Portugal

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In recent years, the implementation of residue control started only in the second half of the year, which is not in line with EU requirements (20) and did not allow the fulfilment of the plans and of the minimum sampling frequencies laid down in EU legislation (21), even if the competent authority always planned 0.5% more samples than required by EU legislation.

In 2023, only 4077 (62%) of the 6574 planned samples were taken, out of which 3588 samples were analysed by the laboratories, therefore only 55% of the samples planned were taken and analysed.

In 2024, the sampling plans were transmitted to the regional offices in September, and 4911 (74%) of the 6654 planned samples were taken, and 4631 samples were analysed, therefore only 70% of the samples planned were taken and analysed. In addition, 70% of all samples were taken in October and November, which is not in line with EU legislation (22) to ensure an even spread of sampling throughout the year.

A total of 280 taken samples in 2024 could not be analysed in the laboratory analysing most samples. For four of the 280 samples, transport-related matters were indicated as the reason, for 70 ­ sampling-related obstacles and for 206 ­ the laboratory highlighted breakdowns of the technical equipment and staff holidays and shortages. In June 2025, the competent authority cancelled the request of analysis for 44 samples taken in 2024, as the analyses had still not started.

For both years 2023 and 2024, the auditors observed that, in addition to the sampling carried out largely in the second half of those years, in several cases, multiple sampling was performed to fulfil the requested sample numbers, especially during the last weeks of the respective years. This multiple sampling was not always performed in line with EU legal requirements which set the conditions to be respected for double sampling. Notably, no specific identification of the operator could be found, nor any risk-based justification. This appeared to be done only to improve overall sample numbers at the end of the year. There was no other justification (23).

Other deficiencies in the implementation of the plan, such as incorrect matrices sampled, could not be corrected on time, as they were only discovered when the sampling year was already over.

In addition, the turn-around times between the arrival of the sample and the availability of the analytical result from the laboratory in charge of most analyses, exceeded, for most of the samples, the 30 days agreed with the competent authority. In the 2023 and 2024 sample files verified by the auditors, several delays of 6-8 months were observed before the analytical result was available. At the time of the audit, there was no systematic verification by the competent authority regarding the turn-around times of samples in the laboratory.

For 2025, the sampling plans were distributed to the regional offices by email on 5 May 2025. Until the time of the audit, 2552 (39%) of the 6506 samples planned were taken by 6 October 2025, out of which 746 were registered as analysed. In the same laboratory, as mentioned in the previous finding, the auditors were informed that for 324 of the 1572 analysed samples (all plans), the turn-around time already exceeded 30 days. The laboratory explained the reasons for these delays as linked to staff holidays, staff shortages and breakdowns of technical equipment. (22) Point 1 of Annex III to Delegated Regulation (EU) 2022/1644. (23) Point 8 of Annex III to Delegated Regulation (EU) 2022/1644. 5

The responsibilities of the competent authorities involved, and the regional sample distribution procedures are the same as indicated for the national risk-based control plan (see findings 2, 3 and 4).

In 2023, while all planned samples were taken, 92% were analysed. For 2024, 184 (93%) of the 198 planned samples were taken, and 171 of those were analysed, for an overall implementation of the plan at 86%. Out of the 13 samples not analysed: 11 were due to sampling deficiencies (e.g. incorrect matrices sampled); and two samples were not (33) Procedure manual ­ non-compliant cases (GROUPS A AND B) (v02). (34) Procedure for Verification and Supervision Actions (v02). (35) Article 5(1)(b) of Regulation (EU) 2017/625. (36) Sampling Procedure DSSA-DSP, version 01_Rev2 of 31/01/2024. (37) Annex V to Delegated Regulation (EU) 2022/1644. (38) PNPR - National Control Plan for Residues of Pharmacologically Active Substances 01/2025 version 02 of 13/01/2025. (39) In its response to the draft report, the competent authority stated that honey was included in Plan 2 of the 2026 plan. 7 analysed due to laboratory-related matters, like breakdown of laboratory material and staff shortages.

In 2025, up to the date of the audit, 81 (42%) of the planned 195 samples had been taken. For 21 samples (11% of the planned samples), analytical results were available at the time of the audit.

In 2023, 569 (92%) of the 621 planned samples were taken, of which 502 (81%) were analysed, for the same reasons as indicated in finding 18. Even though the CA did not execute its full planned programme (502 collected against 621 planned), it met the mandatory minimum number of 470 (55).

For 2024, 472 (68%) of the initially planned 690 samples were taken. Due to budgetary issues and delays in the laboratory contracting process, the plan had been reduced during the year 2024 to 589 samples. The implementation rate based on the amended number was at 80% and the laboratory analysed 471 samples. Even though the CA did not execute its full planned programme, it exceeded the mandatory minimum number of 470 (52).

In 2025, up to the date of the audit, 56 samples (9%) out of the 623 planned had been taken. Analytical results were not yet available at the time of the audit.

While there is a clear designation of competent authorities and distribution of the tasks, and the sampling officials are adequately trained and equipped, the overall effectiveness of the residue control plans for pharmacologically active substances and contaminants is seriously undermined by incomplete implementation of the plans combined with uneven distribution of the sampling over the year.

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There are no specific controls to check that antimicrobials in the reserved list referred to in Article 37(5) are not used. DGAV does not conduct controls on veterinarians practicing with companion animals to check this point and PEMV allows the issuing of prescriptions containing these medicines. In addition, (human) pharmacies retailing VMPs are inspected by the human medicines inspectorate, which does not include checks on the dispensing of these substances during their inspections. This is not in line with Article 123(1) and (2). DGAV stated that they will take steps this year to ensure that PEMV does not issue prescriptions containing substances in the reserved list above.

Except in the case of checks to verify compliance with Article 37(5) concerning the `reserved' antimicrobials listed in the Annex to Implementing Regulation (EU) 2022/1255, controls on the prescription and use of antimicrobials are well designed and implemented. This helps the competent authorities to contribute to a more prudent use of antimicrobials through the enforcement of most of the relevant requirements of the VMPR. 5 https://www.ema.europa.eu/en/documents/report/categorisation-antibiotics-european-union-answer-request- european-commission-updating-scientific-advice-impact-public-health-and-animal-health-use-antibiotics- animals_en.pdf 8

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The audit team noted that on the Azores Islands the authorities register milk collection centres (MCCs) instead of approving them as required by Article 4(2) of Regulation (EC) No 853/2004. Considering that the MCCs store milk under temperature-controlled conditions, they cannot benefit from of the exemption laid down in Article 4(2)(c) of Regulation (EC) No 853/2004, therefore, they must be approved. At the time of the audit Azores Islands had 60 milk collection units/MCCs that received/collected milk from several producers and stored it under temperature-controlled conditions before its delivery to the dairy establishments.

The requirement of Article 4 of Regulation (EC) No 853/2004 is not respected across the production chain of milk and dairy products, in particular, in relation to MCCs located in the Azores autonomous region.

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In the past, there were Milk Collection Centres with NCVs in the Despite the above, we Then there was a consensus that these structures should only intend to increase the have one register. maximum frequency between official This decision was based on considering the activity of transporting and controls at collection refrigerating milk as a related operation to primary production, centers to 36 months considering the inherent characteristics of regional agriculture, namely the dispersion of parcels on the same farm, mostly using mobile milking units. The milk from these milkings is delivered to the nearest collection point and never exceeds approximately 15 minutes after milking has finished. On the other hand, since SERCLA is the official service (it belongs to the regional public administration) responsible for taking samples, the competent regional authority is aware daily of all the producers who deliver milk to each of the collection centres.

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One small cheese producer on the Azores had outsourced the HACCP and was not familiar with it and its importance for food safety. The HACCP plan had several shortcomings. The heat-treatment chart was incomplete and lacked indications of start of cleaning in place, start of end of product heat treatment, etc. Product specifications were not available for all products. The HACCP manual lacked page numbers and revision dates and a list of revisions. 13

Laboratories testing and analysing official samples are be recognised for this purpose by the CA and must provide the proof that they comply with the requirements of Article 37 of Regulation (EU) 2017/625 and are ISO/IEC 17025 accredited by the Portuguese Accreditation Institute. The NRL is involved in the recognition process and coordinates the activities of the official laboratory network. All laboratories which are carrying out official testing and analysis must be accredited by the National Accreditation Authority.

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s' A training session is being prepared by the DGAV's central services for First quarter of 2025. authorities (DSAVR) to update and reinforce the general c hygiene requirements applicable to raw milk and milk The target audience for this training will be technicians who carry out controls under the PCOL (primary production) and PACE GA (dairy products - approved establishments). Page: 1 ommendations of report ref. DG(SANTE) 2024-8009 of the audit carried out from 12 May 2024 lated to the safety of milk and dairy products osed by the competent authority Proposed action plan deadline they also intend to organise and carry out training within Until the end of 2024. f PACE GA, with a special focus on identifying and non-conformities. This training will be aimed at all the ecuting technicians in the Autonomous Region of the mall size of some establishments in the Autonomous All controls until the he Azores and their structural characteristics, many of end of 2026 amily-run, we will initially request the presence of support companies that provide food safety services at the next ntrols, in order to increase the involvement of all those in the process.

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In general, DGAV staff has appropriate and properly maintained facilities and equipment to ensure that staff can perform official controls efficiently and effectively. Some difficulties were reported to the audit team regarding the renewal of the fleet of service cars. The absence of temperature measurement equipment was noted at one CA's office.

The audit team was informed that a lack of staff resources was responsible for not being able to respect some of the planned frequencies of inspections. DGAV stated, that there is currently a staff shortage of around 25%. One DSAVR stated, that they cannot provide a dedicated team of inspectors for fishery products, due to staff shortages. The situation is aggravated by the fact that there is a significant rise of export controls for third countries to be carried out by DGAV staff. Establishments approved for export, need to be inspected with a higher frequency than other operators. 4 Training of staff performing official controls

The CAs have structures and organisation, documented procedures, enforcement measures, internal audit and a supervision system in place, which are adequate to perform the majority of their tasks effectively. However, because of the shortage of staff, DGAV is unable to fully implement the planned control programme. Furthermore, the system design does not take account of the additional workload caused by frequent export checks. This can have a negative impact on the effectiveness of the control system. 5 REGISTRATION/APPROVAL OF FOOD BUSINESS OPERATOR ESTABLISHMENTS Legal requirements Article 6 of Regulation (EC) No 852/2004 of the European Parliament and of the Council. Article 4 of Regulation (EC) No 853/2004 of the European Parliament and of the Council. Article 10(2), 138(2)(j) and 148 of Regulation (EU) 2017/625. Article 69 of Commission Implementing Regulation (EU) 2019/627. Article 45 of Commission Implementing Regulation (EU) 2019/1715. Findings Registration of aquaculture farms, fishing vessels and landing sites

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ecruitment procedures are open for 117 technicians for various areas at the - for the Central and Regional Services. As soon as these recruitments are finalised, the shortage of technicians, e.g. for PACE GA, will certainly be overcome. In addition, a reorganisation of tasks is planned among the staff already working in our organisation. These two recruitment procedures have already been officially published in August 2025 "Diário da República" according to the Notices below: Aviso DR_90 DR-Aviso_10884_2024 inspectors.pdf _2-Proc.-Concursal-27

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The audit team noted that the DGAV control system rewards operators that demonstrate better compliance with food safety rules. The audit team noted in particular that: a. the control system does not require the follow up of non-compliances in the categories GC1 and GC2 before the next scheduled control. The operators are not obliged to communicate corrective measures to the CA; b. inspection reports showed that numerous non-compliances in the category GC2 were detected at some operators. Several of these had not been rectified by the time of the next scheduled control. This did not trigger an infringement procedure nor the application of a GC3 non-compliance, as foreseen in the CA instructions. Furthermore, a high number of GC2 non-compliances does not change the compliance category of the operator; c. in one region, 80% of the controls were conducted with prior announcement (one day or more in advance). The SIPACE statistics for that region showed that the detection rate for GC3 and GC4 non-compliances were considerably higher if the controls were unannounced. The CA stated, that this is related to staff shortage and to avoid no-shows at operators.

The inspection reports of one operator highlighted the fact that some activities carried out were not within the scope of approval, and this situation was not remedied by the time of the next scheduled inspection. No other measures were taken, and it took several years from the initial report of the non-compliance before the approval was amended to cover these activities.

Furthermore, the official controls had gaps, as the inspectors had not identified: a. weaknesses in the design and the implementation of operators' good hygiene practices and HACCP; b. nonadherence to temperature requirements for fresh and frozen fishery products; c. the lack of awareness of operators with regard to their obligations relating to food that is not in compliance with food safety requirements and the circumstances 10 under which they need to inform the CAs thereof.

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SSA will reevaluate the effectiveness of the measures to be adopted lowing repeated non-compliance, particularly those classified as GC2. January 2025 Page: 1 to the recommendations of report ref. DG(SANTE) 2024-8019 of the audit carried out from 26 February d safety control systems in place governing the production and placing on the market of fishery products oposed by the competent authority Proposed action plan deadline to PACE GA 2024-2025, DSSA must carry out a clarification session every year on topics applicable to official control ed food establishments within the scope of food safety. ing is preferably carried out online and the topics are chosen taking into he supervisions carried out, the requests/issues raised by the regional ors and the results of internal and external audits. y 2024, the DSSA organized a training course for 125 technicians from nd regional services, including the Autonomous Regions of the Azores ra, on the articulation between the approval and follow-up of regular under PACE GA (food) and PACE SPA (animal by-products), zation of procedures, criteria and records. ning, among other topics, aimed to harmonize procedures during ontrols such as the classi

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The establishments visited during the audit were, in general, of a satisfactory standard regarding structure, hygiene conditions and equipment. Nevertheless, some shortcomings were noted, which were not spotted by official controls: a. Operators are not always aware of the circumstances under which they need to notify DGAV and/or ASAE about food that is not in compliance with food safety requirements. This is an obligation laid down in Article 19(1) of the General Food Law (5). In one case, imported frozen sardines were sampled by the operator and the analytical results showed an exceedance of histamine. The consignment of 8 700 kg was destroyed by landfill in cooperation with the local municipality. Neither the operator nor the municipality informed DGAV or ASAE about it. Therefore, no follow-up measures could be carried out by the CA (e.g. issuing a RASFF notification); b. At two establishments visited, fishery products were treated with a mixture of E- 330, E-331 and hydrogen peroxide to change their colour. However, both the operator and CA regarded this use as an additive acceptable, on the basis that the technical fiche describes hydrogen peroxide as a suitable processing aid. (5) Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety. 9 c. A factory vessel was visited 2 days after landing. The fish holds were sealed by DRM and not available for inspection. The work floor visited had hygiene shortcomings (dirty conveyor belts and machines, leaking hydraulic tubes above the production line (despite an attempted `quick-fix'), general poor hygiene). DGAV staff stated that the vessel would be inspected before departure; d. At one establishment: the thawing of frozen sardines before processing was not controlled regarding the time/temperature process. The temperatures of some sardines were measured as above 4.1°C. The operator was to maintain the fish at ambient temperature for another 12 hours. The process was not described (and therefore, not validated) in the HACCP plan. This could potentially lead to elevated histamine levels; e. At a cold store: temperatures above -15°C were recorded for a number of weeks; f. One establishment used borehole water which was treated with chlorate. The water was checked twice a day internally. The operators stated that the intended concentration would be 0.2 to 0.6 ppm. Sample values showed a concentration of 0.1 ppm in several cases. There was no written standard operating procedure in place to describe the acceptable limits and associated corrective actions when these limits were exceeded; g. Municipality water is monitored by the water supply companies, and test results were available. If the source of the water is from the operators own well, the water used in the establishment must be treated and controlled by the operator in accordance with the provisions of Decree-Law 69/2023. DGAV stated, that the verification of compliance regarding water standards is not their responsibility; h. The audit team did not find evidence that water and/or ice used by operators from their own well/s, is under official controls; i. Unlabelled white boxes were noted in one cold store. The goods were not owned by the operator, who was not aware of their responsibility that all goods present in their establishment must comply with hygiene and other rules, such as labelling; j. Exposed wood was in contact with fishery products. Conclusions on official controls on the production and placing on the market

Furthermore, the official controls had gaps, as the inspectors had not identified: a. weaknesses in the design and the implementation of operators' good hygiene practices and HACCP; b. nonadherence to temperature requirements for fresh and frozen fishery products; c. the lack of awareness of operators with regard to their obligations relating to food that is not in compliance with food safety requirements and the circumstances 10 under which they need to inform the CAs thereof.

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GAV September2024 ediate actions In the meantime, a clarification note has been drawn up to inform FBOs of their obligations to communicate with the competent authorities under the provisions laid down in Article 19 of Regulation EC 178/2002. This clarification will be published on the DGAV's online platforms and disseminated to the DGAV's regional services. DGAV n/a Further actions A proposal for a Decree-Law establishing the implementing rules for Regulation (EC) No 178/2002 is already at the Ministry of Agriculture and Fisheries for approval and publication. ASAE ASAE has a notification procedure for when operators have non-compliant products to do so under the terms of Article 19(3) of Reg 178/2002, published on the following link ASAE website Page: 3 to the recommendations of report ref. DG(SANTE) 2024-8019 of the audit carried out from 26 February d safety control systems in place governing the production and placing on the market of fishery products tion Proposed by the competent authority Proposed action plan deadline

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The establishments visited during the audit were, in general, of a satisfactory standard regarding structure, hygiene conditions and equipment. Nevertheless, some shortcomings were noted, which were not spotted by official controls: a. Operators are not always aware of the circumstances under which they need to notify DGAV and/or ASAE about food that is not in compliance with food safety requirements. This is an obligation laid down in Article 19(1) of the General Food Law (5). In one case, imported frozen sardines were sampled by the operator and the analytical results showed an exceedance of histamine. The consignment of 8 700 kg was destroyed by landfill in cooperation with the local municipality. Neither the operator nor the municipality informed DGAV or ASAE about it. Therefore, no follow-up measures could be carried out by the CA (e.g. issuing a RASFF notification); b. At two establishments visited, fishery products were treated with a mixture of E- 330, E-331 and hydrogen peroxide to change their colour. However, both the operator and CA regarded this use as an additive acceptable, on the basis that the technical fiche describes hydrogen peroxide as a suitable processing aid. (5) Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety. 9 c. A factory vessel was visited 2 days after landing. The fish holds were sealed by DRM and not available for inspection. The work floor visited had hygiene shortcomings (dirty conveyor belts and machines, leaking hydraulic tubes above the production line (despite an attempted `quick-fix'), general poor hygiene). DGAV staff stated that the vessel would be inspected before departure; d. At one establishment: the thawing of frozen sardines before processing was not controlled regarding the time/temperature process. The temperatures of some sardines were measured as above 4.1°C. The operator was to maintain the fish at ambient temperature for another 12 hours. The process was not described (and therefore, not validated) in the HACCP plan. This could potentially lead to elevated histamine levels; e. At a cold store: temperatures above -15°C were recorded for a number of weeks; f. One establishment used borehole water which was treated with chlorate. The water was checked twice a day internally. The operators stated that the intended concentration would be 0.2 to 0.6 ppm. Sample values showed a concentration of 0.1 ppm in several cases. There was no written standard operating procedure in place to describe the acceptable limits and associated corrective actions when these limits were exceeded; g. Municipality water is monitored by the water supply companies, and test results were available. If the source of the water is from the operators own well, the water used in the establishment must be treated and controlled by the operator in accordance with the provisions of Decree-Law 69/2023. DGAV stated, that the verification of compliance regarding water standards is not their responsibility; h. The audit team did not find evidence that water and/or ice used by operators from their own well/s, is under official controls; i. Unlabelled white boxes were noted in one cold store. The goods were not owned by the operator, who was not aware of their responsibility that all goods present in their establishment must comply with hygiene and other rules, such as labelling; j. Exposed wood was in contact with fishery products. Conclusions on official controls on the production and placing on the market

Furthermore, the official controls had gaps, as the inspectors had not identified: a. weaknesses in the design and the implementation of operators' good hygiene practices and HACCP; b. nonadherence to temperature requirements for fresh and frozen fishery products; c. the lack of awareness of operators with regard to their obligations relating to food that is not in compliance with food safety requirements and the circumstances 10 under which they need to inform the CAs thereof.

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mediate actions: n/a n March 2024, following the visits made during the audit, the operators were tified by the DGAV to correct the non-conformities detected. her actions October 2024 training course is being prepared by the DGAV's central services for the nal services (DSAVR) with the aim of updating and reinforcing the general ific hygiene requirements applicable to fishery products. The target dience for this training will be the technicians who carry out controls under PCON/PICOP (primary production) and PACE GA (fishery products - approved tablishments).

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The establishments visited during the audit were, in general, of a satisfactory standard regarding structure, hygiene conditions and equipment. Nevertheless, some shortcomings were noted, which were not spotted by official controls: a. Operators are not always aware of the circumstances under which they need to notify DGAV and/or ASAE about food that is not in compliance with food safety requirements. This is an obligation laid down in Article 19(1) of the General Food Law (5). In one case, imported frozen sardines were sampled by the operator and the analytical results showed an exceedance of histamine. The consignment of 8 700 kg was destroyed by landfill in cooperation with the local municipality. Neither the operator nor the municipality informed DGAV or ASAE about it. Therefore, no follow-up measures could be carried out by the CA (e.g. issuing a RASFF notification); b. At two establishments visited, fishery products were treated with a mixture of E- 330, E-331 and hydrogen peroxide to change their colour. However, both the operator and CA regarded this use as an additive acceptable, on the basis that the technical fiche describes hydrogen peroxide as a suitable processing aid. (5) Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety. 9 c. A factory vessel was visited 2 days after landing. The fish holds were sealed by DRM and not available for inspection. The work floor visited had hygiene shortcomings (dirty conveyor belts and machines, leaking hydraulic tubes above the production line (despite an attempted `quick-fix'), general poor hygiene). DGAV staff stated that the vessel would be inspected before departure; d. At one establishment: the thawing of frozen sardines before processing was not controlled regarding the time/temperature process. The temperatures of some sardines were measured as above 4.1°C. The operator was to maintain the fish at ambient temperature for another 12 hours. The process was not described (and therefore, not validated) in the HACCP plan. This could potentially lead to elevated histamine levels; e. At a cold store: temperatures above -15°C were recorded for a number of weeks; f. One establishment used borehole water which was treated with chlorate. The water was checked twice a day internally. The operators stated that the intended concentration would be 0.2 to 0.6 ppm. Sample values showed a concentration of 0.1 ppm in several cases. There was no written standard operating procedure in place to describe the acceptable limits and associated corrective actions when these limits were exceeded; g. Municipality water is monitored by the water supply companies, and test results were available. If the source of the water is from the operators own well, the water used in the establishment must be treated and controlled by the operator in accordance with the provisions of Decree-Law 69/2023. DGAV stated, that the verification of compliance regarding water standards is not their responsibility; h. The audit team did not find evidence that water and/or ice used by operators from their own well/s, is under official controls; i. Unlabelled white boxes were noted in one cold store. The goods were not owned by the operator, who was not aware of their responsibility that all goods present in their establishment must comply with hygiene and other rules, such as labelling; j. Exposed wood was in contact with fishery products. Conclusions on official controls on the production and placing on the market

Furthermore, the official controls had gaps, as the inspectors had not identified: a. weaknesses in the design and the implementation of operators' good hygiene practices and HACCP; b. nonadherence to temperature requirements for fresh and frozen fishery products; c. the lack of awareness of operators with regard to their obligations relating to food that is not in compliance with food safety requirements and the circumstances 10 under which they need to inform the CAs thereof.

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mediate actions n/a March 2024, following the visits carried out during the audit, the operators re notified by DGAV to correct the non-conformities detected (findings 36 d 39d). rther actions October 2024 ng course is being prepared by the DGAV's central services for the gional services (DSAVR) with the aim of updating and reinforcing the general d specific hygiene requirements applicable to fishery products. The target dience for this training will be the technicians who carry out controls under ON/PICOP (primary production) and PACE GA (fishery products - approved tablishments). Page: 4 to the recommendations of report ref. DG(SANTE) 2024-8019 of the audit carried out from 26 February d safety control systems in place governing the production and placing on the market of fishery products Action Proposed by the competent authority Proposed action plan deadline

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mediate actions: arch 2024, following the visits carried out during the audit, the operators e notified by DGAV to correct the non-conformities detected. Further actions: A training course is being prepared by the DGAV's central services for the October 2024 regional services (DSAVR) with the aim of updating and reinforcing the general and specific hygiene requirements applicable to fishery products. The target audience for this training will be the technicians who carry out controls under PCON/PICOP (primary production) and PACE GA (fishery products - approved establishments).

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A planificação para a execução do controlo oficial de alimentos para animais para o ano de 2024, que inclui a pesquisa de alimentos para animais GM, foi desde já apresentada superiormente, estando o processo administrativo para efeitos do respetivo cabimento orçamento em curso. Prevê-se para 2024, a análise de 20 amostras de alimentos para animais GM a nível da importação de países terceiros. The plan for carrying out the official control of animal feed for 2024, which includes the search for GM animal feed, has been approved by the DGAV's management, and the administrative process for the respective budget allocation is underway. It is planned to analyse 20 samples of GM animal feed imported from third countries in 2024.

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DGAV receives prior notification of all feed imports. In case of GM feed materials, the operators are obliged to complete a GMO declaration, identifying the corresponding events. The DSAVRs complete a documentary check in all cases on imports of feed materials that could be GM. In 2021 and 2022, 10 and three samples of soya and maize feed materials were analysed, of which 11 were declared as GM and two had no declaration. These controls determine if the operators comply with Articles 24 and 25 of Regulation (EC) No 1829/2003 and Article 4(1), (2) and (3) of Regulation (EC) No 1830/2003. DGAV stated that in line with its annual plans, no samples of feed from the internal market have been analysed for GMOs since 2015. DGAV stated that it has not detected any non-compliances through feed analysis in the last 10 or more years. It also explained that the number of samples analysed consistently falls below the target of 20 because there are significant delays in receiving budgetary approval to submit samples to the laboratory (paragraph 49).

While the vast majority of animal feed is GM, and is labelled as such, the consistent failure to complete the annual analysis programme reduces the likelihood that any presence of non-authorised GM events in animal feed will be detected in the course of official controls. 10 5.3.7 Laboratories and Analysis Legal requirements Article 9(1) of Regulation (EC) No 1830/2003 Chapter V of Commission Recommendation 2004/787/EC Article 5 and Annex II of Commission Implementing Decision 2011/884/EU Articles 5 and 6 and Annex II of Commission Regulation (EU) No 619/2011 Articles 34 to 39 of Regulation (EU) 2017/625 Article 5 of Regulation (EU) 2017/625 Article 21(2) of Directive 2001/18/EC Findings

In the seed and food areas, the CAs have access to adequate laboratory capacity. However, in the feed area DGAV does not have access to adequate laboratory capacity contrary to Article 5(1)(d) of Regulation (EU) 2017/625. DGAV has identified and designated an accredited laboratory to conduct GMO analysis on animal feed, but only received budgetary approval to submit samples from their programmes for the calendar years to the laboratory in September 2021 and in July 2022. These significant delays in approving the annual budget for analysis of animal feedstuffs mean that DGAV are consistently unable to complete the planned programme of analysis as describe in paragraph 38. 11 Conclusions on laboratory requirements

The CAs have designated accredited laboratories to assist them in implementing controls on GMOs, but administrative delays in approving the annual budget for analysis of animal feeds results in the consistent failure to complete the annual analysis programme, thereby reducing the likelihood that any presence of non-authorised GM events will be detected.

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l Já foi realizado o pedido de colheita de amostras de milho OGM, conjuntamente com o pedido de colheita de amostras de milho convencional. The request to collect samples of imported GMO maize has already been made, together with the collect of conventional maize lot samples. Page: 1

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The audit team noted that packed and uncovered lettuce was stored in a cold store for a few hours before dispatch. Condensation dripping from a part of the ceiling was observed. This was not spotted by the inspectors as a potential source of contamination with Listeria monocytogenes.

The audit team found that, generally, non-compliances present were identified and reported; some shortcomings had, however, not been noted: · the audit team noted some shortcomings regarding the defined critical limits in the HACCP plans, which had not been identified by the CA; · inability on the inspectors' part to assess the efficacy of operators' own-check systems regarding microbiological risks, in particular regarding the presence of Listeria monocytogenes during processing. Inspectors were not familiar with the sampling of contact surfaces in line with the EU Reference Laboratory's guidelines regarding the right time, place and sampling tools to be used. Inspectors stated that they did not feel sufficiently trained to assess these own-controls effectively. · potential cross-contamination by workers, e.g. produce dropped on the floor and was put back on the transport belt, and workers did not change gloves after touching the floor. Condensation on ceilings over exposed produce was not always detected and dealt with efficiently. Inspectors did not note that clean and dirty crates were stored beside each other, which could lead to cross-contamination or the mixing up of clean and dirty crates. Sprout-producing establishments

The audit team visited the third operator and accompanied the inspectors during their annual control visit. The inspectors used the checklist in place and detected multiple non- compliances · visible gaps around some of the doors between the processing rooms and the exterior, which could allow rodents and insects to enter; · several flycatchers were full of insects and not serviced in time; · dirty and rusty tools, dirty walls, sinks in bad condition, condensation on ceilings; · use of sprouting containers not fit for food contact; · use of duct tape to repair tools in contact with the final product; · dirty containers washed in a high-risk area; · contact surface samples for Listeria monocytogenes were taken once a year but only after cleaning. 13

During official controls of FNAO the inspectors in all regions visited used the harmonised national checklists. This allows a uniform way of monitoring official controls in this sector. However, without sufficiently comprehensive background knowledge regarding Listeria monocytogenes, inspectors could overlook aspects relevant to the prevention of this particular microbiological risks.

Regarding processing plants, inspections were carried out according to plan. Nonetheless, not all aspects were controlled effectively, impacting in turn on the effectiveness of the official controls in ensuring correction of all deficiencies identified. 5.2.5 Official sampling procedures Legal requirements Articles 34 and 35 of Regulation (EU) 2017/625 and Annex I, Chapter 1 of Regulation (EC) No 2073/2005. Findings

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During the second half of 2023, training will be reinforced on the identified issues (Listeria monocytogenes testing, cross- ng, contamination, critical control points). ive However, several training actions on HACCP and associated flexibility have already been carried out this year, in which the DGAV collaborated with the Portuguese Meat Industry Association (APIC). In two of them (May 17th and 19th) a total of 6 technicians and managers from two regions participated. DRAP Norte mentioned: Already expressed to DGAV, on this need. To fill this gap, the DRAPN has conducted periodic training sessions on harmonisation of procedures and approach of practical cases. Another measure adopted has been practical training through the carrying out of official controls with teams composed of a novice inspector with experienced inspector(s). DRAP Centro mentioned: Regarding the aspects detected in the controls carried out by the DRAPC teams, we believe that reinforced training in hygiene aspects could avoid the minor errors that may have occurred.

In order to improve the implementation of the Control Plan for Establishments producing sprouts (PCER) and the performance of technicians involved in the control of establishments that produce sure sprouts, the DGAV held a meeting with technicians on 26.05.2023 4)(b) to review the control procedures provided for in the PCER, where it was agreed to implement, with effect from 2024, a set of measures to improve and strengthen control actions, namely: - It was agreed that, although it is planned to perform at least 1 control per establishment per year, the frequency of control may be intensified, depending on the risk analysis made by the Coordinators (CR) and Technical executors (TE), the operator's track record and complaints. Following the visit to the operator during the audit mission, which had determined the suspension of its activity, a new control was made to the sprout production establishment. This new control aimed to verify the correction of non-conformities detected and resulted in the lifting of the suspension of the activity as the non- conformities were effectively corrected. - Performing 100% of Verification Checks on operators with unsatisfactory results, according t

Ares (2023)4446298-16.6.2023 - To improve the effectiveness and efficiency of the official Action plan (DGAV) received: control system for sprout-producing establishments, the DSMDS, in association with the DRAPs, made improvements to the plan, in addition to those previously communicated, as indicated below: ing the second half of 2023, - Regular checks on sprout-producing establishments will training will be reinforced on the now be carried out every six months. identified issues (Listeria - The supervisions carried out by the DSMDS on the monocytogenes testing, cross- controls carried out by the DRAPs will be at least one on- contamination, critical control site supervision per region/year; the results of the points). supervisions, shown in the supervision reports carried out by the DSMDS, will be presented and discussed with the However, several training actions technicians carrying out the controls on HACCP and associated - Training for TEs will be at least one session per year and an initial training session for new TEs involved in the Plan; flexibility have already been - An orientation guide for sprout production will be carried out this year, in which the written and disse

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Not all operators processing FNAO foodstuffs are necessarily registered by DGAV and therefore are not all integrated in the official food safety control system.

DGAV stated that all operators have business and other official licenses provided by local and regional levels. However, this data is not available in a workable format to DGAV and DRAPs. Therefore, the DGAV register SIPACE (Sistema de Informação do Plano de Aprovação e Controlo dos Estabelecimentos) does not contain all FNAO processing establishments. On its website, DGAV informs that a registration is optional but highly recommended. If an operator applies for DGAV certificates to export to third countries, the DGAV registration is obligatory.

There are no national provisions for penalties or other enforcement measures regarding unregistered processors. The CAs stated that, in principle, DGAV/DRAPs can register operators by official order. There is no data on the number of unregistered processors.

The system does, however, not allow CA inspectors to identify all operators subject to the official control system. 5.2.3 Organisation and scope of official controls Legal requirements Article 17 of Regulation (EC) No 178/2002 of the European Parliament and of the Council and Articles 9, 10 and 65 of Regulation (EU) 2017/625. Findings

However, the system has gaps in identifying high-risk growers and in the registration of processors, thus products with potentially high food safety risks may not be subject to official control. 5.2.4 Implementation of official controls over operators' obligations Legal requirements Articles 9(1)(d), 14 and 44(1) of Regulation (EU) 2017/625. Articles 4 to 8, and Annexes I and II to Regulation (EC) No 852/2004, Article 18 of Regulation (EC) No 178/2002, Article 3 of Commission Implementing Regulation (EU) No 208/2013, Commission Implementing Regulation (EU) 2020/2235, Article 1 and Annex I to Commission Regulation (EC) No 2073/2005. Findings Cultivation

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ood business operators must notify the DGAV of all establishments under their control engaged in any of the stages of production, processing and distribution of foodstuffs, with a view to register each establishment with the DGAV under Regulation (EC) No 852/2004 (Article 6). This information is available online in the DGAV Portal (updated in March 2023). - A project proposal was submitted under the SIMPLEX programme (programmes to modernise the State and strengthen its capacity to act, with the aim of simplifying administrative procedures and enhancing communication between public Page: 1 report ref. DG(SANTE) 2023-7739 of the audit carried out from 27 February relating to microbial safety of food of non-animal origin ction Proposed by the competent authority ntities) for the interconnection of the DGAV platform for the egistration of establishments processing FNAO (SIPACE) with he licensing platforms (industrial and commercial). If this roject is approved, it is estimated to be implemented by the end f 2025. evertheless, a working group has already been set up between he bodies of the Ministry of Agriculture and Food and the gency for Administrative Modernisation (AMA) to assess

t has been agreed to prepare an information brochure about the PCER, for dissemination online, aimed at informing potential stakeholders in the production of shoots for their duties. The brochure is intended to be prepared and disseminated by 31.12.2023

s(2023)4446298-16.6.2023 - Before starting work, all food establishments of non-animal ion plan (DGAV) received: origin must be licensed, i.e. registered with the respective Licensing Coordination Entities. This is an obligation of the FBOs. ood business operators must Licensing/registration legislation provides for sanctions in ify the DGAV of all the event of non-compliance with this obligation, namely: ablishments under their control - Responsible Industry System (SIR), approved by Decree- aged in any of the stages of Law no. 169/2012, amended, and republished by Decree- duction, processing and Law no. 73/2015 (article 75 of the incisive Sanctioning tribution of foodstuffs, with a Regime II). w to register each - Legal Regime for the Access to and Exercise of Commercial, Service and Restaurant Activities (RJACSR), ablishment with the DGAV approved by Decree-Law no. 10/2015 (article 28). er Regulation (EC) No As previously reported, we are working to ensure that the /2004 (Article 6). This registration/licensing platforms for these establishments ormation is available online in communicate with the official control platform (SIPACE). DGAV Portal (updated in ch 2023). Failure to c

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The non-designation of an NRL for foodborne viruses is in contravention of Article 100(1) of Regulation (EU) No 2017/625. 5.2.7 Procedures for the performance and reporting of control activities Legal requirements Articles 5, 12 and 13 of Regulation (EU) 2017/625. 16 Findings

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esignation of INSA (Food Microbiology Laboratory) as ation National Reference Laboratory for detection of foodborne iruses made by DGAV in line with Article 100 (1) of egulation (EU) No 2017/625 (Declaration of Commitment) mplementation/Deadline: Since June 2023 Page: 2

No comment from DSMDS. tion de explorações agrícolas que produzem exclusivamente GAONA é de cerca ub_boui=437178558&PUBLICACOESmodo=2 pelo que o valor Page: 2

2023)4446298-16.6.2023 - tion plan (DGAV) received: signation of INSA (Food crobiology Laboratory) as tional Reference Laboratory for tection of foodborne viruses de by DGAV in line with ticle 100 (1) of Regulation (EU) 2017/625 (Declaration of mmitment) plementation/Deadline: Since ne 2023 es(2023)4418190-22.6.2023 - tion plan (DSMDS) received: Page: 9 023 plan submitted by the competent authorities of Portugal in response to Report ref. DG(SANTE) 2023-7739 of o 14 March 2023 in order to evaluate the system of official controls relating to microbial safety of food of non- petent Action Proposed Page: 10

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The audit team noted that the facilities in place for official controls on live animals and goods of animal origin at the BCP Lisbon airport were generally compliant with the requirements for BCP's, in line with Article 64(3) of the OCR and Articles 3, 4, 5 and 6 of Regulation (EU) 2019/1014. However, the team found that the facilities in place for official controls on goods of non-animal origin were not compliant with those minimum requirements, and noted the following shortcomings: · there were no storage facilities for food of non-animal origin, which is not in line with Article 3(1)(c) of Regulation (EU) 2019/1014; · adjacent commercial storage facilities of cargo handlers were used for storage of food of non-animal origin, including detained and rejected consignments. The team visited the facilities of one such cargo handler and noted that conditions for the hygienic storage of goods were not in place, and that there was no lockable or fenced off area for goods presenting a risk, which is not in line with Article 3(12) of Regulation (EU) 2019/1014; · there were no storage rooms for consignments of feed of non-animal origin requiring temperature control, which is not in line with Article 3(1)(c) of Regulation (EU) 2019/1014.

The audit team noted that facilities in place at the inspection centres Sotogus and Liscont as part of the port BCP Lisbon were not compliant with the requirements laid down in Articles 64(3) of the OCR and Articles 3, 4, 6 and 8 of Regulation (EU) 2019/1014. The following shortcomings were noted during the visits to the two inspection centres: 12 · both inspection centres did not have adequate drainage in the unloading, inspection and storage areas or rooms, which is not in line with Article 3(2) and (3) of Regulation (EU) 2019/1014; · at the inspection centre Sotagus, the storage room for ambient goods of animal origin intended for human consumption was not easy to clean and disinfect due to the presence of a wooden floor, which is not in line with Article 3(2) of Regulation (EU) 2019/1014; · at the inspection centre Sotagus, there were no storage facilities for food of non- animal origin, which is not in line with Article 3(1)(c) of Regulation (EU) 2019/1014; · at the inspection centre Liscont, storage rooms were in place for food of non- animal origin, however their use was not authorised by Customs. Consequently, no storage facilities were available for food of non-animal origin, which is not in line with Article 3(1)(c) of Regulation (EU) 2019/1014; · at the inspection centre Liscont, the inspection room for food of non-animal origin which was adjacent to those storage rooms was poorly maintained and was therefore not easy to clean and disinfect, which is not in line with Article 3(2) of Regulation (EU) 2019/1014. In addition, the inspection room did not have a supply of hot water and was not equipped with the necessary equipment for sampling of goods, which is not in line with Articles 3(1)(b) and 4(2) respectively of Regulation (EU) 2019/1014; · as regards the facilities for feed of non-animal origin, there was no storage room for frozen consignments at the inspection centre Sotagus, while there were no storage rooms for chilled or frozen consignments at the inspection centre Liscont, which is not in line with Article 3(1)(c) of Regulation (EU) 2019/1014.

The audit team noted in the case of the BCP Setubal port, based on their evaluation of the assessment table and supporting documents provided, that that there were no storage facilities for food of non-animal origin, which is not in line with Article 3(1)(c) of Regulation (EU) 2019/1014.

While the evaluated BCPs were generally compliant with the minimum requirements for BCPs for the categories of animals and goods of animal origin for which they had been designated, shortcomings were identified with respect to the facilities in place at three BCPs, for the storage of goods of non-animal origin intended for human consumption for which the BCPs had been designated, which have the potential to reduce the overall effectiveness of the official control system.

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To address the recommendation, the following actions were taken: · The cargo handler visited and referred in point 44, [*] was formally notified to provide storage facilities for food of non- animal origin (FNAO), that allow storage at hygienic conditions and that can be lockable or fenced when storing goods presenting a risk. The cargo handler has 6 months to comply with the notification. The notification was identified with reference REL/7/2024/DRAPLVT and process number CQAI/2/2024/DRAPLVT from 2024/1/12. [*] · The responsible of the inspection centre Liscont, visited and referred in point 45, was formally notified to provide adequate drainage, to improve maintenance and to guarantee supply of hot water in the inspection room. The inspection centre has 3 months to comply with the notification. The notification was identified with reference REL/259/2023/DRAPLVT and process number CQAI/109/2023/DRAPLVT from 2023/11/16. [*] · The responsible of the inspection Centre Liscont had a meeting with Customs (18/10/2023) and submitted, in pect the provisions of Article 339 of the Lisbon Treaty as regards confidentiality. report ref. DG(SANTE) 2023-7781 of the audit carried out from 17 Octo

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The audit team noted that: · The designation of Fitolab was in line with provisions of Article 37 of Regulation (EU) 2017/625 following a series of audits by DGAV and the NRL. The NRL supervises the activity of the designated laboratory in line with EU rules; · In 2020 and 2021 there were significant delays in the completion of the Xf tests by the NRL due to the lack of human resources and the limited availability of PCR reagents. In 2021, the NRL analysed 8,096 plant and insect samples for Xf, 79 of them tested positive. At the time of the audit the laboratory had a weekly capacity for 250 samples with a theoretical response time of 7-15 days, which were significantly longer in the main sampling periods in 2021; · The designation of Fitolab provided additional capacities, however the response time for samples from the DA averages 28 days due to the available laboratory capacities and other technical aspects; · The delays in the completion of the laboratory tests contributed to the delays in the implementation of the eradication measures (see section 5.5.1). Due to the reasons above it is considered by the audit team that the laboratory capacity issues present at the time of the 2020 audit have not been fully addressed. Conclusions on the organisational aspects of Xf controls

The applied methodology and the laboratories' participation in proficiency tests provide assurances regarding the reliability of test results. Although the designated laboratories have initiated procedures for accreditation to EN ISO/IEC 17025, this process was not finalised and therefore the required guarantees for the analytical performance are not 7 provided. Delays in completing the laboratory tests can compromise the timely implementation of the eradication measures.

In relation to the inventory of the plants to be removed in the IZs, the audit team noted during the site visits that: · The work is carried out by DRAP or ICNF inspectors. This activity is particularly difficult and time consuming in the Porto DA, due to the very high number of plant species/genera tested positive for Xf subspecies multiplex; · CA inspectors possessed the necessary botanical knowledge. For the identification of unknown species, a publicly accessible internet application was used. The number and geographical location of the identified plants is duly recorded on the IT platform; · Access issues in steep or inaccessible parts of the IZs and legal access rights to some private properties significantly hindered or made it impossible to complete the inventories.

In the infected zones of the Porto outbreaks there are very long delays in the identification and removal of plants, specified by the EU legislation, due to lack of inspection, administrative and plant removal capacities, difficulties in identifying and notifying the landowner and in accessing sites. Consequently, the eradication of Xf is very unlikely and there is a considerable risk of spread of the disease within the DAs and to other parts of the country.

The 2021 statistically based surveys in the BZs were planned fully in line with the provisions of the EU legislation. Due to staff shortages, many of the selected sites were not checked in the Porto and Lisbon BZs. In addition, and in particular in the Porto BZs the territory of the selected sites could not be inspected entirely due to access issues. Therefore, the minimum requirements of the EU legislation for the surveys were not met and the actual extent of the outbreak is not known in those areas. This prevents the proper implementation of the eradication measures. In the Tavira BZ the surveys were completed in line with the EU rules.

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sentido de cumprir com esta recomendação o ICNF, I.P.: · Tem neste momento em curso o desenvolvimento de um procedimento concursal para aquisição de serviços especializados para eliminação da vegetação no âmbito das medidas de Proteção fitossanitária associadas ao controlo de Xylella fastidiosa para o ano de 2022, na zona demarcada; · Manterá a afetação dos recursos humanos atualmente existentes, com reforço de atuação/estabelecimento de prioridades, em função dos riscos. A DRAPN pretende contratar serviços externos (2 equipas: 4 técnicos e 2 viaturas). A DRAPLVT pretende realizar recrutamento externo de pessoal devidamente qualificado com recurso à bolsa de recrutamento disponível do último concurso externo. A DRAPALG já realizou em 2022 a contratação de 2 Técnicos superiores ­ Inspetores fitossanitários na DRAP Algarve, para dar cumprimentos às exigências previstas (controlos oficiais e outras atividades oficiais relacionadas com a Xylella fastidiosa). No que se refere à capacidade laboratorial, o ICNF, I.P. e a DGAV já contratualizaram para 2022 aquisições de serviços especializados para a realização de análises laboratoriais para deteção de Xylella fastidiosa de amostras recolh

der to comply with this recommendation, the ICNF, I.P.: · Is currently developing a tendering procedure for the purchase of specialised services for the elimination of vegetation under the plant protection measures associated with the control of Xylella fastidiosa for the year 2022 in the demarcated area; It will maintain the allocation of existing human resources, with reinforced action/prioritisation, depending on the risk. DRAPN intends to procure external services (2 teams: 4 technicians and 2 cars). DRAPLVT intends to carry out external recruitment of suitably qualified staff using the available recruitment bursary of the last external competition. DRAPALG already contracted 2 Senior Technicians -- Phytosanitary Inspectors at DRAP Algarve in 2022 to comply with the requirements (official controls and other official activities related to Xylella fastidiosa). As regards laboratory capacity, the ICNF, I.P. and the DGAV have already contracted for 2022 purchases of specialised services for carrying out laboratory analyses to detect Xylella fastidiosa of samples collected in the LFA, as a reinforcement of the previous year. Page: 1 ns (updated) 25 January 2023 by the competent auth

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The audit team noted that the laboratories are not accredited in accordance with the standard EN ISO/IEC 17025, although it is required by Article 37(4)(e) of Regulation (EU) 2017/625. The NRL has made preparations for the accreditation of a range of molecular methods on quarantine and regulated non-quarantine pests with molecular methods, including Xf analysis with PCR. Fitolab is in an advanced stage of the accreditation for the detection of quarantine and regulated non-quarantine pests listed in the DGAL official designation, with molecular methods. It is expected that the accredited status will be achieved in the first semester of 2022.

The applied methodology and the laboratories' participation in proficiency tests provide assurances regarding the reliability of test results. Although the designated laboratories have initiated procedures for accreditation to EN ISO/IEC 17025, this process was not finalised and therefore the required guarantees for the analytical performance are not 7 provided. Delays in completing the laboratory tests can compromise the timely implementation of the eradication measures.

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O INIAV, enquanto Laboratório nacional de referência, está acreditado desde 2008 e tem sempre trabalhado em ambiente de qualidade, e trabalham em estreita colaboração com o EURL. Este é um processo em melhoria contínua e ao longo dos anos tem sido expandido o âmbito da acreditação (https://www.iniav.pt/acreditacao). Na área fitossanitária, incluindo a Xylella fastidiosa, contam que esse processo seja completado no 1.º semestre de 2023. No que se refere ao Laboratório privado, FITOLAB, o mesmo já foi designado como laboratório oficial e encontra-se já acreditado de acordo com o standard EN ISO/IEC 17025 como requerido pelo artigo 37(4)(e) do Regulamento (EU) 2017/625, bem como para o método de ensaio para a deteção de Xylella fastidiosa. Anexamos os documentos comprovativos.

INIAV, as the National Reference Laboratory, has been accredited since 2008 and s always been working in a quality environment and working closely with RL. This is a process of continuous improvement and the scope of creditation has been expanded over the years (https://www.iniav.pt/acreditacao). the plant health area, including Xylella fastidiosa, it is expected that this ocess will be completed in the 1st half of 2023. regards the private laboratory, FITOLAB, it has already been designated as an ficial laboratory and is already accredited according to EN ISO/IEC 17025 andard as required by Article 37 (4) (e) of Regulation (EU) 2017/625, as well as r the test method for the detection of Xylella fastidiosa. Please find enclosed the pporting documents. Page: 3 ns (updated) 25 January 2023 by the competent authorities of Portugal in response to Report ref. DG(SANTE) 2022-7400 of er to evaluate the situation and controls for Xylella fastidiosa Action Proposed by the competent authority Additional information: INIAV: In progress. We expect to have an IPAC (Portuguese Institute of Accreditation) audit in the first half of 2023.

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The structure and information content of the national Xf contingency plan of Portugal and the action plans are largely in line with provisions of the EU legislation. However, as there are no clear procedures on how to make available the minimum resources necessary for the controls, the timely implementation of the actions necessary for the eradication is not guaranteed.

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A DGAV irá proceder a alteração, no capítulo adequado do plano contingência, mencionando os recursos necessários ao cumprimento dos planos de ação, até ao final de 2022. le Page: 2 ember 2022 port ref. DG(SANTE) 2022-7400 of the audit carried out from 03 May 2022 tidiosa ion Proposed by the competent authority

will amend the appropriate chapter of the contingency plan by mentioning the resources needed to comply with the action plans by the end of 2022. Additional information: The contingency plan was revised at the end of 2022, to be aligned with your remarks and is annexed to this answer.

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In relation to the inventory of the plants to be removed in the IZs, the audit team noted during the site visits that: · The work is carried out by DRAP or ICNF inspectors. This activity is particularly difficult and time consuming in the Porto DA, due to the very high number of plant species/genera tested positive for Xf subspecies multiplex; · CA inspectors possessed the necessary botanical knowledge. For the identification of unknown species, a publicly accessible internet application was used. The number and geographical location of the identified plants is duly recorded on the IT platform; · Access issues in steep or inaccessible parts of the IZs and legal access rights to some private properties significantly hindered or made it impossible to complete the inventories.

In the infected zones of the Porto outbreaks there are very long delays in the identification and removal of plants, specified by the EU legislation, due to lack of inspection, administrative and plant removal capacities, difficulties in identifying and notifying the landowner and in accessing sites. Consequently, the eradication of Xf is very unlikely and there is a considerable risk of spread of the disease within the DAs and to other parts of the country.

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(EU) O ICNF tem neste momento em curso o desenvolvimento de um ocedimento concursal para aquisição de serviços y especializados para eliminação da vegetação no âmbito das idas de Proteção fitossanitária associadas ao controlo de s, Xylella fastidiosa para o ano de 2022, para cumprir com os cedimentos previstos para a zona demarcada. CNF manterá o procedimento de notificação de todos os prietários localizados na ZD, via edital, no sentido de agilizar mplementação das medidas de erradicação, podendo, de rdo com o Artigo 15º do D.L. n.º 67/2020, 15 de setembro o ado substituir-se aos proprietários no caso da falta de atuação os mesmos. RAPN tem em curso um procedimento de contratação de empresa para arranque das plantas, cujo processo está já em lise pelo júri do concurso para a remoção dos vegetais etados e todos os identificados infetados da lista da ZD. RAPLVT irá realizar em 2023 um contrato de prestação de viços para apoio nesta atividade.

The ICNF is currently developing a tendering procedure for the acquisition of specialised services for the elimination of vegetation under the plant protection measures associated with the control of Xylella fastidiosa for the year 2022, in order to comply with the procedures laid down for the demarcated area. The ICNF will maintain the notification procedure for all owners located in the LFA, by means of an official notice, with a view to speeding up the implementation of eradication measures. According to Article 15 of Decree-Law 20, the State may, in the event of failure to act by the owners, take the place of the owners. Page: 4 ns (updated) 25 January 2023 by the competent authorities of Portugal in response to Report ref. DG(SANTE) 2022-7400 of er to evaluate the situation and controls for Xylella fastidiosa ction Proposed by the competent authority he DRAPN is in the process of contracting a plant start-up company, the process f which is already being examined by the selection board for the removal of nfected plants and all those identified infected from the LFA list. RAPLVT will carry out a service contract in 2023 to support this activity. econd answer: n the case of DRAPN

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Tables II and III summarise the implementation of the 2021 surveys in the BZs. In order to facilitate the access of survey teams to private premises, DGAV issued a general official notice for the Porto DAs (Edital) which informs the landowners about the restrictions applied in the BZ including the annual surveillance activity. Table II. Planned and completed sample numbers of the 2021 BZ surveys Buffer Epidemiological Sample number Collected Implementation Positives zones unit required by RIBESS+ samples % 3,915 24 Porto Urban 2,024 1,290 192% 6 Agricultural 2,216 58% 0 Lisbon Forest 1,611 323 20% 0 Semi natural 1,823 318 17% 0 Urban 320 1,078 337% 0 Agricultural 410 24 6% 16 Buffer Epidemiological Sample number Collected Implementation Positives required by RIBESS+ samples % zones unit 0% 0 404 0 0 Forest 325 1342 413% 0 407 178 44% Tavira Agricultural Forest Source: DGAV Table III. Planned and checked inspection sites (100m x 100m squares) of the 2021 BZ surveys in the Porto outbreak Survey performer Squares allocated Squares with Completion % for surveys completed surveys DRAP North 326 78.8% ICNF 245 257 22.8% Municipalities 120 56 286% Source: DGAV 344

The 2021 statistically based surveys in the BZs were planned fully in line with the provisions of the EU legislation. Due to staff shortages, many of the selected sites were not checked in the Porto and Lisbon BZs. In addition, and in particular in the Porto BZs the territory of the selected sites could not be inspected entirely due to access issues. Therefore, the minimum requirements of the EU legislation for the surveys were not met and the actual extent of the outbreak is not known in those areas. This prevents the proper implementation of the eradication measures. In the Tavira BZ the surveys were completed in line with the EU rules.

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e As ações propostas na recomendação n.º 1, no que se refere aos compromissos assumidos pelas DRAP e ICNF, também mitem assegurar a resposta a esta recomendação.

The actions proposed in recommendation 1, with regard to the commitments made y the DRAP and ICNF, also make it possible to ensure that this recommendation s addressed. econd answer: n the buffer zone, each square is assigned to one single entity, considering the lass of soil provided by Corine Land Cover. In this sense, there are no squares ith a shared responsibility, acting each entity in an individual manner. In case he entity to which the square was assigned considers it was not properly assigned, he square is given back to DGAV, to reassign it to the correct entity. So, Page: 5 ns (updated) 25 January 2023 by the competent authorities of Portugal in response to Report ref. DG(SANTE) 2022-7400 of er to evaluate the situation and controls for Xylella fastidiosa Action Proposed by the competent authority considering the additional information provided now in recommendation 1, the tasks will be performed by each entity using the means at their disposal.

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A DGAV guidance document requires vector collection by net sweeping in 10% of the survey squares allocated to the participating organisations. The preferred collection time is late spring and early autumn. However, no further guidance is provided about how to select the allocated squares to be checked, e.g., to prefer the sites located in the vicinity 17 of the IZs with delayed plant removals. The collected insects are processed as described in Section 5.5.2.

In the Porto BZs, DRAP and ICNF carried out vector collections. No positives were found. None of the vectors collected in the Lisbon and Tavira BZs by DRAP tested positive. Philaenus spumarius, the main vector of Xf in the EU was not collected during the surveys in Tavira. 5.5.4 Measures against vectors

The application of the agricultural practices to control all stages of the vector population in the DAs is not checked by the CAs. Therefore, the implementation of these measures, which play an important role in the reduction of the risk of Xf spread, is not ensured.

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are Com base no documento de orientação da DGAV em vigor, está e a ser elaborada uma ficha de inspeção para efetuar e registar os f the controlos oficiais realizados na zona demarcada, o que permitirá Page: 3 ember 2022 port ref. DG(SANTE) 2022-7400 of the audit carried out from 03 May 2022 tidiosa e competent authority em breve tornar estas ações mensuráveis e assim avaliar o seu a realizar até ao final do ano de 2022. Page: 4

On the basis of the DGAV guidance document in force, an inspection sheet is being drawn up to carry out and record the official controls carried out in the marcated area, which will soon make these actions measurable and thus assess their degree of compliance, to be carried out by the end of 2022. Second answer: The inspection sheet, to check and register the compliance with the agricultural practices is in annex to this answer. In this sheet, it has to be registered the period of execution of those practices, the type of locations subject to the intervention, and the methods applied for it. These items are checked by the inspector and registered by him in the sheet. This approach is followed the same manner for agricultural and forestry areas and will be disseminated for immediate implementation, in the same way, by DRAP and ICNF. The percentage of inspections on agriculture, forest and seminatural areas is indicated. In case of detection on non-compliances, and considering that these measures were previously informed through a notification procedure, and being considered plant health measures, according to article 17 of Decree Law 67/2020, non- compliance is subject to the respec

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ABP from treatment of hides and skins The DGAV has requested (through the letter attached), the collaboration of the Portuguese Association for Tanning Industries (APIC) to inform its associates of the need to ensure the elimination of ABP arising from tanning activities in accordance with the animal by-products regulations. DGAV has also requested the collaboration of the Portuguese Environment Agency (APA) to inform landfills operators, that the acceptance of ABP resulting from the tanning industries violates the ABPR. DGAV has also requested (through the mail below) the collaboration of ASAE for the enforcements of provisions regarding the disposal of ABP by operators from the tanning sector. The Regional Services of DGAV (DSAVR) have been informed (through the mails below), about the abovementioned measures and have been requested to take legal action against operators who do not comply with the provisions regarding the disposal of ABP resulting from tanning activities, in line with the provisions of EU legislation. Page: 1 port ref. DG(SANTE) 2022-7421 of the audit carried out from 10 October ntrols on animal by-products (ABP) and derived products (DP) ority garding the applic

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Domestic legislation authorises, throughout the country, on-site burial of animal carcasses and Category 2 material, consisting of ABP from on-farm slaughter, provided that the amount does not exceed 40 kg a week. This is not in line with EU rules, in particular Article 13 of Regulation (EC) No 1069/2009, which do not provide for any exemption for routinely burying these types of ABP (outside of remote areas).

For bovine animals, an authorisation from DGAV (regional services) is required before on-farm slaughter takes place; animals must be younger than 12 months and the number of slaughters is limited to two per year. As part of the authorisation process, DGAV must verify that ABP from such slaughter is collected by an authorised ABP operator. In one of the regions visited, where more than 800 authorisations were granted between 2019 and 2022, the abovementioned rules were enforced. In the other region visited, where between 10 to 20 authorisations were given on an annual basis, the on-farm slaughter was in certain cases authorised without any prior check that ABP would be collected by an authorised ABP operator.

In one of the regions visited, official controls identified that ABP from the treatment of hides by tanneries (before the tanning process) were incorrectly disposed of as municipal waste, contrary to Article 14 of Regulation (EC) No 1069/2009. DGAV informed the audit team that, to date, no solution had been found to process such material in Portugal. Category 3 (and Category 1) processing plants were not willing to accept these by- products from hides due to difficulties in processing them. Consequently, at the time of the audit, such ABP were not disposed of in line with ABP rules. Conclusions on the system in place for collection, use and disposal of ABP and DP

The system in place for collection, treatment and disposal of ABP is largely capable of ensuring a safe management of ABP an DP. However, ABP from the treatment of hides are not disposed of in line with EU rules and some ABP from on-farm slaughter are disposed of by burial, while this is not authorised under EU rules for ABP.

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As this is a matter beyond the competencies of this Directorate General, the matter was forwarded to the office of the Minister of lture and Food and is under analysis for decision purposes.

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Domestic legislation defines the areas that have been categorised as `remote' under Article 19(1)(b) of Regulation (EC) No 1069/2009. In mainland Portugal, five geographical areas are designated as `remote'. The reasons being that these areas have low density of animal population, include natural parks or mountains and, because of their geography, present collection difficulties and are distant from establishments for processing and disposal of ABP. In these areas, on-the-spot burial of bovine, ovine, caprine, and porcine animals is authorised. However, within these remote areas, burial of dead animals is not authorised for holdings considered intensive and for dead bovine animals aged 48 months and over.

Based on discussions held with the ABP operator managing collection of fallen stock in the northern and central parts of Portugal, collection is possible in most areas, except those 5 where trucks have no physical access. In addition, the fact that ABP are collected from farms with intensive animal production located in remote areas implies that trucks have access to, at least, part of these areas. Therefore, since there are viable collection and transports arrangements in parts of the areas categorised as `remote', such areas do not meet the definition of a `remote area' in Article 3(23) of Regulation (EC) No 1069/2009.

The designation of some areas as `remote' is not fully justified since means of collection operate in parts of these areas. In addition, the total bovine animal population located in such areas exceeds, by far, the maximum authorised under EU rules.

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As this is a matter beyond the competencies of this Directorate General, the matter was forwarded to the office of the Minister of iculture and Food and is under analysis for decision purposes The DGAV adopted a "Guide on the alternatives for the disposal of fallen stock throughout mainland Portugal" with the objective of avoiding the negative impact of their burial, on the environment. This Guide which is available on the Website of DGAV is destined to inform farmers of the alternatives for the elimination of cadavers of different animal species (cattle, sheep, goats, pigs, lagomorphs, poultry and equidae) and to assist them in making decisions on the most appropriate method for this purpose.

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The designation of some areas as `remote' is not fully justified since means of collection operate in parts of these areas. In addition, the total bovine animal population located in such areas exceeds, by far, the maximum authorised under EU rules.

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In 2023 a control methodology will be established for these areas and the selection criteria will be defined, with the start of rols in 2024.

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Official controls on collection and disposal of ABP are in place at food business operators. However, they are not effective enough to verify compliance with all applicable requirements and can either overlook incorrect disposal of ABP or not ensure timely correction by the operators. There is also an insufficient level of attention paid to the operators' documented procedures for management of ABP. Finally, no regular controls have been implemented to verify burial conditions in areas designated as remote. All of this weakens the guarantees that ABP and DP generated by food business operators are collected and disposed of in line with EU rules.

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Official Controls at Slaughterhouses Page: 3 port ref. DG(SANTE) 2022-7421 of the audit carried out from 10 October ntrols on animal by-products (ABP) and derived products (DP) roposed by the competent authority onal Coordinator as well as the Regional Coordinators anitary inspection at slaughterhouses are closely monitoring liance by slaughterhouses of the rules applicable the cation, collection, and disposal of ABP. ter regarding animal by-products, of the Sanitary on Manuals (attached below) has been amended to provisions clearly defining the tasks of official rians present at slaughterhouses, as regards the tion of compliance by food business operators, of the es established in their HACCP Plans for the collection, t, storage, handling and use or disposal of animal by- , including specified risk material for inspectors all DGAV staff preforming tasks at rhouses level as regards the classification, collection, orized destinations for the different categories of ABP e place in the first trimester of 2023. ched presentations have been prepared to the effect. controls at retailers ­ ASAE l prepared a Technical Inspection Form to aimed at g the requirements for the collection and di

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ficial controls regarding the use of milk derived products for ng farmed animals will begin in February 2023. his purpose, separate Technical Notes (attached) regarding upplying of by milk by-products, by milk establishments, he feeding of farmed animals and for the use of these by- cts by farms, have been drawn up and, will be made able on the website of the DGAV, after homologation by the tor General. ical Note - Milk establishments supplying milk by- cts ical Note ­ Farms receiving milk by-products ionally, PACE 2022-2023 has been updated to include a oint 10.4 regarding the use of milk by-products for the ng of farmed animals. This updated version is awaiting ogation. ollowing Checklists (CL) have been drawn up for official ols at milk establishments supplying milk by-products and receiving these by-products. List - Milk establishments Check List ­ Farms Page: 5 port ref. DG(SANTE) 2022-7421 of the audit carried out from 10 October ntrols on animal by-products (ABP) and derived products (DP) Page: 6

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However, the audit team noted that the guidance on ante-mortem inspection (AMI) of poultry at the holding of provenance (DGAV Order 23/G/2016) allows that "approved veterinarians" perform AMI at the holding of origin (EU legislation requires that AMI should be carried out by an official veterinarian (OV)). In this regard, DGAV informed the audit team that this document had been in place before the new EU legislation was applicable and it has not been updated as yet. They explained that the procedure was applied in the past, and in a small number of slaughterhouses due to the lack of available human resources. They added that this option is no longer practiced, as additional OVs have since been employed, and that, in any case, DGAV intends to amend the provisions contained in this document in order to bring them in line with EU requirements.

National legislation and guidelines necessary to ensure implementation and/or enforcement of the EU requirements applicable to the meat sector are in place and they are largely in line with EU legislation, with the exception of one guideline, which was not up-to-date and, as a result, certain provisions of its content are contrary to EU legislation.

According to national rules, AMI of poultry can be done at slaughterhouse by OVs or, when necessary, at the holding of origin by approved veterinarians. DGAV explained that "when necessary" means when the CAs detect a lack of OVs at a specific slaughterhouse for a particular day or period. In this regard, there is a specific procedure under Order 23/G/2016 (see paragraph 3), which describes the steps to follow and, among other things, requires OAs to perform a simplified AMI under the responsibility of the OV. DGAV added that at the time of this audit this procedure was not being applied in any slaughterhouse and AMI is always carried out by OVs at the slaughterhouse.

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DGAV Despatch 23/G/2016 will be repealed and Chapter III ted to Part A of the Poultry Meat Inspection Manual (on ante-mortem inspection) will be adapted to remove the references to this despatch and to AMI in the holding of provenance. The repeal document is being prepared. The amendments are expected to be completed by the end of June 2022. Page: 1

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Forest rangers follow a surveillance method based on a 100 ha grid of coordinates established throughout the buffer zone and its adjacent area for the identification of dead trees and trees in decline. They visit stands with high density of trees and stands found whilst crossing towards the targeted areas. As the areas to be monitored are not homogenous, the effectiveness of the surveys depends on the density of the stands with trees to be inspected. Additional work is planned and carried out in areas with dense pine forest, areas with dead and declining trees and high risk areas. The multi-annual action 9 plan provides for at least two visual surveys for spotting trees in decline throughout the year, in particular for plots located in high risk areas. Although this is considered a continuous action, surveys are mainly carried out after the summer, with some areas in close proximity or adjacent to the buffer zone not surveyed at a frequency, which would allow the earliest possible identification of declining trees (see also section 5.3 below). The ICNF stated that given the large size of the area in question (ca. 3.1 million hectares and 34 458 operational plots within the grid of coordinates), an extensive and continuous monitoring throughout the area, based on human resources, is obviously not permanent and that surveys are focusing on the autumn-winter season where the expression of declining symptoms on trees is high. The ICNF also stated that in collaboration with research and development entities are investigating the possibility for carrying out surveillance remotely.

Annual surveys are carried out according to the multi annual action plan elaborated by the CAs for the control of the PWN. The increased number of samples taken, particularly when sampling in the crown and placing traps and baits whilst targeting high risk areas, provide additional assurance with respect to the stated absence of the PWN from the buffer zone. However, a substantial part of the activities of the forest rangers is allocated to tasks other than surveillance for trees showing early declining symptoms. This reduces the likelihood of the earliest possible detection of PWN spread in the buffer zone, particularly during the summer.9

During its visits in different areas within the buffer zone the audit team spotted isolated trees and/or stands of dead trees and trees in decline, which were not affected by fire or storm. Some of these had already been recorded in FITO and marked to be felled by the private owners, whilst others were not. The ICNF stated that these trees had only recently started declining and that in any case, felling and removal operations could only take place in winter after signing a new contract with the felling operators. The ICNF also stated that due to the prohibition of movement of machinery for felling trees in the forest areas during the summer period when the probability of forest fires is high, they have extended the deadline for felling dead and declining trees in the winter until the end of March 2022. This was also the case in previous campaigns as there was high risk of forest fires during the summer. The non-marked trees were subsequently recorded in FITO for felling and sampling. 16

This approach results in dead and/or declining trees still standing after the end of the flight period of the vector in the summer, increasing the risk of PWN spread in the buffer zone. This is not in line with the first paragraph of point 3(b)(ii) of Annex II to Decision 2012/535/EU providing for the immediate felling and destruction of dead or declining trees identified on site. Instead, the ICNF systematically implements the provisions of the second paragraph of the same point to dead or declining trees in the buffer zone, which exclusively concerns trees affected by fire or storm. In any case, the risk of PWN spread is mitigated by the fact that PWN has not been detected so far in the buffer zone and by the fact that the incidents of forest fires during the 2019-2021 period were limited.

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dead or A identificação dos exemplares suscetíveis com declínio e dos mortos tem vindo a ser efetuada com base numa grelha de will be quadrículas operacionais de 100 ha, estabelecida em toda a zona Annex Tampão e numa faixa de 5 km adjacente a essa zona. Está prevista, e é efetuada, a monitorização das quadrículas com exemplares suscetíveis, não obstante, naturalmente, haja uma maior concentração do trabalho nas áreas com mais pinhal e nas áreas com mais declínio e, bem assim, naquelas com maior risco. Dada a elevada dimensão da área em apreço (3,1 milhões de hectares e 34 458 quadrículas operacionais) a monitorização extensiva e contínua, em toda a área, assente em recursos humanos, não é, obviamente, permanente, motivo pelo qual: - O Plano de Prospeção e Monitorização anual prevê a realização, no mínimo, de duas ações de prospeção de declínio, por ano, sobretudo nas quadrículas localizadas nas áreas de maior risco; - O ICNF, I.P. tem vindo a colaborar com entidades de I&DT com vista à procura de soluções remotas de identificação de exemplares suscetíveis, de fácil implementação e utilização, para complemento do trabalho desenvolvido. De sublinhar ainda que, embora esta ação seja

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The audit team visited an agricultural supplies retailer holding wood and WPM and a supermarket holding WPM, both located in the buffer zone, and witnessed the controls carried out by ASAE. Inspectors stated that apart from carrying out controls in line with the ASAE centrally designed plan they also carry out unannounced inspections controlling the compliance of different operators with very wide range of legislation and that they write a report when they detect non-compliances or infringements. They also stated that they had attended targeted training and were carrying out controls on wood and WPM based on a manual with standard operating procedures and specific information concerning the WPM and the situation in the buffer zone. During the inspections the audit team noted that: · The business operators met were not aware of the national and EU legal requirements relevant to WPM used for the packaging of commodities they receive. They were advised during the visit of the audit team about the measures that they should take if consignments packed on non-compliant pallets or other WPM were to arrive; · In one case, inspectors did not cross-check the registration numbers of marked WPM against any list of heat treatment companies provided by the DGAV as required by the inspection procedures implemented by ASAE In addition, they had 19 not raised any concerns about the presence of pallets, which were not ISPM 15 marked and had been stored on the premises for many years. As a result they could not verify that the requirements of Article 10 of Decision 2012/535/EU were complied with; · In a second case, inspectors, despite having the documented procedures in hand, were unable to identify non-compliance due to inaccurate and/or illegible ISPM 15 marks. Following the observations and comments made by the audit team, the non- compliant pallets and WPM were seized and were not to be moved until they were sent for treatment, safe disposal or destruction.

Controls of movements of susceptible material are carried out at different stages in the supply and transport chain. Appropriate action is taken in the event of a non-compliance or an interception. However, the controls of retailers in the buffer zone are not adequate to identify the movement of potentially non-compliant WPM. 5.6 Authorisation and supervision of heat treatment facilities and marking in accordance with ISPM 15 Legal requirements Articles 13, 14, 15 and 16 of Decision 2012/535/EU Findings

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PM During 2022 DGAV will promote actions for knowledge cle 11 of improving to the inspectors of ASAE, towards an adequate PM application of procedures in force, in line with the established in 12 of the with point 1 of Article 11 and Article 12 of Decision 2012/535/EU. Page: 7

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The DGAV informed the audit team that according to the national Decree Law, professional operators carrying out the activities referred to in Article 65(1) of Regulation (EU) 2016/2031, in Portugal, are obliged to be registered in a register kept by, or accessible by, the DGAV, and shared a summary list of registered operators to the audit team. Other operators, such as producers of citrus fruits (orchards) are registered under agricultural legislation, but the DGAV does not have direct access to those registers.

According to Article 65 referred to above, Member States may decide for further categories of operators to be registered if so justified by the pest risk presented by the plants that they grow. Portugal has not yet made use of that possibility, but the DGAV informed the audit team that this is currently being considered. 5.5.2 Measures in case of suspicion of Trioza erytreae

The DGAV informed the audit team that the DRAPs shall locate and map abandoned host trees and orchards in the BZ and in the surveillance zone. The DRAPs however do not have access to information about active orchards in the DAs. This was confirmed during an on-site visit in a DA, when the DRAP showed the audit team a citrus orchard which they knew of only because its owner reported a suspected case of infestation with T. erytreae to the DRAP. The suspicion was later confirmed, and measures such as phytosanitary treatments, pruning and placing of yellow traps were applied in the orchard. The orchard was in an existing DA when the owner reported the suspected finding.

The CA does not have access to information about active orchards in DAs or elsewhere, and therefore cannot check that phytosanitary measures are carried out in orchards, as required. This potentially undermines the measures for eradication taken in a DA.

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ds A informação requerida pode ser obtida com o estabelecimento da obrigatoriedade do registo das parcelas, para todas as culturas instaladas. A base legal para a realização obrigatória desse registo on geral das culturas será obtida através de uma legislação a publicar, cuja proposta se encontra em avaliação no Ministério da gricultura, e cuja publicação se tem vindo a aguardar. Esse registo geral das culturas dará toda a informação necessária sobre os pomares localizados em zonas demarcadas.

information required may be obtained by establishing the obligation to register parcels (plots) for all crops planted. The legal basis for the mandatory production of such a general crop register will be obtained by means of legislation to be published, the proposal for which is being evaluated by the Ministry of Agriculture, and which is expected to be published. This general crop register shall provide all necessary information on orchards located in demarcated areas. The legal basis for the mandatory crop register was approved by the ministers of Agriculture and Economy and it's expected to be published in next weeks. The legislation provides for a rule that the DGAV, the Regional Directorates of Agriculture and Fisheries and ASAE have direct and permanent access to the data included in the register

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The DGAV informed the audit team that national legislation provides the possibility to impose penalties on private individuals for not implementing the required eradication measures. However, the DRAPs do not have measures in place to enable them to immediately take the necessary phytosanitary measures in cases when these are not carried out by the owner or any other person on behalf of the owner. In such cases, the matter must first be taken to court, although the DGAV stated that they had never taken private individuals to court for failing to implement the eradication measures. One DRAP further stated that this would be time consuming and that they would not have the resources needed. This means that measures to eradicate Union quarantine pests may not be taken immediately, as required by Article 17 of Regulation (EU) 2016/2031. 13

The CA cannot immediately take measures to eradicate T. erytreae in private gardens unless the owners cooperate voluntarily. Given the large number of host plants present in private gardens, this situation potentially risks undermining efforts made by the CA and professional operators to eradicate the pest and increases the risk for its further spread.

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Os jardins privados constituem locais que reúnem as condições (EU) mais adequadas para a realização de largadas do parasitóide Tamarixia dryi, sendo essa uma estratégia mais eficaz de tigação do risco da praga, obtendo-se uma melhor colaboração dos particulares, quando são contatados pelos inspetores. Estes contatos também são aproveitados para ações de sensibilização. Page: 1

te gardens are places that meet the most ropriate conditions for shooting the Tamarixia dryi parasitoid, which is a more Page: 1 tions (updated) received 29/09/2022 ted by the competent authorities of Portugal in response to Report ref. DG(SANTE) 2021-7284 of r 2021 in order to evaluate the situation and controls for Trioza erytrea and citrus greening on Proposed by the competent authority ctive strategy to mitigate the risk of the , with a better collaboration of individuals surveyed by inspectors. These counts also used to raise awareness national legislation on plant health ady provides the legal basis for action in ate areas, including gardens in private s, as well as the sanctions that can be ied to them. However, the level of ersion of T. erytrea in the territory and its r host plants, no longer allows its total ication. All our efforts are focused on cing the population level of the pest, ying all the phytosanitary measures lable, including biological control, both rivate and public areas. idering that eradication in some areas is feasible anymore, we have sent NTE the attached letter on containment ures for T. erytreae. Page: 2

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The classification of production, included in the IPMA procedure MB 01, foresees three types of classification: permanent, provisional and not classified, depending on the number of results available during the review period. The audit team noted that: For provisional classification, a reduced number of sampling results (between 12 and 23) in three years is sufficient for IPMA to classify provisionally a specific species in a production area with a better class than other species in the same area. The audit team considered that less than 24 results in three years does not ensure that results are representative of a production area, as required in Article 57 of Regulation (EU) 2019/627. Nonetheless, IPMA could use those results for the initial classification if twelve of them are obtained within six months, as foreseen in the mentioned guidance document of the European Union Reference Laboratory (EURL) for monitoring bacteriological and viral contamination of bivalve molluscs10. According to the procedure, IPMA should not classify a production area if there are less than twelve sampling results for a given species in less than three years. However, this is not implemented and IPMA classifies all species existing in an area with the less favourable permanent classification given to the area. In principle, there are no negative implications with this practice but it is not in line with its own procedure. 5.1.2 Monitoring of classified production areas

According to the procedure MB 02, laboratory reports have to include the Most Probable Result (MPR) of E. coli per 100 grams. However, the number of dilutions made during the analyses of samples from class B production areas is not enough to provide an exact number when results are > 18,000. Therefore, it is not possible to determine if these areas exceed the limit of 46,000 established in Article 54.3 of Regulation (EU) 2019/627 for class B production, and decisions for reclassification and/or closure of production areas cannot be adequately taken. b) For the presence of toxin-producing plankton in water

According to the procedure MB 03, and in line with Article 61.4 of Regulation (EU) 2019/627, the indicator species shall be sampled on a weekly basis (other species only when testing of indicator species result is over the limits for biotoxins). However, for different reasons (e g. indicator species not available, weather conditions, etc.) IPMA does not always respect this frequency. IPMA does not always take the samples at the points designated in the procedure according to Article 61.1 of Regulation (EU) 2019/627. Indicator species are sometimes sampled in other locations or other species are sampled instead and used as indicator.

The decisions following results over the limits are included in the procedure MB 01, but it has a number of deviations from the legislation: a) For microbiological quality of live bivalve molluscs The procedure does not foresee the closure or reclassification of production areas when health standards for live bivalve molluscs are not met (i.e. between 230 and 700 E. coli NMP/100 g for class A production areas, between 4,600 and 46,000 E. coli NMP/100 g for class B production areas), contrary to Article 62.1 of Regulation (EU) 2019/627. IPMA reclassifies production areas when monitoring results are >700 E. coli NMP/100 g for class A production areas and closes production areas when monitoring results are >46,000 E. coli NMP/100 g for all classes of production areas. It carries out an investigation to determine the possible reasons for the unexpected result. The audit team reviewed the two cases and noted that the outcome of the investigation was not conclusive. Despite this, IPMA considered these results as anomalous and therefore excluded from the data set considered during the review period for classification. b) A downgrade in classification when results are exceeded is reverted following two good results within the expected limits (i.e. 230 E. coli NMP/100 g for class A production areas, 4,600 E. coli NMP/100 g for class B production areas) separated 15 days. This reversion should only take place if the evaluation of the results available for the review period determine compliance with the corresponding standards, as established in line with Article 52 .3 of Regulation (EU) 2019/627. c) For the presence of toxin-producing plankton in water The audit team noted that, except in one case, IPMA always followed the procedure. Exceeding prohibition limits triggered the preventive closure of production areas for all species of molluscs as required by Article 62.1of Regulation (EU) 2019/627. d) For the presence of biotoxins in live bivalve molluscs The audit team noted that IPMA only closes preventively production areas due to a lack of samples available when samples are not available for more than 2 12 In their response to the draft report IPMA confirmed that they could not use reference material of bivalve matrix because it was not available on the market. 9 weeks. This is not in line with Article 61.4 of Regulation (EU) 2019/627 that requires weekly testing for biotoxins. e) For the presence of chemical contaminants in live bivalve molluscs The audit team saw several examples of classified production areas closed due to exceeding levels of heavy metals.

As, in general, the classification of production areas is consistent with the EU classification requirements and supported by recommendations from sanitary surveys, there is confidence that the level of contamination of molluscs harvested corresponds to the value expected according to their classification. The provisional classification based on a reduced number of results may overestimate the microbiological quality of mollusc.

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.

The fact that IPMA: i) does not close or reclassify the production area when certain regulatory limits for microbiological quality are exceeded; ii) reverts the classification downgrade without an evaluation of the results for the review period; iii) excludes unexpected results without conclusive investigation, may result in the placing on the market of bivalve molluscs that exceed the health standards.

The current monitoring programme for biotoxins covers most of the requirements of EU legislation but the fact that the IPMA does not fully respect the sampling points and frequencies diminishes its value.

Medlemsstatens svar

Review of the IPMA, I.P./SNMB procedure MB01 in line with Articles ons 54.2 and 3, 57, 61 62 and 63 of Regulation (EU) 2019/627 Review proposal of next classification accordingly. Until end of 2nd 2021 semester.

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IPMA analyses all monitoring samples in its laboratories and there is a dedicated budget line to pay for these analyses. IPMA staff take monitoring samples, but also individual harvesters, harvesters' associations or aquaculture production companies with a contract with IPMA (there is no financial compensation for the sampling activities or for the samples themselves). Since 2015, IPMA has enhanced the content of contracts for 10 The guidance document of the EU Reference Laboratory for monitoring bacteriological and viral contamination of bivalve molluscs ("Good Practice Guide; issue 7", December 2018). 5 sampling to make them more comprehensive, to include a training session from IPMA staff to samplers and a manual with the requirements for the adequate collection of samples. In the last years, IPMA started to supervise these samplers; since the beginning of 2020, its objective is to supervise 35% of them every year. IPMA confirmed its intention to formalise all this in a procedure. Although the use of non-official staff for monitoring sampling is not explicitly foreseen in EU legislation, Article 65.2 of Regulation (EU) 2019/627, allows competent authorities to take into account the results of checks carried out by food business operators or organisations representing food business operators when deciding on the classification, reclassification, opening or closure of production areas. This is possible provided that: the laboratory carrying out the analysis is designated by the competent authorities, and the sampling and analysis are performed in accordance with a protocol agreed upon jointly by the competent authorities and food business operators or organisation concerned. In addition, Article 30 of Regulation (EU) 2017/625 establishes the conditions for delegating certain official control tasks to natural persons. Therefore, although not foreseen as such in EU legislation, this type of sampling should not, in principle, be a problem because sampling is performed in accordance with a protocol agreed upon jointly and because IPMA has arrangements in place to verify the reliability of the sampling, avoiding in this way any possible impartiality or conflict of interest by the samplers. a) For microbiological quality of live bivalve molluscs

The IPMA's intention to formalise the procedure for sampling of classified production areas by non-official staff is essential to ensure that samples taken in the context of official monitoring are reliable.

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IPMA, I.P./SNMB will write a new procedure to reflect the current f practice on training and supervision of official and non-official samplers. Concluded (Annex 1)

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According to the procedure MB 02, monitoring samples have to be analysed using a method recognised by the National Reference Laboratory that should preferably be standardised. The audit team saw that the analyses of a certain number of samples from two production areas (they are remoter therefore more difficult to transport the samples on time) deviated from the method accredited and their analyses started more than 24 hours after collection. Accordingly, laboratory reports do not display the accreditation logo. However, IPMA used these results for classification and for decisions following monitoring. IPMA informed the audit team of an ongoing project to estimate the difference in results when analyses start more than 24 hours after the collection of samples; subsequently IPMA will consider an amendment in the scope of the 6 laboratory's accreditation to bring this in line with Article 37(5)(a) of Regulation (EU) 2017/62511.

The results of microbiological analysis using non-accredited testing methods are not 11 reliable and thus they generate the risk of misclassification of the areas. However, this risk is limited to only some of the monitoring samples of two of the 39 classified production areas.

The head of the biotoxins laboratories presented the facilities and equipment of the laboratories. The facilities of the three laboratories are appropriate. The equipment of the ASP and PSP laboratories is also adequate. There was only one piece of equipment validated for lipophilic toxins. In case of breakdown or regular maintenance (which is regularly required for this type of equipment), samples were analysed using a screening test which does not comply with the requirements of Chapter III.B of Annex V to Regulation (EU) 2019/627. In addition, this test only detects two of the regulated compounds (OA and DTX) so the total toxicity of the lipophilic toxin group can be underestimated.

Although the IPMA laboratory for lipophilic toxins routinely uses the EU analytical reference method to determine these toxins, the use of a non-recognised method on certain occasions means that the result in this biotoxin group, could be sporadically 15 non-reliable or underestimated.

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cal IPMA, I.P. is making a statistical study on the influence of time in b) sample results to prove that arrival later 24h up 36h does not affect he results. Until end of 2nd 2021 semester. Acquisition and validation of LC-MS/MS equipment, to reinforce the analytical capacity of the Biotoxins Lab. Until end of 1st 2022 semester.

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The decisions taken by IPMA following results over the limits apply only from the moment when they are formalised (e.g. some days after the sample was taken). Similarly to the previous audit, the audit team noted that Portugal has not designated an authority responsible for withdrawing from the market those bivalve molluscs harvested between the day when the sample was taken and the day when the results are available. In the worst-case scenario, this period can be up to three days. As an example, the audit team noted one case where wedge clams were harvested in a production area closed on the same day due to lipophilic toxins. These clams, destined to another Member State, were sampled at the wholesaler of destination and resulted over the limits for Okadaic acid (which triggered a RASFF notification). 5.1.4 Recording and exchange of information

The exchange of information between the two competent authorities audited has clearly improved since the previous audit. IPMA presented evidence of regular and ad-hoc meetings with DGRMA and with other authorities. However, a significant lack of cooperation seems to persist in relation to the investigations derived from RASFFs notifications when they relate to health standards (i.e. microbiology and biotoxins). According to IPMA, except in one case, the contact point for RASFF (i.e. the DGAV) has never informed them of any notification or request any further investigation/explanation from them. This is not the case for RASFF notifications related to traceability: DGRM stated that DGAV referred to its services all notifications related to irregularities in the registration documents and, since the beginning of 2020, DGRM began to receive RASFF notifications directly. 10 5.1.5 Official controls of certain bivalve molluscs harvested outside classified production areas

Marine gastropods (except limpets) for human consumption, which can be harvested outside classified production areas, are not subject to the official controls required by Article 11 of Regulation (EU) 2019/624. At the time of the audit, Portugal has not designated an authority responsible for these controls. 5.1.6 Movement of live bivalve molluscs and registration document accompanying batches

The flow of information regarding monitoring results and the prompt update of available information helps the system to avoid mistakes due to delays. However, the current improvable cooperation between authorities and the absence of designated authorities for some parts of the food chain create the risk of molluscs that could pose a risk for consumers reaching and staying on the market.

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aw IPMA, I.P. sent letters to the potential Competent Authorities that may be appointed to deal with withdraw from the market molluscs that can pose a risk to consumers: ed ASAE & DGAV (Annex 2)

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The audit team reviewed two registration documents issued by harvesters with a license to harvest Japanese clams in a classified production areas in the Sado Estuary. In this estuary, the maximum daily limit of gathering per harvester is not regulated, whereas it is in others, e.g. in the Tagus Estuary, where there is a daily limit of 80 kg per harvester and the harvester has to use the fishing gear authorised for the purpose. In the Sado Estuary: there are two production areas with Japanese clams (among other molluscs species): one is classified as B and the other as forbidden due to very high levels of faecal contamination (>46,000 E. coli/100 g). The audit team review two registration documents, indicating 1,500 and 3,516 kg respectively. The audit team considers it physically impossible for a single person to harvest those amounts within a day. Conclusions on official controls on bivalve molluscs

There are indications that Japanese clams harvested in forbidden areas regularly reach the market. The current design and implementation of official control on licensed harvesters and registration documents facilitates quantities of molluscs much higher than those physically possible to catch and molluscs from forbidden areas reaching the market.

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IPMA sent letters to the potential Competent Authorities that may be appointed to deal with preventing harvesting of LBM in closed classified production areas. PM & GNR-UCM (Annex 3)

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In every establishment visited, the audit team checked the DSAVR feed inspectors' assessment of operators' hazard analysis and critical control points (HACCP) plans. In a few cases, the inspectors' assessment was sufficient. However, in eight of the 11 establishments visited, the audit team noted shortcomings in relation to the adequacy of operators' risk assessment for some ingredients used for the production of feed additives, and for some of the feed additives themselves (predominantly contaminants of chemical origin, e.g., heavy metals, dioxins/polychlorinated biphenyls (PCBs), lack of information on bacterial strain used for production of certain additives, etc.). The failure 5 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 been identified in any of the previous inspection reports. In one operator, there was no adequate HACCP plan in place at the time of the visit. (6)

The new inspection planning system 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. However, the effectiveness of the inspections is weakened by under-implementation, deficient assessment of operators' HACCP-plans and incomplete verification of the appropriateness of operators' retained samples. The many minor deficiencies in the quality of labelling observed by the audit team suggest that the competent authority's verification of the correctness of labelling is not sufficient to guarantee operators' compliance with labelling requirements. 5.2.2 Sampling 5.2.2.1 PLANNING OF OFFICIAL SAMPLING

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ss DGAV proposes to increase national training, emphasizing the levant hazards connected to feed according to the nature and in of feed additives and other ingredients, allowing an adequate evaluation of feed business operator's risk assessment. A course for official inspectors was already proposed for 2020, to be conducted in three training sessions to involve all five regional services (DSAVRs) of DGAV and if possible the Autonomous Regions of Madeira and Azores (Annex I)

Competent authority response received on 9 and 16 March 2020 DGAV proposes to increase national training, emphasizing the relevant hazards connected to feed according to the nature and origin of feed additives and other ingredients, allowing an adequate evaluation of feed business operator's risk assessment. A course for official inspectors was already proposed for 2020, to be conducted in three training sessions to involve all five regional services (DSAVRs) of DGAV and if possible the Autonomous Regions of Madeira and Azores (Annex I).

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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. In the vast majority of cases they could not be considered as adequate due to (a) the absence of a pre- (6) In its response to the draft report the Competent Authority noted that the situation observed was mainly due to the specificity of the sector, namely the broadness of hazards related to the risk of a high number of different natures and origin of ingredients used in animal nutrition. For this reason, dedicated and specific BTSF training courses should be envisaged/improved, or the current HACCP BTSF courses should consider also feed sector. 6 established written procedure (on the taking of retained samples) by the operators and (b) an absence of sealing. This is not in line with the requirements laid down by part 4 of section "Quality control" of Annex II to Regulation (EC) No 183/2005. The audit team noted that this issue had not been identified as a non-compliance in the available inspection reports.

The audit team noted that retained samples of ingredients were rarely taken in the majority of the FeBOs visited. The audit team was informed by the DAA that this is due to an erroneous Portuguese translation of part 4 of section "Quality control" of Annex II to Regulation (EC) No 183/2005 where requirements on the taking retained samples of ingredients had been overlooked. 5.2.1.4 LABELLING

The new inspection planning system 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. However, the effectiveness of the inspections is weakened by under-implementation, deficient assessment of operators' HACCP-plans and incomplete verification of the appropriateness of operators' retained samples. The many minor deficiencies in the quality of labelling observed by the audit team suggest that the competent authority's verification of the correctness of labelling is not sufficient to guarantee operators' compliance with labelling requirements. 5.2.2 Sampling 5.2.2.1 PLANNING OF OFFICIAL SAMPLING

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In what concerns Finding 28, DGAV has already taken actions. For this check list inspection report for 2020 under national feed ficial control (CAA) at establishment level was already updated and improved (Annex II, Section 3.5.). In what concerns Finding 29, DGAV has already sent an email to the Secretariat of the translation services of the Council in order to amend the Portuguese version of part 4 of section "Quality control" of Annex II to Regulation (EC) No 183/2005 where requirements on the taking retained samples of ingredients had been overlooked (Annex III). DGAV has also sent a notice to the National Association of Compound Feed Manufacturers (IACA) in order to clarify this situation and the need to clarify stakeholders (Annex IV).

Competent authority response received on 9 and 16 March 2020 In what concerns Finding 28, DGAV has already taken actions. For this check list inspection report for 2020 under national feed official control (CAA) at establishment level was already updated and improved (Annex II, Section 6.3.5.). In what concerns Finding 29, DGAV has already sent an email to the Secretariat of the translation services of the Council in order to amend the Portuguese version of part 4 of section "Quality control" of Annex II to Regulation (EC) No 183/2005 where requirements on the taking retained samples of ingredients had been overlooked (Annex III). DGAV has also sent a notice to the National Association of Compound Feed Manufacturers (IACA) in order to clarify this situation and the need to clarify Page: 1 ties of Portugal in response to Report ref. DG(SANTE) 2019-6633 of the audit carried out from 26 official controls on feed additives, their ingredients and traceability Action Proposed by the competent authority stakeholders (Annex IV).

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The audit team noted that the inspectors could spot different labelling deficiencies (albeit minor) in the vast majority of the labels randomly chosen by the audit team. The widespread labelling deficiencies observed in combination with the apparently good knowledge of the inspectors on the topic raise some questions on whether the official control system is suitable to verify operators' compliance with labelling requirements. 7 Conclusion on the planning and implementation of inspections

The new inspection planning system 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. However, the effectiveness of the inspections is weakened by under-implementation, deficient assessment of operators' HACCP-plans and incomplete verification of the appropriateness of operators' retained samples. The many minor deficiencies in the quality of labelling observed by the audit team suggest that the competent authority's verification of the correctness of labelling is not sufficient to guarantee operators' compliance with labelling requirements. 5.2.2 Sampling 5.2.2.1 PLANNING OF OFFICIAL SAMPLING

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e comments on report for Finding 33 dance for non-compliances under Feed Official Control issued by DGAV central level was already improved in order to define the subsequent measures to adopt after the verification of a non- compliance label at FeBO establishment level (Annex V, Sections I.1., III.2.and III.3.). Page: 1 t ref. DG(SANTE) 2019-6633 of the audit carried out from 26 November , their ingredients and traceability on Proposed by the competent authority

Competent authority response received on 9 and 16 March 2020 Guidance for non-compliances under Feed Official Control issued by DGAV f central level was already improved in order to define the subsequent measures to adopt after the verification of a non-compliance label at FeBO establishment level (Annex V, Sections I.1., III.2.and III.3.). Date of action proposal - 06.2020 Reinforce label controls will be considered under CAA, by regular submission of labels by FeBO to regional DGAV Services (DSAVR) followed by documentary evaluation with adequate check list according to annexed template Adobe Acrobat Document DGAV is also working with IACA (National Association of compound feed manufacturers) on a national CGP for labelling

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A systemic shortcoming was noted by the audit team in terms of the preparation of final samples from the aggregate samples for control of substances where non-uniform distribution of the analyte/substance is presumed. The inspectors would normally use simple manual mixing to ensure appropriate homogenisation rather than special equipment (e.g., mechanical or automatic dividers) which is required by part 9(4) of Annex I to Regulation (EC) No 152/2009. For substances with a non-uniform distribution, simple manual mixing alone cannot ensure complete homogenisation of the aggregate sample. The DAA informed the audit team that mechanical dividers are not available for the DSAVR inspectors, but the third party designated for sampling in certain cases (albeit very minor proportion of the official samples; see finding 39) do have the necessary equipment.

The audit team examined a number of laboratory reports and noted that not all of the parameters (i.e. expanded measurement uncertainty, correction for recovery and moisture content), necessary for interpretation of the results in accordance with the requirements laid down by part C(6) of Annex II to Regulation (EC) No 152/2009, had been reported and thus could not been taken into account by the DAA when making its decision on compliance. In addition, the laboratory reports seen did not provide an unambiguous statement that the number of analytical determinations for non-compliant results had been in accordance with the requirements laid down by part C(3) of Annex II to Regulation (EC) No 152/2009. 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 this element of official controls is weakened by the competent authorities' failure to adhere to planned arrangements and by the fact that the representativeness of sampling, and thus samples' legal and analytical validity, is not ensured for substances with a non-uniform distribution.

The interpretation of the analytical results does not take into account all required parameters thus weakening the legal validity of the decisions made by the competent authority on compliance. 5.2.3 Actions taken on non-compliances

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hat concerns Finding 49, DAA has already taken an action for s, the acquisition of mechanical dividers for all regional units lved in feed official control plan (Annex VI). hat concerns Finding 50, DGAV cannot support the lusions related to the lack of parameters for interpretation of lts in accordance with the requirements laid down by part C(6) nnex II to Regulation (EC) No 152/200, and in what concerns very and uncertainty. Although in some laboratories, ytical reports do not refer them, a list is available for all the yses and nature of sample. (see comments on report for ing 50, as well as Annex VII). ver DGAV agrees with the lack of moisture content rmination. For this a letter was already sent to INIAV in order equest determination for moisture content on solid samples ected for analysis under CAA (Annex VIII).

g, Competent authority response received on 9 and 16 March 2020 ff In what concerns Finding 49, DAA has already taken an action for the acquisition of mechanical dividers for all regional units involved in feed official control plan (Annex VI). In what concerns Finding 50, DGAV cannot support the conclusions related to the lack of parameters for interpretation of results in accordance with the Page: 2 ties of Portugal in response to Report ref. DG(SANTE) 2019-6633 of the audit carried out from 26 official controls on feed additives, their ingredients and traceability Action Proposed by the competent authority requirements laid down by part C(6) of Annex II to Regulation (EC) No 152/2009, and in what concerns recovery and uncertainty. Although in some laboratories, analytical reports do not refer them, a list is available for all the analyses and nature of sample. (see comments on report for Finding 50, as well as Annex VII). However DGAV agrees with the lack of moisture content determination. For this a letter was already sent to INIAV in order to request determination for moisture content on solid samples collected for analysis under CAA (Annex VIII). Date of action proposal - 06.

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In every region visited, the audit team studied a number of non-compliances from previous controls (DGAV's area of responsibility). Examples included deficient labelling, HACCP-related deficiencies, and non-compliant sampling results. While follow-up of deficient labelling and HACCP-related deficiencies was largely adequate and effective, the audit team noted that, for non-compliant results on carry-over and exceeding maximum permitted levels for certain trace elements, the communication with the FeBOs had not contained an unambiguous request for corrective action and consequently no timeframe had been specified for the FeBO to remedy the deficiency(ies). Dedicated and comprehensive follow-ups were not properly carried out by the competent authority. No attempts had been made to ensure that the relevant FeBOs identified the reason(s) for the non-compliances and thus ensured that the issues would not recur. The situation observed is not in line with the requirements laid down by Article 54 of Regulation (EC) No 882/2004.

The audit team noted that there was reasonably detailed and adequate guidance on how to deal with non-compliances and the relevant actions to take ­ but only for Salmonella, processed animal proteins and forbidden substances (as per Annex III to Regulation (EC) No 767/2009). Conclusion on the actions taken on non-compliances

The fact that the competent authority (DGAV) does not ensure that the operators identify the reason(s) for all non-compliances identified and remedy those weakens the effectiveness of the overall control system. 5.2.4 Establishments producing/trading non-authorised (in the EU) feed additives and exporting or re-exporting them from the EU to a third country

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what concerns Findings 55 and 56, the guidance for non- y compliances under Feed Official Control has been already ded and improved, creating complementary action measures, ddiction to penalties, whenever non compliances are detected, ly analytical constituents, Salmonella, Feed additives, sirable substances, veterinary medicines, forbidden tances and processed animal proteins. (Annex V, Section III.). Page: 2

- Competent authority response received on 9 and 16 March 2020 In what concerns Findings 55 and 56, the guidance for non-compliances under Feed Official Control has been already amended and improved, creating complementary action measures, in addiction to penalties, whenever non compliances are detected, namely analytical constituents, Salmonella, Feed additives, Undesirable substances, veterinary medicines, forbidden substances Page: 3 ties of Portugal in response to Report ref. DG(SANTE) 2019-6633 of the audit carried out from 26 official controls on feed additives, their ingredients and traceability uthority ex V, Section III.). Page: 4

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y (a) A DGAV considera que o número de controlos realizados a produtores agrícolas, relativos a equipamento inspecionado é sfatório tendo em consideração que são controlados cerca de nd 10% dos produtores de vegetais em cada ano, (cerca de 150) e, inda, 1% (cerca de 1700) produtores que se encontram a beneficiar de ajudas financeiras no âmbito da condicionalidade. Paralelamente, de modo a melhor conhecer o universo de amentos em uso, foi acordado com o Instituto Nacional de Estatística, ainda durante 2018, a introdução no inquérito às explorações a realizar, no âmbito do Recenseamento Agrícola a iniciar em outubro de 2019, de questões que permitirão identificar o universo dos principais equipamentos de pulverização em uso. Ainda, no âmbito do PANUSPF 2018-2023 está prevista a constituição de um Grupo de trabalho até final de 2019, com coordenação da Direção-Geral de Agricultura e Desenvolvimento Rural, com diferentes entidades do MAFDR, Ministério da Economia, Ministério da Solidariedade, Emprego e Segurança Social com vista à preparação de um quadro legal que regule o registo obrigatório de máquinas e equipamentos, incluindo os de aplicação de produtos fitofarmacêuticos. A DGAV ir

(a) The DGAV considers that the number of checks carried out on agricultural producers in relation to inspected equipment is satisfactory, bearing in mind that around 10% of plant ducers (approx. 150) are inspected every year 8 as well as 1% of producers (approx. 1 700) who benefit from financial aid under cross- compliance. In parallel, in order to improve our f knowledge of the equipment in use, in 2018 it was agreed with the National Statistical Institute incorporate into the survey for farms to be conducted as part of the Agricultural Census from October 2019 questions that would allow us to identify the main spraying equipment used. In addition, under PANUSPF 2018-2023, it is planned to set up a working group by the end of 2019, to be coordinated by the Directorate- General for Agriculture and Rural Development and involving different bodies from the Ministry of Agriculture, Forestry and Rural Development, the Ministry of the Economy and the Ministry of Employment, Solidarity, and Social Security, to prepare a legal framework governing the 1 Ref. Ares(2019)5173100 - 09/08/2019 mendations (updated) received 4/10/2019 ubmitted by the competent authorities of Portugal in response

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The audit team saw two paper questionnaire draft replies (not yet sent to the official services) and several online replies. The producers had marked a number of parameters as 'not being a risk factor' although they had no available data and/or they should clearly have identified them as risk factors. For example, after replying that they had no measurements of relative humidity, gas (CO2 or NH3) concentrations, and/or active ventilation systems (with temperatures in summer frequently exceeding 30°C) none of these was considered a risk factor. The only factor that producers were almost 7 unanimously considering a risk factor was the quality and amount of enrichment material. This, together with registering tail biting were the only areas for improvement included in the holdings' action plans that the audit team saw. Pig sector associations

There is a defined level of tail biting below which pig producers will have to start rearing some batches of pigs with full tails. However, the fact that producers are not yet correctly identifying all risk factors for tail biting is likely to cause significant delays in rearing the first batches of full tail pigs or to result in major tail biting outbreaks in those batches.

The audit team asked why those were the only risk factors identified for improvement. Both producers indicated that those were the only two parameters (chains not being adequate as enrichment material, and lack of registers of tail biting) for which they were not in compliance with mandatory criteria.

Temperatures inside the houses were 35°C and higher (with only a few animals in a few pens showing signs of discomfort, panting), and a number of pigs were concentrated around the bowl drinker in most pens and episodically competed for access to it. Both producers considered these conditions normal and did not identify them in their draft risk assessment as areas for improvement (see also paragraph 29).

Both producers dealt with tail biting outbreaks in similar ways by using management measures such as identifying and separating the biter(s) and/or treating the tails of bitten animals with drying agents. However, they kept using the same enrichment material of only marginal interest, chains, or other marginal or suboptimal materials such as plastic toys.

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The DGAV will seek, in collaboration with the FPAS (Portuguese g in Federation of Pig's Association) and the "Sociedade Científica de Suinicultura" (Scientific Society of Pig Farming), to promote clarification sessions on the theme of tail-docking and management of pig farms. The training curricula of pig farmers will be reviewed within the framework of Animal Welfare, with the aim of consolidating the knowledge on risk factors of tail docking and their prevention. We will seek to strengthen the need to implement the requirements regarding the competence, experience and training of the pigs' holders, with the FPAS and the "Sociedade Cientifica de Suinicultura" (Scientific Society of Pig Farming). The dissemination of the material prepared by the DGAV will be reinforced, within the scope of the reduction of tail-docking, prevention of tail docking and the use of manipulable materials.

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Until 2019, the official control reports indicated that routine tail docking was performed but reported this as compliant despite lack of evidence at holdings of injuries to sows' teats or to other pigs' ears and tails, which is not in line with the second paragraph of point 8 of Chapter I of Annex I of the Pig Directive. 10

DGAV updated the manual of procedures for official controls, and relevant associated instructions, in March 2019 (see also Annex 2). They included additional considerations for the official controls to determine if tail docking is to be considered non-compliance by referring to the two recently added compliance criteria, i.e. if the producer does not keep registers of tail biting or does not have an action plan with improvement measures then this should be considered non-compliant.

Official controls correctly detect routine tail docking but they report it as being compliant. This causes under reporting of non-compliances in pig farms in the annual report to the Commission (in connection with Commission Decision 2006/778/EC).

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The Animal Welfare Control Manual, used as a basis for official controls, will be revised with a view to reinforcing the need to register and consider non-compliant tail docking practice in line th the legislation (lack of tail docking records that justify tail docking and failure to take action on identified risk factors). In September/October 2019, targeted training actions for the technical staff of the Regional Directorates for Food and Veterinary (DSAVR) (training actions in different regions) are planned regarding the action plan for tail docking in pigs, where the need to improve the assessment of compliance with the legislation in this area will be reinforced. Within the context of cross-compliance controls, it is intended that from 2020 onwards, the legal criteria relating to the practice of routine tail docking will be assessed in more detail and taking into account the Action Plan and the replies to the producers' Page: 1 mber 2019 report ref. DG(SANTE)/2019-6750-MR of the audit carried out from 13 May tail-biting and avoid routine tail-docking of pigs Action Proposed by the competent authority questionnaires. This matter will be discussed with the local veterinary servi

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Until 2019, the official control reports indicated that routine tail docking was performed but reported this as compliant despite lack of evidence at holdings of injuries to sows' teats or to other pigs' ears and tails, which is not in line with the second paragraph of point 8 of Chapter I of Annex I of the Pig Directive. 10

The most recent official controls (in 2014 to one holding and 2018 to the other) did not report any non-compliance in either of these holdings. The only enrichment material present was chains (identified in the Commission Recommendation (EU) 2016/336 and accompanying Staff Working Document as insufficient to fulfil the essential needs) which, similarly to the absence of registers of tail biting, the producers had recently identified as an area for improvement.

In both holdings animals were in satisfactory conditions and, other than the lack of adequate enrichment material, the audit team did not observe any serious non- compliance with general rearing conditions.

Both producers dealt with tail biting outbreaks in similar ways by using management measures such as identifying and separating the biter(s) and/or treating the tails of bitten animals with drying agents. However, they kept using the same enrichment material of only marginal interest, chains, or other marginal or suboptimal materials such as plastic toys.

Official controls correctly detect routine tail docking but they report it as being compliant. This causes under reporting of non-compliances in pig farms in the annual report to the Commission (in connection with Commission Decision 2006/778/EC).

The new reference criteria have only been recently added to the official controls instructions and verification of their implementation has not started yet. The narrow scope of compliance criteria will prevent inspectors from fully enforcing these 13 requirements.

Medlemsstatens svar

The Animal Welfare Control Manual, used as a basis for official controls, will be revised with the aim of reinforcing the need to consider as non-compliant the exclusive use of chains, as well as routine tail-docking without complying with legal requirements. September/October 2019, targeted training is planned for the DSAVR technical staff (training actions in the different regions) regarding the action plan for tail docking in pigs, where the need to improve the assessment of compliance with the legislation and ction, the assessment of manipulable material will be reinforced. Within the scope of cross-compliance controls, from 2020 onwards, it is intended that the legal criteria regarding the practice of routine tail-docking and the use of manipulable materials are assessed in more detail and taking into account the Action Plan, the answers to the producers' questionnaires, as well as the good practices established and widely disseminated. This matter will be discussed with the local veterinary services at the next follow-up meeting of the Action Plan.

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In March 2019 DGAV established criteria (see also paragraphs 16 and 17) in the updated manual of procedures for official controls that correctly include a combination of both resource-based values and animal-based indicators as required in the Commission Recommendation (EU) 2016/336. Compliance criteria now added are that pig producers must keep records of tail biting and attempt improvement measures. Other added criteria are guidance instead of compliance criteria other than for those explicitly described in the Pig Directive such as slat width, stocking density where a specific value or measure is stated. Guidance criteria, values and indicators include: access to water and feed where it indicates a minimum number of drinkers, and minimum length of feeders available per animal and additionally indicates that the animals must have 'easy access'; gas and dust concentrations/presence where it provides maximum values that official controls should measure and additionally indicates some signs in the animals (i.e. inflammation of the eyes or respective mucosa and/or breathing problems) of the excessive presence of those gases and dust.

In adopting guidance criteria, referenced in paragraph 12, Portugal has failed to define the necessary level of compliance criteria to enable official controls and the pig sector to make an assessment of compliance with the legal requirements of the Pig Directive and of Directive 98/58/EC. Action plan

The competent authorities together with producers, veterinarians and scientific support produced comprehensive guidance and monitoring tools. The authorities will have difficulties to enforce existing legislative requirements related to risk factors as the new criteria they set are mainly guidance instead of compliance criteria.

Portugal's adoption of mainly guidance instead of compliance criteria (see also paragraph 12) for the requirement s of the second paragraph of point 8 of Chapter I of Annex I of the Pig Directive on the avoidance of routine tail docking prevent it from fully complying with its obligations under EU law. The authorities do not regard producers who do not respect the values for the guidance criteria added to the official instructions (such as easy access to feed and water, thermal comfort, sufficient air renewal, gas concentrations, sufficient enrichment material) as non-compliant.

However, Article 2(b) of Commission Recommendation (EU) 336/2016 restates the obligation of Member States to establish compliance criteria with the requirements set out in the legislation. Such mandatory criteria are necessary for official controls to be able to enforce the legislative requirements effectively.

The audit team asked why those were the only risk factors identified for improvement. Both producers indicated that those were the only two parameters (chains not being adequate as enrichment material, and lack of registers of tail biting) for which they were not in compliance with mandatory criteria.

The new reference criteria have only been recently added to the official controls instructions and verification of their implementation has not started yet. The narrow scope of compliance criteria will prevent inspectors from fully enforcing these 13 requirements.

Instructions for official controls under those new requirements are adequate. However the producers' lack of recognition and acceptance of several stress factors present for tail biting, combined with most additional criteria being only guidance, may cause major delays, or even refusal, from producers to act on official controls' indications of areas they should improve.

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The Animal Welfare Control Manual, used as a basis for official controls, will be revised, seeking to improve the way legal requirements are assessed (linked to risk factors for tail docking) d the indicators to determine their non-compliance (animal and resource based indicators). Instructions to producers will be drawn up on the basis of the criteria to be reviewed in the context of controls and found to be non-compliant. Page: 2

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BACKGROUND The 2011 audit identified that the implementation of the residue monitoring plans of 2010 and 2011 was insufficient due to budgetary problems, causing delays to analyse samples taken and consequently limited the effectiveness of follow-up activities in the event of non-compliant results. The reliability of analytical results was also undermined as not all of the methods used for testing samples under the plan were validated. The legal requirements to permit slaughter of horses only on the basis of food chain information contained in the horse passport had not always been respected.

While planning of the residue monitoring plan is in line with EU requirements, the scope of antimicrobial substances planned to be tested is limited in relation to the list of such substances authorised for use in food producing animals and knowledge of their use based on available sales data. 3 5.1.3. Implementation of the residue monitoring plan Legal Requirements Articles 3, 4, 10 and 12 of Directive 96/23/EC; Articles 3, 4, 6 and 8 of Regulation (EC) No 882/2004; Commission Decision 97/747/EC; Commission Decision 98/179/EC; Commission Directive 2002/63/EC; Commission Regulation (EU) No 589/2014; Commission Regulation (EC) No 333/2007; Commission Regulation (EC) No 401/2006; Article 69 of Directive 2001/82/EC; Annex I, Part A III, point 8(b) to Regulation (EC) No 852/2004 of the European Parliament and of the Council; Annex II, Section III, point 3(c) to Regulation (EC) No 853/2004 of the European Parliament and of the Council; Article 5 and Annex I, Section I, chapter IIA, point 1 of Regulation (EC) No 854/2004 of the European Parliament and of the Council; Commission Implementing Regulation (EU) 2015/262. Findings

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e With regard to this recommendation, an exhaustive survey was carried out at the re beginning of April, internally at the DGAV with the Veterinary Medicines Unit, with ioned the Animal Feed Unit and the Public Health Unit. In this work a comparison was made of the molecules of group B1 mentioned in table 1 of Regulation no. 37/2010, with the most sold molecules and used in medicated feed, with the critical molecules defined by WHO and with those already included in the National Residues Monitoring Plan (NRMP), in order to find the molecules that, based on a risk assessment, should be included in the Plan. Based on the results of this assessment, a meeting was held with the National Reference Laboratory (INIAV) to agree on the molecules to be included in the National Residues Monitoring Plan, from the list below, presented as a priority by the DGAV. Class Substance Validated Molecules Requested Molecules to be Standards tested (Competition quinolones Danofloxacin 2018) sulphonamides oxolinic acid ciprofloxacin enrofloxacin tiamulin marbofloxacin Sarafloxacin Difloxacin sulfacloropyridine sulfadiazine sulfadimetoxin sulfadoxin sulfametazole sulfamethoxazole sulfapyridine sulfadimidi

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ed as The recommendation is based on facts that occurred in 2016 and were largely g overcome in 2017, as a result of the accreditation of the INIAV to carry out the and analyzes of group B1. In 2018, the contracts with the INIAV and the External Laboratory comprise approximately 99% of the total analyzes of the plan. These contracts have already been concluded and samples have already been taken regarding these two laboratories. The remaining samples (1%) are sent to national laboratories (Portuguese Institute of the Sea and the Atmosphere (IPMA) and the Economic and Food Safety Authority (ASAE). Regarding the IPMA the contract is already signed and instruction to start sampling has already been issued . Regarding the ASAE, the proposal submitted by this body was deemed to exceed the proposed base price, and so in light of the Public Contracts Code (PCC) the proposal was rejected and a new procedure for an international public contract was initiated.

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At the first FCM manufacturer (producer of PET bottles) the inspectors verified the DoC of the ready-to-use bottle, asked questions regarding the raw materials used, identified an issue with regard to surface/volume ratio and also requested to see the supporting documents. The inspectors confirmed that they were not able to go further on what is already stated in the DoC since more expertise is needed. 13

The second FCM manufacturer (PET bottles blower) was inspected for the first time in relation to FCM. DoCs concerning raw materials and final products were requested and evaluated by the inspectors. However no further supporting documentation was requested and the inspectors did not ask for the risk assessment performed by the BO concerning the blowing procedure in order to evaluate the effect of the process.

At the third manufacturer, the inspectors carried out a verification check in relation to FCM (see paragraph 31). The inspectors examined additional documents provided and decided for which areas action was still required by the BO. They stated that they do not have the expertise to evaluate the completeness of the DoC and the supporting documentation. They informed the audit team that they can only evaluate what the BO provides to them. If a substance is not mentioned in the DoC they do not have the expertise to find out if such a substance is not present in the formula or is not mentioned for whatever reason.

The audit team observed that inspectors rely mainly on what the BOs provide to them during the inspections concerning manufacturing procedures and risk analysis including the presence of non-intentionally added substances (NIAS). The inspectors have limited expertise to evaluate the formula for a product or to identify if information concerning certain substances is missing. There was no documentary evidence that they systematically requested organoleptic test results from BOs.

The audit team noted that official controls on plastics, in most cases, do not include sufficient checks on the supporting documentation for statements in the DoC (final product). In particular, the following were missing: An assessment of the supporting documentation relating to the completeness of laboratory results in matters of SML or organoleptic tests; An assessment of NIAS ­ e.g. impurities, reaction products and decomposition that can occur during the processing of a granulate into the final product; A verification of the BO's risk assessment required under Article 19 of Regulation (EU) No 10/2011.

At one DRAP visited the audit team noted that the evaluation of DoCs covers the formal aspects. The inspectors stated that they do not have the expertise to evaluate the formula of the product and thus they are not able to determine if a substance is not present in a product or if the DoC is incomplete. In a particular case, and although the DoC was forwarded to the NRL and DGAV for their opinion on whether to carry out sampling, neither provided feedback advising DRAP's inspectors that the specific DoC was incomplete (substance missing), since they also rely completely on the information provided by the BO.

The CCA informed the audit team that the risk assessments carried out by FCM manufacturers and/or processors, for substances referred to in Article 19 of Regulation 14 (EU) No 10/2011 had to date not been requested and therefore not evaluated by the inspectors since that requires specific knowledge and expertise and support from central level. However, such a support was not available (and it had never been sought) at the time of the audit.

Hazard Analysis Critical Control Points (HACCP) plans are evaluated by the inspectors also in relation to the chemical hazards associated with FCM used. However, concerning FCM, the inspectors during the documentary checks relied on the information provided by the FBO rather than checking whether chemical risks associated with FCM foreseeable use are adequately identified and managed by the FBO2. 2 In their response to the draft report the CCA noted that relevant questions of this topic can be raised during the visit to the facilities. 15

Regarding this specific case the audit team requested that the inspectors sought an expert opinion. Based on the information they collected on-the-spot a draft expert opinion was prepared by central level identifying certain non-compliances related to the articles/ FCM selected. Some non-compliances not related to the DoCs had not be identified by the inspectors during their control but were mentioned in the expert opinion. The expert opinion drafted contained information on what the inspectors should additionally request of the FCM retailer to be able to conclude whether the article/FCM in question complied with the legal requirements.

ASAE informed the audit team that FCM controls were not a priority at the time of the audit and therefore advice/guidance from central level was rarely sought. It was explained that in 2016, and although a few non-compliances were identified related to the DoC, the possibility of requesting an expert opinion was not availed of.

The audit team examined a case of such a documentary check and saw that the relevant information DoC and supporting documents were attached to the file. The analysis mentioned on supporting documents related to ceramic material whereas the actual import concerned a plastic material. This was not identified by the inspectors during the import control.

During official controls inspectors are able to verify the presence of DoC and, to a certain extent, to assess the completeness of those declarations. Limited controls were made on the completeness of supporting documentation for the DoC, which would lead to inadequate or incomplete risk assessments/DoCs being overlooked. Thus, non- compliant products might go undetected and correct application of the relevant legislation would not be enforced.

The effectiveness of the controls in place is hampered by the fact that inspectors are not suitably trained or experienced to evaluate compliance of FCM legislation, including a thorough analysis of the DoC and supporting documentation. Expertise available at central level is rarely sought3. 3 In their response to the draft report the CCA noted that concerning two DRAPs visited, whenever doubts are raised, an official request for support is sent to the Directorate-General for Food and Veterinary Matters - Department for Nutrition and Food. Different situations may result from the fact that the level of knowledge differentiation among the technicians carrying out the checks is still such that they are not able to determine the relevance of any questions that should perhaps be raised. 17 5.2.5 Official Sampling Procedures and Laboratory Performances Legal Requirements Article 4(2)(c), Article 11, Article 12(1), (2) and (3) and Article 33 of Regulation (EC) No 882/2004. Findings

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Conclusion: 94 ing Associated findings 71, 72, 74, out in The DGAV has already promoted the disclosure of new rocedures to the DRAP/RA regarding the request for evidence ed by concerning the risk assessment of operators and the verification of the organoleptic analyzes of the products. These requirements will be placed on the new version of the control checklist as mandatory issues to be assessed in the course of EO. Associated findings: 91 The procedures for documentary analysis of FCM at import control points were prepared at the end of 2017. These procedures are organized in order to avoid such errors. However the DGAV has already warned about the detected faults during the audit and in the coordination meeting to be held at the end of September, but will again draw attention to the referred detected faults. Conclusion 95: Associated findings 67, 68, 69, The training of the DRAP/RA inspectors who are mostly agronomists or veterinarians is undoubtedly one of the major limitations to the correct implementation of this CPCM plan. However, with the DGAV support, Portugal will continue to invest in the training of inspectors, either through the promotion of training in collaboration

Conclusion: 94 ing Associated findings 71, 72, 74, out in The DGAV has already promoted the disclosure of new rocedures to the DRAP/RA regarding the request for evidence ed by concerning the risk assessment of operators and the verification of the organoleptic analyzes of the products. These requirements will be placed on the new version of the control checklist as mandatory issues to be assessed in the course of EO. Update response of 10th May 2019 The new version of checklist with the requirements referred in the findings is already concluded (see annex, specifically on items B3, B4, B5, C6). Associated findings: 91 The procedures for documentary analysis of FCM at import control points were prepared at the end of 2017. These procedures are organized in order to avoid such errors. However the DGAV has already warned about the detected faults during the audit and in the coordination meeting to be held at the end of September, but will again draw attention to the referred detected faults. Update response of 10th May 2019 In coordination meeting on Import control (FNAO+FCM) held in 6 November 2018, DGAV recapped the specific procedures regarding the import of plastics and ceramics,

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In relation to its NRL duties, the laboratory has not undertaken coordination activities with the other official laboratories dealing with FCM, including organising comparative tests, which is detrimental to enhanced high quality and uniformity of the analytical results. 5.2.6 Procedures for Performance and Reporting of Control Activities Legal Requirements Articles 8 and 9 of Regulation (EC) No 882/2004. Findings

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t is recognised that the national network has been not very active analysis in the recent years. However, all listed laboratories participate in ILABs exercises in their specific scope of analyses: CTCOR in cork, CENCAL in ceramics; etc. Given the small size of the country and respective FCM market, the various laboratories do not overlap in extent, exception to the overall migration that is covered in most of the schemes where the laboratories participate. Proposed actions: - invite OCLs to participate in JRC schemes when this possibility is open to others than the NRL and when the work is under the capability of those lab; - disseminate by email, information received from JRC meetings. Page: 2

t is recognised that the national network has been not very active analysis in the recent years. However, all listed laboratories participate in ILABs exercises in their specific scope of analyses: CTCOR in cork, CENCAL in ceramics; etc. Given the small size of the country and respective FCM market, the various laboratories do not overlap in extent, exception to the overall migration that is covered in most of the schemes where the laboratories participate. Page: 3 of report DG(SANTE)/2018-6376 AUDIT THAT TOOK PLACE IN PORTUGAL L SYSTEM IN FORCE FOR MATERIALS INTENDED TO COME INTO he work een the Labs rmation about nnual meeting ed in these rward up to mme was Page: 4

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The audit team visited a freezer vessel in the Azores approved in February 2010 (date of attribution of the approval number). During the audit team visit, the inspectors indicated that a Hazard Analyses and Critical Control Point (HACCP) plan was not in place in January 2017 during an official inspection to maintain the approval and that it had taken one year for the operator to correct the non-compliance. The audit team while reviewing the official report on the 2017 visit, noted that this finding was not recorded and that the approval was not questioned. The next official control report dated October 2018 and indicated that a HACCP was implemented. During our current visit, the audit team noted that the HACCP plan showed had been created in April 2017 (i.e. after the inspection to maintain approval).

The situation described above, i.e. approval without an HACCP plan in place, is not in compliance with Article 31 (2) (c) and (d) Regulation (EC) No 882/2004. Conclusions on registration/approval of food business operators' establishments.

However, in one autonomous region, the approval of a freezer vessel did not respect the EU rules, in particular Article 31 (2) (c) and (d) Regulation (EC) No 882/2004.

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on Currently, both the DGAV and the Autonomous Region of deira follow the approval procedures described in point 7 "Approval" of the Plan for the Approval and Control of Establishments, 2012-2016 The Autonomous Region of the Azores has its own documentation, and the approval procedures are described in the document "Pace-Açores-Instruções de Trabalho". ("Pace- Azores- Working Instructions"). However, it should be noted that, since the separation between the Establishments' Control Plan (official control) and the approval procedures (official control task as defined in Regulation 2017/625) was carried out in 2018, the DGAV is currently in the process of finalizing the Manual of Approval Procedures, which shall be used by all the Entities with competence to Approve. In this Manual, in addition to all the procedures to be adopted following an application for approval of an establishment/activity, there are checklists adaptable to each activity, which shall be used in the inspection prior to the approval. These lists, allow verifying and confirming that the establishment complies with all legal requirements for final or conditional approval. This Manual also contains the obligation for

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The absence of a monitoring programme of food additive intake impedes efforts to update Community law on food additives in a proportionate and effective way.

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After the exploratory study the next steps for the implementation of the monitoring programme are: Simplify and streamline the process improving the food consumption assessment tool. Although estimates of food additives intake have been obtained, for the future implementation of the monitoring system, the tool for the evaluation of food consumption need some adjustments to simplify and streamline the process. Networking - create a network of public schools representative of the school population where food questionnaires will be periodically carried out. - network with food industry to collect the approximate "real" levels of additives added to each type of products to refine the estimate. - network with the other competent authorities to collect and analyse samples contributing to intakes exceeding ADIs to further refining the estimate. Page: 1

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O Instituto da Conservação da Natureza e das Florestas, I.P. (ICNF, I.P.), enquanto Autoridade Florestal Nacional e entidade responsável pela implementação de ações de contenção e controlo do Nemátodo da Madeira do Pinheiro (NMP), promoverá e zelará pelo cumprimento das medidas de emergência estabelecidas contra a sua propagação na União, e, bem assim, pela implementação das ações enquadradas dentro da esfera das suas competências orgânicas, com especial enfoque para a zona tampão, incluindo igualmente áreas territoriais a estas adjacentes, essencialmente no que se refere: às prospeções anuais sobre os vegetais suscetíveis e o vetor nas zonas tampão por inspeção, amostragem e realização de testes sobre os vegetais e o vetor para a deteção da presença do nemátodo da madeira do pinheiro; e à identificação e eliminação dos vegetais suscetíveis que estiverem mortos, com sintomas de declínio, ou que se encontrem em zonas afetadas pelo fogo ou pela tempestade, tomando todas as precauções necessárias para evitar a propagação do NMP e do seu vetor. Com o objetivo de responder cabalmente e de forma eficaz e eficiente às exigências e níveis de amostragem requeridos, o ICNF, I.P., prevê que a

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Live animals After consulting the BIP, we will include, as precise as possible and as soon as possible, instructions in the manual concerning ctions to be taken in case of non-compliances related to documentary checks. Products of animal origin As regards controls on consignments to animal products which ll within the competences of the DIM: The Operations' Manual in the BIP was reviewed in 2017. It is expected to be published by the end of 2017. The current BIP Manual was reviewed and its publication is expected to be completed and implemented by the end of 2017. At the meeting, examples of administrative errors that may be accepted by the BIP will be given to the official veterinarians of the BIP/coordinators, and of any situation that calls into question the certification should be considered serious and lead to rejection of the consignment. Products of non-animal origin Regarding 6 c., 24, 25, 26, 27, 34, 38 and 43 (old recommendations and findings) 1. During the audit, the Regional Directorate of Agriculture and Fisheries of Lisboa e Vale do Tejo (DRAPLVT), in conjunction with the Directorate for Nutrition, Food and Feed (DSNA- DGAV), took immediate actions regarding this issu

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The implementation of documentary checks is generally carried out correctly in BIPs and DPEs and performed using all available information, with some exceptions. The non-compliances identified by the audit team in relation to documentary checks of racing pigeons and food of non-animal origin weaken the system of import controls and may endanger animal and public health.

When the DPEs and BIPs identify non-compliances during the documentary check, they take appropriate action. However, in some notable cases, consignments were accepted without the required health guarantees, which could lead to the import of live animals, food and feed which does not comply with the EU health requirements, potentially causing a risk to public and animal health.

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ortugal will follow the Commission indications. Also, and equently to the referred by the Commission (...The estions from your services on proposed modifications of the al health legislation pertaining to the importation of racing ons from non-neighbouring third countries have been passed he relevant Commission services...) our Animal Health ices will, in the framework of their competence, follow the er with the Commission. Page: 7

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IGAMAOT stated that the requirement for independent scrutiny of the audit process was a matter of internal concern and that they appreciated the opportunity provided by the DG SANTE audit to discuss the issue and to conduct an independent examination of IGAMAOT's audit process required by Article 4(6) of Regulation (EC) No 882/2004. However, the DG SANTE audit team noted that there are no planned arrangements in place to ensure that this requirement is met on an on-going basis. The Network Reference Document on Independence and Independent Scrutiny (February 2014 - Version 1) defines the independent scrutiny as a "...regular and planned process...". The DG SANTE audit team consider that the DG SANTE audit provided independent scrutiny but is not sufficient to ensure on-going compliance with the requirement for independent scrutiny foreseen by Article 4(6) of Regulation (EC) No 882/2004. Conclusions

No arrangements have been put in place by IGAMAOT to ensure independent scrutiny of the audit process. This means that it misses an opportunity to receive inputs for promoting continuous improvement of the audit process. 10 5.2.3 Auditor competence 5.2.3.1 Legal requirements Articles 2(6) and 4(6) of Regulation (EC) No 882/2004 do not lay down specific requirements regarding the competence of auditors. Article 6 of the same Regulation requires that staff performing official controls "receive, for their area of competence, appropriate training enabling them to undertake their duties competently" and "keep up-to-date in their area of competence and receive regular additional training as necessary" Section 6.6 of the Annex of Commission Decision 2006/677 provides guidance on auditor competence: "Auditor competence and selection criteria should be defined under the following headings: -- generic knowledge and skills -- audit principles, procedures and techniques; management/organisational skills, -- specific technical knowledge and skills, -- personal attributes, -- education, -- work experience, -- auditor training and experience. It is essential to put a mechanism in place to ensure auditors are consistent and their competencies are maintained. Competencies required by audit teams will vary depending on the area they are auditing within the control or supervision systems. As regards the technical knowledge and skills required by auditors, the training requirements for staff performing official controls (Chapter 1 of Annex II to Regulation (EC) No 882/2004) should also be considered." 5.2.3.2 Findings

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IGAMAOT has already prepared a proposal to the Minister of Agriculture, Forests and Rural Development for implementation of regular external scrutiny, in addition to the EC, of the audits system implemented by the General Inspectorate. These are based on two possibilities for implementing the recommendation: - For national CAs - a) Review of the audit process, on the one hand, to be carried out by the General Inspectorate of Finance, or by the internal audit service; and b) Evaluation of the audit universe, risk analysis-based planning, and of the effectiveness of the audit, to be carried out by the Scientific Council of ASAE. - For European CAs ­ Full review of the audit system, with a peer review approach, by two Member States (Experts from the National Audit Systems Network). Updated response received 22 May 2018 The regular external scrutiny of the audit system in IGAMAOT implemented is based on: a) Review of the audit process, regularly carry out by IGAMAOT internal audit service; and Approval of the audit universe and the risk analysis-based planning by the entities of the National Audit System on Regulation (EC) No 882/2004. Page: 1 ority on 22 May 2018 ort ref. DG(SANTE)/20

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iannual Audit Programme is underway, in close collaboration between IGAMAOT and to systematically and exhaustively apply the risk analysis odology developed by IGAMAOT to all of the approximately 60 atic sub-domains of official control. he end of the risk evaluation work, in January 2018, joint ning of the audits will take place for the next five-year cycle 9-2013), based on a suitable frequency established on the basis of , and in order to prevent omissions and overlaps in the coverage of audit universe. exercise will be repeated every year, updating the risk analysis of audited areas, through the results of the audits or of the follow-up ons, which may indicate that the multi-year and annual audit rammes should be adjusted (in particular, the frequency of the t of each thematic area, which may be increased or decreased). regard to the completion of the 2014-2018 audit cycle, the ned audits will be carried out, and will ensure full coverage of the t universe. ific audits r sporadic and specific audits may, each year, be instructed by authorities, or initiated by IGAMAOT to the authorities, through cumented proposal based on facts ascertained in audits or other ons, to be carried o

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The audit programme of DGAV foresees the coverage of all national control plans as defined in the MANCP to be audited at least once in the five-year cycle. There are 30 such areas and in some cases an audit can cover more than one area of activity (e.g. official import controls at the border inspection posts and the RASFF). The CCA commented that the multi-annual audit programme has considered the risk that each area represents. In addition, in the preparation of the annual audit programme the CCA considers the results of previous audits, emerging issues and requests from regional authorities, and adds a maximum of 10% to the total number of routine audits (so-called sporadic audits) for such areas. The CCA explained that the higher risk areas are audited more than once in the five-year cycle but this selection and the prioritisation over the lower risk areas is not documented. Therefore it cannot be demonstrated and justified why some thematic areas are selected for more frequent audits than others.

In 2013, IGAMAOT developed a comprehensive risk analysis methodology to be used in the preparation of the audit programme. This methodology was communicated to DGAV as a tool to be considered in the preparation of their audit programme. The audit team noted that this methodology has not been systematically used so far by either CCA.

The CCAs have properly defined certain audit areas (e.g. animal health controls are defined by different thematic areas, namely eradication and monitoring of tuberculosis and brucellosis in ruminants, bluetongue disease, transmissible spongiform encephalopathies, Salmonella control programmes in poultry, avian influenza, diseases of farmed fish, bee health, etc.). However, some other areas are not sufficiently detailed (e.g. the approval and control of establishments covers meat, meat products, and fish but is it not made clear how different types of meat are categorised based on the varying foodborne hazards inherent to each type and whether catering facilities, restaurants etc. are considered and/or covered). IGAMAOT provided during the audit an updated map (audit universe) of the areas of official controls.

The CCAs have arrangements in place audit programming and the effective coverage of the defined areas of official controls in the five-year audit cycle. However, the process for developing the audit programme is not well-documented or transparent and it is not clear as to the order of its risk-based prioritisation. The CCAs could not demonstrate the risk basis for deciding the frequency of auditing of specific areas.

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A of the Autonomous Region of Madeira will proceed with the mentation of the auditing system for application of Article 4(6) gulation (EC) No 882/2004: DGAV/Audits Office will carry out s of the official control systems of this regional CA. To this end, A of Madeira will endeavour to establish a written agreement for boration with DGAV on the conduct of audits. ed response received 22 May 2018 udit system implemented for application of Article 4(6) of ation (EC) No 882/2004 in the Autonomous Region of ra is based on the collaboration with DGAV: e CA of Madeira established with DGAV a written greement for collaboration on the conduct of audits. AV/Audits Office will carry out audits of the official trol systems of this regional CA, from October 2018. Page: 3

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Although the DG SANTE audit focussed on these two main CAs based on the assessment of the audit arrangements for the coverage of the official controls in Portugal, the audit team requested clarifications as regards the extent to which Madeira implement Article 4(6), as no information was available during the audit. The competent authority in Madeira in a reply to an IGAMAOT email confirmed that no audit arrangements are in place to cover the official controls in that region. In this context, it is worth positively highlighting the Azores model, in which an agreement between the regional CA and DGAV is in place to ensure compliance with Article 4(6). The audit team noted that this is a useful model for dealing with the challenges of implementing Article 4(6) on small islands with autonomous regional CAs.

The multi-annual audit programme agreed between DGAV and IGAMAOT (see findings 3 and 4) does not cover the official controls in Madeira, for example, the border inspection posts and the Rapid Alert System for Food and Feed (RASFF). This means that the arrangements in place for the co-ordination to ensure a seamless audit process across the relevant competent authorities are not sufficient in the case of the audits on official controls in Madeira. IGAMAOT stated that its co-ordinating role covers the auditing of official control systems in the mainland of Portugal, but nevertheless, the Madeira CA is always invited to the co-ordination meetings but has attended only once. Conclusions

The absence of an audit system in Madeira means that the official controls in that region are not subject to a systematic and independent examination and there are no guarantees on the extent to which the official controls systems comply with the relevant EU legislation and meet the objectives of Regulation (EC) No 882/2004. 7

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However, the DGAV informed the audit team that at another inspection point at Lisbon port the unloading bay at the place of inspection is too limited and that it is not possible to fully unload the consignment from containers. They have been in discussion with other official services to obtain access to the adequate place of inspection which would allow complete unloading of the containers. This is not specifically required by Directive 98/22/EC, although the absence of such facilities means that the DGAV in not in a position to ensure that checks can be carried on the entirety or a representative sample of consignments, as required by Article 13a(1)(b)(ii) or (iii) of Directive 2000/29/EC. 12

The audit team noted that, with respect to sampling: The inspectors stated that during busy periods they take a sample to achieve 95% confidence level to detect 1% infestation level, otherwise they take a larger sample to achieve 99% confidence level to detect 1% infestation level in line with ISPM 31. In case of citrus fruits, inspectors confirmed that they apply a sample size of 200 fruits, based on the sample size required by Decision 2016/715, regardless of the origin of the lot being sampled. In the case of limes, imported from Columbia (two containers with 21 600 kg each), the inspector stated that four boxes were taken from the first two rows to compile the sample of 200 fruits. In this case the containers were not unloaded as it was not considered necessary because it was a mixed consignment of a regular trade from a known exporter with a good history of compliance. In the case of a mango consignment which consisted of 1 551 boxes (with 7 fruits per box), 64 boxes were taken to obtain a sample of 448 fruits for visual inspection (99% confidence level to detect 1% infestation level). The same approach was taken during the plant health checks of two other mango consignments. In all cases inspectors had access to the entire consignments of mango, but only took a sample for visual inspection from a single pallet, selected by the inspector. Inspectors stated that in the case of cut flowers consignment from Thailand (2 000 stems in 10 boxes) they selected five boxes and visually checked the entire content of each box.

The DGAV stated that concerning the representativeness of the sample, the inspection guide and instructions provide that samples should be taken from different parts of the consignment. Similarly, for containerised consignments, containers should be fully unloaded to allow proper inspection. However, the inspections observed by the audit team and interviews with inspectors confirmed that this was not always implemented. In addition to that, as noted in section 5.4.1 above, there was a lack of proper inspection facilities at one inspection post at Lisbon port which prevented access to consignments 14 in containers. The sample size is adequate, however, in certain cases, it could not be fully ensured that the sample was actually representative of the consignment, as required by Article 13a(1)(b)(iii) of Directive 2000/29/EC.

The import checks in Portugal are carried out meticulously, in line with EU legislation. However, due to the lack of facilities at one inspection post and the practice of taking all the samples from a single part of the consignment, in some cases the representativeness of the samples is not ensured.

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n In response to point 59, we would inform you t that a protocol has been prepared with the veterinary control services, part of the DGAV, which will be signed in the very near future in order to allow plant health inspectors to use some of the facilities of the former, thus making it possible to unload the full content of the containers. A partir do próximo dia 20 de julho, os serviços de inspeção fitossanitária no porto de Lisboa passarão a dispor de mais um cais de encosto para abertura de contentores e de uma área suficiente para albergar a totalidade das paletes transportadas no seu interior, passando assim a ser possível descarregar por completo o conteúdo dos mesmos. With regard to the issue dealt with in the fourth indent of point 66, and referred to again in point 67, the DGAV will reinforce instructions that all plant health inspectors must ensure that the consignment is both of a suitable size and sufficiently representative Page: 1 tions received 30 May 2018 bmitted by the competent authorities of Portugal in response to Report ref. DG(SANTE)/2017-6146- 29 November 2017 in order to evaluate the system of import controls for plant health nt authority spection. in future

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Based on data provided by the ICNF, the audit team estimated that overall, one FTE was responsible for the survey and monitoring of more than 100,000 ha. The ICNF staff involved in these tasks confirmed the difficulty in doing everything in a timely manner in such a big area, especially for those who were also responsible for other tasks. The audit team indeed noted that despite the motivation of staff, they had difficulty to keep up with all their tasks in the territory they were responsible for (see section 5.4). 5.1.4 Laboratories

The system is undermined by human resources available which are too limited to ensure that all PWN-related control measures are implemented throughout the buffer zone in accordance with the national plan or guidance (see sections 5.2.3 and 5.4).

In the two Regions visited, the regional service of the ICNF informed that the territory of the buffer zone had been divided up and allocated to different teams of one or two staff members. They stated that all the territorial units were visited at least once a year and that a number of them were visited more than once (see also section 5.2.2). Although their objectives was to identify as many trees dead or in decline in Autumn- Winter with a view to "clean" the buffer zone before the start of the flight season, the ICNF staff stated that it was not possible to visit all the territorial units during this period. After the Summer of 2016, allocation of resources had been increased in areas affected by fire in the district of Viana do Castelo and those affected by drought and close to the infested zone in the district of Castelo Branco. This had been done by shifting resources within Regions and requesting support from the central service of the ICNF.

The audit team noted that the FITO system did not cater for recording monitoring activities except when trees were identified and sampled. Several ICNF staff members involved in the monitoring stated that they had been working in the forest area and/or in the same Region for many years and did not need such a tool to make sure that all parts of the buffer zone under their responsibility had been monitored. Some of them were using printed maps to mark those territorial units monitored over a certain period. The ICNF informed the audit team that work had been initiated in order to adapt the national recording system FITO so that field teams could record their monitoring activities and the central service is able to monitor progress made and confirm that the entire buffer zone is monitored in a comprehensive and timely way. 15

The audit team visited the buffer zone in two Regions and noted that forest areas were in good condition, with the exception of areas affected by fire in the Region North. The audit team noted the presence of some declining trees in different locations. In a number of these locations, these trees had already been identified and sampled. In some other locations, only a portion of the trees had been identified and the ICNF stated that the additional trees would be identified (i.e. recorded in FITO) and sampled at felling. In other locations, dead or declining trees had not been identified and sampled although, in some cases, the ICNF staff stated that they were aware of their presence but had had no time to sample and record them in FITO. The audit team noted that many of the unidentified trees had started declining in the past few months.

The identification of trees dead or in decline and their sampling is largely performed in accordance with point 3(a) of Annex II of Decision 2012/535/EU. However, the fact that human resources are not sufficient to allow the identification, recording and sampling of all dead or declining trees 1) to always be done as soon as they are noticed by the staff involved and 2) throughout the buffer zone during the Autumn-Winter, prevents the timely elimination of these trees and therefore lead to a risk of PWN spreading into the buffer zone.

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O processo de identificação de árvores com sintomas de declínio (mortas, enfraquecidas, ou que se encontrem em zonas afetadas pelo fogo ou por tempestades e sejam suscetíveis à oviposição pelo inseto vetor do Nemátodo da Madeira do Pinheiro), está a decorrer em toda a extensão da Zona Tampão, sendo efetuado com caráter intensivo e observando os procedimentos estabelecidos pelo ICNF, de modo a garantir que a amostragem cobre adequadamente todo o território e que todo o arvoredo identificado com declínio é referenciado para respetiva eliminação. Igual ação está a decorrer na circunvizinhança da Zona Tampão, em especial nas zonas onde foram detetados casos positivos de NMP que se encontravam localizados a poucos quilómetros dessa zona. A identificação de árvores com declínio decorre anualmente, em função da disponibilidade das equipas do ICNF, conferindo-se prioridade às áreas de maior risco. Quanto aos recursos humanos envolvidos, o ICNF possui quadros técnicos, assistentes operacionais e vigilantes da natureza, localizados quer ao nível dos seus departamentos regionais, quer ao nível dos serviços centrais, que também apoiam a execução de ações no terreno, os quais se encontram dotad

The process of identification of trees showing A reorganization is being considered, symptoms of decline (dead, weakened or in based on the experience gained in the fire- or storm- affected areas and susceptible last 5 years, especially that resulting to egg-laying by the pinewood nematode from the impact of last year's forest fires. vector insect) is ongoing throughout the Buffer Zone, at an intensive pace and They are still being analyzed issues observing the procedures established by the related to the current capacity of ICNF and the identification of all the core ICNF in order to guarantee that sampling competence areas of the Institute, for properly covers all of the territory and that all which we have the greatest trees identified as showing signs of decline responsibility, like the implementation of are listed for felling. phytosanitary plant protection measures. Similar measures are being implemented in It is expected that during March 2018 a the area surrounding the Buffer Zone, new proposal of an organic law for the particularly in areas where positive cases of ICNF will emerge that looks for a PWN have been detected a few kilometres reinforcement of the intervention aw

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However, the audit team noted that the protocol only covers non PDO/PGI wines, and therefore ASAE does not report on the activities carried out on PDO/PGI wines. As a result, IVV is not aware of the result of controls on PDO/PGI wines carried out by ASAE. The audit team was shown several files where ASAE found severe non- compliances which had not been detected by the relevant CBs at those operators (one example is described in paragraph 53). ASAE did not inform IVV and therefore IVV could not use this information to evaluate the effectiveness of the controls carried out by the CBs at the same operators. This may affect the performance of the coordination and overseeing tasks assigned to IVV in Decree-Law 94/2004 and Decree-Law 66/2012. This lack of adequate coordination between the CAs is also not in line with Article 4(3) of Regulation (EC) No 882/2004.

During the closing meeting, both CAs stated that they cannot access all relevant information kept by the other CA (e.g. all details in the registry of operators kept by IVV and all results of controls carried out by ASAE as described in the previous paragraph). Specific information can only be obtained on demand, usually following complaints made by third parties. As a consequence, ASAE does not have all necessary information which may be needed by ASAE for an adequate planning of inspections at PDO/PGI operators. They also stated that it is foreseen to amend the protocol, with the purpose to address this weakness by improving the access to the information kept by each CA. 5 Conclusions on Competent Authorities

CAs are designated and their tasks described. Although the co-operation is overall good between ASAE and IVV, there is a limited access to the information kept on operators´ activities and on the results of controls, which may affect the effectiveness of the activities carried out by the CAs. 5.2.2 Control Bodies Legal Requirements Articles 83 and 84 of Regulation (EC) No 555/2008. Article 90 (3) of Regulation (EU) No 1306/2013 in conjunction with Articles 2(5) and 5 of Regulation (EC) No 882/2004. Article 94 (2) (i) of Regulation (EU) No 1308/2013 Findings

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Está a ser preparada uma nova legislação no sector vitivinícola, nt acautelando que a ASAE, IVV e os OC, devem assegurar o d out intercâmbio de dados relativos a medidas cautelares tomadas sobre determinado produto ou operador, quando existam riscos para a segurança alimentar ou disciplina sectorial. Nesse sentido, pretende-se no decurso do corrente ano, densificar o protocolo existente entre IVV e ASAE, por forma a permitir a operacionalização da nova legislação, assegurando a troca de informação entre os dois organismos.

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In 2015, all male animals were systematically excluded from bTB testing for the purpose of maintenance of OTF herd status in some parts of the country (e.g. where the prevalence of bTB is between 0.2% and 1%). This was not in compliance with the requirements of points 3 and 4.4.2 of the 2015 bTB Programme nor with Annex A(I)(2)(c) to Directive 64/432/EEC. For the purpose of maintenance of OTF herd status, the 2015 national operational instructions on bTB testing requested, for these areas, to test only female animals older than 6 weeks.

The 2016 bTB Programme modified this point. It requires testing of males not intended for fattening and females older than 6 weeks (for the maintenance of OTF herd status in areas where herd prevalence is between 0.2% and 1%). This measure is not fully in line with the requirements of Annex A(I)(2)(c) to Directive 64/432/EEC. For these areas, the 2016 operational instructions on bTB testing instruct that males for breeding older than 6 weeks should also be tested. In one region visited, the OPP coordinating veterinarian stated that only male animals that will, according to the keeper, be kept for breeding will be subject to bTB testing.

Exclusion of male animals from testing in some areas on mainland Portugal may have compromised the maintenance of the OTF herds in these areas in 2015. Also, exclusion of 25% of herds on the mainland from field testing, decreases the ability of the system to detect and eliminate the infected animals as early as possible. As a consequence, the time window for the infection to find another susceptible animal is prolonged as well as the time to finally eliminate the infection. This to some extent explains the continuous persistence of Mycobacterium infection in some areas. This approach decreases the confidence in the true level of bTB infection in cattle population on mainland Portugal and most likely increases the overall long term cost of the eradication efforts. Although animals from fattening herds are subject to slaughterhouse surveillance, due to its limitations, a high number of infected animals may not be detected at the slaughterhouse4.

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reeding males are specifically included in the 2016 programme, according with the rrection submitted to the EU Com (please see annexed document below, point 2.). ated also in our 2017 TB Programme, the only males excluded from bTB testing r the purpose of maintenance of OTF herd status are those for fattening and located regions where the average breeding herds prevalence is not more than 1% in ccordance with Annex A (I)(2)(c) to Directive 64/432/EEC. This risk assessment and the areas were the derogation is applied is carried out each year at central and regional levels and results are communicated to OPP. nitary programmes submitted by OPP are approved if they are in compliance with the established rules. In addition, the specific rules are incorporated in PISA.Net in order to allow validation of OPP activities by the veterinary services in accordance with the programme. The animal movement control system electronically established in SNIRA in 2015, receives information on the health status of farms and the pre-movement tests of animals, in order to allow or to block the issuing of transit permits - non free herds have therefore movement restrictions.

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Disponibilização da informação relativa às autorizações no site in da DGAV (24, 8, e 9): Para poder responder à exigência estabelecida nos pontos 1 e 2 do go 57.º, a curto prazo, a DGAV está a disponibilizar na sua página de internet, um ficheiro em formato Excel que é actualizado sempre que ocorrem alterações às autorizações concedidas. A médio e longo prazo, como a informação relativa às autorizações se encontra dispersa em 4 ficheiros distintos e que não estão interligados, o que causa problemas na gestão e divulgação da informação, a DGAV irá abrir durante 2017, concurso para a aquisição de software de gestão processual, na sequência da aprovação em 2016 da candidatura no âmbito da modernização administrativa. O sistema de gestão processual permitirá efetuar a gestão eletrónica dos pedidos e a divulgação imediata das autorizações concedidas pela DGAV no seu site. Por outro lado, a DGAV irá, ainda durante 2017, a reforçar a equipa técnico-administrativa com um Assistente técnico que irá desenvolver a sua actividade no âmbito da gestão e divulgação da informação relativa a autorizações, pretendendo-se também, que possa trabalhar com o sistema comunitário de gestão de autorizações

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ns Os rótulos indicam as mais recentes atualizações (26, 18 e 19): Em 2016 a DGAV reiniciou as actividades de controlo de qualidade dos produtos fitofarmacêuticos e a colheita de amostras em vista, também, o controlo da rotulagem das formulações Page: 1 eport ref. DG(SANTE)/2016-8789-MR of the audit carried out from 14 June f plant protection products ontram no s quais tos idade e cede ao re- ção de venda permitindo Ficheiro número ações ção e das que há r adição ou isto não está . Contudo, o, face a esse mesmo dição do antindo-se, a produto e a a eport ref. DG(SANTE)/2016-8789-MR of the audit carried out from 14 June f plant protection products superfície média das explorações agrícolas é, também, bastante reduzida, as embalagens têm dimensões reduzidas o que dificulta a legibilidade dos rótulos, pois tem de cumprir com todos os requisitos legais estabelecidos. Não obstante, a DGAV tem vindo a autorizar a elaboração de folhetos que acompanham a embalagem primária do produto fitofarmacêutico, com as informações complementares não obrigatórias sempre que a dimensão da embalagem não permitir a fácil leitura do rótulo. É também autorizada a elaboração de rótulos em livro de modo a aco

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During its visits in public and private green sites where Citrus plants are grown as ornamentals and in Citrus fruit orchards located within or outside the demarcated areas in the North and Central regions the audit team noted that: 13 Larger scale commercial citrus fruit producers and producers of Citrus propagating material routinely implement crop protection schemes for other non-regulated pests of Citrus like citrus leaf miners, scales and aphids. Depending on the degree of aphid infestation, they apply two to four treatments per year. In general, the applications of insecticides by producers of citrus propagating material are far more intensive; The implementation of control measures against T. erytreae, which include insecticide applications, severe pruning on young shoots and destruction of plant debris, is compulsory for Citrus trees and other host plants grown within the infested zone of the demarcated area. DRAPN stated that after the detection of the pest in the Porto metropolitan area, it was not possible to carry out any systematic monitoring of ca. 35,000 private properties such as backyard gardens, where owners are often absent; In one case examined in detail, Citrus trees grown as ornamentals in a public green site located within the infested zone, had been sprayed once in early spring and according to the technician in charge no further symptoms or actual presence of T. erytreae had been observed during the summer. However, the audit team identified a number of specimens of adults feeding on leaves and nymphs of different development stages on recently flushed foliage; In another case, the owner of an orchard with Citrus trees in a private garden had reported to the regional plant health services the possibility of T. erytreae presence in August 2015. Traps placed by the DRAP of the North region indicated that T. erytreae was present in the region and that the flight period reached its peak in June. Following the finding, the owner carried out severe pruning of the trees and applied insecticide treatments using a professional contractor for this purpose. Three treatments were carried out late June, mid-July and late August, which is too late to inhibit the early development of T. erytreae from nymphs to adults and overall suppress its population dynamics. The inspectors stated that it was not critically important to start applying early insecticide treatments in the centre of the infested zone, particularly whilst there are other factors governing when the plants can be treated: the continuous flowering of lemon trees (presence of bees) and the need to observe a withdrawal period before picking lemons. 5.3.4 Movement of susceptible material

The competent authority has elaborated control measures that should, if applied systematically, inhibit further spread of the pest in line with Article 16(1) of the same Directive. However, these measures are not systematically applied or their enforcement within the infested zone of the demarcated areas is not efficient and the pest continues to spread. This is not in line with the requirements of Article 16(1) of the same Directive 15 that all necessary measures must be taken to eradicate, or if that is impossible, inhibit the spread of the pest.

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Todas as medidas necessárias para inibir a propagação de T. erytreae ve estão a ser tomadas nas zonas demarcadas, incluindo a proibição da circulação de plantas hospedeiras, que é executada através da destruição de todas essas plantas em viveiros, centros de jardinagem e lojas nas zonas infestadas e zonas tampão, e a aplicação de insecticidas autorizados e poda severa para suprimir a praga nas zonas infestadas. Conforme consta do relatório, essas medidas foram bem-sucedidas com poucos insectos de T. erytreae observados em plantas hospedeiras na zona infestada, e nenhum noutras áreas. Foram e continuarão a ser tomadas medidas para uma ativa sensibilização do público para a importância da praga e a necessidade de pronta implementação das medidas de controlo notificadas assim que a praga for detectada, o que ajudará a assegurar que as medidas necessárias sejam aplicadas de forma consistente, em momentos e frequência adequados. Devido aos números envolvidos, a DGAV não pode verificar se cada proprietário implementou as medidas necessárias nos momentos e frequência apropriados. Continuará a monitorizar qualquer dispersão da praga, e irá focalizar a verificação do cumprimento das medidas

Todas as medidas necessárias para inibir a Os proprietários das plantas hospedeiras propagação de T. erytreae estão a ser localizadas nas zonas infestadas tomadas nas zonas demarcadas, incluindo a continuarão a ser notificados para proibição da circulação de plantas aplicarem tratamentos fitossanitários de hospedeiras, que é executada através da forma sistemática e nas alturas mais destruição de todas essas plantas em viveiros, apropriadas, a fim de se limitar a centros de jardinagem e lojas nas zonas dispersão natural do inseto. Serão infestadas e zonas tampão, e a aplicação de reforçados os controlos oficiais para insecticidas autorizados e poda severa para verificação da realização dos tratamentos, suprimir a praga nas zonas infestadas. em particular nas zonas limite da zona Conforme consta do relatório, essas medidas demarcada. Os proprietários das plantas foram bem-sucedidas com poucos insectos de hospedeiras localizadas nas zonas tampão T. erytreae observados em plantas serão igualmente informados para a hospedeiras na zona infestada, e nenhum realização de tratamentos preventivos. Os noutras áreas. serviços fitossanitários continuarão a Foram e continuarão a ser tomadas medi

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No sentido de dar cumprimento ao disposto nesta recomendação, foi revista a possibilidade dos condutores obterem o certificado de idão profissional (CAP), ao abrigo do nº 5, do Artº6º, do gulamento 1/2005, de 22/12/2004, mediante o reconhecimento das qualificações profissionais, como sejam a licenciatura em Medicina Veterinária, Engª Zootécnica e Engª de Produção Animal. Pelo exposto e de acordo com o novo despacho relativo aos cursos de formação na área da Proteção dos animais, todos os condutores que pretendam requerer o certificado de aptidão profissional, tem que obrigatoriamente frequentar uma ação de formação na área da proteção dos animais no transporte O referido despacho encontra-se para aprovação da Ministra da Agricultura e do Mar, pelo que será remetido assim que se proceder à sua publicação. Page: 1

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The ability of the monitoring plan to detect goods not complying with the required guarantees is undermined by the clustering of sampling in a limited period and the inability of the competent authority to ensure availability of laboratory capacity in time. The long storage of samples and the delays in obtaining results compromise the ability of the competent authority to take immediate action in case of animal or public health risk. The verification activities have not acted upon the problems encountered with the availability of laboratory capacity. 7

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For 2016 the competent authority has already developed the monitoring plan that covers the main products and the associated No risks. The network of laboratories to carry out the sampling analysis es during official controls is already designated, and complies with the requirements of Article 12 of Regulation (EC) No 882/2004. We await approval of the state budget to disseminate and distribute the plan to the regional veterinary services, which we are planning to do by the end of this month.

For 2016 the competent authority has already developed the monitoring plan that covers the main products and the associated No risks. The network of laboratories to carry out the sampling analysis es during official controls is already designated, and complies with the requirements of Article 12 of Regulation (EC) No 882/2004. We await approval of the state budget to disseminate and distribute the plan to the regional veterinary services, which we are planning to do by the end of this month. Updated AP received on 20 October 2016 a) The official laboratories designated to perform the analyses under the monitoring plan (PCAPIF) comply with the requirements foreseen at Regulation (CE) 882/2004. All analytical methods are accredited in accordance with EN ISO/IEC 17025 and regarding microbiological controls, the methods are also in compliance with the requirements of Regulation (EC) 2073/2005. The present procedures allow, if necessary, amending the initial plan, including the analyses to be performed and the laboratories of destination of the samples. Currently, simple administrative measures are required, provided that the cost of the analyses is covered by the approved budget for th

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procedimentos para o registo dos produtores primários serão definidos por um Grupo de Trabalho onde participarão elementos DGAV, IFAP, DGADR e DRAP.

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Já existem instruções de trabalho adequadas para a realização dos controlos, que abrangem as disposições do Anexo I, Capítulo 3.3 A.1 do Regulamento (CE) No 2073/2005 e do artigo 3.º do Regulamento (UE) No 211/2013. A DGAV irá reforçar a formação dos Técnicos Executores e supervisionará os próximos controlos oficiais aos estabelecimentos que produzem rebentos, a fim de assegurar que o cumprimento destas disposições é corretamente avaliado. A ASAE irá reforçar, nas ações de formação a ministrar aos inspetores afetos a esta matéria, aspetos relativos à análise e avaliação de documentos de acompanhamento de sementes para geminação e rebentos.

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O INIAV disponibilizará oportunamente procedimento de resolução das constatações encontradas. Page: 1

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Transporters of ABP/DP are inspected annually in order to authorise the containers or trailers used to carry such products, in accordance with national requirements (see finding 8). However, these controls do not include checks on relevant EU requirements including traceability and documentation systems (see finding 23). This is not in line with Article 32 of Regulation (EU) No 142/2011.

At the transporter of ABP/DP visited, the audit team confirmed that the main focus of the annual official controls is the authorisation of containers and trailers used to carry such products, in accordance with the national rules (see findings 8 and 13) and in practice, no checks are carried out to verify that the relevant EU requirements are fulfilled as required by Article 45 of Regulation (EC) No 1069/2009 and Article 32 of Regulation (EU) No 142/2011. The audit team confirmed that the operator had maintained a comprehensive documentation and traceability system which satisfied the requirements of Article 22 of Regulation (EC) No 1069/2009 and also recorded the sequence of different loads carried. However, the unauthorised use of an ABP tank to transport a food product had been overlooked by the competent authorities.

The checks carried out by the competent authorities to confirm the arrival and dispatch of consignments of ABP/DP in Portugal, combined with the attention paid to traceability and documentation requirements during official controls of most operators in the ABP/DP chain, provides adequate assurances that ABP/DP is used or disposed of in accordance with EU requirements. However, the lack of checks on these and other relevant issues carried out during controls of transporters of ABP/DP undermines the ability of the competent authorities to ensure that the EU requirements are fulfilled throughout the distribution chain. 6

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The national control plan of ABP establishments, plants and 5 of operators is undergoing adaptation in order to include transporters of ABP/DP, as required by Article 45 of Regulation (EC) n.º 1069/2009. Official controls on transporters of ABP/DP are being extended to cover traceability and documentation systems maintained by operators, as required by Article 32 of Regulation 142/2011, in addition to the requirements for vehicles, currently covered by official controls. The written procedures related to controls on ABP/DP transporters will be concluded until the end of 2015. Page: 1

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of The Qlikview is the ideal tool to ensure that the system for erification covers effectively the use of TRACES by different users. Unfortunately, the Regional Competent Authorities (RCA) doesn't have the possibility to use it ­ DG-SANCO has informed us that there is a financial constraint to allow the use of Qlikview by the RCA users. Meanwhile, DGAV is preparing a training session with the RCA users dedicated to the use of pre-selected reports from DWH that allow us to obtain similar results for this kind of controls. To improve the official controls by all TRACES users it was created a dedicated Intranet site with all instructions, procedures, manual, TRACES release notes, etc. We will also be request to the TRACES team, in European Commission, a specific training session that allows the best use of the tools provided by TRACES to ensure that the system for verification by different users is correctly applied.

likview is the ideal tool to ensure that ystem for verification covers effectively The DGAV will prepare a training session the use of TRACES by different users. with the RCA official users dedicated to the Unfortunately, the Regional Competent use of pre-selected reports from DWH in the Authorities (RCA) doesn't have the 4th quarter of 2014 and 1st quarter of 2015. possibility to use it ­ DG-SANCO has Meanwhile, we have already started to train Regional Coordinators and their informed us that there is a financial constraint veterinarians certifiers and controllers. to allow the use of Qlikview by the RCA users. In this kind of training sessions we will, first, Meanwhile, DGAV is preparing a training evaluate the work carried out in each LVU session with the RCA users dedicated to the and, second, make a survey of their biggest use of pre-selected reports from DWH that difficulties. The training sessions will focus allow us to obtain similar results for this kind on work weak points and other major issues of controls. that we have found during the evaluation and the survey. To improve the official controls by all The contents of the training session are the TRACES users it was crea

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d The National Control Plan of Intra-Union Trade of Live Animal (P12) published in the DGAV Intranet site, contains all the dies instructions to achieve an adequate control of all the consignments. Although we have in mind that the "Manual of operations in PIF" , as needs to be updated in some points, as soon as possible ideally till the end 2014, it is important to note that were send to the BIPs and LVUs e-mailed instructions on the subjects referred to, and the relevant instructions have been placed on DGAV intranet which is available to all users of DGAV. POA.zip Page: 1 014 eport ref. DG(SANCO)/2014-6999 -MR of a/an audit carried out from 27 stem. Page: 2

National Control Plan of Intra-Union of Live Animal (P12) published in the V Intranet site, contains all the tructions to achieve an adequate control of the consignments. hough we have in mind that the "Manual operations in PIF" needs to be updated in e points, as soon as possible ideally till end 2014, it is important to note that were d to the BIPs and LVUs e-mailed tructions on the subjects referred to, and relevant instructions have been placed on mpetent Authority on 5 August 2014 uthorities of Portugal on 19 May 2014 in response to Report ref. DG(SANCO)/2014-6999 - y 2014 in order to evaluate the use of the TRACES system. users

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Competent authorities perform adequate documentary and verification checks along the chain which, coupled with generally adequate measures put in place by the operators, allows them to largely guarantee that only eligible PAP is used for the production of aquaculture compound feed. This is despite the fact that the scheduled official control plan on feed was not fully implemented.

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e PAP Until the end of 2015, the procedures related to inspections of establishments under the PACE plan, namely processing plants producing PAP, particularly with regard to official control report and actions in case of non-compliance will be reviewed, aiming the simplification, in order to increase the human resources availability to perform inspections. In what concerns feed business operators - FBO, the National Feed Official Control (CAA) for 2015 was already superiorly approved and sampling and inspections are in place. The planning took into consideration risk assessment related to the activities developed by FBO in order to define frequency and sampling strategy. The foreseen informatics integration of FBO establishments and ABP establishments management and control under a unique data base system, will also improve cooperation between different units of DGAV as well as guarantee a better performance of official controls. Page: 1

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pecific national legislation for SCP, which is expected to be published until 2016, defines which biosecurity measures that poultry farms must meet and the sanctions regime in the event of non- compliance. Is in preparation, in conjunction with the production, a guide of biosecurity asures for poultry farms, for which a working group is being created. Biosecurity measures in try farms are often checked by the regional official services. Information about the frequency of controls and results are sent twice a year to central services, through the procedure established in October 2014.

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Under the SCP, on each visit of the official services to collect samples in a holding, the existing records are checked. ce 2008, DGAV implements a National Control Plan for the Use of Medicines (PNCUM). This consists of a surveillance system aimed at verifying the conditions of transfer and acquisition of medicines and veterinary medicinal products, the conditions of use and registration of medicines and veterinary medicinal products in farm animals and unauthorized or unlawful treatment of farm animals. Under this plan, surveys are carried out to some poultry farms included in the PNPR (National Control Plan for Residues) and PPA (Animal Protection Plan). For 2015 the SCP holdings will be included in the target sample.

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r the process of contestation of results, a procedures manual is in the final stages of drafting. In this manual, the conditions for the acceptance or refusal of the contestation are set by the CA. n order to accept the contestation, the official services must check, in relation to the holding, the fulfillment of FBO own-checks under the SCP, the track record of results and the biosecurity measures. Page: 1 Ref. Ares(2015)321527 - 27/01/2015 to the recommendations of Report ref. DG(SANCO)/2014-7161 -MR of a/an audit carried out from 11 uate the Salmonella National Control Programmes for particular poultry populations (breeders, laying rough this evaluation, the contestation will only be accepted in holdings which: Fully comply with own-checks in all the flocks and Don't have repetition of positivity in the same house, flock or immediately previous flock and Have a favorable assessment of the CA on the implementation of the BS measures. is expected until the end of March the dissemination of the procedures manual. anual das ntestações

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though, Portugal has legislation in place giving legal power for the CA to act within the scope the Salmonella Control Programmes (SCP) specific legislation is currently in the final stage of egal review, prior to publication. ecific national legislation for SCP, which is expected to be published until 2016, defines the nctions to be applied in the event of non-compliance of the PNCS by the FBO. each visit of official services to laying hens holdings an application for verification and lidation of own-checks is filled in. This form allows the CA to check all the information lated to the FBO own-checks for all the flocks on the holding. erificação AC- GP r the process of contestation of results, a procedures manual is in the final stages of drafting. In is manual the conditions for the acceptance or refusal of the contestation, are set by the CA. order to decide the acceptance of contestation, the official services must check, in relation to Page: 2 Ref. Ares(2015)321527 - 27/01/2015 to the recommendations of Report ref. DG(SANCO)/2014-7161 -MR of a/an audit carried out from 11 uate the Salmonella National Control Programmes for particular poultry populations (breeders, laying the h

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Although, Portugal has legislation in place giving legal power for the CA to act within the scope the Salmonella Control Programmes (SCP) specific legislation is currently in the final stage of legal review, prior to publication. fic national legislation for SCP, which is expected to be published until 2016, defines the sanctions to be applied in the event of non-compliance of the PNCS by the FBO. ough currently the CA has access to all information of farms and flocks, it lies in the initial stage of an information system project under development which shall include all data related to existing flocks, including the own-checks carried out by the FBO (undated forecast for operation), that will facilitate the task of analyzing data and evaluating the situations. Page: 3

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CNF,I.P., procedeu à formação dos técnicos envolvidos na execução by de ações de identificação e amostragem de coníferas hospedeiras com nio, tendo sido ministrada formação específica, por forma a dotar as equipas de mais conhecimentos quanto à biologia dos organismos volvidos, procedimentos de prospeção de árvores com declínio e de amostragem. Neste âmbito, refere-se ainda que estão já em curso novas ações de formação dirigidas a técnicos e outros agentes do ICNF, I.P., para consolidação dos procedimentos a implementar no âmbito das medidas de contenção a que Portugal se encontra sujeito, destinadas ao controlo do NMP, consolidando aspetos relacionados com o estabelecimento de prioridades a conferir à realização das diferentes ações.

ure and Forest Conservation Institute (ICNF, I.P.), has trained the technicians Posteriormente à apresentação do plano de involved in the identification and sampling of host conifers showing samples of decline: ação que procede à implementação das specific training has been provided to increase knowledge within the teams of the recomendações proferidas em sede do biology of the organisms involved and of the procedures for surveying and sampling of relatório de auditoria do FVO, ref.ª trees showing symptoms of decline. DG(SANCO)/2014-7193­MR, foram realizadas duas ações de formação, uma em Julho e outra em Outubro do corrente ano, We would also note here that new training especificamente dirigidas a vigilantes da activities are currently under way for natureza e outros técnicos envolvidos nas technicians and other staff of the ICNF, I.P., ações de prospeção, amostragem e de to consolidate the procedures to be acompanhamento das ações de identificação implemented as part of the containment e eliminação de árvores com sintomas de measures to which Portugal is subject and declínio. that are geared towards control of the PWN: Estão já calendarizadas 6 novas ações de these will focus on

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Os técnicos, os inspetores fitossanitários e outros agentes de fiscalização que verificam o cumprimento da legislação fitossanitária, têm vindo a ser formados, no sentido de atuarem sempre que são detetados incumprimentos, mesmo em áreas que não estão e atribuídas à esfera da sua competência. obstante tal formação e enquadramento técnico e legal conferido pelas competências das diversas instituições, encontram-se definidos procedimentos de atuação, para uma correta fiscalização e controlo dos operadores económicos que comercializam ou utilizam material lenhoso de coníferas. Está em curso a revisão desses procedimentos no sentido de um maior detalhe, a fim de se garantir que as ações de fiscalização detetem todos os possíveis incumprimentos no que diz respeito ao material de embalagem de madeira. Também com esta finalidade está prevista a realização pela DGAV e ASAE de um programa de formação complementar ministrado aos inspetores da ASAE com o objetivo de aprofundar os seus conhecimentos e competências na execução das ações de fiscalização aos estabelecimentos comerciais. Page: 1 port ref. DG(SANCO)/2014-7193 ­ MR of an audit carried out from 18 Bursaphelenchus xylophilus

he technicians, plant health and other nspectors who check on compliance with Estão previstas 4 novas Ações de Formação, lant health legislation have been trained to a realizar em conjunto pela DGAV, ICNF e ake action in all cases when instances of ASAE, a ocorrer no 1º trimestre de 2015, on-compliance are detected, even in areas após conclusão da revisão dos procedimentos ot directly within their area of responsibility. de inspeção e de fiscalização, que se prevê his training and the technical and legal estar finalizada em Janeiro de 2015, no ramework provided by the responsibilities of sentido de promover uma mais eficiente e he various institutions notwithstanding, eficaz articulação entre todas as entidades rocedures are in place for correct inspection envolvidas. nd monitoring of economic operators that ell or use timber from conifers. These rocedures are being revised to make them ore detailed in order to ensure that nspection activities detect all possible nstances of non-compliance involving wood ackaging material. With the same objective n mind, plans are in place for the mplementation by DGAV and ASAE of an dditional training programme aimed at SAE inspectors with a view

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, I.P., instituiu um sistema de manifestação prévia e obrigatória a a atividade de corte, eliminação de sobrantes e circulação de material lenhoso até aos destinos de transformação ou de tratamento zadas, quer esta seja realizada pelos proprietários florestais e/ou pelos operadores económicos, permitindo, para além da rastreabilidade terial lenhoso de coníferas, a supervisão pelo ICNF, I.P. e, bem o controlo e a fiscalização dessas ações pelas diferentes des, de modo a garantir o cumprimento da legislação em vigor to-Lei n.º 95/2011, de 8 de agosto e Decisão de Execução 35/UE, da Comissão de 26 de setembro), e das medidas de ão fitossanitária nelas assentes, prevendo-se sanções nos casos umprimento.

The ICNF, I.P., has set up a system for mandatory prior declaration of all felling of Importa clarificar que, de acordo com o nº 3, trees, disposal of waste and movements of do artº 6, do DL nº 95/2011, de 8 de agosto, timber to authorised processing or treatment apenas se encontra excecionada a facilities, whether this is done by the forestry obrigatoriedade de declaração do ato de owners and/or by the economic operators: abate, nos casos que envolvam até três this will not only enable conifer timber to be coníferas hospedeiras ou o equivalente a uma traced but also permit supervision by ICNF, tonelada, que se destinem, exclusivamente, a I.P. and monitoring and inspection of these consumo próprio e desde que, tasks by the various bodies, thus guaranteeing cumulativamente, ocorram no período de 1 compliance with the legislation in force de Novembro a 1 de Abril. (Decree-Law No 95/2011 of 8 August 2011 Salienta-se que esta exceção não isenta da and Commission Implementing Decision obrigatoriedade de cumprimento das 2012/535/EU of 26 September 2012) and medidas de proteção fitossanitária aplicáveis with the plant health measures based thereon, ao abate de coníferas e eliminação dos p

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o de ação nacional, dirigido ao território continental português, controlo do NMP, segue, regra geral, as disposições e medidas estabelecidas na Decisão de Execução 2012/535/UE, da Comissão de 26 setembro, tendo em conta o cenário de contenção em que Portugal neste momento se encontra. mbora se considere que todas as medidas constantes na referida o são de aplicação direta e imediata, mesmo que neste não lhes feitas quaisquer alusões no Plano de Ação, sendo portanto eradas subsidiárias a este, o mesmo foi revisto em conformidade ado aos competentes Serviços da Comissão Europeia, por forma a r e a clarificar o modo de atuação na Zona Tampão, adamente ao nível da amostragem de árvores com sintomas de io, da prospeção do inseto-vetor do NMP, da implementação do olo de higiene e quanto ao conjunto de ações a implementar no e serem detetados casos positivos de NMP nessa zona.

eneral rule, the national action plan for trol of the PWN in mainland Portugal Está consagrada na revisão do Decreto-Lei lows the provisions and measures laid 95/2011, de 8 de agosto, neste momento em n in Commission Implementing Decision análise pelo Governo, a inclusão de um 2/535/EU of 26 September 2012, taking artigo especificamente dirigido à limpeza de ount of the containment scenario currently veículos e maquinaria, obrigando os place in Portugal. operadores económicos ao cumprimento das medidas de proteção fitossanitária e hough all of the measures laid down in t Decision are deemed directly and respetivos requisitos técnicos específicos, de ediately applicable, even though no modo a prevenir a dispersão do NMP, erence is made to them in the Action Plan, constantes do protocolo de higiene y are considered subsidiary to the Plan, estabelecido e publicitado pelo ICNF, I.P., ch was duly revised and sent to the no seu sítio da internet. petent Commission services to ensure Quanto às questões relacionadas com a t it includes and clarifies the method for monitorização do inseto vetor do NMP, com ion in the Buffer Zone, particularly with a amostragem de árvores e áreas ardidas e a

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GAV irá manter a coordenação com as restantes entidades das no controlo do Nemátodo da Madeira do Pinheiro no o de ser cumprido o prazo de comunicação previsto no artigo 9 Decisão de Execução 2012/535/UE, da Comissão de 26 de Page: 2 port ref. DG(SANCO)/2014-7193 ­ MR of an audit carried out from 18 Bursaphelenchus xylophilus setembro. O ICNF, I.P., continuará a assegurar que os resultados das medidas de contenção realizadas anualmente no âmbito das ações de controlo do nemátodo da madeira do pinheiro (NMP) no território continental, designadamente os relativos à prospeção anual realizada sobre as coníferas suscetíveis ao NMP e ao seu inseto vetor e, em particular, os relativos ao número de árvores identificadas, eliminadas e testadas quanto à presença de NMP que se localizem na zona tampão, serão comunicadas à Comissão e a todos os outros Estados-Membros, até ao dia 1 de março do ano seguinte, através de relatório especificamente elaborado para o efeito e nos termos definidos pelo artigo 9 (3) da Decisão de Execução 2012/535/UE, da Comissão de 26 de setembro. O mesmo se aplicará à Região Autónoma da Madeira, a qual comunicará igualmente os resultados das ações de contenção do NMP

GAV will continue to coordinate with odies involved in the control of Wood Nematode in order to meet the ine for communicating results stipulated ticle 9(3) of Commission Implementing ion 2012/535/EU of 26 September CNF, I.P. will continue to ensure that esults of the containment measures mented each year in mainland Portugal rt of the Pine Wood Nematode (PWN) ol plan -- in particular those relating to nnual survey of conifers susceptible to nd its vector insect and, more fically, results relating to the number of identified, destroyed and tested for the nt Authorities of Portugal on 31 July 2014 in response to Report ref. DG(SANCO)/2014-7193 - h 2014 in order to evaluate the situation and control for Bursaphelenchus xylophilus. presence of PWN located in the Buffer Zone -- will be communicated to the Commission and all the other Member States by 1 March of the following year in a report drafted for that specific purpose and in accordance with Article 9(3) of Commission Implementing Decision 2012/535/EU of 26 September 2012. The same will apply in the Autonomous Region of Madeira, which will also report on the results of its measures to contain PWN implemented each year on the isla

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A DGAV continuará a assegurar que os resultados dos controlos eferentes à circulação de vegetais, madeira, material de embalagem e casca de coníferas suscetíveis a partir de zonas demarcadas para a zona ld tampão ou para zonas não demarcadas, serão comunicados à Comissão ent e Estados-Membros com uma periodicidade mensal. Quanto à Região Autónoma dos Açores, sendo aquele território uma região não demarcada, aplica-se o disposto no ponto 2 do artigo 11º da Decisão 2012/535/EU. Assim, de acordo com o ponto 3 do mesmo artigo, o relatório deverá ser enviado anualmente. A Região Autónoma dos Açores está em 2014 a efectuar os controlos previstos no referido ponto 2 que serão reportados até 1 de Março de 2015.

DGAV will continue to ensure that the controls on the movements of , wood, packaging materials and bark usceptible conifers from demarcated nt Authorities of Portugal on 31 July 2014 in response to Report ref. DG(SANCO)/2014-7193 - h 2014 in order to evaluate the situation and control for Bursaphelenchus xylophilus. areas to the Buffer Zone or to non- demarcated areas are communicated to the Commission and the Member States on a monthly basis. The Autonomous Region of the Azores, as a non-demarcated area, will be subject to the provisions of Article 11(2) of Decision 2012/535/EU. Thus, pursuant to paragraph (3) of the same Article, the report is to be sent once a year. During 2014, the Autonomous Region of the Azores is carrying out the controls provided for in the cited paragraph (2) and these will continue until 1 March 2015.

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Com vista ao cumprimento das medidas de proteção fitossanitária impostas, o ICNF, I.P., tem vindo a proceder à notificação de todos os Page: 3 port ref. DG(SANCO)/2014-7193 ­ MR of an audit carried out from 18 Bursaphelenchus xylophilus titulares de árvores com sintomas de declínio, com especial incidência para os localizados na zona tampão e em locais positivos, denominados he de locais de intervenção (freguesias onde o NMP foi detetado ou existe o risco da sua instalação ou dispersão), para a correta e devida eliminação das árvores referenciadas e implementação de demais medidas de contenção. Estas notificações e bem assim a divulgação generalizada sobre as medidas de contenção aplicáveis, têm ocorrido de forma sistemática desde que todo o continente português é considerado como zona demarcada para afeitos de controlo do NMP, já desde 2008, ano a partir do qual se instituiu a Zona Tampão ao longo da fronteira com Espanha. Salienta-se ainda, uma ampla divulgação da obrigatoriedade de eliminação de todas as coníferas hospedeiras identificadas com declínio, afogueadas, tombadas e dos seus respetivos sobrantes, sobretudo na Zona Tampão e sua vizinhança e, bem assim, da elaboração de

With a view to compliance with the plant health measures in place, the ICNF, I.P., has Foi reforçada a sensibilização e a divulgação sent notice to all owners of trees showing de informação junto dos cidadãos, tendo sido symptoms of decline, particularly those produzidos 50 000 folhetos sobre a proteção located in the Buffer Zone or positive areas, do pinhal contra o NMP e 50 000 folhetos known as intervention areas (parishes where sobre o corte e transporte de resinosas. the PWN was detected or there is a risk that it Esses folhetos foram distribuídos pelos e will take hold or spread) to ensure correct and serviços desconcentrados do ICNF e estão, appropriate destruction of the trees concerned desde agosto, a ser entregues às pessoas que and to implement other containment nt Authorities of Portugal on 31 July 2014 in response to Report ref. DG(SANCO)/2014-7193 - h 2014 in order to evaluate the situation and control for Bursaphelenchus xylophilus. he issue of such notices, and the se deslocam aos balcões de atendimento dissemination of the contention público do ICNF, às entidades que fazem plicable, take place parte das comissões municipais de defesa da lly now that the whole of th

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rk Estão a ser operacionalizadas campanhas de divulgação de informação e de sensibilização, promovidas pelo ICNF, I.P., DGAV e associações do setor, sobre a aplicação das medidas previstas na Decisão de Execução 2012/535/UE, da Comissão, com especial enfoque para os operadores económicos, incluindo retalhistas que produzem, transformam ou comercializam material lenhoso de coníferas. Estão também a ser desenvolvidas comunicações diretas com associações profissionais (ex. de retalhistas, de equipamentos pesados, de construtores civis), para informação sobre regras e procedimentos Page: 4 port ref. DG(SANCO)/2014-7193 ­ MR of an audit carried out from 18 Bursaphelenchus xylophilus relacionados com as medidas de proteção fitossanitária impostas.

areness-raising campaigns promoted by e ICNF, I.P., DGAV and associations thin the sector, concerning the application the measures laid down by Commission plementing Decision 2012/535/EU, cusing in particular on business operators, cluding retailers who produce, process or rket timber from conifers, are being rried out. ere is also direct communication with ofessional associations (e.g. of retailers, avy equipment, civil engineering, etc.) to ovide them with information on the rules d procedures related to the plant health asures in place. nt Authorities of Portugal on 31 July 2014 in response to Report ref. DG(SANCO)/2014-7193 - h 2014 in order to evaluate the situation and control for Bursaphelenchus xylophilus.

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ts De acordo com os procedimentos estabelecidos para a prospeção do NMP, estão a ser conduzidas ações de monitorização de coníferas hospedeiras, sobretudo dirigidas à identificação e amostragem de árvores com sintomas de declínio, com exceção dos exemplares totalmente destruídos por incêndios florestais, conferindo-se especial atenção à zona tampão, por forma a cumprir esquema de amostragem definido pela EFSA (EFSA Supporting Publications 2012:EN-385), por forma a garantir que o regime de amostragem na Zona Tampão, é capaz de confirmar, com um nível de confiança de 99 %, que a presença do nemátodo da madeira do pinheiro nessas árvores é inferior a 0,02 %. Salienta-se o facto de que a amostragem é essencialmente dirigida para a presença dos sintomas de declínio sensu lato, dado se entender que são estes os potenciais e possíveis hospedeiros do NMP, uma vez que não são absolutamente inequívocos os sinais que denunciam a presença de NMP, nem tampouco serem evidentes os indícios da presença do seu inseto vetor, o Monochamus.

ccordance with the procedures in place PWN surveying, measures to monitor host fers are being implemented, aimed in icular at identifying and sampling trees symptoms of decline, with the exception hose completely destroyed by forest fires paying particular attention to the Buffer , in order to comply with the sampling defined by the EFSA (EFSA Supporting ications 2012:EN-385) and thus antee that the sampling scheme in the er Zone is capable of confirming, with a idence level of 99%, that the level of ence of the pine wood nematode in such s is lower than 0.02%. ould emphasise that sampling is ntially aimed at detecting the presence of toms of decline in the broad sense: the s affected by such symptoms are idered to be potential and possible hosts he PWN, since the signs indicating the ence of PWN are not absolutely uivocal and the signs of the presence of vector insect, Monochamus, are also not ous. nt Authorities of Portugal on 31 July 2014 in response to Report ref. DG(SANCO)/2014-7193 - h 2014 in order to evaluate the situation and control for Bursaphelenchus xylophilus.

Rekommendationen anger som grund

In the area of Trás-os-Montes, on a significant number of positive holdings where vaccination coverage was investigated, animals have not been vaccinated as required by Point 4.4.7 of the BMEP.

Movement restrictions are largely applied according to Point 4.4.9 of the BMEP. However, full control and enforcement of movement restrictions of animals from BMNF herds to common pastures is not implemented in areas where 90% of holdings are dependent on common pastures on a daily basis.

The low vaccination coverage on positive holdings in the area of Trás-os-Montes, compromise the overall effectiveness of vaccination in this area. As a consequence the disease frequently occurs in non-immunised animals.

Lack of reliable information on all locations where animals are kept on a permanent or temporary basis prevents full traceability of animals, as well as enforcement and verification of movement restrictions. As not all common pastures are registered, the enforcement of movement restrictions and verification of their effectiveness cannot be fully ensured. Although tracing of movements of animals to common pastures is part of an epidemiological investigation, this information is of limited value because not all new brucellosis outbreaks have been investigated. Failure to fully inforce the movement 14 restrictions and traceability favours the spread and persistence of infections in areas with high disease prevalence, where common pastures have a high impact on disease spread.

There is a lack of procedures to verify on-the-spot implementation of certain control and eradication measures (for example sampling, vaccination, cleaning and disinfection) in order to evaluate their quality, completeness and effectiveness as well as to ensure corrective actions when needed. Thus, the CA cannot demonstrate that activities and measures are implemented as described in the approved programme contrary to the requirement in Article 15.1(a) of Commission Implementing Decision 2013/722/EU.

The CCA has established information systems that support continuous monitoring and evaluation of implementation of the BMEP measures. Desk-top evaluations allow to monitor the indicators of the progress of implementation of the programme (such as number of animals sampled, tested, vaccinated, observation of deadlines). The absence of checks on-the-spot, to evaluate implementation of measures carried out by OPPs (such as sampling and vaccination) as well as lack of verification of implementation of measures such as movement restrictions and cleaning and disinfection on infected holding, preclude the CCA from evaluating the quality, completeness and effectiveness of the specific BMEP measures. This could jeopardise the financial contribution by the Union as the CA might have difficulties demonstrating that activities and measures are implemented as described in the approved programme.

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n of A necessidade de aumento da taxa de cobertura vacinal é discutida sistematicamente em reuniões ion dos Planos de Erradicação. ls A partir de janeiro de 2015 os dirigentes das DAV da DSAVR Norte deram início a reuniões eir mensais com as OPP e a reuniões trimestrais conjuntas de todas as OPP, dirigentes das DAV com s 4 o Diretor de Serviços, nas quais para além de serem tratados todos os assuntos relacionados com os . Planos de Erradicação, são sistematicamente alertados para as necessidades de aumento das taxas vacinais. Os detentores continuarão a ser notificados para a necessidade de comunicarem às OPP sobre 97. animais com idade para serem vacinados. Na sequência dos abates totais, na Região Norte, após o vazio sanitário o repovoamento só é autorizado com a introdução de animais vacinados. Ações propostas: - reforço das reuniões com as OPP nas zonas de vacinação (já iniciado) - notificação aos produtores para a comunicação dos animais a vacinar aos OPP (já iniciado) - divulgação de Edital da vacinação (em Julho e em Janeiro) - controlo in loco da atuação das OPP em relação aos procedimentos de vacinação (2º sem. 2015) Movimento dos animais para as pastagens comuns Foram env

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sibility are defined and there is no overlapping of AC involved in official controls. The DGAV e entire food chain and is responsible for the the food industry. ASAE is the control body, criminal in this context can act throughout the food chain. The the retail level is ensured by ASAE.

es and structures included in the Ministry of redefined (DL n. º 18/2014, Article arifying the role of DRAP's in the d in official control plans relating to food well as the actions framed in official control hemes under the common agricultural policy, rticle 4 of Regulation No 882 / 2004.

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anisms for coordination and cooperation ved in the official controls exist and apply in prove the linkage between DGAV and ASAE and the egies to promote food safety, 2 annual meetings will be two bodies, with this specific purpose. oordination and cooperation between DGAV and ly definite in the official control plans.

plement in 2014 a specific plan for products of non-animal origin. on of: strategic) the control and forms of communication with d on risk criteria al supervision

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g activities under the rules applicable to the first is planned for October 2013. irected to the officials responsible for official controls d to training within the sampling rnal experts ASAE DRAP or services tended that the training activities related to les are coordinated and are an integral part in one nsible for official controls of DGAV, DRAP and n priority for participation in "Better training for Page: 1 013-6658-MR of an audit carried osed by the Competent Authority ries" Control of contaminants in feed and foodstuffs has trained two ASAE technicians, 2 Technicians of technicians of the DGAVA. ASAE has tter even before the audit. ASAE ensures the ring of Technical Specimen Collection and is also crops. A teaching program was made on June 28 in sed, among other issues, the new models for Auto and Laboratory Requisition with a clear indication lot.

AO directed to technicians of DGAV, control (doc. attached), was held in Page: 1 658-MR of an audit carried Action Proposed by the Competent Authority contaminants in products of non- include specific training in this area, sampling. indústrias.xlsx.x

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ear 2013 a sampling plan will be set for monitoring ill include the identification of the ementation, which will be acquired by the

rdinate the endowment of the official be used in sampling under the -animal origin, mentioned in 2, in 6 and subparagraph d) of paragraph 2 of the material and equipment used in the g to their availability.

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the final meeting of the Mission, the schedule (Appendix 1) to take measures for the fficial controls in processing establishments' of non-animal origin. s have been made as follows: racterization of the whole control (Annex 2). an to control the direction of DGAV (Annex 3). The by all DRAP for consideration. The plan will be day 30/09/2013. Page: 2 013-6658-MR of an audit carried the Competent Authority on of the whole control was elaborated (Annex 2). an to control the direction of DGAV (Annex 3). The by all DRAP, for consideration. The plan will be day 30/09/2013. he DRAP took place on 30/07/2013 for analysis of nd the conditions necessary for its implementation res will be implemented according to the planned ms official controls based on risk in retail and less ndustry.

Ensure that controls on FNAO processing establishments are carried out regularly, on a risk basis and with appropriate frequency to meet the requirements of Article 3(1) of Regulation (EC) No 882/2004.

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port, the inspectors of DRAP are ng inspections of conditionality in Portugal and for the primary production of food of non- ssociated operations, as provided in Article 4. and Regulation (EC) n. 852/2004.

he cross-compliance checks to contaminants in primary production in cases Page: 2 658-MR of an audit carried y the Competent Authority

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the DGAV will designate national reference e control of contaminants, as defined in Article 33. º of n to mycotoxins, the measures necessary for inter- ve been initiated by ASAE, including the transmission Page: 3 013-6658-MR of an audit carried the Competent Authority articipation in these trials, promoted by IRMM. In ll be a meeting between those laboratories in this

Ensure that all NRLs relevant for contaminant controls are designated as required by Article 33 of Regulation (EC) No 882/2004 and actively fulfil their duties.

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ndation does not differ from the contents of est that it be removed.

tories carrying out official controls in of inter-laboratory tests. y for heavy metals for food of animal origin we assure our duties as LNR. We are studying, ty, the possibility to extent to INIAV some NRL like heavy metals in food of non-animal

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ear 2013 a sampling plan for monitoring set. This plan will include the designation t can perform analyzes of official samples for research dstuffs of non-animal origin.

Ensure the designation of laboratories that may carry out the analysis of official samples for contaminants in FNAO in line with the requirements of Article 12 of Regulation (EC) No 882/2004 and to ensure adequate laboratory capacity as laid down in Article 4.2(c) of the same Regulation.

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rections were given to the team that receivers of tory to verify the information contained on documents submitted with the sample. st laboratory analysis" which came into force after ncludes space to record the weight of the sampled lot. st laboratory analysis" which came into force after ncludes space to record the weight of the sampled lot. ice" already included space to record the weight of t it was not always filled by sampling technicians. he audit, all teams were again sensitized that carry ately the "Collection Notice", including information Page: 4 013-6658-MR of an audit carried Action Proposed by the Competent Authority the lot. This issue was addressed in the training 8.

so we can only accept samples that e in quantitative terms. analysis also has its own space to indicate tch targeted for sampling.

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this recommendation relates to the validation of the ation of 3-PCPD and PAHs. As explained to the he INIAV performs a small number of the request of some private clients and within never conducted analyzes of official n preparation of the sampling plan by the end of mine the situation and take the necessary measures are validated and meet the performance criteria set If not, the DGAV resort to another laboratory that ons.

assure that official samples for food of analyzed with validated and accredited heavy metals in food of non-animal Page: 3 658-MR of an audit carried petent Authority ot yet accredited. Concerning other tact with the competent authority in order to cide if we are going to implement and validate detection of the compounds of interest in our able to send the samples to other accredited y, performs this kind of analysis by routine.

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r Agroindustry (PCAI), the Recommendation n. º 5, scope, the verification of the actions taken by the food within the procedures based on the HACCP 5. º Reg 852/2004) in order to ensure compliance with ear 2013 will set a sampling plan for monitoring d of non-animal origin, which include statements wing aspects: the search for contaminating food, sampling methods, sampling procedures, including rding and reporting of sample collection, use, recording and reporting of samples, ed, measures to be taken following the obtaining of Page: 5 013-6658-MR of an audit carried the Competent Authority retail level, official controls of contaminants are carried nce with documented procedures, in accordance f Reg 882/2004, set out in Schedule of samples and in tion of Samples (PNCA).

Ensure that official controls on contaminants in FNAO are carried out in accordance with documented procedures as required by Article 8(1) of Regulation (EC) No 882/2004.

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the withdrawal of this en the following: of alert is detected in food and the situation involves e or third country, Portugal notifies the RASFF; of alert is detected in food and the situation is ational territory, Portugal does not notify the RASFF esolution of the problem is only required to you. ation of restricted situations nationally overloads the no benefit in terms of food security or protection of h are the goals of the system. ained during the mission, Portugal asked the on the need to report cases restricted to the the position of the Commission was to meet our ese reasons, we consider that the FVO should clarify e Commission. After that, the matter should be Member States, so that everyone can proceed as already reported, has had as a procedure to notify s for which there is at least a suspicion that the ts a risk, left the territory of origin (the Portuguese m the other country (MS or PT), a situation Page: 6 013-6658-MR of an audit carried the Competent Authority response to request for clarification of the RASFF h are attached. However the request was reinforced o examine the necessary elements in order not to place esults that do not comply. If there is sufficient d

Ensure that all non-compliant samples which pose a direct or indirect risk to human health are notified to the Commission RASFF network as required by Article 50 of Regulation 178/2002.

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a coordenação com as restantes entidades envolvidas emátodo da Madeira do Pinheiro no sentido de ser prazo de comunicação previsto no artigo 9 (3) da Decisão de /UE, da Comissão de 26 de setembro. que os resultados das medidas de contenção realizadas ito das ações de controlo do nemátodo da madeira do esignadamente os relativos à prospeção anual realizada s suscetíveis ao NMP e ao seu inseto vetor, respetivos stragem realizada para a deteção da presença do NMP e, relativos ao número de árvores identificadas, eliminadas à presença de NMP que se localizem na zona tampão do ental, serão comunicadas à Comissão e a todos os outros até ao dia 1 de março do ano seguinte, através de icamente elaborado para o efeito e nos termos definidos da Decisão de Execução 2012/535/UE, da Comissão de

a coordenação com as restantes entidades envolvidas adeira do Pinheiro no sentido de ser unicação previsto no artigo 9 (3) da Decisão de /UE, da Comissão de 26 de setembro. que os resultados das medidas de contenção realizadas ito das ações de controlo do nemátodo da madeira do esignadamente os relativos à prospeção anual realizada s suscetíveis ao NMP e ao seu inseto vetor, respetivos stragem realizada para a deteção da presença do NMP e, relativos ao número de árvores identificadas, eliminadas à presença de NMP que se localizem na zona tampão do ental, serão comunicadas à Comissão e a todos os outros até ao dia 1 de março do ano seguinte, através de icamente elaborado para o efeito e nos termos definidos da Decisão de Execução 2012/535/UE, da Comissão de

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ora das áreas consideradas contaminadas (nas áreas contaminadas são apicadas medidas de contenção para redução da pressão de infeção) as prospeções serão realizadas apenas pelos serviços oficiais regionais (DRAPs). As inspeções aos pomares nas áreas contaminadas para verificação da aplicação das medidas de controlo serão igualmente feitas por inspetores das DRAPs.

ide of the contaminated areas (containment measures are applied in contaminated areas in order to reduce the effects of the infection) surveys will be conducted exclusively by the regional official services (DRAPs). Inspections performed at plantations in order to verify application of control measures will also be conducted by inspectors of the DRAPs. This action is implemented since April 2014.

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s focos, atualmente sob erradicação, detetados em locais de produção ial de propagação de Actinidea foram notificados à Comissão em Dezembro de 2013. Iremos tomar medidas para que de futuro as notificações sejam imediatas.

The Commission was notified in December 2013 of the outbreaks (currently being eradicated) detected in places of production of plants for planting of Actinidia. We will take the measures necessary to ensure that in future all notifications are immediate.

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as as amostras oficiais são exclusivamente analisadas em laboratórios com competência reconhecida pela DGAV ou por laboratórios oficiais reconhecidos por autoridades fitossanitárias nacionais de outros Estados membros. Pese embora não esteja ainda aprovado o protocolo de diagnóstico da OEPP iremos solicitar aos laboratórios que apliquem a metodologia de análise prevista no respetivo projeto de protocolo, em particular para as plantas assintomáticas.

All official samples are tested exclusively in laboratories authorised by the DGAV or by cial laboratories recognised by the 08 June 2014 t Authorities of Portugal on 18 March 2014 in response to Report ref. DG(SANCO)/2013- 25 October 2013 in order to evaluate the situation and official controls for Pseudomonas syringae national phytosanitary authorities of another Member State. Despite the fact that the EPPO diagnostic protocol has not yet been approved, we will request that laboratories apply the analysis methodology laid down in the EPPO draft protocol, particularly for asymptomatic plants. This action is implemented since April 2014.

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locais de produção de material de propagação de Actinidea localizados em áreas indemnes continuarão a ser sujeitos inspeções oficiais minuciosas, amostragens e testes, incluindo as zonas circundantes e as plantas-mãe presentes no local mesmo que não estejam a ser utilizadas para a produção de plantas. Page: 1

Places of production of plants for planting of Actinidia located in pest free areas will n continue to undergo thorough official inspections, sampling procedures and tests that also cover surrounding areas and include the mother plants found on the premises, even if these are not being used to produce plants.

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DGAV vai, sempre que surjam casos positivos em concelhos ainda não afetados, comunicar imediatamente esse foco à DRAP respetiva e instruí-la da necessidade de notificar urgentemente todos os operadores económicos localizados nesse concelho do novo estatuto desse concelho e das respetivas implicações no que se refere à produção e circulação de batata. Igualmente será assegurada a comunicação à Comissão Europeia.

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As DRAP vão ser instruídas para a realização de: - inspeções aleatórias a armazéns localizados fora das zonas demarcadas, mesmo que não estejam referenciados para o embalamento de batata - incremento de vigilância nos movimentos de batata para fora das zonas demarcadas, através de controlo documental para verificação da origem da batata e necessidade de passaporte fitossanitário.

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âmbito de todos os controlos associados à expedição de batata para fora das zonas demarcadas vai ser recomendado às DRAP que, nos controlos realizados, verifiquem sempre a informação constante no passaporte fitossanitário e, caso esta esteja obsoleta, informem o operador das alterações necessárias e dos prazos em que a mesma deve ocorrer.

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caso de deteção de Epitrix num novo concelho a DGAV, para além da ação proposta no nº1, vai também instruir a DRAP respetiva para verificar obrigatoriamente o cumprimento dos requisitos de expedição de batata para fora da zona demarcada em todos os campos registados para o efeito, pelo menos durante um ciclo cultural completo, em todos os atos de expedição de batata. Page: 1 014 port ref. DG(SANCO)/2013-6810 -MR of an audit carried out from 15 ied for Epitrix.

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Tal como verificado na auditoria e consta no presente relatório "O Plano de Aprovação e Controlo de Estabelecimentos (PACE) é baseado nos riscos, tal como o Plano de Controlo Oficial à Produção de Leite Cru (PCOL). (...) A frequência dos controlos a nível dos estabelecimentos tem em conta vários critérios, entre os quais o risco da atividade (manipulação dos produtos ou obabilidade de gerar riscos durante a produção), o risco da dimensão (de acordo com o Regulamento do Licenciamento da Atividade Industrial português, calculado a partir do número de pessoal do OESA e da energia elétrica) e o grau de cumprimento. O grau de cumprimento de quatro níveis segue o grau de cumprimento de sete indicadores: instalações/equipamentos, higiene geral, HACCP, requisitos analíticos, qualidade da água, rastreabilidade e subprodutos animais. Caso sejam encontrados níveis 4 e 3 significativos de não-conformidade, devem ser realizadas visitas de seguimento no prazo de um e três meses, respetivamente." 2. Na região Autónoma dos Açores os controlos oficiais são efetuados de acordo com os procedimentos definidos no Plano de Controlo Oficial Sistemático dos Estabelecimentos de Alimentos de Origem Animal (

s verified during the audit and noted in the report, We enclose the current status of inspections to establishments of the meat sector in the Azores (Annex "The Plan for Approval and Control of Establishments (PACE) is risk based as is the Plan for Official Control of 1). When this priority action plan is completed, the Raw Milk (PCOL). (...) The frequency of controls at requested information will be sent to the FVO. establishment level takes into account several criteria, Considering that the risk management system in place amongst them the activity risk (manipulation of products ensures that official controls are carried out regularly, on or probability of generating risk during production), the a risk basis and with appropriate frequency to achieve dimension risk (according to the Portuguese industrial the objectives of the Regulation n. º 882/2004, DGAV licensing regulation calculated from the number of FBO believes that the introduction of changes in the system is staff and the electric power) and the compliance degree. not a priority at this moment, so it will be scheduled for The four level compliance degree follows the degree of a subsequent time. compliance with seven indi

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Tal como verificado na auditoria e consta no presente relatório "O Plano de Aprovação e Controlo de Estabelecimentos (PACE) é baseado nos riscos, tal como o Plano de Controlo Oficial à Produção de Leite Cru (PCOL). (...) A frequência dos controlos a nível dos estabelecimentos tem em conta vários critérios, entre os quais o risco da atividade (manipulação dos produtos ou probabilidade de gerar riscos durante a produção), o risco da dimensão (de cordo com o Regulamento do Licenciamento da Atividade Industrial português, calculado a partir do número de pessoal do OESA e da energia elétrica) e o grau de cumprimento. O grau de cumprimento de quatro níveis segue o grau de cumprimento de sete indicadores: instalações/equipamentos, higiene geral, HACCP, requisitos analíticos, qualidade da água, rastreabilidade e subprodutos animais. Caso sejam encontrados níveis 4 e 3 significativos de não-conformidade, devem ser realizadas visitas de seguimento no prazo de um e três meses, respetivamente." 2. A implementação do Plano de Controlo Oficial do Leite Cru (PCOL) teve início, Page: 2 CA response received 04 June 2013 na Região Autónoma dos Açores, em 15/04/2013 (Anexo 2), depois de uma fase de d

s verified during the audit and noted in the report, The Control Plan of Raw Milk (PCOL) implemented in the Azores (Annex 2) was elaborated from the plan "The Plan for Approval and Control of Establishments (PACE) is risk based as is the Plan for Official Control of drawn up by DGAV, but was adapted to the Azores Raw Milk (PCOL). (...) The frequency of controls at (RAA). establishment level takes into account several criteria, Additionally, DRADR designed a Priority Intervention amongst them the activity risk (manipulation of products Plan applicable to all farms whose geometric average or probability of generating risk during production), the somatic cell count exceeds 750.000 or the geometric dimension risk (according to the Portuguese industrial mean plate count at 30ºC exceeds 100.000. licensing regulation The plan is already in full implementation, having calculated from the number of FBO staff and the electric already been performed 130 controls. power) and the compliance degree. The four level compliance degree follows the degree of compliance with seven indicators: facilities/equipment, general hygiene, ditional CA response received 13 September 2013 CCP, analytical require

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1. Dada a ausência de factos que suportem esta recomendação no que diz peito aos controlos oficiais realizados no resto do território nacional, consideramos que a mesma se aplica apenas à Região Autónoma dos Açores. 2. Na Região Autónoma dos Açores foram estabelecidas medidas imediatas para o setor das carnes, que preveem a realização de controlos oficiais até ao final do 1.º semestre de 2013 de todos os estabelecimentos cuja data do último controlo seja anterior a 2012 (Anexo 6). As medidas foram divulgadas por todos os serviços de ilha (Anexo 1). Os procedimentos em curso preveem o cumprimento integral do artigo 31º (2) do Reg 882/2004, tal como foi explicado aos auditores na reunião de abertura em S. Miguel e tal como verificado com o processo de suspensão de um estabelecimento visitado pela Equipa Auditora. Até ao momento foram já efetuados 21 controlos oficiais de estabelecimentos que se encontravam nesta situação, faltando ainda efetuar, à data da presente resposta, 7 controlos (Anexo 6).

ven the absence of facts supporting this In order to make clear the need to check, during the nts recommendation as regards the official controls carried official controls performed for the approval of t in the rest of the national territory, we consider that establishments, the requirements for the design and this recommendation applies only to the Autonomous implementation of procedures based on HACCP of the Azores. principles, DSSA issued Circular n.º 40/DSSA/2013 In the Autonomous Region of the Azores, immediate (Annex 3) with specific procedures regarding this asures were established for the meat sector, providing matter. r official controls to be carried out until the end of the rst half of 2013 in all of the establishments that had last Despite having been observed some shortcomings en checked before 2012 (Annex 6). The measures were during the FVO audit, in the Azores, the procedures in place require the assessment of HACCP in every sseminated to all of the island's services (Annex 1). The approval visit. This can be confirmed in the example going procedures provide for full compliance with case in Annex 4, which is a report of an inspection ticle 31(2) of Regulation 882/20

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1. Tal como foi verificado na auditoria e consta no presente relatório, a Autoridade Competente definiu e implementa procedimentos que visam verificar a eficácia dos controlos oficiais e garantir que sejam tomadas medidas corretivas, se necessário, nomeadamente: a) O Plano de Acompanhamento da Inspeção Sanitária (PAIS) diz respeito à supervisão das tarefas desempenhadas pelos Veterinários Oficiais e Page: 3 response received 04 June 2013 xiliares Oficiais nos matadouros; No que diz respeito ao Plano de Aprovação e Controlo de Estabelecimentos (PACE), as ações de supervisão são efetuadas pelos serviços regionais e centrais, e incidem nas tarefas exercidas pelos ecutores dos controlos oficiais, sendo verificados os seguintes aspetos: Relatório de controlo efetuado (enquadramento, fundamentação de facto e de direito, proposta de decisão e adequação das medidas propostas); . Notificação do operador para correção dos incumprimentos (fundamentação de facto e de direito e prazos concedidos); i. Cumprimento da frequência de controlo definida; . Introdução da vistoria no SIPACE; Realização de controlos de verificação (quando previsto). Na Região Autónoma dos Açores foi efetuada, pelo serviç

verified during the audit and noted in this report, the We enclose a copy of the Protocol signed between the fy Competent Authority defined and is implementing DGAV and DRADR (Annex 6). The protocol sets out rocedures aimed at checking the effectiveness of the how the two authorities cooperate with respect to design fficial controls and ensuring that corrective measures are and implementation of official control plans, training, aken if necessary. These include: a) The Plano de supervision and audits. companhamento da Inspeção Sanitária (PAIS, health Under this protocol, the following actions are planned: nspection monitoring plan) with regard to the supervision a) One training session on post mortem inspection in f the tasks performed by official veterinarians and November 2013 and another one in 2014; b) One fficial assistants in slaughterhouses; b) With regard to the training session on HACCP in November 2013 and lan for Approval and Control of Establishments (PACE), another one in the first half of 2014; c) One training upervision activities are carried out by the regional and session on traceability in the first half of 2014; d) The entral services and focus on the tasks perfo

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Tal como foi verificado na auditoria e consta no presente relatório "a equipa de uditoria do SAV recebeu informações relativas às auditorias organizadas pela quipa de auditoria interna da DGAV. As auditorias no setor da carne e dos dutos lácteos tiveram lugar em 2009 e 2010, com seguimento em 2011. Foi ambém realizada uma auditoria interna para avaliar os controlos oficiais dos produtos animais. Os relatórios da auditoria englobaram os mesmos tópicos brangidos durante as auditorias do SAV. Em resposta aos relatórios de auditoria to das AC, as regiões têm de fornecer um plano de ação que responda às ecomendações dos relatórios de auditoria das AC". Assim, consideramos que sta recomendação se aplica exclusivamente à Região Autónoma dos Açores. . O protocolo de colaboração entre a DGAV e a DRADR, referido nas ações a omar face à recomendação n.º 4, inclui os aspetos relativos às auditorias que erão efetuadas naquela região autónoma. age: 5 CA response received 04 June 2013 3. As auditorias dos planos de controlo oficial serão realizadas de acordo com o Manual de Procedimentos de auditorias internas em vigor, sendo as equipas auditoras constituídas por técnicos da Direção de Serviços d

s verified during the audit and noted in this report, Please find enclosed the Protocol for cooperation of "the FVO audit team received information on audits between DGAV and DRADR (Annex 6). organized by the DGAVs' internal audit team. Audits in Summary of the main Decisions related with Audits to the meat and dairy sector took place in 2009 and 2010 be carried out in Azores: a) During the first 12 months with follow-up in 2011. An internal audit was also carried after signing the Protocol internal audits will be carried out to evaluate the official controls over animal by- out in Azores by the Audit Unit of DGAV, in products. The audit reports evaluated covered the same accordance with a Program prepared by the Audit Unit topics as those covered during FVO audits. In response to and DSV Azores, approved by DGAV and DRADR; b) the CA audit reports, the regions have to provide an action During the above period DGADR staff will be prepared plan to the recommendations of the CA audit reports." We to perform internal audits; c) After the 12 month period thus consider that this recommendation applies referred to above Audits will be carried out by DGADR exclusively to the Autonomous Reg

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1. As medidas de reforço da componente de supervisão dos controlos oficiais, descritas a propósito da recomendação n.º 4, aplicam-se também em relação a esta recomendação. 2. As áreas de inspeção post mortem, rastreabilidade e rotulagem e HACCP serão objeto de um reforço, no que diz respeito à formação e instrução dos técnicos envolvidos nos controlos oficiais. Nesse sentido serão realizadas, até ao final de 2014, 24 ações de formação, nas seguintes matérias: i) Inspeção post mortem (8 ações) ii) Rastreabilidade e rotulagem (8 ações) iii) Auditoria de HACCP (8 ações) 3. Até ao final de 2013, serão desenvolvidas instruções relativas aos procedimentos a efetuar durante os controlos oficiais, no que diz respeito à verificação do HACCP e rastreabilidade.

e measures to reinforce the supervision element of In relation to HACCP training courses, the timeline was official controls, described in the response to reviewed in order to be completed by the end of June mmendation No 4, also reply in relation to this 2014. recommendation. Our comments on the recommendation n.º 4 also apply to this one. 2. Post-mortem inspections, traceability and labeling, and HACCP will be reinforced with regard to training of and instructions for the specialists involved in the official controls. To this end, 24 training sessions in the following subjects will be provided by the end of 2014: i) Post- mortem inspection (8 sessions), ii) Traceability and labeling (8 sessions), ii) HACCP auditing (8 sessions). 3. By the end of 2013, instructions will be drawn up concerning the procedures to be followed during official controls with regard to HACCP checking and traceability.

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1. No sentido de reforçar as medidas estabelecidas no Plano de Controlo Oficial do Leite Cru (PCOL) para assegurar que o leite fornecido aos estabelecimentos de produtos lácteos cumpre os requisitos definidos no Anexo III, Secção IX, Capítulo I, Page: 6 A response received 04 June 2013 rt Parte III do Regulamento (CE) 853/2004, a DGAV estabeleceu como objetivo stratégico para 2013 o reforço dos controlos oficiais no âmbito deste plano. . Com o objetivo de uniformizar a atuação dos serviços regionais, será definido, té ao final de Julho de 2013, um quadro de referência de atuação que stabeleça as medidas a tomar face aos resultados verificados. Essas medidas erão em conta a dimensão do desvio dos resultados em relação aos critérios e a volução dos resultados no tempo. . Os critérios definidos e a atuação da DGAV assegurarão que os controlos ficiais são efetuados em conformidade com o Anexo IV do Regulamento (CE) n.º 54/2004 e que o leite fornecido aos estabelecimentos de produtos lácteos umpre os critérios definidos no Anexo III, Secção IX, Capítulo I, Parte III do egulamento (CE) n.º 853/2004.

order to reinforce the measures provided for in the DGAV reinforced the official controls on dairy farms in Plan for Official Control of Raw Milk (PCOL) to ensure order to meet more thoroughly the goals of Regulation that the milk supplied to dairy establishments fulfills the (CE) nº 853/2004. One of the DGAV's 12 strategic rements of Annex III, Section IX, Chapter I, Part III goals for 2013 is related with the controls of raw milk. Regulation (EC) No 853/2004, the DGAV has defined In 2011 and 2012 we carried out 2154 and 2193 official reinforcement of official controls in the framework of this controls, respectively. For 2013 the goal is to achieve at Plan as one of its strategic objectives for 2013. least 2500 with a benchmark of excellency of 3250 2. In order to standardize the activities of the regional controls. services, a reference framework setting out the measures In addition, we are working on the revision of the plan to be taken in the light of the results obtained will be (PCOL) which will include setting a reference defined by the end of July 2013. These measures will take framework setting out the measures to be taken in light tional CA response received 13 September

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. As ações indicadas em resposta à recomendação n.º 7 aplicam-se igualmente a esta recomendação. Page: 7

e actions referred to in the response to The actions referred to in the response to ommendation No 7 also apply to this recommendation. recommendation n.º 7 also apply to this recommendation.

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AV, we will schedule before the end of sampling techniques, for all the inspectors that

PT clarification er the reorganization of V, we will The CA at central level is DGAV edule before the end of that have the coordination and 2, update training supervision competences. The sampling techniques, for regional authorities responsible for the inspectors the border controls are DRAP's or t working in import DGAV regional staff. All the trols. bodies will attend to the training schedule for November (3 working

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of equipment for performing sampling at the list we preparing a check list of the existing he necessary equipment for sampling

preparing the list of days training). The training is schedule for 5-7 November. for performing We are preparing, joint to the pling at the DPE, PC or training, a basic list of equipment that the PIF will have. the list we At the PC the inspectors work the FBO provide the equipment. This paring a check list of the was a condition for the approval of the PC. sting material, and them, will buy the necessary ipment for sampling ording the UE rules.

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defined. The list was published in gpp mation was sent to the Commission.. ormation on DGAV weblink e/portal/DGV/genericos?actualmenu=4096418& 96427

rol points, are eady defined. The list ublished in gpp and V websites and Page: 1 the recommendations of Report ref. DG(SANCO)/2012-6278-MR of an audit carried import controls on food of non-animal origin posed by the Authority PT clarification rmation was sent to sion. nfirm these n on DGAV

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he list was published in gpp and DGAV nt to the Commission DGAV web link: e/portal/DGV/genericos?actualmenu=4096418& 96427

PI, are already defined. st was published in gpp V websites and information was sent to ommission nfirm these n on DGAV

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e verified and approved after the

and DPE and DPI After the mission, all the PC and e verified and approved customs warehouse were visiting r the previous inspection. and verified the requirements according the check list. This list is published in our website.

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ted since the end of the mission. Page: 1 78-MR of an audit carried mpetent Authority

lready After march 1st, the PT authorities nted since the end of (GPP and DRAP) implemented the Page: 2 the recommendations of Report ref. DG(SANCO)/2012-6278-MR of an audit carried import controls on food of non-animal origin n Proposed by the etent Authority PT clarification ission. rules according the Circular letter 3/2012 of GPP, and all the CA (GPP, DRAP and AT) promoved the information. At GPP this CL was published in the webpage.

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f the draft report, and the DRAP ­LVT d to these issues.

comment to the pag This question will be clarified with he draft report, and the the inspectors in the next training, VT email in and will be treated according the related to these Q&A document. s We are preparing a sampling procedure for this training.

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e frequencies are verified quartly. With this omply and verify if the analytical controls are d frequency

e end of 2011, all the See our comment to the quencies are verified recommendation 1. DGAV, at ly. With this procedure Central level, will have the tend the comply and coordination and supervision of the y if the analytical FNAO import controls. ols are done according efined frequency

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that we are preparing for the training this

ampling procedure The training is schedule for 5-7 we are preparing for the November. ng this issue will be detailed. Page: 3 the recommendations of Report ref. DG(SANCO)/2012-6278-MR of an audit carried import controls on food of non-animal origin n Proposed by the etent Authority PT clarification

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Ensure that the incremental samples of the required weight are Idem taken according to Annex I D.2. of Regulation (EC) No 401/2006.

This issue will be clarified at the training session and ,we intend to prepare for this session, a procedure for sampling.

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The Law 26/2013, of 11 April, transposes into the national legislation the Directive 2009/128/EC, as required.

Ensure that the provisions of Directive 2009/128/EC are transposed into the national legislation, as required by Article 23 of the same Directive.

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e National Action Plan (NAP) establishes the training of the ectors from all the inspection authorities. As soon as the NAP is approved, there will be contacts with ASAE to develop a training plan. ASAE gives training to its inspectors covering the different areas of expertise, and there has been a reduction / change on the staff that leads to the need to renew the training courses for new inspectors, two actions are usually performed annually in the most important areas.

rama de formação específica na área dos .

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The NAP establishes the increasing of inspections along the years of ration of the Plan. Also the training referred above will contribute to possibility of the development of an annual plan of control. e is a strengthening of cooperation between the two authorities of ASAE and DGAV, achieving that relevant information is made available to the inspectors in time where an action is scheduled planned, ASAE counting now with the collaboration of phytosanitary inspectors to monitor the situations identified

dimento, com base na legislação comunitária, a das as entidades envolvidas na execução destes

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The NAP establishes the implementation of an annual plan of control that analyses a sample of 5% of the products in the market. Page: 1 Report ref. DG(SANCO)/2012-6298-MR of an audit carried Action Proposed by the Competent Authority

a execução das análises das formulações, no

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Laboratory of Formulation Analysis is already being assessed and tivated, and the accreditation request is foreseen for last trimester of 3.

Ensure that the official laboratory designated for formulation analysis of PPPs is assessed and accredited in accordance with the European standards, as required by Article 12(2) of Regulation (EC) No 882/2004.

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The control of the use of PPPs is addressed in the NAP, foreseeing its ension beyond the inspections related with cross-compliance. arding the control of application of PPPs according the conditions of el, it will be one of the indicators to be verified in the context of additional control. Madeira will adapt it to the specificities of agriculture practiced, the hodology that will be established at national level to ensure the icial control of the substances involved. PC - We will try to comply, at regional level, as defined in the ional Action Plan and additional control in this matter mentioned re, prepared by the various entities involved.

olo de resíduos é estabelecido a nível nacional e munitária. Page: 1 012-6298-MR of an audit carried ompetent Authority acional de controlo de resíduos em GAV é a entidade coordenadora. la ASAE. estão envolvidos três laboratórios: da DRAPNorte. realização de colheita de 260 amostras.

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Project of the National Action Plan (NAP) was completed by the king group and is now, since the 20th March until the 30th April, in ublic consultation, as required by Article 4 of Directive 2009/128/EC.

Ensure that a National Action Plan is adopted for setting up quantitative objectives, targets, measures and timetables to reduce the risks and impacts of pesticide use to human health and environment as laid down in Article 4(1) of Directive 2009/128/EC.

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SA-Madeira performs its activity trying to follow the guidelines of Page: 2 Report ref. DG(SANCO)/2012-6298-MR of an audit carried ction Proposed by the Competent Authority he Document SANCO/12495/2011 and the Article 28 of Regulation EC) No 396/2005. RVSA-Madeira expects the audit team to specify the guideline aspects hat are not followed. he DRAPN- Laboratory follows the Document SANCO/12495/2011. he L-DRAPN was audited in 17e18-04-2013, IPAC Assessment for xtension of scope of accreditation (multiresidues method - EN12393-2 ethod P) - 24 pesticides. he LRP (INIAV) follows the Document SANCO/12495/2011 in its aily analytical activity, so the internal procedures of MQ are in ccordance with this document and for that reason we do not understand he statement where it is said that we do not fully apply the Document ANCO/12495/2011. he LRP quality control procedures, both internal and external are in ompliance with the Document SANCO/12495/2011. n what regards the external quality control, the LRP has always taken art in the EU Proficiency Tests, and it was only in 2012 that the articipation was reduced due to financial difficulties.

ras colhidas na Região Autónoma da ão entregues no LRVSA entre as enviadas em 2011 pela ASAE foram ladas. tações do Documento SANCO/12495/2011. com sucesso, em 17 e 18-04-2013, pelo mbito da acreditação (método multiresíduos ­ pesticidas to habitual de entrega de amostras no LRP- os procedimentos internos, consiste na entrega Page: 2 012-6298-MR of an audit carried ty sco e no próprio dia em que são te e neste caso têm de ser o. facto de várias amostras do laboratório congeladas tratou- s dificuldades que ocorreram resolvidos e as entregas das com o procedimento egaram ao laboratório não se põe pois as amostras formado pelos técnicos do ta ao laboratório. as de homogeneização seriam seria preciso descongelar um ver os caroços, contudo o lava amostras deste tipo

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LRVSA-Madeira is equipped with an LC-MS/MS, a GC-TOF/MS and C's as GC-ECD, GC-NPD or GC-FPD. LRVSA-Madeira grees that GC-MS/MS is, nowadays, the state-of-art equipment for e screening analysis, which permits to achieve appropriate sensitivity and an substitute several GC's with selective detectors. On the other hand, C-TOF/MS cannot be judged as an obsolete equipment since it is more age: 3 Report ref. DG(SANCO)/2012-6298-MR of an audit carried Action Proposed by the Competent Authority multipurpose than GC-MS/MS. It also permits to achieve the necessary sensitivity for many pesticides and a degree of confidence in qualitative analysis higher than GC-MS/MS. The LRP (INIAV) has got a GC-TOF/MS and a GC/MSN; as to LC- MS/MS Equipment, efforts are being made for its acquisition, as early as possible.

ossui, atualmente, condições financeiras para mento GC-MS/MS. Page: 3 012-6298-MR of an audit carried he Competent Authority ao equipamento de LC-MS/MS, manifesta a sua participar num procedimento que contemple o envio amostras colhidas no continente português para a álise dos parâmetros que não estão a ser analisados, oratório Nacional de Referência ­ INIAV cução das análises a laboratórios que garantam os ios, preferencialmente junto do INIAV ou na sua to de outro laboratório.

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The number of samples taken for pesticide residue analysis is decided in an annual basis, according to the EU Implementing Regulations ncerning the multiannual control plan and the agricultural products have particular national or regional interest and / or an historical past of non-compliances. The NAP also establishes the progressive increase of the number of samples and products.

o de amostras considerado anualmente idas pela regulamentação comunitária. al de controlo prevê um controlo de 260 e analisadas nos laboratórios da DRAPNorte.

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The technicians of the official laboratories have received training and technical support given by the LNR (LRP-INIAV) since its foundation, particularly for its installation and beginning of activity. Some certificates of these training were presented during the audit. The technical support that the LNR gives to the official laboratories is varied, covering new methods of analysis, quality control procedures regarding Accreditation and support in daily routine activities. In fact, training and workshops have not been lately organized; neither have comparative tests between official laboratories, due to difficulties felt by the LNR, which were caused by internal restructuring and Page: 4 Report ref. DG(SANCO)/2012-6298-MR of an audit carried Action Proposed by the Competent Authority ncial problems. Nevertheless, the support is given to official ratories, whenever it is necessary and requested. It is the LNR ntion, as soon as the conditions allow it, to promote new ning/workshops and proficiency tests between official laboratories.

e Referencia (LRP-INIAV) está a planear a rkshop dirigido a todos os laboratórios que nal de laboratórios oficiais. orkshop está prevista para o final do ano. tão da realização de Ensaios Interlaboratoriais , uma vez que o número de laboratórios oficiais é ndendo a que é necessário condições específicas realização deste tipo de ensaios, optou-se pela ção da participação de todos os laboratórios oficiais Page: 4 012-6298-MR of an audit carried ction Proposed by the Competent Authority saios Interlaboratoriais externos, além URL. ções são depois comunicados ao LNR que a um dos laboratórios.

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se see the answer given at recommendation 3

termos da legislação comunitária, um às entidades envolvidas nestes controlos ribuem para a elaboração do respetivo

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ion ASAE always raises a process of CO, and is made known to the trader of irregularities found and the respective economic sanctions by the fication under art. 50. ª RGCO. Through the analysis of results of nspetives actions traders found illegally will be targets to regularly tor, within the availability achieved between the planned ations. According to the regulations established, this information is smitted to the competent authority (DGAV) responsible for eting authorization, which is responsible for preparing a report unicating the corrective measures to implement, being responsible to follow these situations

cedimento, com base na legislação comunitária, a as entidades envolvidas na inspeção e na tórios de inspeção, que submeterá a essas adoção e cumprimento.

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NAP establishes that the entities that perform the controls shall send GAV the report of the actions of control during the first trimester of e following year, which will allow DGAV to make its report within the ired deadlines.

des que realizam os controlos devem es de controlo durante o primeiro o que permitirá à DGAV elaborar o relatório

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ommon actions and the training that are established in the NAP Page: 5 Report ref. DG(SANCO)/2012-6298-MR of an audit carried Action Proposed by the Competent Authority will force the increasing in the coordination that is recommended. (1) Already answered in 3: there is a strengthening of cooperation between the two authorities, and it was agreed the collaboration of phytosanitary inspectors working in DGAV for monitoring of situations of violations identified in the inspective actions of the ASAE (2) In matters in question in the Autonomous Region of Madeira intervene only two distinct entities, the Regional Directorate of Agriculture and Rural Development, through its various directions services based on pre-established procedures, and the Regional Inspection of Economic Activities. The link between these two bodies is governed by a protocol established between both parties. Within their areas of competence they communicate directly with the respective national authorities.

de inspeção, com base na legislação prosseguir por todas as entidades envolvidas na Page: 5 012-6298-MR of an audit carried Competent Authority

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The fact that it has been assigned to the General Inspector of the ASAE decision-making power over the processes raised of CO, in the short- term will allow the rapid conclusion of them and permitting to sanction offenders in due time.. This circumstance leads to the consequent correction and by extension the prevention of non-conformities detected, simultaneously with the enhanced performance of phytosanitary inspectors working in DGAV for monitoring of situations of violations identified The Plan for Food Security of the Autonomous Region of Madeira, which articulates with the National Plan for Control of Pesticide Page: 6 Report ref. DG(SANCO)/2012-6298-MR of an audit carried Action Proposed by the Competent Authority idues in respect to samples of vegetable production site has proper ceability thereof. Whenever one is detected nonconformity with licable legal requirements, the services of the Regional Directorate of iculture and Rural Development with expertise in the area of hnical assistance to farmers, are informed by Alert, under which carry a direct contact with the offender, evaluate the cause of the urrence and issue technical recommendations considered important to adop

dimento de inspeção, com base na legislação e prosseguir por todas as entidades envolvidas na ão dos respetivos relatórios de inspeção, dos quais nte as ações a prosseguir em caso de não as subsequentes inspeções de zar, e que submeterá a essas entidades para mprimento.

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MAOT is carrying out an external audit covering both official controls of pesticide residues and official controls on the use of PPPs that will be concluded on the 1st semester 2013. ing the next cycle of our MANCP (2014-2018) ernal or external audits will be performed based on an approach risk evaluation. Page: 7

Page: 6

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, Foi, em 2011, constituído um grupo de trabalho multidisciplinar int composto por representantes da Direção Geral de Alimentação e Veterinária (DGAV), de três laboratórios de investigação (Laboratório Nacional de Energia e Geologia - LNEG; Laboratório de Nematologia do Instituto do Mar - IMAR do Departamento de Ciências da Vida, Faculdade de Ciências e Tecnologia, Universidade Coimbra; Instituto Nacional de Investigação Agrícola e Veterinária ­ INIAV); e de empresas registadas de tratamento de casca. Este grupo elaborou um plano de ação com diferentes atividades científicas a desenvolver em 2011 e 2012 de forma a validar um método de tratamento (natural ou artificial) eficaz na eliminação do NMP. Os relatórios preliminares destes estudos foram já enviados à DG-SANCO. Os resultados obtidos até ao presente, no que respeita o tratamento térmico artificial da casca, são muito promissores e esperamos ter a conclusão dos mesmos em outubro/novembro do presente ano. Assim, contamos elaborar um protocolo e requisitos técnicos para tratamento térmico artificial da casca que nos permita garantir uma eliminação eficaz de todas as espécies de Bursaphelenchus assim como de outros nemátodos even

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f Portugal estabeleceu e colocou em prática um sistema de reabilidade de material lenhoso de coníferas hospedeiras e instituiu um sistema sancionatório específico, a fim de garantir a observância das Page: 1 dations of Report ref. DG(SANCO)/2012-6305-MR of an audit carried nd control for Bursaphelenchus xylophilus Action Proposed by the Competent Authority and exigências no movimento do material lenhoso susceptível. Portugal ood continuará a promover ações de sensibilização e, para além das ações de fiscalização rodoviária, irá reforçar o controlo dos estabelecimentos comerciais (retalhistas) localizados na zona tampão que comercializam material lenhoso suscetível proveniente da zona afectada, em articulação com a ASAE.

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rtugal continuará a promover as ações de controlo rodoviário dos movimentos do material de embalagem suscetível da zona afectada para a zona tampão e para os outros Estados membros. Serão s reforçadas a identificação e fiscalização dos estabelecimentos na zona tampão que recebem mercadoria da zona afetada acondicionada com material de embalagem suscetível, em articulação com a ASAE. Serão ainda efetuadas fiscalizações a operadores localizados na zona afetada que forem identificados como fornecedores de estabelecimentos localizados na zona tampão de mercadorias acondicionadas em material de embalagem suscetível, dando prioridade aos que comercializam produtos para construção civil ­ utilizadores de one way pallets.

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re Foram eliminadas antes do início do período de voo do inseto vetor do NMP, as 89 483 árvores que foram identificadas, durante o período de Outono/Inverno (2011/2012), com sintomas de declínio e que à data da 2. Missão (março de 2012) ainda se encontravam por cortar. Page: 2 dations of Report ref. DG(SANCO)/2012-6305-MR of an audit carried nd control for Bursaphelenchus xylophilus Action Proposed by the Competent Authority Portugal tem vindo a realizar ações de identificação e eliminação de árvores com sintomas de declínio localizadas na Zona Tampão, tendo dado prioridade à eliminação das que foram identificadas em 2011, dado o risco que representam à possível instalação da doença, pese embora não haja qualquer indício da sua presença na proximidade. Efetivamente, trata-se de um processo de atuação dinâmico e contínuo que dificilmente se poderá conter em prazos fixos, razão pela qual são geridos os riscos associados e estabelecidas as respetivas prioridades de intervenção tendo em conta o período de identificação das árvores com sintomas de declínio.

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and Foi instituído um sistema de informação de sanidade florestal para gestão e acompanhamento de todas as ações de identificação, amostragem e eliminação de coníferas, que permite garantir a monitorização de todas as manchas com ocupação de pinheiro e bem . assim a amostragem de todas as árvores identificadas com declínio. Não serão amostradas de forma intensiva, árvores que se encontrem completamente afetadas pela ação dos fogos florestais.

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at Todos os sobrantes resultantes da exploração de coníferas hospedeiras s do NMP, localizados na Zona Tampão, serão imediatamente eliminados, cordo com a legislação nacional em vigor (Decreto-Lei n.º 95/2011, de 8 de agosto) Page: 3

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prático de maneio e despovoamento de espécies pecuárias em es de emergência" prevê um conjunto de critérios para a seleção do de atordoamento e abate. critérios relativos à dimensão e localização dos surtos suspeitos serão os de acordo com diferentes cenários de surtos de doença animal e ncluídos nos diferentes manuais de operações até Abril de 2013.

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al sistema de registo das explorações pecuárias (ruminantes e permite o conhecimento atualizado das populações animais e petiva localização. O cruzamento destes dados através de ferramentas icas permite visualizar a distribuição espacial destas zonas. de dados SNIRA gerida na componente informática pelo IFAP momento a ser adaptada, incluindo também a georreferenciação lorações. Não sendo previsível a data da conclusão desta ão, está prevista a realização de um ensaio piloto em Março de

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os sobre vacinação de emergência para a Febre Aftosa, Peste Clássica e Gripe aviária serão elaborados e incorporados no respetivo manual de operações até Abril 2013.

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evisão do tronco comum e manuais de operação das várias doenças s deverá estar concluída em Abril 2013. Page: 1 Action Proposed by the Competent Authority tronco comum e manuais de operações passarão a ser atualizados de is em dois anos e sempre que a AC (DGAV) entender por onveniente.

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(DGAV) irá promover um exercício de simulação em tempo real Febre Aftosa previsivelmente em Maio de 2013 condicionado no ntanto à situação económica e financeira de Portugal.

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INIAV irá entrar em contacto com o organismo "Animal Health and eterinary Laboratories Agency" (AHVLA) para solicitar e formalizar acordo mútuo para a Febre Aftosa e Doença Vesiculosa dos Suínos.

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lista dos laboratórios de referência para as várias doenças será ificada, atualizada e disponibilizada ao público até Abril de 2013

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V vai prosseguir com a acreditação dos ensaios de diagnóstico s doenças epizoóticas, prevendo-se a auditoria de avaliação do Page: 2 ion Proposed by the Competent Authority tituto Português de Acreditação (IPAC) para 2º semestre de 2013. NIAV vai proceder a auditorias internas a todos os procedimentos nicos para avaliar o grau de conformidade com as recomendações dos RL e Manual da OIE. ão elaborados os relatórios de validação para demonstrar a ivalência dos métodos de ensaios diferentes dos recomendados (BT, e EHD).

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(DGAV) irá preparar um documento com o objetivo de especificar taxas de abate previsíveis para os diferentes métodos de atordoamento e são, o que facilitará a escolha do método a utilizar em função da ão e localização de surtos suspeitos, bem como estabelecer íveis derrogações aos requisitos do Regulamento nº 1099/2009. Este umento estará finalizado em Abril 2013.

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(DGAV) está a preparar os procedimentos operacionais lizados para os diferentes métodos de atordoamento e eutanásia. procedimentos, irão complementar, os procedimentos já descritos no "Guia prático de maneio e despovoamento de espécies pecuárias em uações de emergência" que estarão finalizados em Abril 2013. Page: 3

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É intenção das autoridades portuguesas dar cumprimento integral às recomendações da FVO quanto à melhoria dos procedimentos de controlo. Assim, já se realizou uma reunião de trabalho entre a AT e a DGAV, tendo sido gizados procedimentos que asseguram o envolvimento e a articulação das várias autoridades/entidades com responsabilidade nesse controlo, tendo ficado acordado entre as partes: - Aprovação pela DGAV de alguns pontos de entrada de animais de companhia sem caráter comercial em marinas (Continente e Regiões Autónomas) tendo por base três critérios para a sua seleção: localização geográfica, dimensão e movimento de embarcações provenientes de países terceiros. A AT irá colaborar nesse apuramento. - Implementação de uma colaboração mais estreita entre DGAV, empresas gestoras das marinas e a AT no que se refere aos controlos veterinários nas marinas, assegurando que os animais de companhia só entrem nos pontos de entrada autorizados. Page: 1 Action Plan received from CA on 12 February 2013 f Report ref. DG(SANCO)/2012-6513-MR of an audit carried rried out at border inspection posts and specific issues at selected Proposed by the Competent Authority AV e a AT irão também articul

nter The Portuguese authorities intend to comply and fully with the FVO's recommendations on h clear improving the control procedures. Thus, the AT and the DGAV have already held hat a working meeting, procedures ensuring the t of involvement and coordination of the various n Article authorities/entities with responsibility for this control have been set out and the parties have agreed the following: - approval by the DGAV of some points of non- commercial entry for pets in marinas in mainland Portugal and the Autonomous Regions, chosen on the basis of three criteria: geographical location, size and movement of vessels from third countries. The AT will cooperate in this analysis. - implementation of closer cooperation between the DGAV, undertakings that manage marinas and the AT on veterinary checks at marinas, ensuring that pets come in only at authorised points of entry. The DGAV and the AT will also coordinate procedures for scheduling random checks throughout the year in marinas with and without Page: 1 Updated Action Plan received from CA on 27 March 2013 - clarifications on recommendations, 1,3,4 ed by the Competent Authorities of Portugal on 20 February in response to Report

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l No Plano Anual de Auditoria para 2013, há 3 Auditorias de IP, pontos de entrada e de certificação para serem 2 Action Plan received from CA on 12 February 2013 f Report ref. DG(SANCO)/2012-6513-MR of an audit carried rried out at border inspection posts and specific issues at selected he Competent Authority l Central e 2 a nível regional). Vamos lacionado com pontos de entrada não inas) no âmbito dessas auditorias. a será incluída no âmbito das r posteriormente. da ex DSSPA/STI-PT (agora DSECI/DIM) icar a eficácia das ações exercidas a todos os PE criados e caso se será revisto.

with The Annual Audit Plan for 2013 includes three nts to audits of BIPs, points of entry and certification cle 4 (6) to be carried out (in one case at central level Page: 2 Updated Action Plan received from CA on 27 March 2013 - clarifications on recommendations, 1,3,4 ed by the Competent Authorities of Portugal on 20 February in response to Report ref. d out from 23 to 26 October 2012 in order to evaluate import controls not carried out at border elected border inspection posts Action Proposed by the Competent Authority and in two at regional level). We are going to include the matter in relation to non-designated points of entry (like marinas) in the scope of these audits. The matter will also be incorporated into the audits conducted subsequently. The control plan of the former DSSPA/STI-PT (now the DSECI/DIM), which was drawn up to verify the effectiveness of measures taken at Points of Entry, applies to all those created and will be reviewed if necessary

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o na ausência da publicação do Decreto-lei (que relembramos ultrapassa as competências da DGAV) irá ser rodutos de origem animal detetados que sejam apreendidos sejam custos suportados pelo operador as apreendidas serão colocadas dentro istente e duplo, para evitar possíveis idamente selado e acondicionadas a devidamente fechada à chave. Para ida o n.º do selo constará no auto o volume de apreensões o justifique das serão encaminhadas para com os métodos legais em vigor. Action Plan received from CA on 12 February 2013 f Report ref. DG(SANCO)/2012-6513-MR of an audit carried rried out at border inspection posts and specific issues at selected Action Proposed by the Competent Authority Será efetuado o registo da data de destruição de cada remessa. A AT irá proceder à publicação das instruções tendo em vista o cumprimento desta determinação.

O in Even if the Decree-Law is not published (and e we recall that this legislative act is not within Article the DGAV's remit), it will be determined that products of animal origin detected in postal consignments that are seized will be destroyed, the costs being borne by the respective operator. Seized consignments will be placed in strong, double-layer plastic bags to avoid any spillage, which will then be duly sealed and kept in a locked refrigerator. The seal number for every seized consignment will be included in the record of seizure. Seized consignments will be Page: 3 Updated Action Plan received from CA on 27 March 2013 - clarifications on recommendations, 1,3,4 ed by the Competent Authorities of Portugal on 20 February in response to Report ref. d out from 23 to 26 October 2012 in order to evaluate import controls not carried out at border elected border inspection posts Action Proposed by the Competent Authority sent for destruction by legal methods when the volume of seizures justifies this course. The date of destruction of every consignment will be recorded. The AT will publish the instructions for compliance with this decision. CA response received on 27 March 2013

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oram desencadeados esforços no sentido da rápida aprovação e publicação do Decreto-lei, cuja proposta foi remetida ao MAMAOT em Junho de 2012.

Efforts have been made with a view to prompt ide a approval and publication of the Decree-Law, controls the proposal for which was sent to the ision of MAMAOT in June 2012. of CA response received on 27 March 2013 Informação não disponível.

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tão a ser elaboradas instruções que visam: - Informar o pessoal responsável pela gestão de aeroportos que terá de providenciar, antes da aterragem de aeronaves provenientes de países terceiros, informação relativa á obrigação dos passageiros depositarem os restos de alimentos não consumidos durante a viagem, em locais devidamente assinalados para o efeito; - Informar o pessoal responsável pela gestão dos aeroportos que o n.º de troleys contendo ICW deverá ser contabilizado por aeronave devendo ser guardado esse registo de forma a que possa ser fornecido à AC com uma periodicidade a determinar. - Informar a empresa de catering que o número de troleys recolhidos diariamente das aeronaves deverá ser contabilizado diariamente em conjunto com a informação Page: 4 Action Plan received from CA on 12 February 2013 f Report ref. DG(SANCO)/2012-6513-MR of an audit carried rried out at border inspection posts and specific issues at selected on Proposed by the Competent Authority voos que estiveram na sua origem bem como com o total daí resultante. o ser revistas as check lists que visam auxiliar aquando ealização dos controlos oficiais os técnicos que os uam com vista á elaboração subsequente

he Instructions are being drawn up for: - informing the staff responsible for managing s airports who, before aircraft coming from third nd countries land, will have to provide information g official on the obligation on passengers to deposit the of remains of food that is not consumed during the Page: 4 Updated Action Plan received from CA on 27 March 2013 - clarifications on recommendations, 1,3,4 ed by the Competent Authorities of Portugal on 20 February in response to Report ref. d out from 23 to 26 October 2012 in order to evaluate import controls not carried out at border elected border inspection posts Action Proposed by the Competent Authority journey in containers that have been duly identified to this end; - informing the staff responsible for managing airports that the number of trolleys containing International Catering Waste (ICW) will have to be recorded per aircraft and this record kept for presentation to the competent authorities at intervals to be determined. - informing the catering undertaking that the number of trolleys collected from aircraft each day must be recorded every day, along with the information on the flights from which these were taken and the tota

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ão a ser elaboradas instruções que visam: dicar que em todos os pontos de entrada se encontrem onibilizados contentores, estanques, laváveis e nfetáveis, devidamente identificados para deposição restos de cozinha e de mesa de embarcações enientes de países terceiros. struir o pessoal responsável pela gestão de portos ou nas para providenciar, antes da atracagem de rcações provenientes de países terceiros, informação ipulação relativa á obrigação dos restos de cozinha e esa terem de ser colocados em locais devidamente nalados para o efeito e a forma como os mesmos rão ser colocados (em saco plástico resistente, duplo, damente fechado de forma a evitar extravasamentos). truir as empresas que procedem á recolha de resíduos dos nos pontos de entrada que todo o lixo recolhido Page: 5 Action Plan received from CA on 12 February 2013 f Report ref. DG(SANCO)/2012-6513-MR of an audit carried rried out at border inspection posts and specific issues at selected e Competent Authority ser encaminhado para incineração r possível para aterro devidamente s que caso não procedam a uma s os resíduos daquelas viaturas terão ntico ao referido no parágrafo s responsáveis pela gestão dos resíduos empre

for Instructions are being drawn up for the I following purposes: 2011 - stating that duly identified, air-tight, washable ints. and disinfectable containers are available at all points of entry for depositing kitchen and table Page: 5 Updated Action Plan received from CA on 27 March 2013 - clarifications on recommendations, 1,3,4 ed by the Competent Authorities of Portugal on 20 February in response to Report ref. d out from 23 to 26 October 2012 in order to evaluate import controls not carried out at border elected border inspection posts he Competent Authority iving from third countries. aff responsible for managing inform the crews of vessels untries of the obligation to ble waste in facilities that to that end and how such d (in strong, double-layer ly closed to avoid spillage) enter port. akings collecting solid waste hat all waste collected there ineration (or, when this is proved burial). rises that, where they do not collection of waste from aste will have to be treated preceding paragraph. dertakings responsible for waste that any such waste the bodies that manage the ts or marinas), with a record tainers collected/emptied, litres, etc.), the days on ns are made, the Page

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Due to the Portuguese reorganization, the administration of INRB is waiting for the new Organic Law and competences to take forward the editation process

The INRB foresees to fuse the GMO analysis in one of its official laboratories in order to maximize the existing qualified and experienced f as well as the equipment. By this means, during 2012, there will be o need for new staff recruitment. Equipment will be calibrated and maintained according to the manufacturer exigencies.

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ASAE has implemented a program for control and sampling of GM products (PCOGM 2011). Since November 2011, 2 samples were yzed and the results were GM negative

Checks, including sampling and analysis (qualitative and quantitative) are carried out, as required by Article 9.1 of Regulation (EC) No. 1830/2003. In particular, with respect to controls of food.

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Although the Portuguese authorities consider that the sample collection cedures for the GMOs control, based on Reg 401/2006 are statistically representative, we will implement the change in procedures in order to use the Recommendation (EC) 2004/787/EC for the sampling of packaged products.

The samples of food, including pre-packed foodstuffs, are representative of the consignment, in line with Recommendation (EC) 2004/787/EC.

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See response to nº 1 recommendation

The approach stated in line 1 will increase the capacity to INRB perform functions of Nacional Reference Laboratory. Moreover, INRB foresees submit to the Portuguese Accreditation Body (IPAC) the tension of the accreditation for these methods during the year of 2012.

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sponse to nº 1 recommendation Page: 1 s of Report ref. DG(SANCO)/2011-6260-MR of an audit carried rols for genetically modified organisms including their deliberate Action Proposed by the Competent Authority

ted in line 1, the new GMO laboratory will have adequate facilities nd equipment. Page: 1 s of Report ref. DG(SANCO)/2011-6260-MR of an audit carried rols for genetically modified organisms including their deliberate Action Proposed by the Competent Authority

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According the plan control 01, all the controls of FNAO are according the risk analysis, and in line with Article 3 of Regulation (EC) 882/2004. The control in the retail market is made according the control plan 32 and the procedure PCOGM 2011, performed by ASAE.

Official controls address identified risks, in particular those linked to the presence of GM events, other than Bt63, in rice products originating from China, in line with Article 3 of Regulation (EC) 882/2004.

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This procedure was implemented since the Mission. Now, the procedure is the following: after the analytical result of the second (supplementary expert) opinion, if the first result is non-compliant, or 10 working days after the notification to the operator of the non- conformity the template of the RASFF notification of border rejection is filled by the respective DRAP/RA, and sent to GPP, that will send to the National Contact Point (GTI, DGV), in accordance with the procedures and models contained in the RASFF.

Information is provided immediately to other Member States in the RASFF, following confirmation of the existence of a risk, as required by Article 50 of Regulation (EC) 178/2002.

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all take into consideration this recommendation and implement the provisions of Regulation (EU) No. 619/2011, through systematic use of screening markers used by companies introducing plant varieties of authorized or non-authorized GM into the EU. Thus, besides CaMV 35S terminator, NOS terminator, NPT II and endogenous DNA control markers, PFMV, PAT, BAR and CP4 will be considered as Page: 2 s of Report ref. DG(SANCO)/2011-6260-MR of an audit carried rols for genetically modified organisms including their deliberate Action Proposed by the Competent Authority

Regulation (EU) No 619/2011 is implemented and controls are carried out for non-authorised GM events in feed.

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ell, aiming to the detection of non-authorized events. All positive esults will be subject to quantification. The amounts provided for in nnex I, in accordance with the nature of the sample will also be taken nto account upon sample collection. T only uses accreditated laboratories under the EN ISO/IEC 17025, for arry out GMO analysis. Most of the methods are accreditated and some re validated according the JRC performance requirements. age: 3

INRB foresees submit to the Portuguese Accreditation Body (IPAC) the extension of the accreditation for these methods during the year of 2012. Page: 2

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sis of the final report ref. DG(SANCO)/2011-8858-MR, the nt Authority (PCA) have some difficulties to the scope of this recommendation, since the DGV staff for collecting samples for the RMP received adequate training, by Article 6 of Regulation (EC) No 882/2004. Since 2008 14 , related to this issues, with approximately e an extensive training program for all staff ction. DGV have sent this information on during the FVO audit ASAE provided data ty of samples in line with Article 11(7) of assured. It is written on page 5 of the FVO elivered in suitably sealed and labeled heir integrity and anonymity." k with this recommendation is the comment he laboratory due to a number of factors of matrix to be tested and the wrong matrix out that in 2011 only 0.09% (7 samples the samples were rejected by LNIV, which quantities of matrix to be tested; rix being collected; Page: 1 pril 2012 ref. DG(SANCO)/2011-8858-MR of an audit carried idues and contaminants in live animals and animal Action Proposed by the Competent Authority inadequate labeling. y established a procedure in which LNIV will always rejected samples. the list of rejected samples: (Annex I)

he financial difficulties the country is experiencing have not allowed the he National Veterinary Research Laboratory to take the measures necessary 2) of for the proper processing of samples. The LNIV is engaged in obtaining the necessary resources form the the MAMAOT. The DGV began the process of debt settlement with LNIV in this year and requested a budget increase from the MAMAOT. (Information 12/G/2012 dated 16.03.2012). Additional clarification The national reference laboratories are in restructuring. During this period DGAV out-sourced some RMP analysis to LGC in England. On 15 of June was published the legal support for the new tax for the health and food safety fund. This fund can be used to support costs relating to the implementation of official controls, namely official residues controls.

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fficulties the country is experiencing have not allowed the ary Research Laboratory to take the measures necessary for ng of samples. s engaged in obtaining the necessary resources form the egan the process of debt settlement with LNIV in and requested a budget increase from the MAMAOT. 012 dated 16.03.2012).

ficial Samples will be analyzed by laboratories using validate analytical line procedures within the scope of their accreditation. If properly financed, the National Veterinary Research Laboratory (LNIV) now included in the ewly created National Institute for Agricultural and Veterinary Research (INIAVE) will analyze the samples for which it has validated and accredited procedures. For the analysis of the other samples, it will subcontract accredited laboratories. LNIV will make all the necessary efforts to validate and accredited all the Page: 1 Updated Action Plan received on 19 July 2012. ocument can be found on the web page for this audit (http://ec.europa.eu/food/fvo/rep_details_en.cfm?rep_id=2893) recommendations of Report ref. DG(SANCO)/2011-8858-MR of an audit carried uate the monitoring of residues and contaminants in live animals and animal ucts Action Proposed by the Competent Authority ning analytical methodologies to reduce the volume of subcontracted tical work within the next two years. LNIV wants to be able to ze the entire 2015 RMP. ional clarification ditation continues to be one of the main objectives of LNIV. ding to the attached documents L0445A1 and L0445A2, t

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ll be analyzed by laboratories using validate analytical scope of their accreditation. If properly financed, the nary Research Laboratory (LNIV) now included in the stitute for Agricultural and Veterinary Research ze the samples for which it has validated and accredited analysis of the other samples, it will subcontract ries. the necessary efforts to validate and accredited all the l methodologies to reduce the volume of subcontracted hin the next two years. LNIV wants to be able to analyze Page: 2 pril 2012 ref. DG(SANCO)/2011-8858-MR of an audit carried idues and contaminants in live animals and animal Action Proposed by the Competent Authority P.

MP National Veterinary Research Laboratory (LNIV) now included in the created National Institute for Agricultural and Veterinary Research VE), as National Reference Laboratory will take all the necessary res to assure that official samples from RMP will be analyzed by ated methodologies in accordance with annex 2 and 3 of Commission ion 2002/657/EC. ional clarification as National Reference Laboratory is prepared to assist the CA to e that official samples will be analyzed by analytical methods ated under the Commission Decision 2002/657/EC.

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Research Laboratory (LNIV) now included in the titute for Agricultural and Veterinary Research nal Reference Laboratory will take all the necessary that official samples from RMP will be analyzed by ogies in accordance with annex 2 and 3 of Commission EC.

ake In order to ensure that the official veterinarians take into account relevant g of information about equidae intended for slaughter when performing ante mortem inspections, DGV sent written instructions reminding the official y veterinarians that the supplementary food chain information should always C) be complemented with the information included in equidae passport or in Page: 3 Updated Action Plan received on 19 July 2012. ument can be found on the web page for this audit (http://ec.europa.eu/food/fvo/rep_details_en.cfm?rep_id=2893) recommendations of Report ref. DG(SANCO)/2011-8858-MR of an audit carried uate the monitoring of residues and contaminants in live animals and animal ucts Action Proposed by the Competent Authority Resenho Oficial de Substituição'. (Annex II). ional clarification orm 'Resenho Oficial de Substituição' will no longer be in use at the f October, with the release of the "green books" for breeding and ction horses, as stated in the answer to Recommendation No.5. In its on IX this document will, provide up to date information on the food , as is the case with the blue books currently in effect, for registered s.

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e that the official veterinarians take into account relevant ut equidae intended for slaughter when performing ante DGV sent written instructions reminding the official hat the supplementary food chain information should always th the information included in equidae passport or in al de Substituição'. (Annex II)

s under implementation of Reg. 504/2008 for all horses in the nal territory, through the Plan Identification of equine conditions implementation is expected to be completed by the end of July p. f . after, all owners of horses (horses and other equines) may request the ctive Identification Document containing information on the food (in Section IX) ional clarification 2007, the passports for registered horses (Blue Books), issued by the ation Alter Real (FAR), are in accordance with this Regulation as ds the indications for the food chain. This foundation is making es to the database of the RNE, according to instructions issued by in order to adjust these passports to the regulation, also extending ssuing of a model (Green Paper) to horses destined for breeding and ction. Page: 4 Updated Action Plan received on 19 July 2012. ocument can be found on the web page for this audit (http://ec.europa.eu/food/fvo/rep_details_en.cfm?rep_id=2893) recommendations of Report ref. DG(SANCO)/2011-8858-MR of an audit carried uate the monitoring of residues and contaminants in live animals and animal ucts n Proposed by the Competent Authority the restructuring of this Foundation, the Service respon