Romania

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Despite the above procedures, and training arrangements, the audit team found gaps in the knowledge of a number of CA staff, especially in relation to Regulation (EC) No 2073/2005 and also on Hazard Analysis and Critical Control Points (HACCP) principles. This failure to keep the knowledge of staff conducting official controls up to date is not in line with article 5(4) of Regulation (EU) 2017/625. The appreciation of the risk level of some hazards, in particular in high-risk RTE production areas, had an impact on the effectiveness of official controls in those areas. See also findings 50, 54 and 60. 5.2.2 Supervision of CA staff and audits

Although a system to deliver instructions, information and training material to CA staff is in place, covering topics relevant to the sector audited, it is not effective to routinely cater adequately for training needs on specific subjects, in particular official controls on the production of RTE meat products with high risk of microbiological contamination. This weakness impacts the effectiveness of the official controls.

In three of the six establishments visited, the audit team found that, in areas where exposed RTE meat products were produced, handled and/ or stored, the OVs failed to identify some non-compliances, did not correctly assess the importance of non- compliances identified or did not take the necessary measures to ensure that the FBO tackled the root cause(s) of some issues which, as a result, recurred. For instance: In one establishment, producing high volume of sliced product able to support the growth of Listeria monocytogenes, the following points, observed in the high-risk production area, were classed as minor by the OV: · Some condensation over the area feeding final product to the slicer used for RTE meat products. This posed a high risk of contamination of the final product as well to the slicer (potential contamination of next batches passing through the same production line); · Poor post-operational cleaning, especially in the slicer used for RTE meat products; · Damaged wall panels rendering them not easy to clean and disinfect. In another establishment, the barriers protecting the walls in the slicing room were allowing the concentration of organic material (leftovers of the production) as well as the pooling of disinfectant after the cleaning process. Both matters posed a risk of cross contamination (microbiological and chemical, respectively). In these establishments, after this high-risk production area, the sliced RTE meat products were not subjected to any further steps able to address or eliminate the hazard. In another establishment the audit team found some long-standing issues that the official controls had either not identified or the OV had not taken appropriate measures to ensure that the FBO remedied the non-compliance and prevented further occurrences. These issues created a risk of cross contamination to the exposed RTE meat product and included the following: 10 · Inadequate ventilation that resulted in the pooling of water from condensation in a chiller used to store exposed RTE meat product, some of which was placed in low racks very close to the floor; · Long-standing dirt in ventilation grills in the same chiller containing exposed RTE meat product; · Cross flows between raw and RTE meat products, as slicing and packaging of RTE meat products was carried out in the same area as a packaging line for meat preparations. This is not in line with Annex II, Chapter I, point 1 and 2 of Regulation (EC) No 852/2004. HACCP based procedures

However, during the on-site visits, the audit team identified some non-compliances that had not been identified or reported by the CA in some of the establishments, mainly: · Product flow diagrams incomplete or not reflecting reality in one of the establishments. · Some hazards not considered or inadequately assessed. For instance, in one of the establishments Listeria monocytogenes and Staphylococcus aureus had not been identified as hazards in the packing/ slicing area. · In one establishment, the critical limit of the critical control point `temperature of fresh liver at reception' was set at 60 C, above the legal requirement of 40 C as specified in Annex III, Section II, Chapter V, point 1(b) of Regulation (EC) No 853/2004. Microbiological criteria

In two establishments visited producing RTE meat products able to support the growth of Listeria monocytogenes, it was noted that the CA accepted that samples from the processing area and equipment were preponderantly taken after cleaning and disinfection. The European Union Reference Laboratory on Listeria monocytogenes (EURL Lm) Guidelines on sampling the food processing area and equipment for the detection of Listeria monocytogenes recommends that the sampling should be carried out during processing in order to increase the probability of detecting a persistent strain. Sampling only after cleaning and disinfection makes the detection of the pathogen difficult and can lead to a false sense of security.

Official controls are risk based, supported by instructions and checklists and there is evidence that, in general, they are effective in identifying relevant non-compliances, in particular those regarding maintenance and hygiene requirements. However, these controls are not sufficiently effective to identify and enforce correction of non- compliances in relation to high-risk RTE production areas and in relation to shortcomings in the FBOs' food safety management systems.

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In two establishments visited producing RTE meat products able to support the growth of Listeria monocytogenes, it was noted that the CA accepted that samples from the processing area and equipment were preponderantly taken after cleaning and disinfection. The European Union Reference Laboratory on Listeria monocytogenes (EURL Lm) Guidelines on sampling the food processing area and equipment for the detection of Listeria monocytogenes recommends that the sampling should be carried out during processing in order to increase the probability of detecting a persistent strain. Sampling only after cleaning and disinfection makes the detection of the pathogen difficult and can lead to a false sense of security.

The audit team reviewed some of the shelf-life studies used to demonstrate the aforementioned point and found that the demonstrations for different products in one of the establishments visited were done on the basis of a single durability study per meat product. These products had pH and water activity characteristics that supported the growth of Listeria monocytogenes.

According to the EURL Lm technical guidance document on challenge tests and durability studies for assessing shelf-life of ready-to-eat foods related to Listeria monocytogenes, it is not recommended to implement durability studies to validate a shelf-life related to Listeria monocytogenes because of its low prevalence, its low contamination level and its heterogeneous distribution in the food. The guidance mentions in this regard that, in most cases, results will be obtained from samples not contaminated with Listeria monocytogenes making it impossible to conclude on its 12 evolution in the product.

It was also noted that the above shelf-life studies did not take into account the expected storage temperatures at final consumer level and had therefore not been carried out under reasonably foreseeable conditions of distribution, storage and use as required in Article 3.1(b) of Regulation (EC) No 2073/2005.

Some of the shelf-life studies carried out by FBOs producing RTE meat products to demonstrate compliance with food safety criteria, and accepted by the CA, were not carried out in accordance with Regulation (EC) No 2073/2005. As a result, their validity to demonstrate that Listeria monocytogenes will not exceed the limit of 100 cfu/g throughout the shelf-life of the product could be called into question.

The ability of some FBO's own-controls to detect Listeria monocytogenes in environmental samples is weakened by the FBOs choice of the timing of sampling. This timing, which is accepted by the CA, can impact the ability of the FBO to identify the sources of persistent strains of Listeria monocytogenes and provide a false sense of security.

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Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

The national identification and registration system satisfies the requirements set out in EU rules and arrangements are in place to ensure that all registered entities are under veterinary supervision. However, inconsistencies between the numbers of animals born, identified and removed from the system call into question its reliability for disease tracing purposes.

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In the first six months of 2025, checks were carried out on 3,897 small ruminant establishments (of which 2,574 were backyard holdings). No further suspected cases of disease were detected. However, experience during 2024 showed that infected flocks and herds often showed few clinical signs. In these circumstances, relying on clinical inspections Relying on rather than the routine use of laboratory-based diagnostic tests reduced clinical the sensitivity of this surveillance exercise. surveillance 87. In addition, the veterinary authorities performed pre-export PCR tests for leaves the export of small ruminants to certain third countries. Approximately questions 50,000 animals originating on farm establishments throughout the about country were tested in this way between 2024 and 2025. No positive disease results were reported. persistence.

When assessing the significance of this surveillance, it is important to consider that: a. the categories of sheep and goats that are exported to third countries are quite specific in terms of their production and are not representative of many other categories of small ruminant establishments in Romania. b. The number of animals tested (50,000 heads) among the total number of animals exported (during 2024, 1,231,121 sheep were exported to third countries and 517,787 sheep were traded with EU Member States) provides a statistically low level of confidence that the disease would be detected in the exported animal cohort, if present.

In response, the veterinary authorities prepared a PPR surveillance plan. However, substantial funding would be required for its execution and Government approval to proceed had not been granted at the time of the audit. Conclusions on outbreak management

By relying on clinical surveillance and targeted testing of animals intended for export, the veterinary authorities can provide only limited assurance that PPR is no longer present in Romania.

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Based on statistics on PPPs provided by the NPA, 416 out of the 1 387 PPPs, currently authorised in Romania, contain active substances considered as candidates for 5 substitution. Representatives from NPA stated that, in general, when authorising or renewing the authorisations of PPPs containing such active substances, there were no alternatives. However, the audit team noted that a comparative assessment had not been carried out for any of these PPPs to demonstrate that other, safer alternatives were not available. This is not in line with Article 50 of Regulation (EC) No 1107/2009. Representatives from NPA provided a procedure describing criteria and responsibilities for carrying out comparative assessments, however, it was noted that this procedure is in a draft form and has not been approved yet. Emergency authorisations

The general process of PPP authorisation involves representatives from three authorities, is clearly defined, sufficiently transparent and, despite some resource limitations, is generally implemented in a way that ensures scientific evaluation while limiting significant delays. Nonetheless, despite a relatively high number of PPPs containing candidates for substitution authorised in Romania, the CAs have not carried out comparative assessments against alternatives with potentially safer active substances, contrary to EU requirements and the Farm to Fork Strategy to reduce the risk of PPPs.

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re regarding comparative assessment in Romania, in accordance with art. 50 of Regulation (EC) no. 1107/2009, regarding the evaluation of a new application for authorisation of a PPP containing an active substance approved as candidate for substitution or for the renewal of the authorization according to art. 43 of Regulation 1107/2009 of PPPs containing candidates for substitution, is in final stage and will be discussed and approved in the next CNOPPP meeting, until the end of 2024 . From the beginning of 2025, the comparative assessment procedure according to art. 50 of Regulation (EC) no. 1107/2009 will be approved and implemented in Romania.

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On 3 August 2023, Romania granted three emergency authorisations under Article 53 of Regulation (EC) No 1107/2009 for outdoor use of seeds treated with a PPP containing imidacloprid (a neonicotinoid), contrary to the judgment of the Court of Justice of the European Union of 19 January 2023 in Case C-162/21 Pesticide Action Network Europe and Others which clarified that even in emergency situations Member States are not permitted to authorise the placing on the market of PPPs for seed treatment, or the placing on the market and use of seeds treated with those products, where the placing on the market and use of seeds treated with those products have been expressly prohibited by an implementing regulation.. These emergency authorisations were notified to the Commission on 26th September 2023. On 9 November 2023, the Commission informed Romania that these emergency authorisations were not compatible with Article 53 of Regulation (EC) No 1107/2009 as interpreted by the Court and recommended not to grant further similar emergency authorisations. Despite this, representatives from the NPA confirmed to the audit team that three more emergency authorisations for the treatment and sowing of treated seeds were granted on 16 November 2023, two for the use of imidacloprid and one for thiamehoxam. These authorisations were not notified to the Commission, contrary to Article 53(1) of Regulation (EC) No 1107/2009. Conclusions on authorisation of plant protection products

Emergency authorisations for the outdoor use of certain PPPs containing neonicotinoids have been granted repeatedly in violation of EU legislation, as interpreted by the Court of Justice of the European Union, the most recent of which were not notified to the 6 Commission. This entails potentially serious risks for pollinators.

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emergency authorizations are issued in accordance with MARD agricultural policies, taking into account the specific agro-climatic conditions and the pressure of harmful organisms.

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On 3 August 2023, Romania granted three emergency authorisations under Article 53 of Regulation (EC) No 1107/2009 for outdoor use of seeds treated with a PPP containing imidacloprid (a neonicotinoid), contrary to the judgment of the Court of Justice of the European Union of 19 January 2023 in Case C-162/21 Pesticide Action Network Europe and Others which clarified that even in emergency situations Member States are not permitted to authorise the placing on the market of PPPs for seed treatment, or the placing on the market and use of seeds treated with those products, where the placing on the market and use of seeds treated with those products have been expressly prohibited by an implementing regulation.. These emergency authorisations were notified to the Commission on 26th September 2023. On 9 November 2023, the Commission informed Romania that these emergency authorisations were not compatible with Article 53 of Regulation (EC) No 1107/2009 as interpreted by the Court and recommended not to grant further similar emergency authorisations. Despite this, representatives from the NPA confirmed to the audit team that three more emergency authorisations for the treatment and sowing of treated seeds were granted on 16 November 2023, two for the use of imidacloprid and one for thiamehoxam. These authorisations were not notified to the Commission, contrary to Article 53(1) of Regulation (EC) No 1107/2009. Conclusions on authorisation of plant protection products

Emergency authorisations for the outdoor use of certain PPPs containing neonicotinoids have been granted repeatedly in violation of EU legislation, as interpreted by the Court of Justice of the European Union, the most recent of which were not notified to the 6 Commission. This entails potentially serious risks for pollinators.

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Page: 1 2 August 2024 f report ref. DG(SANTE) 2024-7974 of the audit carried out from 20 February of marketing and use of Plant Protection Products Action proposed by the competent authority and deadline by which it will be completed

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The audit team noted the following: - Apart from the need to consider previous non-compliances and, for CAP agricultural users inspected on behalf of APIA, also the size of the farm, there are no risk criteria established at central level to prioritise inspections of PPP operators. For example, the following criteria are not considered: in case of PPP users, the type of crop cultivated, the risk due to the presence of water surfaces or neighbouring protected/vulnerable areas, and the results of the water monitoring programmes or, in case of wholesalers and retailers, their size/complexity. This is not in line with Article 9(1) and 24(2)(a) of Regulation (EU) 2017/625. - Due to the national legal framework (see findings 28 and 29), with the exceptions of the inspections carried out in the framework of the FITOS programme and those carried out on non-CAP agricultural PPP users, all inspections of registered PPP operators are not only carried out with several days prior notice but are generally also done at the same predictable time each year (just before the date of renewal of? ). Inspections of CAP agricultural users are usually carried out with a two-week prior notice, although the memorandum of understanding (see finding 20) clarifies that the prior notice should be kept as short as possible and be no more than 14 days. This general and extensive use of prior notifications is not in line with Article 9(4) of Regulation (EU) 2017/625. Conclusions on planning of official controls

However, the planning of inspections is very limited, and they are generally not risk- based. In addition, there is a general and extensive use of prior notifications of inspections to all registered PPP operators and to a significant number of agricultural users. These shortcomings undermine the general effectiveness of controls and may be 10 one of the reasons for the remarkably low rate of non-compliances identified during inspections (see conclusions 54 and 61). Delegation of certain tasks Findings

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Updating the procedure regarding the planning and carrying out of official controls at the operators who carry out activities of marketing and use of PPPs. Deadline: November 2024

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The audit team noted the following: - Apart from the need to consider previous non-compliances and, for CAP agricultural users inspected on behalf of APIA, also the size of the farm, there are no risk criteria established at central level to prioritise inspections of PPP operators. For example, the following criteria are not considered: in case of PPP users, the type of crop cultivated, the risk due to the presence of water surfaces or neighbouring protected/vulnerable areas, and the results of the water monitoring programmes or, in case of wholesalers and retailers, their size/complexity. This is not in line with Article 9(1) and 24(2)(a) of Regulation (EU) 2017/625. - Due to the national legal framework (see findings 28 and 29), with the exceptions of the inspections carried out in the framework of the FITOS programme and those carried out on non-CAP agricultural PPP users, all inspections of registered PPP operators are not only carried out with several days prior notice but are generally also done at the same predictable time each year (just before the date of renewal of? ). Inspections of CAP agricultural users are usually carried out with a two-week prior notice, although the memorandum of understanding (see finding 20) clarifies that the prior notice should be kept as short as possible and be no more than 14 days. This general and extensive use of prior notifications is not in line with Article 9(4) of Regulation (EU) 2017/625. Conclusions on planning of official controls

However, the planning of inspections is very limited, and they are generally not risk- based. In addition, there is a general and extensive use of prior notifications of inspections to all registered PPP operators and to a significant number of agricultural users. These shortcomings undermine the general effectiveness of controls and may be 10 one of the reasons for the remarkably low rate of non-compliances identified during inspections (see conclusions 54 and 61). Delegation of certain tasks Findings

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ame no 4 cial on

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These samples are analysed using a network of laboratories, part of the NPL, all accredited to ISO5 standard 17025/2018 and participating in inter-laboratory comparative tests of PPPs with other Member States. The analyses include the determination of the content of active substances and the chemical-physical properties of 5 The International Organization for Standardization (ISO) is an independent, non-governmental, international standard development organization composed of representatives from the national standards organizations of member countries. 11 PPPs. Nonetheless, the audit team noted that co-formulants and impurities in active substances are not included in the analyses and this is not in line with Article 24(1) of Regulation (EU) 2017/625. Consequently, the CAs are unable to verify the absence of unacceptable co-formulants in PPPs, in violation of what stated in Article 27 of Regulation (EC) No 1107/2009 and listed in its Annex IIII and cannot determine whether certain impurities do not exceed the maximum content permitted in the approval of the relevant active substances, as required by Article 6(b) of the same Regulation. Moreover, only around 25% of these analyses have the analytical method included in the scope of accreditation. Representatives from the NPL explained that they are working to obtain a flexible scope of accreditation. Conclusions on laboratories used for formulation analysis of plant protection products as part of official controls

NPL is the designated laboratory for PPP formulation analyses, and it is accredited to ISO 17025/2018. This provides some basis for ensuring reliable results of tests and analyses although this basis could be strengthened by extending the range of analyses included in the scope of accreditation. Moreover, not including analyses for unacceptable co-formulants and regulated impurities in the sampling programme undermines the overall capability of the controls system to ensure the safety of the PPPs placed on the market.

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ntly, the laboratory is developing and validating the f method for determining the relevant impurity - Formaldehyde (present in samples containing glyphosate), which will be accredited by the end of 2025, following also for other relevant impurities. At the same time, the laboratory participates in interlaboratory comparison tests organized by European laboratories for the determination of certain impurities and co-formulants. Page: 2 2 August 2024 f report ref. DG(SANTE) 2024-7974 of the audit carried out from 20 February of marketing and use of Plant Protection Products Action proposed by the competent authority and deadline by which it will be completed Starting with the year 2025, for each sample, a full screening will be performed using GC-MS and LC-MS techniques for the qualitative confirmation of the co-formulants declared in the composition at the product authorization, as well as the verification of the presence/absence of unacceptable co- formulants.

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Furthermore, the audit team noted the following: - at retail level, the sale of PPPs authorised for professional use is not restricted to persons holding a certificate of training, and official controls do not pay attention to that, contrary to Article 6(2) of Directive 2009/128/EC. Representatives from the 13 NPA stated that this is due to the difficulties in interpreting what constitutes `professional use' of a PPP in Romania and that their priority is to ensure that retailers undergo the required training and are included in the certification system as laid down by Article 5(2) of Directive 2009/128/EC. - At the re-packer visited the audit team noted that inspections are carried out at least once per year, but the scope of the inspections is limited to the verification of the labelling of the final products and does not include controls, for instance, of the purchase of PPPs and the re-packing activities as such. Representatives from the central division of the NPA confirmed that the same limited scope of inspection applies to all re-packers and manufacturers and explained that this is because Romania considers that this is all EU legislation on PPPs provides for. Therefore, national legislation is expected to be adopted by the end of the year, allowing NPA to carry out more comprehensive controls on PPP manufacturers and re-packers. The audit team noted that Article 10(1) of Regulation (EU) 2017/625 provides sufficient legal basis for carrying out comprehensive controls at all relevant establishments. Controls on imports

There is a relatively high number of inspections of operators marketing PPPs, but inspections of re-packers and manufacturers have insufficient scope, which may have contributed to the fact that the export of non-authorised PPPs went unnoticed and without control. Moreover, there are insufficient arrangements to ensure that inspectors at local level are aware of key information about PPPs where recent changes of the authorisations took place. These weaknesses undermine the effectiveness of official controls of these PPP operators, a symptom of which may be the very low rate of non- compliances identified during inspections. Controls on the use of plant protection products Legal Requirements Articles 11 to 14 and 137 to 139 of Regulation (EU) 2017/625 Articles 28, 31, 55 (first and second sentences) and 67(1) of Regulation (EC) No 1107/2009 Articles 5 and 6 of Directive 2009/128/EC Regulation (EU) No 547/2011 Findings

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The national legislation regarding the manufacture, sale and , use of PPPs is in the process of being updated, in which distinct chapters have been introduced to regulate repacking and export activities, and after its approval, subsequently, by ministerial order, the specific requirements and norms for carrying out official controls. Deadline: second quarter 2025

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Staff is recruited through competitions at the CA's central level, which include a written examination and an interview. At least a bachelor's degree on forestry, biology, agriculture or similar subjects is required for inspectors to apply for these competitions. All civil servants are then required to keep themselves updated within their area of responsibility. Representatives from the central division of NPA explained that there are no planned trainings to keep inspectors' knowledge up to date, nor regular meetings with them, but inspectors are always advised to regularly access the NPA website where the minutes of the NCAPPP's meetings are uploaded and, in case of requests from CPOs, or special needs identified by the central division of the NPA, online meetings are arranged. Nonetheless, the audit team noted that no minutes of these meetings are generally drawn up and that certain important information was not available to some inspectors met (see finding 48).

During their controls inspectors make use of `pest.exp' database, designed to include the necessary information about the PPPs authorised in Romania. However, the audit team noted that the database did not contain all the information included in the relevant PPP authorisations, in particular, information on the risk mitigation measures (e.g. buffer zone) is neglected. This has an impact on the implementation of controls on the use of PPPs (see finding 60). Conclusions on the competent authorities for official controls

Inspectors have a higher education highly educated, have access to control procedures and a database of authorised PPPs when carrying out checks on the marketing and use of PPPs. Nonetheless, these arrangements alone are not sufficient to ensure effective controls due to limitations of the database and the lack of arrangements ensuring the knowledge of all inspectors is updated in a structured manner. Planning of official controls Findings

Inspectors met were generally sufficiently knowledgeable. Nonetheless, two of them were not aware of recent restrictions on the use of PPPs containing sulfoxaflor or terbuthilazine and were therefore not able to enforce relevant provisions on label changes or withdrawal of the affected PPPs. One of the retailers visited was storing several packages of a PPP containing sulfoxaflor with an obsolete label, but this was not noted by the inspector. Representatives from the central division of NPA explained that when such restrictions were decided these were included in the minutes of the meetings which are uploaded in the NPA website, but this may have been overlooked by inspectors. Without such information, inspectors are not able to perform the effective and appropriate checks required in Article 5(1)(a) of Regulation (EU) 2017/625.

There is a relatively high number of inspections of operators marketing PPPs, but inspections of re-packers and manufacturers have insufficient scope, which may have contributed to the fact that the export of non-authorised PPPs went unnoticed and without control. Moreover, there are insufficient arrangements to ensure that inspectors at local level are aware of key information about PPPs where recent changes of the authorisations took place. These weaknesses undermine the effectiveness of official controls of these PPP operators, a symptom of which may be the very low rate of non- compliances identified during inspections. Controls on the use of plant protection products Legal Requirements Articles 11 to 14 and 137 to 139 of Regulation (EU) 2017/625 Articles 28, 31, 55 (first and second sentences) and 67(1) of Regulation (EC) No 1107/2009 Articles 5 and 6 of Directive 2009/128/EC Regulation (EU) No 547/2011 Findings

The inspectors met were sufficiently experienced and qualified. Nonetheless the inspector of the two agricultural users was not aware of certain risk mitigation measures (standard phrase SPe37) required for the use of a PPP containing the active substance deltametrin, in particular the 15-metre buffer zone to protect waters surfaces, included in the current authorisation certificate of the PPP. When asked about clarifications, the 7 SPe3 (standard phrases for safety precautions for the environment) to protect aquatic organisms/non-target plants/non-target arthropods/insects, as laid down by Annex III to Regulation (EU) No 547/2011. 16 inspector explained that from the information available in the database `pest.exp' this risk mitigation measure was not included, therefore a general 3-metre buffer zone was to be considered sufficient. The audit team confirmed that the technical sheet of the PPP in question downloadable from the database `pest.exp' did not contain any information on risk mitigation measures. Representatives from the central division of NPA confirmed that due to a limitation of the software, risk mitigation measures associated with PPPs could not be included in such database. As a result, inspectors are not able to perform the effective and appropriate checks required in Article 5(1)(a) of Regulation (EU) 2017/625. Furthermore, by looking at digital maps of the farmer's fields available from APIA website, the audit team observed that, in case of plots bordering a watercourse, only a generic warning reminding of the obligation to respect a 3-metre buffer zone was included; the need to apply a wider buffer zone depending on the PPP was not mentioned. Conclusions on controls on the use of plant protection products

A relatively high number of inspections of PPP users are carried out, but they identify a very low number of non-compliances. Moreover, certain provisions applicable to PPPs requiring risk mitigation measures to protect water surfaces are not verified because they are generally not available to inspectors. This is a matter of concern, exacerbated by the fact that the results of the water monitoring framework are not considered as risk criteria to prioritise inspections of agricultural users of PPPs.

Medlemsstatens svar

ficial information of the inspectors with the legislative th changes. Deadline: 5 working days from the publication of the list of CNOPPP decisions

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At the point of entry, the audit team became aware that a Romanian PPP manufacturer had been importing a non-EU approved active substance (thiophanate methyl) for the manufacturing of a PPP destined for export. This activity had been authorised by the Ministry of Environment but, although the establishment was registered and was subject to inspections by the relevant CPO (see finding 28), the central division of the NPA was not aware of such activity and confirmed that no particular inspection arrangements had been put in place to ensure that the PPP containing this active substance was exported from Romania, contrary to Article 28(2)(d) of Regulation (EC) No 1107/2009. Conclusions on controls on the marketing of plant protection products

There is a relatively high number of inspections of operators marketing PPPs, but inspections of re-packers and manufacturers have insufficient scope, which may have contributed to the fact that the export of non-authorised PPPs went unnoticed and without control. Moreover, there are insufficient arrangements to ensure that inspectors at local level are aware of key information about PPPs where recent changes of the authorisations took place. These weaknesses undermine the effectiveness of official controls of these PPP operators, a symptom of which may be the very low rate of non- compliances identified during inspections. Controls on the use of plant protection products Legal Requirements Articles 11 to 14 and 137 to 139 of Regulation (EU) 2017/625 Articles 28, 31, 55 (first and second sentences) and 67(1) of Regulation (EC) No 1107/2009 Articles 5 and 6 of Directive 2009/128/EC Regulation (EU) No 547/2011 Findings

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o 7 Page: 3

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The audit team noted that the majority of the documented procedures had not been updated to reflect the requirements of the OCR and could not therefore ensure the effectiveness and appropriateness of official controls, which is not in line with Article 5(1)(a) and 12(3)(b)of the OCR. For example, the competent authorities do not have up- to-date documented procedures for prior notification, the performance of documentary, identity and physical checks, including the frequency rates, on consignments of animals and goods and official controls on consignments of goods of animal origin in transit (see section 5.2).

The audit team also noted that the arrangements in place for the implementation of the measures referred to in Articles 65, 66 and 67 of the OCR and contingency arrangements are incomplete, which is not in line with Article 64(3)(d) and(e) respectively of the OCR.

There is a system of official controls in place for animals and goods of animal and non- animal origin entering the EU though BCPs in Romania, which is supported by information technology systems and cooperation and communication within and between the competent authorities. However, shortcomings related to the lack of up-to-date documented procedures and arrangements in place and a shortage of staff have an adverse impact on the effectiveness of implementation of official import controls. 5.2 IMPLEMENTATION OF OFFICIAL CONTROLS ON ANIMALS AND GOODS ENTERING THE EU The audit team evaluated the implementation of official controls on consignments of animals and goods entering the EU through BCPs in Romania against applicable EU requirements detailed in Annex II, based on an initial selection of 34 valid CHEDs recorded in TRACES- NT, evidence obtained during the on-site visits to three BCPs, one control point and an approved warehouse, and additional data in TRACES-NT. 5.2.1 Prior notification of arrival of consignments

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Following the receipt of the draft translated report of the audit as DG(SANTE) 2024-8075 carried out between January 30 and February 20, 2024, it was issued the Note no. 26045/23.05.2024 on which was sent to the county sanitary veterinary and food safety directorates that have border control posts under their control. The note includes aspects related to all the non-conformities identified during the audit mission and the measures to be taken by official veterinarians/BCPs inspectors to reduce these non- conformities as much as possible. Regarding the update of the procedures, we note that PS - 77 - DEITIGAIE regarding documentary check at the border and PS - 78 - DEITIGAIE regarding the identity check at the border have already been updated, the rest of the procedures/instructions of a general nature (physical check, transit, transshipment, transit in warehouses, completing of the CHEDs, the procedure that includes the existing mechanisms for the implementation of the measures mentioned in articles 65, 66 and 67 of the OCR and the procedures for emergency situations) will be completed by 31.08.2024, and the procedures covering aspects related to import conditions by category of li

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At one BCP of introduction visited, the BCP staff stated that in case of official controls on consignments of goods of animal origin in transit, the vehicles or transport containers in which such consignments leave the BCP were not sealed by the BCP staff, which is not in line with Article 19(d) of Regulation (EU) 2019/2124. This practice was further confirmed to the audit team during subsequent meetings with staff at other Romanian BCPs.

During the visit to a port BCP of exit, the BCP staff stated that they did not perform an identity check to ensure that consignment of goods leaving the EU through this BCP corresponded to the consignment referred to in the associated CHED. This is not in line with Article 33 of Regulation (EU) 2019/2124. The staff at this BCP of exit explained that part III of the CHEDs was completed solely based on receiving copies of CHEDs from the relevant customs agents. According to TRACES-NT, this port BCP accounted for 8 402 out of a total of 12 317 consignments exiting in transit through Romanian BCPs of which about 7 000 have part III completed. 10

During their visit to the approved warehouse, the audit team noted that the competent authority did not confirm the arrival of the consignments at the warehouse in part III of the CHED, which is not in line with Article 26(4)(c) of Regulation (EU) 2019/2124.

The audit team also noted that the competent authority did not ensure that the operator responsible for the consignments leaving the warehouse submitted a CHED in TRACES- NT and consequently failed to authorise the movement by finalising the CHED which must accompany consignments leaving the warehouses to third countries, other warehouses and disposal places. The competent authority instead completed part III of the CHED which accompanied the consignment upon arrival at the warehouse. This is not in line with Article 28(a) and (b) of Regulation (EU) 2019/2124. Consequently, the staff at the BCP of exit could not confirm in TRACES-NT its arrival and compliance. 5.2.4 Documentary, identity and physical checks of consignments 5.2.4.1 Checks on consignments of animals

The system of official controls on animals and goods entering the Union though BCPs in Romania showed significant shortcomings in the frequencies at which identity and physical checks are performed on goods of animal origin and in the performance of official controls on consignments of goods of animal origin in transit. Other shortcomings were noted concerning the implementation of official controls on certain consignments of animals and goods of non-animal origin. Collectively, these shortcomings significantly undermine the overall effectiveness and appropriateness of official controls to ensure that only compliant consignments of animals and goods enter the EU.

Medlemsstatens svar

Regarding finding 32 regarding consignments of goods of animal origin products in transit that left BCPs unsealed by BCPs staff, eal to the Note mentioned above clearly states that "official veterinarians in the entry BCP shall ensure that consignments of animal products animal origin, germinal material, animal by-product, derived products, hay, straw and composite products are accompanied by CHED and leave the BCP in vehicles or Page: 1 rt ref. DG(SANTE) 2024-8075 of the audit carried out from 30 January to s and goods entering the European Union and verification of compliance of roposed by the competent authority and deadline by will be completed rs sealed by the authority in the BCP, if the original seal the origin has been broken for carrying out the full identity k or if the consignment was not sealed at the place of origin the competent authority that certified the consignment" g finding 34, the Note states that: "veterinarians from the xit BCP carry out an identity check to ensure that the ent presented corresponds to the one mentioned in the n CHED that the seals applied to the transport vehicles or containers l intact and record the result of the checks official in part CH

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The audit team noted that, for one selected CHED-A evaluated for a consignment of twenty-four commercial dogs and cats, not all animals in the consignment were subjected to a physical check, which is not in line with Article 4(3) and point II.1 of Annex I to Regulation (EU) 2019/2130. The BCP staff stated that this this was due to a lack of staff and increased workload at the BCP. The audit team further noted similar findings in the CHED-As in TRACES-NT for 32 of 53 similar consignments in 2022 and 2023. 5.2.4.2 Checks on consignments of goods of animal origin

The system of official controls on animals and goods entering the Union though BCPs in Romania showed significant shortcomings in the frequencies at which identity and physical checks are performed on goods of animal origin and in the performance of official controls on consignments of goods of animal origin in transit. Other shortcomings were noted concerning the implementation of official controls on certain consignments of animals and goods of non-animal origin. Collectively, these shortcomings significantly undermine the overall effectiveness and appropriateness of official controls to ensure that only compliant consignments of animals and goods enter the EU.

Medlemsstatens svar

no. 26045/23.05.2024 also includes aspects related to non- iance with the frequency of physical checks of animals in 3 rt ref. DG(SANTE) 2024-8075 of the audit carried out from 30 January to s and goods entering the European Union and verification of compliance of Action Proposed by the competent authority and deadline by which it will be completed accordance with the legislation in force. Regarding compliance with the frequency of physical controls on animals, the central competent authority will periodically monitor in the TRACES NT system whether the BCPs comply with the frequency of physical controls on animals in accordance with the legislation in force. Deadline for performing the analysis of compliance with the frequency of physical control of animal consignments: quarterly Also, these aspects are checked during the periodic controls carried out by the central authority based on the approved Annual Control Plan regarding the activity of BCPs, Control Points, Entry Points, Exit Points and Traveller Entry Points, with the taking of measures administrative measures that are imposed in case of non- compliance with the legislative provisions. Regarding finding no. 39 regarding th

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The audit team noted that the frequency of physical checks performed on goods of animal origin was not in line with the baseline frequency rate set out in Articles 4(1) and 11 5(1) and Annex I to Commission Implementing Regulation (EU) 2019/2129. This finding predominantly relates to consignments of poultry meat from Ukraine entering the EU; approximately 3 000 consignments of poultry meat in 2023 were subjected to physical checks at a rate of 3% compared to the required minimum frequency of 30%. 5.2.4.3 Checks on consignments of goods of non-animal origin

However, identity and physical checks on consignments subject to measures set out in Commission Implementing Regulation (EU) 2020/1158 had not been carried out in line with the minimum frequency rate set out in Article 5(2) of that Regulation. Based on data provided by the competent authorities, approximately 1.7% (4 out of 240) of such consignments in 2023 were subjected to identity and physical checks compared to the required minimum frequency of 20%.

The system of official controls on animals and goods entering the Union though BCPs in Romania showed significant shortcomings in the frequencies at which identity and physical checks are performed on goods of animal origin and in the performance of official controls on consignments of goods of animal origin in transit. Other shortcomings were noted concerning the implementation of official controls on certain consignments of animals and goods of non-animal origin. Collectively, these shortcomings significantly undermine the overall effectiveness and appropriateness of official controls to ensure that only compliant consignments of animals and goods enter the EU.

Medlemsstatens svar

te no. 26045/23.05.2024 includes also aspects related to the non-compliance with the frequency of identity and physical controls on the consignments of animal origin products and the consignments of food and feed for animals originating in third ountries following the accident at the Chernobyl nuclear power plant. Page: 4 rt ref. DG(SANTE) 2024-8075 of the audit carried out from 30 January to s and goods entering the European Union and verification of compliance of Action Proposed by the competent authority and deadline by which it will be completed Regarding compliance with the frequency of identity and physical checks on the above-mentioned goods, the central competent authority will periodically monitor in the TRACES NT system whether BCPs comply with the frequency of identity and physical checks of goods in accordance with the legislation in force. Deadline for carrying out the analysis of compliance with the frequency of identity and physical checks of the above- mentioned goods consignments: quarterly Also, these aspects are checked during the periodic controls carried out by the central competent authority based on the approved Annual Control Plan regarding the activity of B

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The audit team noted that no BCPs have been designated and listed for food contact materials, (i.e. category PNAO-NHC(other)), and that official controls on consignments of food contact materials entering the EU are instead performed at the importers' warehouses, which is not in line with Article 49(1) of the OCR.

The audit team found that facilities and equipment at the port BCPs Constana North and Constana South and the airport BCP Bucharest Henri Coand were generally compliant with the minimum requirements for BCPs for the categories of goods for which they had been designated. However, the loading and storage facilities for goods of animal and non-animal origin at these three BCPs, and the inspection facilities at the airport BCP Bucharest Henri Coand, were not maintained and thus not easy to clean and disinfect. This is not in line with Article 3(2) and (3) of Regulation (EU) 2019/1014 and 64(3) of the OCR.

The audit team visited one control point used for identity and physical checks on consignments of non-animal origin. The audit team found that the control point was not compliant with the minimum requirements for BCPs, which is not in line with Article 53(1)(a) of the OCR. There were no clearly dedicated unloading, inspection and storage areas, there was no drainage in these areas, and the floors of these areas were poorly maintained and thus not easy to clean and disinfect. In addition, the inspection area did not have a supply of hot and cold running water and hand washing facilities and it was equipped with a table that was not easy to clean and disinfect. Conclusions on the compliance of border control posts with minimum requirements

The evaluated BCPs, except for a suspended BCP for animals, had the minimum facilities and equipment in place for the categories of animals and goods of animal origin for which they had been designated, but the three BCPs visited were not well maintained. In addition, the Romanian authorities perform official controls on consignments of food contact materials entering the EU without having designated BCPs for this category of goods. The control point visited does not comply with the minimum requirements for BCPs for the categories of goods for which it has been designated. These shortcomings have the potential to reduce the overall effectiveness of the official control system.

Medlemsstatens svar

he reply of National Sanitary Veterinary and Food Safety Authority: sts Through the address no. 108/23.05.2024, the county sanitary veterinary and food safety directorate Ilfov submitted to the National Veterinary Health and Food Safety Authority (NSVFSA) the action plan regarding the remediation of the infrastructure deficiencies identified following the audit mission at the control module of of animal origin products within BCP Henri Coanda- Bucharest. The following stages were completed: - preparation of the necessity report no. 104/16.05.2024 by BCP Henri Coanda - Bucharest; - the purchase of the repair service was posted on the website of the Electronic Public Procurement System, together with the technical specifications. Page: 5 rt ref. DG(SANTE) 2024-8075 of the audit carried out from 30 January to s and goods entering the European Union and verification of compliance of by e end of itary has he it mission l urgiu been ficiencies and the f the ailable by g to ructure ess of the Control Point . the rt ref. DG(SANTE) 2024-8075 of the audit carried out from 30 January to s and goods entering the European Union and verification of compliance of by o. ies carried and feed, plant

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The Romanian authorities made resolute efforts in recent years to increase among backyards' operators the levels of awareness about, and compliance with requirements on animal traceability. However, despite introducing new legislation and strengthening official controls on the matter, the inadequate powers available to officials to enforce those new provisions keep holding back progress in this area.

An undetermined, but still significant number of illegal movements in the backyards population, and the underreporting to the national database of other events from those establishments (e.g., on-site slaughter), have an uncertain impact on surveillance for ASF and keep impairing epidemiological investigations when the disease is suspected or confirmed.

When ASF outbreaks occur in backyards, authorities do not always take effective measures to mitigate the risk of local disease spread. Persistent shortcomings in animal traceability and biosecurity allow the virus to circulate between backyards, leading to clusters of outbreaks that last longer than expected, even when the number of primary cases is limited.

Those non-compliances are not in line with EU provisions laid down in: · Articles 109(1)(c) of Regulation (EU) 2016/429, on the information related to pigs to be kept by the competent authorities in the computerised database, and Articles 112(d), 113(1)(c) and 115, on obligations of operators on notification to the database; · Articles 52(1), 56(b) and 57 of Delegated Regulation (EU) 2019/2035, further developing the obligations in Regulation (EU) 2016/429; and · Articles 3 and 15 of Implementing Regulation (EU) 2021/520, on notification of movements within seven days, and on the time to ensure identification of pigs. The latter must be read in conjunction with national legislation.

Despite improvements in traceability compliance in backyards and, to animal a lesser extent, former type A farms, the Romanian authorities still traceability in lack full enforcement powers. This limits their ability to apply backyards 12 effective and proportionate measures to prevent illegal practices. This is not in line with Articles 5(1)(g) and 139 of Regulation (EU) 2017/625, on the legal powers available to the authorities to take action, and to impose penalties as part of enforcement. Biosecurity on pig holdings Reinforced legal 30. Law no. 122/2023 introduces biosecurity requirements for all provisions for establishments keeping pigs. Those requirements are stricter for biosecurity establishments involved in commercial activities, including former measures type A farms, and less demanding for backyards. Key provisions aim to prevent exposure of pigs to ASF virus risks, e.g., requiring premises to prevent contact with wild animals and that visitors to those premises were not exposed to those environmental risks recently. Good guidance 31. To implement those measures, Order no. 132/418 of 12 October 2023, and instructions lays down specific biosecurity requirements for all types of pig farms. for operators on It mandates large industrial farms to have approved biosecurity plans, lays down principles for those plans, and requires local authorities to biosecurity approve and endorse them annually after a verification check. The measures and Order also reaffirms and further details biosecurity measures for backyards. plans

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Persistent weaknesses in the application of biosecurity measures by operators of 3 This type of animal establishments, still present in Romania at the time of this audit, keep animals of several species, usually a variable number of pigs, more than in backyards, and often including several sows. They frequently engage in commercial activities involving pigs, selling them to other similar establishments and to backyards, but they have been for years subject to less strict biosecurity requirements than large industrial farms. They represented for years a significant risk for the transmission of listed diseases. The Romanian authorities were at the time of this audit in the process of reorganising this subpopulation of establishments with the objective of further mitigating that risk ­ see section 6 for further details. 5 backyards, and the limited empowerment of the authorities to enforce legal requirements in that respect, reduce their effectiveness to prevent the introduction of ASF and increase the risk of local spread of the disease in case of infection.

When ASF outbreaks occur in backyards, authorities do not always take effective measures to mitigate the risk of local disease spread. Persistent shortcomings in animal traceability and biosecurity allow the virus to circulate between backyards, leading to clusters of outbreaks that last longer than expected, even when the number of primary cases is limited.

Despite improvements in traceability compliance in backyards and, to animal a lesser extent, former type A farms, the Romanian authorities still traceability in lack full enforcement powers. This limits their ability to apply backyards 12 effective and proportionate measures to prevent illegal practices. This is not in line with Articles 5(1)(g) and 139 of Regulation (EU) 2017/625, on the legal powers available to the authorities to take action, and to impose penalties as part of enforcement. Biosecurity on pig holdings Reinforced legal 30. Law no. 122/2023 introduces biosecurity requirements for all provisions for establishments keeping pigs. Those requirements are stricter for biosecurity establishments involved in commercial activities, including former measures type A farms, and less demanding for backyards. Key provisions aim to prevent exposure of pigs to ASF virus risks, e.g., requiring premises to prevent contact with wild animals and that visitors to those premises were not exposed to those environmental risks recently. Good guidance 31. To implement those measures, Order no. 132/418 of 12 October 2023, and instructions lays down specific biosecurity requirements for all types of pig farms. for operators on It mandates large industrial farms to have approved biosecurity plans, lays down principles for those plans, and requires local authorities to biosecurity approve and endorse them annually after a verification check. The measures and Order also reaffirms and further details biosecurity measures for backyards. plans

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Implementation of surveillance for ASF in wild boar varies significantly between counties, but it confronts since the 2021/22 hunting season increasing challenges to find and test dead animals, which became a rare event in many of them4. Besides, the reluctance of the competent authorities to enforce requirements on ASF surveillance in hunting grounds, and delays in approving new legal provisions to introduce economic incentives to encourage searching for and testing of wild boars, keep impairing early detection and control of the disease.

The national action plan and legal framework to manage wild boar populations for ASF control, alongside the natural impact of the disease, led to a steady population decline until spring 2023. However, disagreements with part of the hunting community in some areas of the country, resulting in weak compliance with and enforcement of hunting quotas, exacerbated by recent climatic and environmental challenges, contributed to reverse that trend. While many hunting grounds apply biosecurity measures effectively, inconsistencies in population management and limited enforcement of ASF control policies create uncertainty about long-term disease control.

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Implementation of surveillance for ASF in wild boar varies significantly between counties, but it confronts since the 2021/22 hunting season increasing challenges to find and test dead animals, which became a rare event in many of them4. Besides, the reluctance of the competent authorities to enforce requirements on ASF surveillance in hunting grounds, and delays in approving new legal provisions to introduce economic incentives to encourage searching for and testing of wild boars, keep impairing early detection and control of the disease.

The national action plan and legal framework to manage wild boar populations for ASF control, alongside the natural impact of the disease, led to a steady population decline until spring 2023. However, disagreements with part of the hunting community in some areas of the country, resulting in weak compliance with and enforcement of hunting quotas, exacerbated by recent climatic and environmental challenges, contributed to reverse that trend. While many hunting grounds apply biosecurity measures effectively, inconsistencies in population management and limited enforcement of ASF control policies create uncertainty about long-term disease control.

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An undetermined, but still significant number of illegal movements in the backyards population, and the underreporting to the national database of other events from those establishments (e.g., on-site slaughter), have an uncertain impact on surveillance for ASF and keep impairing epidemiological investigations when the disease is suspected or confirmed.

Persistent weaknesses in the application of biosecurity measures by operators of 3 This type of animal establishments, still present in Romania at the time of this audit, keep animals of several species, usually a variable number of pigs, more than in backyards, and often including several sows. They frequently engage in commercial activities involving pigs, selling them to other similar establishments and to backyards, but they have been for years subject to less strict biosecurity requirements than large industrial farms. They represented for years a significant risk for the transmission of listed diseases. The Romanian authorities were at the time of this audit in the process of reorganising this subpopulation of establishments with the objective of further mitigating that risk ­ see section 6 for further details. 5 backyards, and the limited empowerment of the authorities to enforce legal requirements in that respect, reduce their effectiveness to prevent the introduction of ASF and increase the risk of local spread of the disease in case of infection.

When ASF outbreaks occur in backyards, authorities do not always take effective measures to mitigate the risk of local disease spread. Persistent shortcomings in animal traceability and biosecurity allow the virus to circulate between backyards, leading to clusters of outbreaks that last longer than expected, even when the number of primary cases is limited.

Those non-compliances are not in line with EU provisions laid down in: · Articles 109(1)(c) of Regulation (EU) 2016/429, on the information related to pigs to be kept by the competent authorities in the computerised database, and Articles 112(d), 113(1)(c) and 115, on obligations of operators on notification to the database; · Articles 52(1), 56(b) and 57 of Delegated Regulation (EU) 2019/2035, further developing the obligations in Regulation (EU) 2016/429; and · Articles 3 and 15 of Implementing Regulation (EU) 2021/520, on notification of movements within seven days, and on the time to ensure identification of pigs. The latter must be read in conjunction with national legislation.

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However, the authorities do not keep properly updated the list of those designated food business operators and their activities, that should be accessible to the Commission and to the other Member States to facilitate their verification activities on compliance with EU trade rules. Nevertheless, despite the inaccuracies present on that list for some operators, this deficiency was not increasing the risk of transmitting ASF outside of Romania, as they comply with the activities for which they are designated.

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However, the audit team noted that the guidance on ante-mortem inspection (AMI) of poultry at the holding of provenance (NSVFSA Service Note 25901/12.04.2019) allows that "designated veterinarians" perform AMI at the holding of origin (EU legislation requires that AMI should be carried out by an OV). In this regard, NSVFSA 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. In addition, NSVFSA stated that they intend 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 is carried out at the holding of origin by "designated veterinarians". In this regard, there is a specific procedure under the Service Note 25901/12.04.2019 (see paragraph 3), which describes the steps to follow and, among other things, requires OVs or OAs (under the supervision of the OV) to perform a simplified AMI at the slaughterhouse.

Medlemsstatens svar

SA has elaborated a Service Note in order to update the Instructions regarding official controls on ante-mortem and post-mortem inspection in poultry (NSVFSA Service Note No. 901/12.04.2019), in conformity with the EU and national legislation in force. s will dispose the necessary measures for implementing the requirements of the vant EU and national legislation in force concerning official controls on ante-mortem and post-mortem inspection in poultry, especially for performing ante-mortem inspection of the holding of origin by an official veterinarian, by 10th of August, 2023. At the same time, in the 2023 Professional training Plan of the Food Safety Official Control Service, approved by the NSVFSA president, it is scheduled in trimester IV 2023, a training on" Ante-mortem and post-mortem inspection in poultry according to Regulation (EU) 2017/625, Regulation (EU) 2019/624, and Regulation (EU) 2019/627 ­ comprising theoretical and practical parts (in poultry slaughterhouses)". Training will be performed by trainers from the NSVFSA central level, in 2 training centres: CSVFSD Bacu and Iai, 3 training days per centre.

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Since the CCA carried out the final classification of production areas, the revision of classification has been based on monitoring results obtained during the harvesting period (see section 4), which could be sufficient if harvesting is officially allowed exclusively during this part of the year. However, it is not clear if exceeding results are only (4) Community guide to the principles of good practice for the microbiological classification and monitoring of bivalve mollusc production areas, available at https://food.ec.europa.eu/safety/biological-safety/food- hygiene/guidance-platform_en 4 disregarded from the dataset for revision of classification in the case that investigations lead to conclusive results (see paragraph 26). 5.2.2 Monitoring of classified production areas

The competent authority can reopen production areas if at least two consecutive analytical results separated by at least seven days are below the criteria for class A production areas. This meets the requirements of Article 63(1) of Regulation (EU) 2019/627. However, it is not clear if exceeding results are adequately disregarded from the dataset for revision of classification. The audit team reviewed a case where they were disregarded without a robust conclusion reached during the investigation. b) For the presence of biotoxins in live bivalve molluscs

The decisions taken by competent authorities following results surpassing the established limits during the harvesting season should help to avoid risky products reaching the market. However, failures in the proper implementation and disregard of exceeding result without reaching a robust conclusion could jeopardise this protection mechanism.

Medlemsstatens svar

view DSAOA Answer DSAOA elaborated a draft service note establishing in detail the measures on that must be carried out by the SVFSD in case, there is obtained a result exceeding the 700 E. coli limit per 100 g of meat and intravalvar liquid, during molluscs sampling. In such situations, the area must be closed, and the reopening of the area can only be carried out after obtaining at least two consecutive results with lower values than the admitted limit for A production zones, for samples collected at least a seven days interval. However, in certain suspicion situations regarding a result exceeding the limit of 700 E coli per 100 g of meat and intravalvar liquid, the SVFSD may carry out a detailed investigation to identify if, the result obtained above the accepted limit was caused by an accidental discharge from a wastewater treatment plant, following the alluvium generated by torrential rains or caused by samples damaged by the noncompliance with the conditions for sampling, storage and sending to the laboratory. The SVFSD must carry out further investigations to identify if, the cause of the contamination above the legal limit represents a possible new source of pollution. In t

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According to the relevant procedures, competent authorities periodically monitor classified production areas in order to check the microbiological quality of LBM, and the presence of marine biotoxins and chemical contaminants in LBM and, since recently, for the presence of toxin-producing plankton in water, as required respectively in Article 59(b)(c) and (d) of Regulation (EU) 2019/627. The monitoring in one of the production areas was very limited, therefore not meeting these requirements. a) For microbiological quality of live bivalve molluscs

According to the relevant procedure, all points have to sampled once per month, which comply with the requirements of Article 61(1) of Regulation (EU) 2019/627; however, in practice, this frequency is only implemented during the harvesting period and the months immediately prior and subsequent to it (see section 4 and paragraph 9, regarding seasonal harvesting), which could be sufficient if harvesting was officially allowed exclusively during this part of the year, which was not the case at the time of the audit.

According to the relevant procedure, monitoring has to be carried out with a frequency that varies between once per week (during the harvesting season) to once per month (from October to April), which would be in line with Article 61(1) an (4) of Regulation (EU) 2019/627 if harvesting was officially allowed exclusively during part of the year. However, at the time of the audit, this frequency was not met. According to the information provided to the audit team, there were different factors that prevented the sampling plan to be fulfilled (e.g., availability of vessels and other logistic problems, rough weather conditions), or that undermined the usefulness of complying with these frequencies (i.e., the long turnaround of results currently provided by the biotoxins laboratory).

According to the relevant procedure, monitoring has to be carried out with a frequency similar to the biotoxins; therefore, the same observations made above (paragraph 17) regarding required frequencies and the difficulties faced by counties CA are relevant here.

The classification of production areas would be consistent with the EU classification requirements if harvesting is officially allowed exclusively during the summer (harvesting period). If harvesting is allowed during the whole year, the absence of appropriate frequency for sampling does not allow the authorities to ensure the same level of health and safety guarantees for the mollusc harvested outside this period.

The current design of the monitoring programme for microbiological quality seems adequate for the harvesting period, but the programmes for the presence of biotoxins and phytoplankton are not fully aligned with EU requirements and are not fully implemented. This could compromise the ability of the competent authority to detect possible exceedances of biotoxins limits. The delays in obtaining laboratory test results lower the effectiveness of the monitoring.

Medlemsstatens svar

t DSAOA Answer ed tion The service note mentioned in response to recommendation no. 1 indicates all that the SVFSD must close the areas for the period November-March, when there are not sampled any molluscs for human consumption, when sampling is seasonal. For this purpose, the SVFSD must issue a Disposition to close the area in conformity with Annex II of Service Note no. 26315/ 11.06.2020, which he submits for information to fishermen's associations, mollusc dispatch centres and to the NSVFSA. Based on this information, the NSVFSA must change the existing public data on its own website regarding the classified areas in the Black Sea, in order to inform those interested that, the mollusc sampling areas are closed. The same service note states that if operators wish to harvest molluscs for marketing all year round, the DSVSA is obliged to collect official samples for E coli, marine biotoxins and phytoplankton throughout the year.

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According to the relevant procedure, monitoring has to be carried out with a frequency that varies between once per week (during the harvesting season) to once per month (from October to April), which would be in line with Article 61(1) an (4) of Regulation (EU) 2019/627 if harvesting was officially allowed exclusively during part of the year. However, at the time of the audit, this frequency was not met. According to the information provided to the audit team, there were different factors that prevented the sampling plan to be fulfilled (e.g., availability of vessels and other logistic problems, rough weather conditions), or that undermined the usefulness of complying with these frequencies (i.e., the long turnaround of results currently provided by the biotoxins laboratory).

At the time of the audit, the location of sampling points for water coincided with the points for biotoxins. The competent authorities were considering the inclusion of a second sampling location per production area that would allow the early detection of changes in the composition of plankton containing toxins and the geographical distribution of this plankton that can suggest an accumulation of toxins in LBM flesh, as required in Article 61(3)(a) of Regulation (EU) 2019/627.

According to the relevant procedure, monitoring has to be carried out with a frequency similar to the biotoxins; therefore, the same observations made above (paragraph 17) regarding required frequencies and the difficulties faced by counties CA are relevant here.

According to the relevant procedure, the competent authority must temporary close production areas when monitoring results show E. coli most probable number exceeding 700 per 100 grammes of flesh and intravalvular liquid (it is important to note that all production areas in Romania are class A and at the time of the audit there were no purification centres in the country). This closure is in line with Article 62(1) of Regulation (EU) 2019/627. Based on the information provided to the audit team, this closure is only enforced when such situation occurs during the harvesting period. This approach would be acceptable if harvesting is officially allowed exclusively during this particular time of the year.

According to the relevant procedure, the competent authority should conduct intensive sampling when monitoring results surpass the thresholds established at national level 7 (see paragraph 23). This aligns with Articles 61(3)(a) and 61(7) of Regulation (EU) 2019/627. However, the competent authority confirmed that they currently do not adhere to this procedure. They consider its effectiveness is limited value due to several reasons: the same sampling locations are used for water and LBM, there are no additional water sampling locations for early warning, the long turnarounds times for results established in national legislation, and delays from laboratories results for biotoxins and phytoplankton, etc.

The current design of the monitoring programme for microbiological quality seems adequate for the harvesting period, but the programmes for the presence of biotoxins and phytoplankton are not fully aligned with EU requirements and are not fully implemented. This could compromise the ability of the competent authority to detect possible exceedances of biotoxins limits. The delays in obtaining laboratory test results lower the effectiveness of the monitoring.

Medlemsstatens svar

and DSAOA answer The service note referred to in response to Recommendation 1 requires that the DSVSA collect samples at least weekly for phytoplankton and marine biotoxins throughout the period of harvesting of molluscs for marketing. By the same service note it was ordered that the Institute of Page: 2 ived 22 April 2024 ndations of report ref. DG(SANTE) 2023-7768 of the audit carried out from 04 December m in place for live bivalve molluscs Action Proposed by the competent authority and deadline by which it will be completed Hygiene and Veterinary Public Health-IISPV (laboratory determining marine biotoxins) and the Institute of Diagnosis and Animal Health- IDSA (laboratory determining toxic plankton) should take action so that the results of the tests are communicated to the county DSVSA in time, so that in situations with non-compliant results emergency measures can be imposed for the closure of the area.

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In addition, the monitoring programme for biotoxins does not include marine gastropods, and there are no data that compare the rate of accumulation of biotoxins with the indicator species. This poses a risk that marine gastropods with biotoxins content above the regulated limits might be placed on the market.

Medlemsstatens svar

DSAOA answer the The service note referred to in response to Recommendation 1 directed that in parallel with the collection of live bivalve molluscs, marine gastropods e with be collected from the same sampling point for analysis for marine biotoxins. At the end of August 2025, the results for biotoxins obtained for both live bivalve mollusc samples and marine gastropod samples will be analysed comparatively by the IISPV and it will be decided which is the reference species, i.e. the species with the highest accumulation rate of marine biotoxins. At the same time, the memorandum provides that at the end of August 2025, the IDSA will carry out a comparative analysis of the laboratory results obtained for phytoplankton on the one hand and those obtained for marine biotoxins on the other hand, in order to establish maximum limits for phytoplankton for early warning purposes.

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The competent authority has designated NRLs for E. coli and for biotoxins in LBM, as required in Article 100(1) of Regulation (EU) 2017/625. However, at the time of the audit, the NRL for biotoxins did not meet certain legislative requirements (i.e., Article 100(2) and (3)(c)(e)). 10

The audit team showed evidence of the implementation of part of the tasks established in Article 101(1) of Regulation (EU) 2017/625 by the NRL for E. coli (e.g., participation in proficiency testing organised by the EURL, provision of training and support to official control laboratories); however, this laboratory has not been able to organise an inter-laboratory comparative testing or a proficiency test between official control laboratories (there are only a few of them in the country) (required in Article 101(1)(c) of the same Regulation).

At the time of the audit, the NRL for biotoxins was not in a position to comply with most of the responsibilities and tasks established in Article 101(1) of Regulation (EU) 2017/625.

The competent authorities have designated official control laboratories, as required in Article 37(1) of Regulation (EU) 2017/625. In particular, they have designated three laboratories for E. coli (two testing LBM from production areas and one testing final products from dispatch centres) and one for biotoxins. However, designations do not include all the details required by Article 37(3) and, in the case of biotoxins laboratory, it does not require to use testing methods in line with EU requirements (see paragraph 57). At the time of the audit the laboratory testing for phytoplankton had not yet been designated as it did not comply with part of the national requirements for designation.

With regard to supervision of the designated laboratories, the CCA, in collaboration with the NRL for E. coli, carries out audits of these laboratories at county level, as required in Article 39(1) of Regulation (EU) 2017/625, although limited to the conditions described in the previous paragraph. However, the CCA informed the audit team that a similar type of supervision cannot be carried out over central level laboratories designated for official controls; therefore, audits required by Article 39(1) of Regulation (EU) 2017/625 are not performed over the biotoxins laboratory. 5.3.1 Laboratories for microbiology

These laboratories regularly participate in proficiency testing but they have never participated in a proficiency testing with LBM sample matrix. 11 5.3.2 Laboratory for phytoplankton

There are two analysts qualified for the identification and quantification of plankton species. Both were internally trained and have plans to participate in external training in 2024.

The laboratory consistently conducts internal quality controls, with every sample being analysed by the two analysts by default to ensure the accuracy and consistency of phytoplankton results. The laboratory has never participated in a proficiency testing, but it intends to participate in one in 2024.

At the time of the audit, the long turnarounds times established in national legislation, together with the length of the analysis in this laboratory, limited the value of this monitoring for the competent authorities. 5.3.3 Laboratories for biotoxins

The official control laboratory for PSP and ASP uses testing methods which validation has not been internationally recognised, therefore they do not meet the requirements of Chapters I(A) and (B) and II(A) and (B) of Annex V to Regulation (EU) 2019/627, respectively.

The laboratory for lipophilic toxins uses the EU reference method established in Chapter III(A) of Annex V to Regulation (EU) 2019/627. It mostly follows the EU reference laboratory standard operational procedure with a few deviations (e.g., it does not include part of the certified reference materials, certain quality control criteria, recovery correction and matrix correction). It is accredited by the national accreditation body, as required in Article 37(5)(a) of Regulation (EU) 2017/625. The laboratory has carried out an internal validation for mussel matrix, as this is the species routinely analysed in this laboratory. However, the validation was not carried out for all the relevant toxins compounds and the validation report had a few shortcomings (e.g., it does not include part of the certified reference materials, precision data are obtained with certified reference materials instead of with naturally contaminated samples, etc.). At the time of the audit, this laboratory was not able to detect all the relevant compounds of the lipophilic toxin group established in Chapter III(A)(a) and (c) of Annex V to 5 EN 15204: Water quality - Guidance standard on the enumeration of phytoplankton using inverted microscopy (Utermöhl technique). 12 Regulation (EU) 2019/627, which poses a risk of underestimation of this biotoxin if such an episode occurs. The laboratory has never participated in a proficiency testing organised by a recognised provider; therefore, it could not provide evidence of the correct performance of the method (the laboratory informed the audit team of its intention to participate in one in 2024). The audit team took note of an exercise prepared by the NRL for this official control laboratory to test an unidentified sample of a certified reference material.

According to the information provided to the audit team, biotoxins results are normally issued in 4-5 days; however, it most of the laboratory reports assessed, the reporting time was one week. Despite the fact this is within the deadline established in national legislation, this provides limited value to the competent authorities to adequately manage production areas, therefore it cannot be considered as a timely delivery of test results as required in Article 37(4)(d) of Regulation (EU) 2017/625. Conclusions on laboratories

Although NRLs for E. coli and biotoxins are designated, the fact that they do not always fulfil the conditions of EU legislation for this designation or that they do not carry out all the tasks and responsibilities prescribed can have an impact in the quality and consistency of the results delivered.

The designation of official control laboratories includes all relevant laboratories (except for phytoplankton). As these laboratories do not always fulfil all the conditions for their designation and the designation does not always include all the necessary details to ensure timely and quality provision of results, this can have a negative impact in the quality of official controls over LBM and affect their efficient and effective supervision.

The technical competence and capacity of the official control laboratories for E. coli and phytoplankton, their fitness for purpose and their generally adequate analytical methods, instils confidence in the reliability of their results. This supports the authorities in the monitoring of production areas, allowing them to make informed decisions to safeguard the safety of molluscs.

Despite the technical competence and capacity of the official control laboratory for biotoxins, the fact that the validation of ASP and PSP testing methods is not internationally recognised, makes the reliability and accuracy of the results produced questionable for these two biotoxins. In addition, the fact that the laboratory for lipophilic toxins cannot analyse a number of compounds of this group (although it uses the EU reference method, internally validated and accredited) raises concern about the risk of underestimation of this biotoxin.

The absence of participation of official control laboratories in proficiency testing prevent the authorities to demonstrate the reliability of their results.

The long turnarounds times established in national legislation, together with the laboratories delays in providing timely results, have a negative impact on the quality of 13 official controls.

Medlemsstatens svar

The Animal Health and Diagnostic Institute ­ RNL for monitoring they marine biotoxins and microbial contaminants in bivalve mollusks A. In order to comply with the requirements of Article 100 paragraphs (2) es and (3), letters c) and d) and Article 101 of Regulation 625/2017, IDAH . has carried out or planned the following for the year 2024: hey U) 1. IDAH requested CCA the financing for the acquisition of equipments ished that are necessary for the compliance with the requests of Article 100, indents (2) and (3), letters c) and d) and with article 101, indent (1) letters(b), (c), (g) of the Regulation UE 2017/625, respectively: Page: 3 ived 22 April 2024 ndations of report ref. DG(SANTE) 2023-7768 of the audit carried out from 04 December m in place for live bivalve molluscs Action Proposed by the competent authority and deadline by which it will be completed - Fluorescence detector for the determination of biotoxins from the PSP group UV variable wavelength detector for the determination of biotoxins from the ASP group - Sample purification system for the determination of biotoxins from the PSP group. ACC took into consideration the necessary budget requested by IDAH for the proc

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The CA provided the audit team with a copy of the documented procedures dated 2007, which were prepared by the NPA. This document outlines the general tasks and responsibilities necessary for the inspectors to carry out their plant health duties including templates of relevant forms for use by the operator and CA. The audit team 1 Link to national legislation https://www.madr.ro/protectia-plantelor-si-carantina-fitosanitara/legislatie- nationala-fitosanitar.html 4 noted that the guidelines are based on repealed EU plant health legislation and do not include guidance for the implementation of any of the provisions on plant passporting established by Regulation (EU) 2016/2031 and its implementing acts. This is not in line with Article 12(1) of Regulation (EU) 2017/625. The CA stated that an up-to-date version of this document is being prepared and will reflect the new requirements of the plant health and official controls legislation, however no draft was available.

The CA stated that they do not have control verification procedures in place to ensure consistency of the implementation of the system of plant passporting among the 41 CPOs. This is not in line with Article 12(2) of Regulation (EU) 2017/625. Conclusions on the organisational aspects of the control system related to plant passports

The structure, responsibilities and legal powers of the CA are defined in national legislation. However, the lack of up-to-date documented procedures and control verification procedures and staff training does not ensure that the system of plant passports is implemented in a consistent manner and in line with EU requirements.

The CA stated that they apply Article 65(3) of Regulation (EU) 2016/2031, however they have not exempt operators on the grounds of trading `small quantities', which has not been defined in national legislation. Nevertheless, the CA specifically exclude garden centres and retail outlets that sell directly to the final consumer from registration without the application of `small quantity' criteria. Furthermore, the CA stated they understood that operators selling though distance contracts are not exempt from registration but were unable to register them due to a lack of resources. This is not fully in line with Article 65(3) of Regulation (EU) 2016/2031. Conclusions on the registration of professional operators

There is a system in place for the registration of professional operators as required by EU Regulations. However, Romania provides no guarantees that all operators selling through distance contracts are registered. This may result in the movement of plants without a valid plant passport within the EU. 5.3 AUTHORISATION AND SUPERVISION OF PROFESSIONAL OPERATORS FOR ISSUING PLANT PASSPORTS Legal requirements Articles 89 to 92 of Regulation (EU) 2016/2031 Articles 1 to 4 of Commission Implementing Regulation (EU) 2019/66 Articles 1 and 2 of Regulation (EU) 2019/827 Findings 5.3.1 Authorisation procedures

In Romania, there is only one authorised operator and 1 552 registered operators, which are defined by the CA as 804 producers, 503 importers and 245 exporters. The CA stated they issue the vast majority of plant passports (see paragraph 26). Furthermore, 6 the CA stated, there has been no initiative to encourage registered operators to become authorised. Thus, the competent authority have failed to embrace the concept of Article 84(1) and (2) of Regulation (EU) 2016/2031, and the guidance provided for in recital no. 45 of the same Regulation, has not been considered. Recital no. 45 states that plant passports should generally be issued by the authorised professional operator and gives rise to authorising them to issue plant passports under the supervision of the CA. This is currently not the case in Romania.

According to the CA, the NPA is the authority responsible for the authorising of professional operators. The procedure for authorisation consists of the professional operator sending an email to the NPA, followed by an inspection by the CPO. It was noted that there is no formal documented procedure established for the authorisation of professional operators.

The CA stated that compliance of authorised operators with Article 89(1) of Regulation (EU) 2016/2031 is verified without the assistance of formal work instructions. Furthermore, the CA does not verify the obligations of the authorised operator to identify and monitor the points of its production process, and the requirements concerning the movement of plants, plant products and other objects, as required by Article 90(1) of Regulation (EU) 2016/2031. The CA stated that it determines informally the extent to which professional operators fulfil the criteria, by way of regular day-to-day interaction with the operator (see paragraph 11, 14, 18, 19, 22, 23). In addition, the competent authority has not made available technical guidance on the criteria to be fulfilled in the examinations to professional operators possibly interested in applying for authorisation which is not in line with Article 2 of Regulation (EU) 2019/827.

The CA are required to carry out official controls on professional and authorised operators at least once per year in order to verify compliance with EU requirements. During the site visits, the audit team learnt that inspectors plan controls on operators based on the biology of the pest or around the growing season of the plant. During the site visits the inspector examined the crop closely for the presence of pests and recorded their findings on official inspection forms. Copies of these inspection reports were 2 https://www.anfdf.ro/sanatate/ghid/ghiduri.html 7 provided to the audit team (see also paragraph 23). In addition, the inspectors frequently visit operators upon request, to carry out official controls on new consignments when they arrive or when notified of the suspected presence of a pest. Many of these new consignments include regulated goods from other MS that are accompanied by a plant passport. Some of these operators were visited at least once a week. The CA stated that this is something they always did since before the new EU requirements came into force. The audit team observed that a risk assessment is not always applied to these controls. Data such as, species, type of plant produced, origin, growing cycles or history of compliance is not taken into account and therefore do not justify these increased level of checks as required by Article 2 of Regulation (EU) 2019/66. The option for reduced frequency controls as provided for in Article 1 of Regulation (EU) 2019/66 is not applied in Romania.

As part of these controls the CA stated, they also carry out checks on compliance with the format of the plant passport. However, the CA did not identify plant passports which were not issued in accordance with Article 83 of Regulation (EU) 2016/2031 as provided for in Articles 1 and 2 of Implementing Regulation (EU) 2017/2313. Issues such as the absence of a border line, the background colour being determined by the colour of the packaging, the absence of the EU flag, the word `plant passport' not placed where it should be. In some cases, the plant passport had the EU flag and word plant passport cut off, due to the potential issues with printer used etc (refer also to paragraph 28 and 29). Furthermore, it was noted by the audit team that the CA has not reported any plant passport non-compliances since the new EU plant passport Regulations came into force. Conclusions on authorisation and supervision of professional operators for issuing plant passports

The CA has not fully embraced the concept of the new system of plant passporting with the objective of placing greater responsibility on professional operators.

In 2021 the border control post (BCP) issued 5 015 passports for imported goods coming from third countries. The audit team noted that majority of the formats of these 10 plant passports issued at the BCP mostly met the EU requirements, however there were some inconsistencies identified in the format of traceability code `C' used by two BCPs. Some BCPs were using the CHEDPP number and others were using their own in-house coding system. This is not fully in line with Article 4(2) of Regulation (EU) 2017/625, where the CA should ensure consistency and effectiveness of official controls across its territory. 5.5.2 Issuance of plant passports by authorised operators

The authorised operator visited, printed the passports directly onto the trade unit under the supervision of the CA. According to the CA these passports are checked randomly but without formal work instructions. (Refer to paragraph 19 where the audit team identified issues). In the case of own produced plants, the packages were issued with the operator's own registration and traceability code and in the case of purchased seed a replacement passport was issued containing information pertaining to the original consignment. Registered operators are required to keep all plant passport records for at least three years. 5.5.3 Plant passports combined with certification labels

The audit team noted during a visit to a professional operator, the CA did not issue replacement plant passports for imported vegetable seeds being sold on in smaller lots than the original imported consignment to other professional operators. According to the operator a replacement plant passport wasn't necessary because the checks were already carried out at the BCP. It was evident during the visit that the operator did not understand the objective of the EU plant passport requirements. It was also noted at the time, the inspector did not disagree with the operator's comments. Although this was an isolated incident, it resulted in the movement of regulated goods without a plant passport, which is not in line with Article 79(1) of Regulation (EU) 2016/2031. 5.5.5 Application of the exemptions provided for in EU law

The issuance of plant passports is generally in line with EU requirements with the exception of some isolated incidents, where there was misinterpretation of the EU plant passport requirements by both the CA and the operator.

The CA stated that they do not carry out plant passport traceability checks on authorised professional operators, which is not in line with Article 92(1) of Regulation (EU) 2016/2031 (see paragraph 23(c)). However, the operator visited demonstrated to the 12 audit team a functional traceability system for different lots using the operator's own professional IT platform in line with the requirements of Article 89(1)(b) of Regulation (EU) 2016/2031 for authorised professional operators. 5.6.2 Official controls on sales through distance contracts

While traceability of regulated goods was demonstrated to the audit team by the authorised operator visited, it is not checked by the CA. Furthermore, checks on operators selling through distance contracts to the final consumer are largely excluded from official controls. This may result in the movement of plants without a plant passport or movement of plants without a plant passport linked to a traceability system, thus posing a risk to the integrity of the plant passport system in Romania.

The CA informed the audit team that there have been no non-compliances identified in the plant passport system during the audit period from 2020-2021. However, the absence of documented procedures gives no assurances that non-compliances can be dealt with in line with EU requirements (see paragraph 6 on documented procedures). Although requested during the audit meetings and by email, the competent authority did not provide a clear legal basis to take action in the event of a non-compliance with regards to plant passports. This is not in line with Articles 138 and 139 of Regulation (EU) 2017/625. 13 Conclusions on enforcement actions

The CA did not provide a clear legal basis to take enforcement action in the case of non-compliances with regard to EU plant passport requirements. This may result in the CA not having the legal powers to take action in the event of a non-compliance and without the appropriate guidance, therefore risking the spread of regulated pests into the EU.

Medlemsstatens svar

tional Phytosanitary Authority (NPA) - Bureau Implemented ection and Phytosanitary Quarantine The procedure for the registration of all (BPPPQ)must draw up procedures for the economic operators and the issuance of the implementation of the phytosanitary passport phytosanitary passport by the phytosanitary g to the provisions of Regulations (EU) inspections within the County /2031 and Regulation (EU) 2017/625, namely: Phytosanitary Units (Code PS DF 01) was - a procedure for the registration of all economic finalised and sent (on 16.12.2022) by e-mail ators and the issuance of the phytosanitary passport to all County Phytosanitary Units (CPUs). by the phytosanitary inspections within the County https://anfdf.ro/central/carantina/proceduri/ hytosanitary Units. This procedure will include: the procedura_operatori_prof.pdf tosanitary control carried out, according to art. 12 paragraph (2) of Regulation (EU) 2017/625 and the definition for "small quantities" art conf. 65 para. (3) letters (a) and (b) and - a procedure for authorizing economic operators to phytosanitary passports. - The procedure is being drafted. e procedure will include: - Deadline: 15.04.2023 - the requirements that m

-The National Phytosanitary Authority (NPA) - Bureau of Plant Protection and Phytosanitary Quarantine (BPPPQ)must draw up procedures for the implementation of the phytosanitary passport according to the provisions of Regulations (EU) 2016/2031 and Regulation (EU) 2017/625, namely: - a procedure for the registration of all economic operators and the issuance of the phytosanitary passport by the phytosanitary inspections within the County Phytosanitary Units. This procedure will include: the phytosanitary control carried out, according to art. 12 paragraph (2) of Regulation (EU) 2017/625 and the definition for "small quantities" art conf. 65 para. (3) letters (a) and (b) Implemented The procedure for the registration of all economic operators and the issuance of the phytosanitary passport by the phytosanitary inspections within the County Phytosanitary Page: 1 tions received 6 July 2023 ted by the competent authorities of Romania in response to Report ref. DG(SANTE) 2022-7409 of n order to evaluate the implementation of the plant passport system ction Proposed by the competent authority nits (Code PS DF 01) was finalised and sent on 16.12.2022) by e-mail to all County hytosanitary Un

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In all establishments visited, the audit team scrutinised the most recent inspection reports and interviewed the inspectors on their assessment of the operators' HACCP plans. The audit team noted that the inspectors' assessment of the hazard identification part of the HACCP plan was deficient in all five establishments. In general, the hazard identification part of the operators' HACCP plans was inaccurate (several potential hazards were not identified/assessed) or very 4 generic without the level of detail necessary for a proper hazard identification (as required by Article 6(2)(a) of Regulation (EC) No 183/2005) and consequent risk assessment. This issue was not reflected in any of the inspection reports seen and operators were thus unaware that there was a deficiency. The audit team noted that during the interviews some inspectors correctly identified these deficiencies.

In two establishments visited, the FeBOs identified critical control points in their own hazard analysis. However, the audit team noted that the established monitoring/verification procedures were not adequate for these critical control points. Additionally, the corrective actions described in their own hazard analysis were very general and did not correspond to the implemented corrective actions. Based on the scrutiny of the records of previous official controls, these deficiencies were overlooked by the feed inspectors during previous inspections.

While the planning of inspections is largely based on appropriate risk-related factors and allows for official controls to be carried out on all operators on a risk basis and with appropriate frequency, the effectiveness of the inspections, and thus of the overall official feed controls, is weakened by a number of shortcomings in inspectors' assessment of (i) feed business operators' hazard identifications within their hazard analyses and critical control point plans, (ii) operators' traceability systems (in particular collection and storage of retained samples), and (iii) operators' compliance with labelling requirements. 5.2.2 Sampling and analysis 5.2.2.1 Planning of official sampling

Medlemsstatens svar

1. În perioada 22-24.02.2023, ANSVSA a organizat o instruire cu reprezentantii DSVSA responsabili de efectuarea controlului oficial la operatorii din sectorul hranei pentru animale. Unul dintre subiectele prezente pe agenda instruirii a fost referitor la ncipiile i implementarea sistemului HACCP, cu accent pe identificarea si evaluarea pericolelor. 2. De asemenea, fisele de inspectie utilizate in controlul oficial vor fi modificate in sensul detalierii capitolului aferent verificarii programului HACCP, cu obligativitatea consemnarii in fisa de inspectie a documentelor verificate prin sondaj (rubrica "Dovezi de verificare"). 3. Transmiterea fielor de inspecie si a instruciunilor de completare a acestora prin not de serviciu Termen implementare: iunie 2023

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Routine inspections include verification of operators' traceability systems, including the operators' obligation to take samples of ingredients and from 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'), as required in part 4 of the section "Quality control" of Annex II to Regulation (EC) No 183/2005. The audit team scrutinised operators' documentation on collection, packaging, labelling 5 and storage of retained samples, interviewed inspectors who usually control those establishments and made the following observations: · in one establishment, retained samples were not collected (and stored) from feed additives and premixtures used for production; · in two establishments, significant number of the retained samples were not adequately sealed; · in one establishment, the operator did not collect retained samples from "non-critical microelements" such as amino acids and vitamins; · in one establishment, retained samples from finished products were not collected at all. These observations are not in line with the legal requirements established in part 4 of the section "Quality control" of Annex II to Regulation (EC) No 183/2005 and were not identified in any of the recent inspection reports seen.

While the planning of inspections is largely based on appropriate risk-related factors and allows for official controls to be carried out on all operators on a risk basis and with appropriate frequency, the effectiveness of the inspections, and thus of the overall official feed controls, is weakened by a number of shortcomings in inspectors' assessment of (i) feed business operators' hazard identifications within their hazard analyses and critical control point plans, (ii) operators' traceability systems (in particular collection and storage of retained samples), and (iii) operators' compliance with labelling requirements. 5.2.2 Sampling and analysis 5.2.2.1 Planning of official sampling

Medlemsstatens svar

1. Modificarea fiselor de inspectie utilizate in controlul oficial prin introducerea rubricii "Dovezi de verificare" in care s se consemneze documentele care fac dovada ii probelor retinute de operator (Anexa II la Reg (EC) 183/2005 - punctul 4 al sectiunii "Controlul Calitatii"). 2. Transmiterea fielor de inspecie si a instruciunilor de completare a acestora prin Not de serviciu Termen implementare: iunie 2023

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Verification that operators meet legislative labelling requirements forms part of routine inspections. At all of the FeBOs visited, the audit team scrutinised operators' labels and other relevant documents, interviewed inspectors who usually control those establishments and made the following observations: · In two feed material producers, accompanying documentation relating to bulk consignments did not mention that the products were "feed material", which is not in line with the requirements laid down in Article 15(a) of Regulation (EC) No 767/2009. In addition, there was no compulsory declarations (crude protein, crude fibre, starch and total sugar) related to the feed materials placed on the market, which is not in line with the requirements Article 16 (1b) of Regulation (EC) No 767/2009. · In one establishment, for compound feeds marketed in bulk, the accompanying document did not contain information on vitamins, microelements and amino acids used to produce these compound feeds. This is not in line with legal requirements of Article 11(2) of Regulation (EC) No 767/2009 since several of these feed additives (e.g., vitamin A, vitamin D, zinc) have maximum limits for the targeted animal species. · In one label of complementary feed, the type of the feed was not correct which is not in line with the requirements laid down in Article 15(a) of Regulation (EC) No 767/2009. · In one label of complementary feed containing feed additives with established maximum limits, the label did not contain clear dosage instructions, which is not in line with the requirements laid down in Article 17(1)(b) of Regulation (EC) No 767/2009. · In one label of a complete feed containing coccidiostats, the label did not contain the exact concentration of the used coccidiostats but provided a range of concentrations (e.g., 40-50 mg/kg). It is not in line with the requirements laid down in Article 15(f) of Regulation (EC) No 767/2009. Labelling-related deficiencies were not identified in any of the recent inspection reports seen. 6 Conclusion on the planning and implementation of inspections

While the planning of inspections is largely based on appropriate risk-related factors and allows for official controls to be carried out on all operators on a risk basis and with appropriate frequency, the effectiveness of the inspections, and thus of the overall official feed controls, is weakened by a number of shortcomings in inspectors' assessment of (i) feed business operators' hazard identifications within their hazard analyses and critical control point plans, (ii) operators' traceability systems (in particular collection and storage of retained samples), and (iii) operators' compliance with labelling requirements. 5.2.2 Sampling and analysis 5.2.2.1 Planning of official sampling

Medlemsstatens svar

În cadrul instruirii organizat de ANSVSA în perioada 22-24.02.2023 a fost entat i dezbtut inclusiv subiectul referitor la controlul oficial al etichetrii furajelor (a se vedea documentele prezentate la punctul 1). Page: 1 ations of report ref. DG(SANTE) 2022-7431 of the audit carried out from 14 November of official controls on feed hygiene ction Proposed by the competent authority

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The audit team observed official sampling at the three compound feed manufacturers visited (the matrix and parameters to be controlled were suggested by the audit team). In addition, a number of sampling records between 2019 and 2021 were scrutinised. Based on these, the audit team 7 identified that routinely only two final samples were prepared which is not in line with the requirements laid down in part 9.4 of Annex I to Regulation (EC) No 152/2009.

Notwithstanding the risk-based approach adopted for the planning of official sampling and the fact that the laboratories used for testing are accredited and appropriately designated, significant shortcomings in the implementation of sampling and especially in testing of official feed samples (both in validation of analytical methods and in implementation of internal quality control), undermine the legal and technical validity of the samples and the reliability of decisions made on the basis of the results. Cumulatively, these shortcomings weaken the overall effectiveness of the official feed control system. 5.2.3 Actions taken on non-compliances

Medlemsstatens svar

. Prelevarea probelor finale de furaje se va realiza cu respectarea prevederilor tului 9.4 din Anexa I la Reg. (EC) nr. 152/2009. In acest sens, Cererea de Analiza a fi actualizat si va avea anex distinct pentru probele de hran pentru animale. plementare: mai 2023 2. Cererea de analiz împreun cu anexa se vor transmite de ANSVSA ctre SVSA judetene si a municipiului Bucuresti prin not de serviciu pentru implementare ermen implementare: mai 2023

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In the two laboratories visited, the audit team scrutinised the system of preparation of the final samples submitted for testing. In none was there documentary evidence that the amounts weighed out, as provided for in the methods of analysis, were homogeneous and representative of the final samples, which is a requirement laid down in part A.1. of Annex II to Regulation (EC) No 152/2009.

Notwithstanding the risk-based approach adopted for the planning of official sampling and the fact that the laboratories used for testing are accredited and appropriately designated, significant shortcomings in the implementation of sampling and especially in testing of official feed samples (both in validation of analytical methods and in implementation of internal quality control), undermine the legal and technical validity of the samples and the reliability of decisions made on the basis of the results. Cumulatively, these shortcomings weaken the overall effectiveness of the official feed control system. 5.2.3 Actions taken on non-compliances

Medlemsstatens svar

n laboratoarele oficiale desemnate exista proceduri specifice pentru minarile de substante nedorite in hrana pentru animale, care cuprind si capitolul de regatirea probei pentru analiza, unde este detaliata modalitatea de omogenizare. n laboratoarele auditate nu s-a regasit documentare adecvata in proceduri privind mogenizarea probei test pentru analiza. entru toate laboratoarele oficiale desemnate : . LNR va efectua o instruire cu toate laboratoarele desemnate referitoare la regatirea esantionului de laborator si a esantionului de incercare din hrana entru animale cu accent pe omogenizare. . Se vor completa Procedurile specifice de laborator pentru determinarile de ubstante nedorite cu ANEXA omogenitate (pe care o atasam) in care va fi etaliat modul de pregatire al esantionului de laborator privind omogenitatea si ubesantionarea (conform EN ISO 6498). ermen de implementare : cat mai curand posibil dar nu mai tarziu de mai 2023. NR va urmari implementarea masurilor propuse.

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In the two laboratories visited, the audit team scrutinised validation documentation for eight analytical methods (e.g., determination of mycotoxins, heavy metals, pesticides/non-dioxin like polychlorinated biphenyls (PCBs), botanical impurities, etc.) and noted that a number of methods had not been validated for all matrices routinely tested by the laboratories: heavy metals method had been validated for compound feed only while diverse feed materials (including minerals) and feed additives were tested for; pesticides/PCBs method had been validated for wheat only although other feed materials (e.g., sunflower oil, minerals) and feed additives (e.g., lysine) were tested for. Moreover, aflatoxin B1 method had been validated at 10 and 20 ppb (laboratory dependent) while the maximum content for, inter alia, compound feed for dairy cattle is 5 ppb and such products were regularly tested by the laboratories. Such approaches significantly limit the applicability of the methods and not in line with the requirements of part 1(b) of Annex III to Regulation (EU) 2017/625. 8

For the eight analytical methods referred to above, the audit team examined the internal and external quality control systems in place. The audit team noted that, for the aflatoxin B1 testing in compound feed for dairy cattle, the fortification level of the positive control samples was 10 and 20 ppb (laboratory dependent) while the maximum aflatoxin B1 content for compound feed for dairy cattle is 5 ppb thus the fortification level of positive control samples for that type of feed was above the level of interest. For the PCBs method, less relevant matrix (wheat) was routinely used as positive control samples while largely other, very different, matrices (e.g., minerals, compound feed) were tested within the official feed sampling programme. Such approaches do not allow for effective ongoing method performance verification.

Notwithstanding the risk-based approach adopted for the planning of official sampling and the fact that the laboratories used for testing are accredited and appropriately designated, significant shortcomings in the implementation of sampling and especially in testing of official feed samples (both in validation of analytical methods and in implementation of internal quality control), undermine the legal and technical validity of the samples and the reliability of decisions made on the basis of the results. Cumulatively, these shortcomings weaken the overall effectiveness of the official feed control system. 5.2.3 Actions taken on non-compliances

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. Se va extinde domeniul de validare cu matricile relevante din Programul de upraveghere (sectiunea Expertiza hranei pentru animale) pentru metodele de eterminare privind substantele nedorite. en de implementare pentru validare, cat mai repede posibil, in functie de ncarcatura analitica a fiecarui laborator, dar nu mai tarziu de septembrie 2023. Page: 2 ations of report ref. DG(SANTE) 2022-7431 of the audit carried out from 14 November of official controls on feed hygiene ction Proposed by the competent authority 2. Pentru asigurarea validitatii rezultatului, secventa de lucru, va include niveluri de fortificare specifice limitelor maxime pentru matricile analizate in ziua respectiva. ermen de implementare cat mai curand posibil dar nu mai tarziu de mai 2023. 3. LNR va efectua o instruire cu privire la aceste masuri si va urmari implementarea masurilor propuse.

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In the standard operating procedures (SOPs) for heavy metals and PCBs methods, there was no provisions on duplicate analysis in case the result of the first determination exceeds 50% of the maximum content(s) established in Directive 2002/32/EC. This is not in line with the requirements laid down in part C(3) of Annex II to Regulation (EC) No 152/2009.

Notwithstanding the risk-based approach adopted for the planning of official sampling and the fact that the laboratories used for testing are accredited and appropriately designated, significant shortcomings in the implementation of sampling and especially in testing of official feed samples (both in validation of analytical methods and in implementation of internal quality control), undermine the legal and technical validity of the samples and the reliability of decisions made on the basis of the results. Cumulatively, these shortcomings weaken the overall effectiveness of the official feed control system. 5.2.3 Actions taken on non-compliances

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Se vor completa Procedurile specifice de laborator pentru metodele de rminare a substantelor interzise cu informatii privind raportarea rezultatelor, cu arele precizari: . "daca rezultatul primei determinari depaseste 50 % din specificatia controlata, e va efectua o a doua determinare din esantionul 2, iar rezultatul final va fi media ica a celor doua valori obtinute". . "daca rezultatul primei determinari depaseste 50 % din specificatia controlata se ua determinarea umiditatii conform procedurilor de laborator, din esantionul 2, stfel incat rezultatul final, sa fie recalculat la un furaj cu un coninut de umiditate de 2% " ermen de implementare: . Revizuirea procedurilor specifice: mai 2023. . Completare Program de Supraveghere (sectiunea Expertiza hranei pentru animale) de catre ANSVSA: iulie 2023

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The audit team scrutinised a substantial number of analytical tests (with related raw data) and reports related to undesirable substances within the meaning of Directive 2002/32/EC and observed that, when relevant, the expanded measurement uncertainty was properly reported, the analytical recovery was indicated, and the result(s) had been corrected for recovery. However, none of the analytical test results, including where non-compliances had been established, had been recalculated to a feed with a moisture content of 12%. Moreover, the official feed sampling programme does not envisage determination of moisture in any of the official feed samples. Such approach is not in line with the requirements laid down in part C.6. of Annex II to Regulation (EC) No 152/2009. Conclusion on the planning and implementation of official sampling, and testing of official feed samples

Notwithstanding the risk-based approach adopted for the planning of official sampling and the fact that the laboratories used for testing are accredited and appropriately designated, significant shortcomings in the implementation of sampling and especially in testing of official feed samples (both in validation of analytical methods and in implementation of internal quality control), undermine the legal and technical validity of the samples and the reliability of decisions made on the basis of the results. Cumulatively, these shortcomings weaken the overall effectiveness of the official feed control system. 5.2.3 Actions taken on non-compliances

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Propunere modificare /completare Program de Supraveghere (sectiunea xpertiza hranei pentru animale), privind conduita unitara a laboratoarelor oficiale te, cu precizarea « daca rezultatul primei determinari, efectuat din antionul 1 al probei test, depaseste 50 % din specificatia controlata, se va efectua din ul 2 al probei test, determinarea umiditatii precum i a doua determinare a nalitului, conform procedurilor de laborator, astfel incat rezultatul final, sa fie eprezentat de media aritmetica a celor doua determinari, raportat la un furaj cu un Page: 3 ations of report ref. DG(SANTE) 2022-7431 of the audit carried out from 14 November of official controls on feed hygiene t authority 023 Page: 4

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In line with EU requirements (35), all analytical methods used by the laboratories in Clrai (SVFSL Clrai) and Bucharest (IHVPH) for official testing of residue monitoring samples are included in those laboratories' respective scopes of accreditation to EN ISO/IEC 17025. The accreditation was awarded on a broad basis with regard to the scope of the applicable matrices used in testing for residues. (28) Article 13 of Regulation (EU) 2017/625. (29) Articles 5 and 6 of Regulation (EU) 2019/2090. (30) Articles 5(2) and 6(5) of Regulation (EU) 2019/2090. (31) Article 139 of Regulation (EU) 2017/625. (32) Annexes I and II of Council Directive 96/23/EC. (33) PS-01-DGSVSA, Designation of sanitary veterinary and safety laboratories food which may carry out the analysis of samples taken within the framework of official control of feed and products food, animal health and welfare. (34) Article 37 (3) of Regulation (EU) 2017/625. (35) Article 37, 4(e), 5(a) & 5(b) of Regulation (EU) 2017/625. 7 For example, methods accredited for `animal tissue' cover muscle, liver and kidney, however, some methods considered as accredited are not validated for all of the analyte/matrix/animal species combinations. This is not in line with EU requirements (36)(37).

The Charm II screening methods for detection of beta-lactams and tetracyclines (both B1) in muscle and in kidney at SVFSL Alba and SVFSL Bacau were reviewed during the audit. The method performance parameters determined were in line with EU requirements (47) at the time of the method validation (the corresponding validation reports were dated 2019 and 2020). For some analyte/matrix combinations the established CC values used for the identification of screened-positive samples were equal to the respective MRLs, and thus, are not in line with current EU requirements (41), which stipulate that the CC shall be lower than the MRL. The IHVPH indicated that the Charm II screening test is being phased out and replaced by Liquid Chromatography-(Tandem) Mass Spectrometry (LC-MS/MS); in the 2019 plan 43 analytes were screened by Charm II and this has been reduced to 13 analytes in the 2022 plan. (36) Article 3(3) of Regulation (EU) 2021/808. (37) In their response to the draft report the competent authority stated that the documentation for the extension of validations for all the relevant combinations of analyte/matrix/animal species was elaborated. (38) Points 3, 4 and 7 of Annex II to Regulation (EU) 2021/808. (39) Article 37, 4(c) of Regulation (EU) 2017/625. (40) Article 4 and Chapter 3 of Annex I to Regulation (EU) 2021/808. (41) Point 1.1.2 of Annex I to Regulation (EU) 2021/808. 8 5.2.1. Institute of Hygiene and Veterinary Public Health, Bucharest

In respect of method b) above and relating to finding 34, it was found that while the method was fully validated for the `major' animal species (in terms of production volumes, i.e. porcine and poultry), relevant matrices from `minor' animal species were not included in the validation experiments. The laboratory indicated that validation for bovine muscle was in progress at the time of the audit.

The laboratory indicated that when samples of non-validated matrices are analysed, a matrix-matched calibration curve and fortified sample/recovery evaluation at the relevant Maximum Residue Limit (MRL) are used to verify the satisfactory performance of the analysis for the applicable analyte/matrix/animal species combination. While this practice does give some indication of the method performance at the time of testing, it does not provide information on precision, uncertainty of measurement or the appropriateness of the calculated decision limit, CC, to non-validated matrix/animal species combinations. This is not in line with EU requirements (50). (42) National Sanitary Veterinary and Food Safety Authority Order No 205 of 20 December 2007 on the approval of national reference laboratories and their tasks; latest amendment on 10 March 2020. (43) Article 100 of Regulation (EU) 2017/625. (44) Article 101 of Regulation (EU) 2017/625. (45) PG32, Laboratory performance monitoring protocol corresponding to inter-laboratory tests, Edition of 01.09.2016. (46) Article 101 (1(c) of Regulation (EU) 2017/625. (47) Annex I to Commission Decision 2002/657/EC. (48) Annex I to Regulation (EU) 2021/808. (49) Article 7 of Regulation (EU) 2021/808. (50) Article 3 and Chapters 2 and 4 of Annex I to Regulation (EU) 2021/808. 9 5.2.2. Sanitary Veterinary and Food Safety Laboratory Clrai

Two methods and associated validation data were examined by the audit team ­ bioassay screening of chloramphenicol (A6) in muscle, milk, honey, egg and urine and determination of lead and cadmium (B3c) in food. a) For chloramphenicol, all of the required method performance characteristics were evaluated. The CC has been established in line with EU requirements and EURL guidance (52). The method has not yet been validated to meet the requirements of the reference point for action for chloramphenicol due to come into force in November 2022 (53). The laboratory indicated that it aims to complete the required validation prior to the next Romanian Accreditation Association audit scheduled to take place in August 2022. b) For lead and cadmium in muscle, all of the required validation criteria had been generated. The method was fully validated only in poultry muscle and is used to determine lead and cadmium in muscle samples from other species. While the method of sample preparation, calcination, removes the matrix effect from the analysis results, the laboratory could not provide supporting evidence (own experiments or scientific data) that the calcination procedure followed is sufficiently complete to decompose muscle samples with a higher fat content compared to poultry muscle. Conclusions on laboratories

Notwithstanding several opportunities for improvement in validation of analytical methods, the fact that all of the official control laboratories are accredited to EN ISO/IEC 17025 and have measures in place to ensure their effective performance gives the competent authority confidence in the reliability of analytical results.

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nt Laboratories from Romania have engaged in a program to revalidate all methods currently used, as part of the National Residues Control Plan, to meet the requirements of Regulation (EU) 2021/808. As there are a significant number of methods involved and a more complex validation process required by the requirements of Regulation (EU) 2021/808, the revalidation program was set to be completed in June 2025, one year earlier than the deadline set by Regulation (EU) ) 2021/808. The revision of the validations was gradually planned, taking into account the new minimum performance requirements of the analytical methods (MMPR / 2020), the new limits / RPA (Reg 1871/2019) against which the conformity of the results and the transition period imposed by regulations are established. Thus, in view of Regulation (EU) 2019/1871, the revision of validations according to Reg 808/2021, for Nitrofurans and Malachite Green, was planned with the highest priority. At the date of this reply, the validation for dye residues has been completed and experiments for Nitrofurans are ongoing, in accordance with Regulation (EU) 2019/1871 and Regulation (EU) 2021/808. Deadline for completion of nitrofuran resi

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- Through the Internal Note 8533/26031/11.05.2022 instructions were sent in order to update the transporters' Council contingency plans in the authorisation dossiers, with the ity of inclusion of a risk analysis of the most likely animal welfare case of hazards related to such journeys. Therefore, DSVSA Constanta lation informed the transporters' representatives (through letters No. 15396/12.05.2022 and 11593/24.04.2023 on drawing up the rols. contingency plans. Applications for approval/ reapproval of the transporters were submitted accompanied by updated contingency plans. - In April, 2023, a training was organised at DSVSA Constanta by ANSVSA (internal note 25680/31.02.2023 attached), involving persons with authorisation duties as well as persons involved in official controls on animal protection during sea transport. One of the topics on the agenda was the contingency plans. - Moreover, the official veterinarians in the Exit Point verify that contingency plans in the event of emergencies meet the requirements provided for in Article 7 of Commission Implementing Regulation (EU) 2023/372 . - Through letters No. ANSVSA nr 5791/04.04.2023 and 11595/04.10.2023, ANSVSA sent instructi

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The audit team noted that in one county the registration of primary fishing vessels had started in 2021 with the registration of 42 vessels. For Romania, according to the National Fishery Agency, there are around 2 000 commercial vessels for fresh water fisheries and 245 for marine fisheries. NSVFSA has registered 291 fresh water vessels and 96 marine vessels for Romania. The CA stated that the vessels concerned would be very small using traditional fishing techniques and capture low volumes. There was no data available to the audit team to assess the volumes of fish marketed from unregistered vessels.

A registration system is in place comprising aquaculture, fishery vessels and landing sites. However, the majority of commercial fishing vessels are not registered by the CA, which is not in line with Article 6(2) of Regulation (EC) No 852/2004 in conjunction with Article 4(1) of Regulation (EC) No 853/2004.

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The audit team noted that in one county the registration of primary fishing vessels had started in 2021 with the registration of 42 vessels. For Romania, according to the National Fishery Agency, there are around 2 000 commercial vessels for fresh water fisheries and 245 for marine fisheries. NSVFSA has registered 291 fresh water vessels and 96 marine vessels for Romania. The CA stated that the vessels concerned would be very small using traditional fishing techniques and capture low volumes. There was no data available to the audit team to assess the volumes of fish marketed from unregistered vessels.

A registration system is in place comprising aquaculture, fishery vessels and landing sites. However, the majority of commercial fishing vessels are not registered by the CA, which is not in line with Article 6(2) of Regulation (EC) No 852/2004 in conjunction with Article 4(1) of Regulation (EC) No 853/2004.

The current registration and control system does not distinguish between different sizes of fishing vessels.

As described in point 37 the majority of vessels are not registered by NSVFSA. The audit team could not retrieve sufficient statistical data to estimate the volumes of fishery product marketed from unregistered vessels.

It seemed unlikely to the audit team, that approximately 3 000 commercial vessels can be registered and controlled under the current Romanian rules with the existing number of staff. Aquaculture farms

The official control system covers the entire production chain of fishery products including fishing vessels with the exception of unregistered primary production vessels (which constitute the majority of vessels in this category), which is not in line with Article 10 of Regulation (EU) 2017/625 (3).

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However, the audit team noted that the FNAO inspectors have not received guidance to perform Listeria monocytogenes (Lm) environmental tests and/or to verify if and how FBOs carry out environmental samples to investigate Lm occurrence in their establishments. Supervision and Audit

The audit team noted that FNAO inspectors do not check if FBOs have an environmental sampling plan in place and effective procedures to detect Lm, as indicated by "The European guideline on sampling the food processing area and equipment for the detection of Lm, version 3, August 2012 (3) as well as by EFSA Scientific Opinion on "The public health risk posed by Lm in frozen fruit and vegetables including herbs, blanched during processing" (4).

The CAs did not request the FBO to investigate the cause of contamination. The CCA informed the audit team that, up until now, a root cause analysis for Lm contamination is not required from the FBOs and in this case the FBO did not perform a root cause analysis.

Insufficient knowledge of the CA regarding appropriate actions and practices to manage Lm contamination hinders the capacity of the authority to verify that FBOs take the appropriate preventative and corrective measures to ensure that only safe product is placed on the market. 5.2.5 Official sampling 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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On 11.03.2021, the General Directorate for Food Safety approved and sent to the County SanitaryVeterinary and Food Safety Directorates (DSVSA) the Service Note no. 25457 / 11.03.2021 containing instructions for the application of the PROFEL Guide on the contr ol of eria monocytogenes in the production of quick-frozen vegetables. level of the General Directorate for Food Safety, a procedure for "sampling of environmental samples for the detection of Listeria monocytogenes" and a procedure for "control of Listeria monocytogenes in ready-to-eat food establishments" is under development. The estimated deadline for completion and transmission to the county DSVSA is April 30, 2021. The training plan for 2021 developed at General Directorate for Food Safety level covers one online training in every semester of the year, with physical training sessions to be organized depending on the epidemiological situation. Approximately 160 inspectors (4 persons/county) are planned to participate in each of the online training programs, and the following topics will be included: - Sampling from the environment and foodstuffs for the detection of Listeria monocytogenes; - Management of Listeria monocyt

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However, since 2016, these controls were performed only for producers of fruits and vegetables that also have storage and/or processing activities of FNAO and are registered as such. There were 77 producers registered in 2020 and 69 inspections were planned and carried out. Ten non-compliances were detected regarding, for example: the periodic medical evaluation of staff; missing water analysis; pest control; lack of procedures and records on sanitation; analytical reports made in the own-control programme were not available. However, there were no non-conformities reported related to the checks before or during harvest.

As regards other primary producers of FNAO, NSVFSA did not carry out controls with regard to microbial contamination until the end of 2020. As a result, different risk levels for different products are only partly taken into account, contrary to the provisions of Article 9 of Regulation (EU) 2017/625. 9

The risk-based official control system is weakened by the fact that the information available concerning the majority of primary producers is insufficient to take into account higher risks of microbiological contamination of certain produce. This, along with the fact that inspections regarding FNAO microbiological risks do not cover the pre-harvest and harvest stages of the majority of primary producers, hampers the effectiveness of the official control system. 5.2.4 Implementation of official controls over FBO 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) 2019/628, Article 1 and Annex I to Commission Regulation (EC) No 2073/2005. Findings

The county staff informed the audit team that official controls are only implemented at the primary producers of fruits and vegetables that also have storage and/or processing activities of FNAO and are registered as such. Furthermore, the county staff stated that the current registration system does not allow the inspectors to identify the other farms.

The official control system is able to identify and rectify shortcomings only at a limited number of primary producers.

Medlemsstatens svar

eneral Directorate for Food Safety has drawn up a draft order amending and completing order 35/2016 -- Supervision and Control Program, which provides for the following changes: official control of primary production will be carried out at the pre-harvest, harvesting and arvest stages, - a minimum of 20 samples per county/year will be taken in order to determine the logical risk, depending on the specific area and the number of existing FBOs, mit of 0.3 ha from which are included in the official control the producers of veget ables en leaves that are usually eaten raw: tomatoes, vegetables with bulbs and stems, will be eliminated. mated date for the adoption of this order is August 30, 2021. lso asked the Agency for Payments and Intervention for Agriculture (APIA) to in transfering the database with the primary producers. On that date, the discussions ing the videoconferences organised with the county structures on 25.02 and 11.03.2021 that all counties received either from APIA or from the National Agency for Cadas tre Registration, database of primary producers. Official controls in 2021 were planned asis of these databases. rovided by the Official Control General Directorate (OC

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Although the supervision system made it possible to identify shortcomings in the detection and enforcement of non-conformities by local CAs, it was not able to identify other important shortcomings relating to non-compliances with EU legislation, such as import certificate requirement for seeds in sprout-producing establishments, as well as shortcomings in the official environmental sampling relating to Lm (see also findings 60, 61 and 62).

There is a system of supervision in place, however it was not able to identify important shortcomings relating to non-compliances with EU legislation. This limits the CAs to improve the official control system. 6 5.2.2 Registration/approval of food establishments Legal requirements Article 6 of Regulation (EC) No 852/2004, Article 2 of Regulation (EU) No 210/2013 of the European Parliament and of the Council and Articles 10(2), 138(1), 138(2)(c)-(j), 138(3), 138(4) and 148 of Regulation (EU) 2017/625. Findings Registration of primary producers of FNAO

When reviewing the outcome of one of the official controls of a sprout-producing establishment, the audit team noted that no checks were performed regarding import certificates of seeds for sprouting that had been imported from third countries. The CCA stated that for mung beans produced in third countries, certificates accompanying the consignments to the sprouting establishments are not required by the inspectors. This is not in line with Regulation (EU) No 208/2013.

The CCA explained to the audit team that they provided clear instructions to the counties about checking the fitness of seeds for sprouting. However, one of the county inspectors explained to the audit team that he considered an organic certificate for seeds sufficient as evidence for the fitness of the seeds for sprouting. This was not in line with instructions of the CCA and Regulation (EU) No 208/2013.

One of the counties granted a derogation to one sprout producer from preliminary testing of batches of seeds for sprouting, based on Chapter 3, Section 3.3 Part B of Regulation (EC) No 2073/2005. The derogation was granted on the basis of samples that consisted of a mix of seeds from different batches. Additionally, the CCA explained to the audit team that the FBO had not been following the required monthly frequency of tests of the final product even before they had been granted this derogation. The CCA provided written evidence during the audit that the derogation was withdrawn by the county authorities and a financial penalty was imposed to the FBO for not following legal obligations regarding microbiological risk reduction. 12

Official controls of sprouting establishments are not verifying compliance with all the relevant legal requirements. Shortcomings in relation to the verification of compliance with traceability, import certificates, own microbiological analyses (frequency) and granting an unjustified derogation regarding "preliminary tests of seeds for sprouting" weaken the official control system, which could result in contaminated product being placed on the market.

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VFSA prepared and transmitted on 03.03.2021 to all county DSVSA the Service Note no. 03.03.2021 providing clarifications on the conditions for granting derogations regarding Page: 4 ommendations of report ref. DG(SANTE) 2021-7177 of the audit carried out from 26 January2021 to 04 ntrols relatingto microbial safety of foodof non-animal origin osed by the competent authority y testing of seeds intended for germination (sprouting seeds). ou below the Service Note no. 25406/03.03.2021. testare si derogare seminte destinate germinarii.PDF al clarifications and discussions regarding the non-conformities identified during the k place during the videoconference organized with the county structures. g plan for 2021 developed at the General Directorate Food Safety level includes n the following topics: rements of Regulation (EU) no. 208/2013 and of Regulation (EC) no. 2073/2005 Section 3.3 nts for the import and certification of seed for germination. raised during DG SANTE's mission will be addressed in particular in these ided by the Official Control General Directorate (OCGD) ice Note no. 25313/19.02.2021, issued by the representatives of the Official Control ectorate (OCGD), were presente

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The central authority did not apply the programme in 2018, which had a negative effect on the progress of eradication. The national legislation on public procurement caused the authority to miss another spring vaccination campaign in 2021, with likely similar negative effect on the rabies eradication as in 2018 (See Table 1 in Annex 3). Therefore, it could not follow the recommendations of the 2015 EFSA report and the 2015 Commission guidelines advising vaccination continuation for at least two years after the last reported case of rabies. This is not line with Section 2 (point 1(a)) of Chapter 1 in Part 1 of Annex V to Regulation (EU) 2020/689.

The spring campaigns in 2019 and 2020 started at the end of May or beginning of June and finished in July, when the outside temperature was higher. The regular late start and finish of spring campaigns were not in line with the 2015 Commission guidelines. 4

The central authority and contractor took some preventive actions to mitigate risk associated to high temperatures (e.g. reduce efficacy of the vaccine), in particular by adapting the vaccination plan and the daily vaccine distribution schedules prioritising distribution early in the morning and trying to avoid days where temperatures rose over 30ºC. But the authority had not verified their effectiveness, e.g. they had not monitored the virus titre of the vaccine baits after their distribution to confirm that their potency was not altered by the exposure to high temperatures for several days in the environment. This is not in line with Article 5(1)(a) of Regulation (EU) 2017/625 and with Section 2 (point 1(b)) of Chapter 1 in Part 1 of Annex V to Regulation (EU) 2020/689.

The absence of oral vaccination campaigns in 2018 had negative impact on rabies eradication, and resulted in a decrease of the wildlife population immunity and a higher risk of spread of the disease. Similar negative effect on the rabies eradication is likely to happen in 2021 due to the absence of campaign during the spring.

The official controls on vaccine quality, its storage conditions, and manual and aerial distribution provided timely verification that the vaccine quality met the contract specifications, and that vaccine distribution was in line with the approved vaccination plan. The late implementation of the spring campaigns increases the risk of reducing the vaccine efficacy after their distribution. The authority and contractor took some actions to mitigate this risk but they had not verified their effectiveness.

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NSVFSA has requested to the E.C to allow to modify the financed programme for period 2021-2024 for assuring a ntinuous implementation. adresa 26745-13.09.2021-rab In 2021, we could not implement the programme because the public procurement could not be performed. According to national legislation, the Grant Decision had to be approved. For 2022-2024, we intend to do a multiannual programme, if our request will be approved by the E.C. If not, we will start the tender for 2022, immediately after the Grant Decision will be issued. Regarding the start of vaccination campaigns, we provided in the technical requirements of the tender that the spring campaign should take place into the period March- May and the autumn one in September-November. For each campaign, the service provider will have to finish the campaign in 30 days with good wheather conditions for flying. We will request to the service provider that the starting date for the spring campaign to be a soon as possible with respecting the technical specification from the prospectus of the vaccine, for avoiding high temperatures (preferably March or April). Accordingly to the contract provisions, the starting date of the campaign

A has requested to the E.C to allow to modify the co financed programme for period 2021-2024 for assuring a continuous implementation. 2021, we could not implement the programme because the public procurement could not be performed. According to national legislation, the Grant Decision had to be approved. For 2022-2024, we intend to do a multiannual programme, if our request will be approved by the E.C. If not, we will start the tender for 2022, immediately after the Grant Decision will be issued. Regarding the start of vaccination campaigns, we provided in the technical requirements of the tender that the spring campaign should take place into the period March- May and the autumn one in September-November. For each campaign, the service provider will have to finish the campaign in 30 days with good wheather conditions for flying. We will request to the service provider that the starting date for the spring campaign to be a soon as possible with respecting the technical specification from the prospectus of the vaccine, for avoiding high temperatures (preferably March or April). Accordingly to the contract provisions, the starting date of the campaign is requested by the beneficiary

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The table below shows the number of tests carried out in 2019 and 2020. In 2018, the monitoring plan was not implemented. 9 Year No of No of % of No of tests % of No of % of planne Fluorescen planne for marker planne ELISA ELISA t antibody d FAT d tests tests for planned d tests (FAT) antibodies ELISA samples tests for tests for marker 7451 antibodies 7153 2019 8535 8223 96.34 8205 96.13 87.29 2020 8535 7797 91.35 7795 91.32 83.8 Data reviewed in the selected counties showed that the number of foxes shot each year in 2019 and 2020 had been four times the number targeted for monitoring, indicating that there was no shortage of foxes to be sampled. The table above shows that the number of enzyme-linked immunosorbent assay (ELISA) tests carried out was lower than the tests carried out to detect the tetracycline marker, both in 2019 and in 2020. According to staff from the laboratory, this was mainly due to the inadequate quality of the samples received. When they detected that problem, laboratory staff took action to correct the situation (e.g. by providing additional training, or distributing training material to the dispatching county laboratories).

In 2019, the majority of counties sampled 4 or more animals /100 km2, therefore reaching their sampling targets. The percentage of the target reached varied between counties, ranging from 51.33% to 165.46 % (for the fluorescent antibody test (FAT) tests). Seven counties (out of 40) took less than 80 % of their targeted number of samples, with two counties presenting data well below their targets. Those counties sampled only two animals /100 km2 (just above 50% of their plans).

In 2020, the variation between the counties in the percentage of the target reached was similar to the one in the previous year, ranging from 48% to 153.09 % (for the FAT tests). 26 counties achieved their sampling targets. Nine counties reached less than 80 % of their planned number of samples, with four counties well below their targets (less than 60 %). One county, bordering Ukraine; i.e. with a high risk of rabies incursion from the adjacent infected area, was not able to reach 50 % of the planned sampling target (less than 2 animals /100 km2).

The audit team analysed data provided for 2019 and 2020 for some counties showing that there had been an uneven geographical distribution of the samples taken within their territories. Both aspects; i.e. some counties not analysing the necessary number of samples and the potentially biased sample taken only from some hunting grounds, can significantly reduce the representativeness and reliability of the results obtained from their analysis and the validity of the conclusions drawn up at county and national level on the levels of immunity reached.

The authority has access to estimates of the geographical distribution of the population of wild carnivores in Romania, including the yearly hunting quotas and the hunting bags obtained at the end of the season, broken down per species and for each hunting ground. The data (see Map 5 in Annex 3) show an increased density of the jackal population in the southern part of the country, even exceeding in some counties that of the fox population. However, the authority does not take into account the estimates of all population of wild carnivores to fine-tune the planning of the rabies monitoring activities; e.g. targeting the jackal population in the selected area to obtain a representative image of the vaccine uptake and of the levels of immunity reached in this species.

The authority designed the rabies monitoring activities in accordance with the approved rabies programme and with general obligations in that respect laid down in Articles 3(points 1(a)(iv) and (b)(ii)) and 4 (point 1(b)(i)) of Regulation (EU) 2020/689. However, they did not apply those activities as planned. This is not in line with the provisions of the rabies eradication programme, recommendations of the 2013 WHO report and of the 2015 Commission guidelines, and point 1(d), of Section 2 of Chapter 1 of Part I of Annex V to Regulation (EU) 2020/689.

Despite the activities mentioned above, the authorities still lack sufficient understanding of how different factors contribute to the weaknesses identified in some areas of the country, e.g. underperformance in monitoring vaccination effectiveness, low levels of 16 immunity in wildlife in certain counties and under-notification and investigation of suspect cases and indicator animals. They have not identified and shared good practices that resulted in the adequate application of those measures in some well performing counties.

The inadequate implementation of monitoring of vaccination effectiveness in some areas of the country, combined with the sub-optimal surveillance for rabies, do not allow the authority to detect promptly the potential issues in the rabies eradication, in particular in oral vaccination of wild carnivores. This hinders the authority's capability to identify quickly the areas of the country at a higher risk of rabies spread where they need to focus additional prevention, surveillance and control efforts.

Medlemsstatens svar

August 2021, following the conclusions of the audit team, we o conducted a retraining of local veterinary directorates which aterialized in a Service Note nr. 26560/09 august 2021 in which e reiterate the importance and obligation to collect each county a inimum of 29-30 foxes or jackals in passive surveillance, from erent hunting grounds and as scattered as possible. S nr. 26560 din 21 rabie.pdf urrently, we already have about 900 foxes and jackals collected nd tested in the frame of passive surveillance and we hope to test t least 1200 by the end of the year. Incentives of 50 euro/animal ere highlighted again and we have feedback that they have tarted to be paid to the hunters. egarding the monitoring, we also re-trained by Service Note nr. 6560/09 august 2021 the local veterinary sanitary directorates in rder to comply with the fox shooting targets from the program nd we will make sure at that time that the targets will be espected by them. The total number to be harvested in the ountry is 8535 foxes per year and distributed accordingly per ounties to comply with the recommendations of the guidelines of he C.E. of 4 foxes / 100km2.

n August 2021, following the conclusions of the audit team, we conducted a retraining of local veterinary directorates which materialized in a Service Note nr. 26560/09 august 2021 in which we reiterate the importance and obligation to collect each county a minimum of 29-30 foxes or jackals in passive surveillance, from different hunting grounds and as scattered as possible. Page: 4 ns, updated 2023/03/06 tted by the competent authorities ofRomaniain response to Report ref. DG(SANTE) 2021-7262 of rder toevaluate the implementation and effectiveness of the rabies eradication programme on Proposed by the competent authority ently, we already have about 900 foxes and jackals collected and tested in the frame of ive surveillance and we hope to test at least 1200 by the end of the year. Incentives of uro/animal were highlighted again and we have feedback that they have started to be to the hunters. rding the monitoring, we also re-trained by Service Note nr. 26560/09 august 2021 the l veterinary sanitary directorates in order to comply with the fox shooting targets from program and we will make sure at that time that the targets will be respected by them. total number to be harvested in

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raining was conducted with the local veterinary directorates (Service note 26687/01.09.2021) to inform the management of the unting grounds on the rewards of 50 euros for the animals arvested under passive surveillance and the importance of ollecting as much as possible indicator animals. As feedback, we lready have about 900 animals collected under passive urveillance (see attached table). Page: 2 ef. DG(SANTE) 2021-7262 of theauditcarried out from25 May 2021 es eradication programme tion Proposed by the competent authority ssive surveillance NS 21 wild.xls 26687-01.09.2021 ins so, in the case of the visit of local official veterinarians to the useholds of the population, they were specified to inform the pulation about the announcement of the carcasses of wild imals detected. fore starting the vaccination campaigns, we will inform all the stitutions involved in the implementation of this rabies adication program about the actions necessary to be performed r its success. addition to these actions, before the start of vaccination mpaigns, there will be awareness campaigns to warn the pulation by posting informative posters on the public domain.

raining was conducted with the local veterinary directorates (Service note 26687/01.09.2021) to inform the management of the hunting grounds on the rewards of 50 euros for the animals harvested under passive surveillance and the importance of collecting as much as possible indicator animals. As feedback, we already have about 900 animals collected under passive surveillance. Also, in the case of the visit of local official veterinarians to the households of the population, they were specified to inform the population about the announcement of the carcasses of wild animals detected. Before starting the vaccination campaigns, we will inform all the institutions involved in the implementation of this rabies eradication program about the actions necessary to be performed for its success. In addition to these actions, before the start of vaccination campaigns, there will be awareness campaigns to warn the population by posting informative posters on the public domain. Updated response received on 31 May 2022: Page: 10 ns, updated 2023/03/06 tted by the competent authorities ofRomaniain response to Report ref. DG(SANTE) 2021-7262 of rder toevaluate the implementation and effectiveness of

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In the last two years the number of suspect cases reported to the authorities and indicator animals investigated kept falling, as shown in the bar charts here below (see also Table in Annex 3). 12 Total Hunted Found dead NSuumspbe2ecr0t2oc0fasFeAs T Total Hunted Found dead NSuumspbe2ecr0t1oc9fasFeAs T Total Hunted Found dead NSuumspbe2ecr0t1oc8fasFeAs T 50045040035030025020015010050 0 Foxes Wolves Jackals Other wilds carnivores Other wild species Wild species total

The chart above illustrates that the number of found dead foxes tested to detect the presence of the rabies virus has gradually decreased since 2018, and sharply in particular in 2020. The authority explained this could be due to the restrictions imposed for African Swine Fever and to the COVID-19 pandemic, which limited considerably the access for the general public and even for hunters to forest areas, and thus, lowered the chances to find fox carcasses. The central authority acknowledged they had insufficient collaboration with road authorities and local councils to increase the number of the road killed animals sampled for rabies investigation.

Data per county on the number of wild carnivores notified and investigated as suspect cases or indicator animals (see Maps 1, 2 and 3 in Annex 3) indicates that: o In 2018 and 2019 a higher number of the investigated cases originated in counties from the North (areas with a high risk of cross-border spread of rabies from neighbouring countries) and South-West of the country. o In 2020, the number of investigated cases in the same area in the North of the country and in counties with a similar risk profile situated in the East decreased significantly. o When the authorities of some counties found rabies cases in wild foxes, they intensified the application of surveillance, in particular in wide areas around the place where the infected animal was found. That surveillance included a significant increase in the number of foxes hunted in those areas and tested to exclude the presence of rabies (not exactly suspect cases or indicator animals) and a modest increase in the number of foxes found dead investigated. Nevertheless, those measures helped the authorities to better tailor their response to the changing epidemiological situation.

Data on the application of surveillance for rabies in domestic species and the geographical location of the rabies cases detected both in wildlife and in domestic animals complement the epidemiological picture described in the previous point (see Tables 3 - 5, and Map 4 in Annex 3). The data indicates that: o There are several counties with a significantly lower number of cases investigated as part of that surveillance, both in wildlife and in domestic animals. o All rabies cases except one were confirmed in counties with a high risk of cross- border spread of rabies from neighbouring countries not free from rabies (Ukraine and Moldova). o The only exception was a rabies case in a non-vaccinated dog detected in a county in the central part of the country, which had not had any rabies case recently. Despite their efforts in recent years, the county authority had not succeeded to enhance surveillance for rabies in that county, which had investigated hardly any suspect case or indicator animal during that time.

The continuous decrease in the number of suspect cases and indicator animals investigated to exclude the presence of rabies, both in wildlife and in domestic animals, which is more evident in an important number of counties, implies insufficient compliance with general responsibilities on animal health and obligations on disease surveillance for operators, veterinarians and for the authorities, laid down in Articles 10 to 13, 15, 18, 24, 26, 27 and 32(1)(b) of Regulation (EU) 2016/429. That situation is not in line either with the provisions for eradication of rabies laid down in Articles 32(1)(b) and (c), 33 and 34(1)(a) of Regulation (EU) 2020/689, on the basic strategy for the eradication programme, its targeted population and the surveillance the authorities must conduct in that context. 5.1.3 Control measures in the event of suspicion and confirmation of rabies

Although there are well-tailored information campaigns to raise public awareness on the disease, there has been an obvious decrease in the reporting of suspect cases and indicator animals investigated to exclude the presence of rabies in the last two years. This prevents the authorities from having more accurate and up-to-date epidemiological information on the rabies incidence and its geographical distribution in wild carnivores in Romania. Consequently, they might not be able to apply the measures promptly and to adapt them to reduce the risk of spread of rabies.

The inadequate implementation of monitoring of vaccination effectiveness in some areas of the country, combined with the sub-optimal surveillance for rabies, do not allow the authority to detect promptly the potential issues in the rabies eradication, in particular in oral vaccination of wild carnivores. This hinders the authority's capability to identify quickly the areas of the country at a higher risk of rabies spread where they need to focus additional prevention, surveillance and control efforts.

Medlemsstatens svar

cording to national legislation, the NSVFSA Order. 29/2008 ts the measures to be applied in case of rabies outbreaks, that in e case that rabies is confirmed in wild species or in areas jacent to forest environment; among these, huntings will be uested to the hunting ground associations for extracting foxes order to be tested for rabies. Additional information and Service Note will be sent to the local nitary veterinary directorates in order to remaind these ovisions.

According to national legislation, the NSVFSA Order. 29/2008 sets the measures to be pplied in case of rabies outbreaks, that in the case that rabies is confirmed in wild species r in areas adjacent to forest environment; among these, huntings will be requested to the hunting ground associations for extracting foxes in order to be tested for rabies. Additional information and Service Note will be sent to the local sanitary veterinary directorates in order to remaind these provisions. Updated response received on 31 May 2022: Attached is the map with 2021 rabies outbreaks and passive surveillance (in Iasi county, passive surveillance increased a lot by collecting animals found dead, road killed and shot, especially because is one of counties exposed at the higher risk to rabies.) For 2021 were foreseen 1200 samples of foxes and jackals from passive surveillance and a number of 1600 samples was reached. Page: 14 ns, updated 2023/03/06 tted by the competent authorities ofRomaniain response to Report ref. DG(SANTE) 2021-7262 of rder toevaluate the implementation and effectiveness of the rabies eradication programme hority number of wild animals to be collected for passive st 2022: quir

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The epidemiological enquiries are generally weak and seldom establish the source of the disease. Consequently, the local authorities cannot trace the spread of disease between farms. These factors make it difficult to implement effective measures to tackle the spread of ASF.

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Medlemsstatens svar

their products, persons and The NSVFSA elaborated a Service Note no. 251 47/ 21.01.2022 o or from the locality as part (intranet 8350), which was submitted to all territorial SVFSD, containing in cases of suspected or additional instructions to those already existing on: extending the calculation of the possible monitoring period from the occurrence of ticle 8 (3) and (4) and Article disease suspicion in order to identify the probable origin of ASF, at 30- 40 days ; blood sampling for the determination of antibodies in order to nd associated findings 20, establish the possible period of infecting the commercial pig holding, after it has been confirmed with African swine fever (ASF); the check of the commercial pig holding infected with ASF, if it is part of a holding owning other commercial pig farms, slaughterhouses, etc., in order to detect possible epidemiological links regarding the movement of kept pigs, persons, products, vehicles and any other materials or means by which the pathogen may have spread during the relevant period before the suspicion notification or ASF confirmation; carrying out controls in establishments located on the same platform or around the commercial pi

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To evaluate whether relevant legal requirements and standards applicable to ASF have been implemented effectively;

The instructions define several factors that the authorities must take into account when determining the overall risk category of establishments. These include the size of the establishment; the quality of construction; the overall standard of biosecurity; the type of production; and compliance with veterinary and traceability requirements.

The frequency of official controls for each establishment is set according to its risk category: Risk category Inspection frequency Low 1 per year Medium 2 per year High 4 per year Most outbreaks occur 11. So far, the impact of this initiative has been limited. Indeed, most on low or medium risk of the outbreaks on commercial establishments during 2021 establishments occurred on premised in the low or medium risk categories. Out of the commercial establishments keeping more than 65 pigs, around 60 % are assigned a medium risk, and 20% a low or high risk respectively.

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This may be because: a. The risk factors the veterinary authorities use are incomplete. For example, they do not take account of weak points in the biosecurity systems of many commercial establishments: i. commercial links with other establishments (with pigs moving regularly between them without quarantine or post-arrival testing); ii. the direct sale of live pigs to non-professional holdings; iii. close proximity to other commercial establishments. 7 A review of the outbreak files during the audit showed that each of these factors might have played a role in the introduction of disease. b. The risk categorisation is inconsistent. The audit team noted several cases where the authorities at county level overlooked risk factors and assigned a lower risk category than was justified. 13. Veterinary officials also confirmed that the purpose of the official controls is to evaluate compliance with the legal requirements. It was beyond their competence to oblige business operators to put in place more sophisticated biosecurity systems than those that are established in the law. Official controls focus 14. Another factor that may limit the effectiveness of official on compliance with biosecurity controls is their potential to disqualify commercial legal requirements operators from receiving disease compensation. The Government Decision that lays down the disease compensation rules (see finding 43) may exclude from compensation any pig establishment that does not comply with biosecurity rules, or that has been "found by the competent authorities to have infringed the legislation in force". Although the legal interpretation of the latter exclusion is uncertain, the central competent authorities indicated that these exclusions could explain why official veterinarians might be reluctant to identify breaches of biosecurity rules during official controls. They agreed that disqualification from compensation would not be a proportionate penalty in many cases of non-compliance, which is contrary to Article 139 of Regulation (EU) 2017/625. 8

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iate structural and In conformity with the Service Note no . 25526/1 0.03.20 22 (intranet ishments where pigs are 8437), in March and April 20 22, the representatives of the 42 counties on (EU) 20I6/429. were assembled at the headquarters of the NSVFSA, in order to control nd associated findings 3, by survey the way of drawing up Biosecurity Plans for swine holdings. The training consisted in controlling by survey of the procedures as well as of the technological sketches included in the Biosecurity Plans, especially focusing on the following critical points existing at the level of any commercial pig holding: road disinfectant, locker filter, loading- unloading ramp for animals/feed, premises for the storage of by products not intended for human consumption (ABP), etc. Following the analysis of this information, technical conclusions, identified shortcomings and practical recommendations were sent to the territory by Service Note No 25778/07.04.2022 (intranet 8496), with the aim of updating the procedures and technological plans contained in the Biosecurity Plans for commercial pig holdings, as well as verifying their implementation "on the spot". The shortcomings found as a resul

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The Order of NSVFSA No 111/2008 of 16 December 2008 lays down rules for the registration of food businesses engaged in direct sale to final consumers, and supply of foodstuffs of animal origin and non-animal origin to other retail establishments. This Order was not notified to the Commission and Member States, contrary to what is required by Directive (EU) 2015/1535 of the European Parliament and of the Council. It lays down some relevant requirements: a. Article 2 defines direct supply of "small quantities" of raw milk to final consumers or other retail operators as up to 300 l/day for raw cow milk and up to 100 l/day for raw milk originating from other species; b. Article 7 permits the sale of that raw milk at events throughout the national territory; 3 c. Article 17 allows the direct sale of cheese up to 1 500 kg/week and of pasteurised milk/liquid dairy products up to 3 000 kg/week: types of dairy products shall be limited to a maximum of five (Annex I of this Order); d. Articles 3 and 18 establish that food business operators (FBOs) engaged in direct sale or supply of limited quantities to other retail businesses of raw milk or dairy products must be registered with the Cartography, Approval, Registration and IT Evidence Office at county level; e. Article 22 prescribes that such products must bear an identification marking of rectangular shape, bearing the words "produced in retail unit of type....", followed by the letters "VA" (meaning "retail"), the county code and the veterinary health and food safety registration number. The CCA reiterated that this mark also ensures the consumer that the manufacturing operator had been under official control: this qualifies the mark as a health marking, which shape is not defined for use by registered food operators by the EU legislation. Raw milk used in manufacture must comply with all quality and safety parameters laid down in the relevant legislation.

The Order of NSVFSA No 34 of 14 April 2008 lays down veterinary health and food safety rules for granting derogations to establishments producing foodstuffs with traditional characteristics. The order has not been notified through TRIS despite the fact that this notification is required under EU legislation. Derogations are possible for some requirements of Regulations (EC) No 852/2004 and (EC) No 853/2004 concerning floors, walls, ceilings, doors-windows-other openings, and measures and methods for cleaning and disinfecting rooms-equipment-tools. The County Sanitary Veterinary and Food Safety Directorates (CSVFSDs) are responsible for granting such derogations, having such businesses registered in a special register: each business has to be registered with the letters PT ("traditional product") followed by a unique registration number. None of the approved establishments have been currently granted such derogations.

National rules (Orders Nos 168/2014, 111/2008 and 34/2008) had provided national derogations for use of non-compliant raw cow milk, for direct sale of foodstuffs and for manufacture of traditional products. However, these have not been notified to the Commission and Member States, contrary to the provisions of Directive (EU) 2015/1535.

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The recruitment of almost 3,000 authorised veterinarians extends the veterinary authorities' capacity to monitor non-commercial (backyard) establishments. However, the lack of enforceable biosecurity requirements or limits on keeping breeding animals on these establishments means that they continue to play an active role in the persistence and circulation of disease.

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e In view of ensuring the legal competences for the application of biosecurity requirements in non-commercial swine holdings by official and authorized veterinarians, there has been elaborated the draft Emergency Ordinance on setting out the measures regarding pig breeding, in order to approve the Program for the surveillance, prevention and control of African swine fever in Romania, as well as for the amendment of some normative acts, which shall establish this recommendation by the provisions of art. IV and art. V of the draft Emergency Ordinance.

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The veterinary authorities do not have the full support and commitment of hunters or the hunting authorities to apply rigorously the measures needed to control the wild boar population and to eliminate the disease from affected meta-populations. As a result, these animals act as an important reservoir of disease, which can spill over into inadequately protected pig establishments.

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Medlemsstatens svar

n view of ensuring the legal competences necessary to implement the measures for the management of wild boar population and the surveillance d requirements (active, respectively passive) established in the African swine fever eradication plan for wild boars, approved by EU Decision no. 2018/1995, there has been elaborated the draft Emergency Ordinance on setting out the measures regarding pig breeding, in order to approve the Program for the surveillance, prevention and control of African swine fever in Romania, as well as for the amendment of some normative acts, the draft normative document creates the legal framework for the recommendation no. 2 such as the provisions of Chapter III, art.8-12, Chapter VII, art.19-20 and Chapter VIII , art. 24-25.

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The supervision and audit arrangements in place provide the veterinary authorities with reliable and up-to-date information on the completion of planned controls and activities. However, they do not systematically use this information to identify and tackle the issues that are impeding progress in tackling the disease. 9

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At the DGCO level, there was carried out an analysis of the results following the the performance of official controls on PPA regarding the compliance with the biosecurity conditions in the commercial breeding swine holdings, in conformity with N.S. 25300 / 18.02.2021. In conformity with the centralization and analysis of the data submitted by the territorial structures (county SVFSD), there resulted that, out of the total of 361 commercial swine holdings existing in Romania, 343 holdings were Page: 1 27 August 2021 dations of report ref. DG(SANTE) 2020-6971 of the audit carried out from23 November of animal health controls in relation to African swine fever lated at this time. For the ied a total of 39 main contravention sanctions, out of the total amount of 41,100 lei, nsion of the activity. e identified a series of non- e provided corrective action plans umber of 48 control actions. ts obtained during the official 020 and for the first 7 months of recommendations formulated 6971, it was considered cated by the NSVFSA,by the note no. 27085 / 09.10.2021 and uidelines that,the NSVFSAshall es (county SVFSD), there shall be of the procedures used in ity with the provisions of the (EU

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In the commercial holdings visited, the audit team noted the following: a. The majority of adult bovine animals had two ear tags, some had one ear tag and, in one holding, only one animal was without both ear tags. This animal, however, had an electronic collar allowing linking of the animal with the holding register. Moreover, the holding operator had already in his possession ear tag duplicates also for this cow. b. With respect to young calves, in one of the holdings, all the young calves had ear tags while in another at least 10 (out of approximately 200 bovine animals) had not. The operator stated that the calves would be tagged soon (new ear tags were available at the holding) and demonstrated how to link the untagged calves to their mothers using the numbers from the calves' pens and records from the holding birth register. c. The commercial holdings' operators and private practice veterinarians notified newborn calves, movements from or to other locations and deaths of animals; however, in one of the two holdings visited, not all of the newborn animals were notified regularly and in a timely fashion. 6

In the backyard holdings visited, authorised veterinarians met by the audit team were responsible for ear tagging of bovine animals and, if needed, on behalf of the animals' owners, for completing the relevant identification documents (animal passports and movement documents) and inserting data in SNIRA. The veterinarians met kept the stock of new ear tags and maintained identification documents. However, the audit team noted the following: a. Out of the five backyard holdings visited, only one had fully completed passports and a complete set of movement documents. In this case, the situation on the holding also matched up the information from SNIRA and both cows had ear tags. b. In another backyard holding, there were no animals even though SNIRA database indicated the presence of nine bovine animals. Seven passports were available and two were missing and no movement documents "to" and "from" the holding were available. Neither the family representative of the cattle owner (2) nor the authorised veterinarian providing services to this holding were aware of the location where the animals had been moved to. c. In two other backyard holdings, the owners stated that, on an annual basis, they slaughtered one to two animals for their own consumption. In one of these holdings, the information on a recently slaughtered animal had not yet been entered in SNIRA. On the other holding, the owner stated that he did not apply ear tags to animals that would be slaughtered for own consumption, and therefore did not register them at all. d. Another owner of one backyard holding had 67 bovine animals (kept in two herds). One of the herds comprised 28 bovine animals of different ages out of which 10 lacked both ear tags. The age of the non-identified animals varied between few months to three years. The owner could present only 38 passports for his 67 bovines. Most of these passports were issued just prior to the visit of the audit team. Information from SNIRA indicated that some of these animals still belonged to the previous owner. The holding owner explained that he had only recently purchased the animals and the transaction had not yet been entirely finalised. However, he could not present any other evidence (e.g., the purchase agreement) supporting the statement. The CSVFSD officials immediately undertook to investigate the situation. Situations recorded in points c) and d) above constitute non-compliances with Article 4a(1) of Regulation (EC) No 1760/2000 of the European Parliament and of the Council, which requires the owner to identify the bovine animals within a maximum of 20 days. 5.2.2 Official controls

The CSVFSDs have contracts with authorised veterinarians who carry out controls on animal identification and holdings registration. On a monthly basis, each CSVFSD verifies the reports of these controls submitted by the authorised veterinarians. The verification concerns at least 10% of the holdings submitted to the identification actions. The audit team noted that: a. The controls by authorised veterinarians take place regularly, every year and cover at least 3% of holdings in the counties. b. The controls on animal identification and holding registration by authorised veterinarians have a form of an inventory check, cross-checking all animals present in a holding (including bovines) with the status quo report from SNIRA generated prior to the visit. c. The authorised veterinarians inserted in SNIRA information on mismatches between the SNIRA status quo report and situation found at holdings, e.g., absence of animals recorded in SNIRA or presence of animals not mentioned in the SNIRA report. However, the mismatches identified at holdings have not been investigated further. Lack of adequate follow-up of non-compliances is contrary to Article 22 of Regulation (EC) No 1760/2000. 5.2.3 Bovine passports

While SNIRA is operational and available to all relevant users, the data available therein is incomplete for backyard holdings (retaining over 90% of the bovine population) in relation to the sub-populations relevant for the BSE monitoring and as such does not support the BSE monitoring and eradication system.

Official controls on identification and registration of bovine animals (inventory checks) are carried out as planned and are able to detect non-compliances, which are subsequently recorded in SNIRA. However, the lack of regular follow-up of these non-compliances weakens the effectiveness of official controls and in turn does not result in any improvement of the reliability of the national database, in particular, with respect to the absence of recorded movements of animals and of notification of newborn calves. 10

There is an increasing trend in the number of notified dead animals, indicating growing awareness of this obligation amongst the bovine animal owners; nonetheless, the mortality rate is still just above the half of the lowest expected.

Medlemsstatens svar

By NS no. 25996/7466 / 21.04.2020, the NSVFSA ordered the county SVFSD to carry out controls in holdings considered to be at high risk, providing as sampling criteria, the following types of holdings: . - Cattle farms where, there have been kept more than 10 heads that during the last 5 years have not reported any mortality (regardless of age); - Cattle holdings which, during the last two years have had at least one bovine animal for which, there has been registered the exit to the holding RO00000000000; - Holdings with bovines, where, there are females, older than 2.5 years, for which, during the last 3 years, there hasn't been registered any birth; Holdings where bovine mortality was registered in the NBD without being a bovine animal detected for ESB; - Cattle farms which, during the inspections carried out in previous years to check the cross-compliance, showed deficiencies on SMR 7 (identification and registration of bovine animals). Deadline for carrying out controls: during the entire validity period of the NS. In order to correctly manage the operation in the slaughterhouse holding register, through NS no. 25996/7466/21.04.2020, NSVFSA ordered the county SVFSD the following

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The analysis of the available data from GDFS, SNIRA and the Laboratory Information and Management System (LIMS) on the sub-population of bovine animals slaughtered as healthy and eligible for BSE testing shows that: a. The number of bovines slaughtered in slaughterhouses reported by GDFS is lower than bovines notified to SNIRA (see Tables 1 and 2). b. Almost all bovine animals sampled as healthy slaughtered originate from slaughterhouses, while the vast majority of these slaughtered outside slaughterhouses (at holdings) are not sampled (see Tables 2, 3 and 4). c. The number of animals slaughtered outside slaughterhouses (at holdings) and not sampled continuously grows (see Tables 5, 6 and 7). d. The number of animals sampled but not tested since 2016 has a declining trend and is rather marginal (0.04% in 2018) (see Table 7). 5.3.2 BSE monitoring in the sub-population of animals emergency slaughtered and found sick at ante mortem inspection

A proportion of bovine animals slaughtered as healthy and eligible for BSE testing remains not tested; these are mostly animals slaughtered at backyard holdings. Consequently, the data available cannot reliably demonstrate that testing in this sub- population has been effectively implemented.

Medlemsstatens svar

There has been drawn up a service note ordering the implementation of the following measures: - the formation, under the coordination of the deputy executive director, of a team with staff designated by decision of the executive director of the SCOSBA, SCOSA, , SCAÎEI and county LSVSA, in order to meet monthly and to cross-check the results of BSE/EST surveillance so that, there should not be any differences / discrepancies in reporting between the data held by each department, and where differences are detected, there should be provided measures to correct and remedy the identified non- conformities. -such a team shall be formed at the level of ANSVSA, with staff from animal health, food safety, official control, Page: 2 tions of report ref. DG(SANTE) 2019-6635 of the audit carried out from 16 September of the monitoring and eradication measures for bovine spongiform encephalopathy (BSE), ations from previous audits on BSE and animal by-products (ABP) Action Proposed by the competent authority identification and LNR-EST, for the identification of solutions to remedy the non-conformities identified in the report, as well as during the implementation of the program for the surveilla

Rekommendationen anger som grund

In September 2018, the only operator providing throughout the country a service for collection and disposal of ABP (all categories including fallen animals) got bankrupt and ceased its activity. Since then, and up to the date of the audit, there are no ABP processing plants in Romania authorised for collecting and processing ABP of Category (7) Follow-up on this recommendation covered also implementation of corrective measures to recommendation 2011-8950-5 requesting SRM produced as a result of home slaughtering of bovine animals, to be collected, transported and disposed of in compliance with requirements set out in Article 8(1) and Annex V to Regulation (EC) 999/2001. 21 1 and fallen animals. This situation resulted in a serious disturbance in the disposal of ABP originating not only from the husbandry sector but also from other sectors, namely the meat production, processing sector and the retail. Table 13 (see Appendix) presents detailed situation as regards the establishments processing ABP in the country at the time of this audit (8).

Overall, the system of collection and disposal of ABP, including of the fallen bovine animals from backyard holdings, has deteriorated since the previous audit. Therefore, recommendation 2 of audit report DG(SANCO)/2011-8941 remains unaddressed.

Medlemsstatens svar

There has been submitted a service note no. 7425 / ccordance 18.03.2020 by which, the following issues were provided: egulation - the elaboration of a control plan, based on a risk analysis, in the field of territory rendering of all units / operators sanitary veterinary approved / registered and its transmission to NSVFSA; - the carrying out of controls in conformity with the plan drawn up by semestrally reporting to NSVFSA; In conformity with the provisions of Order 16/2010, commercial livestock farms hold service contracts Page: 3 tions of report ref. DG(SANTE) 2019-6635 of the audit carried out from 16 September of the monitoring and eradication measures for bovine spongiform encephalopathy (BSE), ations from previous audits on BSE and animal by-products (ABP) ory rendering ccording to level of non- uested by to ely with the in order to contracts with rized / 9/2009. requesting ent to take well as for dividual ons / schemes t the rendering be discussed tutions 6.04.2020, tify ent to invest llection and g, of animal of

Rekommendationen anger som grund

From a preliminary analysis of the above national rules the audit team noted: The requirements of Regulation (EU) 2015/262, applicable since 1 January 2016, were implemented from 14 August 2017 when Order No 248/79/2017 was enacted. According to the national legislation in place prior to 14 August 2017, the authorities could release only duplicate passports when the equines were identified after the deadline established in the Regulation. This situation was not in line with Article 32(1)(b) of Regulation (EU) 2015/262 which lays down the requirement on the issuing body to issue replacement passports, which exclude permanently the animal from the food chain, in case of late identification. Since 14 August 2017 all types of equine passports (including replacement ones) can and are issued. ANZ explained that it is not possible to substitute the duplicate passports, issued during the above reported period by replacement ones because the national rules: a) cannot be applied retroactively and b) do not allow for charging citizens twice for the same administrative procedure (these types of passports are subject to fees).

National legislation/instructions for implementing EU legislation concerning the areas covered by the audit are in place. However, due to the delay in implementing 3 Regulation (EU) 2015/262, horses that should have been permanently excluded from the food chain, were not. No procedures are currently envisaged by the CCA to replace duplicate passports by replacement ones, resulting in ineligible horses continuing to enter into the meat production chain for human consumption.

The audit team noted that the information in SIIE is not up-to-date and/or reliable, mainly due to the delay in implementing the requirements of Regulation (EU) 2015/262 (see paragraph 2). ANZ stated that it is difficult to keep the database updated because the input should come from other actors (e.g. the owners/keepers, veterinarians) and if they do not notify changes in the status of the animals and/or record them in the database the SIIE cannot be updated. In fact, they know that some horses that, given their age, should be dead are still registered as alive in the system because the owners did not notify the death. An example was also mentioned of 23 horses that were slaughtered but were still alive in the database. ANZ explained that the slaughterhouse did not notify the slaughter of the animals and now, no further actions can be taken because the establishment was closed and nobody is in a position to provide this notification. Movement controls

The central database for equine identification contains all the information required under EU rules. However, the information it contains is not complete, not up-to-date and thus not entirely reliable. 5.4.2 Official tasks at establishment level (2) Organisation of official controls

Medlemsstatens svar

Se va organiza un grup de lucru cu A working group will be organized with reprezentani ai Ministerului Agriculturii i representatives of the Ministry of Agriculture and Dezvoltrii Rurale, Autoritatea Naional Rural Development, the National Phytosanitary Fitosanitar, Ministerului Mediului, Apelor i Authority, the Ministry for the Environment, Waters Pdurilor, Ministerului Sntii, Academiei de and Forestry, the Ministry of Health, the Academy tiine Agricole i Silvice "Gheorghe Ionescu- for Agricultural and Forest Sciences "Gheorghe ieti", Institutul Naional de Statistic .a. în Ionescu-ieti", the National Institute of Statistics scopul implementrii cerinelor articolului 15 and others for the purpose of implementing the (2) (b) i (c) din Directiva 2009/128/CE a requirements of Article 15 (2) (b) and (c) of Parlamentului European i a Consiliului de Directive 2009/128 / EC of the European Parliament stabilire a unui cadru de aciune comunitar în and of the Council establishing a framework for vederea utilizrii durabile a pesticidelor. Community action to achieve the sustainable use of Se vor identifica tendinele în ceea ce privete pesticides. utilizarea anumitor substane active, substane T

A working group will be organized with representatives of the Ministry of Agriculture and Rural Development, the National Phytosanitary Authority, the Ministry for the Environment, Waters and Forestry, the Ministry of Health, the Academy for Agricultural and Forest Sciences "Gheorghe Ionescu-ieti", the National Institute of Statistics and others for the purpose of implementing the requirements of Article 15 (2) (b) and (c) of Directive 2009/128 / EC of the European Parliament and of the Council establishing a framework for Community action to achieve the sustainable use of pesticides. Trends in the use of certain active substances, "substance of concern" as defined in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, will be identified. Page: 1 tions, received 7 August 2020 ania in response to Report ref. DG(SANTE) 2019-6891 of the audit carried out from 15 October tation of measures to achieve the sustainable use of pesticides ion Proposed by the competent authority nt protection products containing certain ive substances will be identified. ority items or good practices will be ntified as

A working group will be organized with representatives of the Ministry of Agriculture and Rural Development, the National Phytosanitary Authority, the Ministry for the Environment, Waters and Forestry, the Ministry of Health, the Academy for Agricultural and Forest Sciences "Gheorghe Ionescu-ieti", the National Institute of Statistics and others for the purpose of implementing the requirements of Article 15 (2) (b) and (c) of Directive 2009/128 / EC of the European Parliament and of the Council establishing a framework for Community action to achieve the sustainable use of pesticides. Trends in the use of certain active substances, "substance of concern" as defined in Regulation (EC) No 1107/2009 of the European Parliament and of the Council Page: 1 recommendations received 12 January 2021 ted by the competent authorities of Romania in response to Report ref. DG(SANTE) 2019-6891 of 2019 in order to evaluate the implementation of measures to achieve the sustainable use of ion Proposed by the competent authority cerning the placing of plant protection ducts on the market, will be identified. nt protection products containing certain ive substances will be identified. ority items or g

Medlemsstatens svar

Se va organiza un grup de lucru cu A working group will be organized with Page: 1 's recommendations received 27 May 2020 ania to the recommendations of report ref. DG(SANTE) 2019-6891 of the audit carried out from 15 October the implementation of measures to achieve the sustainable use of pesticides ion Proposed by the competent authority prezentani ai Ministerului Agriculturii i representatives of the Ministry of Agriculture and d Dezvoltrii Rurale, Autoritatea Naional Rural Development, the National Phytosanitary tosanitar, Ministerului Mediului, Apelor i Authority, the Ministry for the Environment, Waters rilor, Ministerului Sntii, Academiei de and Forestry, the Ministry of Health, the Academy ne Agricole i Silvice "Gheorghe Ionescu- forAgricultural and Forest Sciences "Gheorghe i", Institutul Naional de Statistic .a. în Ionescu-ieti", the National Institute of Statistics pul implementrii cerinelor recomandrii and others in order to implement the requirements of 2. recommendation No. 2. va lua în considerare stabilirea unor Consideration will be given to the establishment of icatori naionali, cantitativi referitori la national quantitative indicators for active substances stane

orking group will be organized with resentatives of the Ministry of Agriculture Rural Development, the National tosanitary Authority, the Ministry for the ironment, Waters and Forestry, the istry of Health, the Academy Agricultural and Forest Sciences eorghe Ionescu-ieti", the National titute of Statistics and others in order to lement the requirements of ommendation No. 2. sideration will be given to the ablishment of national quantitative icators for active substances of particular cern identified in accordance with Article (2) (c) taking into account the data Page: 2 tions, received 7 August 2020 ania in response to Report ref. DG(SANTE) 2019-6891 of the audit carried out from 15 October tation of measures to achieve the sustainable use of pesticides Action Proposed by the competent authority obtained from official controls, which will be included in Measure 3, Specific objective 3 of the current National Action Plan on reducing risks associated with the use of plant protection products. Deadline: end of the first quarter of 2021

orking group will be organized with resentatives of the Ministry of Agriculture Rural Development, the National tosanitary Authority, the Ministry for the ironment, Waters and Forestry, the istry of Health, the Academy Agricultural and Forest Sciences eorghe Ionescu-ieti", the National titute of Statistics and others in order to lement the requirements of ommendation No. 2. Page: 2 recommendations received 12 January 2021 ted by the competent authorities of Romania in response to Report ref. DG(SANTE) 2019-6891 of 2019 in order to evaluate the implementation of measures to achieve the sustainable use of Action Proposed by the competent authority Consideration will be given to the establishment of national quantitative indicators for active substances of particular concern identified in accordance with Article 15 (2) (c) taking into account the data obtained from official controls, which will be included in Measure 3, Specific objective 3 of the current National Action Plan on reducing risks associated with the use of plant protection products. Deadline: end of the first quarter of 2021

Medlemsstatens svar

temul de instruire este creat i se va demara The training system is created and the initial training s instruirea iniial a utilizatorilor profesioniti, of all professional users, distributors and advisors tribuitorilor i consilierilor, cu prioritate a will be started, with priority of professional users lizatorilor profesioniti i distribuitorilor and distributors who have been previously certified e au fost certificai anterior conform according to the national legislation prior to islaiei naionale anterioare Directivei Directive 2009/128 / EC. 9/128/EC. Page: 2 's recommendations received 27 May 2020 ania to the recommendations of report ref. DG(SANTE) 2019-6891 of the audit carried out from 15 October the implementation of measures to achieve the sustainable use of pesticides Action Proposed by the competent authority

e training system is created and the initial training of all professional users, distributors and advisors will be started, with priority of professional users and distributors who have been previously certified according to the national legislation prior to Directive 2009/128 / EC. Deadline for when starting the training: fourth quarter of 2020 Deadline for when all operators will have had the opportunity to receive initial training: second quarter of 2024

e training system is created and the initial training of all professional users, distributors and advisors will be started, with priority of professional users and distributors who have been previously certified according to the national legislation prior to Directive 2009/128 / EC. Page: 3 recommendations received 12 January 2021 ted by the competent authorities of Romania in response to Report ref. DG(SANTE) 2019-6891 of 2019 in order to evaluate the implementation of measures to achieve the sustainable use of Action Proposed by the competent authority Additional information received from the CA on 07/08/2020: Deadline for when starting the training: fourth quarter of 2020 Deadline for when all operators will have had the opportunity to receive initial training: second quarter of 2024 The deadline for when all operators will have the opportunity to receive initial training is rectified with the fourth quarter of 2023.

Medlemsstatens svar

for În legislaia actualizat se va reglementa The updated legislation will regulate the marketing omercializarea produselor de protecie a of plant protection products for professional use only plantelor pentru uz profesional numai ctre to persons holding the certificate referred to in e persoanele care dein certificatul menionat la Article 5 (2) of Directive 2009/128 / EC. articolul 5 (2) din Directiva 2009/128/EC. Termen de realizare: trimestrul II anul 2021 Deadline: second quarter 2021

The updated legislation will regulate the marketing of plant protection products for professional use only to persons holding the Page: 3 tions, received 7 August 2020 ania in response to Report ref. DG(SANTE) 2019-6891 of the audit carried out from 15 October tation of measures to achieve the sustainable use of pesticides Action Proposed by the competent authority rtificate referred to in Article 5 (2) of Directive 2009/128 / EC. Deadline: second quarter 2021

The updated legislation will regulate the marketing of plant protection products for professional use only to persons holding the certificate referred to in Article 5 (2) of Directive 2009/128 / EC. Deadline: second quarter 2021 The deadline for when operators will have the opportunity to receive initial training: fourth quarter of 2023. Page: 4 recommendations received 12 January 2021 ted by the competent authorities of Romania in response to Report ref. DG(SANTE) 2019-6891 of 2019 in order to evaluate the implementation of measures to achieve the sustainable use of Action Proposed by the competent authority

Medlemsstatens svar

Adoptarea proiectului de HOTRÂRE privind Adoption of the draft DECISION on the înfiinarea i funcionarea Registrului naional establishment and operation of the National Register e informare toxicologic. of Toxicological Information.

in Adoption of the draft DECISION on the establishment and operation of the National Register of Toxicological Information. cording to the answer received from the Ministry of Health, the draft Government Decision on the establishment and functioning of the National Register of Toxicological Information is being inter- ministerial approved.

in Adoption of the draft DECISION on the establishment and operation of the National Register of Toxicological Information. Additional information received from the CA on 07/08/2020 According to the answer received from the Ministry of Health, the draft Government Decision on the establishment and functioning of the National Register of Toxicological Information is being inter- ministerial approved. The Ministry of Health communicated that the draft of Decision on the establishment and operation of the National Register of Toxicological Information is under inter- ministerial approval .

Medlemsstatens svar

Achiziia a 6 centre mobile nu s-a finalizat în The acquisition of 6 mobile centers was not decembrie 2019 deoarece ofertantul nu a completed in December 2019 because the bidder did respectat contractul de achiziie conform not comply with the procurement contract according d legislaiei naionale. to national legislation. ntru anul 2020, Ministerul Agriculturii i For 2020, the Ministry of Agriculture and Rural Dezvoltrii Rurale a alocat din nou suma Development has again allocated the necessary necesar achiziiei celor 6 centre mobile care a amount for the acquisition of the 6 mobile centers fost anulat in martie 2020, datorit which was canceled in March 2020, due to the non- neparticiprii ofertanilor. Procedura a fost participation of bidders. The procedure was resumed reluat în luna mai. in May. Actualizarea inventarului echipamentelor de Updating the inventory of PAE for professional use. Page: 3 's recommendations received 27 May 2020 ania to the recommendations of report ref. DG(SANTE) 2019-6891 of the audit carried out from 15 October the implementation of measures to achieve the sustainable use of pesticides ction Proposed by the competent authority plicare a produselor de prote

he acquisition of 6 mobile centers was not completed in December 2019 because the bidder did not comply with the procurement contract according to national legislation. For 2020, the Ministry of Agriculture and Rural Development has again allocated the necessary amount for the acquisition of the 6 mobile centres which was cancelled in March 2020, due to the non-participation of bidders. The procedure was resumed in May. Page: 4 tions, received 7 August 2020 ania in response to Report ref. DG(SANTE) 2019-6891 of the audit carried out from 15 October tation of measures to achieve the sustainable use of pesticides uthority on the r ted). ers about cal checks ipment. on to check of plant al use at the paign, as ut by and user 352 / 2015). thority set the use of r sustainable ssional user if nical tions, received 7 August 2020 ania in response to Report ref. DG(SANTE) 2019-6891 of the audit carried out from 15 October tation of measures to achieve the sustainable use of pesticides Action Proposed by the competent authority controls and calibrations of the equipment for the application of plant protection products. Deadline: second quarter 2021 Deadline for when will start the testing of

he acquisition of 6 mobile centers was not completed in December 2019 because the bidder did not comply with the procurement contract according to national legislation. For 2020, the Ministry of Agriculture and Rural Page: 5 recommendations received 12 January 2021 ted by the competent authorities of Romania in response to Report ref. DG(SANTE) 2019-6891 of 2019 in order to evaluate the implementation of measures to achieve the sustainable use of oposed by the competent authority nt has again allocated the amount for the acquisition of the 6 ntres which was cancelled in March to the non-participation of bidders. dure was resumed in May. the inventory of PAE for nal use. lishment of the database on the of inspections of PAE for nal use (admitted / rejected). to inform professional users about ation to carry out technical checks ration of application equipment. , users have the obligation to check ment for the application of plant n products for professional use at the of each agricultural campaign, as efore carrying out each tary treatment, carried out by recommendations received 12 January 2021 ted by the competent authorities of Romania in response to Report ref. DG(SANTE) 2019-68

Medlemsstatens svar

nformarea operatorilor care dein echipamente Inform operators holding handheld and knapsack e aplicare a produselor de protecie a plantelor PAE of the need to change accessories regularly and ortabile i de spate cu privire la necesitatea of specific risks linked to the equipment. Page: 4 's recommendations received 27 May 2020 ania to the recommendations of report ref. DG(SANTE) 2019-6891 of the audit carried out from 15 October the implementation of measures to achieve the sustainable use of pesticides Action Proposed by the competent authority National Phytosanitary Authority will elaborate a training note that will be sent to the operators who and schimbrii regulate a accesoriilor i a riscurilor use this equipment. e specifice legate de echipament. The implementation of the training referred to in ANF va elabora o not de instruire care va fi Article 8 (3) (b) shall be achieved through the start transmis la operatorii care utilizeaz aceste of the training and certification system. echipamente. Punerea în aplicare a instruirii precizate la articolul 8(3) (b) se va realiza prin demararea sistemului de instruire i certificare. Termen de realizare: trimestrul IV anul 2020 Deadline: f

rm operators holding handheld and knapsack PAE of the need to change accessories regularly and of specific risks linked to the equipment. National Phytosanitary Authority will elaborate a training note that will be sent to the operators who use this equipment. The implementation of the training referred to in Article 8 (3) (b) shall be achieved through the start of the training and certification system. Deadline: fourth quarter of 2020 Page: 6 tions, received 7 August 2020 ania in response to Report ref. DG(SANTE) 2019-6891 of the audit carried out from 15 October tation of measures to achieve the sustainable use of pesticides Action Proposed by the competent authority

nform operators holding handheld and knapsack PAE of the need to change accessories regularly and of specific risks linked to the equipment. f National Phytosanitary Authority will elaborate a training note that will be sent to the operators who use this equipment. The implementation of the training referred to in Article 8 (3) (b) shall be achieved through the start of the training and certification system. Deadline: fourth quarter 2020. National Phytosanitary Authority elaborated the training note and sent it to the county phytosanitary offices in order to communicate the note to the operators of these equipments. The deadline for when operators of these equipments will have the opportunity to receive the training according to art. 8 (3) (b) is rectified with fourth quarter of 2023. Page: 8 recommendations received 12 January 2021 ted by the competent authorities of Romania in response to Report ref. DG(SANTE) 2019-6891 of 2019 in order to evaluate the implementation of measures to achieve the sustainable use of ction Proposed by the competent authority

Medlemsstatens svar

he Autoritatea Naional Fitosanitar actualizeaz The National Phytosanitary Authority shall procedura de pulverizare aerian, conform update the aerial spraying procedure, in observaiilor misiunii de audit, accordance with the observations of the audit pentru punerea în aplicare a punctelor a), b) i c) mission,for the implementation of points a), b) ale recomandrii nr. 8. and c) of recommendation No. 8. Punerea în aplicare a punctului a) se va realiza The implementation of point a) will be achieved prin demararea sistemului de instruire i by starting the training and certification system. certificare. l th ive Page: 5 's recommendations received 27 May 2020 ania to the recommendations of report ref. DG(SANTE) 2019-6891 of the audit carried out from 15 October the implementation of measures to achieve the sustainable use of pesticides Action Proposed by the competent authority Deadline: fourth quarter 2020 Termen de realizare: trimestrul IV anul 2020 The National Phytosanitary Authority verifies the compliance of the legislative provisions in the

ng The National Phytosanitary Authority shall update the aerial spraying procedure, in accordance with the observations of the audit mission, for the implementation of points a), b) and c) of recommendation No. 8. The implementation of point a) will be achieved by starting the training and certification system. Deadline: fourth quarter of 2020

The National Phytosanitary Authority shall date the aerial spraying procedure, in ccordance with the observations of the audit ission, for the implementation of points a), ) and c) of recommendation No. 8. he implementation of point a) will be chieved by starting the training and ertification system. eadline: fourth quarter 2020 egarding point a) we mention that the ranting of an authorization will be issued nly if the applicant holds a training ertificate in accordance with the requirement f art. 5 of Directive 2009/128/EC.

Medlemsstatens svar

Autoritatea Naional Fitosanitar verific phytosanitary field regarding the prohibition of of respectarea prevederilor legislative din domeniul phytosanitary treatments with prohibited products re fitosanitar privind interzicerea efecturii de in water protection areas , sanitary and ecological ted tratamente fitosanitare cu produse interzise în protection areas, as well as in other protected zonele de protecie a apelor, de protecie sanitar areas, including by checking the SMR 10 cross- i ecologic, precum i în alte zone protejate, compliance rules, concerning the placing of plant inclusiv prin verificarea normelor de protection products on the market. ecocondiionalitate SMR 10 -Introducerea pe pia a produselor de protecte a plantelor. Ministerul Agriculturii i Dezvoltrii Rurale prin The Ministry of Agriculture and Rural

The Ministry of Agriculture and Rural Development through the National Phytosanitary Authority verifies the documents on the recovery of pesticide packaging by professional users and providers of phytosanitary services to suppliers of products, as well as remnants. Update of phytosanitary legislation on the recovery of pesticide packaging. Page: 7 tions, received 7 August 2020 ania in response to Report ref. DG(SANTE) 2019-6891 of the audit carried out from 15 October tation of measures to achieve the sustainable use of pesticides on Proposed by the competent authority National Environmental Guard has ection and control attributions, in rdance with Article 13 of Emergency nance No. 34/2012 for establishing the itutional framework for action for the ainable use of pesticides in Romania. his context, NEG organizes annually, atic control actions at economic ators working in the field of pesticides plant protection products, to verify liance with the requirements of storage, ling, dilution of pesticide mixture before handling of packaging and waste icides, removal of mixtures from the tank r application, cleaning of equipment used the application of pesticides, recovery or osal of pest

Ministry of Agriculture and Rural opment through the National osanitary Authority verifies the age: 9 recommendations received 12 January 2021 ted by the competent authorities of Romania in response to Report ref. DG(SANTE) 2019-6891 of 2019 in order to evaluate the implementation of measures to achieve the sustainable use of roposed by the competent authority s on the recovery of pesticide ging by professional users and s of phytosanitary services to s of products, as well as remnants. f phytosanitary legislation on the of pesticide packaging. onal Environmental Guard has on and control attributions, in ce with Article 13 of Emergency e No. 34/2012 for establishing the ional framework for action for the ble use of pesticides in Romania. context, NEG organizes annually, control actions at economic s working in the field of pesticides t protection products, to verify ce with the requirements of storage, , dilution of pesticide mixture before dling of packaging and waste es, removal of mixtures from the tank plication, cleaning of equipment used recommendations received 12 January 2021 ted by the competent authorities of Romania in response to Report ref. DG(SANTE) 2019-6891 of 2019

Medlemsstatens svar

Autoritatea Naional Fitosanitar va întocmi lista Development through the National Phytosanitary produselor de protecie a plantelor care pot fi Authority will draw up the list of plant protection lizate în aceste zone, care va fi aprobat de products that can be used in these areas, which Comisia Naional de Omologare a Produselor de will be approved by the National Commission for rotecie a Plantelor. Approval of Plant Protection Products. Este elaborat un proiect de ordin comuna al A joint draft order of Ministry of Agriculture and MADR prin ANF, MS, cu privire la îndeplinirea Rural Development is elaborated through msurii 2 din HG nr. 135/2019, care st la baza National Phytosanitary Authority and Ministry of realizrii msurii 1 din HG nr. 135/2019, privind Health, regarding the fulfillment of Measure 2 of zonele utilizate de public sau grupuri vulnerabile. Government Decision No 135/2019approving the NATIONAL ACTION PLAN of 12 March 2019 on reducing risks associated with the use of plant protection products , which is the basis for the implementation of Measure 1 of the same normative act, regarding the areas used by the general public or by vulnerable groups. Page: 6 's recommendati

Ministry of Agriculture and Rural lopment through the National Phytosanitary Authority will inform the professional users regarding the observance : 8 tions, received 7 August 2020 ania in response to Report ref. DG(SANTE) 2019-6891 of the audit carried out from 15 October tation of measures to achieve the sustainable use of pesticides Action Proposed by the competent authority f the general principles of integrated pest agement. The Ministry of Agriculture and Rural Development through the National Phytosanitary Authority monitors the harmful organisms to agricultural crops and the issuance of pest forecasting/ warning bulletins. The Ministry of Agriculture and Rural velopment through the National Phytosanitary Authority will identify Advisory services on integrated pest management. Deadline: second quarter 2021. The Ministry of Agriculture and Rural Development through the National Phytosanitary Authority will develop the Pest forecasting and warning system. Deadline: second quarter 2023

he Ministry of Agriculture and Rural evelopment through the National hytosanitary Authority will inform the rofessional users regarding the observance f the general principles of integrated pest anagement. he Ministry of Agriculture and Rural evelopment through the National osanitary Authority monitors the armful organisms to agricultural crops and e issuance of pest forecasting/ warning ulletins. Page: 11 recommendations received 12 January 2021 ted by the competent authorities of Romania in response to Report ref. DG(SANTE) 2019-6891 of 2019 in order to evaluate the implementation of measures to achieve the sustainable use of ion Proposed by the competent authority Ministry of Agriculture and Rural elopment through the National tosanitary Authority will identify isory services on integrated pest agement. dline: second quarter 2021. Ministry of Agriculture and Rural elopment through the National tosanitary Authority will develop the Pest ecasting and warning system. Deadline: ond quarter 2023

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nisterul Agriculturii i Dezvoltrii Rurale prin The Ministry of Agriculture and Rural toritatea Naional Fitosanitar verific Development through the National Phytosanitary cumentele privind recuperarea ambalajelor Authority verifies the documents on the recovery provenite de la produsele de protecie a plantelor of pesticide packaging by professional users and la utilizatorii profesioniti i prestatorii de providers of phytosanitary services to suppliers of rvicii fitosanitare ctre furnizorii produselor, products, as well as remnants. ecum i a resturilor de produse de protecie a Update of phytosanitary legislation on the antelor. recovery of pesticide packaging. tualizarea legislaiei din domeniul fitosanitar ivind recuperarea ambalajelor provenite de la The National Environmental Guard has inspection odusele de protecie a plantelor. and control attributions, in accordance with Article 13 of Emergency Ordinance No. 34/2012 rda Naional de Mediu are atribuii de for establishing the institutional framework for specie i control, în conformitate cu art. 13 din action for the sustainable use of pesticides in G nr. 34/2012. Romania. acest context, GNM organizeaz, anual, aciuni In this context,

agricultural system of advisory services ill be implemented for beneficiaries that take account of requirements of Article 12(2)(e) of Regulation (EU) No 1306/2013. Page: 9 tions, received 7 August 2020 ania in response to Report ref. DG(SANTE) 2019-6891 of the audit carried out from 15 October tation of measures to achieve the sustainable use of pesticides Action Proposed by the competent authority Deadline: second quarter of 2021

ecommendation was not included in the ginal Action Plan in error. ormation received from the CA on 08/2020 Page: 12 recommendations received 12 January 2021 ted by the competent authorities of Romania in response to Report ref. DG(SANTE) 2019-6891 of 2019 in order to evaluate the implementation of measures to achieve the sustainable use of ion Proposed by the competent authority agricultural system of advisory services l be implemented for beneficiaries that l take account of requirements of Article 2)(e) of Regulation (EU) No 1306/2013. dline: second quarter of 2021

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Ministerul Agriculturii i Dezvoltrii Rurale a) The Ministry of Agriculture and Rural prin Autoritatea Naional Fitosanitar va informa Development through the National Phytosanitary ilizatorii profesioniti privind respectarea Authority will inform the professional users rincipiilor generale de gestionare integrat a regarding the observance of the general principles ganismelor duntoare; of integrated pest management. b) Ministerul Agriculturii i Dezvoltrii Rurale b) The Ministry of Agriculture and Rural prin Autoritatea Naional Fitosanitar Development through the National Phytosanitary nitorizeaz organismele duntoare culturilor Authority monitors the harmful organisms to agricole i emiterea buletinelor de prognoz i agricultural crops and the issuance of pest ertizare. forecasting/ warning bulletins. inisterul Agriculturii i Dezvoltrii Rurale prin The Ministry of Agriculture and Rural toritatea Naional Fitosanitar va identifica Development through the National Phytosanitary erviciile de consultan privind gestionarea Authority will identify Advisory services on al integrat a organsimelor duntoare. integrated pest management. rmen de realizare: trimestrul II anul 2021 Deadline: second qu

The Ministry of Agriculture and Rural Development through the National Phytosanitary Authority will verify the implementation of Annex III to Directive 2009/128 / EC by phytosanitary inspectors and continues to collect information on the implementation of integrated pest management by professional users based on a questionnaire assumed by them. Deadline: second quarter 2021

Ministry of Agriculture and Rural elopment through the National tosanitary Authority will verify the lementation of Annex III to Directive 9/128 / EC by phytosanitary inspectors continues to collect information on the lementation of integrated pest agement by professional users based on a stionnaire assumed by them. dline: second quarter 2021

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The documented procedure for the inspection of a livestock vessel prior to approval is substantially a checklist which is part of Order 16/2010. This checklist covers all points included under Section 1 of Chapter IV of Annex I to the Regulation, with the exception of drainage systems (Point 5).

The documented procedure for the inspection of a livestock vessel prior to loading animals is substantially in the form of another checklist: As already described in report 2015/7425, this checklist includes instructions to calculate and record the minimum required quantities of water and feed and available stocking density on board the vessel in order to verify compliance with these three requirements (see also paragraph 27). This checklist was last modified after July 2018 in response to the follow-up action by the Commission's auditing services on a vessel which was seen during the audit to Slovenia to evaluate animal welfare during transport to non-EU countries (report DG(SANTE)2018-6449, hereafter "report 2018/6449"). That vessel had also operated through Romanian ports prior to the audit to Slovenia. As indicated in report 2018/6449, that vessel was deficient regarding several provisions of Section 1 of Chapter IV of Annex I to the Regulation. The Commission services had pointed out that the checklist used by the Romanian competent authorities did not include points on drainage, lighting, or alarm systems. This checklist now covers all points required by Article 20 and Section 1 of Chapter IV of Annex I to the Regulation with the exception of drainage systems. 3

There is no documentary guidance or instructions explaining how to verify compliance with specific technical requirements which are not of a veterinary nature, e.g. ventilation capacity, functioning of emergency systems, and water and drainage pumps.

ANSVSA is drafting a checklist for the inspection of vehicles arriving at the port. This document has not been finalised yet.

Port inspectors are aware of the official controls they are required to do, but the absence of any records for these checks and for any subsequent action that might have been taken does not make it possible to verify whether they were in fact performed, their quality or 5 effectiveness.

CSVFSD official veterinarians are responsible for inspecting and approving livestock vessels. Procedures require that the transporter applying for the approval of a vessel submits all "relevant documents": The official veterinarians were not sure what "relevant documents" they had to collect in order to verify compliance with each of the technical requirements of Section 1 of Chapter IV of Annex I to the Regulation. There is no guidance or pre- established list explaining what should be included in the "relevant documents". Only one of the application files reviewed by the audit team had supporting documents for all the technical requirements indicated in Section 1 of Chapter IV of Annex I to the Regulation. This vessel had previously been authorised to transport animals by a non-EU country which has similar animal welfare standards. 6 All application files had deck plans, and water and drainage circuit plans. The official veterinarians used the deck plans to calculate the maximum surface area available to load animals in each deck (Chapter VII of Annex I to the Regulation). Only one of the application files reviewed by the audit team included the certification of the ventilation capacity for the entire ventilation system. In one application file there was no accompanying documentation certifying the air exchanges supplied by the ventilation systems. In another application file this certification was provided for only two of the ventilation fans.

Procedures for the approval of livestock vessels do not explain how to verify compliance with the specific technical requirements of the vessel, in particular ventilation, drainage and watering systems: All approval records indicated that the vessel had been checked for, and complied with, the minimum air changes per hour of forced ventilation systems in each deck, as required by Point 2 of Section 1 of Chapter IV of Annex I to the Regulation. There was however no documentation to support this decision. The official veterinarians could not explain how they calculated the ventilation capacity on each deck without this documentation. All approval records indicated that the vessel had been checked for, and complied with, the requirement of Point 4 of Section 1 of Chapter IV of Annex I to the Regulation, namely that the freshwater system was capable of continuously supplying water to the animals on each deck and that alternative pumping equipment was available. In each file the supporting documentation available was plans of the water circuit. The official veterinarians however could not properly read these plans (one-way valves, backup generators) nor explain how the watering system was structured and how it worked. Although the approval checklist does not cover the requirements for drainage systems (see also paragraph 2), the official veterinarians indicated that they nonetheless carry out this check against Point 5 of Section 1 of Chapter IV of Annex I to the Regulation, i.e. that the drainage system was of appropriate capacity to drain fluids from the pens, that wells or tanks from where sewage is discharged were equipped with pumps or ejectors and that alternative pumping equipment was available. However they could not properly read the plans of the drainage circuits (one-way valves, wells and tanks, pumps and backup pumps) nor explain how the drainage system was structured and how it worked. The official veterinarians acknowledged that they do not have the technical competence to verify most of these requirements. 7

Port inspectors inspect vessels prior to loading animals. Procedures for this control, to verify that the equipment referred to in Chapter IV of Annex I to the Regulation is in good working order, do not provide the port inspectors with guidance on how to physically carry out these controls (e.g. how to verify that drainage tanks from where sewage is discharged are functioning properly).

All pre-loading checklists seen by the audit team indicated that the vessels inspected complied with the requirements of Section 1 of Chapter IV of Annex I to the Regulation, with the exception of the missing check for drainage systems (see also paragraph 1). The port inspectors were however unable to explain how they verify that certain systems and the relevant equipment (forced ventilation systems, drainage systems and pumps, alarms, back-up generators, etc.) are in good working order.

The insufficient information and instructions for port inspectors together with the absence of suitably qualified staff for assessing technical requirements for livestock vessels translates into a poor evaluation of technical requirements (such as air changes per hour on each deck of a livestock vessel, and the equipment used for watering and drainage systems on board a livestock vessel) during the approval and inspection before 8 loading. Therefore, official controls do no contribute to minimise the animal welfare risk linked to facilities and equipment.

Procedures include the relevant legal requirements but do not provide instructions for CSVFSD official veterinarians and port inspectors on how to verify these requirements as part of a practical inspection of a livestock vessel. Inspections of livestock vessels are therefore dependant on the experience of the inspectors, but not all requirements are adequately verified, which could have major implications for animal welfare during sea journeys.

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There is no documentary guidance or instructions explaining how to verify compliance with specific technical requirements which are not of a veterinary nature, e.g. ventilation capacity, functioning of emergency systems, and water and drainage pumps.

ANSVSA has drafted a new order to improve the system for the approval of livestock vessels. Under this draft order, livestock vessels will be inspected by veterinary and maritime safety authorities and will be approved for maximum three years instead of the current five. A draft cooperation protocol has also been prepared. The intention to establish such a protocol had already been initiated four years ago, and has been mentioned in report 2015/7425.

CSVFSD official veterinarians are responsible for inspecting and approving livestock vessels. Procedures require that the transporter applying for the approval of a vessel submits all "relevant documents": The official veterinarians were not sure what "relevant documents" they had to collect in order to verify compliance with each of the technical requirements of Section 1 of Chapter IV of Annex I to the Regulation. There is no guidance or pre- established list explaining what should be included in the "relevant documents". Only one of the application files reviewed by the audit team had supporting documents for all the technical requirements indicated in Section 1 of Chapter IV of Annex I to the Regulation. This vessel had previously been authorised to transport animals by a non-EU country which has similar animal welfare standards. 6 All application files had deck plans, and water and drainage circuit plans. The official veterinarians used the deck plans to calculate the maximum surface area available to load animals in each deck (Chapter VII of Annex I to the Regulation). Only one of the application files reviewed by the audit team included the certification of the ventilation capacity for the entire ventilation system. In one application file there was no accompanying documentation certifying the air exchanges supplied by the ventilation systems. In another application file this certification was provided for only two of the ventilation fans.

Procedures for the approval of livestock vessels do not explain how to verify compliance with the specific technical requirements of the vessel, in particular ventilation, drainage and watering systems: All approval records indicated that the vessel had been checked for, and complied with, the minimum air changes per hour of forced ventilation systems in each deck, as required by Point 2 of Section 1 of Chapter IV of Annex I to the Regulation. There was however no documentation to support this decision. The official veterinarians could not explain how they calculated the ventilation capacity on each deck without this documentation. All approval records indicated that the vessel had been checked for, and complied with, the requirement of Point 4 of Section 1 of Chapter IV of Annex I to the Regulation, namely that the freshwater system was capable of continuously supplying water to the animals on each deck and that alternative pumping equipment was available. In each file the supporting documentation available was plans of the water circuit. The official veterinarians however could not properly read these plans (one-way valves, backup generators) nor explain how the watering system was structured and how it worked. Although the approval checklist does not cover the requirements for drainage systems (see also paragraph 2), the official veterinarians indicated that they nonetheless carry out this check against Point 5 of Section 1 of Chapter IV of Annex I to the Regulation, i.e. that the drainage system was of appropriate capacity to drain fluids from the pens, that wells or tanks from where sewage is discharged were equipped with pumps or ejectors and that alternative pumping equipment was available. However they could not properly read the plans of the drainage circuits (one-way valves, wells and tanks, pumps and backup pumps) nor explain how the drainage system was structured and how it worked. The official veterinarians acknowledged that they do not have the technical competence to verify most of these requirements. 7

Port inspectors inspect vessels prior to loading animals. Procedures for this control, to verify that the equipment referred to in Chapter IV of Annex I to the Regulation is in good working order, do not provide the port inspectors with guidance on how to physically carry out these controls (e.g. how to verify that drainage tanks from where sewage is discharged are functioning properly).

All pre-loading checklists seen by the audit team indicated that the vessels inspected complied with the requirements of Section 1 of Chapter IV of Annex I to the Regulation, with the exception of the missing check for drainage systems (see also paragraph 1). The port inspectors were however unable to explain how they verify that certain systems and the relevant equipment (forced ventilation systems, drainage systems and pumps, alarms, back-up generators, etc.) are in good working order.

The insufficient information and instructions for port inspectors together with the absence of suitably qualified staff for assessing technical requirements for livestock vessels translates into a poor evaluation of technical requirements (such as air changes per hour on each deck of a livestock vessel, and the equipment used for watering and drainage systems on board a livestock vessel) during the approval and inspection before 8 loading. Therefore, official controls do no contribute to minimise the animal welfare risk linked to facilities and equipment.

Rekommendationen anger som grund

ANSVSA is drafting a checklist for the inspection of vehicles arriving at the port. This document has not been finalised yet.

ANSVSA indicated that port inspectors check all livestock vehicles arriving at the ports but those checks are not being recorded. This is not in compliance with the requirements of Article 9(1) of Regulation (EC) No 882/2004.

For vehicles which travel long road journeys before reaching the port, checks on journey logs include checks that a livestock vessel and a transporter for the sea journey have been identified. The port inspectors indicated that these are generally absent for those few journeys starting in Hungary (only 13 consignments in 2018). Although they are aware of these non-compliances, the port inspectors did not reported any non-compliance to their national contact point for informing the departing authority. Instead, they reported the results of the checks as 'satisfactory' in Traces.

Port inspectors are aware of the official controls they are required to do, but the absence of any records for these checks and for any subsequent action that might have been taken does not make it possible to verify whether they were in fact performed, their quality or 5 effectiveness.

The fact that deficiencies that port inspectors declare they detect are not recorded in Traces, nor transmitted to the national contact point, results in systematic unreported non- compliances to the Member State of departure concerned which, consequently, cannot take the necessary action to correct these issues.

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However, the facilities were not well-maintained (flaking paint in the unloading area for products of human consumption due to an old leak and a damaged unloading ramp) and equipment unrelated to the performance of import controls was kept in the facilities.

In addition, the facilities were used for purposes other than those intended e.g. storage facilities at ambient temperature were used to store office supplies. In the facilities rodent pellets for pest control were exposed.

The fridge in the inspection room for products of human consumption contained meat which could not be traced to its original consignment. The content of another fridge, although in operation, could not be inspected by the audit team as the BIP staff claimed not to have a key. 5.3.2 Albia

The facilities and equipment for import controls of live animals ­ categories "U and E" could be fit for purpose and brought into line with the requirements of Annex A to Directive 91/496/EEC on the condition that the ANSVSA installs appropriate facilities for feed and water supply. The BIP staff stated that for the two recent consignments of re-imported live pigs an ad hoc solution was applied due to the absence of appropriate feed and water facilities.

The facilities and equipment are fit for purpose. Regarding the BIPs, these are in line with the requirements of Annex II to Directive 97/78/EC and the Annex to Decision 2001/812/EC, and regarding DPEs, these are in line with the requirements of Article 4 of Regulation (EC) No 669/2009. However, the facilities were not kept clean (overhead dust and old spider webs) and equipment unrelated to the performance of import controls was kept in the facilities. 5.3.4 Halmeu

The facilities and equipment were not entirely fit for their purpose. Regarding the BIPs, these are in not in line with the requirements of Annex II to Directive 97/78/EC and the Annex to Decision 2001/812/EC, and regarding DPEs, these are not in line with the requirements of Article 4 of Regulation (EC) No 669/2009. The facilities were not kept clean (overhead dust and old spider webs) and had not been maintained following some leaks. In addition, equipment unrelated to the performance of import controls was kept in the inspection room.

The storage facilities for chilled, frozen and ambient products have not been used for the storage of products since the approval of the BIP in 2006, but were kept clean and maintained.

The facilities for live animals were not well-maintained and leaks had caused damage to the walls and floors.

The storage facilities for animal-by-products were not in operation, due to a breakdown in the electricity supply. These products were temporarily stored in a freezer kept in the unloading area for live ungulates and equidae. Conclusions on the suitability of facilities

The facilities, equipment and hygiene of the BIPs/DPEs visited, were in general adequate for undertaking controls on imports though permanent solutions are needed for the feeding and watering facilities for the live animal categories "U and E" in the BIP Albia and for facilities' maintenance in the BIPs.

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BIP Albia: - Equipment for feeding and watering was purchased; - The expertise of building the control module for products not destined for human consumption will be carried out in order to perform the necessary repairs (cracks in the foundation and all the deficiencies resulting from them). Deadline: 30.06.2019 County Sanitary Veterinary and Food Safety Authority Constanta BIP North Constanta: - The hygiene of the premises of the BIP will be provided by the cleaning company with which the DSVSA has a contract. Verification of the hygiene of the premises will be performed daily by the staff of the BIP who will record the findings in the Cleaning and Disinfection Registry; - The equipment and inventory items unrelated to the performance of import controls have been stored in a dedicated space, on 5 December 2018. County Sanitary Veterinary and Food Safety Authority Satu Mare BIP Halmeu: - DSVSA Satu Mare, which have subordinated the BIP Halmeu, will prepare the necessary documentation to be supported by the Technical Economic Commission in order to obtain the necessary funds to remedy the structural deficiencies resulting from leaks in the facilities for animal origin products and l

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Based on a review of this legislation, the audit team noted that some provisions contained in Article 9 of Ministerial Order No 895/2016 are not fully in line with Articles 65(4) and 92 of Regulation (EC) No 889/2008. Article 9 of Ministerial Order No 895/2016 stipulates that the CBs must carry out additional random unannounced visits to at least 10% of operators under contract (Article 92c(2)(c) of Regulation (EC) No 889/2008 stipulates that 10% of the total inspections carried out by the CB must be unannounced). The quantity of product is one of the criteria that must be taken into account for the evaluation of risk for additional visits according to Article 65(4) of Regulation (EC) No 889/2008 while Article 9 of Ministerial Order 895/2016 does not mention this. Conclusions on Relevant National Legislation and Provisions

National laws necessary to implement legally binding EU acts relevant to this audit have been adopted by the CA. However, one national legislative act includes some legal requirements that are not fully in line with EU organic regulations which may result in the implementation of some organic requirements by the CCA or CBs that are not in line with EU organic rules.

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Associated finding 2: Articolul 9 din Ordinul de ministru nr. Associated finding 2: Article 9 of Ministerial Order No 895/2016 prevede c organismele de control trebuie s 895/2016 stipulates that the CBs must carry out additional efectueze vizite inopinate aleatorii suplimentare, la cel puin random unannounced 10 % dintre operatorii contractuali [articolul 92 din visits to at least 10% of operators under contract (Article Regulamentul (CE) nr. 889/2008 stipuleaz c 10 % din 92 of Regulation (EC) No 889/2008 stipulates that 10% of totalul inspeciilor efectuate de organismul de control the total inspections carried out by the CB must be trebuie s fie inopinate]. unannounced). Dei articolul din actul normativ menionat nu este complet Although the article mentioned is not fully in line with în acord cu articolul 65 alineatul (4) i cu articolul 92 din Article 65 (4) and Article 92 of Regulation (EC) Regulamentul (CE) nr. 889/2008, ACC verifica in timpul No. 889/2008, the ACC is checking during the audit the auditului aplicarea prevederilor legislaiei comunitare, application of Community law, it having priority before the aceasta având prioritate în faa celei naionale. Echipa de national l

Associated finding 2: Article 9 of Ministerial Order No 895/2016 stipulates that the CBs must carry out additional random unannounced visits to at least 10% of operators under ACC response: contract (Article 92 of Regulation (EC) No 889/2008 stipulates that 10% of the total Deadline to implement the proposed actions inspections carried out by the CB must be is estimated on march 2019, meaning the unannounced). amending of OM 895/2016. Although the article mentioned is not fully in line with Article 65 (4) and Article 92 of Regulation (EC) No. 889/2008, the ACC is checking during the audit the application of Community law, it having priority before the national law. The audit team was able to confirm that the CB respects the provisions of art. 92 of Reg. no.889 / 2008, namely the finding no. 41 of the Audit Report in Romania: "In 2017, the CB carried out additional visits to 10% of the operators and 10% of the total inspections were carried out Page: 1 mitted by the competent authorities of Romania in response to Report ref. DG(SANTE)/2018-6400- pril 2018 in order to evaluate the control system for organic production and labelling of organic nt authority Commission services' assessm

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The CBs have procedures in place for certification of operators who move between CBs. The audit team reviewed one file related to transfer of operators and noted that not all relevant information related to the operators concerned was exchanged between the CBs involved. The CB just informed the other CB that the relevant operator had irregularities and was no longer covered by that CB as the certification was not renewed. This is not in line with Article 92(2) of Regulation (EC) No 889/2008 which requires that the previous CB must hand over all the relevant elements of the control file and reports referred in Article 63(2) to the subsequent CB.

A system of control is in place in accordance with EU provisions. CAs are designated with a clear division of responsibilities and tasks between CAs and CBs. There is good communication between the CAs and the CBs and other involved parties which includes the regular exchange of relevant information on the results of controls. However, in cases where operators change their CB, the exchange of information between the two CBs involved does not cover all relevant elements of the control file. 5.2.1.1 Control Bodies: Approval, Supervision and Withdrawal Legal Requirements Article 5(2) and (3) of Regulation (EC) No 882/2004. Article 27(5) to (9) and (14) of Regulation (EC) No 834/2007. Article 92c of Regulation (EC) No 889/2008. Findings

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C supravegheaza modalitatea in care organismele de The ACC supervises the way control bodies transfer control ontrol tranfera dosarele de control catre alte OC, in cadrul files to other CB during the annual audits and throughout diturilor anuale si in cursul anului, iar în legislaia the year; the national legislation give the possibility of nal a prevzut posibilitatea sancionrii OC care nu sanctioning CBs that do not comply with the legislative spect prevederile legislative în cazul OP transferai provisions in the case of transferred operators (Annex no. 3 nexa nr.3-Ordinul MADR nr.895/2016, art 9, lit. l) i m), - Order MADR no.895 / 2016, art.9, letter l) and m), art.16, t.16, alin (1) lit a) paragraph (1) letter a) siti atasat un exemplu de raport de audit in care se poate Attached, there is an example of an audit report showing serva monitorizarea schimbului de informatii intre OC in the exchange of information between the CB in the event of z de transfer al operatorilor (Anexa nr.4a -Nota audit a transfer of operators (Annex no. 4a - Audit no. 236001/9 / .236001/9/22.02.2018, pag. 6, primul paragraph i Anexa 22.02.2018, page 6, first paragraph and Annex no. 4b - .4b-Nota de aud

e ACC supervises the way control bodies transfer control files to other CB during the annual audits and throughout the year; the national legislation give the possibility of sanctioning CBs that do not comply with the legislative provisions in the case of transferred operators (Annex no. 3 - Order MADR no.895 / 2016, art.9, letter l) and m), art.16, paragraph (1) letter a) Attached, there is an example of an audit ACC response: report showing the exchange of information between the CB in the event of a transfer of Annex no. 4a - Nota de audit nr. 236001/9 / operators (Annex no. 4a - Audit no. 236001/9 22.02.2018, page 6, first paragraph and / 22.02.2018, page 6, first paragraph and Annex no. 4b - Audit note no.236001 / 44 / 11.06.2018, page 4, point 2, paragraph 2 that Page: 3 mitted by the competent authorities of Romania in response to Report ref. DG(SANTE)/2018-6400- pril 2018 in order to evaluate the control system for organic production and labelling of organic nt authority Commission services' assessment of the competent authority's response 36001 / 44 / aragraph 2) verification by the CA of compliance with Article 92(2) of Regulation (EC) No ty is 889/2008 by the CBs for tra

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RENAR does not notify the CCA of the results of the accreditation audits carried out on CBs. So, this information is not taken into account by the CCA for their supervisory task which is not in line to Article 92c(1) of Regulation (EC) No 889/2008. Moreover, the CCA does not require the CBs to submit their risk analysis procedure which is not in line to Article 92c(2) of Regulation (EC) No 889/2008. This may reduce the effectiveness of supervision as any deficiency related to the CBs' risk analysis may only be detected post factum.

CBs are accredited and approved in accordance with national and EU rules. CBs are generally subject to effective annual supervision by the CCA which includes office and witness audits. However, the CCA neither takes into account the reports of the accreditation body audits nor requires the CBs to submit their risk analysis procedures in advance of annual supervision which may undermine the effectiveness of the CCA supervision. In addition, the CCA did not establish deadlines for the CB to correct deficiencies detected during supervision. 5.2.2 Registration of Operators Legal Requirements Article 28(1), (2) and (5) of Council Regulation (EC) No 834/2007. Article 92(2) and 92b of Commission Regulation (EC) No 889/2008. Findings

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r audit, the ACC assessed the information exchange between CA De asemenea, in urma cazului identificat in timpul auditului the two CBs and analyzed the relevant elements transferred ysis DG SANTE, ACC a evaluat schimbul de informaii realizat from the operator's control file to the new control body. t of între cele dou OC i a analizat elementele relevante Thus, the ACC analyzed how the new control body ensured icle tranferate din dosarul de control al operatorului în cauz that the non-conformities identified by the previous control ctre noul organism de control. Astfel, ACC a analizat body were treated by the operator and that it took the modul in care noul organism de control s-a asigurat c appropriate measures. neconformitile identificate de organismului de control anterior au fost tratate de ctre operator si ca acesta a luat Associated finding 23 : RENAR does not notify the CCA of masurile de punere in conformitate. the results of the accreditation audits carried out on CBs. Associated finding 23: RENAR nu notific ACC cu privire la So, this information is not taken into account by the CCA rezultatele auditurilor de acreditare efectuate cu privire la for their supervisory task whi

Associated finding 23 : RENAR does not notify the CCA of the results of the accreditation audits carried out on CBs. So, this information is not taken into account by the CCA for their supervisory task which is not in line to Article 92c(1) of Regulation (EC) No 889/2008. Moreover, the CCA does not require the CBs to submit their risk analysis procedure which is not in line to Article 92c(2) of Regulation (EC) No ACC response: 889/2008. Attached you can find Annex 23 an 24 regarding evidences on providing the RENAR accreditation report and a copy of RENAR does not directly transmit to the the CB procedure for risk assessment. ACC the CBs evaluation reports, but the competent authority has ensured through national law that they are in their possession before the audit is performed. Thus, according to the provisions of art. 11, letter (h) of OM no.895 / 2016, the CBs have the obligation to submit the evaluation reports issued by the accreditation body to the structure in charge of technical inspections in Page: 5 mitted by the competent authorities of Romania in response to Report ref. DG(SANTE)/2018-6400- pril 2018 in order to evaluate the control system for organic production and l

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The audit team reviewed two CCA office audits to CBs carried out in 2017 and 2018. It was confirmed that all organic requirements described in Order No 895/2016 were checked by the CCA and when irregularities were identified, an action plan with specific deadlines was requested of the CB. The audit team noted that, as results of an office audit in one CB, major non-compliances (e.g. not timely investigation of a series of OFIS notifications in 2016, granting authorisations for the purchase and use of untreated conventional seeds 2-6 months after the sowing of crops, etc) were detected and the CCA asked the CB to take measures to solve the non-compliances. The action taken by the CCA was a written warning in line with Order No 895/2016. The CB replied to the audit report with three letters: the first was an action plan to address the audit findings and recommendations, the second summarised the measures taken by the CB following the direct controls of operators in 2016 (i.e. replacement of the CB manager, more inspectors were contracted, new sampling practices, trainings, etc.) and the third contained a list of new staff in 2017. The action plan provided by the CB in response to the 2017 audit report was mostly a commitment to address the non- compliances without providing concrete actions and a timetable for this. The CCA accepted this action plan and explained that the implementation of actions proposed would be followed-up in the next office audit.

CBs are accredited and approved in accordance with national and EU rules. CBs are generally subject to effective annual supervision by the CCA which includes office and witness audits. However, the CCA neither takes into account the reports of the accreditation body audits nor requires the CBs to submit their risk analysis procedures in advance of annual supervision which may undermine the effectiveness of the CCA supervision. In addition, the CCA did not establish deadlines for the CB to correct deficiencies detected during supervision. 5.2.2 Registration of Operators Legal Requirements Article 28(1), (2) and (5) of Council Regulation (EC) No 834/2007. Article 92(2) and 92b of Commission Regulation (EC) No 889/2008. Findings

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Associated finding 19: Planul de aciune furnizat de OC Associated finding 19: The action plan provided by the CB drept rspuns la planul de audit din 2017 a fost, în in response to the 2017 audit report was mostly a incipal, un angajament de soluionare a neconformitilor commitment to address the noncompliances without fr a furniza aciuni concrete i un calendar în acest scop. providing concrete actions and a timetable for this. The ACC a acceptat acest plan de aciune i a explicat c CCA accepted this action plan and explained that the punerea în aplicare a aciunilor propuse urma s fie implementation of actions proposed would be followed-up monitorizat în cadrul urmtorului audit documentar in the next office audit. ACC propune de fiecare data masuri pentru remedierea The ACC shall always propose measures to remedy the deficientelor constatate atat prin rapoartele de supraveghere deficiencies found in the surveillance reports as well as in cat si prin orice raport de constatate a unor neconformitati si any report of non-conformities and establishes a deadline stabileste un termen pentru transmiterea actiunilor corective for the submission of the corrective actions and / or the si/sau a

Associated finding 19: The action plan provided by the CB in response to the 2017 audit report was mostly a commitment to address the noncompliances without providing concrete actions and a timetable for this. The CCA accepted this action plan and explained that the implementation of actions proposed would be followed-up in the next ACC response: office audit. The ACC shall always propose measures to ACC will send to DG SANTE the first audit remedy the deficiencies found in the report set up in 2019 on the supervision of surveillance reports as well as in any report of CBs for 2018. Anyway, the audit topics will non-conformities and establishes a deadline have include provisions regarding the for the submission of the corrective actions establishing of timetable for the CBs to and / or the measures to be taken by CB to correct deficiencies identified during apply the proposed measures: supervision according to Article 27(8) of Regulation (EC) No 834/2007. Page: 8 mitted by the competent authorities of Romania in response to Report ref. DG(SANTE)/2018-6400- pril 2018 in order to evaluate the control system for organic production and labelling of organic nt authority Commission servi

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However, the audit team noted: The list of operators is not fully updated. A number of operators from a CB which is no longer approved by the CCA and operators from another CB which had voluntarily ceased activity are still on the list; Documentary evidence of operators on the list was not always fully updated; The documentary evidence of operators from one CB was not available.

There is an adequate system in place for the registration of operators and overall it is effectively implemented. The CCA makes available to the public relevant information on organic operators. However, the list of operators is not fully updated and the documentary evidence, in some instances, was missing which is not in line with EU legislation. 5.2.3 Planning and Prioritisation of Controls Legal Requirements Article 41 of Regulation (EC) No 882/2004 and Article 92f of Regulation (EC) No 889/2008. Article 3 of Regulation (EC) No 882/2004. Article 27(3) of Regulation (EC) No 834/2007. Articles 65(1) and (4) of Commission Regulation (EC) No 889/2008. Article 92c(2) of Commission Regulation (EC) No 889/2008. Findings

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Associated finding 31: -lista operatorilor nu este actualizat Associated finding 31: However, the audit team noted: complet. Pe list se afl în continuare o serie de operatori - The list of operators is not fully updated. A number of de la un OC care nu mai este aprobat de ACC, precum i operators from a CB which is no longer approved by the operatori de la un alt OC care i-a încetat în mod voluntar CCA and operators from another CB which had voluntarily activitatea; - ceased activity are still on the list;; - In cazul unui OC, astfel cum s-a explicat in timpul auditului In the case of one CB, as explained during the April audit, din aprilie, documentele justificative trimise de acesta au the supporting documents sent by it were posted on the fost postate pe site-ul MADR pân la retragerea acestuia, in MADR website until its withdrawn in November 2017. luna noiembrie 2017. O data cu retragerea aprobarii acestui Once the approval of the CB was withdrawn, the ACC OC, ACC a considerat ca nu poate posta documentele considered that the supporting documents, received after justificative primite ulterior ramanerii definitive a deciziei the final decision to withdraw the CB's approval, can no

ssociated finding 31: However, the audit team noted: le - The list of operators is not fully updated. A number of operators from a CB which is no longer approved by the CCA and operators from another CB which had voluntarily ACC response: ceased activity are still on the list;; - In the case of one CB, as explained during the Attached you can find a monthly April audit, the supporting documents sent by transmission by CB visited to the CA of it were posted on the MADR website until its documents issued, Annex 30. withdrawn in November 2017. Once the approval of the CB was withdrawn, the ACC considered that the supporting documents, received after the final decision to withdraw the CB's approval, can no longer be ported on the web site. Page: 10 mitted by the competent authorities of Romania in response to Report ref. DG(SANTE)/2018-6400- pril 2018 in order to evaluate the control system for organic production and labelling of organic nt authority Commission services' assessment of the competent authority's response information on ion and ded between the ollowing B. Live products. ormed that for ural products spection terminated on orting product ch was was not ting , as they e CB u

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The CB visited issued documentary evidence for all organic operators under its control in accordance with the model of Annex XII to Regulation (EC) No 889/2008. However, the CB did not issue documentary evidence for operators that had been downgraded and were not able to put organic certified products into the market even though they were still under control of the CB which is not in line with Article 29(1) of Regulation (EC) No 834/2007. This non-compliance was detected by the CCA during the 2018 supervisory activity. The CB, in the action plan provided after that audit, committed to solve this non-compliance.

There is an adequate system in place for the registration of operators and overall it is effectively implemented. The CCA makes available to the public relevant information on organic operators. However, the list of operators is not fully updated and the documentary evidence, in some instances, was missing which is not in line with EU legislation. 5.2.3 Planning and Prioritisation of Controls Legal Requirements Article 41 of Regulation (EC) No 882/2004 and Article 92f of Regulation (EC) No 889/2008. Article 3 of Regulation (EC) No 882/2004. Article 27(3) of Regulation (EC) No 834/2007. Articles 65(1) and (4) of Commission Regulation (EC) No 889/2008. Article 92c(2) of Commission Regulation (EC) No 889/2008. Findings

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Associated finding 32: OC nu a eliberat dovezi documentare Associated finding 32: However, the CB did not issue s pentru operatorii care fuseser retrogradai i care nu documentary evidence for operators that had been 7. puteau introduce pe pia produse ecologice certificate, downgraded and were not able to put organic certified chiar dac înc se aflau sub controlul OC, ceea ce nu este products into the market even though they were still under în acord cu articolul 29 alineatul (1) din Regulamentul (CE) control of the CB which is not in line with Article 29(1) of nr. 834/2007. Aceast neconformitate a fost depistat de Regulation (EC) No 834/2007. This non-compliance was ACC în timpul activitii de supraveghere din 2018. În detected by the CCA during the 2018 supervisory activity. Page: 7 ceived 07 September 2018 mendations of report ref. DG(SANTE)/2018-6400-MR of the audit carried out from 17 April 2018 to 25 April uction and labelling of organic products rity (RO version) Action Proposed by the competent authority (EN version) respectiv, OC s-a The CB, in the action plan provided after that audit, e. ­ committed to solve this non-compliance.­ din Raportul de audit The issues mentioned i

sociated finding 32: However, the CB did ot issue documentary evidence for operators hat had been downgraded and were not able o put organic certified products into the arket even though they were still under ontrol of the CB which is not in line with rticle 29(1) of Regulation (EC) No 34/2007. This non-compliance was detected y the CCA during the 2018 supervisory ctivity. The CB, in the action plan provided fter that audit, committed to solve this non- Page: 13 mitted by the competent authorities of Romania in response to Report ref. DG(SANTE)/2018-6400- pril 2018 in order to evaluate the control system for organic production and labelling of organic nt authority Commission services' assessment of the competent authority's response atement 32 of identified by 3 February red to the lack f the products d Land to operators raded as a (Annex no. 10 - 18, page 5, the control 1-3). e ACC through and by he CB replied medy this procedure 14.05.2018, ess OC Page: 14 mitted by the competent authorities of Romania in response to Report ref. DG(SANTE)/2018-6400- pril 2018 in order to evaluate the control system for organic production and labelling of organic nt authority Commission services'

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The CB plan additional inspections and sampling of organic operators based on a risk assessment. The CB visited uses criteria to classify operators into high, medium and low risk categories. Different criteria to classify operators are used depending on the type of activity carried out by the operator (primary production, processor, importer etc.) which include inter alia previous non-compliances, the size of the business, the risk for exchange of products or the complexity and type of activities. The CB has a complex system for the classification of operators using a number of criteria allocating score points to each criterion using a formula. However, the criterion for risk assessment does not include the quantity produced which is not in line with Article 65 of Regulation (EC) No 889/2008.

According to the CB's procedure, all operators classified in high risk and 80% of operators classified in medium risk must be selected for additional visits. If necessary, low risk operators are included to complete the 10% of additional visits. However, the audit team noted that the selection of operators for additional visits for 2017 was not in line with the described procedures. Only 47% of high risk operators were visited and around 60% of medium risk were visited (specifically 18 of additional audits took place in high risk operators, 238 in medium risk operators and 144 in low risk operators). A significant number of low risk operators were also selected for additional visits. The CB stated that all high risk operators which could not be visited in 2017 were visited at the beginning of 2018. This is not fully in line with Article 92c(2)(a) and (d) of Regulation (EC) No 899/2008. 10

The CB sampling is based on the risk assessment made to select operators for additional visits (see paragraph 40). According to the CB's procedure, 100% of high risk operators and 50% of medium risk operators should be selected for sampling. If necessary, low risk operators are selected to reach the minimum 5% stipulated in the legislation. However, in 2017 the CB did not fully follow its procedure for the selection of operators from sampling as 10 low risk operators were sampled while not 100% of high risk operators and 50% of medium risk operators were subject for sampling. Conclusions on Planning and Prioritisation of Controls

However, the effectiveness of the system is reduced as there is a risk that not all the highest risk operators are selected for additional inspections and sampling as the CB visited did not fully follow its own procedure for selecting operators based on the level of risk and the quantity produced is not taken into account as a criterion for risk assessment.

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s Associated findings 40: OC dispune de un sistem complex de Associated findings 40: The CB has a complex system for ject to clasificare a operatorilor, utilizând o serie de criterii prin the classification of operators using a number of criteria care se aloc puncte fiecrui criteriu pe baza unei formule. allocating score points to each criterion using a formula. Totui, criteriul pentru evaluarea riscurilor nu include However, the criterion for risk assessment does not include cantitatea produs, ceea ce nu este în conformitate cu the quantity produced which is not in line with Article 65 of articolul 65 din Regulamentul (CE) nr. 889/2008. ­ Regulation (EC) No 889/2008.­ In ceea ce priveste criteriul cantitatii de produse utilizat ca Regarding the criterion of the quantity of products used as a factor de risc, in conformitate cu recomandarea DG Sante, risk factor, according to the recommendation of DG Sante, pana la finalizarea procedurii legislative de modificare a until the legislative procedure for amending the MADR Ordinului MADR nr.895/2016, ACC prin DGCAI va Order no.895 / 2016, the ACC will send through DGCAI an transmite o adresa catre organismele de control pentru address to

Associated findings 40: The CB has a complex system for the classification of d operators using a number of criteria by allocating score points to each criterion using a formula. However, the criterion for risk assessment does not include the quantity produced which is not in line with Article 65 of Regulation (EC) No 889/2008.­ Regarding the criterion of the quantity of ACC response: products used as a risk factor, according to the recommendation of DG Sante, until the Attached you can find Annex no. 25, the legislative procedure for amending the ACC letter to the CBs indicating the MADR Order no.895 / 2016, the ACC will inclusion of quantity in the list of criteria send through DGCAI an address to the considered for risk analysis for the planning control bodies for the inclusion of the of additional inspections. quantity of products in the list of criteria considered in the risk analysis for the Evidence that the OC visited select for planning of additional inspections. additional visits and sampling operators with the higher risk will be provided to DG Deadline-09.30.2018. SANTE though the audit report after the audit carried out by ACC in 2019. In each audit mission the ACC mak

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However, the audit team noted that some aspects were not always covered during the inspections, in particular the following aspects: the inspector did not visit all the premises on the farm where potential storage of non-authorised substances could take place; inspectors did not check all the neighbouring cultivations to rule out the risk of potential contamination; The inspector did not carried out any harvest estimation. Conclusions on Controls of Operators

Although inspections observed were overall effective, some aspects were not sufficiently covered during the visits which may undermine the effectiveness of the inspections. 12 5.2.5 Controls on Labelling and Traceability Legal Requirements Article 23 of Regulation (EC) No 834/2007. Article 23(1) of Regulation (EC) No 834/2007 Regulation. Title III of Commission Regulation (EC) No 889/2008. Article 27(13) of Council Regulation (EC) No 834/2007. Article 18 of Regulation (EC) No 178/2002. Findings

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Associated finding 52: Echipa de audit a constatat c unele Associated finding 52: However, the audit team noted that (EC) aspecte nu au fost întotdeauna acoperite în timpul some aspects were not always covered during the ts inspeciilor, în special urmtoarele aspecte: inspections, in particular the following aspects: · inspectorul nu a vizitat toate spaiile din cadrul fermei - the inspector did not visit all the premises on the farm g the unde ar putea fi depozitate substane neautorizate; - where potential storage of non-authorised substances could on take place; · inspectorii nu au verificat toate culturile învecinate pentru - inspectors did not check all the neighbouring cultivations a exclude riscul contaminrii poteniale; - to rule out the risk of potential contamination; - The inspector did not carried out any harvest estimation.­ · inspectorul nu a efectuat nicio estimare a recoltelor ­ At the beginning of the verification carried out by the CB La inceputul inspectiei efectuate de inspectorul OC, acesta a Inspector, he checked the unit's description and noted the verificat descrierea unitatii si a observat masurile de measures to prevent contamination in the field, as well as p

d Associated finding 52: However, the audit team noted that some aspects were not always covered during the inspections, in particular the following aspects: - the inspector did not visit all the premises ACC response: on the farm where potential storage of non- authorised substances could take place; - inspectors did not check all the Attached you can find Annex no. 25 on the neighbouring cultivations to rule out the risk ACC letter no. 227465/19.09.2018 sent to of potential contamination; CBs. - The inspector did not carried out any harvest estimation.­ At the beginning of the verification carried out by the CB Inspector, he checked the unit's description and noted the measures to prevent contamination in the field, as well as the measures adopted by the operator if the plot Page: 19 mitted by the competent authorities of Romania in response to Report ref. DG(SANTE)/2018-6400- pril 2018 in order to evaluate the control system for organic production and labelling of organic nt authority Commission services' assessment of the competent authority's response g wheat). In d to sample this identify the e h the inspector ave a erator about tion the issue in ops is concerned, of the vege

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Control of marketing and labelling of organic food forms also part of the inspections carried out by the DAJs on the market. The market controls carried out by DAJ inspectors also checked the traceability of organic products and also the fraudulent use of the protected terms such as "biologic" "organic" and their abbreviations such us "bio" or "eco" as trademarks, which can mislead the consumers. The audit team witnessed the performance of one official control at a retailer, and noted that, overall, the inspection was not satisfactorily carried out. The inspectors relied on the information provided by the sales manager and did not check the premises to verify the information provided by the operator or the use of the protected terms on products which are not in the system (under organic control). Indeed, the audit team noted that more organic products were available and also found a product that was using the protected terms as a trade mark. This was not noted by the DAJs inspectors.

There is an appropriate system in place covering the organic operators certified by CBs, to ensure traceability of organic products and that the labelling of the products complies with relevant EU provisions. However, controls at retail level are not fully effective to ensure adequate use of terms referring to organic production and labelling of organic products. 5.2.6 Sampling and laboratory analysis Legal Requirements Article 65(2) of Commission Regulation (EC) No 889/2008. Articles 5(2) and 12 of Regulation (EC) No 882/2004. Findings

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Associated finding 59: Inspectorii s-au bazat pe informaiile Associated finding 59: The inspectors relied on the furnizate de directorul de vânzri i nu au controlat spaiul information provided by the sales manager and did not ng of pentru a verifica informaiile furnizate de operator sau check the premises to verify the nic utilizarea termenilor protejai pe produse care nu se afl în information provided by the operator or the use of the tion sistem (sub control protected terms on products which are not in the system ecologic). Într-adevr, echipa de audit a constatat c erau (under organic control). Indeed, the audit team noted that disponibile mai multe produse ecologice i, de asemenea, a more organic products were available and also found a gsit un produs care folosea termenii protejai ca marc product that was using the protected terms as a trade mark. comercial. Inspectorii DAJ nu au semnalat acest lucru. ­ This was not noted by the DAJs inspectors.. ­

d Associated finding 59: The inspectors relied that on the information provided by the sales Page: 22 mitted by the competent authorities of Romania in response to Report ref. DG(SANTE)/2018-6400- pril 2018 in order to evaluate the control system for organic production and labelling of organic Action Proposed by the competent authority Commission services' assessment of the competent authority's response manager and did not check the premises to verify the information provided by the operator or the use of the protected terms on products which are not in the system (under organic control). Indeed, the audit team noted that ACC response: more organic products were available and The checklist prepared for DAJ inspectors also found a product that was using the have been send on 21 November 2018 which protected terms as a trade mark. This was not was accompanied by a letter no. noted by the DAJs inspectors.. ­ 228101/21.11.2018, Annex 26. Some lack of expertise of DAJ inspectors have been identified by the ACC on various occasions where information has been requested from them. That is why MADR started preparing a checklist for retailers to be provided to DAJ inspectors. These will be

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Samples are taken mainly for testing for residues of non-authorised Plant Protection Products (PPPs). The CB can choose the laboratories used for the analysis of samples of organic products subject to being accredited to ISO 17025. The CCA has not designated laboratories for analysis of organic production. The CCA stated that they are in the process of introducing new national legislation for the designation of laboratories for organic production.

However the effectiveness of the sampling programme may be reduced due to the fact that laboratories are not designated by the CCA. In addition, the CB procedure for interpretation of analytical results showing the presence of non-authorised substances is not always appropriate to take adequate measures by the CB. 5.2.7 Exceptional production rules and other derogations. Legal Requirements Article 29 of Regulation (EC) No 889/2008 and Annex IX of the same Regulation. Sections 2 to 4 of Chapter 6 of Title II of Regulation (EC) No 889/2008. Article 22(2) of Regulation (EC) No 834/2007. 15 Findings

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e Unele lacune ale inspectorilor DAJ au fost constatate de Some lack of expertise of DAJ inspectors have been ACC cu diferite ocazii in care au fost solicitate verificari si identified by the ACC on various occasions where informatii din partea acestora. De aceea MADR a demarat information has been requested from them. That is why pregatirea unui ghid de control pentru retaileri care sa fie MADR started preparing a checklist for retailers to be furnizat inspectorilor DAJ. Acestea vor fi trimise catre DG provided to DAJ inspectors. These will be sent to DG SANTE imediat ce vor fi finalizate. SANTE as soon as they are completed. În vederea ducerii la îndeplinire a prevederilor art. 12 i 33 In order to carry out the provisions of art. 12 and 33 of din Regulamentul (CE) nr. 882/2004, Ministerul Agriculturii Regulation (EC) No. 882/2004, the Ministry of Agriculture i Dezvoltrii Rurale a elaborat proiectul de Lege pentru and Rural Development elaborated the draft Law for modificarea i completarea Ordonanei de urgen a amending the Government Emergency Ordinance no. Guvernului nr. 34/2000 privind produsele agroalimentare 34/2000 on organic food products, which at this date is in ecologice,

In order to carry out the provisions of art. 12 and 33 of Regulation (EC) No. 882/2004, the Page: 23 mitted by the competent authorities of Romania in response to Report ref. DG(SANTE)/2018-6400- pril 2018 in order to evaluate the control system for organic production and labelling of organic ction Proposed by the competent authority Commission services' assessment of the competent authority's response inistry of Agriculture and Rural . evelopment elaborated the draft Law for mending the Government Emergency ACC response: rdinance no. 34/2000 on organic food roducts, which at this date is in The Draft Law on the amendment and arliamentary debate. completion of GO no. 34/2000 on organic food products, under national parliamentary ne of the points in the draft law is to create debate, was adopted by the Chamber of he normative framework for the issuance of Deputies on 28.11.2018. econdary legislation, namely the Order on At this time the draft law is submitted to the he designation of official and reference General Secretariat of the Government for aboratories for the analysis of the samples the exercise of the right to refer to the aken during the official controls and the constitut

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In the CB visited, the audit team reviewed four cases where unauthorised substances were detected. The CB has a detailed procedure to be followed for the interpretation of analytical results on PPPs and measures to be taken. The CB classifies the presence of non-authorised PPPs as either a major or minor contamination which leads to different measures to be taken at operators. In cases of minor contamination, the CB did not carry out an investigation but asked the operator to carry out its own investigation that would be reviewed during the next inspection. This is not in line with EU Regulations which stipulate that the use of non-authorised substances is not permitted in organic farming. Therefore, CBs must investigate all cases when the presence of non- authorised PPPs is identified. In cases of major contamination the CB carry out the investigation.

However the effectiveness of the sampling programme may be reduced due to the fact that laboratories are not designated by the CCA. In addition, the CB procedure for interpretation of analytical results showing the presence of non-authorised substances is not always appropriate to take adequate measures by the CB. 5.2.7 Exceptional production rules and other derogations. Legal Requirements Article 29 of Regulation (EC) No 889/2008 and Annex IX of the same Regulation. Sections 2 to 4 of Chapter 6 of Title II of Regulation (EC) No 889/2008. Article 22(2) of Regulation (EC) No 834/2007. 15 Findings

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organiza întruniri cu autoritile implicate. non-authorised PPPs as either a major or minor t the contamination which leads to different measures to be Article Associated finding 67: OC clasific prezena PPP taken at operators. In cases of minor contamination, the CB e neautorizate drept o contaminare major sau minor care did not carry out an investigation but asked the operator to tical conduce la adoptarea a msuri diferite la nivelul carry out its own investigation that would be reviewed in operatorilor. În cazul unei contaminri minore, OC nu a during the next inspection. This is not in line with EU efectuat o investigaie, îns i-a cerut operatorului s îi Regulations which stipulate that the use of non-authorised efectueze propria investigaie, ce urmeaz a fi revizuit în substances is not permitted in organic farming. Therefore, timpul urmtoarei inspecii. Acest lucru nu este în CBs must investigate all cases when the presence of conformitate cu reglementrile UE, care prevd c nonauthorised

ssociated finding 67: The CB classifies the Page: 24 mitted by the competent authorities of Romania in response to Report ref. DG(SANTE)/2018-6400- pril 2018 in order to evaluate the control system for organic production and labelling of organic Action Proposed by the competent authority Commission services' assessment of the competent authority's response are presence of non-authorised PPPs as either a major or minor contamination which leads to different measures to be taken at operators. In cases of minor contamination, the CB did not ases carry out an investigation but asked the operator to carry out its own investigation that would be reviewed during the next inspection. This is not in line with EU Regulations which stipulate that the use of non-authorised substances is not permitted in ACC response: organic farming. Therefore, CBs must investigate all cases when the presence of After ACC letter requesting to investigate all non-authorised cases where positive tests exist. ACC have PPPs is identified.­ been verified some cases regarding the positive test results and the measures taken by the CB. Attached you find Annexe 27. In the cases provided by the table attached the This

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The audit team reviewed several cases of major non-compliances identified at operator level by the CB visited and notified to the CCA. In all cases the audit team noted that the CB asked the operators to submit explanation and corrective actions. In all cases the CB imposed sanction to the operators and the relevant products, land or operators was suspended or de-certified by the CB in line with the catalogue of measures. However, the lapse of time between the identification of the irregularity and the resolution of the case could be up to six months. The CB only notified the CCA on the irregularities at the end of the process which is not in line with Articles 27(5) and 30(2) of Regulation (EC) No 834/2007 and Article 92(4) of Regulation (EC) 889/2008.

The system in place for measures in cases of irregularities and infringements is based on a catalogue of measures providing a framework for harmonized and adequate measures in case of irregularities and infringements of EU organic rules. However, the effectiveness of the system is reduced as major non-compliances are not immediately notified between CBs and the CAs and other bodies involved, which may not allow the relevant bodies to take enforcement actions in a timely manner. The CCA failed to ensure that de-certified operators are excluded from the organic system for a period of five years in line with national legislation.

Medlemsstatens svar

utilizarea PPPs is identified.­ by substanelor neautorizate nu este permis în agricultura of ecologic. Prin urmare, OC trebuie s investigheze toate This practice of the CB was also identified by the ACC cazurile în care se identific prezena unor PPP during the audit before the DG SANTE audit, and neautorizate. ­ clarifications were requested from it. With regard to the CB's explanations, the ACC sent a letter to the CB on the Aceasta practica a OC-ului a fost identificata i de ACC în classification the presence of unauthorized PPPs and the timpul auditului realizat înaintea auditului DG SANTE, fiind measures taken and noted that the competent authority did solicitate clarificari din partea acestuia. Fata de explicatiile not set such measures under national law. The European OC, ACC a trimis o scrisoare catre acesta privind modul de legislation provides that any suspicion of contamination clasificare a prezentei PPP neautorizate si masurile luate si i- with unauthorized substances should be investigated by the a pus in vedere ca autoritatea competenta nu a stabilit astfel CB. de masuri prin legislatia nationala si, mai mult, legislatia The CB was also requested to investigate all ca

Associated finding 83: However, the lapse of time between the identification of the irregularity and the resolution of the case could be up to six months. The CB only notified the CCA on the irregularities at the end of the process which is not in line with Articles 27(5) and 30(2) of Regulation (EC) No 834/2007 and Article 92(4) of Regulation (EC) 889/2008. ­ ACC response: Immediate reporting of irregularities on Attached you can find two exemples of non- product status is verified during the annual compliances which have immediately been notified to the CA by the CB, Annex 28. Page: 26 mitted by the competent authorities of Romania in response to Report ref. DG(SANTE)/2018-6400- pril 2018 in order to evaluate the control system for organic production and labelling of organic nt authority Commission services' assessment of the competent authority's response e year when the nformation s (Annex no. 20 - n identification roduct imported omania's for the third 2018 on the ntamination of EU and the rding the status of the nalyzed during nt out that ty was managed, 895/2016 osed to ormity he sanction. LOT 7472/15 s to improve ol system by Page: 27 mitted by the competent authorities of

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In one case, a major non-compliance was notified by the parent company of the CB located in another MS. In this case, one Romanian operator imported two batches of plums from non-EU countries (the 1st, 20 tonnes of plums from Moldova and the 2nd, 20 tonnes of plums from Serbia) and both were found contaminated with PPPs (cypermethrine and pyrimethanil). The samples were taken from a client of the Romanian operator in France. Both batches were directly transferred from the non-EU countries to France; the role of Romanian operator was to make the arrangements for the import of the products. The CB in Romania was notified about the results of the laboratory analyses that took place in France on 17/08/2016. After that, the Romanian CB carried out an inspection of the Romanian operator and discovered that the two batches had entered the EU market without a certificate of inspection. The CB decided to suspend the activity of the operator on 8/12/2016 and notified the CCA on 9/12/2016. The CB finally decided to withdraw the certificate of the operator on 3/3/2017 but the operator was afterward registered with another CB which is not in line with Article 19(14) of Order 895/2016 (i.e. an operator who has been excluded from the organic farming system is not entitled to register in the organic farming system for a period of five years from the date of exclusion). In addition, the CCA did not notify the case to OFIS as is required in Article 92a(1) of Regulation (EC) No 889/2008.

The system in place for measures in cases of irregularities and infringements is based on a catalogue of measures providing a framework for harmonized and adequate measures in case of irregularities and infringements of EU organic rules. However, the effectiveness of the system is reduced as major non-compliances are not immediately notified between CBs and the CAs and other bodies involved, which may not allow the relevant bodies to take enforcement actions in a timely manner. The CCA failed to ensure that de-certified operators are excluded from the organic system for a period of five years in line with national legislation.

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In ceea ce priveste cazul identificat de echipa de audit DG Regarding the case identified by the DG SANTE's audit Page: 16 ceived 07 September 2018 mendations of report ref. DG(SANTE)/2018-6400-MR of the audit carried out from 17 April 2018 to 25 April uction and labelling of organic products Action Proposed by the competent authority (RO version) Action Proposed by the competent authority (EN version) SANTE, lotul de prune uscate importat din Moldova si team, the dry plum batch imported from Moldova and Serbia, ACC considera ca intreg cazul nu a fost bine Serbia, the ACC considers that the whole case was not well gestionat de OC: managed by the CB: - the CB considered the lack of information from the - OC a considerat o neconformitate minor lipsa operator about the intention to import organic products as informarii din partea operatorului privind intentia being a minor non-compliance, de a importa produse ecologice, - the CB did not immediately inform the ACC of the fact that the exporter's control body was not answering in order - nu a informat imediat ACC despre faptul ca to clarify the irregularities and also failed to inform the organismul de control al exportatorului nu raspu

egarding the case identified by the DG SANTE's audit team, the dry plum batch mported from Moldova and Serbia, the ACC onsiders that the whole case was not well anaged by the CB: the CB considered the lack of information ACC response: rom the operator about the intention to mport organic products as being a minor Operator's exclusion sanction for a period of on-compliance, 5 years is applied by the CBs together with the ACC in the case of serious violations of the CB did not immediately inform the ACC Community law or a severe infringement or f the fact that the exporter's control body an infringement with prolonged effect. as not answering in order to clarify the The previous ACC reply on recomandations rregularities and also failed to inform the Report ref. DG(SANTE)/2018-6400-MR CC about the contamination with residues provide evidences on ACC and CBs actions in case of serious violations of Community Page: 30 mitted by the competent authorities of Romania in response to Report ref. DG(SANTE)/2018-6400- pril 2018 in order to evaluate the control system for organic production and labelling of organic nt authority Commission services' assessment of the competent authority's respon

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In one case, a major non-compliance was notified by the parent company of the CB located in another MS. In this case, one Romanian operator imported two batches of plums from non-EU countries (the 1st, 20 tonnes of plums from Moldova and the 2nd, 20 tonnes of plums from Serbia) and both were found contaminated with PPPs (cypermethrine and pyrimethanil). The samples were taken from a client of the Romanian operator in France. Both batches were directly transferred from the non-EU countries to France; the role of Romanian operator was to make the arrangements for the import of the products. The CB in Romania was notified about the results of the laboratory analyses that took place in France on 17/08/2016. After that, the Romanian CB carried out an inspection of the Romanian operator and discovered that the two batches had entered the EU market without a certificate of inspection. The CB decided to suspend the activity of the operator on 8/12/2016 and notified the CCA on 9/12/2016. The CB finally decided to withdraw the certificate of the operator on 3/3/2017 but the operator was afterward registered with another CB which is not in line with Article 19(14) of Order 895/2016 (i.e. an operator who has been excluded from the organic farming system is not entitled to register in the organic farming system for a period of five years from the date of exclusion). In addition, the CCA did not notify the case to OFIS as is required in Article 92a(1) of Regulation (EC) No 889/2008.

The audit team reviewed four cases notified in OFIS. In all cases the CCA launched an investigation. The CCA, for different reasons, was not always able to upload the results of the investigations in OFIS within 30 days as required in Article 92a(4) of Regulation (EC) No 889/2008. The CCA acknowledges the lack of written procedures to deal with these matters. In any case, the CCA took measures to block the products when necessary and imposed sanctions accordingly. 18 Conclusions on Measures in cases of Irregularities and Infringements

In addition, the CCA does not always notify the cases to OFIS and does not always respond on a timely basis to OFIS notifications to the EU as there is not a procedure in place to properly follow-up in a timely manner which may prevent MSs involved taking appropriate actions.

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Pentru a rspunde recomandrii DG SANTE ACC va In order to respond to DG SANTE' recommendations, the include în OM nr.895/2016, care este instrumentul legislativ ACC will include in OM no. 895/2016, which is the s and pentru supravegherea OC-urilor, prevederi pentru a legislative instrument for the supervision of CBs, h monitoriza finalizarea investigaiilor i a raportului întocmit provisions to monitor the completion of investigations and . în urma acestora, astfel încât ACC s rspund în timp util la the report drawn up in response to them, so that the ACC notificrile OFIS conform art. 92a .alineatul (4) din responds in a timely manner to OFIS notifications, Regulamentul (CE) nr. 889/2008. according to Article 92a (4) of Regulation (EC) No. 889/2008. Cu toate acestea, în ceea ce priveste nerespectarea termenului de 30 de zile prevazut de articolul 92a alineatul However, as regards the failure to comply with the 30-day (4) din Regulamentul (CE) nr. 889/2008, ACC a pregatit deadline laid down in Article 92a (4) of Regulation (EC) dosarele cazurilor OFIS asa cum au fost solicitate de echipa 889/2008, the ACC prepared the OFIS case files as de audit DG SANTE prin planul de audit, unele di

n order to respond to DG SANTE' recommendations, the ACC will include in OM no. 895/2016, which is the legislative instrument for the supervision of CBs, provisions to monitor the completion of investigations and the report drawn up in Page: 32 mitted by the competent authorities of Romania in response to Report ref. DG(SANTE)/2018-6400- pril 2018 in order to evaluate the control system for organic production and labelling of organic by the competent authority Commission services' assessment of the competent authority's response , so that the ACC responds er to OFIS notifications, ACC response: icle 92a (4) of Regulation 8. rds the failure to comply Deadline to implement the proposed actions deadline laid down in Article is estimated on march 2019, meaning the ation (EC) 889/2008, the amending of OM 895/2016. Until then we OFIS case files as have worked on the draft proposal, Annex 29 DG SANTE audit team on provisions regarding the OFIS t plan, some of which were notifications. the audit. In all the OFIS the ACC responded within 30 te of notification as well as f receipt of the reply from the particular situation was in se, when the ACC delayed nse in OFIS for objective ecember it

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The initial response from National Authority for Consumer Protection (NACP) on 24/05/2019: Regarding the conformity of the national legislation with the EU norms, NACP sent in this respect the address no.9707 / 24.11.2017 to the Romanian Parliament considering that Law no. 88/2016 laying down additional mandatory measures for the labelling of fresh milk for consumption and dairy products, given that the said normative act was issued by this institution. Updated action plan received on 23/12/2019: NACP sent a letter to the Ministry of Economy pointing out this issue and asking for support. We mention that the Minister of Economy coordinates the activity of NACP

The initial response from National Authority for Consumer Protection (NACP) on /2019: Regarding the conformity of the national legislation with the EU norms, NACP sent in this respect the address no.9707 / 24.11.2017 to the Romanian Parliament considering that Law no. 88/2016 laying down additional mandatory measures for the labelling of fresh milk for consumption and dairy products, given that the said normative act was issued by this institution.

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initial response from Ministry of Health (MH) on 24/05/2019: Article 2 of the Government Decision (GD) no. 723/2011 provides that this normative act applies to foods for which nutrition and health claims can be established, according to the provisions of Regulation No. 1924/2006. Article 3 (1) also provides that the competent authority for the application of Regulation 1924/2006 on the territory of Romania is the Ministry of Health, hereinafter referred to as the competent authority. At the same time, at art. 12, par. (3) provides that the staff specifically empowered by the Ministry of Health, the National Sanitary Veterinary and Food Safety Authority and the National Authority for Consumer Protection shall ascertain the contraventions and apply the sanctions, according to the legal competences. Also, according to art. 12, par. (4) of Government Decision (GD) no. 723/2011, the joint Page: 1 to the recommendations of report ref. DG(SANTE)/2018-6410-MR of the audit carried out from e the official control systems in place governing food information to consumers and nutrition and hority er 2011of the Minister of Health, of the President of Food Safety Authority and of the President of

initial response from Ministry of Health on 24/05/2019: Article 2 of the Government Decision (GD) no. 723/2011 provides that this normative act applies to foods for which nutrition and health claims can be established, according to Page: 1 January 2020 to the recommendations of report ref. DG(SANTE)/2018-6410-MR of the audit carried out from e the official control systems in place governing food information to consumers and nutrition and authority Updated action proposed by the competent authority (Ministry of Health) 1924/2006. the competent Regulation ania is the eferred to as . (3) provides ered by the Sanitary ity and the rotection s and apply egal (4) of 2011, the 15 December the y Veterinary the ty for e market th claims, Page: 2 January 2020 to the recommendations of report ref. DG(SANTE)/2018-6410-MR of the audit carried out from e the official control systems in place governing food information to consumers and nutrition and authority Updated action proposed by the competent authority (Ministry of Health) f the ibed on the ventions and ded for in art. (2) of the 23/2011 necessary gulation the staff lth. on and health on of n of the acts t. c) is carried the rotection. alth

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The initial response from Ministry of Health (MH) on 24/05/2019: addresses send to the County Public Health and Bucharest Public Health Directorates on Control Actions in the Field of Nutritional Claims to (enclosed) specifies the legislation whose compliance will be verified, and which control actions will include checks such as: - checking compliance with the conditions applicable to nutrition claims on foodstuffs provided in the Annex to Regulation (EC) 1924/2006 - checking compliance with the conditions of use (provided in the Annex to Regulation (EC) No 432/2011) of the health claims provided for in the Community Register. - verifying compliance by the food with conditions of use of the health claim with the health claim on the product label). The Ministry of Health elaborates, since 2014, the addresses for implementation of the thematic control action in the field of nutritional and health claims to be included in the food products with taking in consideration the proposals and observations of the experts from the National Institute of Public Health (INSP). These was sent by INSP via address no. 14031 / 23.10.2014 as a point of view of experts in the field of nutritional and

The initial response from Ministry of Health Reponse for MH (MH) on 24/05/2019: According to the National Plan of thematic actions of control in public The addresses send to the County Public health for the year 2019 no. SP 14593 / Health and Bucharest Public Health 29.11.2018, as well as the responsibility Directorates on Control Actions in the Field of the Ministry of Health in the field of of Nutritional Claims to (enclosed) specifies food labeling from the point of view of the legislation whose compliance will be nutritional and health claims, the State Health Inspectorate within the Ministry of Health ordered the organization on verified, and which control actions will 04.02.2018-23.02.2019 control actions include checks such as: regarding the control of the labeling of - checking compliance with the conditions food products from the point of view of applicable to nutrition claims on foodstuffs nutritional and health claims, with the provided in the Annex to Regulation (EC) exception of the following categories of foods: food supplements, foods with 1924/2006 special nutritional purpose, foods treated - checking compliance with the conditions of with ionizing radiation. use (p

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The initial response from Ministry of Health (MH) on 24/05/2019: MH point 50, point 127, point 119, point 120, point 121, point 122, point 123: e Between 30.01-01.02.2019, MH organized a training for health inspectors on the topic "Labelling of foodstuffs from the point of view of nutritional and health mentions and consumer information" to clarify the weaknesses identified during the audit mission and to discuss the new control sheet. After that the thematic action takes place between 04.02- Page: 6 to the recommendations of report ref. DG(SANTE)/2018-6410-MR of the audit carried out from

The initial response from Ministry of Health (MH) on 24/05/2019: Ministy of Health MH point 50, point 127, point 119, point 120, In PDF you will find the documents e point 121, point 122, point 123: attached to this email regarding: Between 30.01-01.02.2019, MH organized a training for health inspectors on the topic - the report of the control action called "Labelling of foodstuffs from the point of view of nutritional and health mentions and "report no 3023 din 15.03.2019", consumer information" to clarify the training agenda address DSP training weaknesses identified during the audit mission and to discuss the new control sheet. After that the thematic action takes place between 04.02- 23.02.2019 and the reporting template will be accompanied by the control sheet (attached to the checklist). MH Point 95, point 90: The results of the thematic actions will be evaluated by the responsible persons from the SSI- MH, according to the procedure for Page: 11 January 2020 to the recommendations of report ref. DG(SANTE)/2018-6410-MR of the audit carried out from

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In relation to recommendation No 14 the audit team noted that not all the test results of chemical parameters required under Directive 98/83/EC were available at the establishments visited. In this regard the CCA explained that the supplier of potable water is a public entity and the official tests for water are under the responsibility of a different Ministry. Even if both, CAs and FBO, requested the public water supplier to provide them with the results of all the analyses carried out, full information on testing was not provided.

In one establishment the FBO had requested a private laboratory to perform a complete analysis for physical-chemical parameters on water recently. The test results were not available yet. Conclusions on the poultry audit

The actions in response to the recommendations No 14 were not implemented as announced. 5.3.2 Red meat audit Recommendations No 6 (health mark) and No 8 (flexibility in small establishments) Findings

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he IDAH (Institute of Diagnosis and Animal Health) organized a laboratory desktop simulation exercise for CSF. The for simulation exercise recommended by the OIE in order to test capacity, capability and contingency planning mission took place in two steps: - In the first step, the IDAH has sent to the SVFSCLs (Sanitary Veterinary and Food Safety County Laboratories) veterinary instructions for the organization of a simulation exercise in their own laboratories and a questionnaire to be answered at the end of this exercise and sent to the NRL. The questionnaires were sent by the IDAH with the Letter No. 7405 from 2 November 2017, fixing the time limit for replies on the 10th of November 2017. The answers to the questionnaires were, practically, the SVFSCL self-evaluation stage. The questionnaires sent to the SVFSCLs requested the information necessary to know the SVFSCLs capacity, capability and reaction possibilities in a CSF crisis conditions, and also to identify the modalities to increase the number of samples that can be tested in crisis situations and the factors that may affect the normal functioning of the diagnostic in crisis situations. - The data and information given by

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In the context of passive surveillance in domestic pigs, the audit team saw examples where laboratories not accredited for RT-PCR forwarded samples to a laboratory which was accredited. In some instances, the arrangements in place resulted in the samples being held for a number of days (at appropriate temperature) in the initial laboratory before they were despatched.

In one county visited, the time between sample submission from found dead wild boar and reporting of RT-PCR results exceeded 9 days. Conclusions on laboratories

Delays in transferring samples between accredited laboratories reduce the possibility to detect outbreaks of CSF at an early stage. 10

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Ministry of Agriculture and Rural Development issued Order 2017 which defines and resize the pig holdings from ldings Romania. tional Sanitary Veterinary and Food Safety Authority issued in rch, Order no. 20/2018 for the approval of the Sanitary terinary Norm regarding biosecurity in pig holdings. is Order regulate the biosecurity measures in the non- ofessional and commercial farms from Romania, since the /2008 Order, regulated only the biosecurity measures in the mmercial farms. At the same time, this new Order is focus on e prohibition of intra-Community trade and export with third untries from non-professional farms. e Order specifies that all trading holdings have to implement e fitting of shoe disinfectors at the entrance and exit to the filter cker, as well as accessories for their mechanical cleaning, as it is ipulated in the biosecurity level which tis connected with.

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In the Type A and backyard holding visited by audit team, biosecurity was rudimentary and there was no availability of disinfection facilities at the entrance to holding as required by Article 6 of Implementing Decision 2013/764/EU. 5 Conclusions on Biosecurity in pig holdings

The many backyard holdings (~ 535,000 containing just under half the domestic pig population) and Type A holdings, with rudimentary biosecurity, represent the most likely route for the introduction of disease to the domestic pig population.

The risk of spread of disease is much greater from Type A holdings as they breed pigs and can have commercial activity (sale of live pigs).

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hrough Service Note no. 25325/12.02.2018, National Sanitary n to Veterinary and Food Safety Authority (NSVFSA) disposed that r the implementation of the Decision no.764/2013/EU, started om the date of this Service Note, to use the certificate model tached for the consignments of live pigs transported from the proved farms, according to the Decision no. 764/2013/UE, tended for slaughter in slaughterhouses/abattoirs from Romania, r intra-community trade with pork, which is complete in point with the following : "c) pigs comply with Article 2a of Page: 3 received 22 May 2018 commendations of report ref. DG(SANTE)/2018-6477-MR of the audit carried out from 25 application of animal health control measures relating to classical swine fever on Proposed by the competent authority ission Implementing Decision 2013/764/EU

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The competent authority confirmed that in 2016 and 2017 there had been no suspicions of CSF reported in domestic pigs ­ this despite clinical signs of African swine fever recorded in two holdings in December 2017 which were subsequently confirmed as African swine fever outbreaks in January 2018.

In one county visited, the competent authority had recently investigated a pig herd where clinical signs included an increased number of abortions, dullness and discolouration of ears. In a second county, a circumscription veterinarian submitted samples from five backyard holdings in the same locality, at the same time, with no indication on submission forms there may be a common disease problem or that the samples should be processed as a priority. Neither event was treated as a suspicion of CSF.

The fact that there was no suspicion on CSF reported in the country in the past two years indicates lack of awareness of both pig keepers and veterinarians towards this disease. This weakens the field surveillance and thus the capacity to detect early the introduction of the virus.

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018, NSVFSA will improve awareness of private and official ications veterinarians to ensure all notifications of clinical and pathological ve of findings in pigs suggestive of CSF result in an official rule investigation to confirm or rule out the presence of the disease ugh service notes or thru organizing a meeting with them. Page: 4

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During the recent potato crop production periods, the NPA and its regional county offices had not organised information campaigns, conferences or any other events on potato bacteria. Extension and/or consultation services to producers or other operators of the potato production and marketing sectors are provided occasionally at the beginning of the potato surveillance period or after ring rot outbreaks.

Non-registered growers usually state that they do not grow potatoes for commercial purposes but only for their own needs or limited local circulation (family consumption or animal feed). According to the data provided, in 2017 there were 49,125 small scale and 5,547 larger scale (more than one ha) producers who were receiving subsidies from 7 the APIA but were not registered with the NPA. This is not in line with the national requirement for registration with the NPA of potato producers with more than 0.5 ha and Article 6.6 of Directive 2000/29/EC.

The audit team came across cases of small scale non-professional producers growing potatoes on more than 0.5 ha who, despite being registered with APIA, stated that they were not aware of the obligatory registration with the NPA or that, in any case, they could not afford the registration fees imposed by the NPA.

Data from the National Statistics Service of Romania indicate that during 2017 ca. 133,600 ha were cultivated with ware potatoes. However, despite a collaboration agreement between the NPA and APIA, there is no consistent access by the NPA to the database of APIA. The producers with ware potato areas totaling more than 0.5 ha who do not comply with the requirement of registration in the phytosanitary database are not known by the NPA. Overall, producers registered with the NPA correspond only to ca. 9.5% of the total ware potato producing area; the majority (ca. 70%) of the area of ware potatoes is grown by operators who are not registered either with the NPA or APIA. Conclusion on organisational aspects of plant health controls

However, only limited awareness raising efforts regarding ring rot and brown rot have been made by the regional competent authorities to inform potato producers. These do not cover adequately the registration requirements when moving or trading potatoes. Despite the legal obligation for their registration with the NPA, registration of producers is not enforced. A large number of producers remain unregistered, and hence, they are not subject to supervision or systematic controls.

As there is lack of communication functionality between the databases of the NPA and the APIA, compliance with phytosanitary registration requirements cannot be verified against the APIA database. This reduces the capacity of the NPA to have a proper overview and control of the current ring rot situation. The consequences of this are compounded by the fact that a very large proportion of the subsidised potato production in Romania is produced from non-tested farm saved material of unknown origin and health status. 8

Despite the elaboration of the "Programme to eradicate and prevent the spread of harmful organisms Cms and Rs", there is currently no concrete target or action plan for the systematic reduction of incidence and the ultimate eradication of ring rot. However, Article 1 of Directive 93/85/EEC requires Member States to take measures in order to eradicate the disease.

At the time of the audit, Romania had not adopted any provisions to promote or subsidise the use of certified seed by producers and had not launched broad information 17 campaigns in order to inform producers on potato diseases. A memorandum had been prepared with suggestions to producers for using certified seed.

During interviews with regional plant health inspectors and potato producers the audit team also noted that: In some cases producers stated that they could not find certified potato seed for sale. In line with the current system of agricultural subsidies, certain ware potato producers might still be eligible for receiving financial support whilst still not registered with the NPA and continue to use non-certified / non-tested potato propagating material, often of unknown origin. Even large scale seed and ware potato producers and wholesalers do not apply any treatments for the preventive disinfection of potato seed transporting vehicles, agricultural machinery, storage facilities or any other farm equipment such as wooden crates in order to avoid cross contamination and spread of potato bacteria; Despite the generally widespread knowledge about the importance of following good hygiene conditions in the places of production, at national level there is no agreed hygiene protocol covering all aspects of potato production, sorting, storage, transport and processing, indicating the details on the succession and the timeframe of actions to be taken. Conclusions on the specific ring rot and brown rot control programme

There is no concrete action plan for the systematic reduction and ultimate eradication of Cms and the measures taken for its control have only temporary and limited effect. Romania has not adopted any additional measures against Cms, such as, actions to promote or subsidise the use of certified or tested seed. Deployment of a hygiene protocol for use at least in places of production of large scale professional producers, distributors and for processors has not been considered. 5.2.4 Documentation and traceability of potato consignments Legal requirements Article 10 of Directive 2000/29/EC. Point 18.5 of Annex IV, Part A, Section II to the same Directive. Article 3 of Directive 2002/56/EC. Findings

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To ensure that the strategy for Clavibacter michiganensis ssp. sepedonicus control will be re-evaluated to aim for a systematic reduction of the incidence and the ultimate eradication in line with Article 1 of Directive 93/85/EEC. In particular, concrete and concerted actions could be taken under Article 11 of the same Directive, such as: a. awareness raising campaigns for informing potato producers about potato bacteria and their obligations for registration with the National Phytosanitary Authority; b. the promotion/obligatory use of certified or ring rot tested seed potatoes; and, c. the implementation of a hygiene protocol to prevent seed cross contamination. Recommendation based on Conclusions 21, 22 and 54. Associated findings 8, 17, 18, 19, 51, 52 and 53

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Evidence presented by CB1 confirmed there was delayed notification to MARD and other CBs of operators who moved from CB1 to other CBs. This is not in line with Article 92(2) of Regulation (EC) No 889/2008. Conclusions on Competent Authorities and Control Bodies

A control system is in place with clearly defined responsibilities for CAs and CBs. There is good cooperation among these players and regular reporting of control results. However, there is delayed notification of major irregularities (see also chapter 5.2.7) and of operators changing their CB. 3 5.2.1.1 Control Bodies: Approval, Supervision and Withdrawal Legal Requirements Article 5(2) and (3) of Regulation (EC) No 882/2004. Article 27(5) to (9) and (14) of Regulation (EC) No 834/2007. Article 92c of Regulation (EC) No 889/2008. Findings

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MARD annually supervises CBs visited. Reports issued are comprehensive and clear deadlines are indicated for CBs to rectify shortcomings. However, the number of witness and review audits by MARD is low in relation to the number of operators controlled by CBs in Romania. Hence, there is a risk that relevant information is not available to the CA for its evaluation of CBs' performance. Moreover, MARD does not verify whether CBs' risk analysis procedure is fit for purpose (see chapter 5.2.3). 5.2.2 Registration of Operators Legal Requirements Article 28(1), (2) and (5) of Council Regulation (EC) No 834/2007. Article 92(2) and 92b of Commission Regulation (EC) No 889/2008. Findings

Both CBs visited have procedures in place for the planning and prioritisation of controls of their operators. These procedures require that all operators receive at least one annual control and that at least 10% of these operators are subject to an annual additional control based on risk evaluation. Risk criteria defined in the CBs procedures in principle include those referred to in Article 65 of Regulation (EC) No 889/2008.

A significant weakness was noted in the risk assessment methodology used by CB1. It turned out that an operator with parallel production of annual crop having a previous major non-compliance could still be categorised as a low risk operator. This has never been contested by the MARD during its supervision of this CB.

It was also noted that the risk assessment undertaken by one individual in CB1 was not supported by documentary evidence and the approach used was considered to lack transparency and objectiveness.

Both CBs visited define the size of farms by only considering the hectares of land under organic management and leave aside the non-organically managed land. Files reviewed by the audit team confirmed that operators with land under organic management had substantially more land under non-organic management and that this situation was not taken into account for the CBs' risk assessment. CB1 classifies processors into small, medium and big operators. However, there is no quantitative measurement of what defines the CB's understanding of a small, medium and big processor in its procedures.

Both CBs visited undertake a risk assessment to prioritise controls to their operators and had fully implemented their planned controls in 2017. Both CBs exceeded by far the minimum level defined in the EU regulation for additional and unannounced controls. However, the CBs risk analysis can lead to some high risk operators being incorrectly categorised and hence not being subject to the required control frequency. 5.2.4 Controls of operators, traceability and labelling Legal Requirements Articles 8 and 9 of Regulation (EC) No 882/2004. Article 18 of Regulation (EC) No 178/2002. Article 23 and 27(13) of Regulation (EC) No 834/2007. Titles II and III of Regulation (EC) No 834/2007. Article 65 of Commission Regulation (EC) No 889/2008. Title II and IV of Regulation (EC) No 889/2008. Findings

Several files were reviewed by the audit team at CB2. A number of the cases related to parallel production, i.e. the growing of the same annual variety as organic and non- organic which is contrary to Article 11 of Regulation (EC) No 834/2007. The CB, in line with its catalogue of enforcement measures, downgraded the affected parcel and the related harvest had to be sold as non-organic which was confirmed during the following inspection. The CB confirmed that this type of non-compliance is frequently detected during on-site inspections. This CB does not require its operators to notify the annual schedule of production of crops prior to its on-site visit (as required in Article 71 of Regulation (EC) No 889/2008). Consequently this information is not available for input into the risk assessment carried out by the CB. 10

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Documentary evidence issued by the CBs visited does not contain information relating to the non-organic activity carried out by their operators. This is not in line with the model of Annex XII to Regulation (EC) No 889/2008. Conclusions on Registration of Operators

Although there is a publicly accessible register of all organic operators, the absence of information relating to some operators' non-organic activities is a weakness. 5.2.3 Planning and Prioritisation of Controls Legal Requirements Article 41 and Article 92f of Regulation (EC) No 882/2004 5 Article 3 of Regulation (EC) No 882/2004 Article 27(3) of Regulation (EC) No 834/2007 Articles 65(1) and (4) of Regulation (EC) No 889/2008 Article 92c(2) of Regulation (EC) No 889/2008 Findings

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CB1 performed traceability on a selected batch of a final organic product and organic raw material stored in a warehouse. Although the CB inspectors undertook many aspects 7 of the tasks in a satisfactory manner, it took a long time for the inspectors to complete the relatively simple exercise. In addition, the inspectors were not familiar filling in the relevant forms provided by the CB.

The operator (referred to in paragraph 49) claimed that he will use the downgraded wheat for seeds in the next production season. During an unannounced inspection on 29.8.2018 CB2 noted that the above mentioned wheat was sold as non-organic. The CB verified the correctness of this action. However, the evidence was the list of harvest and the invoice with the quantities of wheat corresponding to the 2018 harvest of a parcel with 9.98 ha. There was no lot number on the invoice to establish a directly link between the product sold (type, amount) and the product harvested from the parcel in question.

CB1 inspectors appeared to be unfamiliar with the concept of critical processing steps as referred to in Article 26 of Regulation (EC) No 889/2008 according to which the operator shall establish and update procedures based on a systematic identification of critical processing steps and the application of these procedures shall at all times guarantee that the processed products comply with EU organic rules. Nevertheless, inspection reports reviewed by the audit team include references and description of verification of precautionary measures implemented by the operators such as cleaning measures, identification and separation. Yet some shortcomings were noted by the audit team during on-site visits:

At one processor, the raw material was delivered in bulk and stored in silos until processing took place. For the storage of the organic raw material specifically dedicated silos are used, but the same reception area for organic and non-organic raw material. CB2 interviewed the worker who was aware of the importance of cleaning between the delivery of non-organic and organic batches. As no cleaning records were available the CB inspector was unable to verify this. No measures were in place to test the effectiveness of the cleaning measures.

At the same operator, the processing of organic and the packaging of non-organic products took place at the same time and in the same room. For both products, the company used white big bags. There was no label visible on the big white bag which was about to be packaged during the presence of the audit team. The CB inspector focused checks and verification on the ongoing processing of the organic product but did not verify the non-organic activity ongoing at the same time (Article 67(1)(a) of Regulation (EC) No 889/2008. When asked by the audit team, the CB inspector confirmed that the system of separation implemented by the company can be considered 8 sufficiently effective to reduce the risk of (accidental) mixing of organic and non- organic products. Conclusions on Controls of Operators, traceability and labelling

There is room for improvement with regard to traceability checks as well as the verification of the effectiveness of precautionary measures implemented by operators to eliminate the risk of cross-contamination between organic and non-organic products throughout the production/processing flow. 5.2.5 Sampling and laboratory analysis Legal Requirements Article 65(2) of Commission Regulation (EC) No 889/2008. Articles 5(2) and 12 of Regulation (EC) No 882/2004. Findings

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The operator (referred to in paragraph 49) claimed that he will use the downgraded wheat for seeds in the next production season. During an unannounced inspection on 29.8.2018 CB2 noted that the above mentioned wheat was sold as non-organic. The CB verified the correctness of this action. However, the evidence was the list of harvest and the invoice with the quantities of wheat corresponding to the 2018 harvest of a parcel with 9.98 ha. There was no lot number on the invoice to establish a directly link between the product sold (type, amount) and the product harvested from the parcel in question.

CB1 inspectors appeared to be unfamiliar with the concept of critical processing steps as referred to in Article 26 of Regulation (EC) No 889/2008 according to which the operator shall establish and update procedures based on a systematic identification of critical processing steps and the application of these procedures shall at all times guarantee that the processed products comply with EU organic rules. Nevertheless, inspection reports reviewed by the audit team include references and description of verification of precautionary measures implemented by the operators such as cleaning measures, identification and separation. Yet some shortcomings were noted by the audit team during on-site visits:

At one processor, the raw material was delivered in bulk and stored in silos until processing took place. For the storage of the organic raw material specifically dedicated silos are used, but the same reception area for organic and non-organic raw material. CB2 interviewed the worker who was aware of the importance of cleaning between the delivery of non-organic and organic batches. As no cleaning records were available the CB inspector was unable to verify this. No measures were in place to test the effectiveness of the cleaning measures.

During an annual inspection carried out by CB1 on 27.6.2017, the use of non-organic untreated seeds without prior-derogation was detected. On 17.7.2017, the CB notified the operator that the affected harvest of 2017 must not be sold as organic. This was followed up by the CB during the next inspection. The audit team noted that this measure had little effect on the operator as the harvest in question derived from parcels which were still in either the first or the second year of conversion and in any case would not have been eligible to be sold as organic. Nevertheless, the CB downgraded two of the parcels in conversion year two to conversion year one. All other parcels concerned remained in the status of conversion year one. No other measure was taken against the operator. CB1 notified the above major irregularity to the MARD on 21.7.2017, together with a number of other major irregularities (i.e. declassification of land and products) dating back to January, May, June and July 2017. This is not in line with Article 30(2) of Regulation (EC) No 834/2007 requiring an immediate notification of such cases.

An operator (medium risk) was sampled by CB2 during an annual inspection conducted on 17-19.6.2017. The laboratory results (30.6.2017) indicated the presence of Cyproconazole (0.032 mg/kg) and Axoxystrobing (0.015 mg/kg), both fungicides used in wheat production. The CB temporarily suspended the parcel affected and a counter sample was tested (in agreement with the operator) which confirmed the presence of the residue. On 31.7.2017, the CB informed the operator about the decision to downgrade the 2017 harvest of wheat as well as the field affected to conversion year one. The CB blocked the operator's account for the issuing of transaction certificate for organic wheat in the CB's own transparency-check tool. The MARD was only notified of this irregularity on 2.8.2017. The CB's operator list was updated accordingly, i.e. indicating a conversion period from 19.6.2017 to 19.6.2019 for the plot in question. The audit team noted that, despite this severe irregularity, the operator could continue to sell other produce (flax seed) as organic. The CB stated that, according to the catalogue of measures the operator is decertified, i.e. expelled from the system after three such irregularities. The CB also stated that such a situation has never occurred so far. The MARD stated that, following their own audit, one operator has been expelled from the system in the past. The above mentioned operator stopped all organic production in June 2018 following which the entire account of the operator was blocked in the CB's transparency-check database.

CB2 noted parallel production of wheat during an inspection (16.5.2018) at an operator. The MARD was only notified of this severe non-compliance three months later on 9.8.2018, contrary to Article 30(2) of Regulation (EC) No 834/2007. The CB stated that accreditation standards require the confirmation of detected non-compliances to be confirmed by the CB Certification Council before they are notified to the MARD and that operators concerned must be given the opportunity to appeal. 11 Conclusions on Measures in cases of Irregularities and Infringements

There is clear evidence that CBs do not report major non-compliances in a timely manner to MARD and other CBs.

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In 2018, 18 of the samples taken by CB1 contained residues of non-authorised substances. The audit team noted that the presence of residues was confirmed in only four out of the 18 samples. The CB explained that a second sample is usually tested on request of the operator for which he/she bears the costs. The result of the second (counter) sample is considered valid and no third sample is tested to confirm either of the previous results. This practice of resampling and evaluation was not described in any of the CB's procedures. 9 Conclusions on Sampling and Laboratory Analysis

The approach by CB1 in case of positive samples is not laid down in its procedures. This approach does not guarantee that all positive tested samples are treated the same way which can lead to inconsistency in interpretation of sampling results and hence enforcement of organic rules. 5.2.6 Measures in cases of irregularities and infringements Legal Requirements Articles 54 and 55(1) of Regulation (EC) No 882/2004. Articles 27(5)(d) and 30 of Regulation (EC) No 834/2007. Articles 91, 92, 92(a) and 92(d) of Regulation (EC) No 889/2008. Findings

A national catalogue of enforcement measures is annexed to the Ministerial Order No 895/2016. As these rules are rather broad both CBs have further developed catalogues in place which increases the risk of inconsistencies in sanctions for the same type of non- compliances applied by different CBs.

Several files were reviewed by the audit team at CB2. A number of the cases related to parallel production, i.e. the growing of the same annual variety as organic and non- organic which is contrary to Article 11 of Regulation (EC) No 834/2007. The CB, in line with its catalogue of enforcement measures, downgraded the affected parcel and the related harvest had to be sold as non-organic which was confirmed during the following inspection. The CB confirmed that this type of non-compliance is frequently detected during on-site inspections. This CB does not require its operators to notify the annual schedule of production of crops prior to its on-site visit (as required in Article 71 of Regulation (EC) No 889/2008). Consequently this information is not available for input into the risk assessment carried out by the CB. 10

During an annual inspection carried out by CB1 on 27.6.2017, the use of non-organic untreated seeds without prior-derogation was detected. On 17.7.2017, the CB notified the operator that the affected harvest of 2017 must not be sold as organic. This was followed up by the CB during the next inspection. The audit team noted that this measure had little effect on the operator as the harvest in question derived from parcels which were still in either the first or the second year of conversion and in any case would not have been eligible to be sold as organic. Nevertheless, the CB downgraded two of the parcels in conversion year two to conversion year one. All other parcels concerned remained in the status of conversion year one. No other measure was taken against the operator. CB1 notified the above major irregularity to the MARD on 21.7.2017, together with a number of other major irregularities (i.e. declassification of land and products) dating back to January, May, June and July 2017. This is not in line with Article 30(2) of Regulation (EC) No 834/2007 requiring an immediate notification of such cases.

An operator (medium risk) was sampled by CB2 during an annual inspection conducted on 17-19.6.2017. The laboratory results (30.6.2017) indicated the presence of Cyproconazole (0.032 mg/kg) and Axoxystrobing (0.015 mg/kg), both fungicides used in wheat production. The CB temporarily suspended the parcel affected and a counter sample was tested (in agreement with the operator) which confirmed the presence of the residue. On 31.7.2017, the CB informed the operator about the decision to downgrade the 2017 harvest of wheat as well as the field affected to conversion year one. The CB blocked the operator's account for the issuing of transaction certificate for organic wheat in the CB's own transparency-check tool. The MARD was only notified of this irregularity on 2.8.2017. The CB's operator list was updated accordingly, i.e. indicating a conversion period from 19.6.2017 to 19.6.2019 for the plot in question. The audit team noted that, despite this severe irregularity, the operator could continue to sell other produce (flax seed) as organic. The CB stated that, according to the catalogue of measures the operator is decertified, i.e. expelled from the system after three such irregularities. The CB also stated that such a situation has never occurred so far. The MARD stated that, following their own audit, one operator has been expelled from the system in the past. The above mentioned operator stopped all organic production in June 2018 following which the entire account of the operator was blocked in the CB's transparency-check database.

CB2 noted parallel production of wheat during an inspection (16.5.2018) at an operator. The MARD was only notified of this severe non-compliance three months later on 9.8.2018, contrary to Article 30(2) of Regulation (EC) No 834/2007. The CB stated that accreditation standards require the confirmation of detected non-compliances to be confirmed by the CB Certification Council before they are notified to the MARD and that operators concerned must be given the opportunity to appeal. 11 Conclusions on Measures in cases of Irregularities and Infringements

A catalogue has been provided by the MARD. As these rules are rather broad CBs have further developed catalogues in place increasing the risk of inconsistencies in sanctions applied for the same type of non-compliances by different CBs.

Operators continue to be non-compliant in particular in relation to parallel production and application for derogations which is indicative that sanctions are not sufficiently dissuasive. 6 OVERALL CONCLUSIONS. The CA has made considerable progress in implementing official controls for organic production and labelling of organic products since the first Commission audit in 2013. There are however still some serious weaknesses. Although there is annual supervision by the CA and reports are comprehensive with clear deadlines for the rectification of shortcomings, the number of witness and review audits is low in relation to the number of operators controlled by CBs in Romania. There is a risk that the CA is not furnished with sufficient information to thoroughly assess the CBs performance of official controls in the organic sector. The CBs' risk analysis do not always guarantee that all high risk operators are identified and hence controlled with the appropriate frequency. For example, a major irregularity by an operator in a year does not necessarily lead to an increased control frequency of the operator in question in the following year. CBs are overly focussed on controlling the organic activities of operators and have a tendency to overlook the significance of the operators' non-organic activities. Such an approach also leads to a bias in the risk assessment. Operators were sanctioned in line with the CBs enforcement procedures and in response to major non-compliances such as parallel production of annual crops. Yet such sanctions had little impact on the operators' behaviour. This situation may be due to the fact that, in Romania, many organic operators are entities with large non-organic and a much smaller organic activity. The economic impact of product decertification is low in such circumstances. In addition, operators were rarely suspended.

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The veterinary authorities carried out a preliminary study in 18 counties at highest risk of ASF introduction to assess the impact and feasibility of implementing the new biosecurity rules. Key findings and conclusions reported include: a. A lack of awareness of the new biosecurity requirements among pig keepers, particularly on non-commercial holdings that have infrequent contact with veterinarians; b. Unregistered movements of live pigs between non-commercial holdings without notifying the authorised free practice veterinarian; c. Practical difficulties for veterinary inspectors to distinguish non-commercial holdings that engage in local trading activities from those that keep pigs solely for personal use; d. Many commercial farms in the 'medium farm size' group did not have the required biosecurity programmes in place; e. Compliance with biosecurity requirements on some industrial commercial farms was not satisfactory; f. The targeted enforcement of the biosecurity rules on commercial holdings (type A and industrial) is feasible. This may not be the case for non-commercial holdings.

Prior to the introduction of the new biosecurity rules referred to above (paragraph 1), biosecurity controls on non-commercial holdings were not performed.

According to information provided by the veterinary authorities, approximately 47% of the total pig population (approximately 4.3 million head) are kept by non-commercial keepers on 630 000 holdings. Most of these keepers own less than five pigs, which are kept for personal consumption. However, there is no legal limit and significantly larger numbers of animals may also be kept.

To illustrate this, ADNS reports indicate that at least 1 095 ASF outbreaks occurred on non-commercial holdings between June and November. The vast majority of these outbreaks occurred in holdings keeping one or two pigs. However, 136 outbreaks occurred on non-commercial holdings keeping between 21 and 100 pigs and 15 outbreaks occurred on non-commercial holdings keeping more than 100 pigs.

High levels of non-compliance with Union pig identification, registration and movement notification requirements on non-commercial holdings have been reported in several Commission audit reports. Most recently, mission report DG(SANCO) 2014-7045 included a specific recommendation4 on the subject.

The veterinary authorities have not taken appropriate actions to enforce the legal requirements nor to apply proportionate and dissuasive sanctions in cases of non- compliance, as required by Articles 54 and 55 of Regulation (EC) No 882/2004 respectively.

The absence of reliable data on the location and movement of pigs within the non- commercial sector means that it is often not possible to trace animals that could have carried ASF virus to or from outbreak holdings. It also means that it is not possible for the veterinary authorities to enforce the prohibition to dispatch live pigs originating from the areas included in the Part III territory in the case of non-commercial holdings.

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The operational manual provides instructions on the completion of the epidemiological inquiry: a. Detailed templates (Forms B.7 and B.8) should be used to prepare the initial and final epidemiological inquiry in the case of larger outbreaks (typically on holdings keeping more than 20 pigs). b. In the case of smaller outbreaks an abbreviated epidemiological report template (Form A.4) should be used. It collects contact details for the holding and records basic information about the farm collected during the initial interviews with the animal keeper and local free practice veterinarian.

The audit team reviewed the epidemiological inquiries carried out for several outbreaks on non-commercial pig holdings. In no case did the veterinary authorities trace the movement of persons, vehicles, pigs, carcases, semen, meat and other materials which could have carried the virus to or from the holdings in question, which is not in line with the requirement established in Article 8 of Council Directive 2002/60/EC.

The lack of thorough epidemiological inquiries on non-commercial holdings, which account for more than 90% of all ASF outbreaks, means that opportunities are missed to intercept infected live animals and contaminated products before they spread disease to previously uninfected areas.

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However, they do not specify the checks they should be made to verify compliance with the conditions (30 day residency, negative laboratory test results or regular holding inspections) that the live pigs must satisfy in order for their meat to be placed on the national market.

Furthermore, the service notes do not require official veterinarians responsible for holdings of origin to declare that these conditions have been verified in the documents that accompany the animals to the slaughterhouse. Consequently, official veterinarians responsible for applying health marks and/or certifying that the fresh meat has been produced from eligible animals are not in possession of all necessary information.

The audit team examined the documents that accompanied slaughtered pigs originating within the Part III territory. They had been completed in accordance with the service notes and did not include all necessary information concerning the eligibility of the animals.

Live pigs and their products coming from non-commercial holdings located in the areas defined in Part III of the annex to Commission Implementing Decision 2014/709/EU are entering the national market. This has allowed the disease to spread long distances to counties that were previously free of disease.

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The audit procedure developed by the TAS (Code PS-01-DATC) sets out how to develop the multi-annual / annual audit programme. The main criteria taken into account for its development are as follows: - the areas of NSVFSA competence (the competent authority has defined 33 areas of official controls but this list does not appear in the audit-related procedures) 12 - the results of internal and external audits conducted in previous years - changes in legislation - changes in the organisation of structures involved in the control systems - the national and international epidemiological situation in the area of animal health - the evolution of various animal diseases - NSVFSA policies on the eradication of certain animal diseases - the results of the implementation of the MANCP - the number and size of farms, food establishments, and statistical data on production, imports etc. - rapid alert system for food and feed (RASFF) notifications (this criterion is included in the audit procedure but is not currently used as input for the audit programming ­ the Audit Directorate stated that it would be used in the future) - new scientific data, risk assessments. Whilst the procedure is clear, there are gaps in the way the TAS documents the steps it takes to justify how it draws up the programme using the procedure. Based on the TAS representatives' statements, they partially use the procedure but they do not clearly record how they arrive from the plan to the presentation of the audit programme.

Whilst the audit universe has been defined (albeit not well-documented), the risk universe has not. Out of the 33 areas identified in the audit universe, 16 of these are related to specific animal health issues, two are related to animal welfare issues, and the remaining 15 cover very broad categories such as border inspection posts, food hygiene under Regulation (EC) No 852/2004, poultry meat and derivatives thereof, etc. When the official control areas have not been subject to a detailed breakdown, as is the case with all the areas identified in the audit universe excepting animal health, it is difficult to properly define the risks, as different aspects (e.g. product, process, establishment type etc.) will present a different level of risk. Furthermore, there is no methodology in place to assign a risk ranking to each aspect. For example, in the case of food hygiene, the TAS did not break this area down into official controls in different types of establishment (mobile food sellers, restaurants, primary production, processing plants, wholesalers, retailers, mass catering etc.), size of establishment/volume of production, production processes etc. In the example given, the TAS could not therefore justify why official controls in slaughterhouses, for example, were considered a higher risk than those in restaurants.

The TAS had planned to audit some areas more than once in the five year audit programme cycle but could not demonstrate why some areas were prioritised over others, except for the ad-hoc audits ordered by the President of the NSVFSA. The concept of 'adequate coverage of all relevant areas of activity' of point 5.1 of Decision 2006/677/EC was taken to mean 'audit' of all relevant areas, rather than risk-based consideration of all relevant areas. 14

The approach to risk-based planning is inadequately documented and defined. There is no recorded risk analysis methodology to describe the areas in sufficient detail, and the relevant process is not documented or transparent. Therefore, the TAS could not demonstrate the risk basis for the frequency of auditing some areas nor justify the exclusion of other areas.

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The CA confirmed that they do not undertake any shadow audits of the CB inspectors as part of their supervisory activities. A representative of MARD may occasionally attend the RENAR accreditation audit of a CB as an observer. An accreditation audit occurs once every four years for each CB. However, as no judgement is made by the CA in these observation roles, it cannot be considered to be part of the supervisory activity of the CB. 5

The audit team reviewed a number of the reports prepared by the CA relating to the CB office audits. These mainly describe the findings that the CBs have observed during producers/processor inspections during the previous year. However, the CA does not evaluate the activities of the CB.

The fact that the CA does not carry out any witness audits of the CB inspectors at the operator level does not permit the CA to evaluate the effectiveness of inspections carried out by CBs. This lack of supervisory activities by the CA is not in line with Article 5(3) of Regulation (EC) No 882/2004. The audit team noted some systematic shortcomings in the inspections carried out by the CBs (see paras 33, 34 and 35). Such shortcoming could only be detected through carrying out such witness inspections. Conclusions on Control Bodies

The CA delegates certain official control tasks to CBs which are accredited to ISO17065. Supervision of the CBs by the CA is not fully effective as the supervisory process does not include witness inspections, which is not in line with Article 5(3) of Regulation (EC) No 882/2004. 5.2.3 Prioritisation of Official Controls Legal requirements Articles 37(1) and 38 of Regulation (EU) No 1151/2012. Article 3 of Regulation (EC) No 882/2004. Articles 22(1) and 24 of Regulation (EC) No 110/2008. Findings

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Given the relatively small number of producers/processors of PDO/PGI agriproducts and foodstuffs and GI spirit drinks in Romania the approach taken has been to subject all producers/processors to an annual official control. At the time of the audit the official controls for agriproducts and foodstuffs were delegated to CBs whereas official controls of spirit drinks were undertaken by the CA. The CCA confirmed that all annual official controls at producers/processor level for both types of registered names are announced. 6 This is not in line with Article 3(2) of Regulation (EC) No 882/2004 which states that official controls shall be carried out without prior warning.

All annual official controls of producers/processors of PDO/PGI/TSG agriproducts and foodstuffs and GI spirit drinks are announced which is not in line with Article 3(2) of Regulation (EC) No 882/2004

The audit team visited two producers of PDO/PGI/TSG agriproducts and foodstuffs and three producers of GI spirit drinks. In all cases, a series of inspection reports were available which illustrated that all producers/processors were subject to an annual official control. The audit team was informed that all inspections at operators whether carried out by CAs (spirit drinks) or CBs (agriproducts and foodstuffs) are announced. The CA stated that this approach ensured that inspections take place at the time of processing and that all relevant documents are prepared by the operators. 8 Agriproducts and Foodstuffs ­ Controls Undertaken by CBs

Although official controls are undertaken at an agreed frequency at producers/processors, the inspections are announced, superficial and do not always include each element of the Product Specification/Technical Files. Consequently, this approach does not provide the necessary level of assurance that producers/processors are fully compliant. 5.2.6 Enforcement Measures Legal Requirements Article 13(3) of Regulation (EU) No 1151/2012. Articles 54 and 55 of Regulation (EC) No 882/2004. Article 24 of Regulation (EC) No 110/2008 Findings

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At the time of the audit, there were no risk based market controls in place which is not in line with Article 38 of Regulation (EU) No 1151/2012. Verification of compliance with product specification and specifications in the technical file prior to placing a product on the market

At the time of the audit, the CA confirmed that there were no risk based market controls in place in Romania. However, the NACP undertakes investigations of ad-hoc consumer complaints as they arise. A number of case studies were described by the NACP which illustrated their competence to investigate and to sanction where appropriate. One complicated investigation related to a registered name from a non-EU country. The NACP had received a complaint that coffee which was not the genuine article had been traded in Romania. The NACP successfully identified the source of the problem and implemented the relevant enforcement measures. 7 Conclusions on Prioritisation of Official Controls

Routine risk based market controls of PDO/PGI/TSG agriproducts and foodstuffs and GI spirit drinks were not included in the prioritisation of official controls at the time of the audit. 5.2.4 Procedures and Performance of Official Control Activities Legal Requirements Articles 12, 13(1), 23, 24(1), 36(3), 44 and 46(1) of Regulation (EU) No 1151/2012. Commission Delegated Regulation (EU) No 664/2014, in particular Article 1. Commission implementing Regulation (EU) No 668/2014, in particular Article 4. Article 18 of Regulation (EC) No 178/2002. Articles 8(1), 9 and 10(2)(b)(vi) of Regulation (EC) No 882/2004. Regulation (EU) No 1169/2011. Article 22(1) of Regulation (EC) No 110/2008. Findings Controls at Visited Premises

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In relation to spirit drinks, the annual official control at producers/processors did not include the checking of all elements of the technical file and neither did it include, sampling, for laboratory analysis. This could not ensure compliance with Article 22(1) of Regulation (EC) No 110/2008.

The lack of official sampling and laboratory analysis of spirit drinks means that the requirements of Article 22(1) of Regulation (EC) No 110/2008 are not met.

It was noted that raw materials were accepted on the basis of a general declaration by the supplier, that the raw materials complied with the requirements of the Product Specification. As an example, the CB never raised a non-compliance regarding the absence of labelling of a specific raw material. This acceptance signifies a lack of control measures.

In the spirit drink producers visited, although the operators kept records as regards the production, as well as purchase and sales records, no verification of the information in these were made by the inspectors. The inspectors stated that such controls were undertaken by the revenue authorities. 9

Although official controls are undertaken at an agreed frequency at producers/processors, the inspections are announced, superficial and do not always include each element of the Product Specification/Technical Files. Consequently, this approach does not provide the necessary level of assurance that producers/processors are fully compliant. 5.2.6 Enforcement Measures Legal Requirements Article 13(3) of Regulation (EU) No 1151/2012. Articles 54 and 55 of Regulation (EC) No 882/2004. Article 24 of Regulation (EC) No 110/2008 Findings

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The current multi-annual programme requires sampling and laboratory analysis of domestic pigs found sick or dead, from non-commercial holdings across the entire territory of Romania, where classical and ASF could not be ruled out (passive surveillance). This surveillance does not apply to commercial holdings.

In two industrial commercial farms visited by the audit team, the private veterinarians providing a service had both submitted in 2016, pig carcases to regional laboratories for post mortem examination. In both cases the veterinarian had requested classical swine fever testing but not ASF testing. The authorities confirmed that samples submitted for classical swine fever testing were paid by the authorities but ASF analysis in commercial industrial farms had to be paid by farmer. In contrast, backyard holdings do not have to pay for ASF testing.

The competent authority provided results of passive surveillance in domestic pigs: County 2015 2016 Botosani 0 58 Galati 14 140 Iasi 23 24 Maramures 40 74 Satu Mare 0 103 Suceava 22 126 Vaslui 20 43 Tulcea 33 62 Total 630 152

The number of passive surveillance samples taken has increased between 2015 and 2016. In the counties visited, the audit team confirmed that the majority of these samples were from non-commercial holdings. 10

Should the disease enter the domestic pig population, passive surveillance is more likely to detect it early in backyard holdings, while in commercial holdings, detection will be probably delayed due to the absence of passive surveillance. The existing long laboratory turnaround times hamper early detection and if they persist once the disease is detected, these will create difficulties in the containment of disease.

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The current multi-annual programme (2016 - 2018) for the surveillance and control of ASF requires sampling and laboratory analysis of all wild boar found dead or sick and those killed in road traffic accidents from the entire territory of Romania (passive surveillance). In normal conditions it is expected that the minimum number of wild boar to be found in a given area is ~ 1% of wild boar population at risk. Based on this, the minimum number of wild boar sampled in the eight at risk counties in 2016 should have been ~170 (Total wild boar population was 17021). Additionally, in the eight at risk counties, the programme requires sampling and analysis (by polymerase chain reaction (PCR) and Enzyme-linked immunosorbent assay (ELISA)) for ASF in all hunted wild boar (active surveillance). The competent authority provided numbers of wild boar sampled under active and passive surveillance, in the eight at risk counties: 2015 2016 County Active Passive Active Passive surveillance surveillance surveillance surveillance Botosani Galati 60 0 355 2 Iasi Maramures 140 21 211 10 Satu Mare Suceava 306 0 414 3 Vaslui Tulcea 551 0 738 12 TOTAL 580 0 848 3 339 0 455 4 55 0 271 2 103 0 128 0 2,134 21 3,420 36 8 Passive surveillance

Finding dead wild boars is a challenge due to the large numbers of natural predators, cannibalism by the wild boar themselves and the tendency for dying wild boar to seek secluded areas where it is difficult to find them. Currently, there are no incentives encouraging hunters to overcome this challenge, on the contrary (a) hunters are expected to transport found dead wild boar to the nearest laboratory at their own expense and (b) hunters lose one animal from their hunting bag for each found dead wild boar reported.

The competent authority plans to incentivise reporting of found dead wild boar but cannot implement financial incentives until the budget is approved in line with National Decision 1156/2013 which lays down the budget for all animal disease control in Romania. They indicated this would take at least 60 days.

In 2015, Romania collected a low number of passive surveillance samples - all from one county. In 2016, the situation improved slightly with most at risk counties submitting samples. The numbers of samples submitted is well below the estimates for meaningful passive surveillance and early detection of disease. Active surveillance

The current surveillance programme on wild boars, in particular the poor passive surveillance, does not provide confidence that ASF would be detected at an early stage following introduction. This will delay the detection of the disease and thus the implementation of control measures, increasing the risk for further spread into domestic pigs, particularly into backyard holdings.

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Only domestic pigs from non-commercial holdings, submitted to regional laboratories for classical swine fever passive surveillance, are routinely tested for ASF. When at 2 King et al, 2003 3 Fernandez-Pinero et al, 2013 11 regional level, a sample tests negative to classical swine fever, the samples are then sent to the NRL for ASF testing. The audit team reviewed laboratory reports in Iasi. The interval between initial submission of samples to the laboratory network and reporting of results was up to one month ­ despite haemorrhagic lesions being identified at post- mortem examination in regional laboratory. This does not meet the objectives of the approved programme for early detection of ASF.

The audit team reviewed the 2017 laboratory reports in Satu Mare for passive surveillance in domestic pigs. They showed delays in submission of samples from the regional laboratory to the NRL of up to two weeks. Results of ASF testing were available on the laboratory information management system within two days of receipt by the NRL, but it took another ten days before regional staff became aware of these results.

Should the disease enter the domestic pig population, passive surveillance is more likely to detect it early in backyard holdings, while in commercial holdings, detection will be probably delayed due to the absence of passive surveillance. The existing long laboratory turnaround times hamper early detection and if they persist once the disease is detected, these will create difficulties in the containment of disease.

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None of the four backyard or commercial type A holdings visited by the audit team had an up-to-date register of movements, which is not in line with Article 4(1) of Directive 2008/71/EC ­ this issue was previously identified in DG(SANCO)2014-7045. In contrast, the two industrial commercial farms visited had comprehensive records available showing e.g. movements, daily mortalities and the number and weight of dead pigs sent for rendering.

Circumscription veterinarians perform an annual census on all holdings which includes pigs. If the database has pigs recorded as being present on a holding but the animals are not in the farm when the annual census is done, the circumscription veterinarian moves these animals to a virtual holding ­ named RO0000000000. The authorities confirmed that in 2016, the number of pigs that moved into virtual holding was 1,302,501. 5.3.3 Simulation exercises

Although identification and movement controls for pigs go generally beyond EU legal requirements, the absence of records such as holding registers, geographic co-ordinates and field for sanitary information together with the large numbers of backyard pigs moving to a "virtual holding" (i.e. with an unknown destination) will significantly weaken the tracing of pigs and containment of disease in an outbreak scenario.

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Six out of the eight counties at risk have wild boar densities between 0.25 ­ 0.5 / km². The two remaining counties have wild boar densities between 0.5 ­ 0.75 / km² (see map below). The current ASF strategy for the eastern part of the EU considers a wild boar density of 0.5 wild boar / km² or lower as optimal to reduce the spread of ASF.

Wild boar densities are calculated on the total surface area of a county rather than the area of suitable biotype for wild boar (forest and agricultural land) within the county. Consequently, this does not reflect the true density.

Trends for national wild boar populations provided by competent authorities demonstrate a year on year increase in the wild boar population (see graph). EVOLUTION OF WILD BOARS POPULATION ­ 2008-2015

County representatives of the Ministry of Water and Forestry record census results for each individual hunting ground. The audit team reviewed detailed records in one county visited showing actual and optimum wild boar densities (calculated by the Ministry of 4 Water and Forestry) by individual hunting ground and data relating to hunting quotas approved and actually achieved. In all 55 hunting grounds in one county, the actual number of wild boar exceeded the optimal number calculated for the particular biotype. For the period reviewed, 2015 and 2016, wild boar numbers were shown to increase.

National legislation (Decision No. 830 of 9 November 2016) approves the national programme for the surveillance, prevention and control of ASF in the country. Article 28 applies to wild boar populations and includes e.g. prohibiting feeding of wild boars and selective hunting of females aimed at achieving a wild boar density of < 0.5 / km². The competent authority confirmed that these measures will only be applied on confirmation of the first case of ASF.

The existing contracts between the Ministry of Water and Forestry and hunting ground managers are contributing to a year on year increase in the wild boar population with no evidence of arrangements in place between Ministry of Water and Forestry and the NSVFSA to reverse this trend. This increasing population will favour the spread of ASF and create difficulties in its elimination and control should the disease reach Romania.

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Competent authorities confirmed that the national database for animals, SNIIA, does not contain a complete record of geographic co-ordinates for all registered pig holdings as required by Article 1 (1)(d) to Commission Decision 2000/678/EC.

The database does not have a field where the competent authority could enter sanitary information, which is not in line with Article 1(e) to Commission Decision 2000/678/EC. Consequently, the database cannot be used for implementation and verification of ASF movement restrictions.

Although identification and movement controls for pigs go generally beyond EU legal requirements, the absence of records such as holding registers, geographic co-ordinates and field for sanitary information together with the large numbers of backyard pigs moving to a "virtual holding" (i.e. with an unknown destination) will significantly weaken the tracing of pigs and containment of disease in an outbreak scenario.

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A sampling procedure to ensure risk-based testing of imported animals through the Airport Bucharest Henri Coand in accordance with Part III of Annex II to Decision 97/794/EC had not been developed at the time of the audit although the staff was aware about these requirements. This is not in line with Article 8(1) of Regulation (EC) No 882/2004.

Some procedures and contracts were still under preparation at the time of the audit and were therefore not possible to evaluate. Some procedures were missing altogether and others were insufficient, e.g. procedures for cleaning, disinfection, pest control and sampling of the imported animals. Such gaps could affect the implementation of official controls if they are not resolved before the BIP is approved.

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the - According with the provisions of art. 8, para. 1 of Regulation no. 882/2004, it will be issued a procedure to ensure risk-based testing of imported animals through the Airport Bucharest henri Coanda, in accordance with Part III of Annex II to Decision 97/794/EC. - In order to implement the above mentioned procedure, it was initiated the aquisition procedure of the services of blood sampling, treatment of animals, quarantine of cats, dogs, ferrets and animal euthanasia. - It has already submitted to the aquisition department the Necessity Note, approved by the management of NSVFSA, no. 144/20.01.2017. - Estimated deadline: 30.09.2017

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In 2014 and 2016 the number of caecal samples to be taken from turkey slaughterhouses was not calculated correctly. This is because for this calculation, the only turkey slaughterhouse in the country was treated as a broiler slaughterhouse. As a result, the number of samples allocated for turkey ceca was significantly lower than the one necessary to obtain the required isolates. This does not meet the requirements of point

The competent authority has documented procedures in place to support the implementation of most of the provisions laid down in the legislation. However, delays in the inception of the sampling plan, shortcomings in the proportional allocation of samples and in the selection of the epidemiological units to be sampled, undermine the representativeness of the samples taken. 5.2.2 OFFICIAL LABORATORIES Legal requirements Article 10 of Directive 2003/99/EC; Article 4 and Annex Part A.5 of Decision 2013/652/EU. Article 33 of Regulation (EC) No 882/2004. Findings

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For 2017 the Decision Grant for Antimicrobial Resistance cision monitoring provides sampling slaughterhouse and retail samples from pigs and bovines. For the year of 2018, when sampling will address poultry and turkeys, the National Sanitary Veterinary and Food Safety Authority will implement, in relation to point 2.2 of Part A of the Annex to Decision 2013/652/EU, a separate allocation of samples for turkeys than for broilers, so that the minimum number of isolates for turkeys will be obtained.

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Contrary to the requirements set out in part A of the Annex to Decision 2013/652/EU, the AMR monitoring programme did not ensure that samples were distributed over each month of the year. Instead, monthly sampling took place from March to December in 2014 and from May to December in 2015 and 2016. The competent authority informed the audit team that the monitoring plan was issued only when the Grant Decision, which details the EU funds that would become available for co-financing of the plan, was published. NSVFSA stated that they will consider the possibility to have bi-annual financial plans to avoid this issue reoccurring.

The annual Service Notices state that sampling days should be limited from Monday to Wednesday to ensure that the laboratory starts processing the samples within 48 hours of collection. In the slaughterhouses visited, officials took most of the samples on Mondays. This cannot be considered random and therefore is not in line with point 2.3 of Decision 2013/652/EU.

The Service Notices state that repeated epidemiological units cannot be sampled. Nevertheless, the epidemiological unit definition given therein is not fully in line with Decision 2013/652/EU. As a consequence, in two of the three slaughterhouses visited, the audit team noticed a few examples of repeated epidemiological units sampled. This is not in line with point 2.3.1 of Part A of the Annex to Decision 2013/652/EU.

According to the explanation provided by NSVFSA on this issue, the decision to select these counties was mainly based on the consumption of fresh meat therein. However, 6 the competent authorities did not present any consumption data to show that the actual county selection ensured representativeness. Moreover, the audit team noted that the population in the selected counties was far below the 80% required by EFSA guidance document 2014 representing 54% and 49% for 2015 and 2016, respectively. Therefore, it cannot be concluded that as required by Article 2.2 and point 1 of part A of the Annex to Decision 2013/652/EU, the isolates obtained were representative.

The competent authority has documented procedures in place to support the implementation of most of the provisions laid down in the legislation. However, delays in the inception of the sampling plan, shortcomings in the proportional allocation of samples and in the selection of the epidemiological units to be sampled, undermine the representativeness of the samples taken. 5.2.2 OFFICIAL LABORATORIES Legal requirements Article 10 of Directive 2003/99/EC; Article 4 and Annex Part A.5 of Decision 2013/652/EU. Article 33 of Regulation (EC) No 882/2004. Findings

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required Concerning the actions of avoiding the repeated sampling the n same epidemiological units, the National Sanitary Veterinary and atedly Food Safety Authority has revised, through a Service Note, the information on the number of farms supplying each slaughterhouse. included in the program, as well as the data on the capacities and production of the slaughterhouses. As a result of these actions, the National Sanitary Veterinary and Food Safety Authority has established the allocation for the number of samples for each slaughterhouse in accordance with the observations and reccommendations of the audit mission.

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While the procedures in place were generally in line with the relevant standards, the audit team noted the following: County laboratory: o There were no procedures in place to perform regularly colony counts on inoculum suspensions as requested by ISO 20776-1:2006 and Clinical and Laboratory Standards Institute (CLSI) M07, which are the standards required by point 3 of Part A of the Annex to Decision 2013/652/EU, in order to ensure that the required final inoculum concentration was obtained and therefore the test wells contain an adequate number of cells. o Incubation time and temperatures for MIC determination were not performed fully in line with ISO 20776:2006 or CLSI standards. The time/temperature defined for incubation included small deviations from the above standards. These deviations were not validated in order to ensure that they have no effect on the MIC values obtained. o Despite the corrective action plan mentioned above requiring regular weighing of the microtiter plates to ensure that the wells contain adequate media volume, this procedure was not taking place. o The reference strains were widely used but not when a few isolates were tested, contrary to what is required by ISO 20776-1:2006 and CLSI M07. No validation has been made for this reduced use of the control strains. o The procedures for the media validation for the selective growth of ESBL-, or AmpC producing E. coli were not fully in line with the EURL protocol as required by point 4 of Part A of the Annex to Decision 2013/652/EU. Although the reference strains were regularly used to validate the media after its preparation, the shelf life validation was not performed and documented. This issue was also identified in the IDAH. 9 o Despite being performed correctly, the documented procedures did not detail how to use the automatic reading device to ensure that the epidemiological cut-off points prescribed in Decision 2013/652/EU were applied in the interpretation of the MIC determination. IDAH - NRL for AMR o The incubation time and temperatures for MIC determination were not fully in line with the requirements of the CLSI standard (M45). In particular, the conditions defined for incubation of Campylobacter included deviations by up to 4 hours. Despite the results observed, the reference strains were within the expected range, these deviations were not validated to ensure that they have no effect on the MIC values obtained. o The equipment used to measure the density of the inoculum allows for a considerable variation in the density of the inoculum suspension, which is not in line with the EURL recommendation. o The procedures in place did not ensure that unusual results, which should trigger the repetition of the test as they may indicate that the method did not work appropriately, were not reported to EFSA. IHVPH - NRL for AMR o The procedures for detection of presumptive E. coli producing ESBL and AmpC enzymes were not fully in line with the EURL protocol, as required by point 4 of Part A of the Annex to Decision 2013/652/EU. Two colonies gathered from the first selective media were sub-cultured directly on a non-selective media rather than on a second selective media as required by the EURL protocol. o While the colony counts take place regularly in line with the international standards, the records kept provided limited information as they did not allow a trend evaluation to be performed. o There was no external calibration by an accredited body to ascertain the volume of inoculum added to the plate wells by the auto-inoculator. Moreover, no alternative methods to obtain this information (for instance, through periodic control of the weight of the filled microdilution plates) were developed. o The use of reference strains for the MIC determination was not fully in line with requirements ISO 20776-1:2006 and CLSI M07, as required by point 3 of Part A of the Annex to Decision 2013/652/EU. For instance, the reference strain was used monthly, instead o

A laboratory network of designated official laboratories is in place for official monitoring of AMR. Laboratories are accredited and participate regularly in proficiency tests with satisfactory results. Whilst considerable improvements were noted since the implementation of the monitoring plan, some weaknesses of the quality control system in place, notably the insufficient use of reference strains and some deviations to the standard procedures, could undermine the reliability of the monitoring results obtained.

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rmance Caecal samples: s and Regarding your findings and recommendations we took the owing measures: t in point 3 It was revised the worksheet (Cod: F169/ed3/rev4/December y 2016) for Campylobacter AST, according to the requirements of the CLSI standard (M45). The report for validation of the procedure is ongoing. The previous validation of the Page: 1 t authority on 7 April 2017 e in a separate annex as follows: _reports/details.cfm?rep_id=3789 of report ref. DG(SANTE)/2016-8677-MR of the audit carried out from 5 to 15 icrobial resistance in zoonotic and commensal bacteria in certain food-producing me and 015 and ts, were he dium tubes ty testing, ce mber 2016.pdf k the cording the dillution plates he equipment nation are ential unusual luded in the ined, the sult is port the procedure Page: 2 t authority on 7 April 2017 e in a separate annex as follows: _reports/details.cfm?rep_id=3789 of report ref. DG(SANTE)/2016-8677-MR of the audit carried out from 5 to 15 icrobial resistance in zoonotic and commensal bacteria in certain food-producing Page: 3

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The NSVFSA informed the audit team that currently legal obstacles in Romanian legislation make it impossible to approve sprouting establishments as required by Article 2 of Regulation (EU) No 210/2013. The NSVFSA expects that this impediment to approval will be removed by July 2016.

Sprouting establishments are registered based on a procedure established in Chapter III "Production of food of non-animal origin" of NSVFSA Order no. 111/2008, and included in Chapter III - Annex 9 ­ "Production of food of non-animal origin". The Food Business Operator (FBO) must submit an application to the CSVFSD. The application contains: a written request, the plan of the establishment, a copy of the registration certificate issued by the Commerce Register or other documents specific for the organisation form, and a copy of the identity card of the owner or legal representative of the establishment. The CSVFSD inspectors perform a documentary check and an on-site visit in order to verify the compliance with legislation on food safety. The inspectors complete a report in which they can propose not to register the FBO, in case of non-compliance with food safety legislation. If this is the case, the inspection report will set remedial measures and terms for compliance.

Legislation concerning registration is in place for sprout producers setting out the legal requirements for approval, however, this is not in compliance with Article 2 of Regulation (EU) No 210/2013. 5.2.3 Organisation and Scope of Official Controls Legal requirements Article 17 of Regulation (EC) No 178/2002 and Article 3 of Regulation (EC) No 882/2004. Findings

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ed as required Currently, NSVFSA issued a draft Order to authorise the establishments producing sprouted seeds. The draft Order followed the approval procedure and it is published on NSVFSA website for transparency (http://www.ansvsa.ro/documente/admin/Ordin_autorizare_seminte_germina te_10.10.2016_53707ro.pdf ). It is expected to be in force beginning with December 2016.

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For 2016, controls are planned for producers of fruits and vegetables that also have storage and/or processing activities of FNAO and are registered as such. These FBOs will be visited once in 2016. A risk-based control system, taking into account the EFSA scientific opinions on the public health risk posed by pathogens that may contaminate FNAO, is not in place. This is not in accordance with Article 3.1(a) of Regulation (EC) No 882/2004. For 2017 a risk-based control system is planned to be developed.

A control system of primary producers covering the verification of microbiological risks was in place, however, the controls only started in 2016 and were not planned taking into account the risks posed by pathogens that may contaminate FNAO.

None of the three FBOs were ever inspected before the audit concerning the risks of microbiological contamination of FNAO, as identified by EFSA, only their storehouses had previously been inspected.

By the time of the audit there were no direct imports from third countries of seeds for sprouting in Romania. Conclusions on Implementation of Official Controls over FBO Obligations

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aking into account Beginning with March 2016, the NSVFSA, assisted by Prime Ministers th risk posed by Chancellery and the World Bank, is part in an EU financed Project d by Article (European Social Fund) targeted on development of the institutional capacity to perform the Regulatory Impact Assessment (RIA). This Project has a Pilot component in which the above named institutions are assessing the impact of the quantities of products produced by operators that are not currently included in the NSVFSA database (especially primary producers of FNAO). This assessment is taking into consideration all the aspects of (RIA) one of the main principles being represented by EFSA scientific opinions on the public health risk posed by pathogens that may contaminate FNAO. The RIA Report of this Pilot will represent the basis for NSVFSA to prioritise the controls for primary production of FNAO as required by Article 3.1(a) of Regulation (EC) No 882/2004. Also, in this respect, NSVFSA developed and updated the special assessment document (evaluation sheet) for FNAO primary production operators, which is to be applied for each operator and according to the results of this document; operators are i

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n accordance with On 15.02.2016, NSVFSA issued the Service Note no. 6141 regarding the 04, in application of legislative requirements on seeds for sprouting. seeds for The Service Note provides to CSVFSD instructions on the legal egulation (EC) requirements applicable to suppliers and seeds lots intended for sprouting within the establishments for sprouted seeds. The results of the Note, reported by county Divisions underlined that one sprouts producer revised the criteria for acceptability of seeds suppliers and consequently one seed supplier (internal) was not accepted anymore.

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ANZ confirmed it is not currently possible to print a replacement identification document from database. Consequently, equidae not identified by 12 months of age are issued a standard identification document with no associated restrictions.

Equidae which are issued a duplicate or replacement identification document are not excluded from the food chain contrary to the requirements of Articles 29(2)(c) and 32(2)(c) of Regulation 2015/262. Identification verification (Transponder)

The audit team reviewed two veterinary health certificates (from the previous week) for movement of horses from traders to the slaughterhouse visited, covering 20 and 11 animals respectively. 15 animals in the first, and six in the second, had consecutive transponder numbers. Seven consecutive numbers were checked on ANZ database and all of them had corresponding identification documents issued 1-2 days before slaughter of which two were issued to horses greater than 2 years old. CA agreed that horses with consecutive numbers had been identified at traders holding and had moved there from holding of birth with no identification.

The audit team reviewed 10 passports returned from equidae slaughtered in March 2016 from the slaughterhouse visited. Three were duplicate passports and two were "original" passports (issued for the first time). The ages of the animals ranged from 1 to 15 years old. In eight of the ten, the outline diagram had not been completed and no photograph or print depicting the animals was available.

The audit team checked data held on ANZ database relating to five horses from a holding approved under Commission Decision 2010/346/EU (and visited by audit team). In the week prior to visit, one horse had been identified and issued with a passport for 6 the first time at 5 years of age. A second horse was re-identified and issued a duplicate passport.

Weaknesses exist in the system to issue equine identification documents. These do not contain all the required information and are frequently issued with no regard to the lifetime treatment of horses with veterinary medicinal products or the animals' age. Together with incomplete FCI, this results in ineligible animals entering the food chain. Additionally, late identification results in an unknown number of horses not being tested for EIA in accordance with national surveillance programme requirements.

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ANZ stated they did not have the technical knowledge to complete the administration of veterinary medicinal products section when issuing duplicate / replacement identification documents. They considered this a responsibility of NSVFSA but no mechanism exists to notify NSVFSA when duplicate / replacement identification documents are issued. Consequently, duplicate equine identification documents issued by ANZ do not have the section on administration of veterinary medicinal products completed. This lack of coordination between NSVFSA and ANZ is not in compliance with Article 4(3) of Regulation 882/2004.

Equidae which are issued a duplicate or replacement identification document are not excluded from the food chain contrary to the requirements of Articles 29(2)(c) and 32(2)(c) of Regulation 2015/262. Identification verification (Transponder)

Duplicate identification documents or the identification documents issued to horses older than 12 months (mentioned in paragraphs 26, 27 and 28 above) did not have the section on administration of veterinary medicinal products completed.

Weaknesses exist in the system to issue equine identification documents. These do not contain all the required information and are frequently issued with no regard to the lifetime treatment of horses with veterinary medicinal products or the animals' age. Together with incomplete FCI, this results in ineligible animals entering the food chain. Additionally, late identification results in an unknown number of horses not being tested for EIA in accordance with national surveillance programme requirements.

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ANZ stated they did not have the technical knowledge to complete the administration of veterinary medicinal products section when issuing duplicate / replacement identification documents. They considered this a responsibility of NSVFSA but no mechanism exists to notify NSVFSA when duplicate / replacement identification documents are issued. Consequently, duplicate equine identification documents issued by ANZ do not have the section on administration of veterinary medicinal products completed. This lack of coordination between NSVFSA and ANZ is not in compliance with Article 4(3) of Regulation 882/2004.

The audit team reviewed database entries for the approved holding visited. One horse had been identified the previous week and was issued with a passport for the first time at 5 years of age. Consequently, it could not have been tested for EIA in previous years as required by the annual surveillance programme. A second horse had been re-identified, also the previous week, and issued a duplicate passport. CAs confirmed it is not possible to record in the database that equidae are not intended for slaughter for human consumption contrary to Article 38(1)(l) of Regulation 2015/262. The remaining information, relating to equidae checked by audit team, was correctly recorded in the database as required by Article 38(1) of Regulation (EU) 2015/262.

Order 29 of 2014 requires an annual census of all bovine, ovine, caprine and porcine species by NSVFSA. This is carried out by free practicing veterinarians on behalf of CSVFSA. During this census, a count is taken of the number of equidae present. NSVFSA confirmed that during the census on each holding, free practicing veterinarians do not use the previous year's census or information recorded on ANZ database as a reference for the number of equidae present on a particular holding. In counties visited, CSVFSA establish a new set of records for each census2. 7

Equidae sent for rendering are accompanied, inter alia, by a sanitary veterinary certificate issued by free practicing veterinarians. This certificate includes consignor and consignee details and transponder number. On a monthly basis, free practicing veterinarians report all mortalities to CSVFSA. This data is reported on a quarterly basis to NSVFSA who confirmed they did not share this information with ANZ. No other source exists to supply this information to ANZ.

Information on the number of live equidae registered in Romania varied significantly between CAs. In one county visited by audit team, CSVFSA recorded a horse population of approximately 5500 equidae in contrast to 9951 recorded on ANZ database (as of 14 April 2016). At a national level, in 2015, ANZ equine database recorded 762 760 animals while NSVFSA recorded 455 614 equidae. CAs confirmed there is currently no collaboration between them to address this inconsistency. Enforcement

The absence of cooperation and coordination between ANZ and NSVFSA leads to duplication of efforts and data regarding horses and to uncertainty on the reliability of most data and statistics regarding equidae. The opportunities missed to share and update data restricts their usefulness for disease control purposes.

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NSVFSA confirmed there was no written procedure when transponder could not be recovered from the body of an animal slaughtered for human consumption. The OV confirmed that in such a case, carcase would be passed as fit for human consumption with no treatment of the meat or part of the meat containing the transponder as unfit for human consumption. This is not in compliance with Article 34(3) of Regulation (EU) 2015/262.

The lack of instruction and / or training to deal with non-recovered transponders has caused unfit meat to enter the human food chain. 9

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For all three equidae, FCI was not completed at section 3.4 meaning there was no attestation that withdrawal periods, for any veterinary medicines administered over the previous month, had been respected. CA agreed FCI was incomplete. A further five FCI documents from the previous weeks slaughter were reviewed. In three FCI documents (covering 46 horses) section 3.4 had not been completed. Official controls allowed these 46 animals to proceed for slaughter for human consumption. The incomplete FCI is not in compliance with Section III to Annex II of Regulation (EC) No 853/2004.

Weaknesses exist in the system to issue equine identification documents. These do not contain all the required information and are frequently issued with no regard to the lifetime treatment of horses with veterinary medicinal products or the animals' age. Together with incomplete FCI, this results in ineligible animals entering the food chain. Additionally, late identification results in an unknown number of horses not being tested for EIA in accordance with national surveillance programme requirements.

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Horses for breeding and production are issued with a pre-printed identification document. The free practicing veterinarian implants a transponder and completes the outline diagram. This document is then sent to ANZ or, for free practicing veterinarians with access to the ANZ database, uploaded. In all cases, the drawing must be sent in hard copy to ANZ. A pre-printed identification document is then issued. The requirement to include a section for the suspension / revalidation of the identification 3 document for movement of equidae is not included in the pre-printed identification document contrary to Article 7(2)(b) of Regulation 2015/262.

These pre-printed identification documents are currently issued with the section on administration of veterinary medicinal products stapled to the main document as an addendum. The audit team reviewed 20 identification documents returned to two county ANZ offices from slaughterhouses. Examples were seen of this single page being stamped to show association with passport, the single page being cut into separate sections with no attempt to link (stamp) these separate sections to the main passport and the section on administration of veterinary medicinal products being absent. This is not in compliance with Article 7(2)(b) of Regulation 2015/262. Furthermore, the requirement for the passport to be indivisible is not met as required by part 2(c) of Annex I of Regulation 2015/262.

Weaknesses exist in the system to issue equine identification documents. These do not contain all the required information and are frequently issued with no regard to the lifetime treatment of horses with veterinary medicinal products or the animals' age. Together with incomplete FCI, this results in ineligible animals entering the food chain. Additionally, late identification results in an unknown number of horses not being tested for EIA in accordance with national surveillance programme requirements.

The audit team reviewed the identification document relating to a horse for breeding and production, with a positive EIA test result. EIA was confirmed in March 2013 and the animal slaughtered in March 2015. The identification document correctly recorded the positive test result as required by Annex I, Part 1 of Regulation 2015/262. However, movement restrictions applied to this animal could not be recorded as the identification document did not include section III (see (9) above). NSVFSA confirmed that a lack of funding for EIA eradication during the period 2006 ­ 2007 reduced confidence in the compensation process and made some owners reluctant to release their animals for slaughter. Since 2009, the funds for compensation are allocated by the NSVFSA.

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forthcoming audits in the field of otic salmonella, the Audit Department will verify the fulfillment of the action plan tablished by the County Sanitary Veterinary and Food Safety Directorates ho was included in the audit plan. Please note that this audit mission will take place beginning of 2016 and was deferred due lor to limited human resources.

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The CA has not yet ensured that appropriate corrective measures are taken in the light of the results of internal audits on the implementation of SNCPs. 5.2. CONTROLS AT FARM LEVEL Legal requirements Article 3 of Regulation (EC) No 882/2004. Annex I to Regulation (EC) No 852/2004. Chapter I of Annex II to Directive 2009/158/EC. Audit findings

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ta At the level of the General Directorate for icial Control, will be elaborate a le de SERVICE NOTE addressed to the County Sanitary Veterinary and Food Safety Directorates,regarding the official controls vor fi on bio-safety (bio-security)standards according the Reg 852/2004. ie The results and the taken measures will be , in submitted to the General ia Sanitary Veterinary and Food Safety Directorate. atie General Sanitary Veterinary and Food Safety Directorate realized statutory note for future working group, in January 2016, for amending the national legislation towards biosecurity measures to be considered on poultry commercial farms. The amendments refer to President Order of NSVFSA no. 147/2006. Regarding to conclusion no. 31, corrective meseaures have been taken by CA, in order to comply.

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The CA has tools in place to facilitate the monitoring of the implementation of the official and own-check sampling (database, auditing and reporting system) and review and evaluate the progress of the SNCPs. However there are weaknesses in the system as it does not allow the central level to monitor CSVFSDs and CSVFSLs performance and consequently to guarantee that the activities contained in the SNCPs are implemented as described in the programmes themselves. In fact, shortcomings related to sampling frequency and sampling procedures in own-checks detected by the audit team had not been identified/recorded by the official staff at county level and therefore they were not communicated from the county level to the central one. In addition, inconsistency at county level as regards the follow-up actions taken following Salmonella positive results 12 (i.e. antimicrobial sampling in case of confirmatory sampling in laying hen population and imposition of restrictive measures) had not been identified by the CA at central level. 5.4 SNCP FOR BREEDERS Legal requirements Article 5 of Regulation (EC) No 2160/2003. Article 1 of Regulation (EU) No 200/2010. Audit findings

Procedures are in place for the rejection of non-compliant samples collected under the programmes. However, at county level, there are shortcomings in their implementation and this has entailed as a consequence that non-compliant samples have been accepted by the laboratories for analysis. This is not in line with EU requirements and with the approved SNCPs.

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At national level, GSVFSD will organize a orm 23.11 to 04.12.2015, with all the personel involved in the application of at regional level-42 county cial (veterinarians involved in official control in and chek implementation program). Nota de serviciu -instruire Salmoneloze.pdf ie General Sanitary Veterinary and Food , in Safety Directorate realized statutory note for ia future working group, in January 2016, for amending the national legislation towards tatie biosecurity measures to be considered on r poultry commercial farms. The amendments refer to President Order of NSVFSA no. 147/2006 urile Meanwhile all the monitoring and control procedures on SNCP will be updated, de including control and outbreaks , management procedures, in suspicion as well as in confirmation. in General Sanitary Veterinary and Food are. Safety Directorate elaborated and sent to reginal level a service note which provides se information for all persons directly involved or in the collection, handling and reception of samples in SNCP. It has also been elaborated and sent a poster which contains all necessary information regarding SNCP in a simple look, easy to apply and understand . This poster was also elo

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Regarding point 1, General Sanitary nota de Veterinary and Food Safety Directorate ea elaborated and sent to reginal level a service in note which provides information for all persons directly involved in the collection, handling and reception of samples in SNCP. It has also been elaborated and sent a poster which contains all necessary information regarding SNCP in a simple look, easy to apply and understand . This Poster was also displayed in all CSVFSL involved in testing Nota de Serviciu Model Afis.pdf model afis recoltare probe PNCS.pdf Also at national level, GSVFSD will organize a trening, from 23.11 to 04.12.2015, with all the personel involved in the application of SNCP at regional level- 42 county (veterinarians involved in official control and chek implementation program). Regarding point 2 NSVFSA consider necessary sampling confirmation applies to positive flocks, after own check sampling for elimination false positives cases and identify other potential positive flocks that have not been sampled or were sampled incorrectly. tive Also, considering that in case of control of outbreaks in breeders flocks it is necessary to give compensation acording to GD 1214/2009 and it

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Official controls of vaccine storage were carried out in accordance with the CCA instructions but these instructions were incomplete: The CCA informed the audit team that the representatives of the technical commission were permanently present at the airfield during vaccine distribution2. Temperature records regarding the bait storage conditions during 2014 campaign were checked by the technical commission (official veterinarian) once per day during vaccine distribution and the records of the official checks were available. The audit team reviewed the instance when temperature records from the thermometers in the freezing container showed deviation from the established limit (a rise of temperature from -20o C up to -1.2 o C due to a power cut). The deviation was noted by the contractor only after more than 24 hours and the CA was notified. During this 24 hours period, aerial distribution was not carried out. The batches stored inside this container were sampled and re-tested for virus titre in the Institute for Control of Veterinary Biological Products and Medicines. The test results were compliant with contract criteria. The procedure in place did not define the frequency of official temperature controls, and the critical point (combination of raised temperature above limit with maximum allowed time) was not included either.

The adequate pre-distribution quality checks on vaccine batches ensure the quality of the vaccine when it is distributed. The incomplete procedures in place to demonstrate maintenance of the cold chain for baits point to certain weaknesses in the control practices.

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ing to the agreement between ANSVSA and service provider, and leader * contract between the subcontractor and the mpany responsible for transporting and storing bait, maintaining the cold chain exclusive liability and any other issues that may arise from the storage spaces of baits belong to leader * by company transportation and have the obligation to carry out inspections and monitoring of the storage space and the freezing temperature from 3 in 3 hours. The trainings were conducted with people involved in the storage and distribution of baits. Below, you will find a copy of additional training perfromed from ANSVSA to DSVSA and service provider representatives from aerodrome. (separate document)

mention that into the contract between members of the Consortium who perform vaccination against rabies at foxes in n Romania, the company who is performing the transport and storages of the baits has the obligation to verify at every 3 hours the temperature from the display of the thermograph. In the technical documents support for the contract, is the requirement that the service provider is fully responsible for checking and maintaining baits temperature conditions specified by the manufacturer. If these provisions are violated and after retesting in the lab (retesting shall be carried out if the temperature within the storage reaches up to - 5 degrees Celsius) we find that the vaccine titer is below the allowed limit, the supplier is obliged to replace all of the existing baits from the storage at the time of the incident. If it is found that, in the moment of control vaccine baits are defrosted, that quantity of defrosted baits will be refused for vaccination and it will be required to the service provider to replace all existing baits defrosted at that time. In connection with bait left into the plane after the flights, it will be performed the control over them and if it is

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Sampling of foxes to monitor vaccine uptake and fox population immunity was seriously under-implemented and unevenly geographically distributed in 2013-2014: The following table summarises laboratory data for foxes sampled in calendar years 2013 and 2014 Year Rabies cases Number of foxes tested for % tested foxes % tested foxes in contact vaccinated Rabies virus Tetracycline Antibodies with bait 10 2013 286* 2755* 1638 1387 15.32% (251) 9.95% (138) 2014 95* 2269* 2165 2022 27.67% (599) 28.04% (567) For rabies* total numbers under active and passive surveillance In 2013 and 2014 none of the 41 counties met their target of number of planned samples - four foxes /100 Km2 per year (representing approx. 8,500 foxes shot in Romania). Only 0.86 foxes / 100 Km2 were tested for tetracycline and 0.73 foxes /100 Km2 were tested for antibodies in 2013. In 2014 those figures slightly increased to 1.01 foxes / 100 Km2 and 0.95 foxes /100 Km2 respectively, but still were well below the targets. In 2014 the sampling for tetracycline varied between the counties, ranging from

The monitoring of vaccine uptake and population immunity in 2013-2014 was inadequate. The 60 days sampling window applied after vaccination campaign limits the possibility to increase the number of samples. However there has been a significant improvement in sampling after the autumn campaign 2014 as a result of new CA legal powers to enforce sampling by the hunters and more active involvement of the CA.

The supervision from central level during the monitoring period does not ensure that sampling targets will be met in all counties.

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CA will notify all the Local Sanitary Veterinary through a service note that they should submit the samples of the shot foxes from 45 days after the aerial distribution of baits untill the starting of the next vaccination campaign, in order to fulfil the number of the target samples according to the Programme for the eradication Page: 1 spect the provisions of Article 339 of the Lisbon Treaty as regards confidentiality rt ref. DG(SANTE)/2015-7623-MR of an Audit carried out from 19 rabies eradication programme rovisions. ary Directions will be provided amples. fall campaign and we are sure very campaign. nce nd passive surveillance situation by ndar year 2014. t part of the evidence for the fall all 2014 campaign. ize the situation regarding active ted per campaign. After we will and passive surveillance per 014. (table deleted) es situation monitoring per autumn). Page: 2 t the provisions of Article 339 of the Lisbon Treaty as regards confidentiality rt ref. DG(SANTE)/2015-7623-MR of an Audit carried out from 19 rabies eradication programme

e mentioned that we reach the target of animals for sampling for shot foxes and we attached the table regarding results for active , and passive surveillance and monitoring for tetracycline detection and antibodies test Elisa for 2014. (table deleted)

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The procedures of age determination of the monitored foxes were not detailed enough and the determination was based on an insufficiently accurate method: 3 In their response to the draft report the CA noted that for 2014 campaign they reached the target for sampling with a total of 3,826 foxes shot and tested for tetracycline and for antibodies by ELISA test. The target for sampling was 6965 foxes for both campaigns envisaged in 2014. In 2015 they intend to shoot planned number of foxes - 8535 (4 foxes/100 square kilometres) and complete their testing for evaluation of the effectiveness of vaccination in 2015. The same annual targets are planned for the whole period 2015-2017 (Romanian eligible area for the oral vaccination of foxes is 213,375 km2, so the total yearly number for shooting in 2 campaigns is 8375 foxes). 11 No clear cut-off between the category of young foxes (cubs) and adults is set up by the CCA and thereby the age threshold in the counties visited varied between 12 and 15 months. The age determination only by visual inspection of carcases, in particular after autumn campaign, is not providing sufficiently reliable results. The young foxes are already 8-9 months old and grown up which makes visual age classification very difficult. The age has not been verified by more specific laboratory method. 5.3.2 Active/targeted surveillance

Passive surveillance varies between the counties and is inadequate in several counties. The data available are not comprehensive enough to fully assess the effectiveness of passive surveillance: Although requested by the audit team, the CCA did not provided data on the number of foxes tested and found positive for rabies virus broken down by type of surveillance (active; passive). The numbers of suspect cases (tested under passive surveillance) were provided by the CCA per county and per calendar year, but no further details (e.g. numbers broken down by different category of indicator animals such as animals killed with clinical signs, found dead or road-kills), were available. In 2014, 252 suspect samples were tested for rabies (mainly dogs, foxes, cats, bovines, and other species). The number of suspect cases varied between the counties. In six counties and Bucharest municipality no suspect case was reported. The low number of suspect cases were notified particularly in the counties along the southern border of Romania, as well as the very low number of total samples were tested for virus in this region4. Completed submission forms for laboratory analyses allow information collection on the health status of animals, respectively if an animal was found dead, shot, 4 In their response to the draft report the CA noted that as regards to low level of passive surveillance they obtained information from the counties on the recent sharp declination of the mortality in foxes and they consider it as result of their successful immunization. In 2015 (until 11 June) only 13 rabies cases were reported in foxes (out of 20 rabies cases detected in all animal species). Regarding passive surveillance in domestic animals, all cases of mortality or suspect animals with clinical signs are kept under observation or were euthanized after the event and the samples were sent to the laboratory for examination. 5 In their response to the draft report the CA noted that as regards the forms used for submission samples to laboratory the CA is in the process of analysing of the forms and their update. 12 was killed, or euthanized. However it does not provide clear guidance to the sampler to ensure completeness of forms in a harmonised way, e.g. it is no clear when the sampler should specify "shot" and when "killed" animals. The forms do not have a field to provide additional information needed to assess the effectiveness of passive surveillance and progress of the eradication programme, e.g. to distinguish between samples taken from stray and owned dogs5. Some data collected has not yet been used for any analyses.

Supervision of the implementation of the monitoring and surveillance programmes is carried out at various levels and stages of their implementation but this supervision does not prevent the inconsistencies and discrepancies in data and overall underperformance of programmes: Supervision is carried out by County Sanitary Veterinary and Food Safety Directorates and County Sanitary Veterinary and Food Safety Directorate laboratories. In both counties visited, the audit team noted that the numbers of samples provided by the hunters and tested are regularly checked and evaluated against the sampling plan. Copies of all test results are provided by the laboratory to the CA. The records of supervision were available to the audit team. The NRL for rabies receives, on a monthly basis, the situation on the number of laboratory tests performed by the County Sanitary Veterinary and Food Safety Directorate laboratories. The data for some counties reviewed by the audit team showed some inconsistencies, in particular as regards a higher number of foxes tested for tetracycline or rabies antibodies than for virus detection. The discrepancies exist between the number of tests for tetracycline and rabies antibodies. The audit team noted that the NRL staff is aware of those inconsistencies and stated that they notified the CCA who has the power to enforce corrective actions. The audit team noted that no on-going supervision of the sampling plan was carried out by the CCA. In 2013-2014 no corrective action was taken or initiated by the CCA during a sampling year to address under-implementation of the monitoring programme in counties with very few samples taken, or discrepancies noted in data provided by the laboratories. The fitness of samples submitted for laboratory analyses is routinely checked but the age of foxes determined by the hunter is not verified in the laboratory with more specific method (based on the pattern of dentition and counting layers of dentine in canines) (for more see chapter 5.3.1) 5.3.6 Analysis of the effectiveness of the rabies eradication programme

The age determination of the monitored foxes is not verified by laboratory method, which undermines the reliability of the age data used to assess the effectiveness of the autumn campaigns in particular.

Monitoring since 2011 was insufficient to provide quality data to assess the effectiveness of the rabies programme. Provided that the oral vaccination and monitoring will be implemented in the future as it is after the 2014 autumn vaccination campaign, then the CA should have representative data to assess the progress.

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on the recommendations of the Audit Report, starting with accination campaign May-June 2015, the age determination the shot foxes, in addition with the one done by hunters, will lso performed by laboratories involved in the monitoring of accination (NRL for Rabies and Iasi County Sanitary inary Laboratory), according to the EU-RL methods (based e pattern of dentition and counting layers of dentine in es).

Based on the recommendations of the Audit Report, starting with he Vaccination campaign May-June 2015, the age determination of the shot foxes, in addition with the one done by hunters, will be also performed by laboratories involved in the monitoring of the vaccination (NRL for Rabies and Iasi County Sanitary Veterinary Laboratory), according to the EU-RL methods (based on the pattern of dentition and counting layers of dentine in canines), through specific procedures.

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All foxes submitted to the laboratory under the vaccination monitoring programme, are tested for rabies virus before any other tests are carried out. The audit team noted that: In 2014, 2,269 foxes have been examined for the rabies virus, including foxes tested under active and passive surveillance. One of the national measures taken in the protection zone around rabies cases is to request additional samples of foxes for virus detection. In the two cases reviewed by the audit team, this measure was requested by the CA but not implemented by the hunters and no additional foxes were shot during the period while the measures were imposed (30 days). 5.3.3 Passive surveillance and awareness

Passive and active surveillance programmes for rabies are in place. However, the effectiveness, in particular of passive surveillance, varies between the counties and is inadequate in several counties. This means that surveillance results are not sufficient to reliably assess the rabies incidence in all regions. Furthermore, the surveillance data reported to central level are not detailed enough to allow the identification of potential risks to the overall success of the eradication programme.

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ase find attached the active and passive surveillance per es and counties in 2014. he fall campaign 2014 we reached the target for shooting esting of foxes for surveillance and monitoring. ttached table for monitoring. (tables deleted)

Please find attached the active and passive surveillance per species and counties for 2014. (table deleted) Page: 2 respect the provisions of Article 339 of the Lisbon Treaty as regards confidentiality Report ref. DG(SANTE)/2015-7623-MR of an Audit carried out from 19 the rabies eradication programme

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The CA took measures, in line with national requirements, when rabies is suspected and confirmed but the national requirement applied on contact animal with rabies case are not epidemiologically sound: When rabies is confirmed in domestic or wild animals, specific control measures are applied, in accordance with the NSVFSA President Order No. 29/ 28.03. 2008 for the approval of a sanitary veterinary norm regarding general measures of prevention and control of rabies in domestic and wild animals. Measures applied include carrying out epidemiological enquiry, establishment of the protection and the surveillance area, and implementation of the control plan with deadlines and responsibilities. The audit team noted that emergency vaccination is carried out around the rabies cases and in 2013 emergency vaccination included 8,247 domestic animals, e.g. sheep, cows, goats, pigs and horses. The audit team reviewed two rabies cases in 2013 and 2014 and noted that the measures taken were in line with the national legislation. The length of observation of animals (including those not vaccinated against rabies) which were in contact with a rabies case is 14 days, from the moment of contact. However, this 14 day period of isolation and observation of contact animals is insufficient to ascertain that such animals are not incubating rabies.

The public have been made aware of the risks and typical symptoms of rabies. The actions taken to control the risk of spread to humans and domestic animals in the 6 In their response to the draft report the CA noted that a comparative analysis of the effectiveness of rabies vaccination for 2013 and 2014 campaigns has been carried out. The analyses shows slight increase of seroprevalence in fox population in this period (from 28.35% in 2013 to 32,52% in 2014 ) and sharp increase of tetracycline detection in samples tested in 2014 (from 28.26% in 2013 to 71.25% in 2014). 15 vicinity of rabies cases in foxes are adequate but the period of isolation of animals in contact is too short. Furthermore, the implementation of the 2014 compulsory vaccination programme for dogs is seriously hampered by owner reluctance to bear the costs of the recently introduced compulsory microchipping and registration of their animals. This increases the risk of dog rabies, particularly in young unvaccinated dogs.

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e CA had to involve a working group of experts in order to se and review the control measures in rabies, such as the vation period of the contact animals, from 14 days at the moment to 21 days and then to proceed of the modification of the Page: 3 pect the provisions of Article 339 of the Lisbon Treaty as regards confidentiality rt ref. DG(SANTE)/2015-7623-MR of an Audit carried out from 19 rabies eradication programme legislation on rabies, the President Order no.29/ 08 for the approval of the sanitary-veterinary norm for ention and control of rabies in domestic and wild animals.

s These are our proposal (IDAH- NRL rabies, ANSVSA, and nstitute for Control of Medicine Products) for modification of resident order no.29/2008 where are specified all measures taken k of regarding to a rabies outbreak. We are kindly asking you to onfirm to us is our proposal for modification are right. nimals bitten by other animals that are not identified are kept nder observation 3 months, no matter if are vaccinated or not. with mention that unvaccinated animals will be vaccinate for ecessity into the shortest time possible). nimals bitten by other animals who has rabies (FAT positive for abies) : - Those who are not vaccinated will be euthanasiated - Those who are vaccinated will be kept under observation 3 months. nimals that bit and are identified/isolated are kept under bservation for 14 days. Animals who were bitten by this category ill be get out from observation if the animal who bit did not howed nervous clinical signs into the 14 days period. If into the 4 days period, the animal who bit show clinical signs (FAT abies positive), the animals with who came in contact, if are nvaccinated are been euthanasiated and if are vaccinated will be ept under observation 3 moths.

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In 2014 vaccination against dogs and cats had not been implemented as planned in the approved programme and only small proportion of known dogs have been vaccinated/revaccinated: Vaccination against rabies of domestic dogs and cats in Romania is compulsory. Each animal shall be vaccinated from the age of three months with yearly revaccination. The revaccination is organised in campaigns held at the end of the calendar year from October until the end of December. The obligation to have the dog microchipped which entered into force in 2014, had a major negative impact on the numbers of dogs vaccinated in the anti-rabic vaccination campaign in 2014. The vaccination coverage dramatically decreased. At the end of 2014, out of 3,519,886 known dogs only 280,510 were vaccinated. Although the cost related to vaccination is provided by the state free of charge, the 13 cost related to microchipping is borne by the dog owner. The CAs visited, noted a low number of vaccinated dogs, acted upon the situation and took some measures to remedy the situation. In one county, the CA requested local authorities to financially support dog owners from public resources, in another county, the CA reminded local authorities to enforce legislation and sanction those owners whose dogs are not vaccinated. Due to the situation, the anti-rabic vaccination campaign in dogs and cats in 2014 was extended until the end of February 2015. The population of stray dogs is large in the cities but is not covered by the organised vaccination campaign. All stray dogs entering shelters are vaccinated against rabies. Some of these dogs remain in the shelter while others are re- homed. 5.3.5 Supervision of the monitoring and surveillance programmes

The public have been made aware of the risks and typical symptoms of rabies. The actions taken to control the risk of spread to humans and domestic animals in the 6 In their response to the draft report the CA noted that a comparative analysis of the effectiveness of rabies vaccination for 2013 and 2014 campaigns has been carried out. The analyses shows slight increase of seroprevalence in fox population in this period (from 28.35% in 2013 to 32,52% in 2014 ) and sharp increase of tetracycline detection in samples tested in 2014 (from 28.26% in 2013 to 71.25% in 2014). 15 vicinity of rabies cases in foxes are adequate but the period of isolation of animals in contact is too short. Furthermore, the implementation of the 2014 compulsory vaccination programme for dogs is seriously hampered by owner reluctance to bear the costs of the recently introduced compulsory microchipping and registration of their animals. This increases the risk of dog rabies, particularly in young unvaccinated dogs.

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nuary 2015 according ord.1 / 2014, rabies vaccination of ogs is carried out obligatory only on microchipped dogs. of this, we had trouble to vaccinate dogs with owners, ly in rural areas. nding these difficulties in achieving vaccination of dogs, ith local authorities conducted information campaigns ic awareness to support microchipping and rabies ion. y, we found an increase in the number of dogs and cats ed and we are sure that soon we will have fully vaccinated g ord. 29/2014 of ANSVSA, owners are obliged to accination of dogs and cats. g the extended national rabies compulsory vaccination , the number of vaccinated dogs increased.from 280510 ber 2014 to 1 028 035 ( approximate 29,45% of the total on). e compulsory vaccination, the rabies vaccination program anion animals is continuing all over the year, even these covered by the government and are covered by the owners period out of the national programme for vaccination.

accination programme for dogs and cats against rabies is of ongoing accordingly to the National Strategic Programme. We ad some difficulties in it implementation because from this year s obligatory that any own dog can be vaccinated against rabies Page: 3 respect the provisions of Article 339 of the Lisbon Treaty as regards confidentiality Report ref. DG(SANTE)/2015-7623-MR of an Audit carried out from 19 the rabies eradication programme if it is microcipated. Because not all the population can rd to support cost for microchiping, we proposed that these s for microchiping can be supported and from local authorities t,.We are in the discussion with all parts involved. tionaly we propose a change for National Strategic ramme to can vaccinated all the year all the dogs against es, until now was only in the period of November-February.

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In the Institute for Control of Veterinary Biological Products and Medicines the audit team noted that every batch of vaccine used in a vaccination campaign of foxes is tested for virus titres. Although the method used is under the scope of accreditation, the result from the proficiency test organised by the EURL in 2011 was unsatisfactory. Since then the institute had not participated in any other proficiency test. Although recommended by the European Union Reference Laboratory, no further training was provided to the staff on this method. 5.4.2 Role of the NRL in the rabies eradication programme

Although included in the scope of accreditation, the method used for titration of virus in vaccine baits has never been validated with a satisfactory result in international comparative tests. This makes it difficult for the CA to assess the reliability of these results.

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icipation at the proficiency testing organized by EURL Page: 4 pect the provisions of Article 339 of the Lisbon Treaty as regards confidentiality rt ref. DG(SANTE)/2015-7623-MR of an Audit carried out from 19 rabies eradication programme r rabies (European Union Reference Laboratory for rabies RL) - * in November 2011 took place when the titration thod for rabies virus was not validated and accredited. bies virus titration method was accredited in 2012. early 2013 I.C.B.M.V. contacted EURL r rabies - * to allow the participation of an expert from our boratory to training having as bies vaccine control lab theme. Application C.B.M.V. was accepted that, but A.N.S.V.S.A. did not have cessary founds in the budget. address the recommendation no. 7 - contained in the annex to e report, I.C.B.M.V. will make all necessary to participate to e Competence inter-laboratories test which will have as subject Live rabies virus titration". e results obtained will be presented at rther audits. tion against rabies at foxes. This campaign started in 12.05.2015 and is about to ing cold chain of the storages of the bait and to the aerial distribution of the for vaccination. e baits and we had a strictl

t was mentioned in the address 6354 din ory 28.05.2015 the attendance of the I.C.B.M.V. to the etence test organized by the EURL for Rabies from * e November 2011 took place even the method of virus ering was not validated and accredited at that time. The od validation was finalized in December 2011, and editation came in March 2012. Following to the remark of the FVO inspectors with visit in January 2015, referring to the fact that the itute did not attend to any other competence test since to day, ICBMV requested information to the EURL for es from ANSES/France if other competence test was nized since 2011, and the answer was negative. The aspect was certified also by the * Institute many) and the answer was, also, negative. When the ICBMV from Romania insisted relating to ssity/lack of competence test for virus tittering, EURL ented this request to the Annual General Meeting of the rinary official laboratories (OMCL). With this rtunity, OMCL requested to the EURL to present a plan rganize such test until the end of 31 August 2015. At the beginning of 2013, I.C.B.M.V. requested to Page: 4 respect the provisions of Article 339 of the Lisbon Treaty as regards confidentiality Report

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BIPs have appropriate and properly maintained facilities in compliance with the requirements of Decision 2001/812/EC. However, BIPs do not have proper equipment to perform physical checks, including sampling, contrary to the requirements of Article 4(2)(d) of Regulation (EC) No 882/2004 (see section 5.5). Conclusion on the development of the monitoring plan

Even though the monitoring plan requires the taking of samples for microbiological examination, the BIPs visited did not have proper equipment (see section 5.5) to implement the physical checks and the sterility. In accordance with the written procedures, BIPs take the extra sample for the supplementary opinion (if required by the operator), however those samples were stored sealed in BIP facilities without proper labelling. Therefore, sampling and handling of samples in BIPs did not follow the requirements of Article 11(7) of Regulation (EC) No 882/2004. BIPs store both samples until the person responsible for the load collects them for transportation to the laboratory concerned.

The implementation of the monitoring plan is undermined due to deficiencies in targeting consignments, the lack of equipment for sampling and transportation of samples to the laboratories. Therefore, the implementation of the monitoring plan does not fully achieve the objective of the monitoring plan.

The audit team noted that inspection rooms were not equipped with the necessary technical equipment for performing identity and physical checks contrary to the requirements of Article 2(1) and Annex to Decision 2001/812/EC: A thermometer to measure surface temperature and sterile bags were not available and a core thermometer was out of order at inspection centre "IC1" of Albia BIP. 11 A core thermometer, a saw, and sterile bags were not available at Constana South ­ Agigea BIP. A knife and sterile bags were not available at inspection centre "IC1" of Bucharest Henri Coandã BIP Conclusion on the compliance of the facilities, equipment and hygiene conditions of the inspection centres visited

The equipment is not fully fit for purpose for the categories included in their approval and may compromise the hygienic sampling and handling of the consignments subject to veterinary checks.

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remedy the deficiency of lack of equipment have already been purchased thermometers for measuring the surface and depth temperature of products of animal origin, knives and knife sterilizers. There are already ongoing procurement procedures for sterile bags, sampling probes, sampling recipients for liquid animal origin products and other equipments used for physical checks, including sampling. Deadline: 31.07.2016

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The Trade, Import, Export, BIPs Directorate (hereafter ­ the Import Directorate) within the NSVFSA is responsible for the planning of the monitoring plan on imported 3 products of animal origin. The representatives of the Import Directorate informed that they revise the monitoring plan on an annual basis without consulting other Directorates of NSVFSA or Romanian laboratories. This can lead to shortcomings such as possible lack of laboratory capacity or incorrect interpretation of legal requirements (see findings 5 and 6). This has an impact on the implementation of the monitoring plan.

The audit team noted that the monitoring plan is very prescriptive and it does not foresee adjustments during the year to take into consideration the changes of import patterns, in particular the plan does not cater for the possibility that BIPs may not receive the commodities specified in the monitoring plan. This, in turn, can lead to not targeting the correct consignments or to not sampling at all (see finding 16) resulting in weak implementation of the monitoring plan which is contrary to the requirements of Article 4(2)(a) of Regulation (EC) No 882/2004.

The competent authority has developed a monitoring plan to monitor conformity of goods with the requirements of EU legislation. However the lack of communication between those involved in the development and implementation of the monitoring plan, combined with the lack of a mechanism to ensure flexibility in its implementation, reduces the effectiveness of the monitoring plan in overseeing that imported goods comply with EU requirements. 5.1.2 Implementation of the monitoring plan

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The monitoring plan on 2016 was issued in collaboration with the experts of Institute of Hygiene and Veterinary Public Health, in which are organized national reference laboratories for Hygiene and Veterinary Public Health, in order to eliminate the shortcomings as possible lack of laboratories capacity or incorrect interpretation of legal requirements. To not reduce the effectiveness and to ensure flexibility in the implementation of the monitoring plan, the Import Directorate will foresee adjustments of the monitoring plan during the year 2016 taking into consideration the changes of import patterns and the situations when the BIPs not receive the commodities specified in the monitoring plan. Page: 1 rt ref. DG(SANTE)/2015-7664-MR of theauditcarried out from07 rced checks on imported products of animal origin The Import Directorate will assess quarterly the implementation of monitoring plan in every BIP in order to be done the necessary adjustments. The Service Note no. 25.111/15.01.2016, addressed BIPs, mentions the following aspects regarding the implementation of monitoring plan: - the samples for detection of dyes have to be sampled from aquaculture products not from fishery

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Even though the monitoring plan requires the taking of samples for microbiological examination, the BIPs visited did not have proper equipment (see section 5.5) to implement the physical checks and the sterility. In accordance with the written procedures, BIPs take the extra sample for the supplementary opinion (if required by the operator), however those samples were stored sealed in BIP facilities without proper labelling. Therefore, sampling and handling of samples in BIPs did not follow the requirements of Article 11(7) of Regulation (EC) No 882/2004. BIPs store both samples until the person responsible for the load collects them for transportation to the laboratory concerned.

Romanian national legislation requires that the person responsible for the load covers the costs of the transportation of samples to the laboratory, as required by Article 27(1) of Regulation (EC) No 882/2004. However, the person responsible for the load collects the official samples from the BIPs and delivers them to the laboratories concerned, contrary to the requirement of Article 11(7) of Regulation (EC) 882/2004 since the official services can no longer guarantee the legal and analytical validity of the official import samples.

The implementation of the monitoring plan is undermined due to deficiencies in targeting consignments, the lack of equipment for sampling and transportation of samples to the laboratories. Therefore, the implementation of the monitoring plan does not fully achieve the objective of the monitoring plan.

The audit team noted that the economic operator is also responsible for financing the transportation to the laboratories of official samples taken in case of suspicion (see finding 17). 8 Conclusion on actions in case of suspicion

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remedy the deficiencies relating to samples transport, in f conformity with the new provisions of National Sanitary Authority President order no. samples from the sampling point to the BIPs, by courier transport companies, tions for the products in question". /15.01.2016, was imposed at border elling of official samples, with CVEDs's good traceability and to identify them

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There is no instruction in place which would prompt the BIP staff to take actions in case of suspicion (including detention and sampling) in order to follow the requirements of Article 20 of Directive 97/78/EC. This is contrary to the requirements of Article 8(1) of Regulation (EC) No 882/2004. Furthermore, the BIP staff does not have direct access to RASFF (see finding 34). In practice, BIP suspicions are limited to the tracing of the consignments which are subject to various EU safeguard decisions or imposed checks following information in TRACES. These controls are correctly recorded as "Suspicion" in box 28 of the common veterinary entry document for products (CVEDPs) and consignments are detained until the laboratory test results are received.

Sampling in case of suspicion is limited to following safeguard measures and imposed checks subject to EU safeguard decisions. There are no instructions on actions in case of suspicion. The absence of further sampling under suspicion, together with the limited implementation of the monitoring plan, undermines the ability of the competent authority to detect consignments for which the veterinary legislation might have been not complied with or for which there is doubt.

The representatives of the Import Directorate confirmed that there is no system in place for consultation between the national RASFF contact point and the Import Directorate before the information is provided to the Commission, contrary to the requirements of Article 2(5)(b) of Regulation No 16/2011.

The BIP staff do not have direct access to RASFF and they are not able to get the detailed information for all the consignments which might be of interest to import controls. This issue limits the ability of the BIP staff to be proactive in case of suspicion or obtaining more information on consignments rejected by other Member States (see finding 25). 9

The use of RASFF by the Import Directorate and BIPs is limited, therefore it cannot be used for consultation to identify the possible suspicious consignments.

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e Directorate of Trade, Import-Export, BIPs will issue an uction which will prompt the BIPs staff to take actions in case ention and sampling) in order to follow 20 of Directive 97/78/EC. Page: 3

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In the three BIPs visited there was no written procedure on how to use the available information (screening of manifests, monitoring of Customs database) to identify consignments that should be subject to veterinary inspection. 5.2.2 Veterinary checks Legal requirements Regulation (EC) No 882/2004, Council Directive 91/496/EEC, Council Directive 97/78/EC, Commission Regulation (EC) No 136/2004, Regulation (EC) No 282/2004, Commission Decision 94/360/EC, Commission Decision 97/794/EC, Commission Decision 2000/208/EC, Commission Decision 2000/25/EC and Commission Decision 2001/812/EC. Findings

The audit team noted that the competent authority relies on Customs to identify transhipped consignments where the BIP of entry is in Romania and direct them to the BIP. The audit team found two consignments destined for Romania which had been issued with transhipment CVEDs by BIPs in other Member States. Both consignments were incorrectly released for free circulation by Customs when they arrived in Romania as Customs did not know the difference between different types of CVEDs and BIPs in Romania were not involved in either case. The competent authority stated that the procedure for transhipments is currently in draft stage. The audit team noted that the relevant EU Commission guideline was not available at this BIP. 4

There is a lack of available procedures in some cases (e.g. procedures for screening of manifests and/or Customs database, transhipments) and the competent authority has not taken into account all the relevant monitoring parameters in the preparation of the 5 monitoring plan. These reduce the effectiveness of the official import controls in preventing non-compliant consignments from entering the EU.

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Through letter no. 29508/18.12.2014, the Trade, Import, Export, BIPs Directorate (TIEBIPD) requested to National Customs Authority ­ Information Technology, Communication and Customs Statistics Directorate (NCA-ITCCSD), the access to the customs databases for all staff from the BIPs, involved in border veterinary checks, in conformity with the art. 7 from the Regulation no. 136/2004 and art. 6 from the Regulation no. 282/2004. Through the above mentioned letter, it was requested to the NCA- ITCCSD the installation of customs databases, provided at point 12 from the Addendum no.1 to the Protocol between National Sanitary Veterinary and Food Safety Authority and National Customs Authority, no. 1130/2008. A detailed instruction regarding the verification and the use of information from customs databases it will be issued by TIEBIPD following the consultation with BIPs coordinators and following utilisation of these databases by all the staff from the BIPs for a period of at least 3 months, enabling them to draw some conclusions. This instruction will contain details regarding the cross verification with information from other documents, as: pre- notifications, manifests, cargo ­ manif

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In two of the BIPs visited (port, airport), staff stated that they carry out cross-checks between data available on the Customs database and transport manifests in order to verify that no imports violate the requirements of Article 4 (1) of Directive 91/496/EEC and Article 3 of Directive 97/78/EC. This process includes screening 100% of manifests to identify consignments which may contain products of animal origin. The audit team randomly selected seven examples from the files to assess the system, as follows: A consignment of live birds originating from a third country and coming from another Member State was highlighted in the manifest hard copy by BIP staff. However, there was no evidence on file of any follow-up/cross check with the Customs database in order to identify whether this consignment was subject to veterinary check or had already been checked in the previous Member State. The competent authority contacted Customs at the time of the FVO audit and established that the consignment had a CVEDA. Two consolidated consignments selected by the audit team for which ''product of animal origin'' was highlighted on the manifests by BIP staff but there was no follow-up to identify whether there were consignments subject to veterinary check. BIP staff stated that they check 100% of manifests and identify consignments of products of animal origin on the manifests. However, they do not follow these up or ensure that they are 3 subject to BIP checks. The BIPs rely on Customs identifying all consignments on the positive list which require veterinary checks. The CN codes of products listed in Commission Decision 2007/275/EC are flagged in the Customs database and Customs require a CVED in order to lift the flag and release such consignments.

Two of the BIPs (port, airport) visited had access to the Customs database. However staff were only using this access to follow-up veterinary consignments when there was a specific question (e.g. to check if the consignments in transit had left the country). There was no cross-check to verify whether all consignments that required veterinary inspection had been presented to the BIP.

The road BIP visited had no access to the Customs database. The competent authority stated that this was due to a lack of compatibility of the local IT system with the Customs database. According to the competent authority the issue had remained outstanding for approximately five months and at the time of the FVO audit no action had been planned to address it. The audit team noted that there are approximately 1,000 consignments that pass through this border point each month and the lack of screening of the available information to identify consignments subject to veterinary inspection, may lead to a situation in which such consignments enter the EU without undergoing veterinary checks.

In the three BIPs visited there was no written procedure on how to use the available information (screening of manifests, monitoring of Customs database) to identify consignments that should be subject to veterinary inspection. 5.2.2 Veterinary checks Legal requirements Regulation (EC) No 882/2004, Council Directive 91/496/EEC, Council Directive 97/78/EC, Commission Regulation (EC) No 136/2004, Regulation (EC) No 282/2004, Commission Decision 94/360/EC, Commission Decision 97/794/EC, Commission Decision 2000/208/EC, Commission Decision 2000/25/EC and Commission Decision 2001/812/EC. Findings

The system for import controls covers the consignments presented at the BIPs and the official controls are generally performed correctly. However, the competent authority does not use available information (Customs database, manifests) to ensure that all consignments subject to veterinary control are presented to the BIPs and there is partial enforcement of the requirement to notify the goods prior to arrival at the BIPs.

There is a lack of available procedures in some cases (e.g. procedures for screening of manifests and/or Customs database, transhipments) and the competent authority has not taken into account all the relevant monitoring parameters in the preparation of the 5 monitoring plan. These reduce the effectiveness of the official import controls in preventing non-compliant consignments from entering the EU.

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gence There were solved the problems linked by the incompatibility of the informatical systems from the BIPs with customs databases. Page: 2 arch 2015 Ares(2014)4214644 eport ref. DG (SANCO)/2014 -7022-MR of a/an audit carried out from 14 r live animals (LA) and products of animal origin (POAO) There were already started the trainings for all BIPs staff by IT specialists of NCA, in order to use the customs databases. We estimate to finish such trainings at the end of April 2015. Regarding the consolidates (groupage) consignments: In port BIPs, the consolidates consignments from the unloading list are deconsolidates in manifest page, detailing products description, the weigh and the destination. The BIPs have access to these information. In air BIP, the competent authority requested to cargohandling agents, that in case of consolidated consignments, these to be deconsolidated and sent by e-mail to the competent authority from the BIP. The BIP received the permission.

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In the airport BIP visited, several consignments were not pre-notified contrary to the requirement of Article 2(1) of Regulation (EC) No 136/2004. In the port BIP, a full assessment of pre-notification by the audit team was not possible as the individual import files created prior to August 2014 did not contain a part I of the CVED signed and dated by the person responsible for the load. Evidence of pre-notification was available in files created post August 2014. In the road BIP visited, pre-notification was in line with the legal requirements.

The system for import controls covers the consignments presented at the BIPs and the official controls are generally performed correctly. However, the competent authority does not use available information (Customs database, manifests) to ensure that all consignments subject to veterinary control are presented to the BIPs and there is partial enforcement of the requirement to notify the goods prior to arrival at the BIPs.

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Through Service Note no. 294/25154/19.01.2015 it was imposed f to the BIPs staff the verification of pre-notification of imports ods subject to veterinary border control, to be sent in advance of hysical arrival of the consignment at the BIP, within the term Page: 3 arch 2015 Ares(2014)4214644 eport ref. DG (SANCO)/2014 -7022-MR of a/an audit carried out from 14 r live animals (LA) and products of animal origin (POAO) stipulated by EU legislation in force and to be signed by the person responsible for the load. The pre-notification have to be archived in import dossier. If the pre-notification is sent in a way which do not allow to sign it, this one will be signed by the responsible for the load before the control to be carried out. The verification of pre-notification and the correctness of its filling in, it is one of the topics of the checks carried out by TIEBIPD, in frame of Annual Control Plan of BIPs activities. In case of non-compliance of the legal provisions regarding the pre-notifications, there is the legal possibility that the importers to be sanctioned by the competent authority from the BIP, in conformity with art. 3, letter c), point 6 from Government Decision no. 9

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Monitoring Plan for 2015 was issued taking into consideration the ting following aspects: ) - number of the imports registered on 2014 in BIPs; in - the types of products of animal origin imported through each BIP and the associated risks, in the previous year; - the previous monitoring results; - RASFF messages and other relevant aspects. There has not been introduced the monitoring of some substances, pathogens or contaminants for the animal origin products which have not been registered in BIPs , in previous year. A assignation Plan of each BIP to accredited laboratories was sent. One of the topics of Training Plan on 2015 will be represented by sampling of animal origin products intended for laboratory testing. Term: July 2015 Page: 4 arch 2015 Ares(2014)4214644 eport ref. DG (SANCO)/2014 -7022-MR of a/an audit carried out from 14 r live animals (LA) and products of animal origin (POAO)

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Figures from the TRACES database indicate that 24 consignments were channelled from EU BIPs to destinations in Romania during the 18 months prior to this audit. Receipt at destination was confirmed by completing box 41 of the CVED in 12 of these cases.

There were five re-imported consignments during the same period and three had been confirmed as received at destination via completed box 41. 5 5.2.7.2 At the point of introduction

There are three Control Posts approved in accordance with Council Regulation (EC) No 1255/97 in Romania. There are no instructions for recording official controls carried out at Control Posts in TRACES and officials do not record such controls in TRACES. 5.2.9 INTRA module

There is no national instruction that official controls related to ante-mortem inspection for animals arriving from other Member States should be recorded in TRACES (18% of such consignments had those controls recorded during 2013 in TRACES but according to the competent authority all consignments would have been subject to ante-mortem controls).

A national instruction on the implementation of the requirements of Regulation (EC) No 1069/2009 requires that TRACES should be used to confirm receipt at destination of category 3 animal by-products arriving from other Member States. However, it does not include a similar requirement for Categories 1 and 2 animal by-products which are also included in Article 48(3) of Regulation EC (No) 1069/2009. According to the TRACES database, less than 20% of arriving consignments of processed animal protein and categories 1 and 2 in the DOCOM module were recorded in TRACES as being controlled at destination during 2013. It was not possible to confirm what percentage of consignments were actually controlled at destination.

Many consignments rejected by BIPs and sent for destruction were not recorded in box 41 of the CVED in TRACES as being received at destination and there is no instruction on this. 5.2.10 DOCOM module

Most CVEDs, INTRA-certificates and DOCOMs are issued correctly in Romania. However, for many consignments which require confirmation of receipt at destination, TRACES is not used in compliance with the legal requirements for ensuring traceability, e.g. consignments arriving from other Member States (slaughter animals, animal by- products) and imports (reimports and channelled consignments). The impact of the shortcomings is limited as some controls are implemented but not recorded in TRACES. The system of randomly checking notifications related to arriving products does not ensure that the LVU is aware of all consignments which require follow-up. Feedback received from other Member States in TRACES is not always followed up in accordance with planned arrangements and therefore increases the chances of recurrence of the original issue. 7

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Through Service Note no. 293/25072, it was sent all the BIPs the Contingency Plan for the situation in which TRACES site is not available more than 24 hours. nnelling procedure was updated and includes a requirement for local veterinary authority to register in TRACES receiving confirmation at the destination of the channelled consignments, mentioning the steps from TRACES Manual. Channelling procedure was sent to all BIPs and Sanitary Veterinary Food Safety Directorates through Service Note no. 297/25366/09.02.2015. It was issued the specific procedure regarding the transhipment of live animals and animal origin products coming from third countries (PS ­ 93 - DCIEPIF). The Guide regarding the transit and transhipment, issued by the Commission, it was translated and posted on NSVFSA website. In order to avoid the customs clearance in an inappropriate way of the transhipped consignments, NSVFSA will issued an instruction regarding to these types of consignments, applicable by customs authority from the air and port border crossing points. Term: 1.07.2015 Page: 1 h 2015 ort ref. DG (SANCO/2014-7023 ­ MR of a/an audit carried out from 14 unty s in 5.2.5.2 ­ 15, ies he f vities Ps staf

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The Order of the Minister of Water, Forests and Fish farming no. 2014, in conformity with the article 11, in order to develop the programmes for the surveillance, prevention, control and on of the classical swine fever, requests the specialized rsonnel of the hunting fund managers and of the protected areas strations, to implement the obligations regarding the cooperation with the county sanitary veterinary and food safety directorates, in view of submitting samples from wild boars. In conformity with the provisions of the Programme for the monitoring and control of classical swine fever for 2015, in the chapter ,,Surveillance in wild boars", there is specified the fact that, samples shall be collected from the wild boars found dead, killed in accidents (in these categories there being included also the wild boars found dead because of road accidents). In the service note on the implementing of the Programme for the monitoring and control of classical swine fever for 2015, there shall be mentioned also the sampling from the wild boars dead because of road accidents

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ficial Inspection and Control Directorate, during 2015, will ry out checks to verify compliance with Art. 4 (2) (b) and will provide training to staff specialized in the field for compliance h Art. (6) and 8 (1) of Reg 882/2004. - At the level of the General Directorate for Official Control, there has been elaborated the SERVICE NOTE 25452 (intranet nr. 5666) on 17.02.2015, having as subject the " organization of Page: 1 t ref. DG(SANCO)/2014-7045 -MR of a/an audit carried out from 03 classical swine fever control and monitoring programme. the official controls regarding the assessment of the implementation of the national program for the monitoring, control, eradication of classical swine fever, as well as the marking and certification of fresh meat, minced meat, prepared meat and pork meat products, or which contain pork meat, in conformity with the provisions of the Commission Decision 2013/764/UE.

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the audit mission in the framework of the CSF field, included t Programme from 2015, in order to check on the spot, shall be selected those counties which obtained sfactory results regarding the implementation of the CSF oring and control Programme. Also, during this audit, there shall be assessed the measures undertaken following the audit in ield from 2013. In conformity with the identified formities, recommendations shall be established. The audit drawn up by the structures audited for the established endations, shall be assessed by the audit team, so that, this should eliminate the nonconformities. Division ine movement from non-professional holdings to the fair om the fair to other holdings, is carried out in conformity he NSVFSA President Order no. 67 on the sanitary ­ nary conditions which must be complied with regarding the nt of live swine on the territory of Romania, and ng certain sanitary veterinary norms. regard to the draft report, point 5.2.2, the NSVFSA ted the amendment of the Order 45/2010 on the sanitary ­ nary functioning conditions of live animal fairs with strict ions regarding domestic swine, so that there should be Page: 2 t ref. DG(SANCO)/2014-7045 -MR of a

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ovement of all animals in Romania, is carried out only if y are identified, registered in the National Data Basis, and ompanied by the movement form. The sanitary veterinary ivities are carried out by the empowered free practice erinarian only for the animals identified and registered in the ional Data Basis. With this occasion if, in the holding there are identified animals, these shall be identified in conformity with legal provisions in force. At the same time, there are carried the potential animal movements as being introduced in the ding, for which, the owner did not notify the movement. There ll be submitted a service note in which, the focus will be on the uation of swine movement in Romania, in order to take all essary measures to reduce the uncontrolled swine movements. thout complying with the legal provisions in force). re shall be carried out trainings, in which, the situation of ne movement shall be presented, as well as the request by the nty SVFSD colleagues, of opinions on finding supplimentary utions regarding the decrease of swine movements in Romania, ch do not comply with legal provisions in force. In the mework of the trainings, the county SVFSD shall be requi

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the Service Note no. 25040 (intranet no. 5163)/9.01.2014 there ed the instructions regarding the assessment of l holdings which request approval for carrying out unity trades in fresh pork meat, prepared meat and products: ity with the Service Note no. 25216 (intranet no. 5190) 4, there are provided the guidelines on the dispatch of ignments towards the slaughterhouses in order to carry Community trades in fresh pork meat, prepared meat and products: orate of Safety of Animal Origin Food issued the te No. 27844(intranet no. 5149)/20.12.2013 through ns were transmitted to the County Sanitary Veterinary afety Directorates regarding the requirements to e trade in fresh pig meat, minced meat, meat ns and meat products consisting of, or containing pig rding to the provisions laid down in the Commission 013/764/UE concerning animal health control measures o classical swine fever in certain Member States. Page: 4 t ref. DG(SANCO)/2014-7045 -MR of a/an audit carried out from 03 classical swine fever control and monitoring programme. ctorate of Safety of Animal Origin Food issued the rder No. 191/2014 amending the Sanitary Veterinary ablishing the procedure for marking and sanitary ry certi

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al NSVFSA Common Order amending and completing Order of minister of agriculture and rural development, minister of environment and forests and president of National Sanitary Veterinary and Food Safety Authority Nr. 187/2155/42/2011 approving legal requirements for management of environment and identification and registration of live animals within aid measures and schemes for Romanian agriculture, with further amendments, was published in Romanian Official Gazette Part I, No. 280/16.IV.2014. This Order provides delegation of competencies to NSVFSA regarding official control on legal requirements for public health at the primary producers who applied for support to Agency of Paying and Intervention for Agriculture (APIA). In this context, NSVFSA and APIA will extent the existing Agreement for Delegation of Competencies with the new NSVFSA competencies in order to be able to start the organization of official control for public health at the level of primary producers mentioned above. Deadline: end of 2014.

NSVFSA NSVFSA will issue a strategy including Common Order amending and completing timelines for implementation, as it was Order of minister of agriculture and rural requested by FVO Letter no. Ref. development, minister of environment and Ares(2014)2775508 - 25/08/2014 regarding forests and president of National Sanitary a possible FVO audit on Veterinary and Food Safety Authority Nr. hygiene in primary production of food of 187/2155/42/2011 approving legal non-animal origin. This document will be requirements for management of environment sent to FVO till mid September. and identification and registration of live animals within aid measures and schemes for Romanian agriculture, with further amendments, was published in Romanian Official Gazette Part I, No. 280/16.IV.2014. This Order provides delegation of competencies to NSVFSA regarding official control on legal requirements for public health at the primary producers who applied for support to Agency of Paying and Intervention for Agriculture (APIA). In this context, NSVFSA and APIA will extent the existing Agreement for Delegation of Competencies with the new NSVFSA competencies in order to be able to start the 1 ons received 2

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NSVFSA NSVFSA organised in March, 2014 a meeting with MH representatives to discuss organisation of sampling and Page: 1 ay 2014 f Report ref. DG(SANCO)/2014-7168 -MR of a/an audit carried out from 20 nts in food. analyses for contaminants in baby foods. NSVFSA asked MH, responsible for this field, to prepare the final decision regarding sampling and analytical capacity till the end of first semester of 2014. MH The MH's capacity of performing sampling and analyses for contaminants in baby foods is in a process of analysis. When a decision is taken (at high level) the NSFVSA will be officially informed.

NSVFSA MH: The NIPH's laboratory from Regional NSVFSA organised in March, 2014 a Centre of Public Health of Cluj Napoca was eeting with MH representatives to discuss accredited in 23.01.2014 by RENAR organisation of sampling and analyses for (accreditation certificate no. LI 696/2014) contaminants in baby foods. NSVFSA asked for Lead and Cadmium in baby food. The MH, responsible for this field, to prepare the NIPH has planned to extend its analytical final decision regarding sampling and capacity for baby food for mycotoxins (aflatoxins M1) and HPA during the analytical capacity till the end of first following year (depending on the budget). semester of 2014. MH The MH's capacity of performing sampling and analyses for contaminants in baby foods is in a process of analysis. When a decision is taken (at high level) the NSFVSA will be officially informed.

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propriate NSVFSA ticular, OCGD According to the national training program, during the staff, as second semester of year 2014, Inspections and Official and Control Directorate will organise a training session of 2 days y as with all Chiefs of County Food Safety Official Control Offices, involved in official controls of contaminants throughout food of non-animal origin. The training session will be focused on theoretical and practical issues concerning the monitoring and control of contaminants in food, risk assessment related to contaminants in food, sampling and testing of food of non- animal origin, measures to be taken when the results of laboratory analysis are unsatisfactory. DNOFS Training on contaminants for FNOA will be organised within an EC funded project till the end of 2015. Page: 2 ay 2014 f Report ref. DG(SANCO)/2014-7168 -MR of a/an audit carried out from 20 nts in food. MH Ministry of Health will organize the training for the sanitary inspectors responsible for the official controls on contaminants.

NSVFSA NSVFSA will draft instructions for controls n OCGD of chemicals contaminants in FNAO till the ed to end of year 2014 and will implement this in According to the national training program, the first quarter of 2015. 2 ons received 29/8/2014 omania on28 May 2014in response to Report ref. DG(SANCO)/2014-7168 -MR of a/an audit rder to evaluate controls of contaminants in food. se during the second semester of year 2014, MH approved the organising of training for Inspections and Official Control Directorate sanitary inspectors. This training will take will organise a training session of 2 days with place until the first half of the following year all Chiefs of County Food Safety Official (Annex 1) Control Offices, involved in official controls of contaminants throughout food of non- animal origin. The training session will be focused on theoretical and practical issues concerning the monitoring and control of contaminants in food, risk assessment related to contaminants in food, sampling and testing of food of non- animal origin, measures to be taken when the results of laboratory analysis are unsatisfactory. DNOFS Training on contaminants for FNOA will be organised within an EC

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VFSA 12 NSVFSA will issue a Service Note signed by the NSVFSA president with the designation of the NSVFSA laboratories in official control for the specific field of competencies, till the end of first semester of 2014. MH MH asked to the NIPH to specify in the annual sampling methodology that contaminants analyses must be tested only in the accredited labs and to specify which are these labs.

NSVFSA NSVFSA issued NSVFSA presidential NSVFSA will issue a Service Note signed by Orders Nr. between 97 and 137 from the NSVFSA president with the designation 23.07.2014, Nr. 140/31.07.2014 and Nr. of the NSVFSA laboratories in official 145/12.08.2014 (one Order for each control for the specific field of competencies, NSVFSA laboratory designated in official till the end of first semester of 2014. control) with the designation of the NSVFSA laboratories in official control for the MH specific field of competencies. All laboratories designated in official control on MH asked the NIPH to specify in the annual contaminants are accredited. sampling methodology that contaminants MH: The NIPH has planned to extend its analyses must be tested only in the accredited analytical capacity for baby food for labs and to specify which are these labs. mycotoxins (aflatoxins M1) and HPA during the following year (depending on the budget) (Annex 2)

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rate NSVFSA A training on sampling for contaminants testing for FNOA, will be organised within an EC funded project till the end of 2015.

or NSVFSA A Service Note signed by NSVFSA e president provided that laboratories A training on sampling for contaminants designated in official control have to have sting for FNOA, will be organised within an written procedures in place (at sample EC funded project till the end of 2015. reception stage) with acceptance/rejection criteria with regard to minimum weight of incoming samples, will be issue till the end of trim III 2014. Department for control of medical products, nutrition and laboratory will elaborate and implement a plan of control of the provision of this Service Note till the end of 2014. 4 ons received 29/8/2014 omania on28 May 2014in response to Report ref. DG(SANCO)/2014-7168 -MR of a/an audit rder to evaluate controls of contaminants in food.

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of NSVFSA C) NSVFSA president Order No. 205 approving National Reference Laboratories and their attributions, published in Romanian Official Gazette No. 20 from January 10th, 2007 will be modified and completed in order to designate NRL for contaminants where a NRL was not designated yet. Deadline: end of 2014

NSVFSA on NSVFSA president Order No. 205 approving National Reference Laboratories and their attributions, published in Romanian Official Gazette No. 20 from January 10th, 2007 will be modified and completed in order to designate NRL for contaminants where a NRL was not designated yet. Deadline: end of 2014

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NSVFSA A Service Note signed by NSVFSA president provided that e laboratories designated in official control have to ensure that Page: 3 ay 2014 f Report ref. DG(SANCO)/2014-7168 -MR of a/an audit carried out from 20 nts in food. all analytical methods needed for the analysis of official samples for contaminants are validated and are demonstrably fit for purpose by meeting method performance criteria as defined in applicable EU legislation e.g. Regulations (EC) No 401/2006 (mycotoxins), Regulations (EC) No 1882/2006 (nitrates), Regulations (EC) No 333/2007 (3-MCPD, heavy metals, PAHs) will be issued till the end of trim. III, 2014.

e NSVFSA e NSVFSA Department for control of medical y A Service Note signed by NSVFSA president products, nutrition and laboratory will n provided that laboratories designated in elaborate and implement a plan of control of official control have to ensure that all the provision of this Service Note till the end analytical methods needed for the analysis of of 2014. official samples for contaminants are validated and are demonstrably fit for purpose by meeting method performance criteria as defined in applicable EU legislation e.g. Regulations (EC) No 401/2006 (mycotoxins), Regulations (EC) No 1882/2006 (nitrates), Regulations (EC) No 333/2007 (3-MCPD, heavy metals, PAHs) will be issued till the end of trim. III, 2014. 5 ons received 29/8/2014 omania on28 May 2014in response to Report ref. DG(SANCO)/2014-7168 -MR of a/an audit rder to evaluate controls of contaminants in food.

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g NSVFSA A procedure for verification that the contaminants monitoring programme is effectively implemented as required by Article 8 of Regulation (EC) No 882/2004 will be issued till the end of 2014. MH For implementation of the provisions of art. 8 of EC Regulation no. 882/2004, the Ministry of Health has developed the procedure for verification and control of sanitary inspectors' activity from local public health departments. This procedure was approved through the Ministerial Order no. 1277/2009 and updated in April 2014. It is in the process of re-approval. Page: 4

VFSA procedure for verification that the ntaminants monitoring programme is fectively implemented as required by ticle 8 of Regulation (EC) No 882/2004 ll be issued till the end of 2014. r implementation of the provisions of art. 8 EC Regulation no. 882/2004, the Ministry Health has developed the procedure for rification and control of sanitary spectors' activity from local public health partments. This procedure was approved rough the Ministerial Order no. 1277/2009 d updated in April 2014. It is in the process re-approval. 6

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alised MADR ­ ANF: Autoritile competente din România implicate in Approval procedura de evaluare a dosarelor produselor de protecie a plantelor îi vor (EC) No întri colectivele de evaluatori, fiecare pe domeniul de competen, pentru a asigura finalizarea etapei a IIa a procesului de reomologare la sfâritul anului 2016, pentru produsele pentru care s-a finalizat etapa a Iaa procesului de reomologare.

f PPPs is finalised MARD ­ NPA: The Romanian competent he relevant authorities involved in evaluating the PPP files will cle 13 of strengthen their teams of evaluators, each in their particular field of competence, in order to ensure that stage II-a of the re-registration process is finalised by the end of 2016, for those products for which stage I-a has been finalised.

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fication of MADR ­ ANF: În luna mai 2014, Agenia Naional Fitosanitar a semnat Article 5 un Protocol de colaborare cu Direcia General Industrie Alimentar, reprezentat prin Compartimentul Consultan, extensie i formare profesional, pentru organizarea i funcionarea sistemului de instruire i certificare în domeniul utilizrii durabile a produselor de protecie a plantelor. Scopul protocolului vizeaz iniierea aciunilor necesare pentru dezvoltarea i implementarea sistemului de instruire i certificare în conformitate cu prevederile art. 5 ­ Instruirea din cadrul Ordonanei de urgen a Guvernului nr. 34/2012, respectiv al Directivei 2009/128/CE. Agenia Naional Fitosanitar i Direcia General Industrie Alimentar prin Compartimentul Consultan, extensie i formare profesional vor demara procedurile pentru organizarea i dezvoltarea sistemului de instruire în domeniul utilizrii durabile a produselor de protecie a plantelor (PPP), la nivel naional i local, prin structurile teritoriale existente în sectorul fitosanitar, respectiv al consultanei, extensiei i formrii profesionale în agricultur. În baza protocolului de colaborare nr. 160.380/14.05.2014 cele dou Page: 1 ommendations, received 22 July 2014 ia

ing and certification MARD ­ NPA: In May 2014 the National cordance with Phytosanitary Agency (NPA) signed a protocol of /EC is collaboration with the Directorate- General for the Food Industry, represented by the Department of Agricultural Consultancy, Extension and Professional Training, on the organisation and operation of a system of training and certification in the sustainable use of plant protection products. The purpose of the Protocol is to initiate the actions necessary for developing and implementing a system of training and certification in conformity with the provisions of Article 5 ­ Training of Government Emergency Ordinance No 34/2012 and of Directive 2009/128/EC. The National Phytosanitary Agency and the Directorate-General for the Food Industry, through the report recommendations, received 17 October 2015 an submitted by the Competent Authorities of Romania on24 July 2014in response to Report ref. DG(SANCO)/2014-7179 - om 18 March 2014 to 26 March 2014in order to evaluate controls of pesticides. the Department of Agricultural Consultancy, Extension and Professional Training, will launch the procedures for the organisation and development of a system of training in

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68 of MADR ­ ANF: În Planul Naional Unic de Control Integrat pentru România (PNC) 2014-2016, s-a propus intensificarea controalelor oficiale Ps are la utilizatorii profesioniti, conform legislaiei în vigoare, astfel se vor pecified efectua peste 10.000 de inspecii/an la productori agricoli. he same De asemenea Agenia de Pli i Intervenie pentru Agricultur (APIA) va efectua peste 10.000 de controale/an la productori agricoli. în vederea respectri, de ctre acetia, a cerinelor de ecocondiionalitate, respectiv SMR 9. Astfel ANF i APIA au încheiat în acest sens protocolul de colaborare Nr.160.400 din 16.05.2014, privind implementarea cerinei legale în materie de gestionare referitoare la ,,Introducerea pe pia a produselor de Page: 2 ommendations, received 22 July 2014 ia to the recommendations of Report ref. DG(SANCO)/2014-7179 -MR of a/an audit carried er to evaluate controls of pesticides. protecie a plantelor", respectiv: Statutory Management Requirements (SMR 9), conform O.M. 234/2004 privind modificarea i completarea Ordinului ministrului agriculturii i dezvoltrii rurale, al ministrului mediului i pdurilor i al preedintelui Autoritii Naionale Sanitare Veterinare i pentru Sigurana Al

ls under Article 68 of MARD ­ NPA: Under the Single Integrated 7/2009 cover all the report recommendations, received 17 October 2015 an submitted by the Competent Authorities of Romania on24 July 2014in response to Report ref. DG(SANCO)/2014-7179 - om 18 March 2014 to 26 March 2014in order to evaluate controls of pesticides. sure that PPPs are National Control Plan (NCP) for Romania 2014- conditions 2016, it is proposed to step up official controls on out in Article 55 of professional users, in accordance with the legislation in force. Thus, over 10 000 inspections per year will be carried out on agricultural producers. The Paying and Intervention Agency for Agriculture (APIA) will also perform more than 10 000 checks per year on agricultural producers to verify their observance of cross-compliance requirements, i.e. SMR 9. It was to this end that the NPA and APIA concluded Protocol of Collaboration No 160.400 of 16 May 2014 on the implementation of Statutory Management Requirements (SMR 9) concerning the 'Placing on the Market of Plant Protection Products', in accordance with Ministerial Order (OM) No 234/2004 amending and supplementing Order No 187/2.155/42/2011 of the Minister f

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ow the MADR ­ ANF: În prezent, se implementeaz o serie de msuri / aciuni r Article relevante privind gestionarea integrat a duntorilor, care corespund icular principiilor menionate în Anexa nr. 3 la OUG nr. 34/2012: ements of · rotaia culturilor; utilizarea tehnicilor de cultivare adecvate; rea de soiuri / varieti de plante rezistente la condiiile pedo- ale României; rea de semine i material sditor certificate; rea fertilizrii echilibrate; tarea infrastructurii de irigaii i gestionarea eficient a apei pentru irigare; ea bunelor practici de utilizare în siguran a produselor de a plantelor, inclusiv curarea mainilor i echipamentelor în revenirii rspândirii organismelor duntoare ; rea i utilizarea zonelor de protecie; ntarea sistemului de prognoz i avertizare; Page: 3 ommendations, received 22 July 2014 ia to the recommendations of Report ref. DG(SANCO)/2014-7179 -MR of a/an audit carried er to evaluate controls of pesticides. · aplicarea de metode durabile (biologice, fizice, alte metode ne- chimice) în domeniul agriculturii ecologice, asigurând un control corespunztor al duntorilor. Monitorizarea se realizeaz de ctre organismele de certificare, acreditate de MADR; · utilizarea / apl

s of PPPs follow MARD ­ NPA: A series of appropriate integrated as required under pest management measures/actions are currently o 1107/2009, in being implemented which correspond to the l users meet the principles set out in Annex No 3 to Government and Annex III of Emergency Ordinance No 34/2012. -crop rotation; -use of appropriate cultivation techniques; -use of species/varieties of plants resistant to -the climatic conditions of Romania; -use of certified seeds and plant-propagating material; -balanced use of fertilization; -rehabilitation of irrigation infrastructure and efficient management of water used for irrigation; -implementation of best practices for the safe use of plant protection products, including cleaning machinery and equipment so as to prevent the spread of pests; -designation and use of protection zones; the report recommendations, received 17 October 2015 an submitted by the Competent Authorities of Romania on24 July 2014in response to Report ref. DG(SANCO)/2014-7179 - om 18 March 2014 to 26 March 2014in order to evaluate controls of pesticides. -implementation of a forecasting and warning system; -application of sustainable (biological, physical and other no

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cide MADR - Laboratorul pentru Controlul reziduurilor de pesticide their în plante i produse vegetale - Laboratorul Central: In 2015 se va valida cope so metoda de ditiocarbamai. Page: 4 ommendations, received 22 July 2014 ia to the recommendations of Report ref. DG(SANCO)/2014-7179 -MR of a/an audit carried er to evaluate controls of pesticides. s ANSVSA ­LSVSA: Bucureti a solicitat alocarea de fonduri pentru cide demararea procedurilor de achiziionare a celor necesare dezvoltrii lation metodei monoreziduale i acoperirii pesticidelor din programul comunitar I de control a reziduurilor de pesticide i a Regulamentului nr. 669/2009, s urmând ca pan la sfaritul anului 2015 s se finalizeze validarea metodei e de analiz. e Ministerul Sntii - Institutul Naional de Sntate Public: ed in Pentru efectuarea analizei multi-reziduuri, extinderea numrului de analii, detectarea limitelor reduse de pesticide de ctre laboratoarele aflate în subordinea Institutului Naional de Sntate Public implicate în controlul oficial al reziduurilor de pesticide din alimente pentru copii, este necesar finanarea pentru: - achiziionarea de echipamente adecvate (GC ­ MS) pentru dotarea Centrului Regional de Sntate P

ries for pesticide MARD - Laboratory for Pesticide Residues methods in their Control in Plants and Plant Products: ­ expand the scope Central Phytosanitary Laboratory: ers and In 2015, the LPRCPPP proposes to validate two Control single residue methods: s, as required - 1. Method for determination 2,4 D ­ to be (EC) No finalised in september 2015; Annex I of 69/2009. - 2. Method for determination -dithiocarbamate ­ es designated for to be finalised in november 2015. h should have ds to expand ANSVSA ­LSVSA: Bucharest has requested the of pesticides allocation of funds to make the purchases needed . in order to develop a single residue method and cover the pesticides included in the EU Control Programme for pesticide residues and Regulation (EC) No 669/2009, with validation of the analysis the report recommendations, received 17 October 2015 an submitted by the Competent Authorities of Romania on24 July 2014in response to Report ref. DG(SANCO)/2014-7179 - om 18 March 2014 to 26 March 2014in order to evaluate controls of pesticides. method to be finalised by the end of 2015. Ministry of Health (MS) - National Institute of Public Health (INSP): - For the INSP's subordinate laboratorie

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e 4(2) of I. The National Sanitary Veterinary and Food Safety Authority dequate legal (NSVFSA) requires Ministry of Environment and Forests Changes nce for CSF in (MEFC) to set up legal provisions which shall oblige gamekeepers wn in the CSF to send samples as an indispensable condition in obtaining of the 13 by Decision hunting authorization. To this end, MEFC taking into account the responsibilities of gamekeepers listed in Order of the Minister of Agriculture and Rural Development (MARD) no. 219/2008, requires that specialized personnel from gamekeepers and from protected areas administration to implement their obligations of cooperation with territorial veterinary authorities (County Sanitary Veterinary and Food Safety Division -CSVFSD) in order to send the samples from wild boar. C:\Documents and Settings\Blank User\D II. Simultaneously, in the draft proposal for modification of Government Decision No. 984/2005 establishing the sanctions and contraventions to the veterinary and food safety rules, there were introduced provisions regarding punishments for the officials representative of the Territorial Inspectorate for Forestry and Hunting and also for the officials representat

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f Regulation If the owners of pigs non-professional holdings ask for their animals tive, identification later than the legal period of time, they shall be firstly s appropriate, to sanctioned by paying the labour of the veterinarian practitioner ts on empowered with identification activities; otherwise, the cost related d down in to animal identification is supported by state budget -in conformity of animals in with the provisions of article 7, paragraphs 2, point (b) (c) of the No. 23 of 24 March 2010 on the registration of pigs, sheep, goats and equidae, and n and completion of some legal acts, as amended the operation costs for the identification and s, sheep, goats that have exceeded the maximum ication and registration specified by legislation e owner thereof." pliance with the legal provisions on registration of animals shall be sanctioned in provisions of the Government Decision n the contravention and sanctions related with ood safety sanitary veterinary norms, as ented, under which, the following facts tions to sanitary veterinary rules and are the recommendations of Report ref. DG(SANCO)/2013-6789 -MR of an audit carried out e implementation of the Classical Swine Fever e

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(6) of Regulation The General Directorate for Official Control, within the NSVFSA n without delay shall perform official control procedures in order to verify the internal audits aimed effectiveness of the official controls carried out in accordance with ols. the Regulation regarding the organization and functioning of the NSVFSA, approved by the Order no. 823 of September the 23rd, 2013. The Audit Directorate within the NSVFSA performed an audit of the control system on CSF during 22.05-20.06.2013. Based on the recommendations received, directorates within the NSVFSA with competences in the audited area drew up an action plan consisting of the following: - allocation of funds to purchase the kits needed by the official laboratories; - organization of training courses for the territorial veterinary authorities (CSVFSD) on implementation of the Program of CSF surveillance and control; - monitoring by the central level of the extent of implementation of the Program of CSF surveillance and control and reviewing in case of failures; -analysis in order to review legislation on bio-safety conditions for type A holdings and legislation on marking the pork obtained from animals reared on R

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e context of the The Program for CSF monitoring and control for years 2012 i 13 by Decision 2013, approved by CE Decisions, have been sent through Service funded within Note to local authorities (County/Bucharest Sanitary Veterinary and ctive Food Safety Directorates). The monitoring of this program n be considered fit implementation has been done through: analyze of received data; ew and can yield transmission of messages containing the evaluation of these data as miological situation regard the appropriate way of implementation of the instructions for pplying the principles of active and passive surveillance; video- onferences. rder no. 43/2012 of NSVFSA approving the Methodological Norm detailed procedures) as regard the implementing of the Program for urveillance, prevention, control and eradication of animal diseases, the recommendations of Report ref. DG(SANCO)/2013-6789 -MR of an audit carried out e implementation of the Classical Swine Fever eradication programme. of those transmissible from animals to humans, animal and environment protection, the identification and registration of bovine, pigs, sheep and goats, for the year 2012, as well as the Methodological Norm for the

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e context of the If a case or outbreak of classical swine fever is confirmed, Romania 13 by Decision applies control measures laid down in Council Directive no. funded within 2001/89/EC on Community measures for the control of classical the recommendations of Report ref. DG(SANCO)/2013-6789 -MR of an audit carried out e implementation of the Classical Swine Fever eradication programme. rning system swine fever, which specify that sick and suspected animals and also rom their contacts are killed and the dead bodies are neutralized. At the throughout same time, zones with restrictions for movement of infected animals down in are set, the infected holdings are subject for mechanical cleaning, the findings, disinfection, disinsection and deratization, and these holdings are pected subject to restocking, after a period of time in accordance with the Directive. In order to be prepared to face cases of major swine viral diseases (classical swine fever, African swine fever, foot and mouth disease and swine vesicular disease), Romania has Contingency Plans establishing the command and administrative structures with role in disease eradicating, and Operational Manuals of procedures establish

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signated as points of entry of plants and plant l to the Commission on 26 July 2013.

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July 2013 and no 5567/23 July 2013 of premises from airport and seaport to allocate ection conditions, in line with the minimum 98/22/EC, for border inspection posts

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hat the appropriateness of the additional declaration is umentary checks in line with the provisions he phytosanitary inspectors from all BIPs, 18127/ 29.07.2013

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nitary Agency will develop the inspection size of sample to be taken from specified sual inspection. cember 2013

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61/2008 establishing the methodology of plant modify. December 2013

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ry Agency sent to the all BIPs a address to carry out Page: 1 /2013-6796-MR of an audit carried Action Proposed by the Competent Authority plants in particular for the detection of other than Hirschmanniella gracilis (Address no.

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aterial bearing the ISPM -15 mark, it was rder Inspection Posts (Address no. 117544 from 29 hecks with sampling and sent samples to CPL August 2013, the Central Phytosanitary d analyzed 33 samples taken from wood ring ISPM-15 mark. s were negative.

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small quantities of plants and plant products owner or recipient for non-industrial and non- r for consumption during transport, specified and l Order no. 34/2011, will be modify. f September 2013.

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persons (one from National Phytosanitary Agency osanitary Laboratory) in order to ensure that sent no later than two working days, in line with l Directive 94/3/EC. Page: 2

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e 2013, NPRC provides a higher number of samples for all species nimals according to Annex IV of Directive 96/23/EC, so that to ensure an efficient monitoring of substances used in farms and the ts would-be occurring issues shall not endanger the carrying out of NPRC.

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In order to improve the system of documents'check regarding food chain he level of slaughtering establishments, the following actions were arried out and shall be further performed: cles -In conformity with the annual programme of annual training of the staff the veterinary field, DTSAOA planned the carrying out of 6 training ions with official veterinarians that ensure the sanitary veterinary eillance, sessions in which there shall be carried out trainings rding the ante-mortem exam of animals, respectively the mpanying documents, clinical exam, decisions regarding animals. conformity with Service Note no.25466/28.02.2013, in March, 14-16, , there took place in Bacau the first of the 6 training sessions at h participated 30 official veterinarians from the counties of Bacau, t, Suceava, Botosani and Iasi. Within this sessions there have been ented issues on the ways of checking the documents on food chain the identified deficiencies by DG (SANCO)/2013-6843 Mission rding these documents. final term provided for this training session is 30/06.2013. Page: 1 Action Plan received from CA on 14 May 2013 of Report ref. DG(SANCO)/2013-6843-MR of an audit carried idues and contaminants in l

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In May 2013, DCTIRLRCAFV shall organize a training on the theme `Residues'control of live animals and animal products', where there shall be presented guidelines on the way of carrying out controls in animal farms, in case of occurrence of non-conforming results within The m to NPRC. dues

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The new passports for equidae shall be issued in conformity with the requirements of art.5 of Regulation EC no. 504/2008. During 2013, there shall be organized trainings of official veterinarians of free practice in each county residence. Trainings shall be carried out by the professors of veterinary faculties and experts of competent veterinary authority. Page: 2 Action Plan received from CA on 14 May 2013 of Report ref. DG(SANCO)/2013-6843-MR of an audit carried idues and contaminants in live animals and animal products the Competent Authority ll be sent a newsletter on the way of filling in

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In order to ensure that testing of the raw milk by FBOs is ar carried out with respect to the EU legislation, in particular with as regard to sampling, calculating geometric average and analysing, as laid down in Regulation (EC) No 853/2004 Chapter III, Section IX, Chapter I, and monitored by the Competent Authority as laid down in Regulation (EC) No 854/2004 Annex IV Chapter II, NSVFSA elaborated and transmitted to the CSVFSD in all the counties the Service Note (SN) no. 2718/09.10.2013. According to this SN, official veterinarians from all CSVFSDs must perform controls to verify how the tests for the quality parameters according to the requirements of the Regulation (EC) No 853/2004 Chapter III, Section IX, Chapter I, are performed, in particular if: - sampling of the raw milk for laboratory testing is performed from each milk producing holding which delivers milk to processing either directly, or through the collecting centres, according to the NSVFSA sampling instructions. - the analyses performed on raw milk in the frame of FBO's own control programme are done in sanitary veterinary authorized laboratories, on samples taken from farms/ milk cows holdings which deliver milk to

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Central competent authority will perform a training session in the s in first semester of 2014 with the representatives of County Sanitary a Veterinary and Food Safety Directorates involved in official nd 4.4 controls throughout raw milk production chain and monitoring of raw milk analysis and audit of milk processing establishments according to the Strategic National Program of Prevention, Control and Surveillance on safety food field approved by Governmental Decision. The training session will be focused on relevant aspects regarding official controls to be performed by the official veterinarians at farms/backyard farms of milking cows delivering raw milk to the processing establishments, milk collecting centres, transport of raw milk and milk processing establishments level. The session training will be also focused on sampling and testing of raw milk, monitoring of analysis, including calculating of geometric average. Organizing the training in the first semester of year 2014 is due to the fact that in October 2013 was requested European Commission's support, but till present no answer was received. In the same time, in order to monitor the raw milk tests, and to properly ensur

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Regarding the laboratories carrying out the testing of raw milk, sults, in the NRL has organised a proficiency test for SCC in milk (05.12- 004. 18.12.2013). The number of participating laboratories was 76 (40 official labs and 36 private labs). The report of the PT is attached. For the year 2014 NRL has programmed a training session for "Raw milk quality- testing and reporting of SCC and TBC" on the 2-nd quarter of the year. Also on the 2-nd quarter 2014 is scheduled a proficiency test for TBC on raw milk for official labs and private labs. The proficiency tests programme for 2014 is available for consultation on www.iispv.ro and is also attached. Page: 4 port ref. DG(SANCO)/2013-6891 -MR of a/an audit carried out from 17 s related to the safety of food of animal origin, in particular to the transitional establishments as laid down in Commission Decision 2009/852/EC as. Medicinal Product, Nutrition and Laboratory Control Service within Inspection and Official Control Directorate (IOCD) has issued Service Note no. 25476/19.02.2014 on developing control programs for 2014 in the field of laboratories, as stipulated Order no. 114 of December 30, 2013 regarding approving sanitary veter

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d The Sanitary Veterinary and Food Safety Authority has taken measures to remedy the deficiencies found during FVO audit line mission, as follows: Ear tag duplicates were applied to bovine animals where the ear tags were missing. A statement form has been drawn up and duplicates of passports have been issued for bovine animals to which passports were missing. In order to find and remedy the deficiencies regarding the identification and registration of animals, the National Sanitary Veterinary and Food Safety Authority is performing the following activities: 1. Official controls of at least 3% holdings/farms of cows in order to find the cases of breach of provisions of Regulation (EC) No. 1760/2000, according to the provisions of Regulation (EC) No. Page: 5 port ref. DG(SANCO)/2013-6891 -MR of a/an audit carried out from 17 s related to the safety of food of animal origin, in particular to the transitional establishments as laid down in Commission Decision 2009/852/EC as. 1082/2003 laying down detailed rules for the implementation of Regulation (EC) No. 1760/2000 as regards the minimum level of controls to be carried out in the framework of the system for the identification and regi

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ry Inspection and Official Control Directorate (IOCD) sets up yearly d, Page: 6 port ref. DG(SANCO)/2013-6891 -MR of a/an audit carried out from 17 s related to the safety of food of animal origin, in particular to the transitional establishments as laid down in Commission Decision 2009/852/EC as. e National Control Program in the food safety field. e Inspection and Official Control Directorate (IOCD) within e National Sanitary Veterinary and Food Safety Authority SVFSA) will perform the audit of milk processing tablishments in the year 2014, according to the National Control ogram. e prioritisation of official controls for food industry tablishments, including milk processing establishments, is tablished, by the IOCD, under the National Control Program, sed on: risk category of food establishments; - assessment results of official control activity performed by the VFSD. Page: 7

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dy applies the provisions of Art. 21 of Directive Article 4 of Regulation (EC) No 1830/2003. words used on the official label of seed lots Romania U legislation on the marketing of seeds (e.g Directive art. 11a "In the case of seed of a variety which has been odified, any label or document, official or otherwise, which or accompanies the seed lot, under the provisions of this all clearly indicate that the variety has been genetically hat the words used according to the European seed re more appropriate than the words provided by the Article 4 (EC) No 1830/2003 (`This product contains genetically nisms' or `This product contains genetically modified nism(s)]'). The reason of this consideration is that in the ed, we are speaking about a product 100 % GM. ication of this issue, Romania will propose an item on the next Standing Committee on seeds in order to clarify e on the official label on seed, in the case of GM Varieties, esentatives of the European Commission. of threshold issue we appreciate that for the sake of Page: 1 ANCO)/2012-6306-MR of an audit carried modified organisms, including their deliberate release ction Proposed by the Competent Authority plementation of the EU le

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griculture and Rural Development (MARD) took the it is a high priority for Romania to develop and accreditate for GMO's testing of Central Laboratory for the Quality Propagating Material, under MARD, which is an official TA accredited for seeds testing. rocess of accreditation the lab will accomplish all the ns made by FVO experts. hat the seeds crop of 2013 will be tested according to the

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ory for GM food and feed (IDAH) will current activity, starting with 2013, the methods for GMOs listed in the Compendium, published by the EURL-

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of Agriculture and Rural Development (MARD) took the it is a high priority for Romania to develop and accreditate for GMO's testing of Central Laboratory for the Quality Propagating Material, under MARD, which is an official Page: 2 ANCO)/2012-6306-MR of an audit carried modified organisms, including their deliberate release ed by the Competent Authority TA accredited for seeds testing. rocess of accreditation the lab will accomplish all the ns made by FVO experts. hat the seeds crop of 2013 will be tested according to the

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rence Laboratory for GM food and feed (IDAH) will current activity, starting with 2013, the analytical methods se of Regulation (EU) No 619/2011. Page: 3

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n Resources was he staff is not assigned in an l Directorate, Litigation and Human will promote a new ROF eration) for SVFSD counties and to consider the personal resources to in order to carry out official controls on re, as provided in Article 4 (2) (c) of 4

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and of Bucharest s the the frequency of the official ctors. rvice note no. e submitted the following: pection on Animal Welfare-Annex 1 ts, subject to veterinary control on the requency of controls taking into s, Annex 2 .doc Anexa 2.xls

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priate facilities and In order to ensure that BIPs have appropriate facilities and equipment to aff can perform official guarantee that staff can perform official controls efficiently and effectively as tively as required in required in Article 4 (2) (d) of Regulation (EC) No 882/2004, there were n (EC) No 882/2004. approved by NSVFSA management the Necessity papers in view of purchase by each BIP of the equipments, as follows: - laboratory materials necessary for inspection rooms with Necessary paper no. 2579/12.06.2012; - electric equipments necessary for inspection rooms with Necessary paper no. 3027/5.07.2012; - protective equipment necessary for carrying out of official checks in BIPs with Necessary paper no. 3026/5.07.2012. Deadline: 31.10.2012 For the time being, NSVFSA evaluate the infrastructures deficiencies from airport BIP Henri Coanda Otopeni in view of purchase of repair services in order to ensure appropriate facilities for performing the official border control activity. We mention that the airport BIP Henri Coand Otopeni ­ live animals module, is temporary suspended.

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res for verification of Competent authority from the BIPs carry out official controls in accordance rols and to ensure that with documented procedures. 1 needed as laid The border control procedures are permanent updated in according with the (EC) No 882/2004. amendments of the EU legislation. The updated procedures are posted on the NSVFSA website. Verification of compliance with control procedures by BIPs staff is performed in frame of annual control program nr. 39/27.01.2012 and conducted by the Directorate of Control and BIPs Coordination, Import, Export, Transit and Trade. The results of annual control program are the pylon of identification of training issues of BIPs personal, which ensure the corrective actions as laid down in Article 8.3. of Regulation 882/2004. Deadline: permanent

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or the import Given the Audit program for 2012, counselors within the Technical Audit riate measures in and Control Directorate ­ Technical Audit Service conducted in February uired in Article 4 (6) of 2012 an mission on three Border Inspection Posts ­ Albita, Siret, and Constanta South, in accordance with Article 4(6) of EC Regulation 882/2004. The audit mission aimed at assessing the official control systems for the import, export and transit of live animals and food and covered the period of time from the last audit conducted in November 2010 until February 2012. During this audit, progress against the recommendations made in the audit performed in 2010 was assessed. Following those missions in the 3 Border Inspection Posts, audit reports were prepared, including findings made during the audit, the action plan of the audited body and the final conclusions of the auditors. Final reports were submitted to the President of NSVFSA, the Director of Directorate of Control and BIPs Coordination, Import, Export, Transit and Trade and audited bodies, and to the coordinators of the three audited BIPs, respectively. We mention that the non-conformities found during those audits were simila

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shipped at In order to ensure that the consignments transshipped at Romania BIPs are 2 h the checked in line with requirements laid down in EU legislation the followings f Directive measures have been taken: - Based on Protocol no. 1408/2010 with shipping companies and collaboration protocol with customs authorities no. 135/6.03.2012, shipping companies provide staff BIP, before the physical arrival of the ship, unloading permission, unloading list and cargo manifests. For unloading: - BIP staff select of the consignments subjected to veterinary checks, record the consignments in transshipment record and archives the documents; - BIP staff endorse the unloading permission which permit to customs authority to authorize the vessel downloading; For loading: - When the goods are loading, BIP staff select the consignments subjected to veterinary checks, in order to verify the duration of the storage in terminal area. - Depending on the duration of the storage, official veterinarian take the followings decisions: - the consignments which have been stored between 0-7 days are loaded without veterinary checks, the unloading permission and unloading lists are endorsed, which permit to custo

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ignment in transit Annual training program in veterinary and safety food field will include also received conforms to issues linked by the consignments in transit and the BIPs Coordination ntroduction as Directorate will verify the compliance of transit procedure in according with on Decision Article 3 of Commission Decision 2000/208/EC in frame of annual control program nr. 39/27.01.2012. The BIPs coordinators will quarterly verify if the consignments in transit there were confirmed in TRACES system. Deadline: 31.10.2012 4

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rusological testing in the context of active surveillance gs, National Sanitary Veterinary and Food Safety nt to the territory a planning with the numbers of to be harvest in December 2012 for CSF virusological ce. The planning was represented by the number of llected (tons / spleen) from pigs slaughtered for m the backyards farms that have pigs, backyards es in the areas of 3-10 km surrounding the ed in Channeled System. The number of using prevalence of 5% and confidence of 95% gs with pigs in each locality, taking into ecember in every backyard at least one pig is n consumption. Below you can find the planning of lementation of this planning, implementation electronically system. C:\Documents and Settings\Blank User\D urveillance in the backyard holdings, below you m our electronically system at 24.12.2012 Page: 1 G(SANCO)/2012-6585 MR of an audit carried swine fever in the context of the approved Action Proposed by the Competent Authority

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e effective functioning and reliability of the intra-Union trade of fresh pig meat produced in the CS, National Sanitary Veterinary and Food Safety series of instructions. These instructions are address inarians in charge with the certification of the live pigs slaughter to a slaughterhouse included into the CS o to the veterinarian officers who certify the fresh e intra- Union trade from the slaughterhouse included n order that all of certifying officers have all information g of intra-Union certificates in accordance with n Directive 96/93/EC, in particular as regards CSF surveillance plan in the holdings of origin of e slaughterhouse and in the area surrounding them, e 8(c)(1)(v), (vi) and (vii) of Decision 2008/855/EC. tions are inserted below. Page: 2 G(SANCO)/2012-6585 MR of an audit carried swine fever in the context of the approved etent Authority

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e document "General Procedures ol of plant protection products on sale and use". e of inspection, phytosanitary inspectors will s of plant protection products that are obliged to otection products they use, for at least three ticle 67 of Regulation (EC) 1107/2009.

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propose the analysis of organic sample illance and control for non animal products in ogramme" the fact that starting with 2012 ic products according to the Regulation EC ort of every supplier from every country of randomly sampled products for the next imports

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n took into account the results from previous ducts. of CPHDs organize and carry out the official ing account the operators past records . ols are foreseen in the Annual Control Plan lth Compartment. Page: 1 2011-8991-MR of an audit carried n mpetent Authority s in BIPs and the final import point of there first import of every supplier from every d randomly for the next imports, and for the r the products origin third countries and any e established a control once per year for every e products that they are not the first rol programme is drafting taking into criteria: mmodities in national food consumption; gh residues/non-compliance rate in ears; n processed form; , EU or third country; s of the population, e.g. baby food; luded in the EU coordinated

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er of pesticides so that to be able to cover all 669/2009 EU Regulation starting with the 2nd Page: 2 2011-8991-MR of an audit carried n oposed by the Competent Authority coordinated multi-annual Community ill increase number of pesticides staff and budget). pesticides standards that will be validated SANCO/10684/2009, and for the year 2012 we idues compared to last year. rom the National Institute of Public Health will esticides in 2012 by acquisition the necessary