2012/535, i.e. `the period secos y sintomáticos y tala y from 1 April to 31 October, except where there is eliminación inmediata de los mismos technical-scientific justification for a different durante el período de vuelo del duration'. In response to the recommendation, the vector. cutting and elimination processes comply with the Decision, being carried out within the defined period Comunidad Autónoma de Castilla y or a different period where there is technical- León: En Castilla y León durante el scientific justification. período de vuelo del vector se volverán a inspeccionar los árboles This applies to all the active nematode outbreak sites con decaimiento para su tala, análisis in and around Spain. y eliminación inmediata, esta medida se

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Durante el periodo de vuelo del insecto vector los propietarios particulares no tienen permitido cortar árboles de especies sensibles, y en concreto árboles secos o sintomáticos. Sólo la Administración realiza los trabajos de retirada y destrucción de árboles secos o sintomáticos durante este período con arreglo a lo dispuesto en la letra b) del punto 7 del anexo I de la Decisión 2012/535/UE. Para garantizar el contenido del punto 8 del anexo I de la Decisión 2012/535/UE, toda la madera de especies sensibles talada es enviada según normativa con guías de traslado, controlados en origen y destino, a los puntos de eliminación previamente autorizados por la Junta de Castilla y León. No se han realizado cortas en montes particulares, salvo una pequeña parcela particular en Sancti-Spíritus que ha sido talada, astillada y guiada por la Administración al punto de transformación autorizado. En todo momento se ha realizado seguimiento de la trazabilidad y control del material por parte de la Administración, de los puntos de talado hasta la industria de transformación, sea cual fuera la propiedad.

Answer of the Autonomous Community of Galicia: Comunidad Autónoma de Galicia: th Los propietarios particulares tienen el s During the flight season of the vector insect, deber de comunicación a las by individual owners may not cut trees of susceptible autoridades oficiales de cualquier species and in particular dried or symptomatic trees. corta de especies sensibles a realizar Only the authorities carry out removal and en la Zona Demarcada. La gestión de destruction work on dried and symptomatic trees in estas actividades se realiza según lo this period in accordance with point 7(b) of Annex I definido en el punto 1 del presente to Decision 2012/535/EU. documento. Answer of the Autonomous Community of Castile- Comunidad Autónoma de Castilla y Leon: León: Los propietarios particulares solo pueden realizar cortas, en el In order to comply with point 8 of Annex I to Decision 2012/535/EU, all felled wood of susceptible ns (updated) received 23/01/2015 tent Authorities of Spain on N/A in response to Report ref. DG(SANCO)/2014-7195 -MR of a/an er to evaluate the situation and control for Bursaphelenchus xylophilus. species is sent in accordance with the law with periodo de 1 de noviembre

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Se realiza un muestreo de todos los árboles secos o sintomáticos detectados y eliminados. En caso de árboles aislados se toma una t muestra de cada árbol. En caso de un grupo de árboles localizados en el mismo punto, se toma una o varias muestras conjuntas en función del número total de árboles detectados. Se apean y muestrean todos los árboles con decaimiento, de manera que siempre se cumple que el sistema de muestreo que confirma con un 99% de fiabilidad que el nivel de presencia del nematodo en plantas en las que no se ha detectado la presencia del mismo no supera el 0.1% según exige la asistencia técnica de la EFSA para la aplicación de la estadística de muestreos. Cada muestra se toma de un máximo de 5 árboles, si en el foco de Page: 10 t ref. DG(SANCO)/2014-7195 -MR of a/an audit carried out from 13 May elenchus xylophilus. decaimiento hay más pies con decaimientos, el número de muestras se aumenta, correspondiendo cada una a un máximo de 5 árboles en decaimiento.

nswer of the Autonomous Community of Galicia: All detected and eliminated dried or symptomatic Comunidad Autónoma de Galicia: Se trees are sampled. All isolated trees are sampled. In ha ejecutado el plan de muestreos the case of a group of trees located at the same point, establecido en el plan de acción de one or more samples are taken depending on the total acuerdo con la Decisión comunitaria. number of detected trees. Se han realizado muestreos sistemáticos a través de mallas de muestreo tanto en la zona demarcada Answer of the Autonomous Community of Castile- como en el resto del territorio de la Leon: comunidad autónoma. También se All trees showing decline are felled and sampled han muestreado los árboles secos o using a sampling scheme able to confirm with 99% sintomáticos detectados y eliminados reliability that of presence of PWN in those dentro de la zona demarcada y en susceptible plants is below 0.1%, as required by todas las zonas de riesgo. Los EFSA technical assistance for sampling statistics. resultados de las acciones llevadas a Each sample is taken from a maximum of five trees; cabo y los muestreos realizados se ns (updated) received 23/01/2015 tent Authorities of

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En el caso del foco de As Neves, se cumple escrupulosamente lo establecido por la Decisión en este aspecto, no obstante se va a comprobar y si fuera necesario mejorar los procedimientos de e comunicación interna y coordinación en tiempo real para garantizar que cualquier control de movimiento de material susceptible está disponible para su chequeo inmediato en las bases de datos por el personal involucrado en los trabajos de control e inspección de este tema. En las inspecciones de los controles relativos al traslado de material sensible de zonas demarcadas a zonas no demarcadas y de zonas infestadas a zonas tampón se cumple lo dispuesto en el apartado 1 y 2 del artículo 11 de la Decisión 2012/535/UE, incluido el material sensible en forma de embalaje de madera reparado. Así, los embalajes con varias marcas de sello SPMF-15 no infringen ninguna normativa, considerando que la norma ISPM-15, sección 4.6, indica que aunque las administraciones pueden obliterar sellos dobles, en general la legislación no lo exige. Existe una excepción, para el material reciclado, cuando se reemplaza más de un tercio de sus componentes. Además los pallets con menos de un tercio de sus componentes reempl

Answer of the Autonomous Community of Galicia: En el marco de sus competencias icular care is taken at the As Neves outbreak site todas las Comunidades Autónomas a omply with the Decision in this respect. través de sus equipos de inspección rtheless, we will check whether the procedures fitosanitaria proceden a periódicas nternal communication and real-time coordination inspecciones de las instalaciones to be improved in order to ensure that any productoras y procesadoras (las cuales rols on the movement of susceptible elements are incluyen las de reparación) de lable for immediate checking in the databases by material de embalaje. Un claro f involved in control and inspection work in this ejemplo de esta acción es la revisión . continuada de las autorizaciones expedidas a estas compañías, que son comunicadas de inmediato a la er of the Autonomous Community of Castile- Comisión Europea para que actualice : a su vez la lista de alta y bajas de compañías y de procesos autorizados inspections carried out during the controls of en cada caso. eptible material being moved from demarcated s to non-demarcated areas and from infested areas uffer areas comply with Article 11(1) and (2) of si

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oducción Agraria está onómicos y medios humanos para llevar ción y autorización de productos iodo de tiempo. Actualmente sigue dientes de reevaluar y eda ser resuelto antes del 2015.

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de Comercialización y del a el año 2014, se indicará de lo posible, las inspecciones que omunidades Autónomas deberán

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os laboratorios de control oficial s, a través de un Grupo de Trabajo, y dichos laboratorios, para conocer el estado con el fin de poder planificar la re los laboratorios oficiales. Para ello, s agroalimentarios y de seguridad (en desarrollo), respectivamente. un documento para identificar las trol oficial, incluidos los residuos de mizar los recursos técnicos y humanos de los Page: 1 an audit carried out the Competent Authority

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s del Estado español, son las rgadas de designar los laboratorios para residuos de pesticidas y definir su alcance.

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ción con los laboratorios oficiales pesticidas, informan de la obligación cipar en los ensayos que organizan d de ampliar su alcance de acreditación. las comunicaciones de los EURL para y toda la información recibida que afecte a icial.

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ia del Uso de Productos indicará expresamente que, en la e los criterios para la selección de la ias a inspeccionar por las Comunidades cuenta los resultados de los propias explotaciones agrarias. Page: 2

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En relación al MAGRAMA: durante la auditoría efectuada en España, el equipo auditor pudo ver el Listado de Operadores de la Agricultura Ecológica que es una aplicación temporal que permite dar cumplimiento desde el 1 de enero de 2013 a lo establecido en el artículo 92 ter del Reglamento (CE) Nº 889/2008 de la Comisión y que permanecerá en funcionamiento hasta que sea plenamente operativo el Registro General de Operadores Ecológicos (REGOE), previsto para finales del presente año. Hasta la plena entrada en aplicación del REGOE y con objeto de solventar el problema detectado: 1. Antes de finales de junio de 2014 se incluirá la calificación "primer año en prácticas" en la aplicación temporal "Listado de Operadores de Agricultura Ecológica". Se ha revisado el protocolo de actualización de dicho Listado. En este sentido, se está remitiendo en los últimos cinco días de cada mes una comunicación telemática a las autoridades competentes de las CCAA en materia de agricultura ecológica con un recordatorio para que remitan al MAGRAMA la actualización de los datos de sus operadores ecológicos para su carga en la aplicación temporal. 3. En relación a la puesta a punto del "Registro General de O

n relación al MAGRAMA: El Real Decreto 833/2014, de 3 de octubre, por el que se establece y regula el Registro General de Operadores Ecológicos y se crea la Mesa de coordinación de la producción que se publicó en el Boletín oficial del Estado (BOE) el 17 de octubre de 2014 establece por un lado la base legal para la creación de la base de datos REGOE, de carácter nacional, y por otro la Mesa de coordinación de la producción ecológica, dando respuesta a esta primera recomendación. En cuanto a la obligatoriedad de la publicidad de la lista (contenido expreso de la Recomendación 1), se ha incorporado dicha obligatoriedad en el Real Decreto en su artículo 4.3. Por último, y hasta la plena puesta en marcha de la base de datos REGOE, y con objeto de solventar el problema detectado durante la visita de la FVO se han llevado a cabo las siguientes actuaciones: 1. La inclusión de la calificación "primer año en prácticas" en la aplicación temporal "Listado de Operadores de Agricultura Ecológica" se ha terminado. Asimismo se ha incluido, en el Real Decreto 883/2014 antes citado, en su artículo 4.1 la calificación de primer año en prácticas dentro de la estructura básica del REGOE. Plazo: Ya re

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· En la Comunidad Valenciana se está elaborando la normativa que garantice las excepciones al control de aquellos establecimientos que venden productos ecológicos envasados, sin posibilidad de manipulación por parte del vendedor y destinados al consumidor final. Plazo de ejecución: antes de finales de 2014.

· En la Comunidad Valenciana se está elaborando la normativa que garantice las excepciones al e control de aquellos establecimientos que venden productos ecológicos envasados, sin posibilidad de manipulación por parte del vendedor y destinados al consumidor final. Plazo previsto de le ejecución: principios de 2015. 7 Page: 2 tent Authority, 12 November 2014 ain to the recommendations of Report ref. DG(SANCO)/2013-6652 -MR of a/an audit carried out from 14 evaluate the control systems for organic production and labelling of organic products.

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entro del marco del Plan de Control Oficial de la Cadena Alimentaria (PNCOCA) en las Directrices para la elaboración del documento "INFORME DE RESULTADOS DE LOS CONTROLES DEL PROGRAMA DE CONTROL OFICIAL DE LA PRODUCCIÓN ECOLÓGICA 2014" (DI-CA-ECO) se ha incluido esta recomendación. Plazo: fecha de aprobación de las Directrices: ejercicio 2014. · Además en la Comunidad Autónoma de Andalucía, 1. Por un lado, la Dirección General de Calidad, Industrias Agroalimentarias y Producción Ecológica (DGCIAPE): ha modificado la Circular 3/2013, que incorpora las inspecciones no anunciadas. Ver en página web: http://www.juntadeandalucia.es/agriculturaypesca/portal/areas- tematicas/produccion-ecologica/informacion-de-operadores/instrucciones/index.html Plazo: ya realizado. 2. Por otro lado, el organismo de control está modificando el Procedimiento PGT-04 sobre auditorias/controles para incluir la definición de visita no anunciada. Plazo implantación: 30 de mayo de 2014 Page: 2 recommendations, received 7 August 2014 ain to the recommendations of Report ref. DG(SANCO)/2013-6652 -MR of a/an audit carried out from 14 evaluate the control systems for organic production and labelling of organic produ

· Dentro del marco del Plan de Control Oficial de la Cadena Alimentaria (PNCOCA) en las Directrices para la elaboración del documento "INFORME DE RESULTADOS DE LOS CONTROLES DEL PROGRAMA DE CONTROL OFICIAL DE LA PRODUCCIÓN ECOLÓGICA 2014" (DI-CA-ECO) se ha incluido esta recomendación. Plazo: Ya realizado. · Además en la Comunidad Autónoma de Andalucía, 1. Por un lado, la Dirección General de Calidad, Industrias Agroalimentarias y Producción Ecológica (DGCIAPE): ha modificado la Circular 3/2013, que incorpora las inspecciones no anunciadas. Ver en página web: http://www.juntadeandalucia.es/agriculturaypesca/portal/areas- tematicas/produccion-ecologica/informacion-de-operadores/instrucciones/index.html Plazo: Ya realizado. 2. Por otro lado, el organismo de control ha modificado el Procedimiento PGT-04 sobre auditorias/controles para incluir la definición de visita no anunciada. Plazo: ya realizado · Por otro lado la Comunidad Valenciana, en su Instrucción General del Area de Inspección "IT-01" del Manual de Calidad del CAECV, se ha incluido la recomendación de visitas de control aleatorias adicionales sin previo aviso. Plazo: Ya realizado.

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s controles realizados por los inspectores dentro del Plan de Controles de la Producción Ecológica son lizados de forma eficaz. No obstante para dar refuerzo a esta recomendación se han llevado a cabo las uientes actuaciones: En la Comunidad Autónoma de Andalucía: Por un lado, el organismo de control: Ha desarrollado actividades de formación a los inspectores dentro del Plan Anual de Formación 14 y del Procedimientos General de Capacitación, Selección, Formación y Cualificación de rsonal. Plazo: ya realizado 10-11 abril 2014 y 12 de mayo de 2014. Modificación de los formularios de comprobación de ganadería en su punto "C16" (Animales), en su punto "C17"(Instalaciones y zonas al aire libre) y el de comprobación de agricultura en punto "C.14 (Control de Plagas y Enfermedades). Plazo implantación: 30 de mayo de 2014. Por otro lado, la DGCIAPE: · Ha aprobado una nueva versión del Procedimiento Específico de inspección a los organismos con tareas de control delegadas en el alcance de producción ecológica, con el fin de reforzar las actuaciones de verificación del cumplimiento y la eficacia de los controles efectuados por los organismos de control. Plazo: ya realizado. · Ha aprobado el P

Los controles realizados por los inspectores dentro del Plan de Controles de la Producción Ecológica son realizados de forma eficaz. No obstante para dar refuerzo a esta recomendación se han llevado a cabo las siguientes actuaciones: · En la Comunidad Autónoma de Andalucía: 1. Por un lado, el organismo de control: · Ha desarrollado actividades de formación a los inspectores dentro del Plan Anual de Formación y del Procedimientos General de Capacitación, Selección, Formación y Cualificación de personal 2014 ya realizados durante el 10-11 abril 2014 y 12 de mayo de 2014. Plazo: Ya Page: 3 tent Authority, 12 November 2014 ain to the recommendations of Report ref. DG(SANCO)/2013-6652 -MR of a/an audit carried out from 14 evaluate the control systems for organic production and labelling of organic products. realizado Se han Modificado los formularios de comprobación de ganadería en su punto "C16" (Animales), y en su punto "C17"(Instalaciones y zonas al aire libre) y el de comprobación de agricultura en su punto "C.14 (Control de Plagas y Enfermedades). Plazo: Ya realizado. . Por otro lado, la DGCIAPE: · Ha aprobado una nueva versión del Procedimiento Específico de inspección a los organ

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El Instituto Nacional de Consumo (INC), en la actualidad el AECOSAN (Agencia Española de nsumo, Seguridad Alimentaria y Nutrición), está cooperando con las Administraciones de Consumo las CCAA en el desarrollo de una Campaña Nacional de inspección y control en mercado en el año 14 sobre etiquetado ecológico con la participación de 11 Comunidades Autónomas. En la fecha ya se Page: 3 recommendations, received 7 August 2014 ain to the recommendations of Report ref. DG(SANCO)/2013-6652 -MR of a/an audit carried out from 14 evaluate the control systems for organic production and labelling of organic products. ha realizado dicha campaña en la Comunidad Valenciana.

El Instituto Nacional de Consumo (INC), en la actualidad el AECOSAN (Agencia Española de onsumo, Seguridad Alimentaria y Nutrición), está cooperando con las Administraciones de Consumo e las CCAA en el desarrollo de una Campaña Nacional de inspección y control en mercado en el año 014 sobre etiquetado ecológico con la participación de 11 Comunidades Autónomas. En relación con as dos Comunidades Autónomas visitadas durante la misión, ya se han realizado la campaña en la omunidad Valenciana y la Comunidad Autónoma de Andalucía ( Esta última con 96 controles de tiquetado y 12 tomas de muestras en 49 visitas a establecimientos).

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· En la Comunidad Autónoma de Andalucía, la DGCIAPE ha aprobado el Procedimiento sobre la autorización de excepciones a las normas de producción ganadera ecológica conforme al Reglamento (CE) nº 889/2008. Plazo: ya realizado. · En la Comunidad Valenciana, se está elaborando una instrucción en el Manual de Autoridad Competente para la correcta aplicación de las excepciones. Plazo de aplicación de la medida: 12 de diciembre 2014.

Page: 4 tent Authority, 12 November 2014 ain to the recommendations of Report ref. DG(SANCO)/2013-6652 -MR of a/an audit carried out from 14 evaluate the control systems for organic production and labelling of organic products. En la Comunidad Autónoma de Andalucía, la DGCIAPE ha aprobado el Procedimiento sobre la autorización de excepciones a las normas de producción ganadera ecológica conforme al Reglamento E) nº 889/2008. Plazo: ya realizado. En la Comunidad Valenciana, se está elaborando una instrucción en el Manual de Autoridad Competente para la correcta aplicación de las excepciones. Plazo previsto de ejecución: finales 2014.

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· En la Comunidad Autónoma de Andalucía:, 1. Por un lado, la DGCIAPE tiene disponible y se puede ver en su web los siguientes documentos: http://www.juntadeandalucia.es/agriculturaypesca/portal/areas-tematicas/produccion- ecologica/informacion-de-operadores/instrucciones/index.html a. El Procedimiento sobre la autorización de excepciones a las normas de producción ganadera ecológica conforme a los Reglamentos (CE) nº 834/2007 y (CE) nº 889/2008. Plazo: ya realizado. b. La Instrucción de 12 de noviembre de 2012, de la Dirección General de Calidad, Industrias Agroalimentarias y Producción Ecológica, sobre semillas y material de reproducción vegetativa para la producción ecológica. Plazo: ya realizado. c. El Procedimiento para la solicitud de autorización de ingredientes de origen agrario no ecológicos, aprobado con fecha 30 de noviembre de 2009. Plazo: ya realizado. d. La instrucción sobre modificaciones del periodo de conversión y reconocimiento de la fecha de Page: 4 recommendations, received 7 August 2014 ain to the recommendations of Report ref. DG(SANCO)/2013-6652 -MR of a/an audit carried out from 14 evaluate the control systems for organic production and labelling of organic p

· En la Comunidad Autónoma de Andalucía:, Por un lado, la DGCIAPE tiene disponible y se puede ver en su web los siguientes documentos: ttp://www.juntadeandalucia.es/agriculturaypesca/portal/areas-tematicas/produccion- cologica/informacion-de-operadores/instrucciones/index.html El Procedimiento sobre la autorización de excepciones a las normas de producción ganadera ecológica conforme a los Reglamentos (CE) nº 834/2007 y (CE) nº 889/2008. Plazo: ya realizado. La Instrucción de 12 de noviembre de 2012, de la Dirección General de Calidad, Industrias Agroalimentarias y Producción Ecológica, sobre semillas y material de reproducción vegetativa para la producción ecológica. Plazo: ya realizado. El Procedimiento para la solicitud de autorización de ingredientes de origen agrario no ecológicos, aprobado con fecha 30 de noviembre de 2009. Plazo: ya realizado. La instrucción sobre modificaciones del periodo de conversión y reconocimiento de la fecha de inicio en producción ecológica. Plazo: ya realizado. Por otro lado, el organismo de control tiene un Procedimiento Comprobaciones en auditoría las rificaciones de los requisitos supeditados a autorizaciones según art. 29, y art. 42 a 47 del gl

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En relación al MAGRAMA: para fortalecer el sistema, se han modificado los documentos disponibles la Web del MAGRAMA en los que se ha indicado de manera más explícita la necesidad del mplimiento de la obligación por parte del importador de prenotificar al Servicio de Inspección IVRE la importación que se pretende llevar a cabo de las partidas de productos ecológicos de nformidad con el artículo 33 del Reglamento (CE) nº 834/2007, para que se sometan al ocedimiento previsto en el artículo 13 del Reglamento (CE) nº 1235/2008 antes de su despacho a bre práctica en el mercado de la UE. Dichos documentos son: "Importaciones de países terceros de productos de la agricultura ecológica" http://www.magrama.gob.es/es/alimentacion/temas/la-agricultura- ecologica/IMPORTACIONES_DE_PA%C3%8DSES_TERCEROS_DE_PRODUCTOS_DE_LA_ AE_tcm7-220473.pdf "Requisitos autorización de importaciones de productos ecológicos según ART. 19 R (CE) 1235/2008 de la Comisión": http://www.magrama.gob.es/es/alimentacion/temas/la-agricultura- ecologica/REQUISITOS_PARA_LA_AUTORIZACI%C3%93N_DE_IMPORTACIONES_DE_PR ODUCTOS_ECOL%C3%93GICOS_SEG%C3%9AN_EL_ART%C3%8DCULO_19_DEL_REGL AMENTO__CE__1235_2008_DE_LA_COMISI%C3%93N_tcm7-220

ación al MAGRAMA: para fortalecer el sistema: Se ha modificado el documento disponible en la Web del MAGRAMA ("Octubre 14.Importaciones de países terceros de productos de la agricultura ecológica"), en el que emás de contemplarse la reciente publicación de la Orden ECC/1936/2014, de 16 de octubre, por que se dictan normas de control e inspección en la importación de productos ecológicos ocedentes de terceros países, se ha indicado de manera más explícita la necesidad del mplimiento de la obligación por parte del importador de prenotificar al Servicio de Inspección IVRE la importación que se pretende llevar a cabo de las partidas de productos ecológicos de nformidad con el artículo 33 del Reglamento (CE) nº 834/2007 y del artículo 19 del Reglamento E) nº 1235/2008, para que se sometan al procedimiento previsto en el artículo 13 del Reglamento E) nº 1235/2008 antes de su despacho a libre práctica en el mercado de la UE. Plazo: Ya alizado- link: tp://www.magrama.gob.es/es/alimentacion/temas/la-agricultura- ologica/IMPORTACIONES_DE_PA%C3%8DSES_TERCEROS_DE_PRODUCTOS_DE_LA_ _tcm7-220473.pdf tp://www.magrama.gob.es/es/alimentacion/temas/la-agricultura-ecologica/ difusion eco importaciones

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· En la Comunidad Autónoma de Andalucía: 1. La DGCIAPE ha aprobado: a. La modificación de la Instrucción para las comunicaciones de los organismos privados de control de la producción ecológica a la autoridad competente, que entre otros se ha modificado el apartado 4.3.2 sobre resultados de los controles realizados a los operadores que revelen o hagan sospechar un incumplimiento, haciéndose distinción de plazos de comunicación en función de la gravedad del incumplimiento. Plazo: ya realizado. Aclaración: En cuanto al plazo de ocho días hábiles establecido para comunicar los incumplimientos detectados en los controles, desde la DGCIAPE se quiere exponer que dicho plazo ha sido determinado teniendo en cuenta la organización y sistemática de trabajo de la mayoría de los inspectores de los organismos de control que operan en Andalucía. b. La Circular nº 4/2014 sobre el intercambio de información relativa a las entidades de certificación de Agricultura Ecológica que sustituye la Circular nº 1 /2010. Plazo: ya realizado. · En la Comunidad Valenciana: la Autoridad competente recibe la información sobre irregularidades inmediatamente al ser miembro del comité de certificación CAECV.

· En la Comunidad Autónoma de Andalucía: 1. La DGCIAPE ha aprobado: a. La modificación de la Instrucción para las comunicaciones de los organismos privados de control de la producción ecológica a la autoridad competente, que entre otros se ha modificado el apartado 4.3.2 sobre resultados de los controles realizados a los operadores que revelen o hagan sospechar un incumplimiento, haciéndose distinción de plazos de comunicación en función de la gravedad del incumplimiento. Plazo: ya realizado. Aclaración: En cuanto al plazo de ocho días hábiles establecido para comunicar los incumplimientos detectados en los controles, desde la DGCIAPE se quiere exponer que dicho plazo ha sido determinado teniendo en cuenta la organización y sistemática de trabajo de la mayoría de los inspectores de los organismos de control que operan en Andalucía. Page: 7 tent Authority, 12 November 2014 ain to the recommendations of Report ref. DG(SANCO)/2013-6652 -MR of a/an audit carried out from 14 evaluate the control systems for organic production and labelling of organic products. b. La Circular nº 4/2014 sobre el intercambio de información relativa a las entidades de certificación de Agricultura Ecológica

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· En la Comunidad Autónoma de Andalucía: la DGCIAPE ha aprobado los siguientes documentos: 1. Nueva versión del Procedimiento Específico de inspección con tareas de control delegadas con el Page: 6 recommendations, received 7 August 2014 ain to the recommendations of Report ref. DG(SANCO)/2013-6652 -MR of a/an audit carried out from 14 evaluate the control systems for organic production and labelling of organic products. fin de reforzar las actuaciones de verificación y la eficacia de los controles. Plazo: ya realizado. . Dispone del Programa anual de Inspecciones correspondiente al año 2014. Plazo: ya realizado. . Circular 4/2014 que sustituye a la Circular 1/2010 sobre intercambio de información relativa a las entidades de certificación de agricultura ecológica incluyéndose como nueva comunicación en SICE que los organismo de control activos comuniquen los resultados de las auditorias realizadas por sus correspondientes entidades de acreditación así como los resultados de las supervisiones efectuadas por otras autoridades competentes.. Plazo: ya realizado. . Procedimiento de supervisión de los organismos de control por parte de la DGCIAPE en la que, entre otras cosas, se establec

En la Comunidad Autónoma de Andalucía: la DGCIAPE ha aprobado los siguientes documentos: . Nueva versión del Procedimiento Específico de inspección con tareas de control delegadas con el in de reforzar las actuaciones de verificación y la eficacia de los controles. Plazo: ya realizado. . Dispone del Programa anual de Inspecciones correspondiente al año 2014. Plazo: ya realizado. . Circular 4/2014 que sustituye a la Circular 1/2010 sobre intercambio de información relativa a las ntidades de certificación de agricultura ecológica incluyéndose como nueva comunicación en ICE que los organismo de control activos comuniquen los resultados de las auditorias realizadas or sus correspondientes entidades de acreditación así como los resultados de las supervisiones fectuadas por otras autoridades competentes.. Plazo: ya realizado. . Procedimiento de supervisión de los organismos de control por parte de la DGCIAPE en la que, ntre otras cosas, se establece que si en una supervisión se detectara incumplimiento que suponga uspensión de la delegación de tareas, comunicar inmediatamente a la autoridad competente donde adique la sede del organismo de control. Plazo: ya realizado. Page: 8

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ocumento adjunto se detalla la estrategia con la que las toridades competentes españolas piensan dar cumplimiento a las obligaciones que establece el Reglamento 852/2004, en el ámbito de la producción primaria agrícola. 140220_NOTA ESTRATEGIA IMPLEM Se pretende desarrollar la estrategia en el año 2014, con la finalidad de iniciar la aplicación de la misma, y por lo tanto dar cumplimiento a las obligaciones del Reglamento 852/2004, a lo largo del año 2015.

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Ensure that staff performing official controls in the area of contaminants have access to adequate sampling equipment as required by Article 4.2(d) of Regulation (EC) No 882/2004 so they can perform official controls efficiently, effectively and in line with specific EU legislation on contaminants.

Medlemsstatens svar

Ensure risk-based planning of contaminant sampling plans as required by Article 3 of Regulation (EC) No 882/2004 taking into consideration all contaminant groups listed in Commission Regulation (EC) No 1881/2006.

Medlemsstatens svar

La base de datos estará disponible y operativa a final del año 2014. á empezar a utilizarse por parte de los laboratorios para introducir sus datos en el mes de septiembre y si podrán incluir los métodos que Page: 1 ort ref. DG(SANCO)/2013-6661-MR of an audit carried out n food tion Proposed by the Competent Authority n. incluirá ninguna matriz ni analito que no esté acreditado o en su ecto validado pendiente de acreditación en la siguiente auditoría

Medlemsstatens svar

Ensure that samples taken for official control purposes and accepted by laboratories for the analysis of mycotoxins and nitrates have an adequate weight/quantity and are representative of the lot which has been sampled, as stipulated in Annex I to Commission Regulation (EC) No 401/2006 and Commission Regulations (EC) No 1882/2006.

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ge: 2

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The CA should ensure the quality and consistency of official controls at all levels, in particular the effectiveness and appropriateness of official controls of fishery products at all stages of production, processing and distribution, as required in Article 4(4) of Regulation (EC) No 882/2004.

Medlemsstatens svar

The CA should ensure that internal or external audits are carried out, and should take appropriate measures in the light of their results, to ensure that it is achieving the objectives of Regulation (EC) No 882/2004 - as required in Article 4(6) of Regulation (EC) No 882/2004 - in particular to the official controls of fishery products.

Medlemsstatens svar

The CA should ensure that establishments and vessels are approved for the activities concerned only if the FBOs have demonstrated that they comply with the requirements of Regulation (EC) No 852/2004 and those of Annexes II and III of Regulation (EC) No 853/2004, as required by Article 31(2)(c) of Regulation (EC) No 882/2004.

Medlemsstatens svar

The CA should ensure that FBOs place fishery products on the EU market only if they have been prepared and handled exclusively in freezer vessels that the CA has approved, as required in Article 4(1)(b) of Regulation (EC) No 853/2004.

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t ref. DG(SANCO)/2013-6672-MR of an audit carried out place governing the production and placing on the market of ction Proposed by the Competent Authority Page: 2

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The CA should ensure that, when carrying out audits of HACCP based procedures, it verifies that FBOs apply such procedures continuously and properly, as required in Article 4(5) of Regulation (EC) No 854/2004.

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The CA should ensure that consignments of fishery products that are unloaded from a vessel flying the flag of Spain in a third country - this third country is considered the country of dispatch as referred to in Article 6(l)(a) of Regulation (EC) No 853/2004 and in paragraph 1 of Annex VI to Regulation (EC) No 854/2004 ­ and are then introduced into the EU, undergo veterinary checks in accordance with Directive 97/78/EC and with Regulation (EC) No 882/2004.

Medlemsstatens svar

The CA should ensure that BIPs reject or detain all non- compliant consignments of fishery products in accordance with Article 17 of Directive 97/78/EC and that the detained consignments are separated from the compliant products.

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t ref. DG(SANCO)/2013-6672-MR of an audit carried out place governing the production and placing on the market of tion Proposed by the Competent Authority

Medlemsstatens svar

Se ha solicitado a todas las CCAA que informen de los criterios que utilizan para la icación de los establecimientos en función del riesgo. El programa de control oficial en alimentación animal 2011-2015 incluye una valoración detallada de los elementos a tener en cuenta a la hora de categorizar el riesgo de los establecimientos de la cadena de producción de piensos, en el capítulo VIII del programa, y una ponderación de la mayoría de estos criterios en el Anexo VI del mencionado programa, incluyendo la fiabilidad de los autocontroles que se incluye dentro de la categorización del riesgo en función del historial. a revisión del programa correspondiente al año 2014, se revisarán en profundidad estos terios en el seno de la CNCAA para incluir algunos nuevos, si se estima oportuno, y para ar de forma independiente la fiabilidad de los autocontroles y la importancia del tipo de secado que emplea el establecimiento. Además, aunque la inmensa mayoría de las CCAA utilizan los criterios de riesgo del programa de control de alimentación animal, se insistirá en la CNCAA en la importancia de utilizar estos criterios generales acordados en el programa, así como aquellos que establece el Reglam

a) Se ha solicitado a todas las CCAA que informen de los criterios que utilizan para la clasificación de los establecimientos en función del riesgo. to El programa de control oficial en alimentación animal 2011-2015 incluye una valoración detallada de los elementos a tener en cuenta a la hora de categorizar el riesgo de los establecimientos de la cadena de producción de piensos, en el capítulo VIII del programa, y a ponderación de la mayoría de estos criterios en el Anexo VI del mencionado programa, incluyendo la fiabilidad de los autocontroles que se incluye dentro de la categorización del riesgo en función del historial. En la revisión del programa correspondiente al año 2014, se revisarán en profundidad stos criterios en el seno de la CNCAA para incluir algunos nuevos, si se estima oportuno, y para ponderar de forma independiente la fiabilidad de los autocontroles y la importancia del tipo de secado que emplea el establecimiento. Además, aunque la inmensa mayoría de las CCAA utilizan los criterios de riesgo del programa de control de alimentación animal, se insistirá en la CNCAA en la importancia de utilizar estos criterios generales acordados en el programa, así como aquellos q

Medlemsstatens svar

Ensure that residues sampling is evenly spread over the whole year and that multiple sampling from individual producers is avoided as required by point 2 of the Annex to Commission Decision 98/179/EC.

Medlemsstatens svar

Ensure that food chain information is structured in such a way to guarantee that when properly completed and signed by the producer in line with the requirements stipulated in Annex 2, section III to Regulation (EC) No 853/2004, animals cannot be sent for slaughter within veterinary medicinal product withdrawal periods.

Medlemsstatens svar

Ensure that officials in charge of controls in slaughterhouses always carry out inspection tasks related to food chain information as required by Article 5 of Regulation (EC) No 854/2004.

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Ensure that all relevant competent authorities involved in the implementation of the RMP carry out internal audits or have external audits carried out, and take appropriate measures in the light of their results as required by Article 4.6 of Regulation (EC) No 882/2004.

Medlemsstatens svar

Page: 1 thority's response to the recommendations has been received. Please check back again later to see this response. port ref. DG(SANCO)/2013-6760-MR of an audit carried out contaminants in live animals and animal products tion Proposed by the Competent Authority

Medlemsstatens svar

Ensure that follow-up actions are sufficient to prevent products which potentially contain residues of veterinary medicinal products from being placed on the market, as required by Article 14 of Regulation (EC) No 178/2002.

Medlemsstatens svar

Ensure that the NRLs fulfil all of their functions as laid down in Article 14 of Council Directive 96/23/EC, particularly in relation to co-ordinating the standards and methods of analyses for each residue regarding all laboratories performing RMP testing and ensuring that the methods used in the Autonomous Community laboratories are sufficiently sensitive to detect abuse of illegal substances in line with EURL recommended values.

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are Se han tomado las medidas establecidas en el artículo 5.1 de la Decisión de la Comisión 2012/697/UE, de 8 de noviembre de 2012, relativa a las medidas para evitar la introducción en la Unión y la propagación en el interior de la misma del género Pomacea (Perry); en fecha 23 de abril de 2013, se publicó la Orden AAM/63/2013, de 16 de abril, por la que se modifica la Orden AAR/404/2010, de 27 de julio, que declara oficialmente la existencia de un foco de caracol manzana en el hemidelta izquierdo del Delta del Ebro, en esta orden se establece la zona demarcada en Cataluña para esta plaga, la cual comprende las comarcas del Baix Ebre y Montsià, (se adjunta Orden). Por otro lado, también se ha publicado una resolución donde se fijan nuevas medidas de lucha contra el caracol manzana a aplicar durante el periodo hibernal, Resolución AAM/2291/2013, de 30 de octubre, por la cual se fija como medidas de control del caracol manzana (Pomacea sp.) el tratamiento con agua de mar y el secado hibernal de determinadas zonas del Delta del Ebro (Se adjunta resolución). Respecto al procedimiento sancionador a aplicar en el caso de incumplimiento de las medidas de lucha contra el caracol manzana, s

Medlemsstatens svar

of Se ha modificado el protocolo de limpieza de la maquinaria, donde se recogen las características de bioseguridad que han de cumplir los puntos donde se realice la limpieza de la maquinaria. (Se adjunta protocolo). Actualmente estamos realizando las gestiones para ubicar los SANCO)/2013-6803 -MR of a/an audit carried out from 16 r Pomacea. ntos de manera que reúnan las condiciones de dad establecidas en el protocolo, de manera que se dé nto a lo que establece el artículo 5.1 de la Decisión de ón 2012/697/UE, de 8 de noviembre de 2012, relativa a as para evitar la introducción en la Unión y la ón en el interior de la misma del género Pomacea

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sp. Por parte del Departament d'Agricultrua, Ramaderia, Pesca, e Alimentació i Medi Natural, se están llevando a cabo todas las to medidas necesarias para luchar contra la plaga y controlar la n del caracol manzana. Es por ello que durante el periodo e invierno se están realizando las medidas de secado de das zonas del Delta del Ebro y medidas de tratamiento de mar en otras zonas. licado una nueva normativa complementaria a la ya , sobre la obligatoriedad de llevar a cabo las medidas de to con agua de mar y de secado de determinadas zonas, n AAM/2291/2013, de 30 de octubre, por la cual se fija das de control del caracol manzana (Pomacea sp.) el to con agua de mar y el secado hibernal de determinadas Delta del Ebro (Se adjunta resolución). Las zonas donde n cada una de las medidas está publicada en la página de del Departamento w20.gencat.cat/docs/DAR/AG_Agricultura/AG02_Sanit l/AG02_02_Plagues/Documents/Fitxers_estatics/Cargol a_assecat_aiguamar.pdf lución complementa la normativa vigente sobre las aplicar para luchar contra el caracol manzana, ente la Resolución AAM/1455/2012, de 16 de julio, por fijan las medidas que deben adoptarse para controlar el SANCO)/2013-6803 -MR of a/an

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risk of Existe un protocolo muy definido y contratado de desinfección de embarcaciones, que fue desarrollado en la cuenca del río Ebro con rt. 5 motivo de la aparición hace años de la especie exótica invasora cebra". Este protocolo, que puede consultarse en el link, ne versiones en inglés, francés y alemán, va a ser do, adaptado al caracol manzana, mediante una acción a y coordinada entre la Confederación Hidrográfica del ponsable del dominio hidráulico), la demarcación de esponsable de la desembocadura del Ebro en sus riberas), erio de Fomento (responsable de la matriculación de las ones) y la Generalitat de Cataluña (gestora del o). Dicho protocolo puede consultarse en el link: w.chebro.es/contenido.visualizar.do?idContenido=11945 544 hay una serie de medidas de confinamiento ativo activas contra el "mejillón cebra", que son de idad y uso al "caracol manzana". De una forma resumida: ga a un confinamiento administrativo de las embarcaciones en los embalses afectados por la plaga SANCO)/2013-6803 -MR of a/an audit carried out from 16 r Pomacea. (embalses de tipo C): una embarcación que navega en un embalse afectado no puede navegar en ningún otro embalse de la cuenca del Ebro las i

Medlemsstatens svar

Se prevé realizar una campaña de sensibilización de acuerdo con bro lo establecido en el artículo 5.2 de la Decisión de la Comisión UE, de 8 de noviembre de 2012, relativa a las medidas ar la introducción en la Unión y la propagación en el de la misma del género Pomacea (Perry), la cual se pondrá antes del mes de abril, mes en el cual se celebran las SANCO)/2013-6803 -MR of a/an audit carried out from 16 r Pomacea. vacaciones de Semana Santa y que es una época importante de turismo en esta zona. En la campaña se prevén editar hojas informativas y carteles divulgativos sobre la plaga dirigidos a los turistas y al público en general, con la finalidad de alertarlos sobre las características del caracol manzana, y sobre los riesgos que implica su difusión a otras zonas. Adicionalmente se va aprovechar a nivel nacional la experiencia adquirida por la Confederación Hidrográfica del Ebro en folletos informativos en varios idiomas sobre el "mejillón cebra". Está previsto desarrollar una acción coordinada entre las Administraciones competentes y preparar una campaña informativa común basada en esta experiencia, centrada en el caracol manzana.

Medlemsstatens svar

mine Según los solicitantes de ayudas de la PAC del año 2013, existen 1) of en torno a los 12.000 productores de patata y 4500 has cultivadas. tive Estos productores y superficie es la que se encuentra registrada y ons sobre la que se va a realizar la selección de parcelas a muestrear. Existe un gran número de productores particulares, con producción para autoconsumo, estimándose que la superficie total cultivada puede alcanzar las 19.000 has. Éstos productores no se encuentran en ningún registro y es más difícil su control, de todas formas se intentará realizar controles aleatorios sobre ellos para poder determinar de la forma más exacta posible la distribución de la plaga. La próxima campaña se realizará un importante incremento del muestreo, de forma que se pretende muestrear al menos el 3% de la superficie de cultivo declarada, en torno a las 135 has, así como una superficie suficientemente representativa de las parcelas no declaradas, en las cuales se intentará inspeccionar en torno a las 300 has. El diseño del muestreo se realizará sobre la relación de parcelas provisional de parcelas declaradas para el año 2014 lo cual permitirá adelantar el inicio de los muestreos dos meses

Medlemsstatens svar

Se darán instrucciones a los inspectores para que se notifiquen to inmediatamente cualquier posible presencia de Epitrix, tanto en ticle las parcelas muestreadas cómo en parcelas ajenas a las Page: 1 Report ref. DG(SANCO)/2013-6804 -MR of a/an audit carried out from 09 sures applied for Epitrix. seleccionadas aleatoriamente para el muestreo. Estos positivos serán notificados asimismo, en el menor tiempo posible, a las autoridades sanitarias nacionales. Así mismo se intensificará la campaña informativa a todos los almacenes de patata para que ante la presencia de síntomas de Epitrix en almacén se informe a los servicios oficiales sobre las parcelas afectadas para su demarcación.

Medlemsstatens svar

Se va a proceder a demarcar zonas más amplias, de forma que 5(1) of engloben a todas las parcelas que dieron un resultado positivo , (2) hasta el momento. Las zonas demarcadas quedarán delimitadas por las comarcas en las que se hayan registrado positivos en los últimos años. De esta forma se establecen cómo zonas demarcadas las siguientes: A Coruña y Pontevedra: toda la provincia. Ourense: Tres zonas en torno a las parcelas infestadas en Cenlle, Ourense y Piñor de Cea. Se demarcará una zona de 500 metros en torno a estas parcelas. En caso de que se detecten nuevos positivos fuera de las zonas demarcadas, la demarcación se producirá en los siete días siguientes a la confirmación por parte del laboratorio oficial del positivo por Epitrix. La nueva demarcación se basará en criterios de riesgo, de forma que la nueva superficie demarcada se generará en base al riesgo de expansión de la plaga y a la proximidad de otras zonas demarcadas. En las zonas demarcadas se harán campañas informativas para garantizar que no se producen incumplimientos de la decisión comunitaria. A todos los productores inscritos que se localicen en zona demarcada se le enviará una notificación informándole de que s

Medlemsstatens svar

th A todos los productores que se localicen en zonas demarcadas se les exigirán medidas encaminadas a la erradicación y el control Section del organismo, que incluirán cómo mínimo: - Medidas de erradicación: realización de tratamientos fitosanitarios, desinfección de maquinaria y destrucción de los restos de cultivo, así como el control de malas hierbas, tanto en el cultivo como en los bordes, que puedan servir de hospedantes de la plaga. - Controles intensivos para verificar la presencia o ausencia de la plaga mediante inspecciones continuas. - Vigilancia de los traslados de los tubérculos, de forma que éstos no pueden salir de la zona demarcada. Se informará a los productores situados en zonas demarcadas de que si quieren comercializar su producción, ésta debe ir a un almacén registrado, localizado dentro de su zona demarcada y que realice un adecuado tratamiento de los tubérculos (lavado o cepillado).

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ith Todos los almacenes localizados en zonas demarcadas deberán down inscribirse en el registro para poder emitir pasaporte fitosanitario. In Toda la patata que comercialicen procedente de la zona nd demarcada deberá cumplir con lo especificado en la Sección 2 del Anexo I, de la Decisión 2012/270/UE, e ir acompañados de pasaporte fitosanitario. Todos estos almacenes serán sometidos a inspecciones oficiales para verificar que los lotes expedidos cumplen la normativa comunitaria en cuanto a requisitos de lavado y/o cepillado y ausencia de tierra. Por otra parte se les exigirá un plan de gestión de los restos del proceso de lavado o cepillado, de forma que éstos deben ser sometidos a algún procedimiento que garantice que no son un foco Page: 3 Report ref. DG(SANCO)/2013-6804 -MR of a/an audit carried out from 09 sures applied for Epitrix. de posible contaminación o dispersión.

Medlemsstatens svar

The Competent Authority should ensure that the list of approved establishments producing mechanically separated meat is kept up to date, as required by Article 31(f) of Regulation (EC) No 882/2004.

Medlemsstatens svar

In order to comply with European Union requirements, the Competent Authority should ensure that deficiencies found are corrected in the establishments visited and are not present in other approved establishments (Article 54 of Regulation (EC) No 882/2004).

Medlemsstatens svar

The Competent Authority should ensure that when food business operators' sampling protocols are implemented, the sampling protocols are in compliance with those of Regulation (EC) No 2073/2005.

Medlemsstatens svar

The Competent Authority should ensure that products containing mechanically separated meat are correctly labelled in accordance with the requirements of Directive 2000/13/EC.

Medlemsstatens svar

Page: 1 uthority's response to the recommendations has been received. Please check back again later yo see this response.

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publicó el Protocolo de Inmovilización y ocedentes de terceros países (se adjunta), en nes pormenorizadas a los Servicios de n ser inmovilizadas las partidas, siempre en epción del borrador del informe de esta auditoria, e de 2012, se solicitó a los Servicios de un plan de acción en relación a las posibles enamiento de muestras y partidas. 12, recibió el plan de acción que se adjunta a

Medlemsstatens svar

a todos los PED y PDI, la nota informativa s criterios que deben tenerse en cuenta a la hora bre el tipo de control a realizar sobre una roductos de consumo humano. a nivel central, un procedimiento interno para grado del cumplimiento de las frecuencias de diferentes productos destinados a consumo Page: 1 284-MR of an audit carried out Proposed by the Competent Authority

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ón el proyecto de Orden ministerial por que se n de la tasa por controles oficiales de las piensos y alimentos de origen no animal, liquidación de la misma. opuesta del Ministerio de Sanidad, Servicios Ministerio de Agricultura, Alimentación y sí como diferentes informes emitidos por las specto. r el momento no es posible cobrar el importe ación de los controles sobre los productos del 009, cabe indicar que tanto para los e aplicación este Reglamento, como los l marco de los Reglamentos (CE) nº 2009 y (UE) nº 258/2010, la totalidad de los controles oficiales, incluidos los derivados del l almacenamiento y toda medida adoptada en son asumidos por el importador. Page: 2 284-MR of an audit carried out by the Competent Authority

Medlemsstatens svar

sta recomendación se refiere a uno de los uación se describen las medidas r dicho laboratorio: no con capacidad suficiente para muestras de para conseguir que la totalidad de la muestra o de partícula y consistencia similar al de una ición: 15 de febrero de 2013 ión del molino: realización de estudios de s reales positivas, para la comprobación de la molienda y homogeneización, sobre varias l producto triturado. Los estudios se realizarán presentativas (ej: almendras, cacahuetes, )

Medlemsstatens svar

En toda la zona demarcada está establecido un sistema de redes de trampeo temático, de forma que se estableció una malla de 200x200 m entre 1,5-3 s km, una malla de 1x1 km entre 3-5 km y una malla de 2x2 km entre 5-20 demás, alrededor de la zona demarcada y a lo largo de los 20 km rofes con Portugal se tiene establecida igualmente una malla de 2x2 omo recomendó la FVO en su visita en mayo, a lo largo de la parte de la zona demarcada, donde la malla establecida era de 4x4 km al entre 20-100 km del límite con Portugal, se va a prospectar también, a rgo de 20 km limítrofes con la zona demarcada, siguiendo una malla de m. Page: 1 f Report ref. DG(SANCO)/2012-6308-MR of an audit carried out or Bursaphelenchus xylophilus Action Proposed by the Competent Authority

ce A system of grids with traps is established across all demarcated area ccording to the following size of grids: a 200 x 200 m grid for 1.5 - 3 "As km of distance from the outbreak, a 1 x 1 km grid for 3-5 km, and a 2 x 2 grid for distance between 5 and 20 km from the outbreak. Furthermore, a 2 x 2 km grid is established around the demarcated area, and along the Spanish area of 20 km from the border between Spain and Portugal. At the north of the demarcated area, where a 4 x 4 grid was established initially (given it is situated between 20-100 km from the border with Portugal), the surveys are also being carried out according to a 2 x 2 km grid along the 20 km bordering the demarcated area, as FVO team advised us during their last visit in May 2012.

Medlemsstatens svar

e ha realizado una inspección completa de toda la zona comprendida entre 1,5-5 km, zona que se considera de mayor riesgo, para la localización e identificación de todos los árboles secos ó decaídos. Se han realizado todas las labores necesarias para la retirada y destrucción de todos los árboles identificados, con lo cual en estos momentos se considera que toda esta zona esta limpia, aunque se continuan realizando inspecciones para detectar la posible aparición de nuevos árboles secos o sintomáticos. Se está realizando la inspección visual en toda la zona comprendida entre 5- 20 km para determinar la presencia exacta de árboles secos o sintomáticos, puesto que las cifras existentes hasta el momento eran estimadas. En estas inspecciones se localizan e identifican los árboles secos o sintomáticos y se les notifica a los propietarios para que procedan a su destrucción. En caso de que estos no actúen será la Administración la que realice los trabajos de corta y destrucción.

A complete inspection, across all area between the distance of 1.5 km and 5 km, has been carried out for the location and identification of all l dry trees or trees in decline. It is considered at a higher risk area. C. Therefore, the necessary tasks for the removal and destruction of all identified trees have been carried out. So, nowadays, this area could be considered clear, although inspections are still being carried out to detect the possible occurrence of new dry trees or with symptoms. Visual inspections in all area between the distance of 5 km and 20 km are being implemented in order to determine the tree's precise location (dry trees or with symptoms), because the current figures are only estimates. During these inspections dry or symptomatic trees are located and identified, and their owners are notified to destroy those trees. If they don't take any action, the Official Authorities will assume the tasks Page: 1 of Report ref. DG(SANCO)/2012-6308-MR of an audit carried out for Bursaphelenchus xylophilus Action Proposed by the Competent Authority of cutting and removing.

Medlemsstatens svar

n Una vez localizados los árboles secos o sintomáticos en la zona demarcada se realiza una labor de identificación de la parcela y el propietario en la cual se encuentran. Se remite una notificación al propietario informándole de la presencia de árboles secos o sintomáticos y de la obligación de retirarlos y f destruirlos en un plazo de 15 días. En caso de que no realice estos trabajos la Administración puede actuar a través de medios propios procediendo a la retirada y destrucción de estos árboles, previa extracción de la muestra correspondiente para su análisis. En los casos de árboles secos por causa de incendios las muestras serán representativas de la masa quemada y no de todos los árboles. Page: 2 f Report ref. DG(SANCO)/2012-6308-MR of an audit carried out or Bursaphelenchus xylophilus Action Proposed by the Competent Authority

in The plot and its owner are identified once dry or symptomatic trees are nd located in the demarcated area. The owners are informed about the of presence of dry or symptomatic trees and they have an obligation to removal and destroy the affected trees within 15 days of the notification. If they don't take those actions, the Official Authorities could assume the tasks of cutting and removing through its own means, taking samples to analyse for WPN. In case of dry trees as a result of fires, samples will be considered representative from the buried area but not from every tree.

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s En la Comunidad Autónoma de Extremadura, se ha llevado a cabo un as incremento de las visitas de inspección por personal técnico del Servicio de Sanidad Vegetal a operadores de las zonas demarcadas y limítrofes con la ntera de Portugal para concienciarlos de que el material sensible para salir o cular por ellas debe ir provisto del pasaporte fitosanitario o la Marca NIMF- Además, estas inspecciones se han ampliado a operadores de las zonas ítrofes con las áreas demarcadas y frontera con Portugal que tienen ercio con empresas del interior de dichas áreas. También ha incrementado reparto al público en general y operadores, de prospectos y trípticos ormativos sobre las medidas recomendadas para el control del patógeno en zonas demarcadas de la Sierra de Dios Padre y Valverde del Fresno y en las as limítrofes con Portugal. la Comunidad Autónoma de Galicia, se ha enviado un correo a todas las unidades de montes en la franja de 20 km para informarles del foco y de restricciones al comercio de la madera. También se están haciendo unas niones con los vecinos y responsables para presentarles las medidas ventivas y así mismo informarles del foco y de las consecuencias que dría la extensión

ers In the Autonomous Region of Extremadura, it has increased the number reas of inspection visits to stakeholders (located into the demarcated areas nt and in border zones with Portugal) in order to raise awareness on sceptible plant material to PWN (should be provided by the Plant passport or ISPM-15 mark), respect to movements within the demarcated areas and from such areas to other areas. These inspections have been extended to stakeholders (located in surroundings from demarcated areas and from border with Portugal) trading with companies within those areas. It has also increased the information to the general public and stakeholders, with leaflets on recommended measures to control PWN in the two demarcated areas of Extremadura and in the areas bordering Portugal. In the Autonomous Region of Galicia, a mail has been sent to all forest communities from the area of 20 km, including information about the outbreak and the restrictions to the wood trade. There are also meetings Page: 2 of Report ref. DG(SANCO)/2012-6308-MR of an audit carried out for Bursaphelenchus xylophilus Action Proposed by the Competent Authority with neighbours and stakeholders to show them the preventive m

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) mediante las siguientes acciones: duanas para incorporar del subcódigo FTN al TARIC de las mercancías B de la Directiva 29/2000/CE procedentes de Canarias, así como e tasas. arzo de 2013. os Servicios de Inspección de Sanidad Vegetal para la inspección de os procedentes de Canarias. arzo de 2013. narias como país tercero en el módulo de importaciones de la eclaraciones Adicionales se comprueban correctamente durante la obstante el Ministerio mejorará la eficacia de estas e las siguientes acciones:

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los criterios de la Comisión para las Declaraciones Adicionales de los os mediante una comunicación genérica. 2013 ífica del personal del servicio de inspección fitosanitario en . . Manual de Procedimiento de Inspección de las Declaraciones s de Productos. 013.

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roductos regulados y no regulados mediante la vigilancia de a través de las siguientes acciones: Page: 1 nt Authority, 31 January 2013 ANNEX eport ref. DG(SANCO)/2012-6313-MR of an audit carried out luate the system of import controls for plant health the Competent Authority ular interna con especificaciones relativas al procedimiento de sgo. rcular 20 de febrero de 2013. nual de Procedimiento de Inspección Fitosanitaria. usceptibles de adaptación para responder a las necesidades fitosanitarios mediante las siguientes acciones: ífica del personal inspector en control de Maderas y Embalajes de

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rimera edición: noviembre de 2012. de Procedimiento de las pautas de muestreo de estos cobrar se alineará con los criterios comunitarios mediante las

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ciones a la AEAT de los criterios de aplicación de las tasas en base FVO. e, Junio 2013. la aplicación CEXVEG del procedimiento de cálculo de tasa ficar la adecuación del importe pagado querimientos técnicos. seguirán con sus esfuerzos en la reducción del plazo de es desde que el organismo nocivo haya sido identificado

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XVEG del procedimiento de notificación con objeto de ceptación eliminando eslabones no necesarios. Page: 2 nt Authority, 31 January 2013 ANNEX eport ref. DG(SANCO)/2012-6313-MR of an audit carried out luate the system of import controls for plant health ion Proposed by the Competent Authority

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ento de los criterios comunitarios en la importación para ensayos o ante la siguiente acción: Comunidades Autónomas en el marco del Comité Fitosanitario de destruir todo el material si no se procede al pertinente registro de el ensayo una vez finalizado este. . Page: 3

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To develop appropriate documented procedures for the official controls of the implementation of Commission Directives 2006/125/EC and 2006/141/EC and Regulation (EC) No 1881/2006 as required by Article 8 of Regulation (EC) No 882/2004.

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To provide adequate training on the official controls on the production and marketing of infant formuale, follow-on formulae and baby foods as required by Article 6 of Regulation (EC) No 882/2004.

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To ensure that the organisation of the official control of infant formuale, follow-on formulae and baby foods covers all relevant aspects as required by Article 3 (3) of Regulation (EC) No 882/2004.

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Page: 1 en received. Please check back later to see this response of Report ref. DG(SANCO)/2012-6335-MR of an audit carried out ken by the competent authorities with regard to official controls over ply chain ction Proposed by the Competent Authority

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To ensure that adequate enforcement measures are applied against non-compliances detected with regard to applicable EU legislation for the production and marketing of infant formuale, follow-on formulae and baby foods as required by Article 54 of Regulation (EC) No 882/2004.

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To implement procedures for the verification of the effectiveness of official controls of the production and marketing of infant formulae, follow-on formulae and baby foods as required by Article 8 (3) of Regulation (EC) No 882/2004.

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To ensure that when raw milk not meeting the criteria laid down in Section 9, Annex III to Regulation (EC) No 853/2004 as regards Total Plate Count and Somatic Cell Count is authorised for the production of infant formulae and follow-on formulae on the basis of Chapter II, Annex IV to Regulation (EC) No 854/2004, it is ensured that the use and treatment required will guarantee protection of the public health of the targeted population, in order to comply with the said provision of Annex IV to Regulation (EC) No 854/2004.

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ll be developed in order to inform to the final users and ut the compulsory of the register. will be finish at the end of august, and will be distributed tative bodies, and Competent authorities.

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traders and final users and transporters is available at H of the Ministry of Agriculture, food and environment.

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tion lays down on Annex II the minimum content of the cuments that cover the information required by Article 17 on (EU) No 142/2011 and set out in its Annex VIII (point 6 of ormative note will be developed on the following month hich will be distributed to inform about the minimum t has to be cover by the commercial document. This note t more controls have to be done by the Competent oint of higher control will be remark on the next Official revision (before the end of this year). Page: 1 (SANCO)/2012-6473-MR of an audit carried out ts for organic fertilisers and soil improvers on Proposed by the Competent Authority

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e will be developed on the following month (August at the use of OF/SI must be record ol Program will be revised; a higher risk criterion and trols will be carried out by the competent Page: 2 (SANCO)/2012-6473-MR of an audit carried out ts for organic fertilisers and soil improvers ction Proposed by the Competent Authority

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SOCIALES E MAL DE previo a esta auditoría, se está permita asegurar que los Puestos de entros de Inspección cumplen con los Decisión 2001/812/CE. El sistema ya fue y se está desarrollando mediante tres a les fueron enviados. zado el desarrollo de la Instrucción sobre ocedimientos e Instalaciones (se adjunta s oficiales se realizan basándose en fin de que se lleven a cabo de dad elevada constante. inspector tiene la formación adecuada y equipos apropiados para unciones. en el sistema de control oficial. cacia de los controles oficiales ante las deficiencias detectadas. ue los sistemas de control están Administración como a los Page: 1 and can be found at: http://ec.europa.eu/food/fvo/rep_details_en.cfm?rep_id=2991 f an audit carried out ON_IM-4 ERVISION es en una n del Protocolo bre_2012 e on objeto de ucir los por el n los Page: 2 and can be found at: http://ec.europa.eu/food/fvo/rep_details_en.cfm?rep_id=2991 f an audit carried out hority pre-misión nivel local y os que se tinados a anual/2 siguientes rtaciones de es, s e visiones Page: 3 and can be found at: http://ec.europa.eu/food/fvo/rep_details_en.cfm?rep_id=2991 f an audit carried out suspensión bras de nstancias isiones se

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spección cumplen con todos los el equipamiento establecidos en la Directiva del Consejo disponen de un sistema de para la detección de consideramos que este sistema les, como se explica en la tomar medidas para mejorar ue estos requisitos que deben as concretas para las que están ción de categorías en muchos de se han tomado las siguientes and can be found at: http://ec.europa.eu/food/fvo/rep_details_en.cfm?rep_id=2991 f an audit carried out thority las categorías E y U en el PIF del uctos embalados de la autorización c. (Ver respuesta a la Recomendación se han tomado en cada PIF). os prevista, tras el análisis realizado actividad, se considera necesario que las necesidades de as a tiempo. se solicitará de los responsables y de Sanidad y Política Social que ndo las necesidades de equipamiento e y del volumen de actividad de cada to de cada tramitación con el objetivo los Secretarios Generales de aquellas ubican los PIF la necesidad de que y equipamiento sean atendidas a funcionamiento del PIF.

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and can be found at: http://ec.europa.eu/food/fvo/rep_details_en.cfm?rep_id=2991 f an audit carried out the Competent Authority rtación para productos de origen s PIF adecuadas (cumple con los 2001/812/CE de la Comisión), se s en relación a los PIF visitados: uevas instalaciones del puerto de a actividad inspectora en las mismas Escritos CI A Coruña_comunicación tar categorías para aquellas etamente con la Decisión n de br lla cat Page: 7 and can be found at: http://ec.europa.eu/food/fvo/rep_details_en.cfm?rep_id=2991 f an audit carried out erto mitación Ribeira y OAV_ Limit sión lio 201 Page: 8 and can be found at: http://ec.europa.eu/food/fvo/rep_details_en.cfm?rep_id=2991 f an audit carried out ió ns ectado en los acción, das a endario s. iamente raba que laración o te la nuevos Page: 9 and can be found at: http://ec.europa.eu/food/fvo/rep_details_en.cfm?rep_id=2991 f an audit carried out se cias

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To establish efficient and effective co-ordination between all the CAs involved as is required by Article 4(3) of Regulation (EC) No 882/2004.

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To enforce Article 8(3) of Regulation (EC) No 882/2004 (which states that the CAs must have procedures in place to verify the effectiveness of official controls, to ensure effectiveness of corrective action and to update documentation where needed) on all levels.

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To evaluate urgently all slaughterhouses currently approved in Spain for the slaughter of equidae and small ruminants with regard to the requirements of Regulations (EC) No 852/2004 and (EC) No 853/2004 and inform Commission services about the outcome of this evaluation.

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To ensure that only the establishments which fulfil the approval conditions are listed on the lists of approved establishments as is required by Article 31(2) of Regulation (EC) No 882/2004.

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To ensure that the appropriate corrective action in accordance with Article 54 of Regulation (EC) No 882/2004 is taken when needed and that the sanctions laid down in national legislation are effective, proportionate or dissuasive as required by Article 55 of Regulation (EC) No 882/2004.

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Page: 1 e recommendations has been received. Please see this response. eport ref. DG(SANCO)/2011-6021-MR of an audit carried out to slaughter and processing of fresh meat, in particular fresh ovine ion Proposed by the Competent Authority

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To ensure the full implementation of Council Regulation (EC) No 21/2004, including in particular the last paragraph point B.2 of the Annex to ensure traceability of lambs younger than 12 months.

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882/2004 are FEED IMPORT: No se garantiza que las compañías privadas que orm official toman muestras y el laboratorio privado usado en el puerto de Tarragona sean independientes. En cuanto a la toma de muestras, cada Estado Miembro ha elaborado su propio procedimiento, al tratarse de un tema complejo y difícil. Así en España, sólo se utilizan los medios de las empresas privadas en grandes graneles ya que no se dispone de suficientes recursos humanos y materiales para ello, por lo tanto no existe otra solución que utilizar estos medios pero de forma controlada. Debido a que la descarga de un barco puede durar una semana de forma interrumpida, no se dispone de suficientes inspectores para cubrir todos este periodo, por ello, las citadas empresa colaboran para el control oficial, ya que de otra forma supondría interrumpir las descargas, retrasando los trabajos lo que implica enormes costes adicionales. Además, los inspectores supervisan el plan de muestreo, y como las muestras se están tomando de acuerdo con el mismo. Y por supuesto, no se libera la partida si las muestras no han sido bien tomadas. No obstante, la propia Comisión reconoce la dificultad de la toma de muestras en grande

S Y CONTROL EN FRONTERA: No se garantiza que las toman muestras y el laboratorio privado usado en el puerto de Tarragona cuanto a la toma de muestras, cada Estado Miembro ha elaborado su propio procedimiento, al tarse de un tema complejo y difícil. Así en España, sólo se utilizan los medios de las empresas vadas en grandes graneles ya que no se dispone de suficientes recursos humanos y materiales para o, por lo tanto no existe otra solución que utilizar estos medios pero de forma controlada. Debido ue la descarga de un barco puede durar una semana de forma interrumpida, no se dispone de icientes inspectores para cubrir todos este periodo, por ello, las citadas empresa colaboran para el trol oficial, ya que de otra forma supondría interrumpir las descargas, retrasando los trabajos lo implica enormes costes adicionales. Además, los inspectores supervisan el plan de muestreo, y o las muestras se están tomando de acuerdo con el mismo. Y por supuesto, no se libera la partida las muestras no han sido bien tomadas. obstante, la propia Comisión reconoce la dificultad de la toma de muestras en grandes graneles y ello se está trabajando en este sentido en un Grupo de Trabajo que se ha reunid

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lar when the ous 1/18/EC.

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below the SGMPG: La aplicación correcta de la excepción para el etiquetado de quirements OMG que establece el artículo 24 del Reglamento 1829/2003 es una or technically cuestión que se tratará con las autoridades competentes de los controles ion (EC) No oficiales en piensos en el seno de la Comisión Nacional de coordinación en materia de alimentación animal (CNCAA) y, además, esta cuestión se incluirá en un procedimiento documentado sobre el control oficial de la normativa de OMG en piensos, que la CNCAA ha empezado a elaborar y que se aprobará a lo largo de este año. Page: 2 mmendations of Report ref. DG(SANCO)/2011-8982-MR of an audit carried out l controls of genetically modified organisms including their deliberate release into Action Proposed by the Competent Authority CATALUÑA (Alimentación Animal): En Catalunya, para complementar el Plan de controles de alimentación animal, se ha elaborado una Instrucción técnica específica para la toma de muestras y determinación de OGM, donde se especifica que si el resultado de la presencia de OGM, en piensos no identificados como OGM, es igual o inferior a 0,9%, se solicitará al operador responsable del etiquetado las pruebas que demuest

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ised GM food SGMPG: Este asunto se tratará con las autoridades competentes de los ensure that controles oficiales en piensos en el seno de la Comisión Nacional de ied with. coordinación en materia de alimentación animal (CNCAA) y, además, se incluirá en un procedimiento documentado sobre el control oficial de la normativa de OMG en piensos, que la CNCAA ha empezado a elaborar y que se aprobará a lo largo de este año. CATALUÑA (Alimentación Animal): En la Instrucción técnica para la toma de muestras y determinación de OGM se especifica que en las Page: 3 mmendations of Report ref. DG(SANCO)/2011-8982-MR of an audit carried out l controls of genetically modified organisms including their deliberate release into Action Proposed by the Competent Authority muestras recogidas de piensos se analizarán eventos no autorizados.

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en GMO lots FEED IMPORT: Los identificadores únicos no se facilitan tion (EC) No sistemáticamente cuando se importan OGM: La obligatoriedad de pedir el identificador único en OGM importados esta incluida en el Manual de Procedimientos de Productos de Origen No animal para la alimentación (MP-NSA/001 de 7.2.11). No obstante ya disponían de esta información por escritos anteriores a esta fecha, por lo que los inspectores están informados de que deben pedirlo. Por otro lado, es uno de los aspectos que se valoran cuando se realizan supervisiones. De hecho, este problema se detecto en este Punto de Entrada en una supervisión llevada a cabo antes de la misión, y se informo a los inspectores que debían solicitar dicho identificador único, según informe que se adjunta. Page: 4 mmendations of Report ref. DG(SANCO)/2011-8982-MR of an audit carried out l controls of genetically modified organisms including their deliberate release into Action Proposed by the Competent Authority V:\AREA IMPOR ANIMAL\DOCUMENTA

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checks and SGMPG: Este asunto se tratará con las autoridades competentes de los 1830/2003 controles oficiales en piensos en el seno de la Comisión Nacional de er to ensure coordinación en materia de alimentación animal (CNCAA) y, además, se 1829/2003 incluirá en un procedimiento documentado sobre el control oficial de la normativa de OMG en piensos, que la CNCAA ha empezado a elaborar y que se aprobará a lo largo de este año. CATALUÑA (Alimentación Animal): En la Instrucción técnica para la toma de muestras y determinación de OGM se especifica que en las muestras recogidas de piensos se analizará, además del MON810, otros eventos autorizados.