Greece

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In three compound feed manufacturers visited, the audit team scrutinised the most recent inspection reports and interviewed the inspectors on their assessment of the operators' HACCP plans. In one establishment the hazard identification section of the operators' HACCP plan and the HACCP principles on the critical control point were correct. The feed inspector correctly assessed the plan. In the two other establishments the hazard identification section of the operators` HACCP plan was very generic. Several hazards were grouped and assessed together, although the severity and the probability of these hazards differed significantly (for example several different types of cereals and their related hazards (e.g. heavy metals, toxins) were assessed as a single group). These are not in line with the requirements of Article 6(2) of Regulation (EC) 183/2005 and these shortcomings were overlooked during previous official inspections.

In all establishments visited FeBO`s HACCP systems contained instruction on sampling, cleaning and on other relevant procedures. However, most of these procedures were deficient or did not reflect the real procedures which were implemented by these operators. These are not in line with the requirements of Article 7(1b) of Regulation (EC) 183/2005 and these shortcomings were overlooked during previous official inspections.

The system of planning of inspections is based on appropriate risk-related factors and ensures that the official inspections are carried out regularly, on a risk-basis and with appropriate frequency. While feed inspectors regularly use checklists and guidance documents and official inspections are documented, the effectiveness of these inspections is weakened by several shortcomings in their execution. These relate to the inspectors' assessment of FeBOs HACCP systems and tests on cross-contamination. 5.2.2 Sampling and analysis 5.2.2.1 Planning of official sampling

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The DAFP has also prepared guidance on the assessment of testing methods and test results of FeBOs' tests on homogeneity of mixing and cross-contamination. Although, these set of guidance contained several useful information, but some key elements (e.g. acceptance levels of homogeneity tests, criteria of adequate sampling techniques), which are necessary for a comprehensive assessment of these tests, were not described. Local feed inspectors need to carry out a comprehensive assessment of the FeBOs' tests on homogeneity of mixing and on cross contamination.

Verification of an establishment's tests to evaluate measures designed to minimize cross-contamination, as required by part 2(b) of the "Facilities and Equipment" section of Annex II to Regulation (EC) No 183/2005, is an integral component of inspections, when applicable. In three establishments visited, the written procedures on sampling of cross-contamination tests did not reflect to the sampling procedures implemented by the FeBOs. In two establishments the physical characteristic of the tracer used during the tests were not representative for coccidiostats used during production. In one establishment several samples were collected from the first mix after flushing, however, these samples were pooled and sent to the laboratory as one sample. In one establishment the tracer used for the analyses of cross-contamination tests was scientifically inappropriate because of varying high background levels for the analyses of these types of feed. Feed inspectors met, experienced difficulties in comprehensively assessing the procedures and the results of the cross-contamination tests.

One establishment visited used a manual cleaning procedure to avoid potential cross- contamination. However, it was evident that the procedure is not effective to prevent cross-contamination. This is not in line with the requirements of point 3 of the section "PRODUCTION" of Annex II to Regulation (EC) 183/2005. Local inspector correctly identified the inadequacy of the cleaning procedure.

The system of planning of inspections is based on appropriate risk-related factors and ensures that the official inspections are carried out regularly, on a risk-basis and with appropriate frequency. While feed inspectors regularly use checklists and guidance documents and official inspections are documented, the effectiveness of these inspections is weakened by several shortcomings in their execution. These relate to the inspectors' assessment of FeBOs HACCP systems and tests on cross-contamination. 5.2.2 Sampling and analysis 5.2.2.1 Planning of official sampling

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The DAFP has prepared guidance on official sampling based on the requirements laid down in Annex I to Regulation (EC) 152/2009. In general, the guidance contains 9 several useful information relating to implementation of official sampling, however, there are some key elements which are not mentioned (e.g. mechanical divider, size of the incremental samples).

The audit team observed official sampling in two compound feed manufacturers visited (the matrix and parameters to be controlled were suggested by the audit team). In both cases inspectors sampled a part of the batch (sampled portion). The audit team identified some shortcomings during these official sampling such as: · inappropriate mixing of the aggregate sample · inaccurate calculation of the weight of the aggregate sample · inappropriate reduction of reduced sample to final samples · missing of reference to the sampled portion on the sampling protocol. These findings are not in line with the legal requirements of Annex I to Regulation (EC) 152/2009.

DAFP officials and local feed inspectors stated that they do not have dividers to be used during official sampling. This is not in line with the requirements of point 9.4 of Annex I to Regulation (EC) 152/2009. 5.2.2.3 Testing of official feed samples

Many aspects of the planning and implementation of sampling and testing of official feed samples are positive. A risk-based approach has been adopted for the planning of official sampling, and the interpretation of the analytical results are correct. However, the inappropriate implementation of official sampling procedure and inadequate procedure for designation of official feed laboratories could adversely affect the legal and technical validity of official feed samples and the reliability of decisions made on the basis of the corresponding results. 5.2.3 Actions taken on non-compliances

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The DAFP is responsible for the designation of the official laboratories except for medicated feed. The designation documentation of the three FCL laboratories and two other state-owned laboratories was in line with the requirements laid down in Article 37 of Regulation (EU) 2017/625. The DAFP has no written designation decision in place for the external laboratories, however, formal written agreements were in place for the analysis of official feed samples by both the DAFP and the external laboratories which are in general renewed every year. The audit team reviewed the agreements and associated documents relating to procedures and service delivery and noted that for the laboratories located in other Member States the DAFP was unable to provide any documentation whether the laboratory fulfils the requirements of Article 37(2)(b) to demonstrate the laboratory is already designated as an official laboratory by the competent authorities of the Member State on whose territory it is located.

For the three FCL laboratories and two other state-owned laboratories the methods of laboratory analysis used for the purpose of official controls were included in their respective scopes of accreditation to EN ISO/IEC 17025. Thus, the requirements laid down in Article 37(5)(a) of Regulation (EU) 2017/625 were met for these laboratories. However, the audit team noted that for one of the private laboratories, the method of laboratory analysis used for the purpose of official controls for antibiotics in feed was not included in its respective scope of accreditation to EN ISO/IEC 17025 and the testing was performed outside of EN ISO/IEC 17025 accreditation and accordingly did not meet the requirements laid down in Article 37(5)(a) of Regulation (EU) 2017/625.

Many aspects of the planning and implementation of sampling and testing of official feed samples are positive. A risk-based approach has been adopted for the planning of official sampling, and the interpretation of the analytical results are correct. However, the inappropriate implementation of official sampling procedure and inadequate procedure for designation of official feed laboratories could adversely affect the legal and technical validity of official feed samples and the reliability of decisions made on the basis of the corresponding results. 5.2.3 Actions taken on non-compliances

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The audit team audit team reviewed 11 sampling and one inspection-related non- compliances. The feed inspectors could provide the official reports on the follow-up of these non-compliances. In one case the reports provided sufficient information indicating that the FeBOs had carried out investigations to address the deficiency, and/or identify the root cause, and/or prevent the reoccurrence of the identified non- compliances. This is in line with the requirements of Article 138 of Regulation (EU) 2017/625. However, in the other ten sampling-related and one inspection related cases, the competent authority could not provide written evidence, that FeBOs carried out adequate investigation to find the root cause (e.g. antibiotic in pig feed, aflatoxin in maize, carry over of salinomycin in poultry feed) and took actions to prevent the reoccurrence of the identified non-compliances (e.g. by modification of HACCP procedures) which are not in line with the above-mentioned legislative requirements. Conclusion on the actions taken on non-compliances

Notwithstanding the fact that the competent authority took actions when non- compliances were identified in the course of official controls, the competent authority did not ensure the quality and consistency of official controls in relation to (i) the determination of the origin and extent of the non-compliances, (ii) operator remediation of the non-compliance, and (iii) prevention of further occurrences. Collectively these shortcomings weaken the effectiveness of the system of official controls on feed.

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The Joint Ministerial Decision sets clear conditions for receiving compensation, including compliance with traceability, biosecurity measures, and early notification rules- requirements to be met before the outbreak, and that must be confirmed by an official veterinarian Farmers were during the epidemiological enquiries. Yet, despite the frequent non- fully compliances the audit team found when visiting farms, Greece did not penalise farmer compensation during the three recent epizootics. compensated Authorities did, however, take action for some of those non- despite having compliances and imposed sanctions separately. non- compliances in 12. In all visited farms where compensation had been paid, farmers their farms. received the full amount per animal. However, in most cases, especially in dairy farms, the cost of restocking exceeded the compensation. Farmers reported that, despite the increase in compensation, the amounts still did not reflect the true market value of their animals. Authorities 13. The MRDF imposed two nationwide movement bans, lasting 26 and 8 introduced days, to contain the diseases. The ban was particularly effective disease control during the PPR epizootic. However, a surge in movements after lifting measures the first, longer ban coincided with the likely reintroduction of SPGP beyond those in and unexpectedly helped spread the disease. EU rules. 14. The MRDF temporary suspended all sheep and goat movements from Greece to other Member States during the PPR epidemic. Later, a Commission Implementing Decision prohibited all such movements outside Greece. Authorities ensured compliance with these bans. 15. Regional and local disease control centres adopted additional measures: they reinforced movement controls with help from the Assessment of Hellenic police and of the Port Authorities, imposed disinfection of the epizootics is roads connecting affected farms and grazing areas, cancelled livestock pending, no events and festivals, and raised awareness among hunters to keep their lessons learnt dogs away from livestock facilities. yet to improve future 16. The MRDF, through a Decision, established a group of experts from responses. its services, academia and the Regions, to analyse the recent PPR epizootic and identify how the disease entered and spread in Greece. 7 At audit time, the group had not yet met. It will also evaluate response measures and identify weaknesses. The MRDF also planned to hold a teleconference with affected regions for a lessons-learned review covering PPR and SPGP outbreak responses. Conclusions on authorities and general provisions 17. The overlapping epizootics of PPR and SPGP tested Greece's capacity to manage animal health emergencies. Despite efforts to adapt containment measures, these did not prevent the spread within and beyond affected areas. 18. Limited human resources slowed the response and limited the scope of control measures. Longstanding weaknesses in farm biosecurity, surveillance and animal traceability undermined early detection and disease control. 19. The new compensation policy supported farmer cooperation post-outbreak and improved adherence to disease control measures. However, authorities did not reduce payments for non-compliance with key animal health requirements, weakening the policy's effectiveness in improving compliance and preventing future outbreaks and raising questions about the efficient use of EU cofinancing to support it. 20. National movement bans, going beyond EU requirements, helped to contain PPR However, authorities did not anticipate the negative impact of lifting restrictions prematurely and the resulting surge in animal movements, combined with delayed detection of a new SPGP incursion, contributed to the fast spread of that disease. 21. Greek authorities have not yet analysed and review the data and experiences gathered during the response to the PPR and SPGP outbreaks. This delay limits their ability to implement improvements that wo

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A review of the AMR sampling programme revealed the following: i. The planned sample sizes did not take into account the estimated prevalence of the bacterial species monitored in order to obtain the required number of isolates, which is not in line with point 3.1(b) of Part A of the Annex to the EU Decision. ii. There are limitations to the randomness of sampling, because of the instruction to sample from Monday to Wednesday to allow for delivery to the laboratory. Plans take stratified sampling into account and emphasise not repeating the epidemiological unit. iii. The instruction is to send the samples to the laboratory within 36 hours of sampling. Samples are kept chilled during storage and transport to the laboratory where the temperature on receipt is checked. iv. The circular for 2021 was issued in the first quarter of the year, however, the sampling target was not met in a number of regions (see point 20). v. There was a late start to the sampling process in 2022 (May) and 2023 (June). Therefore, the sampling was not evenly distributed over the monitoring period, as almost half of the year was not included, which is not in line with point 3 of Part A of the Annex to the EU Decision. 5

The sampling plan did not take into account the prevalence of the relevant bacterial species in order to calculate the required number of samples and did not include meat from turkey in the retail sampling in 2022, which may have affected the number of available isolates.

Late implementation of the plans for 2022 and 2023 resulted in an uneven distribution of the samples over the year, negatively impacting the representativeness of the data.

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Regarding Salmonella spp. isolates obtained from the SNCP in 2022: i. Isolates were obtained from samples collected from the populations of laying hens, broilers and fattening turkeys in the framework of the national control plans provided for in Article 5 of Regulation (EC) No 2160/2003. ii. Official and operator samples are analysed in 4 official laboratories and 29 private laboratories in Greece, designated as required by Article 12(1) of Regulation (EC) No 2160/2003. National designated laboratories are obliged to provide Salmonella spp. isolates to the NRL. iii. A total of 40 isolates were obtained from laying hen flocks, mostly from official laboratories, and were referred to the NRL. iv. A total of 13 isolates obtained from broiler flocks, mostly from official laboratories, were referred to the NRL. v. No isolates were available from fattening turkey flocks. vi. None of the isolates obtained was tested for AST, which is not in line with point 4 of Part A of the Annex to the EU Decision.

The lack of adequate sampling at slaughterhouse, retail level and BCPs has resulted in Greece not achieving the planned number of samples since 2021. As a consequence, there was also a low number of isolates available for AST at this level in 2021 and 2023. Additionally, no AST was performed in 2022, resulting in no test data available for transmission to EFSA.

The lack of information available for 2022 combined with incomplete data set for the years 2021 to 2023, raises a concern regarding the gap in AMR information and affects the representativeness of Greek data and its comparability across the EU.

The laboratories involved in AMR monitoring are properly designated, have quality systems in place and participate in proficiency tests with overall satisfactory results. The laboratory performance and reliability of the results provided can be considered satisfactory. However, the continuing pressure on equipment and resources represents a potential risk to the monitoring programme.

There were several instances where AST was not conducted on available isolates (nor reported to EFSA) due to extreme delays in procurement of laboratory consumables. This negatively affects the representativeness of the Greek data.

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Regarding sampling at BCPs: i. Nine BCPs are designated for products of animal origin. The majority of the meat arrives in through the BCPs at Pireus, Athens Airport and Thessaloniki. ii. The BCP sampling plan requires one sample per country of origin in the main ports. This is based on the number of consignments received in the previous year provided by the BCPs. iii. Only one consignment of chicken meat from Brazil was sampled in a BCP in 2022. Two isolates of E. coli were subsequently recovered; however, no AST was performed on these isolates. iv. There were no samples taken in 2021 or 2023. However, a significant number of beef consignments and a small number of pork consignments from different countries of origin that arrived in the BCPs could have been eligible for sampling. The competent authorities agreed that there was a number of eligible consignments that should have been sampled. This lack of sampling is not in line with point 3.3(a) of Part A of the Annex to the EU Decision. 8 Conclusions on sampling framework and analysis

The lack of adequate sampling at slaughterhouse, retail level and BCPs has resulted in Greece not achieving the planned number of samples since 2021. As a consequence, there was also a low number of isolates available for AST at this level in 2021 and 2023. Additionally, no AST was performed in 2022, resulting in no test data available for transmission to EFSA.

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There are six other designated official laboratories. These are responsible for testing approximately 6-7% of samples taken during the course of the annual survey programme. These official laboratories are: · Forest Entomology and Nematodes, Forest Research Institute, ELGO- DIMITRA, · Forest pathology, Institute of Mediterranean Forest Ecosystems, ELGO- DIMITRA, · Crop diseases, Institute of Olive Tree, Subtropical Crops and Viticulture, ELGO- DIMITRA, 4 · Plant Virology and Microbiology Laboratory, Mediterranean Agronomic Institute of Chania, · Biological and Biotechnological Applications, School of Agricultural Sciences, Hellenic Mediterranean University, · Entomology and Agricultural Zoology, Department of Agriculture Crop Production and Rural Environment, University of Thessaly.

The MRDF stated that these laboratories are not accredited to EN ISO/IEC 17025, and that they do not meet all the criteria set out in Article 40(1)(b) of Regulation (EU) 2017/625 that an official laboratory must comply with to avail of the derogation from the condition for mandatory accreditation. Specifically, they do not meet points (iii) and (iv) of Article 40(1)(b) of the same Regulation relating to comparative or proficiency testing and having a quality assurance system. Conclusions on Competent Authorities

The available laboratory capacity provides sufficient support to the CAs for the early detection of relevant priority pests. However, a small proportion of samples are tested in official laboratories which are neither accredited, nor meeting the criteria for the derogation from accreditation, which increases the risk that results from these laboratories may not be accurate.

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In 2022 and 2023, the CAs completed approximately; · 70% of the planned number of visual examinations for X. fastidiosa, · 103% and 86% of the planned number of plant samples and 78% and 44% of the planned number of vector samples for X. fastidiosa, · 70% of the planned number of visual examinations, plant samples and vector samples. for C. Liberibacter spp, · 84% and 96% of the planned number of traps for B. dorsalis.

Fifty-eight per-cent of the planned number surveys were completed, 60% of the planned number of samples taken, and 77% of the planned number of traps placed for all pests in the annual survey programmes for 2022 and 2023. The MRDF stated that while the DRDIs meet their survey targets each year, the DREVs consistently fail to implement the planned number of surveys allocated to them. The MDRF attributes this due to the low priority which DREVs give to plant health survey work, rather than insufficient staff resources. The MRDF and BPI monitor implementation of the survey programme on an ongoing basis, and when implementation falls behind schedule, MRFD issues letters to the DREVs to emphasise the importance of completing the survey programme. MRDF stated that these letters help to improve the performance of the DREVs.

The BPI estimates that in 2025 (Year 2 of the multi-annual survey programme), the survey workload will increase by 15% and by a further 20% in 2026 (Year 3). The MRFD and the BPI acknowledged that this is very likely to mean that the percentage of planned surveys completed will decline in both years, in the absence of additional resources.

Greece does not conduct surveys for priority pests in line with the requirements of Article 24(1) of Regulation (EU) 2016/2031 and for all relevant Union quarantine pests in line with the requirements of Article 22(1) of Regulation (EU) 2016/2031. Finally, it does not conduct surveys for X. fastidiosa in line with the requirements of Article 2 of Implementing Regulation (EU) 2020/1201. This is because while surveys are conducted by knowledgeable inspectors, at appropriate locations and appropriate times, the DREVs consistently fail to implement a sufficiently high number of visual examinations, sampling and testing as appropriate for each priority pest, and as outlined in the annual survey programmes, as required by Article 24(1) of Regulation (EU) 2016/2031. Reporting surveys

The consistent failure to complete all planned surveys, and the likelihood that this problem will worsen in the course of the current multi-annual survey programme, means that any outbreaks of relevant Union quarantine pests (including relevant priority pests) may not be detected promptly.

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Greece had not drawn up all required contingency plans nor had they been communicated to the Commission and other MS and published on the internet by 14 December 2023 contrary to Article 25(1), (4) and (5) of Regulation (EU) 2016/2031. Greece completed and provided 11 contingency plans to the Commission just a few weeks prior to this audit in October 2024. The MRDF stated that a further four plans would be finalised by the end of 2024, and that the final four plans would be completed in 2025.

Given that Greece only completed the first 11 of the 19 required contingency plans in the weeks prior to the audit, it did not have an opportunity to carry out simulation exercises concerning the implementation of the contingency plans as required by Article 26(1) of Regulation (EU) 2016/2031 by the time of the audit in October 2024. Conclusions on contingency plans

Greece has yet to complete the required contingency plans for relevant priority pests, or to undertake any simulation exercises concerning their implementation. This raises doubts that Greece is sufficiently prepared to take effective actions to eradicate any outbreaks of priority pests, in line with EU requirements.

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The number of DREV staff allocated for tasks required by Regulation (EU) 2023/1134 are not sufficient to complete these tasks, in particular with regard to the surveys inside DAs. This is not in line with the Article 5(e) of Regulation (EU) 2017/625. This lack of staff has resulted in significant delays in implementing the required measures. BPI plans to recruit 20 full time equivalent staff to conduct surveys inside DAs to address this problem. While a budget of 850,000 EUR has been secured, the recruitment procedure only started at the end of May 2024, with the result that it will be, at best, a number of months before the required/planned number of surveys are being conducted inside the DAs (see details under Chapter 7.5). 7.1.4 Laboratories

The lack of staff to conduct surveys in DAs, coupled with delays in recruiting additional staff, increases the risk that any new outbreaks in buffer zones will not be detected quickly, thereby increasing the risk of the pest spreading to pest free areas.

The survey design and sampling scheme currently implemented in practice do not comply with requirements of Article 7(c) of the Regulation (EU) 2023/1134. While the survey design seeks to identify a level of pest presence of 0.8% with 95% confidence, delays in recruiting an additional 20 staff for BPI have resulted in only approximately 30% of the planned level of trapping and scouting being conducted by DREV staff. According to the survey plan for 2024, some 355 traps were planned to be placed with weekly checks of each trap. However, only 130 traps had been placed and only 610 trap checks had been done by the start of the audit. The NPPO stated that in the course of the audit more traps had been placed and that the level of trapping had increased to 45% of the planned level. The NPPO stated that some traps would be established later as crops had not yet been planted at the planned locations of some traps. The audit team noted that there were already first four findings of adult males in traps in Crete in 2024. The CAs stated that it was too early to be certain if these adults had flown in from other countries or had emerged from overwintered pupae, and therefore were evidence of pest establishment in Crete.

The NPPO stated that once the 20 extra staff are recruited, the survey target should be met, and that DREV staff could then be reallocated to other mandatory tasks. However, as the recruitment process had only started in late May 2024 it is unlikely that requirements of Article 7(c) of the Regulation (EU) 2023/1134 will be met for the 2024 survey.

In the regions visited by the audit team, the audit team observed that; 8 · 30 traps were placed in the region of Lasithi, while 46 should have been placed according to survey plan. In addition, weekly checks of traps started in late April- early May 2024. While the survey guideline from BPI requires checks every 10- 12 day in the winter and weekly from March onwards, this had not been respected for two out of three traps examined by the audit team. · 43 traps were placed in the region of Heraklion, while 54 should have been placed according to survey plan. Weekly checks of traps started in late April-early May 2024. The authorities in Heraklion stated that prior to the publication of the action plan, they followed the methodology developed for the delimiting survey; · For the whole DA area of Evia and Attica, 49 traps had been placed at the time of the audit while 120 are foreseen in the survey plan. Weekly checks started in early May 2024; · In survey sites visited by the audit team, the traps were correctly placed and data were correctly recorded in the database provided by the BPI. Conclusions on the surveys in DAs

Failing to complete the planned number of surveys and scouting actions increases the risk of the pest not being detected in a timely manner, and consequently delays the implementation of measures required for pest eradication.

In the region of Lasithi, six inspectors are allocated for the official controls described under point 37. A maximum of three such inspections per inspector per week can be undertaken due to other control obligations. Given that there are 460 operators registered for movement controls, it is very unlikely that this inspection target can be met. Similar concerns were expressed also by other regional units of DREVs visited.

Delays in implementing movement controls and lack of resources to meet the inspection targets may have increased the risk in the pest spreading to pest-free areas, given that there was significant quantities of peppers and aubergines moved out from one of the DAs from September 2023 up to the time of the audit without the required controls.

Medlemsstatens svar

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Temporary official veterinarians ("seasonal veterinarians") have been hired to implement ASF measures in four areas of higher risk. During their work they also detected a significant number of not registered non-commercial farms. Since 2023, the number of small pig farms has decreased significantly in Greece as many did not meet minimum biosecurity standards and a depopulation programme was put in place. Nevertheless, there are gaps as regards the registration of non-commercial farms. Incomplete entries and delays in updating the national pig database as well as the farm registers do not allow the competent authority to have a reliable overview of the pig population for animal health control purposes.

Despite a national plan for implementing official controls on biosecurity measures during hunting activities, the competent authority does not carry out such controls as planned; related activities have also not produced any impact so far. In addition, the national plan is not well established as regards scope, inspection records and addressing non-compliances. This means that the competent authority has limited control over the risk of the virus spreading by hunted wild boar.

Passive surveillance of the domestic pig population is implemented through testing of dead animals notified to authorities by farmers. The level of notifications is overall satisfactory for larger establishments, whereas absent or incomplete mortality records in smaller farms make verification of compliance in these operations difficult to estimate.

The number of reported wild boar found dead by hunters is very low compared to the hunting bag (total number of wild boars hunted per year). This is compounded by underreporting and thus a lack of testing of carcasses hunted in restricted areas and destined for private consumption. As a result, the competent authority misses important information on the epidemiological status of the disease. Although the hunting community has comprehensive knowledge of the wild boar population and its dynamics, it has failed to achieve the targets set by the competent authority for reducing the wild porcine animal population. 6

The performance of the NRL in ASF testing allows for reliable detection of the virus. In some cases, however, there have been delays in the timely availability of results due to delays in the dispatch of samples by regional units and the lab's capacity limitations over weekends.

Pig operators located in restricted zones, sending pigs for immediate slaughter are not always in compliance with requirements for movement derogations regarding biosecurity and continuous surveillance. This can increase the risk of spreading ASF virus.

Medlemsstatens svar

1. (390911/10.12.2024) . 03.2024, 2.435 . 880/98766 04.04.2024 . 3. ( , , ).

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FINDINGS AND CONCLUSIONS

In 2023, 70% of the planned samples were actually taken and sampling was heavily concentrated in three months ­ between October and December 53% of the samples were taken and thus sampling was not evenly spread over all months or relevant production period. This is not in line with EU legislation (17). The central competent (9) Circular 1662/318348 of 24/10/2022 (Notification of new Regulations (EU) 2022/1644 and (EU) 2022/1646 on the performance of official controls on residues of veterinary medicinal products and other substances on animals and products thereof). (10) Regulations (EU) 2022/1644 and 2022/1646. (11) In its response to the draft report, the competent authority stated that the indicated deadline is not absolute and binding. (12) Circular 118/11989 of 13/01/2023 (Start of the National Residue Control Programme for 2023). (13) Circular 1140/2536841 of 11/08/2023 (Allocation for the implementation of the National Programme for the Control of Residues of Veterinary Medicinal Products for Production (NRCP) for 2023). (14) In its response to the draft report, the competent authority stated that the low number of samples taken before August 2023 had been primarily due to problems with couriers at the beginning of the year, reduced sampling frequency in summer months due to very high temperatures, and seasonality of certain products such as milk and honey (which account for a high proportion of the total number of samples planned). (15) In its response to the draft report, the competent authority stated that the five biggest bovine slaughterhouses accounted for 26 % of annual production of bovine meat. The remaining 74 % were almost equally distributed between the remaining 83 slaughterhouses throughout the country. (16) Circular 29/7594 of 10/01/2024 (Start of the National Residue Control Programme for 2024). (17) Point 1. of Annex III to Regulation (EU) 2022/1646. 3 authority claimed that the under-implementation of sampling and delays in testing were related to technical difficulties in the laboratories and delays in procurement procedures (18) (19).

At the time of the audit, a high number of 2023 samples were still not analysed despite of a January 2024 DG VET circular (20) which specified that all 2023 testing results must be available by 31 March 2024, and that any unanalysed samples should not be analysed after that date and should be destroyed by the laboratories. During the closing meeting, the central competent authority stated that it had reversed this decision, requiring the analysis of the remaining 2023 samples stored in the laboratories (21).

In 2023, out of the 185 samples planned (corresponding to the minimum frequency (31)), 133 (72%) were registered by the competent authority as taken; 127 samples had been analysed by the time of the audit (32). (27) Point 7 of Annex II to Regulation (EU) 2021/808. (28) In its response to the draft report, the competent authority stated that the existing guidance on storage and transport conditions for samples needed to be updated. The DGVS, in cooperation with the laboratories, intended to amend the above instructions on the basis of knowledge to date and in compliance with the instructions and recommendations of the European Commission and the European Reference Laboratories, for each analyser/matrix combination, in order to ensure the stability of the analytes and the integrity of the samples. (29) Article 6 of Regulation (EU) 2017/625. (30) Point 1 of Annex V to Regulation (EU) 2022/1644. (31) Annex II to Regulation (EU) 2022/1646. (32) In its response to the draft report, the competent authority stated that once the processing of 2023 results had been completed and they had been submitted to EFSA, the completion rate of the Plan 2 was 122 %. 5

For 2023, at the time of the audit, out of the 603 samples planned, 245 (41%) were taken and analysed (33). 5.4. Implementation of the multiannual national control programme for pesticide residues and the Union-wide coordinated multiannual programme

EFET plans and implements controls on contaminants in food of animal origin after the primary production stage. The EFET work instructions for 2023 (42), specify that 15 bovine liver samples and 15 poultry fat samples should be taken as per EU requirements (30). The instructions include a regional distribution of samples, and the month in which the samples should be taken. The instructions do not include any risk-based criteria for sampling, which is contrary to relevant EU legislation (43).

In 2022, sampling at primary production level was implemented as planned by the DG VET. EFET did not carry out any sampling after primary production in that year. In 2023 the primary production sampling plan was partially implemented with 87% (453) of the planned 523 samples taken and 324 of these analysed at the time of the audit (i.e., 62% of the samples planned). Retail sampling carried out by EFET in 2023 was stated to be in line with the planned arrangements (44). (38) 7718/19.07.23 - Carrying out laboratory checks in the context of the 2023 official inspection to check the presence of plant protection products. (39) Article 3(6) of Regulation (EU) 2017/625. (40) Article 12(1) of Regulation (EU) 2017/625. (41) Regulations (EU) 2022/931 and 2022/932. (42) 7712/19.07.23 - Carrying out laboratory checks in the context of the official inspection in 2023 for the determination of polycyclic aromatic hydrocarbons (PAH) in certain types of food, 7713/19.07.23 - Carrying out laboratory checks in the context of the 2023 official inspection to determine mycotoxins in foodstuffs, 7721/19.07.23 - Carrying out laboratory checks in the context of the 2023 official inspection to determine metals in foodstuffs and 9884/27/09/2023 - Carrying out laboratory checks in the context of the 2023 official control to monitor the levels of polychlorinated dibenzodioxins, dibenzofurans, dioxin-like and non-dioxin-like polychlorinated biphenyls in foodstuffs. (43) Point (3) of Annex I to Regulation (EU) 2022/931. (44) In its response to the draft report, the competent authority stated that once the processing of 2023 results had been completed and they had been submitted to EFSA, the completion rate of the programme was 82 %. 7

Notwithstanding that sampling of animal products placed on the market for residues of pesticides and contaminants was, in 2023, performed in line with planned arrangements and EU requirements, there was significant under-implementation of the control plans for pharmacologically active substances in animals and animal products, and for contaminants in animal products intended for placing on the market. Not only were far fewer samples taken than planned but the majority of sampling was concentrated in a three-month period at the end of the year and thus not representative of the entire production period. Furthermore, the fact that samples were stored prior to dispatch to the testing laboratories, often for much longer periods and at temperatures higher than those specified in the DG VET manual on residue controls, questions the analytical validity of the samples in question, the reliability of the results and the true status of the sample as compliant or not. Cumulatively these factors weaken the effectiveness of the control system for residues.

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2025 23, , % . / () ( ) : - 2 2025. , // , , , . 2024. . - . , Page: 1 e to the recommendations of report ref. DG(SANTE) 2024-8090 of the audit carried out from 2 April to 25 sidues of pharmacologically active substances, pesticides and contaminants in animals and animal products Action Proposed by the competent authority Proposed action plan deadline , , .

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At the time of the audit, none of the laboratories testing for residues of pharmacologically active substances, contaminants and pesticides were (46) Available at https://www.minagric.gr/images/stories/docs/ktiniatrika_Themata/Themata_dimosias_Ygeias/entypo_epek 2023_150324.pdf (47) Article 4(4) of Regulation (EU) 2019/2090 and Article 35(4) of Regulation (EU) 2017/625. (48) Article 4(4) of Regulation (EU) 2019/2090. (49) Articles 138 and 139 of Regulation (EU) 2017/625. (50) EFET Compliance Actions Model, 1st issue, 31.03.2021 (https://www.efet.gr/files/pdf/3006202mesEFET.pdf) (51) Articles 137 and 138 of Regulation (EU) 2017/625. (52) Article 37(4)(e) of Regulation (EU) 2017/625. 9 appropriately designated as official laboratories by the competent authorities, contrary to EU requirements (53).

The audit team visited two laboratories, each of which was designated as a National Reference Laboratory (NRL) for specific groups of substances: a. Laboratory 1 was the NRL for substance groups A1a, A1c, A1d, A2d (dapsone), A3c (carbadox and olaquindox), B1d (corticosteroids), and contaminants (organochlorine substances). In contrast to legal requirements (54), most of the analytical methods used for testing the various analyte/matrix/species combinations were not in the scope of accreditation. For example: group A1a ­ stilbenes in liver and muscle; A1c ­ steroids in serum and muscle; A1d ­ resorcylic acid lactones, including zeranol, in serum, liver and muscle; A2d ­ dapsone in milk and muscle; A3c ­ carbadox and olaquindox in muscle, B1d ­ corticosteroids in liver and muscle. Overall, five of the 12 MRDF official laboratories were using non-accredited methods for official controls. b. Laboratory 2 was the NRL for substance groups A1b, A1e, A2c, A2d (chlorpromazine), A3a (dyes), B1a (antimicrobial substances except honey), B1b (anthelmintics), B1c (sedatives), and contaminants (heavy metals, mycotoxins and organophosphorus compounds). The laboratory is designated as the NRL for B1b (benzimidazoles), B1d (NSAIDs) and B2 (anticoccidials) but methods for these substance groups were not operational at the time of the audit and any such samples were being transmitted to other laboratories within the national network (55).

Method validations were performed in 2007 using a commercial software package largely in line with previous EU requirements (59) except for stability studies (both in solution and in matrix) required in both previous (47) and current (60) EU legislation. In contrast to EU requirements (61), no full/reduced re-validation had been carried out when any of the methods had been extended to cover other matrices or substances. The audit team also identified that in one laboratory, a non-validated method was used for determination of dienestrol and hexestrol (subgroup A1a) in liver and muscle (matrices tested in 2022 and planned in 2024).

Notwithstanding the positive aspect that the laboratories involved are accredited to EN/ISO/IEC 17025 and have successfully participated in relevant proficiency tests, several factors undermine confidence in the reliability of the results generated and thus the overall functioning of the residue control system in Greece. The fact that none of the laboratories was appropriately designated and that a significant proportion of the analytical methods used for official control were not included in the laboratories' respective scopes of accreditation, undermines effective enforcement in the event of non-compliant results being found. Furthermore, the absence of information in the control plans on analyte stability (and storage conditions to mitigate the effect), the absence of method validation data for additional analyte/matrix combinations and lengthy delays in testing, cumulatively weaken the overall residues control system.

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- (i) 17 . 88/64002/04.03.2024 , () 2017/625, / ( )

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The manual on residue control (see finding 9) indicates that samples shall be stored at 0°C if they are intended to be sent to the laboratory within 24 hours of sampling. Transportation of samples is, in most of the cases, provided by commercial courier (18) In its response to the draft report, the competent authority stated that by the time of the audit, the procedures for processing the results for 2023 had not yet been completed, as there were changes in the way samples were calculated under the new EU legislation and the results should be submitted to EFSA by 30 June of each year. Therefore, after submission of the results to EFSA, the completion rates of the 2023 programme were 86 % for Plan 1, 122 % for Plan 2, and 41 % for Plan 3 (the low sampling rate for Plan 3 was due to absence of consignments of raw milk and a reduced number of unprocessed bovine meat consignments). (19) In its response to the draft report, the competent authority stated that the fact that the majority of 2023 samples were taken in the last four months of the year had been primarily due to problems with couriers at the beginning of the year, reduced sampling frequency in summer months due to very high temperatures, and seasonality of certain products such as milk and honey (which account for a high proportion of the total number of samples planned). (20) Circular 35/10100 of 12/01/2024 (Completion of the NRCP 2023 - Preparation of the NRCP 2024). (21) In its response to the draft report, the competent authority stated that the DGVS, as central competent authority, had taken into account the reasons of force majeure (technical failure of the analytical bodies) and decided to extend the deadline and to allow the laboratories to complete the pending analyses of the 2023 samples until the deadline for submission of the results to EFSA. (22) Manual on the implementation of the national programme for the control of residues of veterinary medicinal products and other substances in animals and their products in the primary sector, 6th Edition, 30/12/2023. (23) Article 5(4) of Regulation (EU) 2017/625. (24) Article 9(4) of Regulation (EU) 2017/625. (25) Points 5 and 6 of Annex II to Regulation (EU) 2021/808. (26) Point 4 of Annex II to Regulation (EU) 2021/808. 4 services. In some cases, sampling officers bring the samples directly to the laboratory. Samples which cannot be sent to the laboratory within 24 hours of sampling must be frozen at a temperature of -20°C to -30°C immediately after collection and sent to the laboratory within three days. All other samples must be kept deep-frozen from -30°C to -75°C. In spite of this instruction the audit team noted that samples were often stored in the local offices of the competent authorities for more than 30 days, and none of these offices had freezers capable of reaching - 30°C to -75°C. For one of the freezers checked by the audit team, the temperature was -9°C ­ less than half of what would be reasonably expected from a commercially available chest freezer. The central competent authority was not in a position to demonstrate that the storage conditions used in practice were suitable for each analyte/matrix combination to ensure analyte stability and sample integrity. This is not in line with EU legislation (27) (28).

Notwithstanding that sampling of animal products placed on the market for residues of pesticides and contaminants was, in 2023, performed in line with planned arrangements and EU requirements, there was significant under-implementation of the control plans for pharmacologically active substances in animals and animal products, and for contaminants in animal products intended for placing on the market. Not only were far fewer samples taken than planned but the majority of sampling was concentrated in a three-month period at the end of the year and thus not representative of the entire production period. Furthermore, the fact that samples were stored prior to dispatch to the testing laboratories, often for much longer periods and at temperatures higher than those specified in the DG VET manual on residue controls, questions the analytical validity of the samples in question, the reliability of the results and the true status of the sample as compliant or not. Cumulatively these factors weaken the effectiveness of the control system for residues.

The audit team noted that documentation related to the RCPs did not specify the suitable storage conditions for each analyte/matrix combination to ensure analyte stability and sample integrity, contrary to EU legislation (56).

Notwithstanding the positive aspect that the laboratories involved are accredited to EN/ISO/IEC 17025 and have successfully participated in relevant proficiency tests, several factors undermine confidence in the reliability of the results generated and thus the overall functioning of the residue control system in Greece. The fact that none of the laboratories was appropriately designated and that a significant proportion of the analytical methods used for official control were not included in the laboratories' respective scopes of accreditation, undermines effective enforcement in the event of non-compliant results being found. Furthermore, the absence of information in the control plans on analyte stability (and storage conditions to mitigate the effect), the absence of method validation data for additional analyte/matrix combinations and lengthy delays in testing, cumulatively weaken the overall residues control system.

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: () ' ( ) / (/ ) , () 2017/625 () , (), Page: 2 e to the recommendations of report ref. DG(SANTE) 2024-8090 of the audit carried out from 2 April to 25 sidues of pharmacologically active substances, pesticides and contaminants in animals and animal products petent authority Proposed action plan deadline /citizen-menu/officialtestinglaboratories- 24 ( 2.09.2024 . 2.09.2024 . 2.09.2024 . e to the recommendations of report ref. DG(SANTE) 2024-8090 of the audit carried out from 2 April to 25 sidues of pharmacologically active substances, pesticides and contaminants in animals and animal products ction Proposed by the competent authority Proposed action plan deadline ii) (iii) 2025 2025 (4 ), . () 2026 021/808 , , : () 2021/808, 657/2002 () 2021/808 2025 . , , Page: 4 e to the recommendations of report ref. DG(SANTE) 2024-8090 of the audit carried out from 2 April to 25 sidues of pharmacologically active substances, pesticides and contaminants in animals and animal products on Proposed by the competent authority Proposed action plan deadline : 5

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Participation in training is up to each regional unit/directorate and it is not uniform. Some of the official control staff in RVUs that (in addition to several other tasks) approve dairy establishments and/or perform controls in dairy establishments had never participated in training on dairy controls or had only done so in the distant past. The CAs considered that understaffing and work prioritisation had resulted in the reduction of participation in staff training.

Some of the RVUs in the regions visited were understaffed. In one region, only 30 of the 55 posts detailed in the organigram were occupied. Another of the RVUs had 2 official veterinarians employed, out of 11 such posts. The understaffing also resulted in underachievement of the planned controls, as animal health measures and controls of establishments (e.g. slaughterhouses, dairy establishments) had been prioritised over controls on farms. See also paragraphs 20 and 25. Conclusion on competent authorities

The structure and organisation of the CAs responsible for the official control system over the production of milk and dairy products provides, in principle, for an adequate framework for the performance of their tasks. However, staff shortage limits participation in training and the implementation of planned controls. The lack of communication of control results between CAs impairs the follow-up of non- compliances that have not already triggered enforcement actions. Ultimately, all of this limits the effectiveness of the official controls.

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f ) (30-08-2023) 226 , , 163 . 2 , . : 2 . . : . ) (check- lists) , ( . .: 77/05-04-2023 « 2023-2024») (__1). , , 1 2024, , : 1. 036.08.02_ & » 2. 036.10.00_ Page: 1 port ref. DG(SANTE) 2023-7734 of the audit carried out from 06 March 2023 afety of milk and dairy products oposed by the competent authority 024

, , , : 1. , 9-21 2023 14 . , 3 2023 35 s . (_2023-7734-1_1 & _2023-7734-1_2) ( 2024), , 100 (1-2 ). , 2024, .

s ry - - cial DG(SANTE) check-lists . g , - l . , - 2025. b) - , DG(SANTE) 2023-7734, . - (.) - . . - ' 2025 ( 31-12-2024).

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In some regions, the regional EFET directorates perform all controls in dairy establishments while in other regions the RVDs and RVUs perform a part of these controls under regional EFET coordination. However, EFET does not receive the reports of the controls carried out by the RVDs and RVUs, unless enforcement actions have been taken. This does not allow EFET to follow up non-compliances that did not trigger enforcement actions, when they visit the same establishments. 3

The structure and organisation of the CAs responsible for the official control system over the production of milk and dairy products provides, in principle, for an adequate framework for the performance of their tasks. However, staff shortage limits participation in training and the implementation of planned controls. The lack of communication of control results between CAs impairs the follow-up of non- compliances that have not already triggered enforcement actions. Ultimately, all of this limits the effectiveness of the official controls.

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s ry ( 15523/2006, , 2021-2025), Page: 2 port ref. DG(SANTE) 2023-7734 of the audit carried out from 06 March 2023 afety of milk and dairy products port ref. DG(SANTE) 2023-7734 of the audit carried out from 06 March 2023 afety of milk and dairy products Action Proposed by the competent authority : 10159/28-09-2022 (__2). : DG(SANTE) / 2023

1. . .:2024/16-02-2024 « DG(SANTE)/2023-7734 & » (__1). 3 , , & . 2. . .:1982/15-02-2024 « » (__2). : « 2024-2025» . 5 Page: 1 itted by the competent authorities of Greece in response to Report ref. DG(SANTE) 2023-7734 of 23 in order to evaluate the official controls related to the safety of milk and dairy products etent authority's response ­ update 15 April 2024 ( & ) , . , / , (-). & « 2024-2025» , , ) ) 2024-2025 / . , / / , ,

(2024/16-02-2024) ( the / & ) n DG(SANTE) ­ - & . . ) & Page: 1 plan submitted by the competent authorities of Greece in response to Report ref. DG(SANTE) 2023-7734 of March 2023 in order to evaluate the official controls related to the safety of milk and dairy products mpetent authority's response to report recommendations ­ update 24 October 2024 ) , . , 3 / - , , ) ET_ ).

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However, some approval documents stated that the establishments were approved for activities that they were not performing (e.g. a MCC was approved as a processing plant and a processing plant was approved to produce raw ice cream, although according to the CA this activity did not take place in that establishment). The reports of controls in another MCC mentioned a heat treatment equipment. The CA explained that the equipment had been used in previous years for heat treating milk in the MCC.

The approval document requires the FBOs to inform the CA if there is a significant change in the activity of the establishment, or the establishment ceases its operation. The CCA/CAs had not specified what constitutes significant changes. Contrary to the requirements of Article 6 of Regulation (EC) No 852/2004 most of the FBOs visited had either not notified the CA of significant changes (e.g. new production or packing line, new facilities added) or the notifications had been submitted after years of use of the new equipment/facilities. Neither EFET nor the RVD/RVUs enforced FBOs' lack of compliance with Article 6 of Regulation (EC) No 852/2004 when they had noted the (unnotified) changes during the official controls.

In one of the cases, the FBO had built a new establishment in the vicinity of its approved one and started to produce dairy products in the new (unapproved) establishment a few months before notifying the CA of this change. The RVU/RVD carried out an on-site visit some months later; the delay justified by lack of staff. Meanwhile and contrary to the requirements of Article 4 of Regulation (EC) No 853/2004, the FBO produced and placed on the market dairy products made in the (unapproved) new establishment.

At the time of their visit (paragraph 15) the RVU/RVD did not assess the FBO's written HACCP-based procedures. In another region, the official control carried out by EFET, following the approval of a new establishment, identified several non-compliances that triggered administrative and criminal proceedings and the establishment was eventually closed. These findings question the effectiveness of the RVU/RVD assessments. In addition, the RVU/RVD does not always see the establishments in operation before approval (which does not favour the detection of operational shortcomings). See also paragraph 39.

There are procedures in place for the registration and approval of dairy FBOs. However, the RVU/RVD assessment at the time of approval/update of the approval is not fully effective. In addition, the CAs did not adequately keep approvals under- review and did not enforce FBOs' lack of notification of significant changes. The long timeframes for the first official control after approval ­ coupled with the fact that the CAs do not always see the establishments in operation before approval ­ may lead to a delayed detection of inadequate FBO practices and new facilities being in operation without (timely and adequate) CA controls.

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s ( / , ) ) , ) action plan 2024-2026 ) ( 1288/2017), . : - , - ( , ), - « » , , , , - , & . , ( 6 . 852/2004) Page: 4 port ref. DG(SANTE) 2023-7734 of the audit carried out from 06 March 2023 afety of milk and dairy products Action Proposed by the competent authority , , : « / » : « ( 6 . 852/2004) , , , / , .» : ) DG(SANTE) / 2023, ) action plan 2024-2026: 2023, ) : 1 2024 ) « »: .

ts 1. . .:2024/16-02-2024 « in DG(SANTE)/2023-7734 & (5) » (__1). 1-3 ) & , ( ) age: 2 itted by the competent authorities of Greece in response to Report ref. DG(SANTE) 2023-7734 of 23 in order to evaluate the official controls related to the safety of milk and dairy products update 15 April 2024 itted by the competent authorities of Greece in response to Report ref. DG(SANTE) 2023-7734 of 23 in order to evaluate the official controls related to the safety of milk and dairy products Competent authority's response ­ update 15 April 2024 : ) & ) & . : 1_ (, , ) 2_ 3_ & 4_ 5_ ­ 6_ ­ 7_ ( , & , & , )

s (2024/16-02-2024) ( & ) DG(SANTE) ­ - - check lists :« », , (.. ) & - . , 3 / - , , ) ET_ ). Page: 2 plan submitted by the competent authorities of Greece in response to Report ref. DG(SANTE) 2023-7734 of March 2023 in order to evaluate the official controls related to the safety of milk and dairy products mpetent authority's response to report recommendations ­ update 24 October 2024

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In one of the cases, the FBO had built a new establishment in the vicinity of its approved one and started to produce dairy products in the new (unapproved) establishment a few months before notifying the CA of this change. The RVU/RVD carried out an on-site visit some months later; the delay justified by lack of staff. Meanwhile and contrary to the requirements of Article 4 of Regulation (EC) No 853/2004, the FBO produced and placed on the market dairy products made in the (unapproved) new establishment.

At the time of their visit (paragraph 15) the RVU/RVD did not assess the FBO's written HACCP-based procedures. In another region, the official control carried out by EFET, following the approval of a new establishment, identified several non-compliances that triggered administrative and criminal proceedings and the establishment was eventually closed. These findings question the effectiveness of the RVU/RVD assessments. In addition, the RVU/RVD does not always see the establishments in operation before approval (which does not favour the detection of operational shortcomings). See also paragraph 39.

There are procedures in place for the registration and approval of dairy FBOs. However, the RVU/RVD assessment at the time of approval/update of the approval is not fully effective. In addition, the CAs did not adequately keep approvals under- review and did not enforce FBOs' lack of notification of significant changes. The long timeframes for the first official control after approval ­ coupled with the fact that the CAs do not always see the establishments in operation before approval ­ may lead to a delayed detection of inadequate FBO practices and new facilities being in operation without (timely and adequate) CA controls.

The audit team noted some shortcomings on cleanliness and maintenance that had not been detected by the CA (e.g. inadequately cleaned transport vehicle with dirt above exposed milk; inadequate cleaning procedures for milk containers with visibly contaminated containers in a MCC, peeling ceiling above exposed cheese in a large dairy; farm tanks used in open space in another dairy establishment).

The CAs responsible for the controls in these establishments stated that they would classify such non-compliances as minor. The CAs had also classified as minor other non- compliances that they had identified e.g. lack of animal health certificates from the supplying farms (although, according to national rules, this should disqualify the supply), lack of records for temperature check at arrival of milk in MCC. For minor non- compliances the CAs recommend the FBOs to remedy them without a given deadline. If the same non-compliances are detected in 2 consecutive controls (in a period of up to 6 years) the CAs would give a deadline and continue with enforcement, if needed. The enforcement can also be escalated if a high number of non-compliances are detected.

FBOs' management of animal by-products and waste is in the scope of the risk-based CA routine controls. In a large dairy establishment, the CA had not identified that antibiotic positive milk (which is a category 2 animal by-product) was inadequately dispatched as category 3 animal by-product and a small quantity of the whey was discarded in the drain. 11 5.6.3 Hazard Analysis and Critical Control Points based systems Legal requirements Article 5 of Regulation (EC) No 852/2004. Findings

However, these controls were not sufficiently thorough and the CAs had not detected certain non-compliances. a. In one region, the CA: confused the operational limits for pasteurisation with the critical limits and was unaware of the (less strict) critical limits established by one of the FBOs visited; had not noted that one of the FBO's procedures did not mention the holding time for cream pasteurisation; had not checked whether the rapid alkaline phosphatase (ALP) test had been validated against the ISO standard. b. In another region, the CA had not identified that one of the FBOs visited could not demonstrate the monitoring of the (established) critical limit and that its HACCP based procedures included raw butter production. The FBO had produced and sold raw butter in previous years to a bakery (a registered establishment). The CCA clarified that national rules allow such sale only to approved establishments. No evidence was available that the receiving company had been informed that the butter was produced with raw milk or that the FBO's procedures would require this information to be communicated for future sales. c. In another establishment of the same region, the CA had not noted that the FBOs' written procedures for the use of cream differed from the actual described use. d. In both regions visited, the CAs had accepted on-going operation in new facilities (e.g. new packing lines, new cold stores) or in a new dairy plant operation, without an adequate review of the HACCP-based procedures. The CAs had not detected that not all hazards/critical steps had been correctly identified in establishments of both regions. In one of the cases, the CA failed to note that the FBO's hazard analysis did not identify Bisphenol A as a hazard, although the establishment produced and packed dairy involved in a RASFF notification for Bisphenol A.

The CAs met allowed the FBOs to use different time-temperature combinations for milk pasteurisation provided the ALP test was negative. The CAs interviewed were aware that the ALP legislative limit for cow milk is not suitable for goat milk as it may allow unpasteurised goat milk to pass the test. However, they accept the ALP limit for cow milk, as the ALP limits for goat milk had not been established. 12

In the absence of national guidance on how to assess goat milk pasteurisation, the scientific sources/critical limits used by the CAs as guidance varied between the regions. One of the FBOs visited used a critical limit which, according to the scientific guidance used in another region, was not equivalent to 72°C for 15 seconds. After the previous audit, the CA asked the FBO to demonstrate that the chosen critical limits achieve equivalent results to pasteurisation. This resulted in the FBO changing the critical limits to stricter ones. 5.6.4 Microbiological criteria for foodstuffs Legal requirements Articles 3 and 4, and Annex I to Regulation (EC) No 2073/2005. Findings

The CAs do not require FBOs to trend the results of the testing nor to detail what actions they would take in case of non-compliances with microbiological criteria. The official controls on some requirements were not uniform (e.g. some of the CAs met understood that they are not required to check whether the CAs' alternative testing methods had been validated, while others included this aspect in their controls). 5.6.5 Traceability, labelling and identification marking Legal requirements Article of 18 of Regulation (EC) No 178/2002. Article 5 of, and Chapter IV, Annex III to Regulation (EC) No 853/2004. Article 5 of Regulation (EU) 2019/627. Findings

The official controls of the dairy sector identified some relevant shortcomings and took enforcement action for major non-compliances. However, the controls did not cover some relevant control areas with sufficient depth and did not identify a number of relevant shortcomings, in particular as regards general and specific hygiene requirements, and HACCP-based procedures.

The impact of the control was further reduced by the fact that CAs did no not require FBOs to put measures in place to prevent reoccurrence, did not routinely follow-up and did not use deadlines for shortcomings that are considered minor. In certain cases, CAs classified certain aspects, which may potentially endanger food safety, as minor.

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DG(SANTE) 2023-7734, & , : - . - ACCP: & , , - . Page: 5 port ref. DG(SANTE) 2023-7734 of the audit carried out from 06 March 2023 afety of milk and dairy products tion Proposed by the competent authority ) DG(SANTE) / 2023, : 1 2024

. .:2024/16-02-2024 « DG(SANTE)/2023-7734 & » 1). ) of - (2024): & & 48, : ) & ) & . : 1_ (, , ) 2_ 3_ & 4_ 5_ ­ 6_ ­ Page: 4 itted by the competent authorities of Greece in response to Report ref. DG(SANTE) 2023-7734 of 23 in order to evaluate the official controls related to the safety of milk and dairy products Competent authority's response ­ update 15 April 2024 7_ ( , & , & , ) - & , , , .

( / & ), 2025 - DG(SANTE) , . d (, , 3 n / - , ) EFET_ ).

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The approval document requires the FBOs to inform the CA if there is a significant change in the activity of the establishment, or the establishment ceases its operation. The CCA/CAs had not specified what constitutes significant changes. Contrary to the requirements of Article 6 of Regulation (EC) No 852/2004 most of the FBOs visited had either not notified the CA of significant changes (e.g. new production or packing line, new facilities added) or the notifications had been submitted after years of use of the new equipment/facilities. Neither EFET nor the RVD/RVUs enforced FBOs' lack of compliance with Article 6 of Regulation (EC) No 852/2004 when they had noted the (unnotified) changes during the official controls.

There are procedures in place for the registration and approval of dairy FBOs. However, the RVU/RVD assessment at the time of approval/update of the approval is not fully effective. In addition, the CAs did not adequately keep approvals under- review and did not enforce FBOs' lack of notification of significant changes. The long timeframes for the first official control after approval ­ coupled with the fact that the CAs do not always see the establishments in operation before approval ­ may lead to a delayed detection of inadequate FBO practices and new facilities being in operation without (timely and adequate) CA controls.

The report template for the controls is harmonised and it follows the checklist used for controls. The CAs met had used the template for all the establishments visited by the audit team. However, the follow-up is not routinely documented and for several examples there was no evidence that the CA did follow up (whether in writing/by email or on-site) on non-compliances that were consider minor.

According to the CCA and CAs met, if a shortcoming is classified as minor, they are not required to ask the FBO to remedy the non-compliance within a certain deadline, to take actions to determine the origin of the non-compliance or measures to ensure that the operator prevents further occurrences of such non-compliance. This is not in line with Article 138 of Regulation (EU) 2017/625.

The CAs responsible for the controls in these establishments stated that they would classify such non-compliances as minor. The CAs had also classified as minor other non- compliances that they had identified e.g. lack of animal health certificates from the supplying farms (although, according to national rules, this should disqualify the supply), lack of records for temperature check at arrival of milk in MCC. For minor non- compliances the CAs recommend the FBOs to remedy them without a given deadline. If the same non-compliances are detected in 2 consecutive controls (in a period of up to 6 years) the CAs would give a deadline and continue with enforcement, if needed. The enforcement can also be escalated if a high number of non-compliances are detected.

The impact of the control was further reduced by the fact that CAs did no not require FBOs to put measures in place to prevent reoccurrence, did not routinely follow-up and did not use deadlines for shortcomings that are considered minor. In certain cases, CAs classified certain aspects, which may potentially endanger food safety, as minor.

The actions taken on-the-spot by the CA were satisfactory as regards traceability and recall. However, the measures were not fully satisfactory as regards FBOs' procedures/ ensuring that adequate measures are put in place to prevent reoccurrence. a. In one of the cases, the CA had not required the FBO to carry out a root cause analysis. Furthermore, the CA considered the other final products of the FBO as not able to support the growth of Listeria, although the FBO had not been asked to demonstrate this. b. In the other case, the CA had not detected the potential for cross-contamination in the packing area of the final product (this area was also used as a storehouse for packing material), nor the FBO's inadequate monitoring and recording of the CCP/heat treatment. The recalled products were placed on the internal market following the FBO's negative Shiga toxin-producing Escherichia coli test results which does not cater for the uneven distribution of microbiological contamination. Conclusions on Rapid Alert System for Food and Feed (RASFF)

The CA actions on-the-spot in the examples reviewed by the audit team did not comprise an adequate review of FBOs' procedures to ensure that the concerned FBO takes all necessary measures to prevent reoccurrence.

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: , 4235/2014 : ) & , , , / , ) , . & , . ­ / / , Page: 6 port ref. DG(SANTE) 2023-7734 of the audit carried out from 06 March 2023 afety of milk and dairy products port ref. DG(SANTE) 2023-7734 of the audit carried out from 06 March 2023 afety of milk and dairy products Action Proposed by the competent authority , on the spot , . : ) DG(SANTE) / 2023 ) : 2024

, 2 , « ». : 1. . .:2024/16-02-2024 « DG(SANTE)/2023-7734 & » (__1). 4 & . 2. . .:1982/15-02-2024 « » (__2). 4 . 3. . .:13199/11-12-2023 « » (__3). , : & , & , () Page: 5 itted by the competent authorities of Greece in response to Report ref. DG(SANTE) 2023-7734 of 23 in order to evaluate the official controls related to the safety of milk and dairy products mpetent authority's response ­ update 15 April 2024 . . . , . , / ( & , : ) , ) & ) , .

es / & t , : ( / ) - - «» . , , - ( - / ), ) , - & ( ), - . , - & . Page: 3 plan submitted by the competent authorities of Greece in response to Report ref. DG(SANTE) 2023-7734 of March 2023 in order to evaluate the official controls related to the safety of milk and dairy products Competent authority's response to report recommendations ­ update 24 October 2024

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Five alerts related to milk and dairy products of Greek origin had been notified in RASFF between 2019 and 2022. The audit team reviewed the CA action in two RASFF cases issued after detection of pathogens in cheese. The national contact point communicated the information on RASFF to local level one week after its receipt in the first case and after 3 days in the second case. This is not in line with Article 13 of Regulation (EU) 2019/1715. The CCA explained that a management signature is required, which delays the communication to local level.

The CA has designated a national contact point for RASFF and issued procedures for managing RASFF notifications. However, the notifications are not immediately transmitted to the local CAs, which delays the CAs in carrying out appropriate actions on-the-spot.

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, , iRASFF email, , (RASFF alert) , , , . : RASFF alert 2023

, , RASFF, email 24 , . . .: 4232/09.04.2024 4233/09.04.2024 « (RASFF)» _4 & 5). , . _6 & __7). Page: 6 itted by the competent authorities of Greece in response to Report ref. DG(SANTE) 2023-7734 of 23 in order to evaluate the official controls related to the safety of milk and dairy products Competent authority's response ­ update 15 April 2024

To ensure that the measures taken in case of RASFF alerts comply with the requirements laid down in Article 13 Regulation (EU) 2019/1715. Recommendation based on conclusion No 67. Associated finding No 65.

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When ELGO-Dimitra laboratories identify non-compliant test results concerning the quality of raw milk (Plate Count - PC), and/or Somatic Cell Count - SCC) and/or residues of antibiotics) they notify the RVUs. The RVUs in general follow up through letters to the farmers and, for recurring high levels of non-compliance, sometimes also on-farm visits. However, contrary to the requirements of Section IX, Chapter I, Part III (5) of Regulation (EC) No 853/2004, the FBOs do not routinely notify the CA of the 8 (non-compliant) results. When testing takes place in private laboratories, the CA is not always aware of the results, which hinders follow-up at holding level: a. In one of the regions visited, the RVD did not receive notifications from the dairy FBOs in that region, only from ELGO Dimitra; b. In the other region, in two of the three establishments visited one of the RVUs had not received any notifications. Two of the establishments visited did not routinely notify the non-compliant SCC/PC geometric averages or the antibiotic positive results to the CAs.

The CA performing controls in the dairy establishments either did not check whether the FBOs notify the non-compliant results for SCC, PC and antibiotic residues or, when this was checked, the shortcoming did not trigger enforcement ­ the CA recommended the FBO to notify the CA. The option for suspension of milk collection provided by Article 50(2) of Regulation (EU) 2019/627 is not generally used by FBOs and is not required by CAs as the milk is pasteurised. The results for SCC and/or PC testing of many holdings (amongst those with non-compliant results) showed very high counts, repeatedly each month, during a selected period of 12 consecutive months.

Summary statistics provided by ELGO Dimitra for the 2020-2022 timeframe indicate that between 97.4% and 99.3% of the sheep and goat milk collected from milk production holdings had satisfactory results at PC testing. At the time of the previous audit, over 96% of the sheep and goat milk was compliant whereas the level of compliance for raw bovine milk was of approximately 80% for PC and 70% for SCC. Regarding cow milk received in the establishments, the compliance levels reached in recent years (rolling geometrical averages over a two- and three-month period, respectively) were the following: a. In 2020, 89.8% of the milk complied with PC and 60.9% with SCC requirements; b. In 2021, the compliance levels were 92.1% for PC and 75.8% for SCC; c. In 2022, 92% of the milk complied with PC and 69.1% with SCC requirements.

A raw milk sampling and testing framework in line with the EU legal requirements is in place. The compliance of raw milk with PC requirements has improved compared to the previous audit. However, the measures in place had not been effective to 9 improve the raw cow milk compliance with SCC requirements as approximately 30% of the raw cow milk does not comply with the SCC requirements.

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aw / . 8. Page: 8 port ref. DG(SANTE) 2023-7734 of the audit carried out from 06 March 2023 afety of milk and dairy products Action Proposed by the competent authority

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The outcomes of the controls had not been routinely documented in one of the two regions visited. Overall, a small number of the controls planned had been implemented between 2019 and 2021: 357 controls (0.4%) in the 83 396 sheep/goat holdings (of which 5 373 were dairy holdings and the rest mixed holdings); 131 controls (1%) in the 12 209 cattle holdings (of which 4 479 were dairy holdings and the rest mixed holdings). The CA stated this was a result of limited staff availability and in 2020 was also due to challenges faced because of the COVID-19 pandemic. 5.4.1 Health requirements for raw milk and colostrum

The audit team assessed the action taken by the CA after detection of brucellosis in a bovine herd. The RVU had imposed the measures outlined by the procedures in place that aim to ensure the safety of milk obtained from the holding after receiving a positive blood test result. The CA had also required the FBO to sign a sworn statement that they would comply with these measures. However, the actions were not effective to adequately/timely prevent that the milk from positive animals does not enter the food chain, contrary to the requirements of Section IX, Chapter I, Part I(4) and (5) of Annex III to Regulation (EC) No 853/2004. a. The local CA received the (Brucella positive) laboratory result for a milk sample, by post, 10 days after the result was ready. The CCA clarified that the laboratory is required to inform immediately of such positive results. b. The positive milk sample triggered blood sampling of the animals in the herd, but it did not trigger restrictions regarding the milk from the herd until the blood test results had arrived. The RVU only imposed restrictions on the milk upon receipt of the blood samples results, which was 6 days after the confirmed positive milk sample. c. The first blood testing of the herd revealed 25 positive cases, the second (one month later) 33 positive cases, the third one (another month later) 33 positive cases and a new test was due at the time of the audit. These figures question the adequacy of the outbreak handling. d. The CA was not required to verify that the measures are implemented (e.g. the quantity of milk delivered for human consumption was not assessed against the quantity from eligible animals).

In one of the regions visited the scope of the hygiene controls on holdings was comprehensive, the RVU/RVD used the CCA's and locally developed targeted checklist and implemented the inspections largely as planned. The CAs documented their controls and detected relevant non-compliances, except for the lack of protection against vermin of the milk storage premises in the farm visited by the audit team. However, in this region the CA performed an advisory role and had not used enforcement on farms.

In the other region visited, the CAs had recently started to use the checklist issued by the CCA when carrying out on-farm controls. The CAs met explained that previous hygiene controls had not been documented. Overall, the RVUs performed a small number of on- farm controls due to resource limitations (see paragraph 20). In this region, enforcement measures had been taken for shortcomings noted during dairy farm controls.

The RVUs' farm inspections include checks on compliance with the rules for administration of veterinary drugs. In the cases assessed by the audit team, the CAs 7 checked compliance with the withdrawal periods for the treatments registered by the private veterinarian of the farmer in the farm register. However, the mastitis treatment administered by the farmers had not been recorded nor subject to official controls. Conclusions on controls over milk and colostrum production holdings

Official controls on holdings are planned on a risk basis. However, the implementation of these controls was not harmonised between regions and the CAs verify compliance with hygiene requirements on a small number of holdings (the targets for these controls are not reached). While the assessed (performed) controls detected shortcomings, these shortcomings were not enforced in all regions which may further limit the impact of the on-farm controls.

The CAs put measures in place in case of tuberculosis and/or brucellosis in dairy farms and those measures also concern the destination of the milk from the respective herds. However, the measures were not effective to timely prevent milk from positive animals from entering the food chain in the case assessed by the audit team.

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/ d and , . . . . , , . , 4235/2014 : ) , ) , / , / ... Page: 9 port ref. DG(SANTE) 2023-7734 of the audit carried out from 06 March 2023 afety of milk and dairy products port ref. DG(SANTE) 2023-7734 of the audit carried out from 06 March 2023 afety of milk and dairy products Action Proposed by the competent authority , .

, 2024. , 1 2023, Page: 7 itted by the competent authorities of Greece in response to Report ref. DG(SANTE) 2023-7734 of 23 in order to evaluate the official controls related to the safety of milk and dairy products Competent authority's response ­ update 15 April 2024 -, () , . , . (_2023-7734-8).

t 1. 26 , . n 1026/129513/9-5-2024 , , . : DGVS_2023-7734-8_VMP_2023 2. - , Page: 4 plan submitted by the competent authorities of Greece in response to Report ref. DG(SANTE) 2023-7734 of March 2023 in order to evaluate the official controls related to the safety of milk and dairy products nse to report recommendations ­ update 24 October 2024 plan submitted by the competent authorities of Greece in response to Report ref. DG(SANTE) 2023-7734 of March 2023 in order to evaluate the official controls related to the safety of milk and dairy products petent authority's response to report recommendations ­ update 24 October 2024 , , - () - 31.12.2024.

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According to the CA, the NRLs for pathogens perform their task as required by Regulation (EU) 2017/625. The CA provided evidence of training and technical workshops organised by the NRLs as well as dissemination of relevant information to DGVS, EFET and ELGO Dimitra laboratories. However, the CA did not provide evidence that the Listeria NRL coordinates the activities of official laboratories (EFET and DGVS) and, where appropriate, organises inter-laboratory comparative testing or proficiency tests between official laboratories, nor that it ensures an appropriate follow- up of such tests and informs the CAs of the related results and follow-up. Conclusions on official sampling programmes and laboratories

A network of accredited laboratories, working with accredited methods, supports the official control system. The NRLs have been designated and, in general, perform their tasks. This could not be fully demonstrated in the case of the NRL for Listeria.

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/ ) : 1. (Listeria monocytogenes) . (, . / ) , 37 2017/625, . . 2. (Listeria monocytogenes) : () - / , , , (.. -- Listeria monocytogenes). . () Page: 11 port ref. DG(SANTE) 2023-7734 of the audit carried out from 06 March 2023 afety of milk and dairy products petent authority

: _2023-7734-9_DGVS_LABS.

Listeria monocytogenes (_Lm), nd (. /330669/31.10.2023) . 2957/118407/ 04.2024 , . , . , ( 2024) . 474/330669/31.10.2023 , , : () , Page: 6 plan submitted by the competent authorities of Greece in response to Report ref. DG(SANTE) 2023-7734 of March 2023 in order to evaluate the official controls related to the safety of milk and dairy products nse to report recommendations ­ update 24 October 2024 .10.2024 , , 1 (not to be published) 2 3 plan submitted by the competent authorities of Greece in response to Report ref. DG(SANTE) 2023-7734 of March 2023 in order to evaluate the official controls related to the safety of milk and dairy products petent authority's response to report recommendations ­ update 24 October 2024

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The frequency of the dairy internal audits by EFET is approximately once every 5 years. Each audit assesses the CCA and one regional CA. The systemic findings of one audit (in a region) do not trigger actions in the other regions nor an enquiry into whether the same problems arise in other regions, nor related measures to be taken if so needed. The audit team had access to different audit reports that identify similar problems in different regions, but these were in different audit cycles and therefore years apart. Conclusion on system of supervision and internal audits

Internal audits are in place and identify relevant aspects on the performance of dairy controls. However, the audit sample is limited to one region. The audits have not triggered systemic improvements although similar issues persist in other regions. This limits the overall impact. The measures to verify the effectiveness of the official controls were not fully effective.

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Official controls at farm level concerning microbiological contamination at primary production of FNAO (before and during harvest) were not defined in the planning process (2) https://ec.europa.eu/food/audits-analysis/country/profile/download/518 4 nor carried out in any region of Greece. Official controls before and during harvest are not yet implemented.

The audit team visited two growers in two different regions, one grower of strawberries and one grower of leafy green vegetables. However, official controls at farm level concerning microbiological contamination at primary production of FNAO (before and during harvest) are not carried out in any region of Greece and inspectors confirmed that none of those growers visited were inspected previously in the scope of this audit (see paragraph 6). Standardisation and pack-houses / processing plants

Contrary to Article 10 (1) of Regulation (EU) 2017/625 the CA has not implemented any official controls at primary production, before and during harvest.

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DGF has been designated as the central competent authority of MRDF according to article 23 (1ab) of Law 4691/2020 (OJ 108 A´) for the organization, supervision, coordination and carrying out the official controls, including the official controls on microbiological risks, through its Directorates for food of non animal origin at every stage of primary production, as well as during standardization and packaging of these primary products. However, according to PD No 97/2017 (OJ 138 A´) "Organisation of MRDF", DGF consists of four Directorates including DFQS, which have no competency at the stage of primary production, before and during harvest. DFQS, as the designated service of MRDF responsible for the coordination of the audit DG (SANTE) 2023-7738, informed the offices of the Minister and the General Secretary of MRDF about the lack of competency under PD No 97/2017 that has led in practice to lack of a Directorate of DGF, which is competent for the planning and supervision of the system of official controls for safety and hygiene at the stage before and during harvest. Therefore, DGF is going to propose an amendment to article 23 (1ab) of Law 4691/2020 (OJ 108 A´) until the end of

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Contrary to most of the inspections witnessed by the audit team where deficiencies were rarely detected, in one case a team of inspectors demonstrated the capacity to detect shortcomings and to request the necessary corrective actions, also asking the FBO for immediate corrections.

However, all inspectors interviewed informed the audit team that deadlines for corrective actions are not set, if the non-compliances are minor, but, in any case, implementations for corrective actions ought to be verified during the next regular inspection. But if the non- compliances are major, a deadline is set for the company to take corrective actions. The central office of EFET provided a few reports with examples of follow-up inspections of produce not within the scope of the audit. Cultivation

The audit team accompanied the inspectors and found that in general (see paragraph 22), the inspectors did not identify relevant shortcomings, such as potential cross-contamination by staff (e.g. operatives did not change gloves after touching the floor, wearing jewellery in direct contact with product), dirt over the exposed products, condensation water on ceiling of cooling rooms. Other control systems

As regards pack-houses and processing plants, inspections were carried out according to the plans. However, the controls were not effective in identifying relevant shortcomings, and when identified the associated corrective actions were rarely followed-up. All of this has an impact on the effectiveness of official controls. 5.2.4 Official sampling procedures Legal requirements Articles 34 and 35 of Regulation (EU) 2017/625 and Annex I, Chapter 1 of Regulation (EC) No 2073/2005. Findings

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suance of a circular to the inspectors of the competent orities, with guidelines for the control of microbiological risks in foods of non-animal origin. ntil the end of the year 2023. Page: 1 ref. DG(SANTE) 2023-7738 of the audit carried out from 02 May 2023 to obial safety of food of non-animal origin petent authority program for EFET inspectors, regarding with instructions for their correct r of the findings (non-compliances) to ill be a special educational module on oods of non-animal origin 2024. and 2 a circular and a training program PCs' and REVDs' inspectors as well DFQS's competency. 2024. for the implementation of the penalty in which it will be reminded and , medium, high risk) in relation to the ation will be recorded mandatory in the sessment. entailed by the established of time for the implementation of the defined (time of follow up inspection). spection is independent of the time of from the application of article 4 of JMD assification of food businesses in y of official controls". non-conformities are found that safe food, immediate corrective ding the suspension (partial or total) of ess if required. reports must state the non-conformities tial audit and for each

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Regarding internal audit and supervision different services are in charge: · There are dedicated units within both MRDF and EFET that are responsible for carrying out internal audits to verify the correct implementation of official control systems. However, there is no evidence of activities carried out in the scope of this audit. · DFQ is the CCA for supervision of FNAO in the sector of fresh fruit and vegetables, after primary production up to the stage of standardisation - packaging as well as the stage of import. However, evidence of on the spot supervision was not provided. 5 Conclusion on designation of competent authorities and resources for official controls

The CCAs have an adequate structure with arrangements to carry out official controls over the FNAO sector. Nonetheless, the CA activities to verify the effectiveness of the official controls performed is very limited. 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 food establishments

Contrary to most of the inspections witnessed by the audit team where deficiencies were rarely detected, in one case a team of inspectors demonstrated the capacity to detect shortcomings and to request the necessary corrective actions, also asking the FBO for immediate corrections.

The audit team accompanied the inspectors and found that in general (see paragraph 22), the inspectors did not identify relevant shortcomings, such as potential cross-contamination by staff (e.g. operatives did not change gloves after touching the floor, wearing jewellery in direct contact with product), dirt over the exposed products, condensation water on ceiling of cooling rooms. Other control systems

As regards pack-houses and processing plants, inspections were carried out according to the plans. However, the controls were not effective in identifying relevant shortcomings, and when identified the associated corrective actions were rarely followed-up. All of this has an impact on the effectiveness of official controls. 5.2.4 Official sampling procedures Legal requirements Articles 34 and 35 of Regulation (EU) 2017/625 and Annex I, Chapter 1 of Regulation (EC) No 2073/2005. Findings

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ed on the five-year program of internal audits 2020-2024 .01.2023 attached - see page 6), EFET will carry audit to evaluate the system of official controls in and processing of food of non-animal origin with the implementation of hygiene requirements and safety in 2024. se by the end of year 2023, a plan of procedures ry out regular verification checks, including among pot checks, which will consist of: a) checking s held by the regional competent authorities &PCs and REVDs), b) interviewing the tors of the regional competent authorities and c) ng the premises where controls in the framework of competency take place. hecks will include administrative checks of: a) companying documents of imported / exported nments, b) the check lists and reports following the tions for the classification of fresh fruit and bles establishments at risk categories. The entioned documents shall be sent by the regional ent authorities at the request of the CCA. e-spot checks cannot be carried out because of Page: 3 ref. DG(SANTE) 2023-7738 of the audit carried out from 02 May 2023 to obial safety of food of non-animal origin

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Page: 8 e to the recommendations of report ref. DG(SANTE) 2023-7787 of the audit carried out from 20 February measures taken to ensure the respect of requirements in relation to animal welfare rules on animal transport and competent authority e to the recommendations of report ref. DG(SANTE) 2023-7787 of the audit carried out from 20 February measures taken to ensure the respect of requirements in relation to animal welfare rules on animal transport and on Proposed by the competent authority : 2024 , 024 . 023 Page: 10 e to the recommendations of report ref. DG(SANTE) 2023-7787 of the audit carried out from 20 February measures taken to ensure the respect of requirements in relation to animal welfare rules on animal transport and competent authority Page: 11

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The official controls by the Regional Units do not meet the prescribed frequencies, and still do not detect and/or address some major, and long-standing, animal welfare non- compliances. This significantly reduces the reliability of official control assurances of adequate animal welfare at slaughter.

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The official controls by the Regional Units do not meet the prescribed frequencies, and still do not detect and/or address some major, and long-standing, animal welfare non- compliances. This significantly reduces the reliability of official control assurances of adequate animal welfare at slaughter.

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As required by Article 5(1)(d) of Regulation (EU) 2017/625, RVSs have at their disposal a number of designated official laboratories ensuring the examination capacity for samples collected during official controls on ABP. Designated laboratories are accredited to EN ISO/IEC 17025. The audit team noted that in line with requirement of Article 37(5) of Regulation (EU) 2017/625, all ABP related methods of analysis (required by the national sampling programme for official sampling, see finding 21), except three, are within the scope of accreditation. The three methods of analysis, which remain outside the scope of accreditation, are examinations for Clostridium perfringens, Enterococcaceae and the content of glyceroltriheptanoate (GTH). The DGVS and the RVS representatives explained that official Veterinary Laboratories have within their accreditation scopes an analytical method for Escherichia coli. Since ABP legislation allows for substituting the Enterococcaceae analysis with the analysis for Escherichia coli, official laboratories use that method when analysing official samples.

Whilst the competent authority avails of an adequate laboratory capacity and designated official laboratories are accredited, the fact that none of these laboratories have the analytical method for Clostridium perfringens and GTH included in their respective scopes of accreditation, may compromise effective enforcement action being taken in the event of a non-compliant result being found (using an unaccredited method). 6

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In the regions visited, the audit team examined a number of approval files and documents presented by operators of ABP plants visited and noted that assessments of the operators' documents during the approval process overlooked certain deficiencies in both operational and validation procedures. In these cases, this should have resulted in the plants being granted (at most) a conditional approval rather than a full approval. Such deficiencies concerned: a. permanent written or HACCP-based procedures, namely those related to: (i) establishing critical control points and limits for their monitoring and documentation, in particular the daily monitoring of the effectiveness of the size reduction, (ii) written cleaning procedures, and (iii) verification procedures; b. operators' own checks, in particular on: (i) microbiological standards, (ii) GTH, (iii) annual surveillance test for automated monitoring equipment and (iv) the effectiveness of incineration, and; c. validation, in particular the absence of evidence demonstrating that the plants met the required processing parameters, especially for continuous processing methods and for processing method 7.

Whilst the approval procedure is in line with EU requirements, its implementation was deficient with respect to the assessment of the operators' operational and validation procedures resulting in the granting of inappropriate approvals.

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Each of the ten regions manages the programme itself and, via a public tender, contracts operators collecting ABP and fallen farmed animals. This resulted in the signing of contracts by the regions at different times; consequently, regions are at different stages of the programme implementation. While some regions will soon begin the second round of the programme, some are still in the mid-phase of the first round and one region only recently (March 2022) initiated the first round and expects to begin the collection from April 2022 (see Table 1.). (8) Information and data provided by DGVS in response to pre-audit questionnaire and during the audit. 9 Table 1. Timeline of implementation of the programme by the regions year 2019 2020 2021 2022 months region 1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 Eastern Macedonia & Trace Central Greece Peloponnese Crete Epirus Central Macedonia West Greece Attika Thessaly Western Macedonia

According to the data reviewed by the audit team, the ten regions that implemented the programme collected 13,551 bovine animals, 15,304 small ruminants and 3,551 pigs (9).

The public awareness of the programme varies between the regions. In two of the four regions visited, the regional authorities had actively informed animal keepers about the programme, using leaflets, local media and local administrations. In the other two, the information action had a much smaller scale. Consequently, farmers' awareness of the programme varies and is best in those regions where the programme is already being implemented.

Out of the nine regions currently implementing the programme, two have already achieved the foreseen target for collection of fallen bovine animals. In the remaining seven, the collection of fallen cattle ranges from almost half of the expected number of fallen animals (a region with a longer period of implementation) to zero (in a region where the programme has been implemented only since November 2021) (10). In those regions where the collection programme is not fully operational or has not started yet, farmers are burying fallen animals on their own lands (see finding 31).

In two of the regions visited, the audit team visited large bovine holdings (keeping more than 300 animals) and noted that: a. In the region implementing the national collection programme for fallen stock, the farmer had abandoned the earlier practice of burying dead animals and notified all fallen animals to a collector contracted under the programme. The number of fallen animals notified to the collector matched the number of notifications to the national system for animal identification and registration (IVIS). b. In the region where the programme for collection was not yet operational, the farmer notified all dead animals to the system for animal identification and registration but continued to bury fallen stock on a dedicated part of his land. The owner was aware (9) The data do not contain information on the number of animals collected from October 2021 in Epirus region (See Table 1.), since these have not been reported yet, and in Western Macedonia region where collection will begin from April 2022. (10) In its response to the draft report the competent authority explained that data on the implementation of the programme in each Region are sent by the contractor to the regional committees, which check the data and receive the project. The verified official data from the regional veterinary authorities are subsequently sent, on an annual basis, to the central competent authority; therefore exact data from regions which implemented the programme in November 2021 were not available at the time of the audit. 10 that the collection programme will kick off soon and declared his willingness to use it as a more economically viable and legally sound solution.

The programme covers the collection of ABP and fallen animals of the following species: bovine, porcine, ovine and caprine. For all of these species, DGVS has estimated the annual collection target (i.e. the mortality rate) at 4% of the total population. The programme does not cover collection of other farmed species, e.g. poultry or equidae; however, regions may include these upon their own decision. While one of the four regions visited included poultry in the programme, another one excluded pigs. The RVS representatives from the region where the programme did not cover pigs, stated that this situation will change because operators of smaller scale pig holdings and backyard farmers have requested the inclusion in the programme. According to the competent authorities, these operators had found the programme to be financially more attractive to them than disposing fallen pigs based on an individual contract with an ABP processor.

The collection of pigs, sheep and goats is by far less effective than that of cattle. For pigs, the percentage of fallen stock collected (by region) ranges from zero to 29.71% of the expected number of fallen stock (4% of the population). The VS representatives met informed the audit team that in some regions, including those visited during the audit, the outbreaks of African swine fever happening in the recent years resulted in the issuing of a decision allowing for on-site burial of pigs to prevent further spread of the disease. Moreover, large pig farms usually have their own arrangements for collection and disposal of fallen animals directly by ABP processors. However, there are no data available to demonstrate how many holdings have such arrangements in place and what is the percentage or quantity of fallen pigs covered by such individual arrangements. The officials met explained that it is the smaller scale pig producers and backyard farmers that would mostly benefit from the collection provided by the programme.

For sheep and goats, the percentage of fallen animals collected (by region) remains far from the expected target (4% of the population) and ranges from 0.01 to 9.28% of the target. In the regions visited, the RVS officials met explained that sheep and goats spend more than half of the year free-grazing in mountainous areas with difficult access, where collection is practically not possible. This part of the year represents also the period with the highest proportion of deaths of small ruminants as losses usually happen around and shortly after the lambing season.

While since the last Commission audit of 2011 there has been a significant improvement across the country in the collection and disposal of ABP resulting from slaughter and from food establishments handling products of animal origin, the collection of fallen farmed animals has only improved in those few regions were the national collection programme has been operating the longest (since 2019) and even there, the huge variation between different animal species and between regions, illustrates that the implementation of the system is very much a work in progress. . 14

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The RVSs record the controls carried out and their results in the IT system developed to support risk-based planning. The audit team analysed the available information and noted that: a. Except in one Regional Unit, officials carried out inspections on ABP operators and in food establishments handling ABP, mostly as planned. b. In the regions visited, contrary to the requirement of Section 2 of Chapter III in Annex XVI to Regulation (EU) No 142/2011, there were no regular (at least once a year) 8 official controls on low capacity incineration plants incinerating SRM. Out of 55 incineration plants approved in the country, 38 are low capacity incinerators, of which 30 incinerate SRM. c. In the regions visited, which had experienced outbreaks of epizootic diseases, namely African swine fever and avian influenza, the RVSs had partially reduced the frequency of controls on animal holdings due to the restrictions and measures to prevent the spread of the above diseases. d. In 2020 and 2021, the number of controls effectively carried out differed from that planned. Some planned ABP controls did not take place due to COVID-19 related restrictions. The COVID-19 pandemic also affected both the availability of staff carrying out controls and ABP operators.

With the exception of controls on low capacity incinerators and, more significantly, official sampling, official controls are mostly implemented as planned and are largely suitable to check operator compliance with the applicable Union requirements on ABP and DP. However, and similar to what has been seen in the plant approval process, in some instances official controls have erroneously concluded on operator compliance when in fact this is not the case, thus weakening confidence in the reliability of said controls.

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The audit team noted that official controls usually properly assessed compliance with infrastructural, equipment or hygiene-related requirements. However, for other types of requirements, official controls concluded on compliance even though: a. some of the ABP operators recorded the processing parameters in a way which did not allow to demonstrate compliance with permitted operating conditions (parameters were not recorded continuously against real time or information on the quantity of processed/incinerated material was missing), and; b. operators' documents and procedures often missed mention of or reference to: (i) cleaning procedures and their documentation, required by Article 25(3)(e) of Regulation (EC) No 1069/2009; (ii) description of operators' own checks required by Article 28 of Regulation (EC) No 1069/2009) in relation to the verification on microbiological standards (Salmonella and Enterobacteriaceae) and effectiveness of incineration, measured by means of the total organic carbon content or loss on ignition; (iii) the system for monitoring and recording of parameters related to marking certain DP with GTH, required by Point 2 in Chapter V of Annex VIII to Regulation (EU) No 142/2011; (iv) monitoring procedures at critical control points required by Article 29(2)(d) of Regulation (EC) No 1069/2009, in particular for daily monitoring on effectiveness of the size reduction, and; (v) verification procedures demonstrating that measures put in place by the operator are complete and working effectively, required by Article 29(2)(f) of Regulation (EC) No 1069/2009.

With the exception of controls on low capacity incinerators and, more significantly, official sampling, official controls are mostly implemented as planned and are largely suitable to check operator compliance with the applicable Union requirements on ABP and DP. However, and similar to what has been seen in the plant approval process, in some instances official controls have erroneously concluded on operator compliance when in fact this is not the case, thus weakening confidence in the reliability of said controls.

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There are 11 factory vessels approved in Greece. EFET stated that the risk associated with factory vessels was set, by default, as high risk. Consequently, the frequency of 11 controls should be from 6 to 18 months. From the data submitted by EFET, the audit team noted that the set frequency had not been respected, with the exception of two cases. For six of the vessels, the last inspection took place prior to 2012 (in one case the last inspection was in 2007). In another case, the last inspection was carried out in 2016 and for two others, in 2018. This is not in line with Article 9(1) of Regulation (EU) 2017/625, and Article 67 of Regulation (EU) 2019/627.

The audit team noted that according to the description provided by EFET of the activities of five of the factory vessels, these vessels in practice undertake operations typically associated with freezer vessels (gutting, de-heading, freezing and packing). Based on the initial pre-approval inspection for these vessels, the activities indicated were for those of a factory vessel. However, it is not clear whether or not the additional activities associated with factory vessels are still taking place. The audit team noted that official controls in factory vessels are not carried out, or are carried out with many years delay. As a consequence, the competent authority (EFET) is unable to keep their approval under review (in a timely manner), when carrying out official controls as required by Article 148(5) of Regulation (EU) 2017/625. This is of particular importance because if the activities carried out are no longer those of a factory vessel but would be limited to those of a freezer vessel, then these vessels would fall under the responsibility of DGVS.

EFET stated that due to financial constraints, factory vessels operating in third countries are not physically inspected. At the time of the previous audit in 2014, there were three vessels operating in a third country, of which one remained at the time of this audit. In these cases, the competent authority requires factory vessels to provide documents and records by email to the competent authority to monitor their activity. The failure to carry out inspection on the spot is not in line with Article 67 of Regulation 2019/627 and Article 148(5) or Regulation (EU) 2017/625. As indicated in paragraph 17, the Greek competent authorities have not delegated official control duties to other third countries/Member States authorities to cover vessels fishing in other countries and not returning to Greece.

In establishments controlled by the DAOKs, and in the majority of cases, the frequency of inspections had not been observed.

There is a system in place for official controls of approved establishments. However, the frequencies defined following a risk categorisation assessment, have not been followed in the case of factory vessels under the control of EFET nor for establishments on land under the control of the DAOKs. This failure to comply with frequencies of controls compromises the effectiveness of the official control system to achieve its objectives to verify compliance with EU rules.

Medlemsstatens svar

the : 1. , (: 2022). , (: 2023). 2. 2023. 3. / . 4. , . Page: 1 report ref. DG(SANTE) 2022-7452 of the audit carried out from 03 May 2022 to governing the production and placing on the market of fishery products report ref. DG(SANTE) 2022-7452 of the audit carried out from 03 May 2022 to governing the production and placing on the market of fishery products Action Proposed by the competent authority . . , , / .

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Transporters are considered primarily accountable in the case of animals unfit for transport. However, due to limitations in the national legislation in relation to imposing and receiving payments of administrative fines, (the fines must be imposed and paid on- the-spot) no administrative sanctions have been imposed to date. The CCA is currently working on an amendment of this legislation. Conclusions on competent authorities

Officials on the ground have support/legal powers to perform the controls and, more importantly, to enforce the relevant legal requirements. However, regarding transporters, who are considered as primarily responsible for animals unfit for transport, current limitations in national legislation hinder proper enforcement.

Movement declarations were also granted for animals that were unfit for transport (see paragraph 75); even though the existing procedures clearly indicate that such animals should not be transported (see paragraph 97). Once the local DVM's OVs have issued the 12 movement declaration, OVs at slaughterhouses accept the animals without questioning their fitness for transport.

None of the OVs in the 3 slaughterhouses mentioned identifying cases of bovine animals that were considered as unfit of transport and should have been slaughtered at farm. It should be noted that the movement declaration contains a specific clause that explicitly mentions that animals covered by the movement declaration are fit for transport, in line with Regulation (EC) No 1/2005.

Even though the local DVM's OVs responsible for issuing the movement declaration would indicate on the document that the animal(s) listed is/are destined for emergency slaughter (the reason of injury was not always indicated), the ante-mortem records rarely indicated any issues with the animals concerned. Similarly, there was no reference made to this in the accompanying FCI documents.

By examining the available records the audit team observed the following: · There is no consistency in the way that the OVs at the slaughterhouses classify these animals upon arrival to the slaughterhouse, in the application that they use. In several cases, although the cattle had been classified as emergency by the DVM's OV issuing the movement declaration, this was not indicated in the system nor was any further detail documented as to the reasons for the emergency, or the findings identified during the AMI (see paragraph 72). This was attributed, based on the explanations provided by the CCA, to mistakes or omissions due to workload. · Based on documents provided by the CAs and reviewed by the audit team, 4 bovine 13 animals which, based on their clinical condition as indicated on the relevant movement declaration should have been deemed unfit for transport, were allowed to be transported and those animals were accepted by the OVs at the slaughterhouses. These concerned cases of animals unable to move due to serious injuries (i.e. damaged spinal cord, fracture of pelvis, rupture of pubic symphysis and serious prolapse). No enforcement actions were taken to prevent reoccurrence of transport of such unfit animals to the slaughterhouses. · Additionally, in 5 cases reviewed by the audit team, injured animals that suffered fractures (i.e. fracture of femur) or other conditions (downer cows) were accepted for slaughter without any further investigation by the slaughterhouses' OVs as to how and where were those animals injured. This despite the fact that the OVs at the slaughterhouse had identified and recorded those findings during the AMI. · As discussed with the CAs certain fractures that are discovered during the PMI cannot necessarily be attributed to having happened after the bleeding of the animals, as they exhibit certain features (as described on the confiscation certificate) that indicate that they were present before the arrival of the animal at the slaughterhouse. · By examining the list of cattle that had given birth in the previous 15 days prior to being sent for slaughter for years 2019 and 2020, it was evident that half (30 out of 61) of these animals, although they had given birth less than a week beforehand, were transported contrary to the requirements of Chapter I (2c) of Annex I to Regulation (EC) No 1/2005. Procedures for poultry

There are procedures and guidelines in place for official staff for the relevant controls, which include guidance on how to act in different scenarios with regard to the handling of animals unfit for transport. Yet, the non-existence of emergency slaughters at farm level, combined with the findings regarding the condition of some animals arriving at slaughterhouses, implies that bovine animals are transported to the slaughterhouse irrespective of their fitness for transport. Official controls at slaughterhouses identify animals unfit for transport, however, as those animals have already been certified by the local DVMs , no further investigation is carried out nor any enforcement implemented.

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With regard to updating the CBD, farmers have the possibility to directly enter the births of bovine animals of their holdings up to 27 days after birth (i.e. up to 20 days to ear tag new-borns and up to another 7 days to notify). If a farmer is not able to enter the information her/himself, (s)he can request the local DVM to do it. Any other changes are notified in the CBD by the local DVMs, after farmers have informed them of such. This 10 concerns movements and deaths, which need to be notified by the famers within 7 days of the actual event. Generally, as was explained by the CAs, since this is quite demanding it is possible that there can be delays by the DVMs in updating the database.

There is no integration of the database with the collection companies for dead animals. Each company may keep records of the ears tags that it collects but that information is not cross-checked with that of the CBD. This information is communicated to the RUs/DVMs.

With regard to slaughtered bovine animals, in 2019 the CCA performed cross-checks between the bovine database and a database used by slaughterhouse operators to report 11 the classification of the carcases (see paragraph 17) and identified that a number of slaughtered animals were not notified by the OVs in the CBD as having been slaughtered. Based on the information collected by the CCA, around 10% of the bovines slaughtered were not recorded in the bovine database.

The CCA attributed this to understaffing and the workload of the OVs, who, in addition to their other tasks, are also expected to enter the ear tag numbers of the animals slaughtered into the database. Based on the outcome of that cross-check, the CCA sent out a reminder letter to the RUs of their obligations to notify the CBD. A similar cross- check, to be carried out in 2020, did not materialise.

In relation to fallen bovine animals, cross-checks carried out by the audit team in one RU between CBD data and those held by the company appointed for the collection of fallen stock, revealed an underreporting of fallen animals in the CBD. 5.4.2 Official controls at establishment level (slaughterhouses) Legal requirements Article 18 of Regulation (EU) 2017/625. Articles 3, 4, 5, 6, 7 and 8 of Regulation (EU) 2019/624. Articles 10 to 19, 29, 30, 33, 34 and 43 of Regulation (EU) 2019/627. Article 7 of Council Regulation (EC) No 1099/2009. Findings Ante-mortem inspection

Cross-checks carried out revealed significant under-reporting of events in the database, both for slaughters and deaths, which prevents reliable and timely reconciliation of the existing records; this, in turn, hinders the identification of possible non compliances.

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The high mortality rate of cows, as indicated is another factor highlighting the need for better plausibility checks and the necessity to consider this fact in the risk assessment for the selection of the holdings to be inspected. The official controls do not cover the possible causes of the high mortality rates. 18

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The risk-based planning of official controls is defective. When applied, it does not take into account all relevant risks; it does not cover all operators (e.g. pullets, breeders); and it varies between regions. This prevents the authorities from focusing efficiently their resources in farms that present higher risks for the welfare of the animals or from having a harmonised approach throughout the country.

Although the central authorities establish annual control programmes for local authorities, incomplete reporting of the checks performed means that they have limited oversight of the 5 implementation of the controls and of the welfare situation in this sector.

In one region, the authorities did not enforce the correct stocking density during approval of an establishment. In another region, enforcement action is not always applied as quickly as the impact of the non-compliance demands. This means that in some cases non- compliances remain outstanding for a long period or are not addressed at all.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Medlemsstatens svar

1) « » , , - ( , ), , ( 98/58/). : 10.2022 2) : ) . 1824/332840 ( , ' 5718) : « (EE) 2016/429 9 2016 (L 084 . L 057/2017, L 137/2017 L 048/2021), .» , , , Page: 1 ref. DG(SANTE) 2021-7244 of the audit carried out from 01 November aying hens at all stages of production ref. DG(SANTE) 2021-7244 of the audit carried out from 01 November aying hens at all stages of production Action Proposed by the competent authority . 4) . :11.2022

e central competent authority has revised the updated version of the `Handbook The actions planned/taken are sufficient to on the protection of laying hens' for the address the recommendation if realised official veterinarians of Greece, with a focus accordingly. Please clarify whether the on legal requirements, on all inspection Handbook on the protection of laying hens is parameters/modules (for example, beak already updated as indicated or is undergoing trimming, forced moulting and the use of reviewing and amendment as implied in animal indicators, also using the scientific actions described in next recommendations. opinions of the European Food Safety In such a case please confirm the deadline to Authority), the precise calculation of the complete its amendment. In addition please maximum capacity and the addition of confirm what would be the audience of the livestock for the protection of parent flocks of online seminar described. laying hens, the protection of chicks in hatcheries and protection in pullet farms (in accordance with the requirements of Directive 98/58/EC). Compliance timetable for completion and implementation: October 2022 2) The central competent authority h

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In one region, the authorities did not enforce the correct stocking density during approval of an establishment. In another region, enforcement action is not always applied as quickly as the impact of the non-compliance demands. This means that in some cases non- compliances remain outstanding for a long period or are not addressed at all.

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Medlemsstatens svar

1) , , , , , 2017/625. . : 11.2022 2) . 2017/625 . : 12.2022 Page: 3 ref. DG(SANTE) 2021-7244 of the audit carried out from 01 November aying hens at all stages of production Action Proposed by the competent authority 3) « » , . , . : 10.2022

1) When drawing up the annual programme for welfare inspections of laying The actions planned/taken are sufficient to hens, the regional competent authorities address the recommendation if realised throughout Greece will include hatcheries of accordingly. laying hens, breeding holdings and pullet k rearing facilities, in addition to laying farms, always on the basis of a risk analysis, as ed for in the relevant provisions of Regulation (EU) 2017/625. To this end, the central competent authority will issue a circular containing instructions on the planning and procedures for the inspections concerned. Compliance timetable: November 2022 2) The national online register of commercial poultry holdings is already designed to generate a sample of checks for each regional unit on the basis of a risk Page: 5 d by the competent authorities of Greece in response to Report ref. DG(SANTE) 2021-7244 of 2021 in order to evaluate the protection of the welfare of laying hens at all stages of production Action Proposed by the competent authority Commission services' assessment of the competent authority's response analysis. The central competent authority will ensure that all the parameters set out

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Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Medlemsstatens svar

1) 1 , , «». 2) . , . . : 1.2023 Page: 4 ref. DG(SANTE) 2021-7244 of the audit carried out from 01 November aying hens at all stages of production Action Proposed by the competent authority 3) . () 2019.723. . : 12.2022

recommendation 1 regarding the instructions already issued, the online training The actions planned/taken are sufficient to of veterinary staff and further details to be address the recommendation if realised included in the updated handbook of the accordingly. central competent authority, in particular as Page: 6 d by the competent authorities of Greece in response to Report ref. DG(SANTE) 2021-7244 of 2021 in order to evaluate the protection of the welfare of laying hens at all stages of production Action Proposed by the competent authority regards the definition of `perch'. 2) The central competent authority will verify that the capacity of laying hen holdings is recalculated by the regional veterinary services throughout the country and that the new online poultry register is updated accordingly. The new online poultry register will contribute to a better recording and assessment of the relevant checks. The central competent authority will carry out remote spot checks on the matter. Compliance timetable: January 2023 3) The central competent authority will verify the enforcement of administrative penalties and other measures imposed by the regional veterinary services in the ev

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Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Medlemsstatens svar

f 1) . : 12.2022 . : 12.2022 3) « » , . : 10.2022

The competent department of the tral competent authority will carry out an It is not made clear whether the on site ernal audit on the welfare of laying hens. inspections that the central competent authority intend to conduct will be realised pliance timetable: December 2022 by December 2022 only or there is a planned arrangement for systematic verification The central competent authority will activities. Please clarify also whether the ry out on-site inspections of regional verification activities will be a tool to petent authorities. address points in other recommendations of pliance timetable: December 2022 this report. In addition please specify the scope of activities that the internal audit will The central competent authority will cover. out in the revised version of the ndbook on the protection of laying hens' a cedure and a schedule for carrying out ote spot checks on the matter, including sending of documentary evidence of rective action taken in cases of non- pliance detected by the regional erinary authorities. pliance timetable: October 2022 ated CA response 06-03-2023: Page: 8 d by the competent authorities of Greece in response to Report ref. DG(SANTE) 2021-7244 of 2

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Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Medlemsstatens svar

1) 35: Page: 5 ref. DG(SANTE) 2021-7244 of the audit carried out from 01 November aying hens at all stages of production ction Proposed by the competent authority (, , ) . ) « » , , ( 4, . ). . : 10.22 ) . : 12.2022 ) ( . Page: 6 ref. DG(SANTE) 2021-7244 of the audit carried out from 01 November aying hens at all stages of production

ith regard to finding 35: The ent authority of the regional unit in The remote checks may support addressing some of the deficiencies occurring in relation tion informed the central competent to enforcement but not some of the other ority that it had taken action after the ones. Please clarify whether the verification ection of that farm was completed. In activities planned (proposed actions for icular, additional equipment (perches, drinkers) was immediately requested recommendation 4) will cover these aspects installed so that the approved capacity and will be systematic. Page: 10 d by the competent authorities of Greece in response to Report ref. DG(SANTE) 2021-7244 of 2021 in order to evaluate the protection of the welfare of laying hens at all stages of production hority Commission services' assessment of the competent authority's response or the tock : legislation 4 ook ll include . instances , a a final ' ective ral , . re that . 4 thorities 5 . s. ill matter. Page: 11 d by the competent authorities of Greece in response to Report ref. DG(SANTE) 2021-7244 of 2021 in order to evaluate the protection of the welfare of laying hens at all stages of production hority Commission s

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With regards selected methodologies for the detection of ToBRFV, the Virology Laboratory only uses one of the prescribed test methods as laid down in the Annex to the Regulation (EU) 2020/1191 (International Seed Federation (ISF) protocol (2020), with their own modifications to thermal cycling parameters and decreased 5 concentrations of primer and probe). The method of Ling et al. (2019)1, not prescribed in the Annex, is used as the second, confirmatory test due to, in the laboratory's stated experience, superior method specificity. Neither of these methods are formally validated.

The use of alternative, and as yet, un-validated test methods, different to those as stipulated in the Annex of Regulation (EU) 2020/1191, may undermine the effectiveness of the emergency measures.

Medlemsstatens svar

icial samples out the test (NPPO) ( ) . () 2020/1191. , - RT-PCR ISF (2020) RT-PCR (Ling et al., 2019) 100% (please refer to EURL- Virology_PT-2020-01-TOBRFV PROFICIENCY TEST FOR THE DETECTION OF TOMATO BROWN RUGOSE FRUIT VIRUS-FINAL REPORT, Benaki Institute ­ laboratory of Virology: L14). EURL . ived 27 May 2021 ons of report ref. DG(SANTE) 2020-7070 of the audit carried out from 12 October 2020 for Tomato brown rugose fruit virus Action Proposed by the competent authority

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The large increase in the number of pig holdings registered on the national database between 2019 and 2020, is mainly due to the work of the additional veterinary staff hired in 2019 (as described in section 5.2.3). The inspections carried out by that additional veterinary staff detected many holdings that were previously not registered. 9 Therefore, the competent authority did not have an up-to date list of all pig holdings as required by Article 3.1(a) of Council Directive 2008/71/EC or a fully operational register of holdings in a computer database as required by Article 18 of Council Directive 64/432/EEC. Some of the previously unregistered holdings became registered but according to the competent authority, many ceased to keep pigs because of investment/work required to comply with new biosecurity requirements. 14. 93% of the increase in the number of registered non-commercial holdings is confined to the four northern regions where the additional veterinary staff worked. Only 7% were added from the other nine regions, which have not yet been subjected to the same intensive level of inspections. It is probable that many unregistered pig holding have yet to be detected in the nine regions where intensive searches have yet to be carried out and therefore, the same non-compliances as stated in finding 13 continue to exist there. The map below depicts the density of pig holdings throughout Greece according to data provided by the central competent authority from the national database for holding registration and animal identification:

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

The accuracy of the national database for registered pig holdings has been improved in the last year in the four regions of northern Greece with a high-risk of incursion of ASF. This should contribute to improve the application of disease prevention and control measures in that animal population. However, the same level of intensive inspections of pig holdings has yet to be carried out in the other nine regions of the country. Therefore, it is probable that the competent authority do not have an up-to- date list of all pig holdings as required by Article 3.1(a) of Council Directive 2008/71/EC or a fully operational register of holdings in a computer database as required by Article 18 of Council Directive 64/432/EEC. This creates considerable uncertainty as to the capability of the competent authorities to trace animals accurately and rapidly in the event of an outbreak of the disease.

Medlemsstatens svar

rove the accuracy and quality of the tools for the traceability of pigs, in order for them to be effective tools for animal health controls, the Department of Infectious and Parasitic Diseases within the Animal Health Directorate of the Ministry of Rural Development and Food has taken the following measures: (1) Adoption of Circular No 2615/300464/26.10.2020, entitled `Active and passive surveillance to prevent and control African swine fever in domestic pigs and wild boar in the areas included in the Part 1 scheme' (attached), which we sent to the Veterinary Directorates of the Regions of Central Macedonia and Eastern Macedonia and Thrace, asking them to record in spreadsheets all holdings in Part 1 areas (systematic breeding holdings, backyard holdings, herd owners) and send them to the Ministry of Rural Development and Food, requiring them to submit any changes on a monthly basis (already sent). (2) Adoption of Circular No 100/16592/19.1.2021, entitled `Measures to prevent African swine fever from entering the country' (attached), requesting the veterinary services of Greece to immediately register pig holdings. Moreover, the recruitment of thirty-one (31) veterinarians as tempo

rove the accuracy and quality of the tools for the traceability of pigs, in order for them to be effective tools for animal health controls, the Department of Infectious and Parasitic Diseases within the Animal Health Directorate of the Ministry of Rural Development and Food has taken the following measures: (1) Adoption of Circular No 2615/300464/26.10.2020, entitled `Active and passive surveillance to prevent and control African swine fever in domestic pigs and wild boar in the areas included in the Part 1 scheme' (attached), which we sent to the Veterinary Directorates of the Regions of Central Macedonia and Eastern Macedonia and Thrace, asking them to record in spreadsheets all holdings in Part 1 areas (systematic breeding holdings, backyard holdings, herd owners) and send them to the Ministry of Rural Development and Food, requiring them to submit any changes on a monthly basis (already sent). (2) Adoption of Circular No 100/16592/19.1.2021, entitled `Measures to prevent African swine fever from entering the country' (attached), requesting the veterinary services of Greece to immediately register pig holdings. Moreover, the recruitment of thirty-one (31) veterinarians as tempo

: , , .... : 1) , .2615/300464/26.10.2020 : « Part 1» , , Part 1 .... . Page: 1 t ref. DG(SANTE) 2020-7096 of the audit carried out from 12 October 2020 trols in relation to African swine fever Proposed by the competent authority .100/16592/19.01.2021 : , 5/355910/ 21.12.2020 « , , ) . Page: 2 t ref. DG(SANTE) 2020-7096 of the audit carried out from 12 October 2020 trols in relation to African swine fever ion Proposed by the competent authority

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The 2020 National ASF control and eradication programme sets out that the competent authorities will carry out specific official controls regarding biosecurity rules applied during hunting to prevent the spread of ASF. However, up to the time of this audit, the competent authorities had not performed such controls. Hunters have been informed of best biosecurity practices for hunting (e.g. via point 8 in Circular No. 458, issued in February 2020) but in the absence of a clear legal basis, their implementation has not yet been checked.

A new Joint Ministerial Decision, which according to the competent authority should be issued shortly, will provide a legal basis for the application of biosecurity rules during wild boar hunting and will enable the competent authorities to start carrying out official controls and enforce those rules in hunting grounds, which has not been possible until now. That Decision also sets out a framework between the relevant competent authorities and stakeholders to apply a national plan to manage and decrease the wild boar population as recommended in Annex IV to the strategic approach for ASF.

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nsure that all measures under the 2020 national ASF control and eradication me, including biosecurity rules during hunting, are subjected to official controls in r to ensure their effective implementation, the central competent authority (Department nfectious and Parasitic Diseases within the Animal Health Directorate of the Ministry of Page: 2 received 25 June 2021 d by the competent authorities of Greece in response to Report ref. DG(SANTE) 2020-7096 of 20 in order to evaluate the implementation of animal health controls in relation to African swine posed by the competent authority lopment and Food) has taken the following measures: OMPLETED es taken by the central competent authority to ensure compliance with y rules during hunting are as follows: on of Circular No 153/22957/25.1.2021, entitled `Extension of the hunting tivation of hunting squads to address the risk of African swine fever (ASF)' , which has been sent to: terinary services of the regional units where hunting is permitted (Regional Unit Regional Unit of Rodopi and Regional Unit of Xanthi), in accordance with the sterial Decision entitled `Emergency measures for protecting public health from f further spread of COV

nsure that all measures under the 2020 national ASF control and eradication ramme, including biosecurity rules during hunting, are subjected to official controls in r to ensure their effective implementation, the central competent authority (Department nfectious and Parasitic Diseases within the Animal Health Directorate of the Ministry of l Development and Food) has taken the following measures: URES COMPLETED measures taken by the central competent authority to ensure compliance with ecurity rules during hunting are as follows: Adoption of Circular No 153/22957/25.1.2021, entitled `Extension of the hunting on, activation of hunting squads to address the risk of African swine fever (ASF)' ached), which has been sent to: the veterinary services of the regional units where hunting is permitted (Regional Unit vros, Regional Unit of Rodopi and Regional Unit of Xanthi), in accordance with the t Ministerial Decision entitled `Emergency measures for protecting public health from risk of further spread of COVID-19 throughout Greece' as in force (attached); the Forest Management Directorate of the Ministry of the Environment and Energy; and the Greek Hunting Federation. Page: 3 eived 20 Se

2020, (..., , ) : , . 153/22957/25.01.2021 , ()» ( .. , .. .. KYA « Page: 3 t ref. DG(SANTE) 2020-7096 of the audit carried out from 12 October 2020 trols in relation to African swine fever Proposed by the competent authority 19 » . 01.2021 86/B313 : « , , » t ref. DG(SANTE) 2020-7096 of the audit carried out from 12 October 2020 trols in relation to African swine fever Proposed by the competent authority 7 /2014(32) Page: 5 t ref. DG(SANTE) 2020-7096 of the audit carried out from 12 October 2020 trols in relation to African swine fever Proposed by the competent authority 1, , ID 19 KYA « D-19 » . Page: 6 t ref. DG(SANTE) 2020-7096 of the audit carried out from 12 October 2020 trols in relation to African swine fever Proposed by the competent authority 5/355910/ 21.12.2020 « , , ) , Page: 7 t ref. DG(SANTE) 2020-7096 of the audit carried out from 12 October 2020 trols in relation to African swine fever Action Proposed by the competent authority

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The restrictions for the movement of hunted wild boar carcases out of the areas included in Part I of the Annex to Decision 2014/709/EU, as set out in Article 15 of that Decision, were notified to regional veterinary staff by the central competent authority via Circular No. 3158/306795, dated 27 November 2019. This Circular was also forwarded to the Greek Hunting Confederation. However, at the time of this audit there was no legal basis to prohibit the dispatch of fresh meat of feral pigs from those areas. This is a non- compliance with Article 15 of Decision 2014/709/EU, which requires that only fresh meat from hunted wild boar that has been tested for ASF with negative results can be dispatched from the areas included in Part I of the Annex to Decision 2014/709/EU to other areas of the same Member State. According to representatives of the competent authorities, they planned to include such legal requirement in the new Joint Ministerial Decision agreed between the Ministry of Rural Development and Food and the Ministry of Environment and Energy for the management of the wild boar population (as explained in section 5.2.3 below).

This requirement was discussed with staff of the regional competent authorities responsible for the areas included in Part I of the Annex to Decision 2014/709/EU, and they confirmed that they had not yet set up any official control system to ensure compliance with the requirements of Article 15 that Decision. They added that no wild boar hunted within those areas had ever been tested and received a negative result with the intention of taking it out of that restricted zone. On 26 October 2020, the competent 11 authority issued a new Circular to remind staff of the regional competent authorities about that specific requirement laid down in Article 15 of Decision 2014/709/EU. 5.2.3 Biosecurity measures applied on pig holdings Legal requirements and standards Articles 10 to 13 of Directive 2002/60/EC; the strategic approach for ASF and the 2020 National ASF control and eradication programme. Findings

The competent authorities have not taken appropriate action in accordance with Article 15 of Decision EU 2014/709/EU to mitigate the potential animal health risks associated with the possible movement of wild boar carcases from areas included in Part I of the Annex to that Decision.

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re that only fresh meat from hunted wild boar that have been tested for ASF with egative results is dispatched from the areas listed in Part I of the Annex to Decision 014/709/EU, as required by Article 15 of that Decision, the central competent authority Department of Infectious and Parasitic Diseases within the Animal Health Directorate of Page: 6 received 25 June 2021 d by the competent authorities of Greece in response to Report ref. DG(SANTE) 2020-7096 of 20 in order to evaluate the implementation of animal health controls in relation to African swine sed by the competent authority of Rural Development and Food) has taken the following measures: of Circular No 2615/300464/26.10.2020, entitled `Active and passive to prevent and control African swine fever in domestic pigs and wild boar in cluded in the Part 1 scheme' (attached), which we sent to the Veterinary of the Regions of Central Macedonia and Eastern Macedonia and Thrace. The ers to the provisions of Implementing Decision 2014/709/EU that concern in the Part 1 areas by hunting squads and groups of wild boar hunters. these provisions, wild boar carcasses must remain refrigerated until a negative ceived before they are dis

re that only fresh meat from hunted wild boar that have been tested for ASF with Page: 7 eived 20 September 2021 d by the competent authorities of Greece in response to Report ref. DG(SANTE) 2020-7096 of 20 in order to evaluate the implementation of animal health controls in relation to African swine ction Proposed by the competent authority ve results is dispatched from the areas listed in Part I of the Annex to Decision 014/709/EU, as required by Article 15 of that Decision, the central competent authority Department of Infectious and Parasitic Diseases within the Animal Health Directorate of he Ministry of Rural Development and Food) has taken the following measures: 1) Adoption of Circular No 2615/300464/26.10.2020, entitled `Active and passive urveillance to prevent and control African swine fever in domestic pigs and wild boar in he areas included in the Part 1 scheme' (attached), which we sent to the Veterinary irectorates of the Regions of Central Macedonia and Eastern Macedonia and Thrace. The ircular refers to the provisions of Implementing Decision 2014/709/EU that concern unting within the Part 1 areas by hunting squads and groups of wild boar hunters. ccording to these

(..., , ) 2014/709/ 15 , : 1) , .2615/300464/26.10.2020 : « Part 1» 2014/709/ Page: 8 t ref. DG(SANTE) 2020-7096 of the audit carried out from 12 October 2020 trols in relation to African swine fever Proposed by the competent authority 153/22957/25.01.2021 , .. .. A « 19 » . t ref. DG(SANTE) 2020-7096 of the audit carried out from 12 October 2020 trols in relation to African swine fever Proposed by the competent authority 2 14/709/, , 01.2021 86/B313 : « , , » Page: 10 t ref. DG(SANTE) 2020-7096 of the audit carried out from 12 October 2020 trols in relation to African swine fever ction Proposed by the competent authority 2014/709/ 15 . 4 3 : « 2014/709/, , ».

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During 2020, samples from 13 wild boars notified as found dead were tested; samples from 11 had been tested in 2019. In 2020, ten of the wild boars were from two regions, i.e. Central Macedonia and East Macedonia and Thrace. In the 2020 National ASF control and eradication programme, the competent authorities had estimated that, given the size of the wild boar population in Greece, a target of 780 wild boar found dead to be sampled as part of this component of ASF surveillance would be reasonable.

In the 2020 National ASF control and eradication programme, the competent authorities have included targets for active surveillance of wild boar in the areas included in Part I of the Annex to Decision 2014/709/EU that covers partially the territory under the responsibility of five regional units with an estimated wild boar population of 50,000. At the time of the audit, 73 out of an overall target of 980 hunted wild boar had been sampled.

According to data provided by the competent authorities, between January and September 2020, they have investigated suspicions of ASF in 30 pig holdings (including sampling and testing of 35 pigs). Those suspicions occurred throughout those months but mainly until the end of June, with only three investigated since then. All investigated holdings were situated in only two regions, i.e., Central Macedonia and East Macedonia 19 and Thrace. In the 2020 National ASF control and eradication programme, the competent authorities have included an estimated national target for passive surveillance in domestic pigs of 193 pigs from 69 holdings. Active surveillance in pigs

Data provided by the competent authorities on the application of active surveillance in domestic pigs confirm that the plan mentioned above has not yet been implemented. Those data include some 1,700 samples tested by the NRL in Athens (mostly serological testing and some 100 samples tested with a polymerase chain reaction (PCR) method) and 1,118 samples tested (serology) in the laboratory in Thessaloniki. All of them were tested between the date of confirmation of the ASF outbreak and mid-April, when the restrictions were lifted (see more information in section 5.3.3). Those samples were taken in the context of testing activities required within the protection and surveillance zones established in response to the outbreak, e.g. derogated movements to a slaughterhouse from holdings located in those zones and surveillance before lifting the restrictions.

The very limited implementation of surveillance for ASF cannot provide adequate guarantees that this activity is suitable to detect rapidly an incursion of the disease in the wild boar population, notably in the high-risk areas in the north of the country. While testing of wild boar found dead has hardly contributed to that surveillance, plans for active surveillance of hunted animals included in the 2020 National ASF control and eradication programme are far from being fulfilled. Nevertheless, the competent authorities have taken additional action to incentivise and increase surveillance activities before the end of 2020 in order to address those shortcomings.

Surveillance has not been complemented with the implementation of risk-based active surveillance, e.g. regularly testing dead pigs, while the planned serological sampling included in the 2020 National ASF control and eradication programme for commercial holdings has not yet been carried out.

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URVEILLANCE OF WILD BOAR IN GREECE implementation of effective passive and active surveillance of wild boar in Greece in 2020 and 2021 so far is at odds with the measures taken and being taken in response to he COVID-19 pandemic in Greece. n particular, the hunting squads have been unable to go out to the hunting grounds since arch 2020 due to travel restrictions, and during the current hunting season, since ovember 2020, hunters have been continuously banned from going out to hunting grounds Page: 8 received 25 June 2021 d by the competent authorities of Greece in response to Report ref. DG(SANTE) 2020-7096 of 20 in order to evaluate the implementation of animal health controls in relation to African swine roposed by the competent authority ut Greece. January 2021, up to four hunters are allowed to travel, only in the Regional Units , Rodopi and Xanthi, in accordance with the Joint Ministerial Decision entitled cy measures for protecting public health from the risk of further spread of throughout Greece' as in force (attached). COMPLETED ase the effectiveness of passive and active surveillance of wild boar in Greece, the competent authority (Department of Infectious and Parasitic

RVEILLANCE OF WILD BOAR IN GREECE e implementation of effective passive and active surveillance of wild boar in Greece in 020 and 2021 so far is at odds with the measures taken and being taken in response to VID-19 pandemic in Greece. particular, the hunting squads have been unable to go out to the hunting grounds since rch 2020 due to travel restrictions, and during the current hunting season, since vember 2020, hunters have been continuously banned from going out to hunting grounds roughout Greece. nce 20 January 2021, up to four hunters are allowed to travel, only in the Regional Units Evros, Rodopi and Xanthi, in accordance with the Joint Ministerial Decision entitled mergency measures for protecting public health from the risk of further spread of VID-19 throughout Greece' as in force (attached). ASURES COMPLETED increase the effectiveness of passive and active surveillance of wild boar in Greece, the ntral competent authority (Department of Infectious and Parasitic Diseases within the imal Health Directorate of the Ministry of Rural Development and Food) has taken the llowing measures: Page: 10 eived 20 September 2021 d by the competent authorities of Greece in response to Re

: , Page: 11 t ref. DG(SANTE) 2020-7096 of the audit carried out from 12 October 2020 trols in relation to African swine fever Proposed by the competent authority 19 . 20 020 0.01.2021 .. KYA « D-19 » . , : ge: 12 t ref. DG(SANTE) 2020-7096 of the audit carried out from 12 October 2020 trols in relation to African swine fever Proposed by the competent authority 153/22957/25.01.2021 , .. .. A « 19 » . . Page: 13 t ref. DG(SANTE) 2020-7096 of the audit carried out from 12 October 2020 trols in relation to African swine fever Proposed by the competent authority 01.2021 86/B313 : « , , » 2 3 4 , Page: 14 t ref. DG(SANTE) 2020-7096 of the audit carried out from 12 October 2020 trols in relation to African swine fever Proposed by the competent authority t 1, ID 19 KYA « D-19 » 886/B313 Page: 15 t ref. DG(SANTE) 2020-7096 of the audit carried out from 12 October 2020 trols in relation to African swine fever Proposed by the competent authority 211994/31.07.2020 (31) (, 025/355910/ 020 (5731) : « , , ) 6 t ref. DG(SANTE) 2020-7096 of the audit carried out from 12 October 2020 trols in relation to African swine fever Proposed by the competent authority . 2021 , 19 , : 7 t ref. DG(SANTE) 2020

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Although some regional units met during the audit have improved their operational plans for culling pig holdings of various sizes, application of those plans is conditional on the support they should receive from municipal authorities, for instance on supplying of personnel and equipment, or on contracting external companies that could supply carbon dioxide (CO2) for gassing, or apply the depopulation themselves. Representatives of the central competent authority informed the audit team that the Ministry of Rural Development and Food has contacted the Ministry of Interior on the need for the municipalities to get ready to help the veterinary services to respond to animal disease outbreaks, in particular of ASF. However, the current contingency plans do not allow "access to facilities, equipment, personnel and all other appropriate materials necessary for the rapid and efficient eradication of the outbreak" as required by Article 21.1 of Directive 2002/60/EC.

The competent authorities have developed some operational arrangements in their preparedness system, for instance on animal depopulation and disposal of carcasses. However, they have still to address important shortcomings in order to enhance that contingency system to respond rapidly and effectively to outbreaks of ASF in commercial pig holdings and to contain its spread if the wild boar population is affected.

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ce the preparedness system with a view to responding rapidly and effectively to reaks in commercial pig holdings and to containing the spread of the disease, the Page: 17 received 25 June 2021 d by the competent authorities of Greece in response to Report ref. DG(SANTE) 2020-7096 of 20 in order to evaluate the implementation of animal health controls in relation to African swine ion Proposed by the competent authority lowing measures have been taken: Article 24(4) of the Legislative Act of 14.3.2020 in Government Gazette, Series I, No 64 tached) provides for the involvement of municipalities by allocating personnel and ns for the slaughter and sanitary burial of pigs for the control of ASF. There is also the ion of awarding a public contract to private companies if the municipalities concerned k the appropriate staff. The Region of Eastern Macedonia and Thrace is currently carrying out an international dering procedure, of a budget of 500 000, to assign the slaughter and management of d animals to a private company, in the event of measures being taken on farms on ount of an epizootic disease. ) The operational expenditure of the Regions in Greece concern: Costs associated with the

ce the preparedness system with a view to responding rapidly and effectively to reaks in commercial pig holdings and to containing the spread of the disease, the owing measures have been taken: Article 24(4) of the Legislative Act of 14.3.2020 in Government Gazette, Series I, No 64 tached) provides for the involvement of municipalities by allocating personnel and ns for the slaughter and sanitary burial of pigs for the control of ASF. There is also the ion of awarding a public contract to private companies if the municipalities concerned k the appropriate staff. The Region of Eastern Macedonia and Thrace is currently carrying out an international dering procedure, of a budget of 500 000, to assign the slaughter and management of d animals to a private company, in the event of measures being taken on farms on ount of an epizootic disease. Page: 22 eived 20 September 2021 d by the competent authorities of Greece in response to Report ref. DG(SANTE) 2020-7096 of 20 in order to evaluate the implementation of animal health controls in relation to African swine ity Regions in Greece concern: slaughter of animals: rary personnel specifically employed for this d, consumables and specific e

: (64/14.03.2020), 4 Page: 23 t ref. DG(SANTE) 2020-7096 of the audit carried out from 12 October 2020 trols in relation to African swine fever Proposed by the competent authority : 4 t ref. DG(SANTE) 2020-7096 of the audit carried out from 12 October 2020 trols in relation to African swine fever Proposed by the competent authority : / , , 5 t ref. DG(SANTE) 2020-7096 of the audit carried out from 12 October 2020 trols in relation to African swine fever Proposed by the competent authority . , « , , , Page: 26 t ref. DG(SANTE) 2020-7096 of the audit carried out from 12 October 2020 trols in relation to African swine fever ction Proposed by the competent authority

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However, the above evaluation did not make any recommendations or corrective actions as required by Article 12.3(a) of Regulation (EU) 2017/625 on the fact that the specific frequency of "weekly" clinical inspections specified in the Circular detailing the duties of the additional veterinary staff had not been respected, nor that all regions and regional units should use the same checklist and reporting format to inspect the holdings and report their results (see section 5.2.3).

The central competent authority has not verified, as required by Article 12.2 of Regulation (EU) 2017/625, the implementation of Circular (ref.: 458/50853, dated 13.02.2020) laying down instructions for all regions and regional units in Greece, including the nine regions which did not receive additional veterinary staff, to develop a system of surveillance of pig holdings by means of field visits with a specific frequency.

The competent authority has incomplete procedures in place to verify the effectiveness of certain ASF-related official controls and to ensure that corrective measures are taken when necessary as required by Article 12.2 and 12.3(a) of Regulation (EU) 2017/625.

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fy whether the veterinary measures taken with regard to inspections of pig holdings relation to animal identification and traceability requirements and in relation to osecurity measures have been implemented effectively (that frequencies of inspections e complied with and that appropriate inspection tools and report formats are used in a iform manner), the central competent authority (Department of Infectious and Parasitic seases within the Animal Health Directorate of the Ministry of Rural Development and Page: 20 received 25 June 2021 d by the competent authorities of Greece in response to Report ref. DG(SANTE) 2020-7096 of 20 in order to evaluate the implementation of animal health controls in relation to African swine tion Proposed by the competent authority od) has taken the following measures: ASURES COMPLETED ) Adoption of Circular No 2615/300464/26.10.2020, entitled `Active and passive rveillance to prevent and control African swine fever in domestic pigs and wild boar in e areas included in the Part 1 scheme' (attached), which we sent to the Veterinary rectorates of the Regions of Central Macedonia and Eastern Macedonia and Thrace, king them to record in spreadsheets infor

fy whether the veterinary measures taken with regard to inspections of pig holdings relation to animal identification and traceability requirements and in relation to osecurity measures have been implemented effectively (that frequencies of inspections e complied with and that appropriate inspection tools and report formats are used in a iform manner), the central competent authority (Department of Infectious and Parasitic seases within the Animal Health Directorate of the Ministry of Rural Development and od) has taken the following measures: ASURES COMPLETED ) Adoption of Circular No 2615/300464/26.10.2020, entitled `Active and passive rveillance to prevent and control African swine fever in domestic pigs and wild boar in e areas included in the Part 1 scheme' (attached), which we sent to the Veterinary rectorates of the Regions of Central Macedonia and Eastern Macedonia and Thrace, king them to record in spreadsheets information about the constitution of the herd, dates to the register, the marking of pigs and the application of biosecurity measures to l farms in Part 1 areas, and to send them to the Ministry of Rural Development and Food lready sent). ) Adoption of Circular No

: ( ) (..., , ) . ) , .2615/300464/26.10.2020 « Part 1» Page: 27 t ref. DG(SANTE) 2020-7096 of the audit carried out from 12 October 2020 trols in relation to African swine fever Proposed by the competent authority , ...., .100/16592/19.01.2021 , art 1 8 t ref. DG(SANTE) 2020-7096 of the audit carried out from 12 October 2020 trols in relation to African swine fever Proposed by the competent authority » , 9 t ref. DG(SANTE) 2020-7096 of the audit carried out from 12 October 2020 trols in relation to African swine fever Proposed by the competent authority Page: 30 t ref. DG(SANTE) 2020-7096 of the audit carried out from 12 October 2020 trols in relation to African swine fever Proposed by the competent authority (31) 5910/ 21.12.2020 (5731) : « , , 021» 1

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The audit team noted that all salmonella positive results in laying and breeding hen flocks that it analysed (all from official sampling) in which the FBO had placed a 5 written objection with a request for confirmatory sampling that confirmatory sampling was never denied. This is not in line with the EU requirement (in, respectively, Point 4, Part D, Annex II to Regulation (EC) 2160/2003 and Point 2.2.2.2 (c), Annex to Regulation (EU) 200/2010) for confirmatory sampling to be done only in exceptional cases (namely when suspecting false positives), and that requirement is transposed into national legislation as well as into the manuals.

The table below shows CA data, concerning confirmatory sampling and respective results at national level, confirming what the audit team noted in the two regions visited. Positive routine Confirmatory sampling sample Requested Accepted Positive result 3 2019 7 2 2 1 2018 6 2017 3 3 3 2016 10 4 4 1 7 7 5 FBOs are required to provide supporting documentation justifying their request for confirmatory sampling and this was available in all cases analysed by the audit team. The CA informed the audit team that in several cases the FBO had not placed an objection because they had been dissuaded verbally from doing so and therefore these cases are not documented nor reflected in the table above. Nevertheless the reasons quoted always included, amongst others, that FBO sampling had negative results and the holdings had good biosecurity. However: FBO sampling in Greece has an extremely low rate of positive test results compared to official sampling and the CA is aware of this (see also findings 83 and 85); and In one case analysed the veterinary services accepted a request for confirmatory sampling for a laying hen flock in one house of a holding even though: o that same holding had another positive official sample in another house three weeks earlier; and o the FBO had also requested confirmatory sampling for that earlier house which had been accepted; and o the result of the confirmatory sampling in that earlier house had been positive again, and was received one week before the second house was found to also be positive for the same serotype.

The current practice of performing confirmatory sampling when the FBO requests it for breeding and laying hen flocks without good reason to suspect false positives is not in line with the requirement for it to be done only in exceptional cases such as those. This can have negative impacts when Salmonella is present but not detected with the confirmatory test, resulting in a continued contamination and mistakenly reporting lower Salmonella prevalence. Those negative impacts are only partially reduced by the lower number of tests, in the last two years, which were initially positive but became negative after confirmatory testing.

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It is common for the transits between BIPs Evzoni and Peplos and vice versa that the exits take place after working hours when there are no BIP officials available. In this case, the exits controls are done by the Customs officials. This finding was also mentioned in point 24 of the audit report DG(SANTE)2015-7437. This results in a situation where the exit of most consignments transiting between the BIPs Evzoni and Peplos and vice versa cannot be declared in TRACES as, in line with Article 11 (2)(e) of Council Directive 97/78/EEC, only BIP officials are allowed to do this. The audit team verified files of several consignments of animal origin which entered or exited the EU through the BIPs Evzoni and Peplos and could verify on-the-spot the proof that in such cases the consignments had exited (evidence was available from the Customs). However, this practice is not in line with Article 11(2)(e) of Directive 97/78/EC and Article 3 of Commission Decision 2000/208/EC which require verification of seals on the consignment. Moreover, the delegation of the task of the BIP officials as described in the aforementioned articles, i.e. documentary and identity checks, is not based on a written agreement between the Customs and the Directorate General of Veterinary Services of the MRDF.

Evidence was available that TRACES was in general used in line with Article 3 of Commission Decision 2004/292/EC and without undue delay by BIP officials with the exception of the two road BIPs visited, where the exit of transit consignments leaving the EU outside the working hours are not confirmed by BIP staff in TRACES. However Customs confirmation of the exit was available (see finding 26).

Exit controls by BIP officials regarding transit consignments leaving the EU through the road BIPs Evzoni and Peplos are carried out outside normal working hours by BIP officials. Whilst this is not in line with EU requirements, Customs confirmation of exits was available. 5.3 PROCEDURES IN PLACE TO VERIFY THAT OFFICIAL CONTROLS ON IMPORTS OF ANIMALS AND GOODS ARE EFFECTIVE AND APPROPRIATE

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t consignments exiting the EU are The checks regarding the confirmation of exit of the consignments cials in accordance with Article 3 in transit are in compliance with the EU requirements and in hat in the CVED the exit is accordance with article 11.2.e) of Directive 97/78/EC. There is of Council Directive 97/78/EC. confirmation of all consignments of veterinary interest in exit with the relevant declaration on the CVED. In the cases where the confirmation of the exit is made by a customs official, the BIP confirms the exit requesting the MRN document from the Customs authorities. In any case, the BIPs involved in the transit procedure (i.e. the BIP of Evzoni and Peplos) keep both a hard and an electronic copy of all the consignments in transit, where the exit is confirmed for every single consignment. This has been displayed during the visit. Furthermore, when the exit of a consignment in transit is done by Customs, the checks cannot be registered on the CVED in the TRACES system. This has been laid down very clearly in points 5.1. and 5.5 of the mission report DG(SANCO)/2008-8206-MR and has recently been confirmed by COM's officials in the BTSF for Border Inspection Posts that t

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The facilities for animals (categories U and E), however, have serious shortcomings, which might impair the health status of the animals placed into the facilities. The installations do not comply with the requirements of Annex A to Directive 91/496/EEC. The facilities are not pest-proof (evidence of bird and wasps nests), floors are worn-out, and floors and walls are not easy to clean and disinfect. Some of the drinking facilities are rusty and not well-maintained. Conclusions on suitability of facilities

The BIP and DPE facilities visited were fit for purpose except the facilities for import controls of registered equidae and ungulates at the road BIP Evzoni which were unsuitable for these species and the facilities for import of goods of animal and non- animal origin at the road BIPs Evzoni, Peplos and the DPE Kipi Evrou. The facilities of BIP Peplos and DPE Kipi Evrou are located on the wrong side of the road i.e. in the direction of Turkey, causing logistical problems and potentially hampering the implementation of official controls. 13

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controls of animals for the Taking into consideration the difficulties of maintaining the at the border inspection post facilities of the BIP of Evzoni, our service has submitted to the d down in Article 6 and hierarchy a request of amending the approval for certain categories of the BIP. Depending on the decision of our hierarchy, we will come back to you the following weeks with, either the request for amendment, or the action plan for the rectification of the non conformities.

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Regarding the layout and location of the BIP facilities, the shortcoming identified during the previous audits (ref. DG/(SANTE)2016-8867 and DG/(SANTE)2015-7439) remains. The BIP facilities are located on the wrong side of the road i.e. in the direction of Turkey, causing logistical problems.

The MRDF has requested a technical study to identify possible solutions to improve the situation. However, no short-term solutions are in sight. 5.4.2 BIP Evzoni

The facilities for products of animal origin for human consumption are adequate except for the broken cooling equipment of the freezer storage room for products destined for human consumption, which is not in line with Article 4 of Decision 2001/812/EC. During the audit the competent authorities took action to secure the budget to repair the freezing equipment.

The ambient storage facilities for products of animal origin destined for non-human consumption are not in line with the requirement laid down in Article 4 and the Annex to Decision 2001/812/EC as pests such as birds and insects had access to the facilities and there was no adequate artificial lighting.

The BIP and DPE facilities visited were fit for purpose except the facilities for import controls of registered equidae and ungulates at the road BIP Evzoni which were unsuitable for these species and the facilities for import of goods of animal and non- animal origin at the road BIPs Evzoni, Peplos and the DPE Kipi Evrou. The facilities of BIP Peplos and DPE Kipi Evrou are located on the wrong side of the road i.e. in the direction of Turkey, causing logistical problems and potentially hampering the implementation of official controls. 13

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controls of products of animal BIP of Evzoni: t the minimum requirements regarding points 69 and 70, the works for the repair of the broken ision 2001/812/EC. cooling equipment of the freezer storage room for HC products and the rectifications of the non conformities noted in the NHC area have already started and will be finalised until the 30th of July 2019. Please find attached the document with ref number 155/8- 07-2019 of the BIP of Evzoni. BIP of Peplos: In regard of point 66, it has been noted that the BIP facilities are located on the wrong side of the road but neither in previous missions, nor in this one there was evidence to support that veterinary checks are compromised. On the contrary, and despite the BIP location that might cause logistical problems, the official controls are carried out in the most efficient and effective way. As the facilities are in compliance with the requirements of COM Decision 2001/812 and the location of the BIP does not have any impact on the effectiveness of the official controls, we request this recommendation is deleted. Page: 2 ece to the recommendations of report ref. DG(SANTE)/2019-6639-MR of the audit carried out from 04 March he syste

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The facilities for controls of goods of animal origin destined for non-human consumption are shared with the DPE Kipi Evrou for controls of goods of non-animal origin. Consequently, the same shortcoming regarding the lay-out and location of the BIP applies to the DPE facilities.

The MRDF has requested a technical study to identify possible solutions to improve the situation. However, no short-term solutions are in sight. 5.4.2 BIP Evzoni

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) of Regulation (EC) No 882/2004 DPE KIPI EVROU: In regard of point 67, point 68 and point 73, propriate conditions and at a the facilities of DPE Kipi Evrou are located on the wrong side of facilities allowing investigations the road i.e. in the direction of Turkey. Despite the logistical u. problems that arise from the location of the DPE, the official 3 controls are carried out in accordance with the requirements of the European legislation. The facilities meet the requirements described in the Art 16(3) of Reg 882/2004 since "the physical checks are carried out under appropriate conditions and at a place with access to appropriate control facilities allowing investigations to be conducted properly, a number of samples adapted to the risk management to be taken, and the feed and food to be handled hygienically". The wrong location of DPE does not have any impact on the official controls carried out at the DPE. Consequently, we consider that the recommendation should be deleted. Page: 3

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There is a system of official controls in place supported by procedures and applied as required by performing inspections and sampling. Adequate enforcement measures are in place and used when required. RASFF and AAC notifications are followed up satisfactorily. The approach followed by the inspectors regarding purity criteria does not correlate completely to what is prescribed in the relevant guide which might lead to misinterpretation as to what is required to be checked during official controls.

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Greece has national legislation for the verification of the effectiveness of official controls. The DFP plans an annual verification programme in the feed sector. Verification can be done either on-the-spot (in case of higher risk) or by documentary check (in case of lower risk); 8 DREVS each year are covered by this verification plan. Since 2016, 21 DREVS have been checked. Common weaknesses/deficiencies identified to date have been: lack of resources in certain DREVS and absence of assessment of FeBOs' HACCP-plans. The audit team noted that no follow-up of the recommendations made in the reports of these verification inspections or documentary assessments have been carried out as yet. 5.1.2 Registration/approval of feed business operators

All of the FeBOs visited had implemented a HACCP-based system. Detailed assessment criteria for certain aspects of HACCP-based procedures are described in the feed manual. In most cases inspectors met could demonstrate sufficient assessment of the adequacy of the HACCP-based procedures. However in two cases inspectors stated that they had never carried out assessment of FeBO`s HACCP so far and they could not demonstrate sufficient knowledge to do during the visit of the audit team. Also the absence of assessment of FeBOs' HACCP plans was identified as a common deficiency in the internal audits of the DREVS carried out by the central competent authority and the audit team noted that these had not been followed-up (see finding 6).

Inspections on hygiene and traceability at FeBOs are generally carried out as required and adequately verify operators' fulfilment of relevant legislative requirements. Nevertheless, the effectiveness of controls is weakened by the absence of assessment of FeBOs' HACCP plans which had been identified by the central competent authority and by overlooking the requirement for FeBOs to take and appropriately store retained samples.

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The National Control Plan (NCP) for Feed of 2019 has already een issued (ref. n. 150/11033/18-01-2019). In order to emphasise the control on HACCP systems it is made clear that it is one of the priorities for the feed inspectors to evaluate the hazard analysis of the FeBO (section A2, par. 3, section B1, par. 3, section B2 par. 3 of the NCP). Moreover DFP has already organised a series of training sessions addressed to feed inspectors both from DREVS and from the Decentralised Departments ("new" feed inspectors) of the Ministry of Rural Development and Food. The training includes practical part (sampling) which is addressed to the "new" feed inspectors and also theoretical part which is addressed to all feed inspectors. On the 31st of January and on the 1st of February 2019 (invitation 1 & 2, participants list 1 & 2) two theoretical training sessions were held and covered hazard analysis issues. (presentation 2, page 7 & 18). The practical and theoretical sessions will continue for the rest parts of Greece and they will be completed by the end of the first semester of 2019.

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The feed manual contains instructions and checklists as regards controls on retained samples (i.e. those to be taken and kept by FeBOs from ingredients and final products manufactured). The audit team randomly checked some of these samples, and in the majority of the cases these had been appropriately taken, labelled and kept under control in dedicated storage places. However, in several cases retained samples of ingredients and/or final products were not available, and, if taken, had not been sealed properly. 6 This is neither in line with the requirements of the feed manual nor the requirements of point 4 of Annex II "QUALITY CONTROL" to Regulation (EC) No 183/2005. Previous inspection reports in the establishments visited did not mention this non-compliance. 5.2.1.4 Labelling

Inspections on hygiene and traceability at FeBOs are generally carried out as required and adequately verify operators' fulfilment of relevant legislative requirements. Nevertheless, the effectiveness of controls is weakened by the absence of assessment of FeBOs' HACCP plans which had been identified by the central competent authority and by overlooking the requirement for FeBOs to take and appropriately store retained samples.

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s According to the National Control Plan (NCP) for Feed of 2019, it is made clear that it is one of the priorities for the feed inspectors to check that FeBOs meet the obligation of retaining samples (section B1, par. 2 of the NCP). Moreover, during the training sessions mentioned in the Recommendation 1, the verification of the obligation concerning the retaining samples was pointed out to the feed inspectors (presentation 2, page 9).

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The audit team noted that in the FeBOs visited, labels had been checked during previous inspections with no non-compliances having been identified. At the time of the audit, the audit team identified numerous and significant shortcomings in labelling in the majority of the establishments visited. Examples of non-compliances included: Complete and complementary feed was labelled as compound feed which is not in line with the requirements of Article 15(a) of Regulation (EC) No 767/2009. The instructions for proper use indicating the purpose for which the feed was intended were missing on some of the labels seen. This is not in line with the requirements of Article 17(1)(b) and point 4 of Annex II to Regulation (EC) No 767/2009. The identification numbers of feed additives were missing on the labels of feed additives and/or premixtures, which is a legal requirement of Article 16(1)(f) of Regulation (EC) No 1831/2003. The use of certain premixtures containing vitamin A in accordance with the labelled instruction would lead to the established maximum levels of vitamin A in complete feed being exceeded, which is contrary to the requirements laid down in Commission Implementing Regulation (EU) No 2015/724. The exceedance of the maximum permitted levels for vitamin A can adversely affect public health (Question No EFSA-Q-2006-121). Vitamin A content in different types of complete feed exceeded the maximum limit established by Commission Implementing Regulation (EU) No 2015/724.

Generally, the feed inspectors met were aware of the guidance on labelling controls (see finding 14) but, in several cases, despite the training they received (see finding 4) 7 inspectors were not able to follow it and thus could not adequately assess the correctness of the labelling. Conclusion on the planning and implementation of inspections

The effectiveness of official controls on labelling is seriously undermined by feed inspectors' lack of knowledge of the legislative requirements for labelling. Inadequate controls on the additives with established maximum permitted levels raises concerns on the possible impact on public health. 5.2.2 Sampling 5.2.2.1 Planning of official sampling

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s According to the NCP for Feed of 2019, it is made clear that it is of one the priorities for the feed inspectors to check the labelling of Page: 1 port ref. DG(SANTE)/2018-6318-MR of the audit carried out from 24 October tives, their ingredients and traceability tion Proposed by the competent authority e products (section A2-par. 5, section B1-par. 5, section B2-par of the NCP). e training sessions mentioned in Recommendation 1 included a ecial section dedicated to labelling issues (presentation 3).

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The audit team noted that in the FeBOs visited, labels had been checked during previous inspections with no non-compliances having been identified. At the time of the audit, the audit team identified numerous and significant shortcomings in labelling in the majority of the establishments visited. Examples of non-compliances included: Complete and complementary feed was labelled as compound feed which is not in line with the requirements of Article 15(a) of Regulation (EC) No 767/2009. The instructions for proper use indicating the purpose for which the feed was intended were missing on some of the labels seen. This is not in line with the requirements of Article 17(1)(b) and point 4 of Annex II to Regulation (EC) No 767/2009. The identification numbers of feed additives were missing on the labels of feed additives and/or premixtures, which is a legal requirement of Article 16(1)(f) of Regulation (EC) No 1831/2003. The use of certain premixtures containing vitamin A in accordance with the labelled instruction would lead to the established maximum levels of vitamin A in complete feed being exceeded, which is contrary to the requirements laid down in Commission Implementing Regulation (EU) No 2015/724. The exceedance of the maximum permitted levels for vitamin A can adversely affect public health (Question No EFSA-Q-2006-121). Vitamin A content in different types of complete feed exceeded the maximum limit established by Commission Implementing Regulation (EU) No 2015/724.

The effectiveness of official controls on labelling is seriously undermined by feed inspectors' lack of knowledge of the legislative requirements for labelling. Inadequate controls on the additives with established maximum permitted levels raises concerns on the possible impact on public health. 5.2.2 Sampling 5.2.2.1 Planning of official sampling

The audit team noted that the official sampling plan is not designed to check that levels of feed additives with established maximum/minimum limits in compound feed (e.g., vitamin A and D) are respected by producers. In several cases, the audit team identified 8 that the labelled content of vitamin A in different types of feed exceeded the maximum established limit (see finding 27).

Planning of official sampling is risk-based and includes all relevant groups of undesirable substances. Incorrect implementation of some of the legislative provisions on sampling, incomplete sampling records and the omission of testing to verify that maximum limits for certain vitamins are not exceeded weaken the effectiveness of the official sampling programme. 5.2.3 Actions taken on non-compliances

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ess Especially for coccidiostats, the NCP for Feed of 2019 distincts ntrols for checking the maximum permitted levels from controls elated to tolerance limits according to Directive 2002/32. dditionally for the first time, the National Annual Control ogramme for Feed includes controls for checking the limits for tamins A and D (Table 1 of the NCP). phasis has been given to the link of feed additives registry and e uploading of the decisions of approval of the most common d important feed additives in the special webpage of the nistry for feed. reover the training sessions (see Recommendation 1) included ntrols related to maximum permitted levels of feed additives, cluding controls related to labelling of feed additives.

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Generally, the feed inspectors met had a good knowledge of official sampling requirements laid down by Regulation (EC) No 152/2009, with the exception of the concept of 'sampled portion'. The audit team identified sampling reports where the number of incremental samples had been calculated based on the total size of the batch while only a fraction of the batch had been sampled. The size of the sampled portion had not been recorded. The DFP stated this shall be mentioned in the comment part of the sampling protocol template. Not recording the of the size of the sampled portion is not in line with the requirements of points 5 and 10 of Annex 1 to Regulation (EC) No 152/2009. Conclusion on the planning and implementation of sampling

Planning of official sampling is risk-based and includes all relevant groups of undesirable substances. Incorrect implementation of some of the legislative provisions on sampling, incomplete sampling records and the omission of testing to verify that maximum limits for certain vitamins are not exceeded weaken the effectiveness of the official sampling programme. 5.2.3 Actions taken on non-compliances

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ring the last two months of 2018, "new" inspectors from rtain regions of Greece were trained for taking samples. This s a practical session that took place at the premises of feed siness operators. rthermore the training sessions held on the begging of 2019 (see commendation 1), included theoretical guidance about several tters related to sampling, as sample portion, number of cremental samples etc (presentation 1, p. 18). This guidance is so included in the NCP for 2019. Page: 2

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The Commission audit report DG(SANTE)/2015-7508 MR Final states several deficiencies related to the contingency plan, e.g. it does not contain: all relevant provisions to ensure the legal powers necessary for its implementation, detailed information on staff involved in control measures, their skills and their responsibilities, a register of staff that may be called upon nor a clear procedure for emergency staffing to deal with an animal disease crisis. These deficiencies have not yet been addressed.

The contingency plan is outdated and thus it does not reflect the current structure and competences of both central and local veterinary services. This precludes better identification of rules and responsibilities of all services in delivery of the on-the-spot operations. As stated in the 2015 Commission report, it also resulted in the absence of 8 involvement of most major stakeholders during epidemic situation.

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The map below shows the vaccination status at the time of the audit: 10 Vaccination Campaign Regional Units Bovine Population 3rd completed or in progress 17% 33 % 2nd completed or in progress 33% 44% 1st completed 22% 5% 1st initial vaccination campaign 28% 18% in progress Some areas are completing the third vaccination campaigns whereas others have not been vaccinated even once. The first vaccination round is still in progress in the majority of the Greek islands and in some Regional Units in the southern part of the mainland. Those areas have very low vaccination coverage (animal and farm-level) and are below a value sufficient for protection of animals/herds (at least 95% of herds representing at least 80% of cattle population protected). They represent 28 % of Regional Units with 18% of the bovine population. Therefore, the current vaccination coverage is not in line with point 1 (a) of Annex II to Decision (EU) 2016/2008, which requires vaccination of all bovine animals within the vaccination area. Most of the unvaccinated farms in the mainland are free grazing beef herds living in the mountains which are difficult to be gathered for vaccination. The central authority stated that there is a lack of farmers' cooperation as regards vaccination of their herds in those regions. 11

The vaccination coverage varies amongst the regions, with good level of protection in northern and central parts of the country. The herd and in-herd values of the vaccination coverage in the southern part of mainland and the majority of the islands is very low, 14 therefore representing a risk of the rapid spread of LSD when entering those regions.

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In one Regional Unit visited, the audit team noted that there were some discrepancies between the number of cattle in the central bovine database and the number of animals present on a holding during vaccination. The central bovine database contained many animals born before 2000; these animals represented up to 10 % of all registered animals over 6 months in this Regional Unit. Those animals were not vaccinated. The Regional Unit staff considered these animals as "dead". The true vaccination coverage of individual animals in the Regional Unit is estimated by the authorities as 10 % higher than the one based on data in the vaccination database. 12 The authority stated that these "dead" bovines have not been effectively cleaned up from the central bovine database in recent years. The official controls related to compliance with identification and registration rules were not carried out in the Regional Units visited contrary to the EU requirements and the vaccination campaign did not result in improvement of quality of data in the central bovine database for one Regional Unit visited4. Therefore, the requirements of Article 14.C(3) of Directive 64/432/EEC ("The database must be able to supply the following particulars at any time: - a list of all changes of holding for each animal of the bovine species...") were not provided.

The vaccination campaign effectively contributed to stopping the epizootic in 2017. The controls over vaccine distribution and implementation were good. In particular, the vaccination database is an effective tool for monitoring vaccination progress, and it allows the competent authority to assess and thoroughly analyse the situation and to act when needed. The true vaccination coverage is distorted due to the presence of non- vaccinated bovines ­ which in practice might be dead- in the central bovine database.

The pastures are not individually registered in the central bovine database under unique registration number. Instead, only the name of village/municipalities where the pasture is located is entered at the time of each movement. This is not fully in line with the requirements specified in Article 14 C(3) of Directive 64/432/EEC, as regards information required to be provided in a computer database. The competent authority informed on actions taken to address this deficiency with a proposed deadline of June 2018 when all pastures will be duly identified and registered in the central bovine database.

As stated in Commission report DG(SANTE)/2015-7508 MR Final, the central authority did not have full information on the activities on dealers' premises. The central authority informed that dealers are registered in the central bovine database. The cattle database does not allow the identification of registered dealers unless they are specifically flagged (tick box used for two options; one for dealer type A, second for dealer type B); at the time of the audit only three dealers have been flagged. When reviewing available investigation reports, the audit team noted that there were several animal traders operating in affected areas. From the records available, it was not clear if those dealers had premises (according to the national legislation type A dealers) or not (type B dealers). There was no evidence that those traders (at least type A) were registered in the central bovine database. In the reports they were identified only by their names but not by 5 In their response to the draft report, the CA stated that the central competent authority is constantly stressing the need to correctly fill in the health certificates and follow the correct procedures for moving the animals. Responsibility for this lies with the local veterinary authorities. According to our latest information, the situation has significantly improved in this particular Regional Unit which displayed the discrepancies mentioned in this finding. 18 registration number, therefore making any further bovine tracing in the central bovine database very cumbersome.

The central competent authority indicated its intention to update the existing list of approved dealers (both type A-with establishments-and type B-without establishments), in line with Presidential Decree 308/2000, in order to ensure full control over their activities. Ministerial Decision detailing the approval process is in draft stage. Once the Ministerial Decision is in place, the central authority plans to set a deadline for 30 June 2018 by which all dealers need to register online. Until then the information specified in Article 14 C(3) of Directive 64/432/EEC is not provided in a computer database. This practice is also not in line with the objectives of Regulation (EC) No 1760/2000 as regards notification and registration of all movements to ensure full traceability of bovine animals.

The fact that movement restrictions are largely implemented in line with EU requirements gives certain guarantees that the disease will not spread due to movent of animal. However, there controls over unregistered movements through possible "intermediate points" (e.g. dealer premises) are still insufficient to give adequate assurance that the infection will not spread by these. The competent authorities addressed the lack of verification of vaccination status, incomplete health certificates and the limited authority access to information in the central bovine database.

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There is a requirement to notify the movement of cattle to common pastures (for seasonal/summer grazing) to the central bovine database. Those movements are registered by the Veterinary Department staff responsible for the holding of origin, but these movement records were not accessible to other Veterinary Departments. If a pasture was located in the other Regional Unit, the Veterinary Department staff of this Regional Unit did not have access to this movement record in the central bovine database. This is not in line with Article 3 of Regulation (EC) 1760/2000 as regards access of the competent authority to all the information in animal identification and registration system. The central authority stated that this deficiency would be corrected as soon as possible with a maximum two months deadline.

The fact that movement restrictions are largely implemented in line with EU requirements gives certain guarantees that the disease will not spread due to movent of animal. However, there controls over unregistered movements through possible "intermediate points" (e.g. dealer premises) are still insufficient to give adequate assurance that the infection will not spread by these. The competent authorities addressed the lack of verification of vaccination status, incomplete health certificates and the limited authority access to information in the central bovine database.

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The internal audit system of the DACA was not fully operational at the time of the DG SANTE audit and, so far, had only carried four pilot audits (two in relation to Regulation (EC) No 882/2004) in 2017.

According to the MRDF the internal audit system for PPP is planned to be operational by the end of 2019. The fact that the audit arrangements had not yet been put in place did not allow the DG SANTE audit team to evaluate the audit arrangements. Conclusions

Responsibility for auditing of official controls has been clearly allocated, but so far only 7 EFET has put internal audit arrangements in place and carries out audits. Audit systems of MRDF are at an early stage of development and, therefore, cannot provide assurance that official controls are carried out as intended and that instructions or guidelines given to staff carrying out the controls are followed.

DACA stated that the travel budget for 2018 was 1400 Euro and the budget allocated for the first three months of 2018 had to be completely spent before the additional funding is made available. The Director of DACA stated that this amount did only allow performance of even one full audit per year per department and that the administrative rules put additional burdens on the audit body regarding the planning and performance of audits. For example, for the animal by-product pilot audit of 2017 the RU of Attica was selected as the budget available to the audit service was not sufficient in order to visit the RU initially planned for. DACA stated that also the number of staff was not sufficient in order to perform its tasks independently.

DACA carries out specific investigations. According to the Director of DACA the State Secretary may ask at any time to carry out any kind of investigation or controls and that the workload (which cannot be planned) may affect the implementation of the audit programme. The DG SANTE audit team noted that no specific arrangements are in place to ensure that no potential conflict of interests may arise from additional tasks given to the audit service.

In the absence of a clearly defined audit universe and methodology for the identification of risk-based audit priorities (see section 5.2.4), DACA based its multi-annual audit programme solely on suggestions from the relevant Directorates of the MRDF which are involved in controls (issuance of circulars and supervision of controls) and may be subject to internal audits by DACA.

The independence of DACA is compromised by several factors including a limited travel budget which is not adequate to ensure that the audit service can perform audits in all Regions of Greece based on risk-based planning. Furthermore, the independence of the audit service is undermined by a lack of arrangements for the avoidance of conflicts of interest which may arise from special investigations/controls and a planning process which solely relies on contributions from the relevant Directorates of MRDF.

MRDF has no arrangements for the independent scrutiny in place, but DACA stated that it also considers organising the independent scrutiny in the form of a peer-review with another MS. Conclusions

MRDF has no taken steps to ensure that independent scrutiny is systematically carried out. 5.2.3 Auditor competence 5.2.3.1 Legal requirements Articles 2(6) and 4(6) of Regulation (EC) No 882/2004 do not lay down specific requirements regarding the competence of auditors. Article 6 of the same Regulation requires that staff performing official controls "receive, for their area of competence, appropriate training enabling them to undertake their duties competently" and "keep up-to-date in their area of competence and receive regular additional training as necessary" Section 6.6 of the Annex of Commission Decision 2006/677 provides guidance on auditor competence: "Auditor competence and selection criteria should be defined under the following headings: -- generic knowledge and skills -- audit principles, procedures and techniques; management/organisational skills, -- specific technical knowledge and skills, -- personal attributes, -- education, -- work experience, -- auditor training and experience. 11 It is essential to put a mechanism in place to ensure auditors are consistent and their competencies are maintained. Competencies required by audit teams will vary depending on the area they are auditing within the control or supervision systems. As regards the technical knowledge and skills required by auditors, the training requirements for staff performing official controls (Chapter 1 of Annex II to Regulation (EC) No 882/2004) should also be considered." 5.2.3.2 Findings

No arrangements are in place to identify training needs of DACA staff, although its auditors have to cover a wide range of control activities. However, experts from the territorial Units can be used and for the animal by-products and hygiene of animal feed audits such experts had been used. Conclusions

DACA auditors have an appropriate professional background and work experience but have not received specific training on auditing.

DACA stated that the audit universe is defined in the MANCP with regards to the MRDF responsibilities. Apart from this, there were no other documents or arrangements for defining the relevant audit areas and audit coverage. The objective of DACA is that each of its departments carries out one audit per year, which cannot achieve to cover the main areas set out in the MANCP within a 5-year period.

DACA established at the end of 2016 a 4-year multi-annual internal audit programme for the period 2017-2020 based on contributions from the relevant Directorates of MRDF. The Directorates were asked by DACA to take risk criteria into consideration for audit areas proposals and to identify territorial Units to be visited during the audits. DACA stated that the programme will have to be revised as the Directorate of Agriculture was late in delivering suggestions for audit topics and that this was the reason why the programme did not specify audit areas for the DACA Department of Agriculture.

DACA's planning process is not defined in terms of risk-based criteria, coverage of audit areas and geographical coverage. The 2017-2020 programme can achieve neither an adequate territorial coverage nor can it cover the areas of official controls for which MRDF is responsible.

DACA has issued some notes to files with some basic guidance regarding the implementation of the audit process, but has not issued sufficiently clear and comprehensive procedures including guidelines and supporting documents, to ensure that audits are consistent between auditors and follow a systematic approach. DACA stated that a Joint Ministerial Decision, which was at draft stage at the time of the DG SANTE audit, needs to be adopted in order to provide a procedural framework for the audit system based on which more detailed instructions and guidance can be issued. 5.2.5.2.2 Compliance with planned arrangements

Regarding DACA only two of the four 2017 pilot audit reports were relevant to this DG SANTE audit. However, the audit reports and the statements made by the auditees met, indicate that the auditors evaluate compliance with planned arrangements. However, the audit team noted that not all statements of the audit report were supported by evidence. 5.2.5.2.3 Verification of the effective implementation of planned arrangements and their suitability to achieve objectives

Neither audit service could demonstrate that they had arrangements in place to systematically cover verification of the effective implementation of planned arrangements and their suitability in their internal audits.

DACA does not yet have arrangements for the review of the audit process in place. Conclusions

MRDF is in an early stage of the development of the audit systems and did not yet have sufficient arrangements in place in terms of procedures, documentation and the review of audit conclusions and audit process. 5.2.6 Follow-up of audit recommendations 5.2.6.1 Legal requirements Article 4(6) of Regulation (EC) No 882/2004 requires, inter alia, that "Competent authorities shall carry out internal audits or may have external audits carried out, and shall take appropriate measures in the light of their results". In section 5.3 of the Annex of Decision 2006/677/EC further guidance is provided to Member States on `Independence', in relation to follow-up of audit recommendations: "Where the audit team makes recommendations for corrective and preventive action, the auditee should choose the methods to be applied for such action. Active audit team involvement in follow-up should be limited to assessing the suitability of the action plan and the effectiveness of the corrective and preventive action." Section 6.3 of the Annex of Commission Decision 2006/677 provides guidance on follow-up of audit outcome: "Where appropriate, an action plan should be drawn up and delivered by the auditee. It should propose time-bound corrective and preventive action to address any weakness identified by the audit or audit programme. The audit team should assess the suitability of the action plan and may be involved in verifying its subsequent implementation: -- an Action plan enables the audit team to assess whether the proposed corrective and preventive action is sufficient to address the recommendations of the audit report. Action plans should include risk-based prioritisation and time frames for completion of corrective and preventive action. A wide range of different action plans could be considered satisfactory. It is for the auditee to choose from the various options available, -- Corrective and preventive action should not be confined to addressing specific technical requirements but should, where appropriate, include system-wide measures (for example communication, cooperation, coordination, reviewing and streamlining of control processes, and so forth). A root cause analysis of any non-compliance should be conducted by the auditee in order to determine the most appropriate corrective and preventive action. Any differences of opinion between the auditee and audit team should be resolved, -- Close-out: Mechanisms should be established to ensure that action plans are appropriate and that corrective and preventive actions are effectively completed in a 22 timely manner. Procedures for verifying the close out of the action plan should be agreed between the auditee and the audit team" 5.2.6.2 Findings

DACA has similar arrangements in place for the follow-up but these arrangements are not yet supported by sufficiently detailed procedures and no mechanism for escalation has been considered yet. Conclusions

DACA is in an early stage of the development of the audit process and therefore could not yet demonstrate the arrangements for the follow-up of audit recommendations. 5.2.7 Transparency 5.2.7.1 Legal requirements Article 4(6) of Regulation (EC) No 882/2004 requires, inter alia, that "audits ........shall be carried out in a transparent manner". Section 5.2 of the Annex of Commission decision 2006/677 provides guidance on transparency, including the following: 23 "In order to demonstrate the audit process is transparent, documented procedures should, in particular, include a clearly defined audit planning process, audit criteria and audit report approval and distribution mechanisms. Management and implementation of the audit process should be transparent to all relevant stakeholders. In particular, there should be full transparency between the audit service and the auditee. Ensuring the audit process is transparent in the eyes of other stakeholders will assist in the dissemination of information, and in particular in the sharing of best practice within and between competent authorities. The Member States should adopt the appropriate measures to ensure their audit systems are transparent, taking national legal and other requirements into account. To that end, the Member States should consider encouraging practices that improve the transparency of the process." 5.2.7.2 Findings

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At the closing meeting the CCA provided copies of the 2017 packing lists from the vaccine bait supplier, CCA acceptance reports, submission forms to the laboratory, and dispatch lists for vaccine deliveries to airfields. These documents showed that not all delivered lots were sampled by the CCA for titre control, and no further samples for titre control were taken from those lots that were kept in intermediate storage of up to five weeks. 7 In 2017, the first vaccine bait delivery arrived on 31 March, a second delivery arrived on 19 April, and a third on 3 May. Whilst most lots were dispatched to airfields shortly after acceptance and sampling, the dispatch to airfields on 10 May included four of the 68 lots delivered on 31 March (40 days' storage) and 22 of the 28 lots delivered on 19 April (21 days' storage). The longest storage times in 2016 were 20 days. The samples for vaccine titre controls were taken within days of each delivery to Greece. There was no protocol in place defining the maximum storage time before re-testing of the vaccine titre should take place.

The results of titre controls on vaccine baits are not available until after the campaign, which means that the CCA cannot take timely corrective action if non-compliant results are reported from the laboratory. No post-storage verification of titres take place on those batches that have been kept in storage for up to five weeks between delivery and use.

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d d mpromise . . , , . ( ) 1490100 - . , , , , ( Page: 1 November 2017 of report ref. DG(SANTE)/2017-6111-MR of the audit carried out from 06 June ess of the rabies eradication programme Page: 2 November 2017 of report ref. DG(SANTE)/2017-6111-MR of the audit carried out from 06 June ess of the rabies eradication programme Page: 3 November 2017 of report ref. DG(SANTE)/2017-6111-MR of the audit carried out from 06 June ess of the rabies eradication programme

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The contracts specify that the aircrafts must be equipped with two electronic recording systems, one for actual flight tracks and one for vaccine bait drop locations. Bait drop data (and the planned flight routes) are submitted electronically to the CCA on a daily basis, and such data can be sent directly from the distribution consortium. Data on the actual flight routes are not submitted to or verified against bait drop data by the CCA. This is not in line with the instructions from the Commission services or the procedure described in the approved eradication programme. Furthermore, there are no records on what has been checked, when it was done, the outcome of the checks, or any corrective actions taken. The electronic data (vaccine bait drop locations and planned flight routes) from the aerial distribution are sent by the operator to a designated person in the Directorate of Technical Studies Structures and Topography of the Ministry of Rural Development and Food. 4 In their response to the draft report the competent authority stated that, for the 2017 autumn campaign, calibrated thermometers were used to verify temperatures for transport and storage. A tendering procedure for temperature data-loggers for use in the 2018 campaign is on-going. 11 There were no instructions explaining the purpose of the checks or how the checks on vaccine bait drop data should be carried out and documented. The person carrying out the checks was not familiar with which distance between vaccine bait drops would result in the desired density. Checks were reportedly carried out on the vaccine bait drop data on a daily basis. No records or reports of the checks were maintained. Gaps in the distribution were assumed to be linked to lakes, mountains or villages, but this was not verified against a map. If the bait density deviated substantially from the one agreed for the programme the CCA would be notified over the phone. This had reportedly happened on a few occasions, but neither the phone calls, nor the corrective actions had been documented. Due to the lack of actual flight line data, no checks could be made to verify that the vaccine bait drop data matched the actual flight routes. Such checks have been specifically required by the Commission and are described in the approved eradication programmes. At the end of the ORV campaign colour coded bait density maps were sent to the CCA without any comment or statement on the type of checks carried out on these files, or the outcomes of such checks. These maps verified that the minimum bait density had been achieved in the 2017 spring campaign but that there were certain areas with much higher bait densities (sometimes exceeding 50 vaccine baits/km2), which confirmed the aerial distribution strategy described by the CCA and the operator (finding 24). 12 Conclusions on oral vaccination of foxes

Documented official controls on vaccine bait storage and distribution are in place at arrival to Greece and at the airfields. Colour-coded maps prepared after the campaigns indicate that the vaccine bait density on the ground has been as planned. However, the CCA does not request all data from the aerial distribution that would be necessary for carrying out adequate comparisons of actual flight lines with the recorded vaccine bait drop locations, as required by the Commission. Furthermore, the lack of instructions and records of the checks currently carried out on vaccine bait drop data undermine any verification of such controls.

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data ing and these Page: 4 November 2017 of report ref. DG(SANTE)/2017-6111-MR of the audit carried out from 06 June ess of the rabies eradication programme Proposed by the competent authority 2017, hop BTSF : «Rabies eradication dlife: Oral rabies vaccination (ORV) campaigns», , workshop, . 017, Page: 5 November 2017 of report ref. DG(SANTE)/2017-6111-MR of the audit carried out from 06 June ess of the rabies eradication programme Action Proposed by the competent authority ( ) email excel (Attached 3) .

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The contracts specify that the aircrafts must be equipped with two electronic recording systems, one for actual flight tracks and one for vaccine bait drop locations. Bait drop data (and the planned flight routes) are submitted electronically to the CCA on a daily basis, and such data can be sent directly from the distribution consortium. Data on the actual flight routes are not submitted to or verified against bait drop data by the CCA. This is not in line with the instructions from the Commission services or the procedure described in the approved eradication programme. Furthermore, there are no records on what has been checked, when it was done, the outcome of the checks, or any corrective actions taken. The electronic data (vaccine bait drop locations and planned flight routes) from the aerial distribution are sent by the operator to a designated person in the Directorate of Technical Studies Structures and Topography of the Ministry of Rural Development and Food. 4 In their response to the draft report the competent authority stated that, for the 2017 autumn campaign, calibrated thermometers were used to verify temperatures for transport and storage. A tendering procedure for temperature data-loggers for use in the 2018 campaign is on-going. 11 There were no instructions explaining the purpose of the checks or how the checks on vaccine bait drop data should be carried out and documented. The person carrying out the checks was not familiar with which distance between vaccine bait drops would result in the desired density. Checks were reportedly carried out on the vaccine bait drop data on a daily basis. No records or reports of the checks were maintained. Gaps in the distribution were assumed to be linked to lakes, mountains or villages, but this was not verified against a map. If the bait density deviated substantially from the one agreed for the programme the CCA would be notified over the phone. This had reportedly happened on a few occasions, but neither the phone calls, nor the corrective actions had been documented. Due to the lack of actual flight line data, no checks could be made to verify that the vaccine bait drop data matched the actual flight routes. Such checks have been specifically required by the Commission and are described in the approved eradication programmes. At the end of the ORV campaign colour coded bait density maps were sent to the CCA without any comment or statement on the type of checks carried out on these files, or the outcomes of such checks. These maps verified that the minimum bait density had been achieved in the 2017 spring campaign but that there were certain areas with much higher bait densities (sometimes exceeding 50 vaccine baits/km2), which confirmed the aerial distribution strategy described by the CCA and the operator (finding 24). 12 Conclusions on oral vaccination of foxes

Documented official controls on vaccine bait storage and distribution are in place at arrival to Greece and at the airfields. Colour-coded maps prepared after the campaigns indicate that the vaccine bait density on the ground has been as planned. However, the CCA does not request all data from the aerial distribution that would be necessary for carrying out adequate comparisons of actual flight lines with the recorded vaccine bait drop locations, as required by the Commission. Furthermore, the lack of instructions and records of the checks currently carried out on vaccine bait drop data undermine any verification of such controls.

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2017 carried out : lia that . 2, email ( ) , . ( -, ) . : - - - ( ) - . excel Page: 6 November 2017 of report ref. DG(SANTE)/2017-6111-MR of the audit carried out from 06 June ess of the rabies eradication programme November 2017 of report ref. DG(SANTE)/2017-6111-MR of the audit carried out from 06 June ess of the rabies eradication programme petent authority

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The CCA provides each Regional Unit with a target number of foxes to be sampled for the monitoring programme. The aim is to test 2 foxes/100 km2 after each ORV campaign, as described in the approved programmes. The hunters are reimbursed with 30 EUR for each fox, but the sampling is far from reaching the target levels and the implementation varies among the Regional Units. In 2016, approximately 9% of the planned foxes were shot and submitted for analysis under the monitoring programme. Monitoring results from Regional Units for the three ORV campaigns from autumn 2015 to spring 2016 showed that, six of the 27 Regional Units involved in one of more of the campaigns had not submitted any monitoring samples at all. The three Regional Units where 38 of the 48 rabies cases (79%) were detected during the outbreak had submitted less than 6% of the expected monitoring samples for 2015 and 2016. Two other Regional Units where rabies cases had been detected did not submit any monitoring samples in 2016. For the two campaigns in 2016, the targets for the 24 Regional Units involved were between 23 and 181 foxes each, adding up to 2033 foxes. One Regional Unit had delivered 67% of their target animals, five other Regional Units had reached 17-26% of their targets, and ten Regional Units had provided less than 9% of their targets. Eight Regional Units (responsible for 36 % of the targeted samples) had not submitted a single animal. 14

Monitoring results between the first spring campaign (2016) and the 2016 autumn campaign show that a large proportion of the foxes submitted for testing were less than one year old. This age group is not a good indicator for the effectiveness of ORV when tested between birth and their first autumn ORV campaign. Although these cubs would still have been inside their dens during the spring campaign a large proportion showed evidence of bait contact. It is not known if fox vixens are likely to bring vaccine baits into the den to feed their cubs. Some cubs were positive for rabies antibodies but it is not possible to establish if these fox cubs had maternal antibodies or had actually been vaccinated. No measures have been taken to discourage shooting young foxes in the summer of 2017. Fox cubs classified as <1 year old between the spring and autumn campaigns would have been born around the time of the 2016 spring campaign, i.e. they would be less than 6-7 months old. Of the 126 foxes sampled between the spring and autumn campaigns, 86 (68%) were classified as <1 year old. Of these, 53% showed evidence of bait contact (TC+) and 12% (9 out of 73 tested) were positive for antibodies to rabies virus. Of the 40 foxes classified as older than one year, 60% showed evidence of bait contact and 68% (24 out of 35 tested) were antibody-positive. 5.3.2 Active surveillance

The under-implementation of the monitoring programme, the sometimes inappropriate age groups tested, and the uneven spatial sample distribution add a high level of uncertainty to any assessment of the effectiveness of the oral rabies vaccination campaigns. The lack of active promotion of this programme from the Ministry of Environment and Energy makes it more difficult for the local veterinary services to engage the local forestry services and hunters in fox hunting, which is not part of their normal activities.

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2017, umbers, , n and C. Page: 8 November 2017 of report ref. DG(SANTE)/2017-6111-MR of the audit carried out from 06 June ess of the rabies eradication programme Page: 9 November 2017 of report ref. DG(SANTE)/2017-6111-MR of the audit carried out from 06 June ess of the rabies eradication programme ion Proposed by the competent authority email (Attached 7). , . 17 ttached 7). .

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When determining the age of foxes the laboratory would differentiate between several age groups and the same animal shot after an autumn campaign would end up in 20 different age classes, depending on whether it was shot before or after 1 January during its first and second winter. This classification follows the instructions from the EURL.

Only foxes with tetracycline lines that can be referred to the most recent vaccination campaign (excluding lines indicating bait contact in previous campaigns) are reported as positive, even if other tetracycline lines show that the fox had been in contact with vaccine baits earlier6. This could be the reason why, in Greece, the results reported to the Commission in 2014, 2105 and 2016 show that certain foxes (5-14%) have antibodies to rabies virus but are reported as negative for contact with vaccine baits (as described in finding 38), which is unexpected considering the nature of the infection and the vaccine baits.

The way the laboratory reports the age of the tested foxes makes it difficult for the competent authority and the Commission to evaluate the effectiveness of the rabies vaccination campaigns. The practice of reporting as positive only tetracycline lines from the most recent vaccination campaign, excluding evidence of bait contact in previous years, may assist the authorities in evaluating the vaccine distribution in the most recent campaign but it distorts the assessment when compared to the sero- prevalence, which is based on antibodies from any vaccination campaign. This practice may explain the consistent reporting from Greece of foxes that are seropositive without evidence of bait contact. The total sero-prevalence and complete bait contact data describe the cumulative effect of several vaccination campaigns on the target fox population and is the reporting method used by other Member States.

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ns are CCA of (2013) on and ( , ­ ) ( ­ - . Page: 10 November 2017 of report ref. DG(SANTE)/2017-6111-MR of the audit carried out from 06 June ess of the rabies eradication programme Page: 11 November 2017 of report ref. DG(SANTE)/2017-6111-MR of the audit carried out from 06 June ess of the rabies eradication programme Action Proposed by the competent authority

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Methods for virus isolation in cell culture or mouse inoculation test are not available in the NRL. No other laboratory has been subcontracted to carry out these tests. Current international standards (Manual of Diagnostic Tests and Vaccines for Terrestrial Animals of the International Organisation for Animal Health, Chapter 2.1.17.) stipulate that one of these tests should be used as a complement to the FAT (referred to as the "gold standard") in case of human exposure to rabies or an inconclusive FAT result. Another alternative is to repeat the FAT test on other tissue samples. Instead, the NRL is using a non-validated, non-accredited real-time PCR method for this purpose.

The diagnostic pathway for confirming rabies cases, particularly in the case of suspected human exposure or inconclusive FAT results, does not follow international standards. The alternative method currently used to confirm the result of the accredited FAT method is not subject to the same quality assurance as the FAT method. This increases the risk of an incorrect overall test result which may have implications for post-exposure treatments of human patients. None of the rabies cases detected in 2012- 2014 had been caused by vaccine virus.

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ase of (PCR) FAT FAT, , , - ( ). FAT , . : , - , 2017 ( 2.1.17., , 2013). EURL 2016 (Presentation EURL - Workshop on Rabies 2017 Budapest 2017). (attached 9) WHO OIE. (attached 9) PCR, . Page: 12 November 2017 of report ref. DG(SANTE)/2017-6111-MR of the audit carried out from 06 June ess of the rabies eradication programme Page: 13

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The DPPP has not issued comprehensive national inspection guidelines for import controls. The DPPP stated that, since inspectors were highly qualified and well trained, there was no need to provide detailed guidance documents, and that, moreover, the specific details of the implementation of import controls was left to the discretion of the regional and local services. The DPPP have issued translations of relevant ISPMs, notably ISPM 23 and 31, which inspectors are instructed to follow. In addition, some specific guidance documents have been issued by the DPPP, which deal with controls of Egyptian potatoes, collecting and dispatching samples for laboratory analysis and record keeping.

The audit team noted that many of the tasks and procedures involved with import controls are not covered by the guidelines prepared by the DPPP, for example, no 5 specific guidance is available on the procedure to follow when carrying out documentary, identity or plant health checks, or the process to follow in the case of non- compliance.

At Thessaloniki seaport, the RCPPQC had prepared a local guidance document on import procedures, the DPPP stated that it had not been approved centrally. At Evzonoi (the land border crossing with the former Yugoslav Republic of Macedonia), the RUDREV explained that they were planning to prepare their own inspection guidelines in order to ensure consistency of approach by different inspectors.

Inspectors carrying out import checks do not have available, written, up-to-date national inspection guidelines, which is not in line with paragraph 1 of the Annex to Commission Directive 98/22/EC.

Whilst observing inspections at five inspection posts, the audit team was informed by the local plant health inspectors that they do not have access to information on interceptions made by other Member States, either directly through EUROPHYT, or via other means. This is not in line with Point 1 of the Annex to Commission Directive 98/22/EC. The DPPP stated that this was due to limitations on the number of user credentials which had been setup by the DPPP for the EUROPHYT system. At the closing meeting of the audit, the DPPP informed the audit team that they had obtained additional user credentials, which would be distributed to each inspector involved in plant health import controls.

During visits to different inspection posts, the audit team noted that there were a number of differences in the implementation of controls across different RCPPQCs and RUDREVs (see sections 5.3.5 and 5.4.4 below). Conclusions on organisation of plant health import controls

The absence of national inspection guidelines means that import controls are not implemented consistently across different inspection posts, and in the case of small 7 quantities of fruits and vegetables imported through Kipi, implementation is not in line with EU requirements (see section 5.3.5 below).

The lack of information on interceptions made by other Member States prevents the targeting of high-risk consignments.

However, the Customs Service at the inspection post at Kipi stated that, in agreement with the RUDREV, small quantities of regulated fruits and vegetables (other than potatoes), are permitted for entry without being referred to the plant health services for import checks. The Customs Service defined 'small quantity' as an amount less than four kilograms in weight and explained that, in these cases they do not check for the presence of an accompanying phytosanitary certificate. Fruits and vegetables in excess of four kilograms are referred to the plant health service. The Customs Service stated that any plants intended for planting, potatoes or soil, are not permitted and would be refused entry, without referral to the plant health services. The RUDREV confirmed that this had been agreed as a local procedure with the Customs Service and that they were unaware that this was contrary to national policy. The approach practiced by the Customs Service at Kipi, in agreement with the RUDREV, is not in line with Article 13(1) of Directive 2000/29/EC.

The audit team noted that, with respect to sampling: During inspections of consignments of citrus, lots were defined differently between the two seaports visited. At Thessaloniki, inspectors considered all lemons of the same variety, from the same exporter, consigned to the same importer and covered by a single phytosanitary certificate as a single lot. At Piraeus port, inspectors also considered the Production Unit Code as a defining characteristic of a lot, so that fruit from different Production Unit Codes were treated as separate lots, as a consequence of which, a significantly larger proportion of the consignment was subject to inspection. The DPPP stated that the approach taken at Piraeus was the correct one. This was not documented in written guidance; Inspectors selected the sample for inspection themselves and were free from interference from third parties; At the seaports and airport, inspectors used table 1 of Appendix 2 to ISPM 31 in order to calculate the sample size required to achieve a 95% confidence level of detecting a 0.5% level of infestation. The size of the lot was based on the number of fruits or vegetables it contained and so too was the size of the sample selected for inspection. Inspectors stated that due to the size of lots received, the sample size was around 600 fruits or vegetables in almost all cases. Inspectors stated that they apply a higher intensity of inspection to plants intended for planting, increasing the confidence level to 99%, defining the sample unit as an individual plant. The confidence and detection levels used to calculate the sample sizes are not specifically provided for in written guidance, but the DPPP stated that they were in line with instructions given during import training courses; As noted in section 5.4.1 above, there was no equipment to permit access to consignments at the inspection posts at Evzonoi and Kipi. It was not possible to unload the lorries carrying the consignments and so samples were taken by inspectors from pallets which were immediately accessible. During the inspections observed by the audit team, samples were collected from just one or two pallets. It could not therefore be ensured that the sample was actually representative of the consignment, as required by Article 13a(1)(b)(iii) of Directive 2000/29/EC; At Kipi, the local inspectors stated that, due to the lack of inspection facilities, it was not possible to apply sample sizes in line with ISPM 31, instead they stated that they apply a sample size of 10 packages or bundles in all cases. The audit team observed an inspection of semi-dried apricots and noted that the inspector did not examine all of the contents of each of the 10 boxes sampled for inspection. The local inspectors stated that consignments arriving through Kipi were often full lorry loads of one or two different 16 fruits or vegetables. The sample size used at Kipi does not take into account ISPM 31, and does not ensure that the sample is large enough to be considered as representative, which is not in line with Article 13a(1)(b)(iii) of Directive 2000/29/EC.

The audit team noted that, with respect to the implementation of the checks: Inspectors had a good knowledge of the different harmful organisms which the commodities they were inspecting were most likely to host; At Piraeus port, destructive sampling was systematically applied at a rate of approximately 10% of asymptomatic fruit in each sample of every lot inspected. The inspectors stated that this was aimed at detecting the presence of pest within the flesh of the fruit, even where no external signs of infestation were visible. This practice was not systematically applied at any of the other inspection posts visited; In the case of any suspect symptoms of the presence of harmful organisms, inspectors took a subsample for closer analysis in the local laboratory, where access to microscopes and equipment for destructive sampling enabled a more thorough check; The checks observed by the audit team at the airport and seaports included a thorough visual examination of the entire sample and were considered meticulous, in line with Article 13a(1)(a) of Directive 2000/29/EC.

Medlemsstatens svar

Ensure that staff performing plant health checks have available, written, up-to-date national inspection guidelines and information on interceptions made by other Member States, in line with paragraph 1 of the Annex to Commission Directive 98/22/EC, as required by Article 1 of the same Directive. The recommendation is based on conclusions No.27 and 28. Associated findings No.13, 14, 15, 16, 19, 25, 54, 72, and 73.

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During their visits to the inspection posts at Evzonoi and Kipi, where there are regular imports of regulated articles by lorry, the audit team noted that: The inspection post at Evzonoi did not have any inspection facilities, including suitable areas for inspection, adequate lighting, or inspection tables, and does not therefore meet the appropriate minimum conditions specified in the Annex to Directive 98/22/EC, specifically those listed in paragraph 3. This is not in line with Article 1 of the same Directive. The plant health services at Kipi do not have access to facilities for proper storage of consignments awaiting results of laboratory testing (see paragraph 77 below). The inspection post does not therefore meet the appropriate minimum conditions specified in paragraph 1 of the Annex to Directive 98/22/EC. This is not in line with Article 1 of the same Directive; At Evzonoi and Kipi, there were no facilities or equipment available to enable access to consignments whilst performing checks. This is not specifically required by Directive 98/22/EC, however, as detailed in section 5.4.4 below, the lack of access does not ensure that checks can be, and are, carried out on the entirety or a representative sample of consignments, which is not in line with Article 13a(1)(b)(ii) or (iii) of Directive 2000/29/EC; In the case of WPM selected for inspection, due to the lack of access to consignments, inspectors could only check the parts of the WPM which were visible from the rear and side of the transport vehicle. Consequently, for most pallets it was only possible to examine one face. However, in the event that any suspicious signs are observed during these checks, the plant health inspectors explained that they would require some unloading of the consignment in order to allow for a more thorough check. The audit team observed an example of this, when wooden pallets were identified which appeared not to bear an ISPM 15 mark. 14

The audit team noted that, with respect to sampling: During inspections of consignments of citrus, lots were defined differently between the two seaports visited. At Thessaloniki, inspectors considered all lemons of the same variety, from the same exporter, consigned to the same importer and covered by a single phytosanitary certificate as a single lot. At Piraeus port, inspectors also considered the Production Unit Code as a defining characteristic of a lot, so that fruit from different Production Unit Codes were treated as separate lots, as a consequence of which, a significantly larger proportion of the consignment was subject to inspection. The DPPP stated that the approach taken at Piraeus was the correct one. This was not documented in written guidance; Inspectors selected the sample for inspection themselves and were free from interference from third parties; At the seaports and airport, inspectors used table 1 of Appendix 2 to ISPM 31 in order to calculate the sample size required to achieve a 95% confidence level of detecting a 0.5% level of infestation. The size of the lot was based on the number of fruits or vegetables it contained and so too was the size of the sample selected for inspection. Inspectors stated that due to the size of lots received, the sample size was around 600 fruits or vegetables in almost all cases. Inspectors stated that they apply a higher intensity of inspection to plants intended for planting, increasing the confidence level to 99%, defining the sample unit as an individual plant. The confidence and detection levels used to calculate the sample sizes are not specifically provided for in written guidance, but the DPPP stated that they were in line with instructions given during import training courses; As noted in section 5.4.1 above, there was no equipment to permit access to consignments at the inspection posts at Evzonoi and Kipi. It was not possible to unload the lorries carrying the consignments and so samples were taken by inspectors from pallets which were immediately accessible. During the inspections observed by the audit team, samples were collected from just one or two pallets. It could not therefore be ensured that the sample was actually representative of the consignment, as required by Article 13a(1)(b)(iii) of Directive 2000/29/EC; At Kipi, the local inspectors stated that, due to the lack of inspection facilities, it was not possible to apply sample sizes in line with ISPM 31, instead they stated that they apply a sample size of 10 packages or bundles in all cases. The audit team observed an inspection of semi-dried apricots and noted that the inspector did not examine all of the contents of each of the 10 boxes sampled for inspection. The local inspectors stated that consignments arriving through Kipi were often full lorry loads of one or two different 16 fruits or vegetables. The sample size used at Kipi does not take into account ISPM 31, and does not ensure that the sample is large enough to be considered as representative, which is not in line with Article 13a(1)(b)(iii) of Directive 2000/29/EC.

The DPPP stated that consignments of high-risk plants which are sampled in order to test for latent infection must be detained at the inspection post until completion of the laboratory tests so that appropriate action can be taken in the event that a harmful organism is present. However, this procedure was not followed at Kipi, where the RUDREV stated that they release lots once the sample has been taken and that several such consignments are imported each month on average. The RUDREV stated that there are no restrictions on what the importer can do with the consignment, but that they are warned that if laboratory tests subsequently confirm the presence of a harmful organism, that measures would then be taken, which would include destruction of the infected lot. The RUDREV confirmed that this would only be possible if the lot could be traced and had not already been processed. The RUDREV stated that they had taken this approach, mainly due to the absence of any facilities to store detained consignments. 17 Conclusions on import inspections

The lack of inspection facilities at Evzonoi and Kipi means that it is not possible for inspectors to carry out checks of representative samples of imported consignments. These checks are not therefore reliable.

Medlemsstatens svar

Ensure that plant health checks are only carried out at places which meet the appropriate minimum conditions specified in the Annex to Commission Directive 98/22/EC, as required by Article 1 of the same Directive, in particular at inspection posts at road border crossings. This should ensure that checks can be, and are, carried out on samples that are representative of the consignment from which they are taken, in line with Article 13a(1)(b)(iii) of Directive 2000/29/EC. The recommendation is based on conclusion No.76. Associated findings No.66, 72 and 75.

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The DPPP stated that inspection data is recorded and stored locally by each RCPPQC and RUDREV, and not in a national system. The DPPP explained that, as a consequence of this, they were not able to provide consolidated import figures for imports of regulated articles for Greece at the time of the audit, although they were provided subsequently. Neither could the DPPP provide consolidated figures on the checks which had taken place on WPM associated with specified commodities from China, and did not provide information on this to the Commission, which is not in line with Article 5 of Decision 2013/92/EU (see section 5.5.2 below). At the closing meeting of the audit, the DPPP stated that a new national IT system was under development, which would be used to record and store inspection data on plant health import controls centrally and that it was intended that this system will interface with TRACES. 6 5.1.5 Planning of official controls

The DPPP stated that they had instructed inspection posts to inspect 100% of WPM associated with specified commodities from China which are referred to them by the Customs Services. The DPPP could not provide figures for the total number of consignments of the specified commodities imported from China or the total number of checks which had been carried out. Consequently, Greece was not able to notify the Commission of the number and the results of the plant health checks carried out in accordance with Decision 2013/92/EU for the 2015/2016 reporting period, which is not in line with Article 5 of the Decision. Conclusions on checks of wood packaging material

The failure to provide information to the Commission, on imports and checks carried out of WPM from China, limits the ability to evaluate the risk posed by this material.

Medlemsstatens svar

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The eight RCPPQCs are tasked with the coordination of the DREVs in their jurisdiction. The RCPPQCs draw up the annual programme of regular on-site inspections jointly with the competent DREVs. However the audit team was informed that such activities had not yet been implemented at the time of the audit (see paragraph 17). Conclusions on Competent Authorities

CAs are designated and their tasks are described in legislation. Coordination of controls by RCPPQCs is not implemented for the PDO/PGI wine sector products with a risk that relevant control requirements are not fulfilled. . 5 5.2.2 Prioritisation of Official Controls Legal requirements Article 90 of Regulation (EU) No. 1306/2013. Articles 25 and 26 of Regulation (EC) No 607/2009. Findings Primary producers for PDO/PGI wine sector products

The national legislation requires that in relation to PGI wines, at least 20% of applications for certifications have to be sampled and analysed as well as at least 20% of the total production quantity of the PGI wine in the relevant regional unit. Given that there is no coordination being undertaken by the RCPPQCs, the audit team could not determine whether or not these requirements were met. In the particular DREVs visited, the inspectors met stated that these requirements had not yet been met.

Although the majority of inspectors met were knowledgeable on oenology, at the time of the observed inspections, there were no obvious guidelines or checklists used by the inspectors. Subsequently, the CCA stated that guidelines and checklists were provided by an implementing circular to the DREVs which were provided to the audit team. There was however no further explanation provided to the audit team as to why these guidance documents were not used by the inspectors observed. During two site visits the audit team requested traceability exercises to be performed. Although these were undertaken satisfactorily, the information of the producer, both in electronic and paper format, were fragmented and required a lot of effort and manpower to complete such traceability exercises.

The RCPPQCs visited had not implement a risk based approach to controls and neither was there any coordination of the DREVs in place. In addition, any communication between DREVs was informal and undertaken on an ad hoc basis. Controls on the Market: (visit to supermarket)

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between all CAs . 3 ) 3 . 5833/155045/12.12.2013 µ . , . 3) , µ µ µµ . () (. . 1749/42334/12.04.2017) , . : , , , µµ , , µ , . Page: 1 ceived 20 April 2017 ndations of report ref. DG(SANTE)/2016-6243-MR of the audit carried out from 15 trol systems related to Protected Designation of Origin (PDO), Protected Geographical 20% 20% (. 4 19 ).

Pursuant to Article 3(3)(a) of Joint Ministerial Decision (JMD) No 5833/155045/12.12.2013, the Regional Centres for Plant Protection and Quality Control (RCPPQC) as the coordinating authorities work with the Directorates for Rural Economy and Veterinary Medicine (DREV) and assist them in their audit work. In addition, pursuant to paragraph 3(b) of the same Article in the abovementioned JMD, the RCPPQCs jointly draw up with the competent DREVs the annual programme of regular on-site inspections and the audit plan for operators. The Central Competent Authority (CCA) reminded all the RCPPQCs and DREVs in letter ref. 1749/42334/12.04.2017 of the obligation to implement the requirements of the abovementioned provisions. It also noted Page: 1 ndations (updated) received 3 August 2017 submitted by the competent authorities of Greece in response to Report ref. DG(SANTE)/2016-6243-MR 25 November 2016 in order to evaluate the control systems related to Protected Designation of Origin wine sector products petent authority carried out: oved for entry in the ators for producing wines, on the approved for entry in Operators for varietal wines, t their wine products sented and ts of wholesale and

between all CAs . 3 ) 3 . 5833/155045/12.12.2013 µ . , . 3) , µ µ µµ . () (. . 1749/42334/12.04.2017) , . : , , , µµ , , µ , . Page: 1 ated) received 3 August 2017 ndations of report ref. DG(SANTE)/2016-6243-MR of the audit carried out from 15 trol systems related to Protected Designation of Origin (PDO), Protected Geographical 20% 20% (. 4 19 ). . . 1749/42334/12.04.2017 , . . 3277/79200/20.07.2017, , , 2017-2018 µµ. , . , , 10 2017, , . . . 1749/42334/12.04.2017 . . 3277/79200/20.07.2017

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During this audit, the audit team visited the production sites of two PDO and three PGI wine sector products in three different regions. All inspections were undertaken by official control staff from the respective DREVs. In all site visits, it was noted that for the majority of inspections, no inspection reports were drawn up making it impossible to determine if all elements of the Product Specification were checked.

Where inspection reports had been issued by the DREVs, they contained very little detail of the site visit and the activities carried out and whether or not all elements of the Product Specification were checked. In addition, there was no documentation attached to the report to substantiate any checks that had taken place. 7

In relation to the PDO/PGI wine sector products selected for this audit, procedures in terms of guidelines, checklists and reporting procedures were not used by the inspectors observed. The effectiveness of inspections, in particular the checking of each element of the Product Specification could not be assessed fully due to the lack of records and inspection reports. In addition, market controls were not in place. 5.2.4 Enforcement Measures Legal Requirements Article 19 of Regulation (EC) No 607/2009. 8 Art 103 of Regulation (EC) No 1308/2013. Findings

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pecifications are . 5 19 . 4)(b) of 5833/155045/12.12.2013 / . , µ µµ µ . µ . 7 19 µ , µ . , . (. . 1749/42334/12.04.2017) , , , . , Page: 2 ceived 20 April 2017 ndations of report ref. DG(SANTE)/2016-6243-MR of the audit carried out from 15 trol systems related to Protected Designation of Origin (PDO), Protected Geographical .

he Product Article 19(5) of Joint Ministerial Decision No red by 5833/155045/12.12.2013 provides for checks (EC) on operators approved for entry in the Register of Certified Operators for producing PDO/PGI wine and varietal wines. These Page: 3 ndations (updated) received 3 August 2017 submitted by the competent authorities of Greece in response to Report ref. DG(SANTE)/2016-6243-MR 25 November 2016 in order to evaluate the control systems related to Protected Designation of Origin wine sector products petent authority the basis of an audit tent RCPPQC in tent DREV the product's rticle 19(7) of the an audit report in II after each on- t is co-signed by the y express any rs' observations or CPPQCs and implement the entioned letter ref. he audit report should e visit and the areas clarify whether all specification were Page: 4 ndations (updated) received 3 August 2017 submitted by the competent authorities of Greece in response to Report ref. DG(SANTE)/2016-6243-MR 25 November 2016 in order to evaluate the control systems related to Protected Designation of Origin wine sector products petent authority nded the sectors entioned audit plan cally: that the operators the conditions laid

pecifications are . 5 19 . 4)(b) of 5833/155045/12.12.2013 / . , Page: 2 ated) received 3 August 2017 ndations of report ref. DG(SANTE)/2016-6243-MR of the audit carried out from 15 trol systems related to Protected Designation of Origin (PDO), Protected Geographical µ µµ µ . µ . 7 19 µ , µ . , . (. . 1749/42334/12.04.2017) , , , . , . KAA . . 3277/79200/20.07.2017 : - , , - , µ , - µ ated) received 3 August 2017 ndations of report ref. DG(SANTE)/2016-6243-MR of the audit carried out from 15 trol systems related to Protected Designation of Origin (PDO), Protected Geographical , - µ . & µ µµ . 2017 . , & . . .

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In relation to the PDO/PGI wine sector products selected for this audit, although the annual verification of PDO/PGI wine sector products is prescribed in national legislation, the relevant sampling is not always undertaken and the scope of laboratory testing did not always reflect the requirements of the Product Specifications. In addition, no market controls were being planned. 5.2.3 Procedures and Performance of Official Control Activities Legal Requirements Article 103(1) and (2) of Regulation (EU) No 1308/2013. Articles 25-26 of Regulation (EC) No 607/2009. Article 18 of Regulation (EC) No 178/2002. Findings Official controls of producers / processors

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n in line with (. . 1749/42334/12.04.2017) , , , , : 100% 20% 20% , 26 . () 607/2009 . 1 ) 13 . 5833/155045/12.12.2013. .

re The CCA reminded all the RCPPQCs and ation DREVs in its letter ref. 1749/42334/12.04.2017 that, inter alia, all the detailed examinations carried out: at a rate of 100 % during the certification Page: 6 ndations (updated) received 3 August 2017 submitted by the competent authorities of Greece in response to Report ref. DG(SANTE)/2016-6243-MR 25 November 2016 in order to evaluate the control systems related to Protected Designation of Origin wine sector products petent authority nd mber of applications east 20 % of the total luded in Article 26 2009 and in also stressed that accredited for the rmine the above ef. rmation from rs that their g analytical testing hods for which ng into account the d in letter ref. those n of which, ng wine are Page: 7 ndations (updated) received 3 August 2017 submitted by the competent authorities of Greece in response to Report ref. DG(SANTE)/2016-6243-MR 25 November 2016 in order to evaluate the control systems related to Protected Designation of Origin wine sector products Action Proposed by the competent authority produced, to be accredited, immediately and before the end of 2017, for the method applied to determine the "Excess pressure" in bar

n in line with (. . 1749/42334/12.04.2017) , , , , : Page: 4 ated) received 3 August 2017 ndations of report ref. DG(SANTE)/2016-6243-MR of the audit carried out from 15 trol systems related to Protected Designation of Origin (PDO), Protected Geographical 3 2017 7 Page: 5 ated) received 3 August 2017 ndations of report ref. DG(SANTE)/2016-6243-MR of the audit carried out from 15 trol systems related to Protected Designation of Origin (PDO), Protected Geographical & . . . 1891/45815/26.04.2017 3278/79202/20.07.2017

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The CAs responsible for PDO/PGI wine sector products selected for this audit confirmed that at the time of the audit, no market controls were being planned. Conclusions on Prioritisation of Official Controls

In relation to the PDO/PGI wine sector products selected for this audit, although the annual verification of PDO/PGI wine sector products is prescribed in national legislation, the relevant sampling is not always undertaken and the scope of laboratory testing did not always reflect the requirements of the Product Specifications. In addition, no market controls were being planned. 5.2.3 Procedures and Performance of Official Control Activities Legal Requirements Article 103(1) and (2) of Regulation (EU) No 1308/2013. Articles 25-26 of Regulation (EC) No 607/2009. Article 18 of Regulation (EC) No 178/2002. Findings Official controls of producers / processors

At the time of the audit, market controls of PDO/PGI wine sector products were not in place. The DREV inspector observed by the audit team had not undertaken any official controls relating to wine sector products on the market since 2013. The inspector had prepared for this observation exercise and had a listing of the key requirements for the labelling of wines. Conclusions on Procedures and Performances of Official Control Activities

In relation to the PDO/PGI wine sector products selected for this audit, procedures in terms of guidelines, checklists and reporting procedures were not used by the inspectors observed. The effectiveness of inspections, in particular the checking of each element of the Product Specification could not be assessed fully due to the lack of records and inspection reports. In addition, market controls were not in place. 5.2.4 Enforcement Measures Legal Requirements Article 19 of Regulation (EC) No 607/2009. 8 Art 103 of Regulation (EC) No 1308/2013. Findings

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that Greece may itional terms // Article 90(1) of / (risk analysis), . . . 5 19 . 5833/155045/12.12.2013 , / . . 9 () µ . Page: 3 ceived 20 April 2017 ndations of report ref. DG(SANTE)/2016-6243-MR of the audit carried out from 15 trol systems related to Protected Designation of Origin (PDO), Protected Geographical , , (. . 1749/42334/12.04.2017) , , / . , , , , , , Excel.

to The CCA intends to organise a system of use carrying out checks on PDO/PGI/varietal rms wines and wines without a PDO/PGI on the market based on a risk analysis, during the ) No next year. This system is currently being prepared in-house. , However, Article 19(5) of JMD No 5833/155045/12.12.2013 provides for checks Page: 8 ndations (updated) received 3 August 2017 submitted by the competent authorities of Greece in response to Report ref. DG(SANTE)/2016-6243-MR 25 November 2016 in order to evaluate the control systems related to Protected Designation of Origin wine sector products petent authority arket, at the points le of PDO/PGI and n, paragraph 9 of the he competent y statement ecks per quarter to CPPQCs and he obligation, hecks of the PDO/PGI the stem has been sted in the same all the checks, at the purchasing stages, ion relating to the nces identified, sent in summary ding to the Excel Page: 9 ndations (updated) received 3 August 2017 submitted by the competent authorities of Greece in response to Report ref. DG(SANTE)/2016-6243-MR 25 November 2016 in order to evaluate the control systems related to Protected Designation of Origin wine sector products petent authority Pag

that Greece may itional terms // Article 90(1) of / (risk analysis), . . . 5 19 . 5833/155045/12.12.2013 , / . . 9 () µ . , , (. . 1749/42334/12.04.2017) , , / . , Page: 6 ated) received 3 August 2017 ndations of report ref. DG(SANTE)/2016-6243-MR of the audit carried out from 15 trol systems related to Protected Designation of Origin (PDO), Protected Geographical , , , , , Excel.

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However, at the time of the audit the CCA confirmed that no CA had been designated as responsible for official controls on microbiological risks at primary production stage (pre- during or post-harvest) of FNAO. Conclusion on Designation of CAs and Resources for Official Controls

No CA has been designated as responsible for official controls on microbiological risks at primary production stage (pre- during or post-harvest) of FNAO contrary to the requirements of Article 4(1) of Regulation (EC) No 882/2004 and this affects the implementation of official controls of FNAO. 5.2.2 Registration / Approval of Food Establishments Legal requirements Article 6 of Regulation (EC) No 852/204, Article 2 of Regulation (EU) No 210/2013 and Article 31 of Regulation (EC) No 882/2004. Findings Registration of Food Establishments

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l controls on microbiological risks DPQC, as the designated service of MRDF responsible for the g or post-harvest) of FNAO are coordination of the audit DG(SANTE)/2016-8726, informed the of Regulation (EC) No 882/2004. offices of the Minister and the General Secretary of MRDF about the lack of clear designation of CAs regarding the scope of the audit, which was the official controls on microbiological risks at primary production stage, in particular at pre-harvest and during harvest. DPQC is competent for the post-harvest stage and in particular at packaging, according to PD 107/2014. In addition to the draft report of the audit and the recommendations posed by the audit team, where the lack of designation is clearly stated, DPQC forwarded an explanatory Informative Note to the offices of Minister and the General Secretary of MRDF, where the current situation is described and the need for a prompt designation of authorities at central level is stressed, with the competence of organising and coordinating the relevant official controls.

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Official controls at farm level concerning microbiological contamination at primary production of FNAO were not defined in the planning process in any region of Greece. This means that the method for risk ranking set out in EFSA's scientific opinion (see above Section 4 Background) was not taken into account.

Inspections were done at the level of pack houses only for export produce where the produce is checked for phytosanitary and quality requirements (see also point 57).

Farms and pack houses have been excluded from the scope of official controls concerning microbial contamination of FNAO for reasons that were not risk based. This does not fulfil the requirement of Article 3(1) of Regulation (EC) no 882/2004. 10 5.2.4 Implementation of Official Controls over Food Business Operators Obligations Legal requirements Article 10(2)(b)(i), 10(2)(c) and 10(2)(d), and Article 15(1) of Regulation (EC) No 882/2004, Articles 4(1), Article 7, Article 8 and Part B of Annex I of Regulation (EC) No 852/2004, Article 18 of Regulation (EC) No 178/2002, Article 3 of Regulation (EU) No 208/2013, Regulation (EU) No 211/2013, Article 1 and Annex I of Regulation (EC) No 2073/2005. Findings

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s so that it covers farms and pack- The clear designation of the authorities for the official controls on ticle 3.1 of Regulation (EC) No microbiological risks at all the stages of primary production (pre- during and post-harvest), will enable the effective planning and implementation of official controls, in particular at the pre-harvest stage of primary production and during harvest. At post-harvest stage, DPQC is undergoing a review of the planning of official controls at the packing houses so that microbiological safety is ensured. This is done through a draft Joint Ministerial Decision, which is setting requirements for the microbiological aspects of the produce post-harvest / at packaging, including the organisation of the relevant official Page: 1 eece to the recommendations of report ref. DG(SANTE)/2016-8726-MR of the audit carried out from 13 June he system of official controls relating to microbial safety of primary production of food of non-animal origin controls, covering this way the whole of produce and not just the produce exported by approved traders which is currently already checked for microbiological hazards.

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The CA verified the sampling plan of the FBO and since his approval (November 2015) the FBO had taken the following samples, as checked by the CA: Two samples of (dry) seeds and three samples of a seed mixture after 48 h of sprouting were analysed for the presence of Salmonella spp. and E. coli. These analyses (quantity, frequency and parameters) are not in line with the requirement laid down in Annex I, Chapter 3.3, Part A.1 of Regulation (EC) No 2073/2005 (as regards preliminary testing of seeds intended for sprouting and sprouts) Monthly samples of water are analysed for E. coli. All reports showed negative results and were considered compliant by the CA inspector.

The audit team noted that at the end of the inspection, the inspectors prepared the report and a copy was provided to the FBO. No non-compliances were highlighted.

The audit team noted that the checklist used by the inspector had clear and very detailed points outlining, among others, sampling requirements for seeds and for sprouts as required by Annex I Chapter 3.3 of Regulation (EC) No 2073/2005.

The CA informed the audit team that, considering the size of the operation and the information provided, the FBO is in compliance with EU Regulations for sprouts.

The audit team noted that no non-compliances regarding the sampling of all batches of seeds as required by Annex I Chapter 3.3 A. 1of Regulation (EC) No 2073/2005 and regarding the sampling of sprouts as required by Annex I Chapter 3.3 A. 2 of Regulation (EC) No 2073/2005 were detected by the inspectors. Moreover in all previous reports there is no evidence of any non-compliance regarding analytical frequency and parameters.

The inspector explained to the audit team that they were not aware that those EU requirements should also be applied to small scale producers. 13 Internet sellers of Seeds for Sprouting

Official controls at sprout-producing establishment, contrary to what is required by Article 1 of Regulation (EC) No 2073/2005, do not adequately verify that FBOs comply with the requirements laid down by Annex I, Chapter 3.3, Part A.1 of the said Regulation (as regards preliminary testing of seeds intended for sprouting and sprouts). As a consequence they can overlook that such requirements are not complied with by FBOs. 5.2.5 Official Sampling Procedures Legal Requirements Article 11 of Regulation (EC) No 882/2004 and Annex I, Chapter 1 of Regulation (EC) No 2073/2005 15 Findings

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lation (EC) No 2073/2005, that Appropriate instructions and clarifications have been provided to compliance with the the inspectors of the local authorities, regarding the correct er 3.3, Part A.1 of the said implementation of the EU legislation requirements for the sprout ng of seeds intended for sprouting producing establishments, on any given occasion i.e. during telephone conversations. Additionally, in order to address the need in a more horizontal way, a document of MRDF (with no 5986/139201/12.12.2016) was disseminated to all the local nd 72 authorities, as a reminder of the importance of the correct and detailed implementation of the relative legislation, no matter what the size of the sprouting establishment is, big or small. Page: 2

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At the time of the audit, the planning of official controls was not fully based on a risk assessment of all PDO/PGI agricultural products and foodstuffs, although efforts have commenced to improve this situation. 5.2.3 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. 5 Articles 8(1), 9 and 10(2)(b)(vi) of Regulation (EC) No 882/2004. Regulation (EU) No 1169/2011 Findings Official controls of producers / processors of PDO/PGI agricultural products and foodstuffs

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icial O .. ­ , , , , (/). , . . : .. ­ , : 1. 2. 3. ( ) 4. / 5. (, ). 2016. . : .. ­ / o , Page: 1 of report ref. DG(SANTE)/2016-8748-MR of the audit carried out from 15 ems related to Protected Designation of Origin (PDO), Protected Geographical cultural products and foodstuffs : 1. 2. 3. ( ) 4. / 5. (, ). , : 6. 7. 2017 2017.

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There are adequate procedures in place and on-site visits were adequately performed. However, according to national legislation it is not compulsory for the Union symbols to be displayed on the stickers printed by the weighing device for bulk/unwrapped products or on the showcase sign at retail level. This is not in line with EU requirements. In addition, market controls did not include PDO/PGI/TSGs from other MSs and non-EU countries except in the case of complaints. 6 5.2.4 Enforcement Measures Legal Requirements Article 13(3) of Regulation (EU) No 1151/2012. Articles 54 and 55 of Regulation (EC) No 882/2004. Findings

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ion 1. . 12783/23.03.2017 ( 1) - le 12(3) (super markets) (), , , /, , , Page: 2 of report ref. DG(SANTE)/2016-8748-MR of the audit carried out from 15 ems related to Protected Designation of Origin (PDO), Protected Geographical cultural products and foodstuffs . , , - .

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There are adequate procedures in place and on-site visits were adequately performed. However, according to national legislation it is not compulsory for the Union symbols to be displayed on the stickers printed by the weighing device for bulk/unwrapped products or on the showcase sign at retail level. This is not in line with EU requirements. In addition, market controls did not include PDO/PGI/TSGs from other MSs and non-EU countries except in the case of complaints. 6 5.2.4 Enforcement Measures Legal Requirements Article 13(3) of Regulation (EU) No 1151/2012. Articles 54 and 55 of Regulation (EC) No 882/2004. Findings

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istered . 12787/23.03.2017 ticle - ( 2),

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At the Pireas port DPE the identity and physical checks take place in the operators' warehouses within the port area. The competent authority informed the audit team that the aforementioned warehouses are not registered as required under Regulation (EC) No 852/2004. The audit team noted that an adequate level of hygiene was maintained in the warehouse during the unloading and sampling of consignments. 3 In their response to the draft report the competent authorities noted that a draft proposal (common ministerial decision) has been prepared by the Directorate of Veterinary Care, Drugs and Extension Care with the contribution of the Animal Health Directorate. 8

At the Thessaloniki port DPE the audit team visited the two dedicated areas where competent authorities perform sampling of products of non-animal origin: The warehouse which is used for sampling fresh fruits/vegetables under enhanced controls is not officially controlled for hygiene conditions as an establishment handling food in the meaning of Regulation (EC) No 852/2004 and there is no dedicated hygienic area for food products. Therefore, non-food products (e.g. coal) would be stored together with fresh fruits/vegetables. The floor is tarmac and not possible to clean and disinfect, and there are no procedures in place to ensure pest control. In the case of the sheltered open space, which is used for sampling of products of non-animal origin (other than fresh fruits/vegetables), there is no hygienic area to 9 ensure the protection of products during unloading from the weather conditions (i.e. wind, rain) and birds (i.e. pigeons). Both locations for sampling used by Thessaloniki port DPE do not comply with the general hygiene requirements under Article 16(3) of Regulation (EC) No 882/2004 nor with the requirements of Article 4 of Regulation (EC) 669/2009. The current practice can cause an immediate and serious threat to food safety4. The above described issue was also identified by the audit DG(SANCO) 2012-6275. In response to the recommendation, the competent authority stated that the tender for the new facilities to be constructed had been announced 10 days prior to this audit visit.

At Athens airport DPE shared facilities ensuring an adequate hygiene standard are used for the DPE and phytosanitary border controls implementing Article 15(2) of Regulation 882/2004. The competent authority stated that detained consignments awaiting laboratory test results are temporarily stored in the operators' warehouse within the airport area. The audit team did not visit the warehouse since the competent authority stated that the aforementioned warehouse is not registered under Regulation (EC) No 852/2004. Conclusions on the general requirements regarding the control system

Minor deficiencies were noted in the BIP facilities visited. The competent authorities make efficiency gains by allowing DPEs and BIPs to share their facilities, although some controls are carried out in establishments that are not registered. The official controls of products of non-animal origin subject to enhanced controls are not always carried out under appropriate hygiene conditions.

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mal origin: During the past few months DPQC, in cooperation with the local authorities, has recorded the status of the DPEs and also the rest of the points where official controls may take place in Greece. The relative DPQC document is: no 1668/41188/05.04.2016 regarding the conformity of the DPEs and other points where official controls may take place to the requirements of Reg. (EC) no 852/2004. The feedback provided by the local authorities is used for the re-assessment and re-evaluation of the existing DPEs. The primary aim is to address any weaknesses noted in the existing DPEs, considering also the possibility to eliminate inactive DPEs from the official list (e.g. "Thessaloniki International Airport "Makedonia", "Port of Astakos", etc). Above procedures include the registration of any unregistered warehouses. As first priority, the re-evaluation and re-assessment targets the 12 DPEs for food of non animal origin (found at: http://www.minagric.gr/images/stories/en_docs/imports_exports/designated_points_entry_25092014.pdf) Port of Pireus Athens International Airport "Eleftherios Venizelos" Port of Thessaloniki: Hygiene conditions have been established, following immediate acti

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The AHD drafted the monitoring plan including sampling instructions with the support of experts from the DHSFAO in 2011. However, this plan does not cover the implementation of the requirements of Article 3(1) of Commission Decision 2010/381/EC. The audit team noted that the competent authority did not set up any plans in order to ensure that official samples are taken from at least 10 % of consignments of aquaculture products imported from India presented at BIPs1. Therefore, Pireas BIP did not implement required sampling for this type of consignment (see finding 34).

The audit team noted that the central competent authority did not provide instructions on principles to be applied in relation to random sampling of consignments of hazelnuts from Turkey in order to implement the requirements of Regulation (EC) No 884/2014 to ensure the balanced frequency of identity and physical checks upon import to different DPEs in Greece2.

There is a system for providing information and instructions to BIPs and DPEs, which supports the implementation of the enhanced controls. The absence of sufficiently detailed documented procedures (instructions) in certain areas allows for local interpretation of the legislation and in some cases lack of controls (sampling). 4 In its reply to the request of the audit team during the closing meeting, the Ministry of Rural Development and Food promptly provided information to the Commission services on actions taken in order to ensure the hygiene conditions during physical checks at Thessaloniki port DPE. The authorities will use the covered facilities within the Thessaloniki port until the construction of a new DPE. 10

At Pireas BIP: Pireas BIP is the only BIP where consignments of aquaculture products from India are imported into Greece. The audit team noted that aquaculture products imported from India and intended for human consumption were not sampled contrary to the requirements of Article 3(1) of Decision 2010/381/EC. The BIP manual or other instructions issued by the central competent authority do not include specific requirements for the sampling of the aforementioned products (see finding 5). Although, the copy of Decision 2010/381/EC was available at the BIP, the staff of Pireas BIP did not take samples for the laboratory tests. The audit team noted that Pireas BIP staff have developed an Excel table, which is used for recording enhanced controls and allows staff to implement sampling at the required frequency and for the appropriate analytes, but it was not used for aquaculture products from India.

At Athens airport BIP: The BIP receives consignments of fishmeal from Japan, which until 9 January 2016 were subject to the special conditions laid down in Commission Implementing Regulation (EU) No 322/2014. Article 10 of this Regulation required random physical checks including laboratory analysis on the presence of Caesium-134 and Caesium-137. The testing was not implemented on any consignment. The audit team noted that the samples taken for detection of chloramphenicol in honey from China in the case of suspicion were correctly detained until the laboratory test results had been received, in compliance with requirements of Article 20 of Directive 97/78/EC.

The audit team noted that there are different arrangements between different BIPs and DPEs regarding the transfer of the sample to the laboratory: The sample is transported to the laboratory by official staff in the case of Pireas port BIP and DPE, and Thessaloniki BIP. Peplos BIP and Kipi Evrou DPEs use a courier service to transport samples. The samples are packaged into an additional box before transportation to the laboratory. At Thessaloniki port DPE, the sample is handed to the handling agent who gives it to a courier service to take it to the laboratory. This practice does not exclude the possibility of the sample being tampered with therefore it does not guarantee the legal and analytical validity of the sample required by Article 11 of Regulation (EC) No 882/2004.

There is an adequate system allowing the implementation of identity and physical checks and ensuring that the consignments are not released before satisfactory laboratory test results are received. However, in Thessaloniki port DPE the conditions under which the checks are carried out do not comply with the general hygiene requirements.

The required sampling frequency is not always respected in DPEs and BIPs. The current sampling practices (i.e. not testing for all analytes subject to enhanced control measures) 15 do not ensure the compliance with requirements of EU legislation regarding sampling scope. 5.3.4 Decision on the consignments Legal requirements Articles 18, 19, 20 and 21 of Regulation (EC) No 882/2004 Articles 4(4), 5(1) and Annex III to Directive 97/78/EC Articles 8(2) and 13 of Regulation (EC) No 669/2009 Articles 9, 11 and 12 of Regulation (EU) No 884/2014 Article 8 of Regulation (EU) No 885/2014 Article 8 of Regulation (EU) No 2015/175 Article 12 of Commission Implementing Regulation (EU) No 2016/6 Findings

The audit team noted that staff of BIPs and DPEs visited (except Peplos BIP and Kipi Evrou DPE) have a procedure in place to verify that the consignment leaves the territory of Greece, requesting the person responsible for the load to submit the bill of lading or other documentary proof. At Peplos BIP and Kipi Evrou DPE, the detained consignments are located in the vicinity of the official facilities, and in case of rejection, 16 are returned to the country of origin. The staff at Peplos BIP and Kipi Evrou DPE could not provide the documented evidence that rejected consignments have left the territory respecting the 60 day deadline contrary to the requirements of Article 21(2) of Regulation (EC) No 882/2004.

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-animal origin: onsidering our comment on Finding 6., there is no inconsistency noted regarding the physical ontrol frequency applied between DPEs/DPIs. n order to address the difficulty of the inspectors to interpret the actual frequency applied under random" at physical controls, that was noted during the FVO visit, DPQC has issued a circular with o 1562/38274/29.03.2016, which was disseminated to all DPIs. The above circular includes specific nstructions regarding the frequency, in terms of %, to be applied when "random" physical control is ndicated in the legislation. Above clarification has been included in the Process Management System eveloped (reference to the PMS bellow). egarding the requirements for establishing hygiene conditions at sampling (DPE Thessaloniki), PQC took immediate action, for which Directorate F has been promptly informed (email of 7.04.2016, including a letter to Mr Andriessen ref no 1744/42354/06.04.2016 and all relative ocuments providing the necessary evidence). n regard to the availability of documented procedures for official controls, the draft Process Ref. Ares(2016)6919152 - 12/12/2016 March 2016 in order to evaluate the system for enhanced impo

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At Peplos BIP/Kipi Evrou DPE: The BIP facilities for identity and physical checks of products for non-human consumption are also used to carry out checks on products of non-animal origin subject to enhanced controls, thus applying the possibility granted by the provisions of Article 15(5) of Regulation (EC) 882/2004. A very low number of consignments of products of animal origin for non-human consumption are introduced into EU via Greece (only six consignments in 2015 and one consignment in January ­ March of 2016). The appropriate measures for cleaning and disinfection after each inspection are in place. The measures put in place by the competent authorities rectify the deficiencies noted during the 2012 audit. At Peplos BIP the changing room in the food for human consumption area was put in place in 2015 following the recommendation of the audit report ref. No DG(SANTE)/2015-7439. However, staff have to traverse the unloading area in order to reach the changing room, which may lead to a cross-contamination and is contrary to the requirements of the Annex to Commission Decision 2001/812/EC. There is no changing room for the areas receiving products for non-human consumption at Peplos BIP, contrary to the requirements of Article 4(2)(b) of Decision 2001/812/EC. The docks for the trucks are located in such a way that a truck blocks the road traffic when it needs to be opened for inspection at the BIP and/or DPE. In their reply to the recommendation of the audit report ref. No DG(SANTE)/2015-7439, the competent authority confirmed that efforts were being made to improve the traffic. At the time of this audit, the situation had not changed.

At the Thessaloniki port BIP the competent authority has taken corrective actions to rectify deficiencies in the facilities reported in 2015: the changing room and ceiling in the unloading room for products for non-human consumption have been put in place, and the walls have a hygienic slope finish. The audit team noted that the BIP staff do not follow the hygiene requirements to steer the flow of personnel (risk of cross- contamination) in the area for products for human consumption.

At Athens airport BIP: The changing area is located in the office. The location of the changing area does not allow the BIP staff to enter directly to the unloading area, contrary to the requirements of the Annex to Decision 2001/812/EC. The audit team noted that the access to facilities for the veterinary checks of products for non-human consumption is only possible via the facilities for the veterinary checks on products for human consumption, which can lead to cross- contamination, and is contrary to the requirements of Article 4(4) of Decision 2001/812/EC.

Minor deficiencies were noted in the BIP facilities visited. The competent authorities make efficiency gains by allowing DPEs and BIPs to share their facilities, although some controls are carried out in establishments that are not registered. The official controls of products of non-animal origin subject to enhanced controls are not always carried out under appropriate hygiene conditions.

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g 15: Actions have been taken by the BIP of Peplos in order to rectify the existing non- pliances in the HC and NHC facilities. Please find attached the relevant documentation including tions. (letter with reference number 521~5-12-2016). It still needs to be l. traffic flow in the BIP area, efforts are being made to improve the current of cross contamination in the area for products for HC has been rectified. A used to avoid any cross contamination during the flow of the BIP staff. ngs of the latest FVO mission related to cross-contamination have been nistration of Athens International Airport. Given the particular requirements of the airport, any kind of modification needs to fulfil the Airport rules and has to eement. arding the deficiencies of the changing room in the HC area, a technical study tion of the relevant costs for the rectification has already started. Please find with reference number 296847/6-12-2016. e access to NHC facilities and in order to rectify the non compliance, a different d with the Administration of the Airport following, a mutual agreement that h sides until the end of December 2016. ious recommendation (2015-7439-6) in follow up by this mission, a new

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The checklist issued by the EFET for controls in establishments producing meat and meat products thereof includes controls on general hygiene requirements, FBOs' HACCP (Hazard Analysis and Critical Control Points) based systems and contains questions on traceability, labelling and sampling for additives. Traceability controls and the checklists used are focused on one step forward and one step backward in line with the requirements of Regulation (EC) No 178/2002. Nevertheless, in some establishments, particularly those which export products, official controls on internal traceability are effectively performed. The CCA confirmed that the checklist does not contain specific questions on the use of additives for which limits are established during manufacturing process such as nitrates and nitrites and this will be reviewed.

The checklist issued by the DGSAPVS is mainly focused on general hygiene and does not contain questions related to traceability, labelling and use of additives. However, in one establishment visited, the local CA used the EFET checklist related to traceability, but not related to labelling and use of additives. The CCA stated that this checklist will be reviewed. 5

A system of official controls is in place and performs effectively. Documented procedures are established and applied. Some checklists are not complete as they do not contain relevant questions on controls on traceability, labelling and use of additives for establishments in the case of establishments under the control of the DGSAPVS and on the use of food additives in the case of the EFET. Both CCA indicated that the checklists will be reviewed in this regard.

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check lists have been revised incorporating all the rements relating to the areas of traceability, labeling and l of additives and should be available to the competent ties by the end of the year.

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The checklist issued by the EFET for controls in establishments producing meat and meat products thereof includes controls on general hygiene requirements, FBOs' HACCP (Hazard Analysis and Critical Control Points) based systems and contains questions on traceability, labelling and sampling for additives. Traceability controls and the checklists used are focused on one step forward and one step backward in line with the requirements of Regulation (EC) No 178/2002. Nevertheless, in some establishments, particularly those which export products, official controls on internal traceability are effectively performed. The CCA confirmed that the checklist does not contain specific questions on the use of additives for which limits are established during manufacturing process such as nitrates and nitrites and this will be reviewed.

The checklist issued by the DGSAPVS is mainly focused on general hygiene and does not contain questions related to traceability, labelling and use of additives. However, in one establishment visited, the local CA used the EFET checklist related to traceability, but not related to labelling and use of additives. The CCA stated that this checklist will be reviewed. 5

A system of official controls is in place and performs effectively. Documented procedures are established and applied. Some checklists are not complete as they do not contain relevant questions on controls on traceability, labelling and use of additives for establishments in the case of establishments under the control of the DGSAPVS and on the use of food additives in the case of the EFET. Both CCA indicated that the checklists will be reviewed in this regard.

The audit team verified the documentation relating to these 12 cases. The outcome of this exercise was as follows: The observations made by the authorities regarding tracing (one step forward ­ one step backward) could be confirmed for all cases regarding meat and meat products thereof. For the samples, in particular, for meat and products thereof, produced and traded within Greece, not all suppliers provided information in trade documents on food supplied with a reference identifying the lot, batch or consignment, as appropriate. Instead in most cases this information is retrieved on arrival by the receiving FBO from the labels attached to the meat. For the 10 cases seen, for which the authorities confirmed traceability, this has not led to an interruption of traceability within the supply chain of meat and products thereof. The labels or copies were not kept in all establishments visited. For one sample, documentation on certain ingredients used was missing (see paragraph 35 below). Documentation to verify the physical flow of the products within the establishments such as production data for reconciliation, the product recipes, the technical specifications of the additives and spice mixtures used were available apart from some ingredients (see paragraph 35 below). The observations made by the authorities regarding labelling could be confirmed, but some additional remarks were made for three cases verified on-the-spot (see paragraph 35 below). In two cases the use of food additives was not in line with the requirements of Union legislation. The amount of nitrite used in one meat product sample was in excess (157 mg/kg) and the amount of nitrite and nitrate used in another meat product sample slightly exceeded (150.2 mg/kg) the maximum amount that may be added during manufacturing and is therefore non-compliant with the requirements set out in Regulation (EC) No 1333/2008 (maximum limit 150 mg/kg).

The authorities identified some minor non-compliances in the traceability and labelling that had no impact on food safety for the eleven traceable samples. The authorities did not identify some non-compliances related to the use of food additives, in particular, the use of nitrites and nitrates. The information referred to in Article 3 of Regulation (EU) No 931/2011 was not available for a particular ingredient used. 5.2.2.2.Official controls on food business operators' obligations Findings

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The field of the use of additives has been of high priority for the Greek Authorities through the annual action plans, whilst providing support through the issuance of circulars, guidelines, training programs and other appropriate actions. For 2016, the following actions were taken: 1. Additional actions on the field of the use of additives, using also laboratory analysis, targeted, among others, to the control of the use of nitrate-nitrite (ref. no. 5888/22-4- 2016) - attached. 2. Issue guidelines for the official control of food additives (ref. no. 4001/22-3-2016) ­ an update of earlier directives. http://www.efet.gr/portal/pls/portal/efet_schema.pck_cont rol_instructions.getFile?fImgName=F2381/odigos_elegxo u_prostheton.pdf

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Depending on the non-compliances found, follow-up normally takes place during additional controls or during the next planned inspection if it does not concern food safety. This could take up to one year. Reports were seen where no clear deadline was given to the FBO to correct the deficiencies identified. In some cases no written evidence was available of following up previous non-compliances found.

The annual control plan was not documented in some regional EFET and local CAs. In most cases the frequency of minimum controls established at central level was followed. As regards follow-up of non-compliances, in some cases deadlines for corrective actions by FBO were not provided, and/or no documented evidence for such corrective action was available. 5.2.2. Implementation of official controls

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The Competent Authorities are working to ensure that corrective res are taken in time which is accomplished in most cases. Page: 1 ef. DG(SANTE)/2015-7391-MR of the audit carried out from 03 ontrols over the post-slaughter traceability of meat, meat products and documentation, a corresponding field in the revised is provided.

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The competent authority informed the audit team that none of the BIPs visited had direct access to information available in Customs contrary to the requirement of Article 5 of Regulation (EC) No 282/2004 and Article 6 of Regulation (EC) No 136/2004 (see finding 5).

The staff at Pireas port BIP stated that they carry out manifest checks (to identify possible consignments not presented for controls at the BIPs) on an ad hoc basis. There is no record of these controls, contrary to the requirement described in the BIP manual. The road BIPs visited do not implement any checks to identify such cases, contrary to the requirements of Article 6 of Regulation (EC) No 136/2004 and Article 6 of Regulation (EC) No 282/2004. The procedure for controls of transits described in the BIP manual does not refer to the above-mentioned requirements for the road BIPs.

The official control system of transit consignments at the entry BIPs ensures that only consignments eligible for transits are accepted as required by EU legislation with the exception of specific shortcomings on (i) the screening of available information on arriving consignments in the road BIPs that reduce the ability to detect consignments that should undergo border controls, and (ii) the identity checks, which are limited to tail checks, therefore do not ensure that the consignment tallies exactly with the description in the accompanying document. All consignments were confirmed at exit. 5.2.2 Controls at the exit Border Inspection Posts

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1. There is a good collaboration between the Customs and the Veterinary Authorities at both central and local level. This is reflected at the Memorandum of Cooperation between the two services, the common meetings, the availability of Customs data to perform cross checks on the imported consignments. Up to now, our service has focused on receiving a direct access in the Customs database, probably due to a misinterpretation of the previous recommendations, clarified during this mission. In collaboration with Customs, our intention is to formalise a written procedure in order to be in line with articles 6 and 7 of Regulation (EC) 136/2004 and articles 5 and 6 of Regulation (EC) 282/2004. Deadline to finalise the procedure 31/05/2016. 2. In regard of this recommendation, the guidance for the controls of transits included in the BIP manual will be modified accordingly to include guidance for the road BIPs. Deadline: 31/03/2016. 3. In accordance with the BIP manual, "the check of manifests must be documented". A reminder will be sent to all BIPs until the 31/01/2016 and a follow up will be done by the CCA during the supervision visits.

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In all the BIPs visited, staff perform identity checks for all transit consignments to ascertain that the products correspond to the information given in the accompanying certificates or documents, , as required in Article 4(4) of Directive 97/78/EC. In Pireas BIP these checks consist of a tail check, also in containers that include several commodities. Tail checks do not fulfil the definition of "identity checks" laid down in Article 2(2)(c) of Directive 97/78/EC (i.e. a check by visual inspection to ensure that the veterinary certificate(s) or veterinary document(s) tally with the product itself). Such tail checks may lead to consignments that do not tally with the description in the accompanying document not being detected.

The official control system of transit consignments at the entry BIPs ensures that only consignments eligible for transits are accepted as required by EU legislation with the exception of specific shortcomings on (i) the screening of available information on arriving consignments in the road BIPs that reduce the ability to detect consignments that should undergo border controls, and (ii) the identity checks, which are limited to tail checks, therefore do not ensure that the consignment tallies exactly with the description in the accompanying document. All consignments were confirmed at exit. 5.2.2 Controls at the exit Border Inspection Posts

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According to the document with reference number 662/10-11-2015 sent by the BIP of Pireas in relation to conclusion n. 22 and point 16, identity checks are in conformity with article with article 4, paragrafh 4 of Directive 97/78/EC. In a few cases, small quantities of 5 or 10 kg are difficult to be identified. The mentioned document is attached. Page: 1 er 2015 DG(SANTE)/2015-7437-MR of theauditcarried out from02 June 2015 e CCA plans to take the following actions: ollow up the procedure on the spot in the 1st semester of 16. send a reminder letter to all BIPs

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Customs stated that all EU goods including food of animal origin and live animals arriving from third countries are always accompanied with customs documents and are subject to a Customs documentary check. There is no arrangement with the veterinary service or any instruction on what checks need to be done for the consignments of veterinary interest when these are of EU origin. The audit team noted that the competent authority is not enforcing the requirement to control EU goods re-entering from external transits as provided in Article 6(1)(a) of Directive 89/662/EEC and Article 7(1) of Directive 90/425/EEC.

The audit team found cases of Intra-trade animal health certificates (INTRA) consignments issued by Greece for which the route is not defined/entered as required in the notes for guidance for intra-Community certification in Commission Regulation (EC) No 599/2004. This hinders notification to the relevant authorities and compromises the capability of the officers at exit points to identify the consignments and perform official controls at the exit contrary to the requirements in Annex I to Regulation (EC) No 206/2010. The same appears on consignments destined to Greece certified in other Member States.

The audit team found no cases of checked consignments in external transit. It is yet unknown whether such movements exist due to the lack of controls (see finding 27) and incomplete registration of intra-trade movements in TRACES (see finding 28).

The official controls do not ensure that if there are movements of EU consignments through third countries into Greece the EU animal health requirements are met. 9

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CA intends to reinforce the controls of goods re-entering the n by: issuing relevant guidance to the Customs authorities, BIPs and U. Deadline 31/03/2016 Training : Currently, during the national training (TRACES urses) addressed to the LVUs started in the second semestre 15 and continuing in 2016, particular attention is given to the ecks that must be performed and registered in part III of the ACES certificate , how the information of the certificate must filled in correctly (especially details regarding the journey log r consignments transiting through the territory of a third untry) and what to do in case of non conformities. You can find tached evidence of the 1st course of TRACES that took in hens in October 2015. Page: 2

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The monitoring plan was last made available to the BIPs and to the authorised island entry points listed in Annex I to Decision 94/641/EC in 2011. Since then it has not been reviewed/amended. The competent authority stated that this was due to a lack of human resources. In this way, the results of previous years are not taken into consideration, contrary to the requirement of paragraph 1 of Annex II to Regulation No 136/2004.

Basically in compliance with the legal requirements, there is a monitoring plan in place to be implemented at the BIPs. The plan is prepared on the basis of risk management in order to ensure that it covers all relevant commodities and the related risks. The plan has not been reviewed/amended since 2011, therefore does not take into account the results of previous monitoring or emerging risks. This means that its ability to detect hazardous goods may be compromised. 5.1.2 Implementation of the monitoring plan

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The results of the previous monitoring plans will be taken into account in the new draft which is foreseen to be finalised until 31/01/2016.

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At the Pireas and Peplos BIPs, the cost of all laboratory tests (including those under re- enforced checks or suspicion) is covered by the State. In the other BIPs visited, depending on the laboratory in which the analysis is performed, some test costs are borne by the operators and others by the State. The cases in which economic operators are not charged for the cost of controls (e.g. sampling and testing) in case of suspicion or re-enforced checks are not in line with the requirement of Article 22 of Regulation (EC) No 882/2004.

There is a system in place which allows BIP staff to take samples in case of suspicion. The system works correctly as per EU legislation and planned arrangements. However, the system does not ensure that the operator responsible for the consignment or its representative is liable for the costs incurred by the competent authority for the actions in case of suspicion.

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The costs of the laboratory tests performed within the scope of ties official controls are covered by the State. The decision defining the possibility of the official labs to perform testing on samples t by privates and which is foreseen in article 5, paragraph 1 of Law 2332/31-08-1995, is still pending. The CCA will address a letter to the responsible Department of the Directorate of Veterinary Care, Drugs and Extension Work to include in this draft decision the laboratory tests performed at BIP level in the framework of suspicion or reinforced checks.

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The memorandum of cooperation between the competent authority and Customs covers the official controls on transits. However, although it foresees the granting of access of the official veterinarians at the BIPs to the Customs database, this is not implemented. The competent authority confirmed that none of the BIPs and the LVUs visited had direct access to information available in Customs contrary to the requirement of Articles 6 and 7 of Regulation (EC) No 136/2004. In addition, the competent authority at central level has not considered using data available in the Customs database to verify the correctness of the controls laid down in Decision 94/641/EC.

With regard to recommendation No 5 of DG SANCO 2013-6977 report, the audit included visits to the islands of Crete and Lesvos and assessment of the performance of the LVUs Iraklio and Mitilini, respectively, as regards the requirements of Decision 94/641/EC. The audit team noted the following: a. Central competent authority i. The competent authority has made available the documented procedures related to official import controls in line with Articles 6(b) and 8(1) of Regulation (EC) No 882/2004. ii. The competent authority performed a supervision visit at the Iraklio LVU in 2013 and an internal audit at the Mitilini LVU in 2014 in line with Articles 4(6) and 8(3)(a) of Regulation (EC) No 882/2004. Several deficiencies were identified during the internal audit in Mitilini (e.g. the operators that were handling imports of fresh fish from Turkey had no approved establishments). b. Iraklio LVU i. There is a pre-notification system, in line with the requirement of Article 2(1) of Regulation 136/2004/EC and Article 3, first indent, of Decision 94/641/EC. ii. A CVED accompanies the consignment to the operator's facilities. The CVED bears a red stamp, indicating that the goods are destined for consumption only on the island of Crete. iii. In one out of five establishments that import through Iraklio port, the operator stamps every carton box with the number of the CVED, and provides the buyer with an invoice that bears the stamp "only for consumption on the island of Crete" in line with the requirement of the third indent of Article 3 of Decision 94/641/EC . The importer keeps an electronic traceability system in line with the requirement of the second indent of the same Article. iv. The establishment visited had good hygiene conditions in line with the requirements of Annex 1 to Regulation (EC) No 852/2004 and was approved as required by Article 6(3) of Regulation (EC) No 852/2004 and Article 4(1) of Regulation (EC) No 853/2004. v. LVU staff perform a cross-check with cargo manifests at the port but not at the airport, contrary to the requirement of Article 6 of Regulation (EC) No 136/2004. vi. The competent authority stated that veterinary checks are performed at arrival in the port of Iraklio as per Article 1 of Annex II to Decision 13 94/641/EC. The LVU staff make regular inspections in the facilities as required by Article 2 of Annex II to Decision 94/641/EC, and document these in the context of supervision visits. vii. In some cases, in order to have access to the entire consignment and ensure that the sample is representative, LVU staff perform sampling under the monitoring plan at the operators' facilities (after the consignments are imported and the CVEDs are already issued). viii. In all cases examined by the audit team, the certificates of origin of the goods indicated that they were eligible for being imported to the EU. c. Mitilini LVU i. According to the competent authority, there were two importers that imported fishery products into Lesvos island, but they ceased import operations in 2013. This is confirmed in the competent authority's annual report to the EU Commission, where 2013 was the last year in which Lesvos had imports of fresh fish from Turkey (approximately 2 tonnes). ii. The files examined indicated the following: 1. There was no pre-notification system, contrary to the requirement of Article 2(1) of Regulation 136/2004/EC and Article 3, first indent, of Decision 94/641/EC. 2. The competent authority did not gather and analyse relevant information to ensure that eligible consignments are subject to veterinary checks under Decision 94/641/EC as required. 3. There was no system equivalent to the requirements of Article 3 of Decision 94/641/EC to inform purchasers that the products are for local consumption only. 4. The documentary checks required in point 1 of Annex II to Decision 94/641/EC are not effective to detect incorrect certification (e.g. consignments of fishery products from Turkey are accepted with

Recommendation No 2 from DG(SANCO)/2013-6977 is addressed. However, appropriate actions have still not been taken as regards recommendations 1 and 5 of the same report. In addition, the system does not ensure in some cases that staff at the LVUs in the Greek islands gather and analyse relevant information to ensure that eligible consignments are subject to veterinary checks under Decision 94/641/EC and that imported consignments are only handled at approved operators' facilities.

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There is a good collaboration between the Customs and the Veterinary Authorities at both central and local level. This is reflected at the Memorandum of Cooperation between the two services, the common meetings, the availability of Customs data to perform cross checks on the imported consignments. Up to now, our service has focused on receiving a direct access in the Customs database, probably due to a misintrepretation of the previous recommendations, clarified during the last mission. Our intention is, in collaboration with Customs, to formalise a written procedure in order to be in line with articles 6 and 7 of Regulation (EC) 136/2004 and articles 5 and 6 of Regulation (EC) 282/2004. Deadline to finalise the procedure 31/05/2016. In addition, the CCA intends to verify the effectivess of the controls performed in products imported under Commission Decision 94/641/EC through: Page: 1 nt authority on 14 December 2015 ref. DG(SANTE)/2015-7439-MR of theauditcarried out from02 June 2015 rted products of animal origin - the supervision of the points of entry - the elaboration of data provided by Customs regading all points of entry under derogation - training of the new staff allocate

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With regard to recommendation No 5 of DG SANCO 2013-6977 report, the audit included visits to the islands of Crete and Lesvos and assessment of the performance of the LVUs Iraklio and Mitilini, respectively, as regards the requirements of Decision 94/641/EC. The audit team noted the following: a. Central competent authority i. The competent authority has made available the documented procedures related to official import controls in line with Articles 6(b) and 8(1) of Regulation (EC) No 882/2004. ii. The competent authority performed a supervision visit at the Iraklio LVU in 2013 and an internal audit at the Mitilini LVU in 2014 in line with Articles 4(6) and 8(3)(a) of Regulation (EC) No 882/2004. Several deficiencies were identified during the internal audit in Mitilini (e.g. the operators that were handling imports of fresh fish from Turkey had no approved establishments). b. Iraklio LVU i. There is a pre-notification system, in line with the requirement of Article 2(1) of Regulation 136/2004/EC and Article 3, first indent, of Decision 94/641/EC. ii. A CVED accompanies the consignment to the operator's facilities. The CVED bears a red stamp, indicating that the goods are destined for consumption only on the island of Crete. iii. In one out of five establishments that import through Iraklio port, the operator stamps every carton box with the number of the CVED, and provides the buyer with an invoice that bears the stamp "only for consumption on the island of Crete" in line with the requirement of the third indent of Article 3 of Decision 94/641/EC . The importer keeps an electronic traceability system in line with the requirement of the second indent of the same Article. iv. The establishment visited had good hygiene conditions in line with the requirements of Annex 1 to Regulation (EC) No 852/2004 and was approved as required by Article 6(3) of Regulation (EC) No 852/2004 and Article 4(1) of Regulation (EC) No 853/2004. v. LVU staff perform a cross-check with cargo manifests at the port but not at the airport, contrary to the requirement of Article 6 of Regulation (EC) No 136/2004. vi. The competent authority stated that veterinary checks are performed at arrival in the port of Iraklio as per Article 1 of Annex II to Decision 13 94/641/EC. The LVU staff make regular inspections in the facilities as required by Article 2 of Annex II to Decision 94/641/EC, and document these in the context of supervision visits. vii. In some cases, in order to have access to the entire consignment and ensure that the sample is representative, LVU staff perform sampling under the monitoring plan at the operators' facilities (after the consignments are imported and the CVEDs are already issued). viii. In all cases examined by the audit team, the certificates of origin of the goods indicated that they were eligible for being imported to the EU. c. Mitilini LVU i. According to the competent authority, there were two importers that imported fishery products into Lesvos island, but they ceased import operations in 2013. This is confirmed in the competent authority's annual report to the EU Commission, where 2013 was the last year in which Lesvos had imports of fresh fish from Turkey (approximately 2 tonnes). ii. The files examined indicated the following: 1. There was no pre-notification system, contrary to the requirement of Article 2(1) of Regulation 136/2004/EC and Article 3, first indent, of Decision 94/641/EC. 2. The competent authority did not gather and analyse relevant information to ensure that eligible consignments are subject to veterinary checks under Decision 94/641/EC as required. 3. There was no system equivalent to the requirements of Article 3 of Decision 94/641/EC to inform purchasers that the products are for local consumption only. 4. The documentary checks required in point 1 of Annex II to Decision 94/641/EC are not effective to detect incorrect certification (e.g. consignments of fishery products from Turkey are accepted with

Recommendation No 2 from DG(SANCO)/2013-6977 is addressed. However, appropriate actions have still not been taken as regards recommendations 1 and 5 of the same report. In addition, the system does not ensure in some cases that staff at the LVUs in the Greek islands gather and analyse relevant information to ensure that eligible consignments are subject to veterinary checks under Decision 94/641/EC and that imported consignments are only handled at approved operators' facilities.

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ease find attached the establishment license provided to the new establishment for the storage of fresh fish by the competent inary authority of Lesvos(doc with reference number 7314/6- 11-2015). According to the information provided by the last, the operational license of the facilities will be provided indicatively until 31/01/2016.

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At Peplos BIP (which is the most significant in terms of import volumes): 6 i. staff do not follow the procedures laid down in the monitoring plan as regards the percentage of samples for testing (only one random sample was taken in 2014 in 3,993 consignments imported) contrary to the requirement of Article 8(1) of Regulation No 882/2004/EC. The head of the BIP stated that this is due to the lack of human resources at the BIP. The competent authority presented at the meeting at Peplos BIP the decision to appoint an additional official veterinarian to support the activities at this BIP. ii. consignments of aquaculture sea bass and sea bream from Turkey destined to several Member States (40% of all EU imports is introduced through this BIP) were tested for antimicrobial substances once in the last three years (in 2013) and the result was satisfactory. iii. consignments of casings imported from Iran were not tested in the last 3 years (the import of Iranian casings destined to the EU via this BIP is approximately 40% of total EU imports). iv. consignments of fish species under the Customs nomenclature code 03048990 were not tested in 2014 (202 consignments were imported via Peplos). The BIP staff stated that these commodities present a low risk. However, all the above- mentioned commodities rank among the 10 largest imports of products of animal origin through the Greek BIPs in terms of quantity in 2014, with the lowest of them being a total import of 3,000 tonnes. On the basis of finding 4 those commodities should have been tested.

The monitoring plan is generally implemented in accordance with the legal requirements. The BIPs are following the planned arrangements with the exception of Peplos (the most significant in terms of import volumes). Thus the capability of the plan to detect hazardous goods is compromised. This is further reduced in cases where sampling of consignments is not representative or where the facilities cannot ensure hygienic handling of samples.

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The activities at the BIP of Peplos have increased significantly the last two years with a tendency to increase in the future. The BIP is also the main point of entry for consignments of live bivalve molluscs for which the application of Regulation 743/2013 requires imposed checks in all consignments. The procedure of appointing an additional official veterinarian to the BIP of Peplos is still ongoing. Regarding the consignments of fish of the species Epinephelus epistictus/Pristipomoides filamentosus , the BIP staff states that no such consignments have entered through the BIP in 2014. Please find attached the following documents of the BIP of Peplos: 1. reference number 466/2-12-2015 2. reference number 467/2-12-2015 Page: 2 ty on 14 December 2015 ref. DG(SANTE)/2015-7439-MR of theauditcarried out from02 June 2015 rted products of animal origin

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Generally the BIPs visited have appropriate hygienic premises and facilities for carrying out routine analyses and taking samples, in line with the requirements of Annex II to Decision 97/78/EC. The audit team noted specific deficiencies related to Article 4 of, and the Annex to Decision 2001/812/EC, that may allow cross-contamination and affect the hygienic handling of the consignments under inspection thus putting into question the validity of the laboratory testing results: a. At Peplos road BIP, there is no changing room for both human consumption/non- human consumption areas. In addition, the BIP is located on the national road in such a way that makes it unavoidable to block the road traffic when a long truck needs to be unloaded (physical inspection) at the BIP. The competent authority stated that in such cases the official veterinarians do not hesitate to stop the road traffic. b. At Thessaloniki port BIP: i. staff have to traverse the unloading area to reach the changing room in the human consumption area (risk of cross-contamination) ii. the BIP staff use forklifts and pallets from port companies when needed and there is no procedure for the decontamination of this equipment before introducing it into the BIP iii. walls are finished with no hygienic slope iv. in non-human consumption area there is no ceiling in the unloading room v. In the non-human consumption area there is no changing room. c. At Evzonoi BIP, the changing room for the non-human consumption area is not appropriately located, so the flows do not contribute to preventing cross- contamination.

The monitoring plan is generally implemented in accordance with the legal requirements. The BIPs are following the planned arrangements with the exception of Peplos (the most significant in terms of import volumes). Thus the capability of the plan to detect hazardous goods is compromised. This is further reduced in cases where sampling of consignments is not representative or where the facilities cannot ensure hygienic handling of samples.

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the compliance of the BIPs with the requirements for facilities equipment, we would like to inform you the following: of Peplos: he main non conformity detected has been rectified. A changing room has been built in the HC facilities. se find attached: e document with reference number 466/2-12-2015 of BIP of Peplos e relevant outline ctures of the works when finalised s stated in the above mentioned document, efforts are made by the BIP staff in collaboration with the responsible for the operation of the BIP and the engineer of the Prefecture, to improve the road traffic and the respective marking. The CCA will make a follow up. of Thessaloniki port: he BIP has been built before the issuing of the Hygiene package and therefore presents some non conformities as far as regards facilities, the level of which, though, is maintained satisfactory with the help of the Port Authorities of Thessaloniki. You will find attached a letter (ref. number 185/10-03-2015) addressed by the BIP to the Port Authorities for the rectification of some existing non conformities. n the NHC facilities, the roof ensures that there is no communication with the external environment and all the storage rooms and

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According to article 8 of law 4036/2012, the Coordinating National Authority (Directorate of Plant Produce Protection) will set an official training program for the staff involved to official controls on plant protection products, as mentioned in the FVO audit report. The existing training program will be reviewed in a six month period according to the audit findings including on-job trainings. he Coordinating National Authority will review the specific procedure (check list) for on-site checks in the inspections of users of PPPs to verify that only authorized PPPs are used in accordance with their conditions of authorization as required by Article 55 of Regulation (EC) No 1107/2009 in a two month period.

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There are sheep and goats herds (holdings) that are not registered in the NHD, which is not in line with Article 7 of Regulation (EC) No 21/2004. In one RU visited, the audit team was informed that small herds, keeping 5 to 10 animals, were not registered. These represented 10% of herds in that RU (around 150 to 200 herds). No action was implemented by the RVD to address this issue.

The amount of herds and animals excluded from the Programme, without any on-the- spot verification, compromise seriously the reliability of the data used for planning, monitoring and evaluation of the effectiveness of the Programme measures.

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In the vaccination zone there is no additional testing of animals (both males and females) in infected herd to speed up the detection and removal of all positives (so to reduce the probability of spread) or to confirm that the disease has been eliminated. Although not required in the Programme, such testing is required in the Article 3(13)(c) and Article 5(5)of Council Decision 90/242/EC. The next testing generally takes place the next year when annual sampling of male animals is scheduled. The CCA explained that as some female animals have been vaccinated as adults, the reliability of serological testing of females would be questionable (due to expected false positive results). However, the fact that females older than 18 months and vaccinated at age of 3 to 6 months are eligible for testing, was not taken into account by the CCA2.

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According to the Ministerial Decision Ref 4888/130873 as well as Official Decisions on measures to be implemented on infected holdings in the vaccination zone, verified by the audit team on the spot, restrictions on movements apply to positive animals only. This is not in line with the Point 4.4.9 of the BMEP nor with the Article 3(13)(a) of Council Decision 90/242/EC, where the prohibition of exit and introduction of animals (except movements for immediate slaughter) applies to the infected flock.

In addition, some practices which deviate from the approved Programme (such as movement restrictions applying only to positive animals, absence of testing of all eligible animals on positive holdings, absence of bacteriological testing on positive holdings, no investigation of abortions, application of EU non-compliant testing scheme to classify a holding as BMOF, no restrictions of use of pastures used by infected animals). These practices have an adverse effect on elimination of the infection and hamper achievement of the Programme objectives to the detriment of the overall cost- effectiveness of the Programme.

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The Ministerial Decision Ref 4888/130873 does not require application of measures to infected pastures. Pastures that held infected animals are not forbidden to be used for at least two months, which is not in line with Article 5(1) of the Council Decision 90/242/EC. None of the Official Decisions verified by the audit team included a requirement as regards pastures used by animals from infected herds. 5.3.6.2 Slaughter of positive animals

In addition, some practices which deviate from the approved Programme (such as movement restrictions applying only to positive animals, absence of testing of all eligible animals on positive holdings, absence of bacteriological testing on positive holdings, no investigation of abortions, application of EU non-compliant testing scheme to classify a holding as BMOF, no restrictions of use of pastures used by infected animals). These practices have an adverse effect on elimination of the infection and hamper achievement of the Programme objectives to the detriment of the overall cost- effectiveness of the Programme.

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Milk from vaccinated animals on infected holdings is considered as milk from non- infected animals. According to the Article 16(7) of the Ministerial Decision Ref. 4888/130873, milk from non-infected animals from an infected holding has to be used according to the provisions of Annex III, Section IX, Chapter I, Paragraphs 3 to 5 of the Regulation (EC) No 853/2004. However, no Official Decisions reviewed by the audit team, imposed restrictions or requirements regarding the use of milk from animals from the infected holding on the same or other holdings. Also, Official Decisions reviewed, did not specify any restrictions as regards the use of milk from infected animals as mentioned in Point 4.4.9 of the approved Programme and Article 3(13) of the Council Decision 90/242/EC. 5.3.6.5 Epidemiological investigation

The absence of measures as regards the use of milk from animals in an infected holding on the same or on another holding in the vaccination zone, prevent minimisation of possible risk of infection of humans or animals. This is in particular relevant for infected herds where vaccination coverage is low.

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The NDCC was not formally established as a crisis unit after the confirmation of the first LSD outbreak, contrary to provisions of Article 8 (2) and Point 1 of Annex IV to Directive 92/119/EEC.

The failure to activate and make the NDCC fully operational prevented the maximum use of resources and the responsibility of crisis management was not shared among all relevant stakeholders. The fact that not all stakeholders exercised their advisory or management role, as foreseen in the contingency plan, resulted in additional pressure and responsibility on veterinary staff who mainly worked alone and under difficult circumstances. The absence of strategic planning at central level and of emergency funds, together with the inadequate preparedness for emergency vaccination, imposed additional burden on local services and other staff directly involved in the crisis operations and delivery on-the-spot. This most likely reduced the effectiveness of the emergency response to prevent the spread of LSD virus at the early stages of the epidemic.

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The contingency plan does not include details for the implementation of emergency vaccination nor details on the quantity of vaccine estimated to be required in the event of recourse to emergency vaccination against a disease crisis. This is not in line with Point 9 of Annex IV to Directive 92/119/EEC. 5.1.2 Activation of the contingency plan at national level

The failure to activate and make the NDCC fully operational prevented the maximum use of resources and the responsibility of crisis management was not shared among all relevant stakeholders. The fact that not all stakeholders exercised their advisory or management role, as foreseen in the contingency plan, resulted in additional pressure and responsibility on veterinary staff who mainly worked alone and under difficult circumstances. The absence of strategic planning at central level and of emergency funds, together with the inadequate preparedness for emergency vaccination, imposed additional burden on local services and other staff directly involved in the crisis operations and delivery on-the-spot. This most likely reduced the effectiveness of the emergency response to prevent the spread of LSD virus at the early stages of the epidemic.

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. 405/20396/18-02-2015 / , & . , 2 . (. 14, 17 32 ) () ( VI 2 ).

. 405/20396/18-02-2015 / , & . , 2 . (. 14, 17 32 ) () ( VI 2 ).

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, .405/20396/18-02-2015 / , & / & , . , , . (. 21 ). , 5 . 2 . ( VI 2 ). (. 14 21) 1/2 2015

, .405/20396/18-02-2015 / , & / & , . , , . (. 21 ). , 5 . 2 . ( VI 2 ). (. 14 21) Updated Action Plan response received on 7 September 2015 . 405/20396/18-02-2015 , 1/2 80% () 2015. . . . 4235/2014.

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, . , 78. . . 2c) ) 64, 39,69,72 ).

, . , 78. . . 2c) ) 64, 39,69,72 ). ed Action Plan response received on 7 September 2015 (. el No 3: "validation_methods_2015". B2b, 2/2 eptember 2015 methods_2015",

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. 0400/18-02-2015 ( 7) 00% (. 64,66,39,69,72 ). , ), . 2/2

. 0400/18-02-2015 ( 7) 00% (. 64,66,39,69,72 ). , ), .

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3397/108310/9-9- , 6 852/2004. FVO, .

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To ensure that all food establishments supplying raw milk are either registered or approved as required by Article 4(2) of Regulation (EC) No 853/2004.

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To take measures to further improve the level of compliance with the criteria for raw cows' milk required in Annex III, Section IX, Chapter I, Point 3 (a) and (b) of Regulation (EC) No 853/2004 and, in particular, to implement a system of controls at holding level to verify that the hygiene requirements at holding level provided by Regulation (EC) No 852/2004 and Regulation (EC) No 853/2004 are being complied with as required by Annex IV to Regulation (EC) No 854/2004.

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To improve the implementation of official controls to ensure that controls over food business operators' general and specific hygiene requirements ensure full compliance with the requirements of Annex II to Regulation (EC) No 853/2004; that official controls are documented as required by Article 9 of Regulation (EC) No 882/2004 (particularly for official controls for dairy hygiene at holding level); that appropriate action is taken in case of identified non-compliances (as required by Article 54 of Regulation (EC) No 882/2004); and that the approval status of establishments is kept under review (as required by Article 31.2(e) of Regulation (EC) No 882/2004).

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To further improve the official controls over food business operators' Hazard Analysis Critical Control Plan based procedure, in particular as regards the critical limits, their monitoring, the corrective action taken by food business operators when deviations take place in order to ensure full compliance with the requirements of Article 5 of Regulation (EC) No 852/2004.

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Page: 1 d. Please check back later to see this response f. DG(SANCO)/2013-6884 -MR of a/an audit carried out from 17 the follow-up action taken by the competent authorities with regard to the

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To ensure that official controls over food business operators' compliance of Regulation (EC) No 2073/2005 cover all the requirements of this Regulation applicable to the dairy sector and that food business operators comply with all applicable requirements of this Regulation.

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To further improve the co-ordination between the competent authorities responsible for carrying out official controls at holding level, establishment level and raw milk laboratory level in order to ensure it is efficient and effective as required by Article 4 (3) of Regulation (EC) No 882/2004 in all regions.

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To ensure that the official controls on potable water cover all the requirements of Council Directive 98/83/EC.

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To further improve the verification of effectiveness of official controls in order to ensure full compliance with the requirements of Article 8 of Regulation (EC) No 882/2004.

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age: 2

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saloniki port has access to the on-line system provided aloniki Port Authority and can verify all incoming The BIP of Pireas has access to the information regarding nsignments delivered by the ship companies. Efforts will o the improvement of the access of the staff of the BIP of e information available to Customs. A meeting of the CCA is regard, in October 2013 with the two handlers of the Port Authorities and the Cosco).

The BIP of Thessaloniki port has access to the on-line system provided by the Thessaloniki Port Authority and can verify all incoming consignments. The BIP of Pireas has access to the information regarding the incoming consignments delivered by the ship companies. Efforts will be focused to the improvement of the access of the staff of the BIP of Pireas to the information available to Customs. A meeting of the CCA is foreseen in regard, in October 2013 with the two handlers of the Port (Pireas Port Authorities and the Cosco). Updated Action Plan received on 17 December 2013 The improvement of access of the BIP staff to data from the Customs database will be based on the bilateral Memorandum between the two competent authorities (Customs- Veterinary Authorities. The CCA has already made a new approach in November 2013 with the Customs authorities but, due to the implementation of the new Customs Page: 1 nt Authority on 17 December 2013 Authorities of Greece on 16 September 2013 in response to Report ref. DG(SANCO)/2013- pril 2013 in order to evaluate the follow-up action taken by the competent authorities with n of Commission Decision 94/641/EC. ctronic system at the beginning of em

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ing manual for live animals has been updated (late mber 2013) in order to cover the deficiencies found upervision visits by the CCA and the late FVO audit. as been amended accordingly to cover the sues: imports of birds (other than poultry) for easons, import of birds destined to a zoo (Greece n national health requirements and a model health , imports of aquaculture animals (including ornamental ts of live snails (national health requirements and ficate), imports of wild animals destined to an anization, imports of racing pigeons and the the manure. It also contains a number of annexes ation that has to accompany the pet animals, d (Annex I) Page: 1 ate Annex and can be found at:http://ec.europa.eu/food/fvo/rep_details_en.cfm?rep_id=3163 SANCO)/2013-6977-MR of an audit carried out authorities with regard to the import/transit control thority cate for the import of birds ex II) cate for the import of live snails ntingency plan and how the BIP l lists as well as the contact details have to be contacted in case of ed in the manual. all the amendments is provided. ontrols of the Animal health update of the manual which is new legislation that comes into the supervision or internal aud

existing manual for live animals has been ated (late update September 2013) in er to cover the deficiencies found during supervision visits by the CCA and the late audit. The manual has been amended ordingly to cover the following issues: orts of birds (other than poultry) for mercial reasons, import of birds destined a zoo (Greece has laid down national lth requirements and a model health tificate), imports of aquaculture animals cluding ornamental fish), imports of live ils (national health requirements and lth certificate), imports of wild animals tined to an approved organization, imports racing pigeons and the handling of the ure. It also contains a number of annexes Page: 2 nt Authority on 17 December 2013 Authorities of Greece on 16 September 2013 in response to Report ref. DG(SANCO)/2013- pril 2013 in order to evaluate the follow-up action taken by the competent authorities with n of Commission Decision 94/641/EC. the mport mport ncy on details to be is he Page: 3 nt Authority on 17 December 2013 Authorities of Greece on 16 September 2013 in response to Report ref. DG(SANCO)/2013- pril 2013 in order to evaluate the follow-up action taken by the competent authorities with n

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of Sanitary Veterinary Controls has carried out a series isits, in conformity with the Ministerial Decision with 390~2-09-2009 and the BIPs of Thessaloniki Port, s International airport, Evzoni, Page: 2 ate Annex and can be found at:http://ec.europa.eu/food/fvo/rep_details_en.cfm?rep_id=3163 SANCO)/2013-6977-MR of an audit carried out authorities with regard to the import/transit control etent Authority were visited the period November 2012- non conformities were described in detail at wn by the CCA and delivered to the BIPs so cessary actions to rectify them. Actions have non conformities regarding the facilities and ongoing (please see point 4). een by the CCA in order to verify the s taken. A detailed program of the visits can works will be completed and always in base resources. e of Veterinary Audits and Controls is going to some of the points of entry under derogation)

department of Sanitary Veterinary trols has carried out a series of ervision visits, in conformity with the isterial Decision with ref. number Page: 5 nt Authority on 17 December 2013 Authorities of Greece on 16 September 2013 in response to Report ref. DG(SANCO)/2013- pril 2013 in order to evaluate the follow-up action taken by the competent authorities with n of Commission Decision 94/641/EC. oni, the d in y the y fy the and se in actions an be y he ry Page: 6 nt Authority on 17 December 2013 Authorities of Greece on 16 September 2013 in response to Report ref. DG(SANCO)/2013- pril 2013 in order to evaluate the follow-up action taken by the competent authorities with n of Commission Decision 94/641/EC. 14. is Page: 7 nt Authority on 17 December 2013 Authorities of Greece on 16 September 2013 in response to Report ref. DG(SANCO)/2013- pril 2013 in order to evaluate the follow-up action taken by the competent authorities with n of Commission Decision 94/641/EC. irectorate of Veterinary Audits and ols has a formalised procedure, ding to ISO 9001. e procedure in question is attached se see in particular pages 5, 6 and 7). ill be notified of the detailed program e audits as soon as it

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update of the ongoing works regarding the BIPs would like to give you a follow up: truction works for the proposed mpleted. Hereby, you will find document. The CCA will officially delisting of the BIP for live animals tegory HC(2). giene problems have been rectified, Page: 3 Annex and can be found at:http://ec.europa.eu/food/fvo/rep_details_en.cfm?rep_id=3163 SANCO)/2013-6977-MR of an audit carried out authorities with regard to the import/transit control thority een stipulated between the BIP t will be responsible for the he live animals in case of need. at you can find attached, the ent at the BIP any time this is improvement of the unloading ed in the budget of 2014 (see 013/12-09-2013). regarding the rectification of ilities of the BIP (no appropriate storage facilities for the NHC, the , conformities regarding hygiene are to be completed at the end of ached some photos of the ongoing he Head of the BIP. he deficiencies regarding the of import/transit of live animals been rectified with the updated manual for live animals. b) The le at BIPs and a procedure etween HC and NHC is Page: 4 Annex and can be found at:http://ec.europa.eu/food/fvo/rep_details_en.cfm?rep_id=3163 SANCO)/2

r as regards the update of the ongoing regarding the BIPs facilities, we would to give you a follow up: P of Idomeni: The construction for the proposed approval HC(2) have completed. Hereby, you will find hed the BIP's relevant document. The ill officially address the request for elisting of the BIP for live animals and pproval for the category HC(2). Page: 8 nt Authority on 17 December 2013 Authorities of Greece on 16 September 2013 in response to Report ref. DG(SANCO)/2013- pril 2013 in order to evaluate the follow-up action taken by the competent authorities with n of Commission Decision 94/641/EC. ted n t, e of u have quired d in . Page: 9 nt Authority on 17 December 2013 Authorities of Greece on 16 September 2013 in response to Report ref. DG(SANCO)/2013- pril 2013 in order to evaluate the follow-up action taken by the competent authorities with n of Commission Decision 94/641/EC. (no w sion ding e to of live Page: 10 nt Authority on 17 December 2013 Authorities of Greece on 16 September 2013 in response to Report ref. DG(SANCO)/2013- pril 2013 in order to evaluate the follow-up action taken by the competent authorities with n of Commission Decision 94/641/EC. at BIP iency wit

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s found during the FVO audit, the CCA has ng actions in order to improve the effectiveness of the ut on products under Commission Decision 94/641/EC: it took place in Iraklio on the 19th and 20th of the 19-08-2013, the representative of the CCA anitary Veterinary Controls) visited the f three of the main importers of Iraklio Port in their system of registering the incoming how these can be diversified by all other e labeling and the way these are stored has also the 20-08-2013 a meeting took place in Iraklio, the Periphery of Crete with the presence of a f the CCA, the staff of the Periphery of Crete ng the controls and the main importers of erogation. The main findings of the FVO audits nd the measures that have to be taken were CCA. All the present agreed to make all the Page: 7 Annex and can be found at:http://ec.europa.eu/food/fvo/rep_details_en.cfm?rep_id=3163 SANCO)/2013-6977-MR of an audit carried out authorities with regard to the import/transit control Proposed by the Competent Authority to conform with the urrent EU legislation. The Crete (document with ref. number the names of the participants and resentative of the CCA (document re attached. number 3588/110184/12-09- ll

Following the deficiencies found during the FVO audit, the CCA has taken the following actions in order to improve the effectiveness of the controls carried out on products under Commission Decision 94/641/EC: 1. A two-day visit took place in Iraklio on the 19th and 20th of August 2013. On the 19- 08-2013, the representative of the CCA (Department of Sanitary Veterinary Controls) visited the establishments of three of the main importers of Iraklio Port in order to verify Page: 20 nt Authority on 17 December 2013 Authorities of Greece on 16 September 2013 in response to Report ref. DG(SANCO)/2013- pril 2013 in order to evaluate the follow-up action taken by the competent authorities with n of Commission Decision 94/641/EC. e s ice of of a he ts e s he he m the e laid Page: 21 nt Authority on 17 December 2013 Authorities of Greece on 16 September 2013 in response to Report ref. DG(SANCO)/2013- pril 2013 in order to evaluate the follow-up action taken by the competent authorities with n of Commission Decision 94/641/EC. Crete en by ormed ted, ts: d x by ge, t has ed ng on e Page: 22 nt Authority on 17 December 2013 Authorities of Greece on 16 September 2013 in response to Report ref.

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. (a) In the first semester of 2012, 31 inspectors from the local CAs as well as the CCAs participated in the training for the implementation of TRACES for food and feed of non animal origin, in the framework of which discussions on import controls and sampling techniques also took place. Questions where answered and guidelines where given by the DPSQCPVO. The above training courses were coordinated by DPSQCPVO and were organized in cooperation with the Center for Public Administration. TRACES training will be planned for the 2nd semester 2012 too. 1 (of 9) ons of Report ref. DG(SANCO)/2012-6275-MR of an audit carried out od of non-animal origin Action Proposed by the Competent Authority (b)The DPSQCPVO is currently exploring the possibility to organize training courses on import controls and sampling techniques in coordination with the Center of Public Administration, in order to address the inspectors of the local CAs. In parallel, the Directorate of Education of MRDF is cooperating with the Center of Public Administration in order to evaluate/assess the needs of MRDF for training & education, with the aim to organize training sessions. 2. Pending the establishment of the interna

date 1. (a) In the first semester of 2012, 31 inspectors from the local CAs as well as the CCAs participated in the training for the implementation of TRACES for food and feed of on animal origin, in the framework of which discussions on import controls and sampling techniques also took place. Questions where answered and guidelines where given by the DPSQCPVO. The above training courses were coordinated by DPSQCPVO and were organized in cooperation with the Center for Public Administration. TRACES training will be planned for the 2nd semester 2012 too. (b) The DPSQCPVO is currently exploring the possibility to organize training courses on import controls and sampling techniques in coordination with the Center of Public Administration, in order to address the inspectors of the local CAs. In parallel, the Directorate of Education of MRDF is cooperating with the Center of Public Administration in order to evaluate/assess the needs of MRDF for training & education, with the aim to organize training sessions. 2. Pending the establishment of the internal audit system, the DPSQCPVO has developed an annual plan for on-site audit of all active DPEs/DPIs starting in September 2012. The aim

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updated list of the DPIs including the exact location of the places where cial controls are actually carried out is uploaded on the MRDF site ww.minagric.gr/images/stories/docs/politis/POIOTIKOS_ELENXOS/pinakas_k 2_2009_rev2_el.pdf In addition, a list of the relevant local CAs at the FPIs is available on the MRDF site as well http://www.minagric.gr/images/stories/docs/politis/POIOTIKOS_ELENXOS/simeia_pr 2 (of 9) ons of Report ref. DG(SANCO)/2012-6275-MR of an audit carried out od of non-animal origin Action Proposed by the Competent Authority ot_eisod_kan1152_2009.pdf

of An updated list of the DPIs including the exact location of he places where official controls are actually carried out is uploaded on the MRDF site http://www.minagric.gr/images/stories/docs/politis/POIO ial TIKOS_ELENXOS/pinakas_kse1152_2009_rev2_el.pdf icle In addition, a list of the relevant local CAs at the FPIs is available on the MRDF site as well http://www.minagric.gr/images/stories/docs/politis/POIO TIKOS_ELENXOS/simeia_prot_eisod_kan1152_2009.pd f

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tion to the immediate reaction following the findings during the audit in March 2012, the following actions were required by the local CAs (PSQCPVO circular ref. no 2600/62191/29.05.2012): - the CA responsible for implementing Reg. (EC) 669/2009 at the DPE of Thesssaloniki was asked to immediately restore, to a satisfactory level, the hygiene conditions of the place where the identity and physical checks are carried out, and retain them. - in a horizontal approach, all CAs carrying out identity and physical checks on food of non animal origin (including the DPE Thessaloniki) are asked to appoint an inspector who will be responsible for the development and the keeping of a cleaning program for the places where above checks are carried out. The abovementioned cleaning program may be developed in cooperation with any relative party, where necessary: e.g. the FBO, if identity and physical checks take place in the FBO premises, the port authorities, if the checks take place within a port, etc.

In addition to the immediate reaction following the findings during the audit in March 2012, the following actions were required by the local CAs (PSQCPVO circular ref. no 2600/62191/29.05.2012): he CA responsible for implementing Reg. (EC) Page: 2 the Competent Authorities of Greece on 12 July in response to Report ref. from 06 to 13 March 2012 in order to evaluate import controls on food of non-animal Action Proposed by the Competent Authority 669/2009 at the DPE of Thesssaloniki was asked to immediately restore, to a satisfactory level, the hygiene conditions of the place where the identity and physical checks are carried out, and retain them. - in a horizontal approach, all CAs carrying out identity and physical checks on food of non animal origin (including the DPE Thessaloniki) are asked to appoint an inspector who will be responsible for the development and the keeping of a cleaning program for the places where above checks are carried out. The abovementioned cleaning program may be developed in cooperation with any relative party, where necessary: e.g. the FBO, if identity and physical checks take place in the FBO premises, the port authorities, if the checks take place wit

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QCPVO has decided the development of a "Standard Operating Procedure Manual (SOPM)", part of this has already been materialised. The aforementioned SOPM is expected to be completed by the end of 2012. An SOP concerning prior notification, which includes the requirements of Regulation (EC) No 669/2009 and (EC) No 1152/2009 is already documented.

DPSQCPVO has decided the development of a "Standard perating Procedure Manual (SOPM)", part of this has already been materialised. The aforementioned SOPM is expected to be completed by the end of 2012. An SOP concerning prior notification, which includes the requirements of Regulation (EC) No 669/2009 and (EC) No 1152/2009 is already documented. Moreover, during a meeting held by the DPSQCPVO in Page: 3 the Competent Authorities of Greece on 12 July in response to Report ref. from 06 to 13 March 2012 in order to evaluate import controls on food of non-animal Action Proposed by the Competent Authority December 2011, the importers were reminded of the requirement of prior notification and its importance and agreed to focus their efforts on complying with it.

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QCPVO took the initiative to translate the EU Commission guideline document "Questions and Answers Paper" into the Greek language, with the aim 3 (of 9) ons of Report ref. DG(SANCO)/2012-6275-MR of an audit carried out od of non-animal origin Action Proposed by the Competent Authority that it will be easier for the inspectors to use and refer to. The translated guideline document is available in the relative site of the MRDF http://www.minagric.gr/images/stories/docs/agrotis/eisagoges_ejagoges/erotiseis_apanti seis_09072012.pdf The consistency to the definition of consignment and its use by the CAs has already been discussed during the TRACES training (response to rec. 1, point 1(a)) and the results will be evaluated in the framework of the on-site audit planned by the PSQCPVO (response to rec. 1, point 2).

The DPSQCPVO took the initiative to translate the EU int Commission guideline document "Questions and Answers Paper" into the Greek language, with the aim that it will easier for the inspectors to use and refer to. The translated guideline document is available in the relative site of the MRDF http://www.minagric.gr/images/stories/docs/agrotis/eisago ges_ejagoges/erotiseis_apantiseis_09072012.pdf The consistency to the definition of consignment and its use by the CAs has already been discussed during the TRACES training (response to rec. 1, point 1(a)) and the results will be evaluated in the framework of the on-site audit planned by the PSQCPVO (response to rec. 1, point 2).

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DPSQCPVO has provided guidance to the CAs on how to duly complete the CED on several occasions: he date of issue of Reg (EC) no 669/2009, DPSQCPVO circulars have included relative guidelines and have addressed deficiencies · during TRACES and BTSF training (response to Rec.1, point 1(a) and 3, respectively) the correct completion of the CEDs is extensively discussed · different SOPs (e.g. for prior notification) also include relevant guidelines · any deficiencies will also be identified and further guidelines will be given in the framework of the on-site visits to the local competent authorities planned by the DPSQCPVO (response to rec.1, point 2)

QCPVO has provided guidance to the CAs on how to duly complete the CED on several occasions: f · since the date of issue of Reg (EC) no 669/2009, DPSQCPVO circulars have included relative guidelines and have addressed deficiencies · during TRACES and BTSF training (response to Rec.1, Page: 4 the Competent Authorities of Greece on 12 July in response to Report ref. from 06 to 13 March 2012 in order to evaluate import controls on food of non-animal Action Proposed by the Competent Authority point 1(a) and 3, respectively) the correct completion of the CEDs is extensively discussed ·different SOPs (e.g. for prior notification) also include relevant guidelines ·any deficiencies will also be identified and further guidelines will be given in the framework of the on-site visits to the local competent authorities planned by the DPSQCPVO (response to rec.1, point 2)

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The response to rec.6 corresponds to the Reg. (EC) No 1152/2009 respectively. 4 (of 9) ons of Report ref. DG(SANCO)/2012-6275-MR of an audit carried out od of non-animal origin Action Proposed by the Competent Authority

response to rec.6 corresponds to the Reg. (EC) No 1152/2009 respectively o

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egarding the onward transportation has been documented in the ition, a DPSQCPVO circular (ref. No 3096/72484/28.06.2012) including detailed procedure to be followed in cases of onward transportation to another MS haw been disseminated to the CAs and already been implemented. updated list of contact points of the Member States for the purposes of onward transportation has been sent to the CAs for this reason. An example of the correct implementation of the procedure of onward transportation is provided as evidence (see Attachment no 3 to cover letter).

An SOP regarding the onward transportation has been documented in the SOPM. n addition, a DPSQCPVO circular (ref. No 096/72484/28.06.2012) including the detailed procedure to be followed in cases of onward transportation to another MS haw been disseminated to the CAs and already been implemented. The updated list of contact points of the Member States for the purposes of onward transportation has been sent to the CAs for this reason. Page: 5 the Competent Authorities of Greece on 12 July in response to Report ref. from 06 to 13 March 2012 in order to evaluate import controls on food of non-animal Action Proposed by the Competent Authority An example of the correct implementation of the procedure of onward transportation is provided as evidence (see Attachment no 3 to cover letter).

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In all procedures/guidelines included in the DPSQCPVO circulars to the CAs, he necessity of efficient and effective co-ordination between different rities is pointed out and described in detail. Moreover, the SOPs describe in detail the actions of each competent authority and the way they should cooperate with each other in each case.

ion In all procedures/guidelines included in the DPSQCPVO circulars to the CAs, the necessity of efficient and ticle effective co-ordination between different authorities is pointed out and described in detail. Moreover, the SOPs describe in detail the actions of each competent authority and the way they should cooperate with each other in each case.

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garding the sampling and the precautions required by Annex I A.3.3 of n (EC) No 401/2006 are being discussed during the TRACES and ning (response to Rec.1, point 1(a) and 3, respectively). However, specific deficiencies are addressed by DPSQCPVO through detailed instructions to the CAs. Moreover, the scope of the on-site audit also includes the implementation of Reg. (EC) No 401/2006 (response to rec.1, point 2)

ssues regarding the sampling and the precautions required by Annex I A.3.3 of Regulation (EC) No 01/2006 are being discussed during the TRACES and BTSF training (response to Rec.1, point 1(a) and 3, respectively). However, specific deficiencies are addressed by DPSQCPVO through detailed instructions to the CAs. Thessaloniki, in particular, is presently using the facilities of a laboratory belonging to the Regional Unit of Thessaloniki, located next door and currently inactive, for the appropriate cleaning of the sampling equipment, meeting this way the requirements of Annex I A.3.3 of the Reg. (EC) No 401/2006. Page: 6 the Competent Authorities of Greece on 12 July in response to Report ref. from 06 to 13 March 2012 in order to evaluate import controls on food of non-animal Action Proposed by the Competent Authority Moreover, the scope of the on-site audit also includes the implementation of Reg. (EC) No 401/2006 (response to rec.1, point 2)

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O: The procedure to designate the laboratories (state and private) for icial controls is currently in progress. The designation will be finalised with 5 (of 9) ons of Report ref. DG(SANCO)/2012-6275-MR of an audit carried out od of non-animal origin Action Proposed by the Competent Authority the issuance of an MD of the Minister of MRDF and is estimated to be completed by the end of October 2012. GCSL: The National Reference Laboratory of the EU for Mycotoxins (Division of Environment - GSGL) intends to fully fulfill its duties to private testing laboratories, used by the authorities for the official control of mycotoxins (starting from the notification of participation in the meeting report of the National Laboratories petition, held in Belgium (Geel), on 26-27 April 2012), as soon as they are designated by the Central Competent Authorities.

DPSQCPVO: The procedure to designate the laboratories s, (state and private) for official controls is currently in y progress. The designation will be finalised with the issuance of an MD of the Minister of MRDF and is estimated to be completed by the end of October 2012. GCSL: The National Reference Laboratory of the EU for ycotoxins (Division of Environment - GSGL) intends to fully fulfill its duties to private testing laboratories, used by the authorities for the official control of mycotoxins (starting from the notification of participation in the meeting report of the National Laboratories petition, held in Belgium (Geel), on 26-27 April 2012), as soon as they are designated by the Central Competent Authorities.

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From a sample of laboratory results taken and examined recently by PVO, there were no deficiencies arisen regarding the application of Annex II 4.4. of Regulation (EC) No 401/2006. Therefore, the finding of lab results not correctly reported may be considered as rare and exceptional. Moreover, the requirements laid down by the provisions of the Reg. (EC) No 401/2006 are a perquisite for the listing as designated laboratories. The scope of the on-site audit also includes the implementation of Reg. (EC) No 401/2006 (response to rec.1, point 2)

for From a sample of laboratory results taken and examined recently by DPSQCPVO, there were no deficiencies isen regarding the application of Annex II 4.4. of Regulation (EC) No 401/2006. Therefore, the finding of lab results not correctly reported may be considered as rare and exceptional. Moreover, the requirements laid down by the provisions of the Reg. (EC) No 401/2006 are Page: 7 the Competent Authorities of Greece on 12 July in response to Report ref. from 06 to 13 March 2012 in order to evaluate import controls on food of non-animal Action Proposed by the Competent Authority a perquisite for the listing as designated laboratories. The scope of the on-site audit also includes the implementation of Reg. (EC) No 401/2006 (response to rec.1, point 2)

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L: As regards the laboratories of the General Chemical State Laboratory, stimation of the measurement uncertainty is carried out in accordance with d operating procedure SOP 00 00 5.04.01 of the GCSL quality assurance system (accredited according to ISO/IEC 17025: 2005 standard). The hes of the SOP applied in GCSL laboratories (including the laboratory of hemical Service of Piraeus visited by the FVO team) are fully in line with 6 (of 9) ons of Report ref. DG(SANCO)/2012-6275-MR of an audit carried out od of non-animal origin Action Proposed by the Competent Authority irements of DG SANCO guidelines "Report on the relationship between ical results, measurement uncertainty, recovery factors and the provisions of EU food and feed legislation, with particular reference to community legislation concerning contaminants in food and undesirable substances in feed" as described in ANNEX II: PROCEDURES FOR THE ESTIMATION OF MEASUREMENT UNCERTAINTY of the report. Specifically, the laboratory of the A' Chemical Service of Piraeus follows the approach of EURACHEM/CITAC Guide, EURACHEM-Quantifying Uncertainty in Analytical Measurement, 2nd edition, 2000, (ANNEX II.2 of DG SANCO report) and the

or GCSL: As regards the laboratories of the General Chemical State Laboratory, the estimation of the measurement uncertainty is carried out in accordance with tandard operating procedure SOP 00 00 5.04.01 of the GCSL quality assurance system (accredited according ty, to ISO/IEC 17025: 2005 standard). The approaches of the SOP applied in GCSL laboratories (including the r laboratory of a A' Chemical Service of Piraeus visited by the FVO team) are fully in line with the requirements of DG SANCO guidelines "Report on the relationship between analytical results, measurement uncertainty, recovery factors and the provisions of EU food and feed legislation, with particular reference to community legislation concerning contaminants in food and undesirable substances in feed" as described in ANNEX II: PROCEDURES FOR THE ESTIMATION OF MEASUREMENT UNCERTAINTY of the report. Specifically, the laboratory of the A' Chemical Service of Piraeus follows the approach of EURACHEM/CITAC Page: 8 the Competent Authorities of Greece on 12 July in response to Report ref. from 06 to 13 March 2012 in order to evaluate import controls on food of non-animal Action Proposed by the Competent Authority Guide, EU

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In the process of designating official laboratories, the methods used by the laboratories (validation and accreditation) are taken into account, so that to avoid non-validated methods. GCSL: In the view of the General Chemical State Laboratory, if a laboratory designated for the official control of food: a) applies a quality assurance system assessed by an accreditation body and b) includes in its scope of accreditation methods with specific analytical techniques and specific range of analyte concentrations, then for any other similar method (same technique and the same range of analyte) applied after full validation (trueness, repeatability, LOD - 7 (of 9) ons of Report ref. DG(SANCO)/2012-6275-MR of an audit carried out od of non-animal origin Action Proposed by the Competent Authority LOQ, participation in proficiency testing schemes etc.) the typical inclusion in the scope of accreditation is not necessary, since the laboratory has proved its technical competence to produce reliable results, within the meaning of the standard ISO/IEC 17025.

MRDF: In the process of designating official laboratories, Page: 10 the Competent Authorities of Greece on 12 July in response to Report ref. from 06 to 13 March 2012 in order to evaluate import controls on food of non-animal Action Proposed by the Competent Authority ls the methods used by the laboratories (validation and ed accreditation) are taken into account, so that to avoid non- validated methods. f GCSL: In the view of the General Chemical State Laboratory, if a laboratory designated for the official control of food: a) applies a quality assurance system assessed by an accreditation body and b) includes in its scope of accreditation methods with specific analytical techniques and specific range of analyte concentrations, then for any other similar method (same technique and the same range of analyte) applied after full validation (trueness, repeatability, LOD - LOQ, participation in proficiency testing schemes etc.) the typical inclusion in the scope of accreditation is not necessary, since the laboratory has proved its technical competence to produce reliable results, within the meaning of the standard ISO/IEC 17025. Concerning GCSL, this recommendation is still under cons

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Pending the establishment of the internal audit system, DPSQCPVO has developed an annual plan for on-site audit of all active DPEs/DPIs, starting in ptember 2012. The aim is to evaluate the overall performance of the local CAs identify any major and minor non-conformities and points of improvement. The on-site audit of the CAs will be followed by a report including the findings, as well as a corrective action plan on behalf of the CAs. Regarding the procedures in place, DPSQCPVO has decided the development of a "Standard Operating Procedure Manual (SOPM)", part of this has already been materialised. The aforementioned SOPM is expected to be completed by the end of 2012. (see also responses to rec. 4, rec. 8 & rec. 16) The implementation of SOPM is included in the scope of this on-site audit system.

le Pending the establishment of the internal audit system, Page: 11 the Competent Authorities of Greece on 12 July in response to Report ref. from 06 to 13 March 2012 in order to evaluate import controls on food of non-animal Action Proposed by the Competent Authority DPSQCPVO has developed an annual plan for on-site audit of all active DPEs/DPIs, starting in September 2012. The aim is to evaluate the overall performance of the local en CAs and identify any major and minor non-conformities o and points of improvement. The on-site audit of the CAs will be followed by a report including the findings, as well as a corrective action plan on behalf of the CAs. Regarding the procedures in place, DPSQCPVO has decided the development of a "Standard Operating Procedure Manual (SOPM)", part of this has already been materialised. The aforementioned SOPM is expected to be completed by the end of 2012. (see also responses to rec. 4, rec. 8 & rec. 16) The implementation of SOPM is included in the scope of this on-site audit system.

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eve that this recommendation should be deleted, because this issue has y been addressed by the DPSQCPVO through the circular no 1055/20752/21.02.2012, which was handed out to the FVO inspectors during the audit and there is also a reference in the FVO draft report (page 21, 2nd paragraph). The above circular, effective from April 2012, describes in detail the procedures/actions to be followed on behalf of both the CAs and the FBOs or its representatives in case of non-compliant consignments. It was disseminated to all the central and local CAs as well as the relative FBO 8 (of 9) ons of Report ref. DG(SANCO)/2012-6275-MR of an audit carried out od of non-animal origin Action Proposed by the Competent Authority associations/confederations and the unions of the FBO representatives, among others. In the meantime, the procedure of re-dispatch is correctly implemented as the attached evidence indicates. (see Attachment no 4 to cover letter) This procedure is also included in the SOPM. (see also response to rec. no 1 (2) and rec. no 15).

We believe that this recommendation should be deleted, - because this issue has already been addressed by the DPSQCPVO through the circular no 55/20752/21.02.2012, which was handed out to the FVO inspectors during the audit and there is also a reference in the FVO draft report (page 21, 2nd paragraph). The above circular, effective from April 2012, describes in detail the procedures/actions to be followed Page: 12 the Competent Authorities of Greece on 12 July in response to Report ref. from 06 to 13 March 2012 in order to evaluate import controls on food of non-animal Action Proposed by the Competent Authority on behalf of both the CAs and the FBOs or its representatives in case of non-compliant consignments. It was disseminated to all the central and local CAs as well as the relative FBO associations/confederations and the unions of the FBO representatives, among others. In the meantime, the procedure of re-dispatch is correctly implemented as the attached evidence indicates. (see Attachment no 4 to cover letter) This procedure is also included in the SOPM. (see also response to rec. no 1 (2) and rec. no 15).

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tten procedures for inspectors performing import controls are included in all PSQCPVO circulars issued for the implementation of the mentioned regulations. Moreover, written procedures are included in the form of SOPs in the framework of the SOPM. 9 (of 9)

ce Written procedures for inspectors performing import controls are included in all the DPSQCPVO circulars ; issued for the implementation of the mentioned regulations. Moreover, written procedures are included in he form of SOPs in the framework of the SOPM. Page: 13

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nating National Authority aff involved to official controls on as mentioned in the FVO audit report. begin in 6 months and will cover the appropriate orage of pesticides.

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olved in the marketing and use f the Commission for the of law 4036/2012). The his Commission is about to be

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eetings where were s and of regular calibrations of opean countries. They have e pilot program Life that ey now evaluate the results to draw conclusions g equipment existing in the country. ty prepares the necessary regulatory documents equipment which will submit to the Committee for

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ecific procedure for the esticide remnants and their packaging by endanger human health or cussing with interested parties. to be finalized by December 2012. ed by the Competent Authority

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fic procedure for of PPPs to ensure the hs time.

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specific circular for the ey are carried out without prior

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o premises of and nating National Authority will of users of PPPs to clarify the above

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document) ask for GC-MS ational Authority that that all designated nd GC-MS/MS equipment. The the end of January 2013.

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a specific circular for the ey are carried out on a risk basis ime. er 2012 for the inspections of are carried out on a risk basis

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ic circular supplying aff to perform effective official of the above mentioned

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ting National Authority sticide use. Horizontal co- of pesticide use was y responsible for controls at as mentioned in the audit at growers for the purposes of ration and the Coordinating lar in two months time supplying control data.

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o ensure that audits are carried procedures are in place to verify ensure that corrective action is

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(EC) No 882/2004). The vel by specifically designated and e for Plant Protection and tion of the inspectors will be the ervice (DREVS) of the ell as their own RCPPQC.

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ate of Veterinary Services: issued in order to draw the attention of the local petent authorities to the importance of the effectiveness of trols and the follow up of the related corrective actions. Page: 1 NCO)/2012-6334-MR of an audit carried out r and processing of fresh meat, in particular fresh on Proposed by the Competent Authority 34,

ate of Veterinary Services: issued in order to draw the attention of the local petent authorities to the importance of the effectiveness of trols and the follow up of the related corrective actions. thority (EFET): the effectiveness of official controls, the EFET will continue d priorities when planning and shaping annual control for 2013; ocal level the periodicity and frequency of controls on the f risk analysis data; e adoption of legislative acts which will improve the rk governing official controls (single system of sanctions, n the marketing and sale of foodstuffs, amendments to the Food erage Code); Page: 1 NCO)/2012-6334-MR of an audit carried out r and processing of fresh meat, in particular fresh ction Proposed by the Competent Authority lement training programmes for 2013 which will meet rol needs; s and conclusions of mission DG(SANCO)/2012-6334 the competent authorities of issues relating to checks on inspection of water in establishments, method for documenting findings, compliance measures; ect and assess information from official controls; effectiveness indicators to enhance official controls.

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: 2 NCO)/2012-6334-MR of an audit carried out r and processing of fresh meat, in particular fresh ction Proposed by the Competent Authority

To take immediate strong action in all approved establishments (Attachment 1) in the country in order to improve the level of maintenance and cleanliness of structures and equipment in line with the requirements of Article 4 (2) and Annex II to Regulation (EC) No 852/2004.

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To take action in all slaughterhouses to correct the deficiencies (Attachment 1) identified in relation to operational hygiene requirements as described in Article 3 of Regulation (EC) No 853/2004.

To take action in all slaughterhouses to correct the deficiencies (Attachment 1) identified in relation to operational hygiene requirements as described in Article 3 of Regulation (EC) No 853/2004.

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General Directorate of the Veterinary Services is in th EFET for the revision of the circular with ref. with regard to the water testing.

General Directorate of the Veterinary Services is in age: 2 NCO)/2012-6334-MR of an audit carried out r and processing of fresh meat, in particular fresh ction Proposed by the Competent Authority with EFET for the revision of the circular with ref. 009 with regard to the water testing.

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currently preparing a draft Ministerial Decision e flexibility for slaughterhouses. The draft will be sent November. Page: 3 NCO)/2012-6334-MR of an audit carried out r and processing of fresh meat, in particular fresh ction Proposed by the Competent Authority

is currently preparing a draft Ministerial Decision e flexibility for slaughterhouses. The draft will be sent of November. hority (EFET): cutting plants and establishments producing preparations in the competent authorities have made use of the derogation ampling frequency for minced meat and meat preparations in he EFET's guidelines.

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To ensure that the identification marking complies with the (Attachment 1) provisions of Article 5 of Regulation (EC) No 853/2004.

To ensure that the identification marking complies with the (Attachment 1) provisions of Article 5 of Regulation (EC) No 853/2004.

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To take strong action in all slaughterhouses to bring the post (Attachment 1) mortem inspection in line with the requirements of Article 5 and Annex I, Section I of Regulation (EC) No 854/2004.

To take strong action in all slaughterhouses to bring the post (Attachment 1) mortem inspection in line with the requirements of Article 5 and Annex I, Section I of Regulation (EC) No 854/2004.

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.2011) 6('221) 38/1997('242). Page: 4 NCO)/2012-6334-MR of an audit carried out r and processing of fresh meat, in particular fresh NCO)/2012-6334-MR of an audit carried out r and processing of fresh meat, in particular fresh the Competent Authority 2013, 6 1996('221) , 013.

veterinary services of Regional Units and Regions in Page: 3 NCO)/2012-6334-MR of an audit carried out r and processing of fresh meat, in particular fresh etent Authority ing action: egional Units in which audit was carried out: S2 (pursuant to our circular 11) stating their recommendations on the on that must be taken and the timetable that d to ensure compliance with Article 6 of cree 327/1996 (Government Gazette, Series I, al welfare at the time of slaughter or killing, 1 December 2012; is found during subsequent checks, impose rovided for in Article 23(6) of Law 2538/1997 ll Regional Units in Greece: eir checks on stunning and record this in which are to be sent, also stating their on the corrective action that must be taken iencies and shortcomings identified, and the must be followed, to ensure compliance with esidential Decree 327/1996 (Government I, No 221) on animal welfare at the time of lling; is found during subsequent checks, impose rovided for in Article 23(6) of Law 2538/1997 NCO)/2012-6334-MR of an audit carried out r and processing of fresh meat, in particular fresh the Competent Authority to the Directorate for Veterinary Affairs of the e 2 of Annex I to our circu

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te of Veterinary Services and more specifically the erinary Public health has increased the number of rhouses in order to ensure compliance with the relevant s, since this June the CCA has already visited 4 d the CA of the Prefectural Units supervising them. Page: 6 NCO)/2012-6334-MR of an audit carried out r and processing of fresh meat, in particular fresh 3 5 4 5 5 5

te of Veterinary Services and more specifically the erinary Public health has increased the number of rhouses in order to ensure compliance with the relevant s, since this June the CCA has already visited 4 d the CA of the Prefectural Units supervising them. Page: 5 NCO)/2012-6334-MR of an audit carried out r and processing of fresh meat, in particular fresh the audit equency, al vices of fices taking to 7 must 1 f 2- d es shall for y in hout ed out open. s, thus it er ance s al ss 2 s not and re not the the ent of n in the e 07, d had 3 s in ses ally as s'

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1.Revised versions of the manuals on the implementation of official f controls for breeding hens, laying hens, broilers of the species Gallus gallus and turkeys is being drawn up, in order to provide additional detailed instructions to official veterinarians concerning detection of deficiencies in the implementation of the SNCP and the evaluation of biosecurity conditions. The above mentioned revised versions are going to be completed by June 2013 the latest. 2. Circular letters with instructions regarding effective implementation of official controls at farm level (proper implementation of the SNCP and biosecurity measures) will be sent to the regional sections by June 2013 the latest. 3. Training seminars will be organised during 2013 by the Department of Zoonosis and NRL with the participation of all the stakeholders involved in the implementation of SNCPs, including poultry farmers and private veterinarians.

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CCA will send as soon as possible an inquire to the Competent EU Authority in order to clarify point 3.1.4. (a), of Annex of Regulation (EC) No 200/2010 where it is Page: 1 of Report ref. DG(SANCO)/2012-6430-MR of an audit carried out al Control Programmes in particular poultry populations (breeders, Action Proposed by the Competent Authority stated that "the faeces samples shall be pooled and thoroughly mixed" As soon as the required clarification is available, a circular letter with clarifications will be sent to Official laboratories involved in the SNCPs , in order to ensure that the number of sub-samples tested in adult breeding flocks is in line with the requirements of point 2.2.2.1(a), Annex of Regulation (EC) No 200/2010.

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. The CCA will send to CA by January 2013 a reminder circular letter with instructions concerning the collection of data of own-check sampling for layers, that has already been sent since 2012 (circular letter 841/20785-21-02-2012).The purpose of this circular letter is to ensure that data on own ­check sampling will be sent to regional veterinary authority in a harmonized way and that regional veterinary authority is informed in a regular basis on the implementation of NSCP by the FBOs. 2. Circular letters with instructions will be sent by January 2013 to the regional veterinary authority in order to enable them to improve their assessment on the implementation of the SNCP by the FBOs. If the competent authority identifies non-compliance, recommendations to FBOs will follow.

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Circular letter with instructions will be sent by January 2013 to the regional veterinary authority in region that have farms with turkeys to intensify official controls in all flocks of fattening and breeding turkey. Page: 2 of Report ref. DG(SANCO)/2012-6430-MR of an audit carried out al Control Programmes in particular poultry populations (breeders, Page: 3

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egards the upgrade of the BIP facilities in conformity with the nd in collaboration with your services, we would like to llow up of the ongoing works : zoni: Works of repair and maintenance (including he inspection room for other animals, changing room rea, unloading area and facilities for U, construction near the office and minor deficiencies regarding the for HC, the unloading area for HC etc) have been omeni: Works of repair and maintenance have been d deficiencies reported in previous missions have ed. Separate facilities for NHC have been builtand a nd changing room for the staff of the BIP has been in conformity with the EU legislation. As one hin the BIP area is destined to become a control post, eparation from the BIP facilities is required and separate workflow will be guaranteed by a new road used by the BIP) which is at the moment under and foreseen to be completed at the end of May e that will completely separate on the other side the office from the BIP facilities is being built on the the control post) expenses. In that way, the cross n will be avoided. After all the works have been ur intention is to withdraw the approval for live Page: 1 2012 DG(SANCO)/2011-6245-MR

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live animals distributed to the BIPs shortly before the d of November 2011- first edition) was a first effort of nted instructions to the BIP staff on import controls animals. The manual is being revised to include issues like fish that were not covered as well as the remarks made ion and giudelines on some extraordinary situation (re- Page: 2 23 April 2012 DG(SANCO)/2011-6245-MR of an audit carried out ystem and border inspection posts Proposed by the Competent Authority nsignment of live animals from a non approved by our staff . All the remarks and deficiencies nto consideration. The 2nd edition of the manual is eted at the end of May 2012 (the revised copy will nically to you. At the moment, you will find enclosed tion the FVO comments, a written procedure ion of consignments of products of animal origin the updated version of the manual for products of is foreseen to be completed at the end of July 2012.

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or by-products have been introduced in the t central level. A document with reference number -2012 has been sent to the BIPs informing them in em instructions on how to proceed in case these ot registered in TRACES . The registration of the nts has been described in the various manuals of VUs. A reminder with instructions on how to system the physical arrival of the channeled l destination will be sent to the LVUs soon. The issue ed during the ongoing TRACES training performed

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terinary audit and Controls has included the audit heir annual program in 2014 (their document with ref. 1-2012 ). Page: 3 2012 DG(SANCO)/2011-6245-MR of an audit carried out ystem and border inspection posts by the Competent Authority fy the effectiveness of the controls according to Reg , with our letter with reference number 133294~25- already made a plan of visits of supervision for 2012 great efforts, independently of the lack of staff and crease the number of visits originally planned in sion with number 261390~2-09-2009 (Each BIP to be ast every 2 years).

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sion 2613902-09-2009 in regard of the system of IPs, also establishes, in the Annexes, all the acilities and the technical equipment, as they are mission decision 2001/812/EC as well as the of the Head of the BIP. in order to ensure the conformity with EU legislation, a summary of the requirements for the technical e sent to the BIPs . Page: 4