Bulgaria

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The FCD has an annual risk-based sampling and analysis plan for GMOs in food. It was planned to take 89 food samples in both 2024 and 2025 for analysis for GMOs under this plan. Raw materials based on soya, rapeseed and maize, ready-to-eat foods, foods for infants and young children based on soya and/or maize and rapeseed oil are targeted for sampling and analysis. All samples are from the internal market (i.e. there are no planned samples at the point of import) and are mainly drawn from manufacturers of snack foods, bakery/confectionary products and meat-based products. Each region is allocated a defined number of samples, and FCD regional staff determine the specific products to sample (according to the instructions described in finding 6) and the sampling locations. Bulgaria grows over 12 000 ha of rice and 3 500 ha of tomatoes per year and has been involved in RASFF notifications related to genetically modified micro-organisms (GMMOs) (finding 70). There are known cases of genetic modification in foods such as rice, linseed, papaya, potato and tomato or GMMOs. The FCD did not plan to collect samples of, at least, rice, tomatoes and GMMOs in 2024 and 2025. It stated that it has never included foodstuffs other than soya, rapeseed and maize in its planned sampling and analysis programme for GMOs. This indicates that the risks associated with commodities other than soya, rapeseed and maize are not taken into account when planning official controls, which is not in line with Article 9(1)(a)(iv) of Regulation (EU) 2017/625.

The BFSA notifies the IASAS in writing within three days of all imports of seed and propagating material. IASAS staff conduct a documentary check on these consignments in all cases. IASAS staff also conduct documentary checks on seed lots of EU and Bulgarian origin. The MANCP 2024-2026, and the annual control programme for GMOs in seeds, both specify that 10 seed samples should be tested for GMOs each year, comprising five maize samples, three rapeseed samples and two soyabean samples. Bulgarian farmers grow over 12 000 ha of rice and 3 500 ha tomatoes each year. The area devoted to soya has declined sharply from 14 000 ha in 2016 and 11 500 ha in 2017 to 500-600 ha in 2024 and 2025. Despite the risks associated with both rice and tomatoes (crops in which genetic modification is known to have occurred) and the collapse in the area devoted to soya, the IASAS stated that the annual control programme for GMOs in seeds has never been changed to include other crops and/or to change the numbers of samples to be analysed each year. Therefore, the annual control programme for GMOs in seeds does not reflect all identified risks (i.e. the risks associated with crops in which 7 genetic modification is known to have occurred other than maize, rapeseed and soya) as required by Article 9(1)(a)(iv) of Regulation (EU) 2017/625. Consequently, it does not meet the requirements of Article 4(5) of Directive 2001/18/EC, as some crops which are grown in Bulgaria and which may be subject to genetic modification (e.g. rice and tomatoes) have never been included in the scope of the IASIS sampling and analysis programme for GMOs in seeds. As a result of this deficiency, GM seeds of these crops would not be detected in the course of planned official controls on seeds. Conclusion on planning official controls

The planned official controls for GMOs in food and seeds provide a reasonable level of assurance that food marketed in Bulgaria and seeds sown in Bulgaria do not contain GMOs but are weakened by the failure to include controls on all foods and seeds where genetic modification is known to occur.

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In 2024, the RFSDs completed 83% of the planned number of controls (dealing with all aspects of feed legislation, including GMOs) on feed business operators. The figures for 2025 were not finalised at the time of the audit but were broadly comparable to 2024, meaning that in both years the CAs failed to perform official controls on GMOs in feed with appropriate frequency as required by Article 9(1) of Regulation (EU) 2017/625. As part of these controls, inspectors were required to conduct controls on GMOs at all operators where GM labelled feeds were present. This amounted to 370 and 295 controls in 2024 and 2025 respectively. Seventeen of the 28 regions completed the planned number of controls, but five regions completed 50% or less of the planned number in both 2024 and 2025. The BFSA explained that this was due to additional work associated with exports in some regions and the limited number of staff dealing with feed in these regions. While staff can be transferred between and within regions as described in finding 2, the audit team noted that this possibility had not been used to redistribute staff to ensure that all regions were able to implement the planned number of risk-based controls.

In both 2024 and 2025, the RFSDs took 18 risk-based feed for analysis for GMOs, rather than the 28 samples in the annual plans, thereby failing to perform official controls on GMOs in feed with appropriate frequency as required by Article 9(1) of Regulation (EU) 2017/625. The FCABPD attributed this discrepancy to the heavy workload on staff and difficulties in obtaining relevant feed samples. The 18 samples in 2024 comprised one feed additive, five compound feeds (four of which had GM ingredients declared on their labels) and twelve feed materials (two of which were declared to be GM). The 18 samples in 2025 comprised one feed additive, six compound feeds (five of which had GM ingredients 10 declared on their labels) and eleven feed materials (one of which was declared to be GM). The 23 feed materials sampled and analysed over the two years were all derived from maize, soya or rapeseed.

Official controls provide a reasonable level of assurance that food and feed marketed in Bulgaria, including rice and rice products imported from China, comply with EU requirements regarding GMOs. Official controls on feed are weakened as just 66% of the planned sampling and analysis programme is completed. Official controls on food are weakened by the failure to include all foods where genetic modification is known to occur in the sampling and analysis programme.

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The audit team examined analysis reports for three seed samples of maize, soya and rapeseed from July 2025. The analysis report for maize showed that 21 (48%) of the 44 known genetic modification events in maize listed by the EURL GMFF were analysed. The analysis report for soya showed that 14 (48%) of the 29 known genetic modification events in soya were analysed. The report for rapeseed showed that the sample was analysed using screening analysis for P35S and T-nos. Based on information provided by the EURL GMFF, this screening analysis is capable of detecting 11 (65%) of the 17 known genetic modification events in rapeseed. The NCPHA confirmed that these analysis reports are representative of the scope of analysis conducted on all seed samples in 2024 and 2025. The limited range of analysis performed for genetic modification events in seeds (48% of known genetic modification events in maize and soya and 65% of known genetic modification events in rapeseed) means that the measures taken by the CAs under Article 4(5) of Directive 2001/18/EC are not sufficient to ensure that seeds sown in Bulgaria are free of GMOs, and therefore that they comply with the requirements of Directive 2001/18/EC.

The NCPHA also confirmed that food samples are also tested using the same approach, and therefore the same proportion of maize, soya and rapeseed genetic modification events are detected in food. This range of analysis is not sufficient to ensure that food marketed in Bulgaria does not contain non-authorised genetic modification events, or GMOs above the legally permitted threshold in cases where it is not labelled as containing, consisting or produced from GMOs, as required by Articles 4(2), 12, and 13 of Regulation (EC) No 1829/2003.

The audit team examined analysis reports for four official feed samples from July, October, November and December 2025. The four samples were all screened for P35S, P- FMV and T-nos. The FCABPD confirmed that this is standard practice for all feed samples, and added that if the screening had indicated GM material was present, further analysis would have been completed. In the four cass examined, the screening analysis showed negative results, so no further analysis was completed. Based on the information provided by the EURL GMFF, this screening analysis is capable of detecting 30 (68%) of 44 genetic modification events in maize, 15 (52%) of 29 genetic modification events in soya and 13 (76%) of 17 genetic modification events in rapeseed. This range of analysis is not sufficient to ensure that feed marketed in Bulgaria does not contain non-authorised genetic modification events, or GMOs above the legally permitted threshold in cases where it is not labelled as containing, consisting or produced from GMOs, as required by Articles 16(2), 24 and 25 of Regulation (EC) No 1829/2003. 15

The FCD and the IASAS both stated that they designated the NCPHA to conduct analysis for GMOs on the basis that the laboratory is accredited for this work as required by Article 37(4)(e) of Regulation (EU) 2017/625. The designations do not include a detailed description of the tasks (i.e. the scope of analysis for GMOs) to be carried out as required by Article 37(3)(a) of Regulation (EU) 2017/625. Similarly, the agreement between the FCABPD and the private laboratory does not include a detailed description of the tasks (i.e. the scope of analysis for GMOs) to be carried out). As a consequence of this deficiency, the laboratories analyse samples using a limited analytical scope capable of detecting 50% of known genetic modification events in maize, soya and rapeseed in food and seeds and two thirds of known genetic modification events in maize, soya and rapeseed in feed as described in findings 57, 58 and 60. The NCPHA stated that it can test for a wider range of genetic modification events than currently conducted on food and seed samples if specifically required by the FCD or the IASAS. The audit team noted that the scope of accreditation of the private laboratory used by the FCABPD covers a wide range of screening methods, and a wide range of specific events in soya, maize, rapeseed and cotton, in addition to events in rice, sugar beet and potatoes, meaning that it could also analyse for a much wider range of genetic modification events if specifically requested to do this by the FCABPD.

Official controls on seeds provide a reasonable level of assurance that conventional seeds of the most widely grown crops do not contain GMOs. The level of assurance provided by controls is weakened by the failure to include all seeds where genetic modification is known to occur in the control programme.

Official controls provide a reasonable level of assurance that food and feed marketed in Bulgaria, including rice and rice products imported from China, comply with EU requirements regarding GMOs. Official controls on feed are weakened as just 66% of the planned sampling and analysis programme is completed. Official controls on food are weakened by the failure to include all foods where genetic modification is known to occur in the sampling and analysis programme.

The failure to specify the range of analysis for GMOs to performed on official samples, and the limited range of analysis performed as a result, means that some non-authorised genetic modification events (in seeds, food and feed), and some cases of GMOs above the legally permitted threshold (in food and feed), are not consistently detected during official controls. 16

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The audit team noted that in all of the six non-compliant results for pharmacologically active substances, the establishing of the non-compliance was not based on pertinent legal requirements 51 since the results obtained had not been assessed against the decision limit for confirmation (CC) as per the laboratory reports seen by the audit team (neither other documents observed had any reference to CC). Furthermore, in three cases of the six results for pharmacologically active substances, the official decision on non-compliance had been made based solely on the outcome of screening testing only without further analysing with a confirmatory method, which is contrary to EU legislation 52. Conclusions on follow-up and enforcement

While the actions taken on non-compliant results were rapid, comprehensive and effective, the decision making on the non-compliance status of the test results for pharmacologically active substances was not based on applicable legal requirements which puts in question the legal validity of the non-compliance decisions made and consequent actions taken by the competent authority. 47 Article 138(1) of Regulation (EU) 2017/625. 48 Articles 4, 5 and 6 of Delegated Regulation (EU) 2019/2090. 49 Articles 5(1)(2) and 6(3)(5) of Delegated Regulation (EU) 2019/2090. 50 As defined in Article 1(4) of Delegated Regulation (EU) 2022/1644. 51 Article 5(1) of Commission Implementing Regulation (EU) 2021/808. 52 Part 1.1.2. of Chapter I of Annex I to Implementing Regulation (EU) 2021/808. 12 5.6. Laboratories, methods of analysis, method validation and internal quality control

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With regard to method validation, the audit team noted the following: a) The majority of analytical methods had been validated in accordance with the applicable EU legal framework that was in force at the time of validation 57. Revalidation of these methods in line with the requirements of the EU legislation in force 58 was ongoing at the time of the audit. b) The methods were validated at the level of interest 59. c) Across all validation files scrutinised, the audit team observed a number of trueness (by recovery) and precision (under within-laboratory reproducibility conditions) values which did not meet the performance criteria established by EU legislation 60. The potential impact of those deviations on the outcome of the validation was not analysed by the laboratory in a documented traceable manner 61. d) In general, the assessment of method ruggedness was not performed and assessed by the laboratory, and stability studies of the analytes in both solution and matrix were not conducted, which is a mandatory performance characteristic to be determined during validation 62. In relation to stability, the laboratory referred to scientific literature or information from another laboratory. Nevertheless, none of the sources presented unambiguously demonstrated that identical conditions had been applied (e.g., storage temperature and duration); this approach is not in line with pertinent EU requirements 63. e) The validation data for the ELISA-based screening method for antimicrobial substances included comprehensive evidence demonstrating that the validation had been conducted in accordance with applicable EU requirements 60. In contrast, the validation documentation for the microbiological screening tests of antibiotics lacked essential information on the experimental design, including details on the number and type of replicate analyses used to determine the detection capability for screening (CC). This omission prevented proper assessment of the method's reliability and compliance with EU validation requirements 64. 57 Commission Decision 2002/657/EC. 58 Chapter 2 of Annex I to Implementing Regulation (EU) 2021/808. 59 Article 2(19) of Implementing Regulation (EU) 2021/808. 60 Parts 1.2.2.1. and 1.2.2.2. of Chapter 1 of Annex I to Implementing Regulation (EU) 2021/808. 61 Article 3 of Implementing Regulation (EU) 2021/808. 62 Part 2.1. of Chapter 2 of Annex I to Implementing Regulation (EU) 2021/808. 63 Footnote (#) to Table 5 in part 2.1. of Chapter 2 of Annex I to Implementing Regulation (EU) 2021/808. 64 Part 2.7 of Chapter 2 of Annex I to Implementing Regulation (EU) 2021/808. 14 f) In quinolones and dyes methods, only four fortification levels with four replicates were applied; this approach differs from the requirements of pertinent EU legislation 65.

Notwithstanding that all of the laboratories comprising the laboratory network are adequately designated, accredited to ISO/IEC 17025, have all of the methods in the laboratories' scope of accreditation and operate sufficient internal quality control, deficiencies in the method validation and the lack of confirmation of the results obtained through screening methods undermine the confidence that the competent authority can have in the reliability of the results generated by the laboratory network. 65 Part 2.2.1.4. of Chapter 2 of Annex I to Implementing Regulation (EU) 2021/808. 66 Chapter 3 of Annex I to Implementing Regulation (EU) 2021/808. 67 Part 1.1.2. of Chapter I of Annex I to Implementing Regulation (EU) 2021/808. 68 Article 38(2) of Regulation (EU) 2017/625. 69 Point 7 of Annex II to Implementing Regulation (EU) 2021/808. 15 6. OVERALL CONCLUSION Notwithstanding that the implementation of official controls on residues of pharmacologically active substances, pesticides and contaminants in animals and animal products is largely in line with EU legal requirements and planned arrangements, the effectiveness of the system is weakened by (i) deficiencies in decision-making in case of identified non-compliances, and (ii) shortcomings in method validation. If left unaddressed, these have the potential to cumulatively reduce the effectiveness of residue controls and consequently undermine confidence in official guarantees on the chemical safety of food. 7. CLOSING MEETING A closing meeting was held on 13 June 2025 with representatives of the BFSA, including its regional branches, and the BFSA laboratory. At this meeting, the audit team presented its main preliminary findings and conclusions. The BFSA representatives did not express disagreement and undertook to take the actions necessary to address the shortcomings identified. 8. RECOMMENDATIONS The competent authority is requested to provide details of the actions taken and planned, including deadlines for their completion ('action plan'), aimed at addressing the recommendations set out below. With regard to those shortcomings noted in the audit report which did not result in a recommendation being made, the competent authority is, nevertheless, requested to address these. The effectiveness of the actions taken to address such shortcomings will be assessed in future audits on this topic. No. Recommendation 1 To ensure that decisions on non-compliance for pharmacologically active substances are based on assessment of the analytical value of the testing against the decision limit for confirmation (CC). Relevant EU legislation: Article 5(1) of Commission Implementing Regulation (EU) 2021/808. Recommendation based on conclusion: 40. Associated finding: 39. 2 To ensure that (i) the validation of analytical methods incorporates all mandatory performance characteristics, (ii) the values obtained are assessed against established legal criteria, in particular for trueness (by recovery) and precision (under within-laboratory reproducibility conditions), and (iii) impact of deviations from said criteria on the outcome of the validation is analysed in a documented traceable manner. Relevant EU legislation: Article 3 of Commission Implementing Regulation (EU) 2021/808. Recommendation based on conclusion: 53. Associated finding: 47. The competent authority's response to the recommendations can be found at: 16 http://ec.europa.eu/food/audits-analysis/rep_details_en.cfm?rep_inspection_ref=CT-2025-0041 17 ANNEX 1 - LEGAL REFERENCES Legal Reference Official Journal Title Regulation (EU) OJ L 95, 7.4.2017, p. Regulation (EU) 2017/625 of the European 2017/625 1­142 Parliament and of the Council of 15 March 2017 on official controls and other official Regulation (EU) OJ L 248, 26.9.2022, activities performed to ensure the application 2022/1644 p. 3­17 of food and feed law, rules on animal health and welfare, plant health and plant protection Regulation (EU) OJ L 248, 26.9.2022, products, amendin

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The audit team noted however that: · Despite the measures taken, birds were still present and nesting in the roof covering the unloading and housing areas for ungulates and equidae, which were consequently not kept clean nor free of pests, and in that respect did not therefore ensure the proper handling of animals to avoid cross contamination nor compliance with relevant biosecurity standards in order to prevent the spread of diseases, which is not in line with Article 64(3)(h) and (i) of the OCR. · The sharp edges, rust and flaking paint noted by the previous audit, were still evident in the unloading and housing areas, which were not maintained so as to avoid injury of the animals and ensure their safety, which is not in line with Article 5(2) of Implementing Regulation (EU) 2019/1014 and are not easy to clean, which is not in line with Articles 3(3) of same regulation. 11 The BFSA informed the audit team that the necessary funding to address the shortcomings in the animal facilities had been allocated, and the necessary remedial work is planned to start in late 2025. · Despite the measures taken by the BFSA aimed at improving the organisation and efficiency of the official controls at the BCP, the BCP facilities for plants, plant products and other objects, and to a lesser extent, for goods of non-animal origin are, as noted by the previous audit, not appropriate to the volume of these categories of goods requiring official controls at the BCP. This is not in line with Article 64(3)(b) of the OCR. The overall capacity of the unloading areas remains limited to the contents of only one means of transport at a time. The BFSA informed the audit team that the BCP has capacity to handle up to 500 freight vehicles/day, while in peak season (i.e. winter) 1 400 to 1 500 vehicles/day may be expected. Conclusions on recommendation 2022-7637-12 of the previous audit

However, despite the many improvements at the BCP Kaptan Andreevo, the animal facilities for the categories ungulates and equidae still do not comply with the rules for minimum requirements for BCPs with respect to the hygiene and maintenance of the facilities, and the overall capacity of the premises for performing official controls on goods of non-animal origin and plants, plant products and other objects, is not appropriate to the nature and volume of the categories of goods handled, especially at peak times.

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The audit team noted, based on data provided by the BFSA, and extracted from TRACES, that the frequencies of identity and physical checks performed on consignments of goods of non-animal origin in 2024 were in general, similar to those found by the previous audit: peppers (13.2% checked vs 20% required), apricot kernel (16.7% vs 50%), cumin (7.3% vs 30%), oregano (14.3 vs 20%), dried figs (10.4% vs 20%), vine leaves (21.4% vs 50%) pistachios (15.4% vs 30%) from Türkiye, and hazelnuts from Georgia (17,5% vs 20%), which is not in line with the requirements laid down in Articles 6 and 8 and Annexes I and II of Implementing Regulation (EU) 2019/1793 and mushrooms (13.3% vs 20% required) from Türkiye, which is not in line with the requirements laid down in Article 5(2) of Implementing Regulation (EU) 2020/1158. Conclusion on recommendation 2022-7637-8 of the previous audit

The corrective action taken to date by the competent authority has not been effective in ensuring that the frequency of identity and physical checks on consignments of goods of non-animal origin are carried out in accordance with the detailed rules for the performance of those checks. 5.2.8. Recommendation 2022-7637-9 To ensure BCP officials (a) check with the competent authorities of the control point whether consignments of goods of non-animal origin have arrived in cases where the authorities have not received confirmation of arrival within 15 days from the day on which the transfer of a consignment to the control point was authorised, (b) inform Customs and (c) determine the actual location of said goods. 8

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The PPQCFFV Directorate and the CLPQ do not have a sufficient number of suitably qualified and experienced staff in the area of plant health as required by Article 5(1)(e) of Regulation (EU) 2017/625. The BFSA stated that there are five staff in the PPQCFFV Directorate and 21 staff in the CLPQ dealing with plant health, with 64 plant health inspectors in the 28 RFSDs. The BFSA noted that the number of staff dealing with plant health matters had halved in the previous ten years, despite an increase in the workload. These numbers include both technical and administrative staff and include staff responsible for implementing all aspects of plant health legislation. The BFSA gave concrete examples where the lack of staff, and in particular the lack of experienced staff, means that legal requirements are not being met. These examples are described in this report and include: · the incomplete nature of multi-annual survey programmes (findings 13 and 15), · the lack of statistically based surveys for X. fastidiosa (finding 17), · the vast majority of survey results for Union quarantine pests not being provided to the Commission and to other MS (finding 32), · delays in developing contingency plans and the lack of detail in these plans (findings 38 and 41).

Limited staff resources in the PPQCFFV Directorate and in the CLPQ, compounded by IT related inefficiencies, mean that a number of legal obligations are not respected ­ the most important of which are determining which Union quarantine pests should be surveyed when developing multi-annual survey programmes, and developing sufficiently detailed contingency plans for all relevant priority pests.

Medlemsstatens svar

: 2026 . tion 2026 . . , , , 5(1)() () 2017/625. : : , .

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The BFSA does not have appropriate and properly maintained Information Technology (IT) facilities and equipment as required by Article 5(1)(f) of Regulation (EU) 2017/625. It has not had an IT system to plan and to record all plant health survey activity since 2007. Instead, information on each survey is recorded in each RFSD using spreadsheets. This information is subsequently compiled by the relevant report rapporteur for priority pests or the PPQCFFV Directorate for other pests. For example, S. frugiperda is surveyed under three separate annual survey programmes ­ for vegetables, for ornamental plants, and for other plants. The resulting data from each of these three surveys is compiled separately in each of the 28 RFSDs, and subsequently reported to the single rapporteur charged with compiling this into a single dataset at national level. The cumbersome and time-consuming nature of this procedure makes it very inefficient to compile survey results and to report these results to the Commission, with the result that less than 20% of all surveys are reported to the Commission.

Limited staff resources in the PPQCFFV Directorate and in the CLPQ, compounded by IT related inefficiencies, mean that a number of legal obligations are not respected ­ the most important of which are determining which Union quarantine pests should be surveyed when developing multi-annual survey programmes, and developing sufficiently detailed contingency plans for all relevant priority pests.

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ies 2026 . Page: 1 February 2025 report ref. DG(SANTE) 2024-7964 of the audit carried out from 11 September e plant health sector Action Proposed by the competent authority Proposed action plan deadline Article , , . , , , 5(1)() () 2017/625. : - 2025 . / ; - 2026 . Page: 2 February 2025 report ref. DG(SANTE) 2024-7964 of the audit carried out from 11 September e plant health sector ction Proposed by the competent authority Proposed action plan deadline ; 2027 . ,

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Under the 2021-2023 programme, the BFSA planned and conducted surveys on 155 pests, comprising 18 priority pests and 137 Union quarantine pests, under a range of crop-specific surveys. The remaining Union quarantine pests (more than 240) were neither included in, nor excluded with a justification from, the programme, which is not in compliance with Article 22(1) of Regulation (EU) 2016/2031.

As was the case for the 2021-2023 programme, 240 or more Union quarantine pests are neither included in, nor excluded with a justification from, the 2024-2028 multi-annual survey programme, which is not in compliance with Article 22(1) of Regulation (EU) 2016/2031.

The multi-annual survey programme for 155 Union quarantine pests (including 18 priority pests) provides a sound basis for the early detection of any outbreaks of these pests. However, at least two thirds of Union quarantine pests, some of which could establish in Bulgaria, are not surveyed, giving rise to the risk that some of these pests could establish, and remain undetected until such time as their eradication would be impossible.

Medlemsstatens svar

30 2025 . e, , , 22(1) () 016/2031.

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Thirty-seven pests are excluded from the 2024-2028 multi-annual survey programme with a clear justification. In the majority of these cases, the justification relates to the ecoclimatic conditions or to the absence of the host species as permitted under Article 22(1) of Regulation (EU) 2016/2031. However, in 40% of cases, the justification is either that official controls take place at the point of import, or that there is a proposal to deregulate the pest, or that the risk of the pest establishing in Bulgaria is low, none of which are permitted as valid reasons for excluding pests from multi-annual survey programmes under Article 22(1) of that Regulation. 6 5.2.2 Planning annual statistically based survey programmes for priority pests

The multi-annual survey programme for 155 Union quarantine pests (including 18 priority pests) provides a sound basis for the early detection of any outbreaks of these pests. However, at least two thirds of Union quarantine pests, some of which could establish in Bulgaria, are not surveyed, giving rise to the risk that some of these pests could establish, and remain undetected until such time as their eradication would be impossible.

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15 2025 . are , Page: 3 February 2025 report ref. DG(SANTE) 2024-7964 of the audit carried out from 11 September e plant health sector Action Proposed by the competent authority Proposed action plan deadline , . 22(1) 2016/2031 .

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Bulgaria did not establish (i.e. did not plan to conduct) a statistically based survey programme for X. fastidiosa in 2023 and 2024 as required by Article 2(4) of Implementing Regulation (EU) 2020/1201, primarily due to a lack of human resources. However, some requirements laid down in Article 2 of this Regulation are complied with in the annual survey programmes for X. fastidiosa, as described in findings 21, 22 and 23. 5.2.3 Planning annual risk-based survey programmes for priority pests

The implementation of the annual risk-based survey programme for priority pests provides a high level of assurance that any outbreaks of these pests will be detected promptly. However, the failure to develop the required statistically based annual survey programme for X. fastidiosa means that the level of confidence the current risk-based survey programme for this pest provides is unknown.

Medlemsstatens svar

e Xylella 30 2025 . le 2(4) fastidiosa (Wells et al.) 2025- 2029 . , . 2(4) () () 2020/1201 .

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Bulgaria generally reports the results of the annual surveys of priority pests to the Commission and to other MS, by the deadline of 30 April for the preceding year as required by Article 24(2) of Regulation (EU) 2016/2031, Article 2(8) of Implementing Regulation (EU) 2020/1201 regarding X. fastidiosa and Article 12(a) of Implementing Regulation (EU) 2023/1134 as regards S. frugiperda. In 2022 and 2023, Bulgaria reported results on 23 and 28 of the 137 pests surveyed to the Commission and to other MS, which is not in line with Article 22(3) of Regulation (EU) 2016/2031. The BFSA attributed the failure to report results for the vast majority of Union quarantine pests surveyed to difficulties in compiling and aggregating survey data, as described in finding 5. 9 Conclusions on survey programmes

The failure to report survey results for the vast majority of Union quarantine pests surveyed each year means that this important information is not easily accessible to the Commission and to other MS.

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year are 30 2025 . ing year, 2(a) of ting . , , Page: 4 February 2025 report ref. DG(SANTE) 2024-7964 of the audit carried out from 11 September e plant health sector Action Proposed by the competent authority Proposed action plan deadline 30 , 22 (3) () 2016/2031, 12 () () 2023/1134 35 (1) () 2020/1201.

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Bulgaria has drawn up pest-specific contingency plans for 11 of the 15 priority pests which are capable of entering into and becoming established in its territory. These plans were communicated to the Commission and to other MS as required by Article 25(5) of Regulation (EU) 2016/2031 by uploading them to internet Rapid Alert System for Food and Feed (iRASFF) plant health portal on 26 August 2024, some eight months after the legal deadline. The BFSA stated that work was ongoing on one of the four remaining 10 required plans at the time of the audit in September 2024, but acknowledged that there was no clear time schedule to conclude this work. Finally, it acknowledged that it had not consulted all relevant stakeholders when drawing up contingency plans as required by Article 25(1) of Regulation (EU) 2016/2031. Therefore, Bulgaria had not drawn up contingency plans for all priority pests capable of entering into and becoming established in its territory by 14 December 2023 as required by Article 25(1) and (4) of Regulation (EU) 2016/2031, Article 4(1) of Implementing Regulation (EU) 2023/1134 as regards S. frugiperda and Article 3 of Implementing Regulation (EU) 2020/1201 as regards X. fastidiosa. The BFSA explained that this delay occurred due to a lack of human resources.

The published contingency plans all share a common format. The audit team examined the contingency plans for S. frugiperda and X. fastidiosa as a representative sample. Based on this examination, the plans comply with most, but not all, requirements of Article 25(2) of Regulation (EU) 2016/2031, Article 4(1) of Implementing Regulation (EU) 2023/1134 and Article 3 of Implementing Regulation (EU) 2020/1201. Specifically, the plans lack sufficient detail regarding CAs' access to laboratories, equipment, personnel, external expertise and resources necessary for the rapid and effective eradication or, where appropriate, containment of the priority pest concerned as required by Article 25(2)(c) of Regulation (EU) 2016/2031.

Bulgaria is not sufficiently prepared to eradicate outbreaks of priority pests. Of the 15 required contingency plans, four remain to be drafted, with no clear deadline for their completion, while the published contingency plans lack the necessary detail to help the authorities rapidly and effectively eradicate any established priority pests. 11

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4 , 11- . 2 517/20.02.2025 . : Thaumatotibia leucotreta . (Meyrick) Bactericera cockerelli (Sulc.), - 2025 . ­ Conotrachelus nenuphar (Herbst) Dendrolimus sibiricus Tschetverikov. , Page: 5 February 2025 report ref. DG(SANTE) 2024-7964 of the audit carried out from 11 September e plant health sector action plan deadline 11- 517/20.02.2025 . . Page: 6 February 2025 report ref. DG(SANTE) 2024-7964 of the audit carried out from 11 September e plant health sector action plan deadline Page: 7

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Applications for the authorisation of a PPP may be submitted at any given time, unless when Bulgaria is requested to act as the zonal rapporteur Member State pursuant to Article 33(2)(b) and Article 35 of Regulation (EC) No 1107/2009. Such applications are only accepted once the RACFC has the necessary resources to conduct the evaluations. This is not in line with Article 33(1) and Article 35 of Regulation (EC) No 1107/2009.

The chronic staff shortages faced by RACFC prevent Bulgaria from serving effectively as the rapporteur MS for zonal authorisations and may dissuade applicants from applying there.

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eply by Risk Assessment Center on Food Chain (RACFC): Assessment Center on Food Chain (RACFC) has a limited capacity of experts - 12 evaluators ut assessments of active substances (2 as rapporteur Member State) and PPPs. he RACFC has confirmed a commitment to carry out an assessment for zonal renewal of 13 products Article 43 of Regulation (EC) 1107/2009. ications for evaluation under Article 33 of Regulation (EC) No 1107/2009 (amendment and ) are planned by the authority. RACFC accepts a limited number of applications- an average of 2 per year. organizes meetings with the industry, where the possibility of taking zonal assessments is also discussed. The slots are planned for a 3 years period. According the Law on the Risk Assessment Center on Food Chain, it is possible to use external evaluators if necessary.

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Emergency authorisations pursuant to Article 53 of Regulation (EC) No 1107/2009 are also managed by the BFSA, through the Council of PPPs, with the Executive Director of BFSA serving as the ultimate authority for authorisation. A designated department within BFSA, along with another from the RACFC, is responsible for determining whether the specific conditions for such authorisations have been fulfilled. However, the risk evaluators from RACFC are not engaged in this process and a simple declaration by the applicant, often citing an existing authorisation in another Member State, is considered adequate. The audit team considers that this may not always be 6 adequate to ensure the consumer safety referred to in Article 53(1) of the mentioned regulation.

The majority of emergency authorisations each pertain to several uses beyond the existing authorisation for already authorised PPPs. The audit team considered, especially when contemplating the issuance of repeated emergency authorisations, that these applications would be better accommodated through label extension within the conventional authorisation framework, for each one of the uses within those bundles, thereby maintaining the system's integrity, as referred to in Commission Staff Working Document on emergency situations according to Article 53 of Regulation (EC) No 1107/20093. Conclusions on authorisation of plant protection products

Regarding applications of emergency authorisations under Article 53 of Regulation (EC) No 1107/2009, the risk assessment authority is not involved, which may make it difficult to guarantee that adequate measures are taken to ensure consumer safety.

It is a policy of BFSA that one emergency authorisation may include multiple crops and/or targets. This is not in line with Article 53 of Regulation No (EC) 1107/2009 for emergency authorisations.

Furthermore, emergency authorisations commonly involve authorised PPPs. The dangers these authorisations are addressing could therefore be contained by other means, namely through authorisation extensions of those PPPs, according to Articles 33, 40, or 51 of Regulation (EC) No 1107/2009. Using emergency authorisations repeatedly instead, waters down the integrity of the authorisation system.

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o this recommendation, the BFSA has taken action to update the current Standard Operating Procedure of the Plant Protection Products, Fertilisers and Control Directorate for the authorisation of plant protection products for placing on the market for limited and controlled use in accordance with Article 53 of Regulation (EC) No 1107/2009, as follows: 1. Authorizations for limited and controlled use under Article 53 of Regulation (EC) No 1107/2009 should be granted only for single use, i.e. the danger of one pest per crop and not more than one pest per crop (one use, one crop, one pest) will be taken into account. the case of applications submitted other than for single use (with more than one pest and/or crop), ch applications for authorisation under Article 53 of Regulation (EC) No 1107/2009 should not be ssible. Such applications should be submitted and examined on the base of Articles 33, 40 or 51 of Regulation (EC) No 1107/2009, where applicable. Page: 1 s recommendations received 21 August 2024 aria to the recommendations of report ref. DG (SANTE) 2024-7973 of the audit carried out from 05 to 19 tion and controls of marketing and use of Plant Protection Products competent auth

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In public green areas, control of the professional use of PPPs falls under the jurisdiction of designated municipal authorities or the Forestry Agency. The forestry agency, which operates under the Ministry of Agriculture, also has the responsibility for monitoring PPP usage within public forests. However, during the audit, the BFSA could not specify which authority oversees the use of PPPs in non-agricultural areas by professional users which do not represent public sector entities, such as on sports facilities (e.g. golf courses, private football fields), and in areas associated with hotels and campgrounds, as well as use of PPPs by professional gardeners and landscapers. The audit team received a list of golf courses from the CA after the audit which would allow the national authorities to check some professional non-agricultural users of PPPs which do not represent public sector entities. However, information about who is authorised to inspect these uses is still missing.

However, at the time of the audit, the coordinating authority was unsure which authority, if any, oversees the private, non-agricultural professional use of PPPs.

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o designate the body that organises and carries out official controls on the use of PPPs in non- ural areas by private professional users, an interdepartmental working group will be set up by rder of the Executive Director of the BFSA. In this WG will be invited representatives of institutions Page: 2 s recommendations received 21 August 2024 aria to the recommendations of report ref. DG (SANTE) 2024-7973 of the audit carried out from 05 to 19 tion and controls of marketing and use of Plant Protection Products Proposed by the competent authority and deadline by which it will be completed in the operation of sports facilities (e.g. golf courses, private football fields), hotel areas, s and other green areas in the private sector. As well as with the participation of representatives the Ministry of Environment and Water, respectively Regional Inspection of Environment and Water, Ministry of Tourism, the Ministry of Youth and Sport, the Ministry of Agriculture and Food. The ill have the task of identifying the necessary legislative changes to ensure the control of PPPs in 15.11.2024. letters of nomination have been sent to representatives of the institutions mentioned above, with ine

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The Central Laboratory for Chemical Testing and Control is designated for performing formulation analyses of PPPs. It is accredited under ISO 17025/2018 with a flexible accreditation scope and engages in inter-laboratory comparisons with other MS. The analyses focus primarily on identifying the content of active substances and certain physical and chemical properties of PPPs. A complete formulation analysis of a PPP has only been done once in recent years. Thus, the analysis programme does generally not cover co-formulants and impurities found in active substances. Consequently, CAs lack the means to confirm the absence of unacceptable co-formulants in PPPs, as stated in Article 27 of Regulation (EC) No 1107/2009 and they are unable to determine whether certain impurities do not exceed the maximum content permitted in the approval of the relevant active substances, as required by Article 6(b) of that Regulation. 12 Conclusions on laboratories used for formulation analysis of plant protection products as part of official controls.

The effectiveness of the control system in guaranteeing that the PPPs placed on the market are in conformity with their compositional specifications as stated in their authorisation is compromised by the lack of testing for unacceptable co-formulants and regulated impurities within the sampling programme.

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nection with the recommendation made, the CLCTC has undertaken the following activities: report to the management of the BFSA with ref. No 459/25.06.2024 was prepared of the CLCTC sing to apply the procedure for designating a laboratory to carry out analyses of the formulation f PPPs in accordance with the requirements of Article 6(b) of Regulation (EU) 1107/2009 and Article of Regulation (EU) 2017/625, on the basis of the justifications provided as to why the CLCTC is a position to be such a laboratory at that time. the basis of the report of the director of CLCTC and report No. -3572/19.07.2024 of the aboratory Control" Directorate, approved by the executive director of the BFSA, a procedure has started to determine a laboratory for official control to carry out analyzes of the formulation of as referred to in Article 24(1) of Regulation (EU) 2017/625. By Order No. 11- .07.2024 of the executive director of the BFSA, a working group was created to take the actions with the -01 "Procedure for determining external laboratories for testing taken for the purposes of official control, carried out by BFSA", approved by Order 11- Page: 3 s recommendations received 21 August 2024 aria to

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Authorisations of PPPs requiring critical label amendments (such as deletion of uses, reduction of doses, and introduction of special risk mitigation measures), resulting from recent and similarly critical regulatory restrictions on their active substances, have been properly and promptly revised. Nevertheless, the audit team noted inadequacies in the official inspections to verify and enforce the implementation of such label updates (see finding 54). 5.1.5. Low-risk substances and candidates for substitution

However, there is no guidance provided for inspectors on how to prioritise their inspection. In all the inspections observed by the audit team, the detailed examination of labels was carried out on PPPs selected at random. This approach means the inspection 13 is very likely to overlook PPPs with recent critical amendments of the labelling requirements that are of relatively high risk of being non-compliant. The audit team noted an example of such PPP (containing sulfoxaflor) with an obsolete label (still including outdoor uses, despite these being withdrawn from its authorisation and the grace period deadline, set according to article 46 of Regulation (EC) No 1107/2009, having passed), which was not selected by the inspectors for detailed examination (only after suggestion by the audit team).

Generally, official controls on the marketing of PPPs are carried out consistently and at an appropriate frequency as per the annual national schedule. However, there is a significant shortcoming in the system when it comes to enforcement of critical label amendments. This puts at risk the proper use of PPP required by Article 55 of Regulation (EC) No 1107/2009. 5.3.2. Controls on the use of plant protection products Legal Requirements Articles 11 to 14 and 137 to 139 of Regulation (EU) 2017/625 Articles 28, 31, 55 (first and second sentences) and 67(1) of Regulation (EC) No 1107/2009 Articles 5 and 6 of Directive 2009/128/EC Regulation (EU) No 547/2011 Findings

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l information on the label of the plant protection product shall be identical to the information ained in the Order authorising the placing on the market and use of PPPs. All Orders are publicly the website of the Bulgarian Food Safety Agency at the following link: a.egov.bg/wps/portal/bfsa-web/home/orders/orders.common owever, in connection with the recommendation made, the Central Office of the Bulgarian Food cy sent a letter to the 28 Regional Food Safety Directorates (RFSD) regarding more gnificant changes to the authorisations for the placing on the market and use of plant protection ucts for the period from May to July 2024 inclusive, in order to draw the inspectors' attention to m. Letter to RDFS_Official.pdf In the letter, the HQ of the Bulgarian Food Safety Agency informed the Regional Food Safety Directorates that it would regularly provide information on significant changes to the authorisations for the placing on the market and use of plant protection products. Major amendments applicable as a matter of priority to the control of plant protection products are mainly: · Withdrawal/suspension of the marketing authorisation and use of PPPs; · Elimination of uses; Page: 4 s

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The CCA has not issued instructions or standard procedures covering the technical as- pects within the scope of this audit. For the official controls at slaughterhouses, there are no guidance/instructions on ante-mortem inspections (AMI), on animal welfare controls and on the verification of food business operators' (FBOs) self-control systems. The cur- rent instructions on post-mortem inspection (PMI), have not been updated to take into account the last changes in EU legislation. During the visits at the slaughterhouses the audit team noted that the official controls were not effective and there is no consistency in the way they are carried out (see paragraphs 28, 30, 33, 36, 38, 45, 50 and 52).

The official control system is supported by national legislation covering the relevant as- pects within the scope of the audit. However, the absence of guidance docu- ments/instructions for the official staff compromises the guarantees that official controls are effective and are carried out in a uniform and consistent way.

The CCA informed the audit team that several checklists are available for use by the OVs during official controls. The audit team noted that the checklists have not been up- dated since 2014 and they are not usually used by the OVs during their controls. The au- dit team assessed one checklist for official controls in poultry slaughterhouses and noted that it mainly reported the requirements laid down in Regulations (EC) Nos 853/2004 and 854/2004 and did not provide technical assistance to the OVs. 5.2.4 Training

In the slaughterhouses visited, the OVs were aware of the requirement to carry out ani- mal welfare checks and to take suitable action when needed. Animal welfare checks were also included in the planned thematic controls (see also paragraph 43) with a mini- mum frequency of two controls per year. The CCA had not issued any instructions to as- sist the OVs on the performance of these duties.

The audit team observed that different systems/methods applied during the PMI in the slaughterhouses for domestic ungulates visited and there are not specific instructions for official staff on how the PMI should be done. For example, the audit team noted: · Different incisions carried out in the different slaughterhouses by the OVs during the PMI. The OVs interviewed provided different information as regards the com- pulsory incisions and checks (visual checks, palpations) of carcases required by EU legislation. · In one of the two bovine slaughterhouses the incisions of the masseters were not 9 made in parallel to the mandible and there was one incision instead of the two re- quired by EU legislation in the outer masseters. · Some organs (i.e., stomachs and intestines) were not always subject to PMI as they were discarded immediately after evisceration. · In the porcine slaughterhouse, there was no correlation of carcases and offal (kid- neys, spleen, stomachs and intestines) during the PMI, · In certain cases, the PMI was limited to visual inspection of organs and no palpa- tion was carried out.

In all but one of the establishments visited the cleanliness of live animals before slaugh- ter was not taken into consideration in the HACCP plans. This was monitored in one of the establishments even though that procedure was not included in the HACCP plan, which also did not include clear instructions or corrective actions. This establishment was approved in 2022 and, in this regard, no observations were noted by the CA.

According to the information provided by the CA, and in addition to the RFSD audits, the FBOs own-checks are evaluated during the OV's thematic inspections. The audit and inspection reports the CA shared with the audit team did not include any remark con- cerning the above-mentioned aspects. The BFSA explained that there are no guidelines concerning assessment of HACCP systems available for the regional inspectors or the OVs. Microbiological criteria Legal requirements Article 35 and 36 of Regulation (EU) 2019/627. Commission Regulation (EC) No 2073/2005. Findings

All the FBOs at the establishments visited had a microbiological sampling plan in place. This plan is verified by the OVs during their thematic controls. There are no official in- structions in place to assist the OVs on this verification and on the subsequent official actions needed in case of non-compliance.

An official control plan, based on risk, is implemented by the CA. However, the limited 14 detection and/or recording of non-compliances at establishment level and, consequently, the lack of enforcement actions to correct the non-compliant situations compromise the effectiveness of the control system in place. In this regard, significant shortcomings in relation to the sanitary conditions and to the animal welfare conditions were noted that had not been previously identified or recorded in any level of official control.

Certain official controls at slaughterhouse level are not carried out in line with the EU requirements. In particular, the serious deviations from the legally required practical ar- rangements concerning PMI and the controls on HACCP-based procedures undermine the reliability of the OVs' decision on the fitness of meat for human consumption.

The AMI and the controls on FCI, animal identification and traceability are in general in line with the EU requirements. However, the lack of procedures for suitable recording and communication of AMI and PMI results by the OVs has, as a consequence, that no feedback is provided to the competent authorities and operators at primary production level in order to take appropriate actions when these inspections reveal a disease or con- dition that might affect human or animal health or animal welfare.

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Bulgarian Food Safety Agency established a working group 02.12.2024 representatives of the Central Competent Authority and the Food Safety Directorates. This working group carried out the task of developing a draft l for the performance of official controls in slaughterhouses for the production of meat of domestic ungulates and poultry. It details the requirements, duties and responsibilities of the official veterinarians and official assistants to carry out ante-mortem and post-mortem inspections for the different species of animals. The process for its approval by the Executive Director of the Bulgarian Food Safety Agency (BFSA) is at a final stage. By Order 11-2776/04.11.2024 of the Executive Director of the BFSA, an ,,Expert Council ­ slaughterhouses" was set up with several main tasks: 1. Develop and propose for approval draft working documents relating to the organization and implementation of the official controls in slaughterhouses on the territory of the Republic of Bulgaria; 2. Hold physical or electronic meetings once every 6 months in order to discuss problems in the performance of the official controls in slaughterhouses and, if necessary, to optimize the Page: 1 to th

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The audit team noted during the on-the-spot visits that the officials did not have a suffi- cient level of knowledge of specific legal requirements to perform their duties properly, in particular concerning PMI, hazard analysis and critical control point (HACCP) sys- tems and the protection of animals at the time of killing (see also paragraphs 33, 36, 38, 48, 49 and 50). 5.2.5 Supervision and audits

A training system is in place however the findings of this audit indicate that this training is not effective or sufficient to ensure adequate knowledge of official inspectors respon- sible for the official controls in slaughterhouses.

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creasing the level of qualification and competence of the official eterinarians and official assistants performing controls in laughterhouses is a top priority. In this regard, the BFSA plans to out theoretical and practical trainings (trainings on the spot) carry out official controls both in establishments producing at from domestic ungulates and in poultry establishments. In , the BFSA plans : g with all official veterinarians (OV) and service in slaughterhouses to clarify and implement the Manual 30.11.2024 ce of the official control in slaughterhouses om domestic ungulates and poultry, which will soon as the document has been approved by the r of the BFSA and the Regional Food Safety ) staff are familiar with the materials provided ning (in slaughterhouses) on ante-mortem and ction of OVs and SSs. An Order 11- Page: 2 to the recommendations of report ref. DG(SANTE) 2024-8030 of the audit carried out from he control systems in place governing slaughter hygiene and meat inspection requirements etent authority Proposed deadline for the action plan utive Director of the BFSA was 28.02.2025 ining, setting out the distribution, 30.12.2024 in which the training will be carried 30.11.

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The official control system is supported by national legislation covering the relevant as- pects within the scope of the audit. However, the absence of guidance docu- ments/instructions for the official staff compromises the guarantees that official controls are effective and are carried out in a uniform and consistent way.

The audit reports were communicated to the RFSD concerned, which should develop an action plan with the corrective actions to be implemented for addressing the issues iden- tified. The executive director of BFSA is responsible for the enforcement of these ac- tions. The CAs explained that further follow up visits in the RFSDs where problems were noted were also planned. At the time of this audit the visits had not taken place yet. The CAs also stated that the conclusions from the audits carried out were also communi- cated to the rest of the RFSDs in order to draw their attention to the systemic issues iden- 5 tified. However, the audit team noted in the four regions visited, that were not audited by the BFSA, non-compliances similar to the ones described in paragraph 17. 5.2.6 Enforcement

Mechanisms are in place to provide guarantees about the effectiveness of the official controls. However, these mechanisms are not working properly because the supervision system over the OVs' performance is not able to uncover the weaknesses in the official controls and, when shortcomings are identified during the internal audits, these remain unsolved.

In all the slaughterhouses (for domestic ungulates) visited, the porcine animals were rou- tinely washed with pressurized water before the entrance to the slaughter line. This was also the case for bovines if they were very dirty. In one establishment it was noted that the bovines were slaughtered and de-hided while they were still wet posing an increased risk of contamination of the carcass. These practices were neither detailed in the FBO's self-control systems nor questioned by the OVs. The audit team noted that none of the FBOs implemented any written procedures in order to ensure that live animals are clean and to deal with excessively soiled animals. Moreover, the OVs met did not verify the FBOs' obligation in this regard during the AMI. This is not in line with Article 11(4) of Regulation (EU) 2019/627.

The audit team observed some non-compliances in relation to the animal welfare in the slaughterhouses for ungulates visited that had not been previously noted/recorded, nei- ther by the OVs nor by the RFSDs during their visits. In all the slaughterhouses visited the maximum number of animals allowed in each of the pens in the lairage was not clear- ly indicated, contrary to what point 2.3 of Annex III to Regulation (EC) No 1099/2009 requires. In one establishment the floor in the lairage was particularly damaged and could lead to the severe injury of the ungulates. In addition, the areas for the isolation and clinical inspection of suspected animals were not indicated or not existed. 8

Serious deficiencies were noted during the stunning and killing of birds in the poultry slaughterhouse visited. The audit team noted that a high percentage of animals showed signs of consciousness after the stunning process (e.g. birds lifting their heads, showing extensive flapping of wings, having their eyes open) and this is contrary to the require- ments of Article 4(1) of Regulation (EC) No 1099/2009. The audit team requested the examination of a stunned bird from the line and observed clear signs of consciousness of the animal (opening and closing of its mouth, shaking its head, reacting to touching). Neither the FBO nor the CA recognised these signs as improper stunning. In their opin- ion, those signs were part of the normal behaviour of stunned birds. In addition, the audit team noted that most of the birds suffered pre-stunning electrical shocks when entering the water bath, as the wings and the body of the birds were touching the water of the stunner before their heads, and there was no `breast comforter' available. All these ob- servations are contrary to requirements provided in Regulation (EC) No 1099/2009. No corrective actions were requested (i.e. stopping the line) by the CAs in this slaughter- house during these findings. Post-mortem inspection

At the slaughterhouses for ungulates visited, the practical arrangements for PMI were not fully in line with the requirements of Regulation (EU) 2019/627: there was not a clear PMI point, with adequate working conditions and with the necessary equipment (ade- quate lighting, equipment for the recording of the PMI results, equipment for the disin- fection of the OV's knives, dedicated wash-hand basins), designated. As a consequence, the OV could not easily perform a visual examination of all the external surfaces and of the cavities of bovine carcases. Moreover, as the OV was carrying out the PMI checks in different locations in the slaughter line, it was not clear the point in the slaughter line where the carcases are declared fit for human consumption (e.g. before or after the wash- ing by the FBO). In one of the establishments the OV had to move to a separate room for the examination of the heads of bovine carcases, as this was the location decided by the FBO, making difficult the correlation between carcases and heads.

The audit team observed that different systems/methods applied during the PMI in the slaughterhouses for domestic ungulates visited and there are not specific instructions for official staff on how the PMI should be done. For example, the audit team noted: · Different incisions carried out in the different slaughterhouses by the OVs during the PMI. The OVs interviewed provided different information as regards the com- pulsory incisions and checks (visual checks, palpations) of carcases required by EU legislation. · In one of the two bovine slaughterhouses the incisions of the masseters were not 9 made in parallel to the mandible and there was one incision instead of the two re- quired by EU legislation in the outer masseters. · Some organs (i.e., stomachs and intestines) were not always subject to PMI as they were discarded immediately after evisceration. · In the porcine slaughterhouse, there was no correlation of carcases and offal (kid- neys, spleen, stomachs and intestines) during the PMI, · In certain cases, the PMI was limited to visual inspection of organs and no palpa- tion was carried out.

Serious deviations from the requirements of the EU legislation on PMI were noted by the audit team in the poultry slaughterhouse visited. More in particular: · The PMI was carried out by the OVs (with the support of slaughterhouse staff). There was no designated and suitably equipped area for the PMI (lack of equip- ment for the recording of the results and the disinfection of the knives, no mirror for the inspection of all the external surfaces, no additional lighting, etc.). · There was no PMI of the offal. The offal was collected and transferred to a sepa- rate part of the establishment to be washed. There was no correlation between car- cases and offal. The livers and intestines of the birds were discarded immediately after evisceration. · There was no recording of the PMI results (neither by the slaughterhouse staff nor by the OV). No relevant information on the cause and the exact quantities of the meat condemned was recorded in the PMI logbook. · After the PMI, the carcases (or part of them), declared unfit for human consump- tion, were collected by the slaughterhouse staff to be disposed. The OV (or the OA) did not carry out (or did not record) any inspection of a sample of these car- cases (or parts of them), contrary to Article 25(1) of Regulation (EU) 2019/627. In addition, there was no daily inspection of the viscera and body cavities of a repre- 10 sentative sample of each flock by the OV (or an OA) as also required by the same Article. 5.3.2 Official controls over food business operators' obligations Food Chain Information (FCI) and animal identification Legal requirements Article 3 of Regulation (EC) No 853/2004 in conjunction with its Annex II Section III and Article 9 and 10, 40, 41 42 and 43.1 of Regulation (EU) 2019/627. Findings

An official control plan, based on risk, is implemented by the CA. However, the limited 14 detection and/or recording of non-compliances at establishment level and, consequently, the lack of enforcement actions to correct the non-compliant situations compromise the effectiveness of the control system in place. In this regard, significant shortcomings in relation to the sanitary conditions and to the animal welfare conditions were noted that had not been previously identified or recorded in any level of official control.

Certain official controls at slaughterhouse level are not carried out in line with the EU requirements. In particular, the serious deviations from the legally required practical ar- rangements concerning PMI and the controls on HACCP-based procedures undermine the reliability of the OVs' decision on the fitness of meat for human consumption.

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ian Food Safety Agency is developing a procedure 30.01.2025 of business operators' self-monitoring procedures, ch provides guidances for auditing specific activities, such as production of domestic ungulates and poultry. The procedure ill provide instructions for follow-up of the implementation of nimum legislative requirements, actions of the auditor in raising non-compliances, follow-up of their elimination until the on-compliances are closed. ernal audit reports are received, in accordance with ) of Regulation (EU) 2017/625, they will be discussed eetings with the Directors and Heads of Units, as it is ently the practice of the BFSA. In cases where deficiencies are in the work of the OV who perform the official control, the be discussed by the Expert council indicated in Note nce with the decisions of the Expert council, Page: 4 to the recommendations of report ref. DG(SANTE) 2024-8030 of the audit carried out from he control systems in place governing slaughter hygiene and meat inspection requirements ed by the competent authority Proposed deadline for the action plan nts and additions will be made in the Manual for the f an official control in slaughterhouses for the duction o

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In some of the establishments visited, the audit team identified a significant number of longstanding non-compliances that had not been previously identified or recorded neither by the OVs during their daily presence nor by the RFSD during their inspections (see paragraph 15) and therefore no enforcement measures had been applied to resolve them. In particular, in one slaughterhouse that the audit team selected, serious non-compliances as regards the sanitary and maintenance conditions were observed. The OVs and the RFSD inspectors responsible for the controls at this establishment explained that they had also detected some of these problems in the past. However, they did not record them in the reports. The OVs added that, in some cases, they had verbally requested the FBO to repair certain parts of the establishment (e.g. the lairage). Despite that, the FBO took no action to resolve the non-compliances observed, the OVs did not impose subsequent enforcement actions and, as a result, the situation remained unchanged.

In the same establishment above-mentioned, the FBO refused to facilitate access to the audit team and CAs to three locked chilling rooms, two of them directly connected to the slaughter area. The OVs that were permanently present in the establishment for the last 4 months had no access to these parts of the premises. The OVs did not consider this situa- tion could be an issue as the FBO told them that these chilling rooms did not belong to the approved part of the establishment and, therefore, had been locked. The CA managed to get access to one of the chilling rooms, breaking the lock, in the presence of the audit team. This was a cold store where large quantities of frozen meat/meat products (aprox. 10 tonnes) were stored in a way which rendered the meat and products unfit for human consumption. The other two chilling rooms were opened when the audit team was not present (i.e. during lunch time). When the team came back to the slaughterhouse, got ac- cess to the rooms and found that one was empty and, the other one was filled with transport cages. In relation to that establishment, and subsequent to the audit team visit, the CA committed to applying enforcement actions. Evidence of the actions taken were provided to the audit team before the end of the audit (condemnation of the meat in ques- tion and temporary suspension of this establishment's activities). 6 Conclusions on competent authorities

The system in place provides official staff with the authority to enforce legal require- ments. However, the effectiveness of this system is compromised because the official controls are not able to detect non-compliances, or they do not record them and so, en- forcement actions are not imposed. Moreover, when non compliances are detected, offi- cials do not always impose enforcement actions to solve the issues.

Serious deficiencies were noted during the stunning and killing of birds in the poultry slaughterhouse visited. The audit team noted that a high percentage of animals showed signs of consciousness after the stunning process (e.g. birds lifting their heads, showing extensive flapping of wings, having their eyes open) and this is contrary to the require- ments of Article 4(1) of Regulation (EC) No 1099/2009. The audit team requested the examination of a stunned bird from the line and observed clear signs of consciousness of the animal (opening and closing of its mouth, shaking its head, reacting to touching). Neither the FBO nor the CA recognised these signs as improper stunning. In their opin- ion, those signs were part of the normal behaviour of stunned birds. In addition, the audit team noted that most of the birds suffered pre-stunning electrical shocks when entering the water bath, as the wings and the body of the birds were touching the water of the stunner before their heads, and there was no `breast comforter' available. All these ob- servations are contrary to requirements provided in Regulation (EC) No 1099/2009. No corrective actions were requested (i.e. stopping the line) by the CAs in this slaughter- house during these findings. Post-mortem inspection

In addition to the thematic controls and the AMI and PMI, the OVs are also tasked with the daily monitoring of the hygiene conditions during slaughtering operations, imposing enforcement measures when necessary. The audit team received some written examples of notices (prescriptions) issued by the OVs as evidence of such enforcement actions in the establishments visited. It was noted that they referred to the cleaning of the premises or the hygiene practices and not to the long-standing deficiencies described above. Hazard Analysis and Critical Control Point (HACCP) Legal requirements Article 5 of Regulation (EC) No 852/2004. Findings 12

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ulgarian Food Safety Agency has developed a new Standard 30.06.2025 ng Procedure (SOP) for verifying the effectiveness of the ial control in the field of food, which would allow more uent and in-depth control on the RFSD's official control ities. The procedure is in the process of being agreed and will lied in 2025. 024, the ,,Food control" Directorate carries out verification r the previous procedure applied by the ,,Verification of the rol" Directorate before the structural changes in the In order to discuss the deficiencies found at the visited pose to improve the effectiveness of the official rols, there have been held on ­ line meetings with all Heads s. At these meetings the Heads of departments were Page: 5 to the recommendations of report ref. DG(SANTE) 2024-8030 of the audit carried out from he control systems in place governing slaughter hygiene and meat inspection requirements etent authority Proposed deadline for the action plan additional trainings of inspectors from . In addition, separate meetings were l" Departments of each RFSDs of the Deputy Executive Director and Control" Directorate to discuss ficial control with a view to improve out inspections at food product

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The audit team observed some non-compliances in relation to the animal welfare in the slaughterhouses for ungulates visited that had not been previously noted/recorded, nei- ther by the OVs nor by the RFSDs during their visits. In all the slaughterhouses visited the maximum number of animals allowed in each of the pens in the lairage was not clear- ly indicated, contrary to what point 2.3 of Annex III to Regulation (EC) No 1099/2009 requires. In one establishment the floor in the lairage was particularly damaged and could lead to the severe injury of the ungulates. In addition, the areas for the isolation and clinical inspection of suspected animals were not indicated or not existed. 8

Serious deficiencies were noted during the stunning and killing of birds in the poultry slaughterhouse visited. The audit team noted that a high percentage of animals showed signs of consciousness after the stunning process (e.g. birds lifting their heads, showing extensive flapping of wings, having their eyes open) and this is contrary to the require- ments of Article 4(1) of Regulation (EC) No 1099/2009. The audit team requested the examination of a stunned bird from the line and observed clear signs of consciousness of the animal (opening and closing of its mouth, shaking its head, reacting to touching). Neither the FBO nor the CA recognised these signs as improper stunning. In their opin- ion, those signs were part of the normal behaviour of stunned birds. In addition, the audit team noted that most of the birds suffered pre-stunning electrical shocks when entering the water bath, as the wings and the body of the birds were touching the water of the stunner before their heads, and there was no `breast comforter' available. All these ob- servations are contrary to requirements provided in Regulation (EC) No 1099/2009. No corrective actions were requested (i.e. stopping the line) by the CAs in this slaughter- house during these findings. Post-mortem inspection

At the slaughterhouses for ungulates visited, the practical arrangements for PMI were not fully in line with the requirements of Regulation (EU) 2019/627: there was not a clear PMI point, with adequate working conditions and with the necessary equipment (ade- quate lighting, equipment for the recording of the PMI results, equipment for the disin- fection of the OV's knives, dedicated wash-hand basins), designated. As a consequence, the OV could not easily perform a visual examination of all the external surfaces and of the cavities of bovine carcases. Moreover, as the OV was carrying out the PMI checks in different locations in the slaughter line, it was not clear the point in the slaughter line where the carcases are declared fit for human consumption (e.g. before or after the wash- ing by the FBO). In one of the establishments the OV had to move to a separate room for the examination of the heads of bovine carcases, as this was the location decided by the FBO, making difficult the correlation between carcases and heads.

The audit team observed that different systems/methods applied during the PMI in the slaughterhouses for domestic ungulates visited and there are not specific instructions for official staff on how the PMI should be done. For example, the audit team noted: · Different incisions carried out in the different slaughterhouses by the OVs during the PMI. The OVs interviewed provided different information as regards the com- pulsory incisions and checks (visual checks, palpations) of carcases required by EU legislation. · In one of the two bovine slaughterhouses the incisions of the masseters were not 9 made in parallel to the mandible and there was one incision instead of the two re- quired by EU legislation in the outer masseters. · Some organs (i.e., stomachs and intestines) were not always subject to PMI as they were discarded immediately after evisceration. · In the porcine slaughterhouse, there was no correlation of carcases and offal (kid- neys, spleen, stomachs and intestines) during the PMI, · In certain cases, the PMI was limited to visual inspection of organs and no palpa- tion was carried out.

Serious deviations from the requirements of the EU legislation on PMI were noted by the audit team in the poultry slaughterhouse visited. More in particular: · The PMI was carried out by the OVs (with the support of slaughterhouse staff). There was no designated and suitably equipped area for the PMI (lack of equip- ment for the recording of the results and the disinfection of the knives, no mirror for the inspection of all the external surfaces, no additional lighting, etc.). · There was no PMI of the offal. The offal was collected and transferred to a sepa- rate part of the establishment to be washed. There was no correlation between car- cases and offal. The livers and intestines of the birds were discarded immediately after evisceration. · There was no recording of the PMI results (neither by the slaughterhouse staff nor by the OV). No relevant information on the cause and the exact quantities of the meat condemned was recorded in the PMI logbook. · After the PMI, the carcases (or part of them), declared unfit for human consump- tion, were collected by the slaughterhouse staff to be disposed. The OV (or the OA) did not carry out (or did not record) any inspection of a sample of these car- cases (or parts of them), contrary to Article 25(1) of Regulation (EU) 2019/627. In addition, there was no daily inspection of the viscera and body cavities of a repre- 10 sentative sample of each flock by the OV (or an OA) as also required by the same Article. 5.3.2 Official controls over food business operators' obligations Food Chain Information (FCI) and animal identification Legal requirements Article 3 of Regulation (EC) No 853/2004 in conjunction with its Annex II Section III and Article 9 and 10, 40, 41 42 and 43.1 of Regulation (EU) 2019/627. Findings

In all but one of the establishments visited, the premises, facilities and hygiene practices were in general satisfactory. However, some deficiencies were noted by the audit team that had not previously been observed/recorded by the CAs (e.g. cleaning of the floor with high pressure splashing water, while exposed carcasses were present, with risk of contamination of meat, dirty overhead rails above exposed meat, lack of cleaning and disinfection of footwear of the workers entering the facilities).

Serious non-compliances were noted in one slaughterhouse of domestic ungulates which had not been detected and/or recorded previously by any level of official controls, nei- ther by the OV not the RFSD (see also paragraphs 20 and 21). More specifically the au- dit team noted: damage to the floors, walls and the ceiling in the evisceration and areas for further processing of the carcases, rusty equipment above exposed meat, damaged equipment in several parts of the establishment, broken surfaces, dirty chillers with sur- faces not able to be suitably cleaned and/ or disinfected, gaps between the floors and the external doors, not allowing suitable pest control, and bad hygiene standards in several parts on the establishment that were linked to the slaughterhouse and were approved for cutting and preparation of meat.

In the establishments visited, the FBOs considered the chilling temperatures of meat as the most important points to control. In all but one of the establishments the evisceration (and the risk of faecal contamination) was not considered as a control point in the HACCP systems assessed. In all the establishments visited, the corrective action provid- ed for in the HACCP plans in case of faecal contamination of carcases was the cleaning with water.

In all but one of the establishments visited the cleanliness of live animals before slaugh- ter was not taken into consideration in the HACCP plans. This was monitored in one of the establishments even though that procedure was not included in the HACCP plan, which also did not include clear instructions or corrective actions. This establishment was approved in 2022 and, in this regard, no observations were noted by the CA.

The audit team noted that in two of the domestic ungulate slaughterhouses visited the OVs had detected (during the last inspections carried out in 2024) that the frequency of the microbiological sampling for process hygiene criteria on meat was not in line with Regulation (EC) No 2073/2005. In response, action plans were provided by the FBOs to 13 correct this non-compliance. In one of these cases the OV accepted a fortnightly (and not weekly) frequency for the sampling of carcases for Salmonella, Enterobacteriaceae and aerobic colony count despite the fact that no negative results in thirty (or six) consecu- tive weeks had been obtained previously. Moreover, the deadline for the FBO to comply with this obligation was 7 months. To be also noted that in the HACCP plan of this es- tablishment, approved in 2022, the relevant sampling frequency was one sample per month and that was accepted by the CA during the approval procedure.

An official control plan, based on risk, is implemented by the CA. However, the limited 14 detection and/or recording of non-compliances at establishment level and, consequently, the lack of enforcement actions to correct the non-compliant situations compromise the effectiveness of the control system in place. In this regard, significant shortcomings in relation to the sanitary conditions and to the animal welfare conditions were noted that had not been previously identified or recorded in any level of official control.

Certain official controls at slaughterhouse level are not carried out in line with the EU requirements. In particular, the serious deviations from the legally required practical ar- rangements concerning PMI and the controls on HACCP-based procedures undermine the reliability of the OVs' decision on the fitness of meat for human consumption.

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he procedure for auditing the food 30.06.2025 . ess operators, the BFSA will order an d out on all meat production s on assessing the adequacy and relating to: s intended for slaughter; principles and the correct control points (CCP), and; ective actions in the case of oratory monitoring programme rdance with Regulation (EC) e reception, accommodation laughter of the animals ents for laboratory monitoring of 15.01.2025 . of 2024, the RFSDs will collect and ams for 2025 to meet the regulatory ncy and criteria of the legislation. If rogation for diluted monitoring in pter 3, point 3.2 of Regulation (EC) s of the BO for each individual or slaughter in the slaughterhouse will send initial information on this check ge: 8 to the recommendations of report ref. DG(SANTE) 2024-8030 of the audit carried out from he control systems in place governing slaughter hygiene and meat inspection requirements etent authority Proposed deadline for the action plan by 15 January 2025. onitoring programs in the set measures by the BOs will be assessed ontrol is performed.

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None of the OVs in the slaughterhouses visited recorded the outcome of the AMI on-the- spot. Therefore, information about the animals that passed satisfactorily the AMI is not transferred to the slaughterhouse (no system of positive release existed). This system does not provide guarantees that only those animals that had been subject to AMI and had been declared fit for slaughter could be processed by the FBO. The CA explained that this is the common practice in smaller slaughterhouses as there is direct communica- tion between the OVs carrying out AMI and the OVs in the PMI positions. The audit team noted that the CA has not issued any instruction/procedure requiring OVs perform- ing AMI to keep records of the outcome (e.g. record all the relevant findings of AMI) and pass this information to the slaughterhouse operator before accepting the animals for slaughter.

At the slaughterhouses visited it was observed that in the logbooks, that are filled out once the slaughter has taken place, the information concerning the identification of the animals and the final AMI decision were recorded (fit for slaughter or not). No further details in relation to animal health or welfare were indicated.

In the same slaughterhouses the OVs did not have an adequate system to record PMI de- tails. In all the cases observed the total quantities of condemnations were recorded in the PMI logbook. However, the specific reasons for which a carcase/meat have been con- demned and the link to a particular batch of animals was not reported (e.g. it was docu- mented the total weight of offal rejected due to pneumonia or ascites without describing the exact offal). Therefore, the system in place does not allow the FBOs and OVs to pro- vide feedback on information that could affect human or animal health, or compromise animal welfare, to other interested parties (e.g. FBO responsible for the holding of prov- enance, CAs responsible for supervising these holding). The CA explained that currently there is no instruction or template model on how and when the communication with the holding of provenance should take place.

Serious deviations from the requirements of the EU legislation on PMI were noted by the audit team in the poultry slaughterhouse visited. More in particular: · The PMI was carried out by the OVs (with the support of slaughterhouse staff). There was no designated and suitably equipped area for the PMI (lack of equip- ment for the recording of the results and the disinfection of the knives, no mirror for the inspection of all the external surfaces, no additional lighting, etc.). · There was no PMI of the offal. The offal was collected and transferred to a sepa- rate part of the establishment to be washed. There was no correlation between car- cases and offal. The livers and intestines of the birds were discarded immediately after evisceration. · There was no recording of the PMI results (neither by the slaughterhouse staff nor by the OV). No relevant information on the cause and the exact quantities of the meat condemned was recorded in the PMI logbook. · After the PMI, the carcases (or part of them), declared unfit for human consump- tion, were collected by the slaughterhouse staff to be disposed. The OV (or the OA) did not carry out (or did not record) any inspection of a sample of these car- cases (or parts of them), contrary to Article 25(1) of Regulation (EU) 2019/627. In addition, there was no daily inspection of the viscera and body cavities of a repre- 10 sentative sample of each flock by the OV (or an OA) as also required by the same Article. 5.3.2 Official controls over food business operators' obligations Food Chain Information (FCI) and animal identification Legal requirements Article 3 of Regulation (EC) No 853/2004 in conjunction with its Annex II Section III and Article 9 and 10, 40, 41 42 and 43.1 of Regulation (EU) 2019/627. Findings

The AMI and the controls on FCI, animal identification and traceability are in general in line with the EU requirements. However, the lack of procedures for suitable recording and communication of AMI and PMI results by the OVs has, as a consequence, that no feedback is provided to the competent authorities and operators at primary production level in order to take appropriate actions when these inspections reveal a disease or con- dition that might affect human or animal health or animal welfare.

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n order to unify the activities of OVs in slaughterhouses, The use of the cluding the records to be kept, in the Manual indicated in point registers and the form templates for ante-mortem and post-mortem document for notifying ction logs for the production of meat from domestic the results of the tes and poultry have been developed and consolidated. In conducted official ters, the OV will compulsorily record both failures control will start on ted during ante-mortem inspection and pathological 01.01.2025. ions and findings (possibly the presence of diseases) cted during meat examination and/or laboratory analyses. 1.01.2025. reporting (notification) of the results of the performed the BO of the slaughterhouse and to the ing of origin, a uniform document has been developed, ion of an information to the holding of ses on non-compliances detected -mortem inspections carried out in of Commission Implementing This document will be compulsorily 9

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Bulgaria has not designated the competent authority or authorities on which they confer the responsibility to organise or perform official controls and other official activities on the sector within the scope of this audit, contrary to Article 4 of Regulation (EU) 2017/625.

Bulgaria has not designated the competent authority or authorities to organise or perform official controls on bivalve molluscs and marine gastropods at primary production, and none of the authorities has taken responsibility to implement the relevant EU legislation.

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s to An interdepartmental working group with all responsible institutions is to be convened in order to organise and distribute tion the official control on bivalve molluscs in accordance with the legal requirements.

An interdepartmental working group with all responsible institutions is to be convened in order to organise and distribute the official control on bivalve molluscs in accordance with the legal requirements. Updated CA response 26 October 2023 Order No RD 09-1101/20.10.2023 was issued on the basis of Article 25(4) and Article 45(1) of the Administration Act and in conjunction with an approved report by the Deputy Minister for Agriculture and Food, 93-5865 of 20.10.2023, establishing an interdepartmental working group with all the institutions responsible in order to organise and distribute official controls on bivalve molluscs in accordance with the legal requirements. Scan2023-10-24_1011 46.pdf

te 27 October 2023 Order No RD 09-1101/20.10.2023 was issued on the basis of Article 25(4) and Article 45(1) of the Administration Act and in conjunction with an approved report by the Deputy Minister for Agriculture and Food, 93-5865 of 20.10.2023, establishing an interdepartmental working group with all the institutions responsible in order to organize and distribute official controls on bivalve molluscs in accordance with the legal requirements. Response 20 July 2023 An interdepartmental working group with all responsible institutions is to be convened in order to organise and distribute the official control on bivalve molluscs in accordance with the legal requirements. Updated response 14 December 2023 : On 9.11.2023, the first meeting of the working group (WG) was held at the Ministry of Agriculture and Food (MAF), formed by an Order of the Minister of Agriculture and Food to prepare a plan for determining the location and boundaries of the production areas in the Black Sea area. The meeting was attended by representatives of the Ministry of Environment and Water, the Ministry of Agriculture, the Institute of Oceanology-Bulgarian Academy of Science (BAS), the Bulgarian Food Sa

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Bulgaria has not fixed the location and boundaries of production areas, contrary to Article 52(1) of Regulation (EU) 2019/627. The BFSA stated that each mussel farm is considered as an individual production area, and that the BFSA's Directorate of Animal Health and Welfare has a register of mussels' aquaculture farms publicly available at the BFSA website, with the farm location and boundaries coordinates provided by the Black Sea Basin Directorate.

Bulgaria has not carried out the sanitary surveys required in Article 56 of the same Regulation. Consequently, it has not classified them, contrary to the requirements of Articles 52(2) and (3) of the same Regulation.

At the time of the audit, there was no monitoring of production areas (or aquaculture farms if they are individually considered, see paragraph 4) for microbiological, chemical contaminants, biotoxins or phytoplankton, contrary to the requirements of Articles 57 to 61 of Regulation (EU) 2019/627.

Consequently, there is neither management of production areas nor record and exchange of information to interested parties, which conditions are established respectively in Articles 61 and 62, and 66 of the same Regulation, with the exception of the BFSA's register of mussels' aquaculture farms (see paragraph 4), which could partially meet the recording of information required in Article 66(a) of that Regulation.

As required by Article 64 of Regulation (EU) 2019/627, the BFSA has in place a sampling programme of final products of bivalve molluscs' origin, either at establishments or at retail level. Official samples of mussels and wedge clams are tested for biotoxins at the NRL and for E. coli and salmonella at the regional official control laboratories. Non- compliant results trigger the recall and withdraw from the market of the batch of bivalve molluscs tested. 5.2.2 Official controls of certain bivalve molluscs harvested outside classified production areas

Bulgaria does not carry out the controls of rapana seasnail required by Article 11 of Regulation (EU) 2019/624. 5.2.3 Movement of live bivalve molluscs and registration document accompanying batches

As explained in paragraph 2, the Executive Agency for Fisheries and Aquaculture carries out official controls in the field of fisheries policy, including for the movement of fishery product from fishing grounds. For this, it has prepared a template with all the information that operators have to fill out for every catch, and it issues pads of individually numbered documents to each operator. In the case of aquaculture mussels, wedge clams and rapana seasnail, the information contained in this document meets the relevant requirements of Chapter I (3) and (4) of Section VII of Annex III to Regulation (EC) 853/2004. Conclusions on official controls on bivalve molluscs

There is no system of official controls of bivalve molluscs and marine gastropods at primary production level in Bulgaria and the majority of the requirement of EU legislation are not met. Although there are certain official controls in place after primary production (carried out at establishments), they are insufficient to provide adequate food safety assurances if the primary production is not controlled. 5

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An interdepartmental working group with all responsible institutions is to be convened in order to organise and distribute . official controls on bivalve molluscs in accordance with the legal requirements. Page: 1

n interdepartmental working group with all responsible institutions is to be convened in order to organise and distribute the official control on bivalve molluscs in accordance with the legal requirements. Updated CA response 26 October 2023 Order No RD 09-1101/20.10.2023 was issued on the basis of Article 25(4) and Article 45(1) of the Administration Act and in conjunction with an approved report by the Deputy Minister for Agriculture and Food, 93-5865 of 20.10.2023, establishing an Page: 1 ons, updated 2023/10/26 itted by the competent authorities of Bulgaria in response to Report ref. DG(SANTE) 2023-7740 of in order to evaluate the control system of live bivalve molluscs thority h all the institutions responsible in order to organise bivalve molluscs in accordance with the legal Page: 2

Update 27 October 2023 s Order No RD 09-1101/20.10.2023 was issued on the basis of Article 25(4) and Article 45(1) n. of the Administration Act and in conjunction with an approved report by the Deputy Minister for Agriculture and Food, 93-5865 of 20.10.2023, establishing an interdepartmental working group with all the institutions responsible in order to organize Page: 2 tions, updated 2023/12/14 bmitted by the competent authorities of Bulgaria in response to Report ref. DG(SANTE) 2023-7740 of 23 in order to evaluate the control system of live bivalve molluscs authority on bivalve molluscs in accordance with the legal p with all responsible institutions is to be convened in the official control on bivalve molluscs in accordance with : f the working group (WG) was held at the Ministry of d by an Order of the Minister of Agriculture and Food the location and boundaries of the production areas in the ttended by representatives of the Ministry of ry of Agriculture, the Institute of Oceanology-Bulgarian garian Food Safety Agency (BFSA), the Basin ion and the Executive Agency for Fisheries and ing decisions were taken: and Food to be prepared and to be sent questions to the o gather info

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The BFSA stated that, with limited exceptions, it did not have documented procedures in place for the conduct of official controls on animals and goods of animal origin entering the EU, including on transhipped consignments, consignments in transit and channelling of consignments, which is not in line with article 12(1) of the OCR.

The limited exceptions concern a documented procedure for the use of TRACES-NT in the case of unsatisfactory laboratory results for certain consignments of goods of animal origin, and a standard operating procedure for the sampling of food of animal origin, the latter of which the audit team noted had not been updated as appropriate in line with Article 12(3)(b) of the OCR.

In contrast to finding 15, the BFSA has documented procedures in place for official controls on food of non-animal origin entering the EU, for the onward transportation and transfer to control points of consignments of food and feed of non-animal origin, and for the exchange of information in iRASFF, which is in line with Article 12(1) of the OCR. A further procedure concerning the action to take for non-compliant consignments of (8) https://btsfacademy.eu/training/ 6 food of non-animal origin and food contact materials had not been updated as appropriate in line with Article 12(3)(b) of the OCR.

The BFSA also stated there are no documented arrangements in place for the implementation of measures on consignments of animals and goods referred to in Articles 65, 66 and 67 of the OCR, which is not in line with Article 12(1) and Article 64(3)(d) of the OCR.

Whilst there is a framework in place for the conduct of official controls on animals and goods entering the EU, underpinned by systematic communication and cooperation between the relevant authorities, certain organisational aspects weaken the effectiveness of the control system. These include the lack of (updated) documented procedures and arrangements and the failure to develop and implement an appropriate monitoring plan. It is likely that the shortfall in the implementation of control verification procedures hindered the ability of the competent authority to identify and address those shortcomings. 5.2 IMPLEMENTATION OF OFFICIAL CONTROLS ON ANIMALS AND GOODS ENTERING THE EU

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The BFSA Border Control Directorate stated that it develops an annual risk-based monitoring plan for official controls on products of animal origin for human consumption entering the EU, as part of its National Monitoring Programme for the Control of Residues of Veterinary Medicinal Products and Environmental Contaminants in Live Animals and Products of Animal Origin 2021 (hereafter `National Monitoring Programme'). The monitoring plan does not include products of animal origin which are not intended for human consumption, or hazards other than residues and histamine. The BFSA informed the audit team that it has established a working group to review the scope of the monitoring plan for 2022, which it expects to be finalised by 31 March 2022.

The competent authority provided data on the number of samples planned, taken and analysed, in accordance with the monitoring plan for 2021, from consignments of goods of animal origin entering the EU in 2021, which are summarised in the following table: No of No of No of No of samples Percentage samples samples samples with sampled planned taken analysed unfavourable - results - Products of animal origin, intended for human consumption (POA-HC) Microbiological Residues (9) (includes histamine) 102 0 0 - Pathogenic organisms (10) Other hazardous substances (11) Total 102 0 0 - Products of animal origin, not intended for human consumption (POA-NHC) Microbiological Residues Pathogenic organisms Other substances dangerous to humans, animals or the environment Total (9) Groups A, B(1), B(2) and B(3) in Annex I to Directive 96/23/EC (10) Dangerous to humans, animals or the environment (11) Hazardous to humans, animals or the environment 7

The BFSA stated that in 2021 no samples were taken at BCPs under the monitoring plan for 2021 due to a significant delay in the approval of the National Monitoring Programme by MAFF. The programme was finally approved on 31 October 2021 and as a result, the BSFA stated that the sampling and analysis included in the monitoring plan for 2021 would be carried out over a limited period, between 1 January and 1 April 2022 only. Up to 8 February 2022, 47 out of 102 planned samples had been taken at the BCPs.

The audit team noted that the monitoring plan as developed and implemented did not achieve the objective of monitoring the conformity of goods of animal origin entering the EU with the rules referred to in Article 1(2) of the OCR, and in particular of detecting hazards. This is not in line with Article 4(5) and point 5 of Annex II to Commission Implementing Regulation (EU) 2019/2130.

Whilst there is a framework in place for the conduct of official controls on animals and goods entering the EU, underpinned by systematic communication and cooperation between the relevant authorities, certain organisational aspects weaken the effectiveness of the control system. These include the lack of (updated) documented procedures and arrangements and the failure to develop and implement an appropriate monitoring plan. It is likely that the shortfall in the implementation of control verification procedures hindered the ability of the competent authority to identify and address those shortcomings. 5.2 IMPLEMENTATION OF OFFICIAL CONTROLS ON ANIMALS AND GOODS ENTERING THE EU

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The audit team evaluated three CHED-Ps authorised for transit of consignments of animal origin and noted that each consignment was subjected to a documentary and identity check, however in all cases the identity check consisted only of a check of the seals on the containers or means of transport, despite the accompanying official certificate not providing information on those seals. This is not in line with Article 3(2) of Regulation (EU) 2019/2130. Those consignments also left the BCP of introduction without the vehicles or transport containers being sealed by the competent authority, which is not in line with Article 19(d) of Regulation (EU) 2019/2124. The BFSA stated that BCP staff relied on the seals applied by Customs.

The audit team further noted that, 106 out of 2 131 transiting consignments in 2020, and 1 604 out of 4 210 in 2021, had been recorded in TRACES-NT without confirmation of arrival and compliance of the consignment at the BCP of exit within a period of 15 days from the date on which the transit was authorised. In 2020, the majority of BCPs of exit were located in Bulgaria (64 out of 106), whereas in 2021, the majority were located in other Member States (1 513 out of 1 604). The BFSA confirmed to the audit team that the BCP staff at the BCPs of introduction in Bulgaria do not systematically follow-up with the competent authorities of the BCPs of exit (either in Bulgaria or in other Member States) on consignments for which Part III of the CHED has not been completed. This is not in line with Article 20(a) of Regulation (EU) 2019/2124. However, the BSFA stated that, in each case, it contacts Customs to confirm that the transiting consignments have left the EU, examples of which were provided to the audit team.

Whilst consignments of animals and goods entering the EU are presented for official controls, which are generally carried out in line relevant EU legislation, shortcomings in their implementation, particularly concerning transits, the performance of identity checks on goods of animal origin and the recording of the outcome of the official controls performed, and any decisions taken, in the CHED, collectively undermine the overall effectiveness of the control system to ensure that only compliant consignments of animals and goods enter the EU.

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Whilst consignments of animals and goods entering the EU are presented for official controls, which are generally carried out in line relevant EU legislation, shortcomings in their implementation, particularly concerning transits, the performance of identity checks on goods of animal origin and the recording of the outcome of the official controls performed, and any decisions taken, in the CHED, collectively undermine the overall effectiveness of the control system to ensure that only compliant consignments of animals and goods enter the EU.

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In one of these three examples, BCP staff did not indicate the BCP of exit in the CHED, which is not in line with Article 56(3)(b) of the OCR and Article 40(2)(b)(ii) of Regulation (EU) 2019/1715. Consequently the BCP of exit could not confirm the arrival of the consignment. 11

The audit team noted that for one of the six CHED-As evaluated, the entry of a consignment non-commercial pet animals was accepted for quarantine. However, the details of the controlled destination (quarantine) were not completed in Part II of the CHED-A. The BFSA stated that this decision to accept entry for quarantine was made in error.

The audit team also noted that the impact of the transport on animals was not completed in Part II of three out of the six CHED-As evaluated, which is not in line with Article 40(2)(b)(ii) of Regulation (EU) 2019/1715. 5.2.4.2 Checks on consignments of goods of animal origin

Whilst consignments of animals and goods entering the EU are presented for official controls, which are generally carried out in line relevant EU legislation, shortcomings in their implementation, particularly concerning transits, the performance of identity checks on goods of animal origin and the recording of the outcome of the official controls performed, and any decisions taken, in the CHED, collectively undermine the overall effectiveness of the control system to ensure that only compliant consignments of animals and goods enter the EU.

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The audit team further noted that in the case of the BCPs Kapitan Andreevo and Kalotina, the BCP facilities for controls of animals entering the EU are used for the performance of official controls on consignments of animals intended for export from the EU. The BFSA provided the team with the necessary risk assessment and measures for the prevention of cross-contamination, which is in line with Article 5(4) of Regulation (EU) 2019/1014. Conclusions on the compliance of border control posts with minimum requirements

The BCPs evaluated comply with the minimum requirements for BCPs for the categories of animals and goods for which they have been designated with one exception at the BCP Kapitan Andreevo, where there were no arrangements in place to ensure that the sharing of facilities for food of animal and non-animal origin does not have an adverse impact on the hygienic handling and storage of those goods.

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

Planning of inspections is based on appropriate risk-related factors and allows for official controls to be carried out on all operators on a risk basis and with appropriate frequency. Implementation of inspections was, however, not effective. The audit team identified shortcomings in inspectors' assessment of (i) feed business operators' hazard identifications within their hazard analyses and critical control point plans, (ii) operators' testing on cross-contamination, (iii) operators' traceability systems and (iv) operators' compliance with labelling requirements. These shortcomings in implementation weaken the effectiveness of the overall feed control system. 5.2.2 Sampling and analysis 5.2.2.1 Planning of official sampling

Medlemsstatens svar

During the 3th and 4th quarters of 2022, training for feed inspectors will be conducted in all Regional Offices involved in conducting official controls of animal feed with final confirmatory test, and a practical presentation in one of the approved establishments for the production, distribution and storage of animal feed. The training will be conducted by a Feed Control and Animal by-Products Directorate from the central office of the Bulgarian Food Safety Agency. During the 3th quarters of 2022 the Feed Control and Animal by- Products Directorate will organise the meeting with feed associations and feed manufactures. Schedule: The proposed measures will be implemented in 2022

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Verification of establishments' tests on minimisation of cross-contamination, required by part 2(b) of section "Facilities and equipment" of Annex II to Regulation (EC) No 183/2005, forms part of the inspections, when applicable. At the three compound feed manufacturers visited (all using coccidiostats in production lines where feed for non-target species was also produced), the audit team scrutinised operators' documentation on the related testing, interviewed inspectors normally controlling those establishments and made the following observations: · In all three establishments, a tracer was used to determine carry-over of coccidiostats. It was not known whether the physicochemical properties of the tracer were similar to the coccidiostats used and thus whether this approach allowed for an accurate assessment of carry-over of the coccidiostats in question. The choice of tracer was not justified. · Notwithstanding the audit team's reservation on the applicability of a tracer to determine the degree of cross contamination for coccidiostats, in one establishment, one result of the carry- over test (4%) exceeded the acceptable levels referred to in recital 5 of Regulation (EU) No 574/2011 - approximately 3% of the authorised maximum content as regards feed for less sensitive non-target animal species, and approximately 1% of the authorised maximum content for feed intended to be fed to sensitive non-target animal species and feed used for the period before slaughter. The FeBO had not identified this irregularity and consequently actions had not been taken to rectify the situation. These deficiencies identified by the audit team had not been reflected in any of the recent inspection/audits reports seen.

Planning of inspections is based on appropriate risk-related factors and allows for official controls to be carried out on all operators on a risk basis and with appropriate frequency. Implementation of inspections was, however, not effective. The audit team identified shortcomings in inspectors' assessment of (i) feed business operators' hazard identifications within their hazard analyses and critical control point plans, (ii) operators' testing on cross-contamination, (iii) operators' traceability systems and (iv) operators' compliance with labelling requirements. These shortcomings in implementation weaken the effectiveness of the overall feed control system. 5.2.2 Sampling and analysis 5.2.2.1 Planning of official sampling

Medlemsstatens svar

During the 3th and 4th quarters of 2022, training for feed inspectors will be conducted in all Regional Offices involved in conducting official controls of animal feed with final confirmatory test, and a practical presentation in one of the approved establishments for the production, distribution and storage of animal feed. The training will be conducted by a Feed Control and Animal by-Products Directorate from the central office of the Bulgarian Food Safety Agency. During the 3th quarters of 2022 the Feed Control and Animal by- Products Directorate will organise the meeting with feed associations and feed manufactures. Schedule: The proposed measures will be implemented in 2022 Page: 1 eport ref. DG(SANTE) 2022-7429 of the audit carried out from 07 March 2022 on feed hygiene Action Proposed by the competent authority

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Routine inspections include verification of operators' traceability systems, including the operators' obligation to take samples of ingredients and from each batch of products manufactured and placed on the market, or of each specific portion of production (in the case of continuous production) in sufficient quantities, using a procedure pre-established by the manufacturer (hereinafter retained samples), as required in part 4 of the section "Quality control" of Annex II to Regulation (EC) No 183/2005. The audit team scrutinised operators' documentation on collection, storage, packaging and labelling of retained samples, interviewed inspectors normally controlling those establishments and made the following observations: · in one establishment, retained samples were not collected and stored from two (of the three) feed materials produced by the company; · in two compound feed producers, the retained samples were not sealed; · in one establishment, the FeBO did not find the retained sample of one ingredient chosen by the audit team for verification. These observations are not in line with the legal requirements established in part 4 of the section "Quality control" of Annex II to Regulation (EC) No 183/2005 and were not identified in any of the recent inspection reports seen.

Planning of inspections is based on appropriate risk-related factors and allows for official controls to be carried out on all operators on a risk basis and with appropriate frequency. Implementation of inspections was, however, not effective. The audit team identified shortcomings in inspectors' assessment of (i) feed business operators' hazard identifications within their hazard analyses and critical control point plans, (ii) operators' testing on cross-contamination, (iii) operators' traceability systems and (iv) operators' compliance with labelling requirements. These shortcomings in implementation weaken the effectiveness of the overall feed control system. 5.2.2 Sampling and analysis 5.2.2.1 Planning of official sampling

Medlemsstatens svar

During the 3th and 4th quarters of 2022, training for feed inspectors will be conducted in all Regional Offices involved in conducting official controls of animal feed with final confirmatory test, and a practical presentation in one of the approved establishments for the production, distribution and storage of animal feed. The training will be conducted by a Feed Control and Animal by-Products Directorate from the central office of the Bulgarian Food Safety Agency. During the 3th quarters of 2022 the Feed Control and Animal by- Products Directorate will organise the meeting with feed associations and feed manufactures. Schedule: The proposed measures will be implemented in 2022

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Verification that operators meet legislative labelling requirements forms part of routine inspections. At all of the FeBOs visited, the audit team scrutinised operators' labels and other relevant documents, interviewed inspectors normally controlling those establishments and made the following observations: · One label did not mention that the product was a "feed material", which is not in line with the requirements laid down in Article 15(a) of Regulation (EC) No 767/2009. · One label of complementary feed did not contain measurement units of some feed additives with established maximum limits, which is not in line with the requirements laid down in Article 15(f) of Regulation (EC) No 767/2009. · One label of complementary feed containing feed additives with established maximum limits did not contain clear dosage instructions, which is not in line with the requirements laid down in Article 17(1)(b) of Regulation (EC) No 767/2009. · On a label of complete feed the concentration of monensin exceeded the maximum limit established in Regulation (EU) No 495/2011. · On a label of a premixture, there was no information on the amount of feed additive in the premixture, although this feed additive had a maximum limit in its authorisation for different food-producing animals. This is not in line with the requirements laid down in point 2(b)(i) of Annex III to Regulation (EC) No 1831/2003. 6 · On a label of a premixture, the identification number of a feed additive was not correct. This is not in line with the requirements laid down in Article 16(1)(f) of Regulation (EC) No 1831/2003 Conclusion on the planning and implementation of inspections

Planning of inspections is based on appropriate risk-related factors and allows for official controls to be carried out on all operators on a risk basis and with appropriate frequency. Implementation of inspections was, however, not effective. The audit team identified shortcomings in inspectors' assessment of (i) feed business operators' hazard identifications within their hazard analyses and critical control point plans, (ii) operators' testing on cross-contamination, (iii) operators' traceability systems and (iv) operators' compliance with labelling requirements. These shortcomings in implementation weaken the effectiveness of the overall feed control system. 5.2.2 Sampling and analysis 5.2.2.1 Planning of official sampling

Medlemsstatens svar

During the 3th and 4th quarters of 2022, training for feed inspectors will be conducted in all Regional Offices involved in ucting official controls of animal feed with final confirmatory test, and a practical presentation in one of the approved establishments for the production, distribution and storage of animal feed. The training will be conducted by a Feed Control and Animal by-Products Directorate from the central office of the Bulgarian Food Safety Agency. Schedule: The proposed measures will be implemented in 2022

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The audit team observed official sampling at the three compound feed manufacturers visited (the matrix and parameters to be controlled were suggested by the audit team). In addition, a number of sampling records from 2019 and onwards were scrutinised. Based on these, the audit team made the following observations: · In two of the three establishments a substantial part of the batch suggested for sampling was not accessible. Therefore, it was impossible to collect incremental samples representatively 7 from the batch. The inspectors collected the incremental samples only from a part of the batch (i.e. sampled portion). The inspectors did not identify the size of the sampled portion and consequently did not record it on the sampling protocol. This is not in line with the requirements laid down in part 10 of Annex I to Regulation (EC) No 152/2009. · In one establishment, the size of each incremental sample was less than 100 g which is not in line with the requirements laid down in part 9.2 of Annex I to Regulation (EC) No 152/2009. · In one establishment, the number of incremental samples collected was lower than the minimum required in part 5.1 of Annex I to Regulation (EC) No 152/2009. · In one establishment, two final samples were prepared which is not in line with the requirements laid down in part 9.4 of Annex I to Regulation (EC) No 152/2009.

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

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uring the 3th and 4th quarters of 2022, training for feed inspectors will be conducted in all Regional Offices involved in conducting official controls of animal feed with final confirmatory test, and a practical presentation in one of the approved establishments for the production, distribution and storage of animal feed. The training will be conducted by a Feed Page: 2 eport ref. DG(SANTE) 2022-7429 of the audit carried out from 07 March 2022 on feed hygiene ion Proposed by the competent authority trol and Animal by-Products Directorate from the central ice of the Bulgarian Food Safety Agency. ing the 2nd quarters of 2022 the sampling protocol template amended was send the mechanism to calculate the number incremental samples, aggregate samples and final samples to feed inspectors. (see the attachment files) edule: The proposed measures will be implemented in 2022

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The audit team scrutinised a number of laboratory results and observed that, in two cases, the level of coccidiostats in complete feed was lower than the minimum content established in the respective authorisation. Thus, the requirements laid down in part B(2) of Annex IV to Regulation (EC) No 767/2009 were not properly taken into account by the BFSA. 5.2.2.3 Testing of official feed samples

The audit team scrutinised a substantial number of analytical tests (with related raw data) and reports related to undesirable substances within the meaning of Directive 2002/32/EC and observed that, when relevant, the results were recalculated to a feed with a moisture content of 12% and that the expanded measurement uncertainty was properly reported. However, in the vast majority of the reports seen, the analytical recovery was not indicated and it was unclear whether the result(s) had been corrected for recovery. This is not in line with the requirements laid down in part C.6. of Annex II to Regulation (EC) No 152/2009. The audit team noted that, in the contracts seen, the BFSA had not requested that the laboratories would perform correction for recovery and indicate the level of recovery, when relevant. Conclusion on the planning and implementation of official sampling, and testing of official feed samples

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

Medlemsstatens svar

ial During the 3th and 4th quarters of 2022, training for feed pectors will be conducted in all Regional Offices involved in ting official controls of animal feed with final firmatory test, and a practical presentation in one of the roved establishments for the production, distribution and rage of animal feed. The training will be conducted by a Feed trol and Animal by-Products Directorate from the central ice of the Bulgarian Food Safety Agency. ing the 2nd and 3th quarters of 2022, written correspondence l be held with laboratories to provide information in ordance with Part C, point 6 of Annex II to Regulation (EC) 2/2009 in the analytical reports. edule: The proposed measures will be implemented in 2022

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In the two laboratories visited, the audit team noted that 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. In the third national laboratory, the method for determination of moisture content was not accredited. This latter finding has the potential to weaken the legal and technical validity and hence the reliability of all tests on undesirable substances carried out by this laboratory since all measurable results must be recalculated to 12% moisture content as required by Directive 2002/32/EC. Thus, the requirements laid down in Article 37(5)(a) of Regulation (EU) 2017/625 are not fully met for this third national laboratory.

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

Medlemsstatens svar

ing the 2nd and 3th quarters of 2022, the agreements ncluded with the laboratories performing official feed control ill be reviewed, including t the accreditation of the moisture. edule: The proposed measures will be implemented in 2022 Page: 3 eport ref. DG(SANTE) 2022-7429 of the audit carried out from 07 March 2022 on feed hygiene tion Proposed by the competent authority

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

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

Medlemsstatens svar

ring the 2nd and 3th quarters of 2022, the agreements ncluded with the laboratories performing official feed control ll be reviewed, which will include a requirement for written cumentation of the preparation of the final samples. hedule: The proposed measures will be implemented in 2022

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The audit team scrutinised a substantial number of analytical tests (with related raw data) and reports related to undesirable substances within the meaning of Directive 2002/32/EC and observed that, when relevant, the results were recalculated to a feed with a moisture content of 12% and that the expanded measurement uncertainty was properly reported. However, in the vast majority of the reports seen, the analytical recovery was not indicated and it was unclear whether the result(s) had been corrected for recovery. This is not in line with the requirements laid down in part C.6. of Annex II to Regulation (EC) No 152/2009. The audit team noted that, in the contracts seen, the BFSA had not requested that the laboratories would perform correction for recovery and indicate the level of recovery, when relevant. Conclusion on the planning and implementation of official sampling, and testing of official feed samples

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

Medlemsstatens svar

ring the 2nd and 3th quarters of 2022, written correspondence l be held with laboratories to provide information in cordance with Part C, point 6 of Annex II to Regulation (EC) 52/2009 in the analytical reports. hedule: The proposed measures will be implemented in 2022

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The audit team reviewed five cases of non-compliances, related to samples taken, and noted that the RFSDs had provided a very detailed description of the events. However, in the vast majority of the cases seen, a comprehensive investigation had not been carried out either by the operators or by the RFSDs to identify the root cause and consequently actions had not been taken to prevent potential reoccurrence of these non-compliances. This is not in line with the requirements laid down in Article 138 (1) of Regulation (EU) 2017/625. Conclusion on the actions taken on non-compliances

Notwithstanding the prompt communication of non-compliances to the feed business operators during official controls, the fact that the competent authorities do not consistently verify that the feed business operators take actions to (i) determine the origin of those non-compliances, (ii) remedy the non-compliance and (iii) prevent further occurrences, weakens the effectiveness of the control system.

Medlemsstatens svar

ring the 3th and 4th quarters of 2022, training for feed spectors will be conducted in all Regional Offices involved in nducting official controls of animal feed with final nfirmatory test, and a practical presentation in one of the proved establishments for the production, distribution and orage of animal feed. The training will be conducted by a Feed ntrol and Animal by-Products Directorate from the central fice of the Bulgarian Food Safety Agency. hedule: The proposed measures will be implemented in 2022 Page: 4

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There is a system for the verification of procedures in place in accordance with Article 12(2) of Regulation (EU) 2017/625. However, the CA informed the audit team that there were no records of any verification procedures conducted, as this activity was not implemented yet because of the COVID restrictions. The BFSA provided the audit team with a copy of a SOP developed for the verification procedures of official controls performed at BCPs and CPs. 5.1.4 Planning of official controls

The system for verification of procedures has been delayed and therefore, it could compromise the effectiveness of the official plant health import controls carried out in Bulgaria.

Medlemsstatens svar

Due to a complicated COVID situation, visits to the BCP to carry out the verification/verification procedures are planned to take place in 2022 in accordance with Article 12(2) of Regulation 2017/625.

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Annex 6 of the inspection manual, in relation to sampling, is in line with the requirements of point 4 of Annex III to Regulation (EU) 2019/2130, although there is no clear reference on how to sample for performing physical checks of WPM consignments. This influences the way physical checks are conducted by inspectors at 10 the BCPs and CPs, as observed during the physical check demonstrations (see paragraph 66).

As indicated in paragraph 32, there is a written procedure on how to conduct inspection of WPM but the audit team could not identify any clear reference in the documentation provided on how to perform sampling for inspection of WPM, which is done at the inspector's discretion. 5.2.8 Scientific imports

Official import controls procedures for plant products and other objects, described in the MMDPHC, do not clearly indicate how to perform sampling for inspection of WPM. Therefore, this does not support a consistent approach to controls by inspectors, 13 compromising the overall effectiveness of the import system for WPM.

The audit team was shown seven video demonstrations of physical checks with commentary from the inspectors on various types of consignments at the following BCPs: Kapitan Andreevo road, Sofia airport, Burgas seaport and Kalotina road. Moreover, the audit team simulated additional inspections using the material presented in the videos in order to corroborate the information provided by the inspectors interviewed at the same BCP. The audit team made the following observations: a) The unit of inspection was not consistently identified in accordance with the guideline for inspection, in the case of the lemon fruits inspection at Kapitan Andreevo, the basil inspection at Sofia airport, the simulated inspection of plants for planting at the same BCP and the simulated citrus inspection at Burgas seaport. b) The correct sample size for physical inspections was not always used, in accordance with the guideline. This was the case in the following demonstrations; the potted plants inspection at Kapitan Andreevo, the lemon fruits inspection at the same BCP, the basil and simulated plants for planting 15 inspections at Sofia airport, the simulated fruit inspection at Burgas seaport and the fruit inspection at Kalotina BCP. c) In the case of the inspection of the WPM, which accompanied the cabbages and the lemon fruits at their respective BCPs, the inspectors did not always determine the number of units to be inspected. At Kalotina, the inspectors could not establish the number of units to be sampled during a simulated scenario of 1500 wooden boxes. d) Also at Kalotina BCP, the two inspectors interviewed, stated that they would not inspect the wooden fruit boxes, because the wood was thinner than 6mm. Some elements of the box, in particular the reinforcements at the corners, were evidently thicker than this. Conclusions on import inspections

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attached Control Scheme (Monitoring Programme for Forest Species), which also includes WPM, sets out detailed sampling . rules for the performance of official controls he introduction of consignments of WPM into the Union. As the Monitoring . Programme was developed in 2020 and does not include detailed information with regard to Implementing Regulation (EU) 127/2021, an indicative letter has been sent to all BCPs to explain the performance of official controls and the corresponding frequency of checks on consignments of WPM arriving from third countries -- Belarus, India and China. The procedure for official control over the introduction of consignments of plants, plant products and other objects is fully updated, Page: 1 mitted by the competent authorities of Bulgaria in response to Report ref. DG(SANTE) 2021-7275 of in order to evaluate the system of import controls for plant health ion Proposed by the competent authority Commission services' assessment of the ing into account and reflecting the ommendations of the audit. will be provided additionally.

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The BFSA also rely on the importers declaration in relation to the control of WPM. According to the information provided by the CA, there is no monitoring plan laid down for WPM in accordance with Articles 2 and 3 of Commission Delegated Regulation (EU) 2019/2125. Bulgaria conducts inspections of WPM when they are found in consignments inspected by other official services, as health, food or veterinary services and when supporting high risk commodities listed in the combined nomenclature (CN) codes and countries of origin indicated in the Annex of the Commission Implementing Regulation (EU) 2021/127. This practical approach must be taken into account when referring to the percentage of inspection achieved by the CA in chapter 4.2 and the target established by the BFSA as in paragraph 37.

There is no monitoring plan developed for WPM, contrary to the requirements of the EU Regulation. Therefore, this represents a plant health risk for the introduction into the EU of live pests with the WPM used.

Medlemsstatens svar

far, a WPM control scheme has been developed and authorised as part of a itoring programme for forest species. ever, a monitoring plan for wood kaging material will be further developed accordance with Article 2 of Regulation ) 2019/2125. ase find the attached information: National monitoring plan for the WPM, as required by Article 2 of Implementing Regulation (EU) 2019/2125. National monitoring plan for WPM.pdf Risk analysis for introduction of consignments consisting of WPM Page: 2 mitted by the competent authorities of Bulgaria in response to Report ref. DG(SANTE) 2021-7275 of in order to evaluate the system of import controls for plant health Action Proposed by the competent authority .pdf 3.) Risk register for WPM for 2022. 2022 .pdf

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The BFSA informed the audit team that the CA rely on Annex 9A to Order NºRD 11 to 1393 from 2015 to conduct compulsory laboratory analysis on some seeds, plants for planting and other vegetable material, including ware potatoes, wood and WPM. This work instruction indicates that samples of the type of commodities and species listed shall be sent to the CLPQ when imported from certain countries, but does not specify which harmful organisms will need to be tested for and the percentage of consignments to be tested. This information is only available in the case of ware potatoes coming from certain countries. The BFSA also informed the audit team that there is no minimum amount of samples, concerning plants for planting, sent to official laboratories for latent infection detection, according to a risk analysis, contrary to point 6 of Annex III, to Commission Implementing Regulation (EU) 2019/2130. 5.1.5 Cooperation with Customs services and operators

Concerning plants for planting, the absence of an updated plan for latent infection detection, compromises the effectiveness of the import control system to prevent the introduction of quarantine pests into the EU.

Medlemsstatens svar

During an audit carried out by DG SANTE in May, the audit team was provided with a developed SOP 06 (sampling procedure) for carrying out physical checks on consignments of plants, plant products and other objects originating in third countries intended for introduction into the Union. Table 2 of that SOP provides information on the compilation of an average sample for laboratory testing against the category of plants, plant products and other objects listed, which also includes information on plants for planting. Page: 3 mitted by the competent authorities of Bulgaria in response to Report ref. DG(SANTE) 2021-7275 of in order to evaluate the system of import controls for plant health Action Proposed by the competent authority In this regard, please find attached an updated Annex 9A to Order No RD 11-1393 of 2015 to carry out mandatory laboratory analysis of certain seeds, plants for planting and other plant material, including ware potatoes, wood and WPM, which sets out reference information to SOP-06.

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The audit team was shown seven video demonstrations of physical checks with commentary from the inspectors on various types of consignments at the following BCPs: Kapitan Andreevo road, Sofia airport, Burgas seaport and Kalotina road. Moreover, the audit team simulated additional inspections using the material presented in the videos in order to corroborate the information provided by the inspectors interviewed at the same BCP. The audit team made the following observations: a) The unit of inspection was not consistently identified in accordance with the guideline for inspection, in the case of the lemon fruits inspection at Kapitan Andreevo, the basil inspection at Sofia airport, the simulated inspection of plants for planting at the same BCP and the simulated citrus inspection at Burgas seaport. b) The correct sample size for physical inspections was not always used, in accordance with the guideline. This was the case in the following demonstrations; the potted plants inspection at Kapitan Andreevo, the lemon fruits inspection at the same BCP, the basil and simulated plants for planting 15 inspections at Sofia airport, the simulated fruit inspection at Burgas seaport and the fruit inspection at Kalotina BCP. c) In the case of the inspection of the WPM, which accompanied the cabbages and the lemon fruits at their respective BCPs, the inspectors did not always determine the number of units to be inspected. At Kalotina, the inspectors could not establish the number of units to be sampled during a simulated scenario of 1500 wooden boxes. d) Also at Kalotina BCP, the two inspectors interviewed, stated that they would not inspect the wooden fruit boxes, because the wood was thinner than 6mm. Some elements of the box, in particular the reinforcements at the corners, were evidently thicker than this. Conclusions on import inspections

Physical inspections are not always carried out in accordance with EU requirements, and as specified in the relevant guidelines. As a result, this increases the risk that the controls do not effectively prevent the introduction of harmful organisms into the EU.

Medlemsstatens svar

In order to harmonise the implementation of checks at BCPs and verify the competence of the CAs, a training programme is foreseen in 2022, which also addresses aspects to enhance the competence of official phytosanitary inspectors. Attached: Training programme 2022 It is planned to conduct the thematic training in the 2nd quarter of 2022 in order to apply a synchronized approach in carrying out the inspections of the BCP / CP. It will be presented additionally.

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With regard to scope and content of the NMPCR the audit team noted: a) the plan includes all relevant commodities except for farmed pheasants which are reared in small quantities for hunting or for release into the wild. There are no processing units in Bulgaria and efforts to identify foreign laboratories for testing feed samples was so far unsuccessful. No farm water samples have been considered for inclusion in the plan. b) the plan largely meets the sampling levels and frequencies laid down in EU law (9) and samples are divided over substance groups according to the prescribed breakdown. However, for milk and eggs 300 samples in total are collected from bovine and ovine milk and from hen and quail eggs, respectively. This is not in line with the EU requirements (10) as milk samples from other animal species (ovine, caprine) and egg samples from other poultry species must be included in the sampling plan as additional samples; c) the plan covers all of the substance groups required except for horses, for which in 2018 and 2019 testing for substance groups B3a, B3b and B3d was not included although required (11). Testing for these substance groups was resumed in 2020; d) matrices tested are largely in line with the recommendations of European Union Reference Laboratories (EURLs) except for 17-oestradiol and 17-testosterone (A3) in pigs (urine) and nitroimidazoles (A6) in poultry (muscle). Conclusions on planning of residue monitoring

The planning of the residue monitoring is timely, takes into consideration the major risk factors and is largely in line with applicable legal requirements. Its effectiveness was negatively affected by the lower than required sample numbers for bovine milk and hen eggs. (8) Annexes I-IV to Directive 96/23/EC, Commission Decision 97/747/EC. (9) Annex I, II and IV to Directive 96/23/EC, Article 1 and Annex to Decision 97/747/EC. (10) Article 1 and Annex to Decision 97/747/EC. (11) Annex II to Directive 96/23/EC. 4 5.1.3. Implementation of the residue monitoring plan Findings

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NDNIVMI (the NRL for AI is located within its structure) has prepared and applied with a project to improve the laboratory capacity, which includes the purchase of equipment for path typing and sequencing. The project was developed under sub-measure 5.1 "Support for investments in preventive measures aimed at mitigating the consequences of probable natural disasters, adverse climatic events and catastrophic events" of Measure 5 "Restoration of agricultural production potential damaged by natural disasters , and the introduction of appropriate preventive measures "within the Rural Development Program 2014-2020" The project has been submitted for approval to the State for Agriculture and is expected to be approved by the end of 2020. After its approval, a public procurement for the purchase of the specified equipment to be launched (expected period for conducting and finalizing the public procurement is January-March 2021). Meanwhile, NDNIVMI has a sequencer that can be used by NRLs as needed. Updated response received on 26 February 2021: Regard to findings 20 and 31. In case of doubt, restrictive measures are to be /shall be/ taken immediately in accordance with Directive 2005/94/E

The NDNIVMI (The NRL for AI is located within its structure) has prepared and applied with a project to improve the laboratory esults capacity, which includes the purchase of equipment for path sures. typing and sequencing. The project was developed under sub- 8) measure 5.1 "Support for investments in preventive measures aimed at mitigating the consequences of probable natural disasters, adverse climatic events and catastrophic events" of nd Measure 5 "Restoration of agricultural production potential damaged by natural disasters , and the introduction of appropriate preventive measures "within the Rural Development Program 2014-2020" The project has been submitted for approval to the State for Agriculture and is expected to be approved by the end of 2020. After its approval, a public procurement for the purchase of the specified equipment to be launched (expected period for conducting and finalizing the public procurement is January- March 2021). Meanwhile, NDNIVMI has a sequencer that can be used by NRLs as needed.

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ease see actions proposed under point 1 and 3. dated response received on 26 February 2021: consider Recommendations 2 been adequately addressed by the above answer to Page: 3 ceived 19 July 2021 ted by the competent authorities of Bulgaria in response to Report ref. DG(SANTE) 2020-7095 of ber 2020 in order to evaluate the application of measures for the prevention and control of avian ction Proposed by the competent authority ecommendation 1

all Please see actions proposed under point 1 and 3.

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The delay by the NRL will be avoid by better implementation of their contingency plan enhances human resources and capacity, prioritization of the samples to be laboratory ested) in emergency situations. oreover, high risk zones will be established with relevant restrictions to be enforced as a reventive measure to avoid the possibility of disease transmission in the affected area. The stablishment of the high risk zones will be based on the risk assessment related to AI. pdated response received on 26 February 2021: e consider Recommendations 3 been adequately addressed by the above answer to ecommendation 1

thout The delay by the NRL will be avoid by better implementation of their contingency plan (enhances human resources and capacity, prioritization of the samples to be laboratory tested) in emergency situations. Page: 1 11 December 2020 of report ref. DG(SANTE) 2020-7095 of the audit carried out from 21 September es for the prevention and control of avian influenza Action Proposed by the competent authority Moreover, high risk zones will be established with relevant restrictions to be enforced as a preventive measure to avoid the possibility of disease transmission in the affected area. The establishment of the high risk zones will be based on the risk assessment related to AI

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esent contingency plan on AI provides information about the human methods for illing in case of emergency animal diseases, in line with the Regulation 1099/2009. nstruction for human killing in case of animal disease outbreak approved by Order 478/29.07.2019 describes the killing method with gas usage. Q of BFSA started procedures for renting of service which will provide gas and gas nstallation to be used in case of outbreak. The contract with a company to deliver that ervice will be signed in case of event. Page: 4 ceived 19 July 2021 ted by the competent authorities of Bulgaria in response to Report ref. DG(SANTE) 2020-7095 of ber 2020 in order to evaluate the application of measures for the prevention and control of avian ion Proposed by the competent authority means of letter issued by the Executive Director of the BFSA ( 613 .10.2020) the RFSDs have been required to draw tailored plans for depopulation which individual for each outbreak. training on the topic is planned to be organized for each RFSDs in the first half of 1. ated response received on 26 February 2021: order to provide conditions for faster eradication of an outbreak of avian influenza and tying of poultry farm

The present contingency plan on AI provides information about a) the human methods for killing in case of emergency animal ) diseases, in line with the Regulation 1099/2009. Instruction for lved human killing in case of animal disease outbreak approved by n as Order 1478/29.07.2019 describes the killing method with gas usage. HQ of BFSA started procedures for renting of service which will provide gas and gas installation to be used in case of outbreak. ). The contract with a company to deliver that service will be signed in case of event. By means of letter issued by the Executive Director of the BFSA ( 613 /09.10.2020) the RFSDs have been required to draw tailored plans for depopulation which are individual for each outbreak. The training on the topic is planned to be organized for each RFSDs in the first half of 2021.

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Sustained monitoring of the depopulated holdings ensures compliance with registration requirements, thereby preventing the resurgence of illegal activities.

The practical and financial challenges that the new biosecurity rules present for family farms that exceed the new stocking limits mean that enforcing compliance on these establishments is a priority.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

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An Action Plan for the Backyard Holdings in Bulgaria in Relation to ASF was drafted by BFSA l and was further approved and in force since the middle of March 2021: following elements of the plan are currently being implemented (as a continuous action or on a ular basis): -Registration process of the backyards (continuous) s on the online trade of pigs and illegal trade/movement (monthly checks) -Informational campaigns (continuous) Elements of the plan which are aimed at long-term actions, such as the clinical and biosecurity checks of the backyards by registered (private) veterinarians are already included in the Control Plan and prevention of the spread of African swine fever in the Republic of Bulgaria for the period 2021 - 2023 approved by Decision 313 of April 9, 2021 of the Council of Ministers and in a draft program for ASF (part of the National programme for eradication, control and surveillance of certain animal diseases and zoonoses) for the period 2022-2024 and are pending approval. In addition, ASF trainings dedicated to the official veterinarians are carried out in regions of the country, elements of which are the biosecurity practices in pig holdings, development and

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On the other hand, the operation of private laboratories without the oversight of the national reference laboratory for ASF calls into question their role in the performance of diagnostic and pre-movement tests for the disease.

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ry Control on the following stages was enforced in relation to the private laboratories involved in the process of testing sampled from live pigs for ASF for the purposes of the pre-movement health guarantees: - On-the-spot visits in the laboratories by representatives of the "Laboratory Controls" Directorate in the BFSA and the Head of the NRL-ASF/CSF aiming to assess their fitness to carry out laboratory testing for ASF, diagnostic methods and capacity. The findings are described in the enclosed: Page: 1 in report received 18 June 2021 a to the recommendations of report ref. DG(SANTE) 2020-7118 of the audit carried out from 02 November e implementation of animal health controls in relation to African swine fever ion Proposed by the competent authority oficiency test was organized by the NRL (in the period 7-18 June 2021) the results of which are ected in a two-weeks time. nthly reports on the tests carried out are required from the laboratories in order to provide the ormation as requested in a letter from the beginning of 2020 (the reporting frequency was nged from weekly to monthly basis in order to achieve realistic controls):

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The decision to suspend control and eradication measures in the areas surrounding confirmed ASF cases in wild boar increases the likelihood that the disease will persist and spread.

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EC was informed on the need of revision of the currently approved Plan for the ASF dication in feral pigs (by Commission Implementing Decision (EU) 2019/484) in order to dress the current phase of the disease in the country together with the hunting practices in place. requirement is currently set out in an Order by the Minister of agriculture, food and forestry, to the shared competences on the subject between the BFSA and the Executive Forest Agency A) with the latter being the CA authority for the hunting in Bulgaria: Page: 2

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Training of official staff does not meet the requirements laid down in Article 6(a) and (b) of Regulation (EC) No 882/2004. In addition, official staff does not have the access to all appropriate equipment for carrying out controls laid down in Article 4(d) of the Regulation. This has had a negative impact both on the verification of vaccine bait distribution and on the monitoring of the effectiveness of vaccinations. In June 2018, the BFSA organised training for selected officials near the airfields on how to carry out, and report, the daily checks on storage temperatures, flight lines 3 and bait drops. However, the trainees were not equipped with adequate hardware, software or IT training to be able to carry out these controls in line with the requirements issued to Member States by the Commission in 2015 (finding 23). Prior to the annual hunting season, the BFSA issues instructions for sampling and sample submission procedures to the RFSDs. The instructions are the same to all RFSDs and cover sampling for both rabies surveillance (head only) and monitoring of bait uptake and sero-prevalence (head + blood/serum samples from foxes and golden jackals). As described elsewhere in this report (findings 31 and 54), several of the official veterinarians at local levels, who are responsible for the sampling and the sample submission, did not implement sampling in accordance with the instructions that the BFSA had issued to the RFSDs. Conclusions on competent authorities

Responsibilities are clearly assigned and national legislation and instructions provide a solid basis for the implementation of the rabies eradication programme. However, the official veterinarians responsible for the daily controls on the aerial distribution of vaccine baits has not received appropriate instructions, equipment or training to carry out these controls. Consequently, the competent authority cannot provide the guarantees required by the Commission that the aerial distribution of vaccine baits has been implemented as agreed in the approved eradication plan.

The training provided has not been sufficient to ensure that the official veterinarians collect and submit the correct samples from the two main categories of wild animals (passive surveillance and monitoring of the effectiveness of vaccination). This has led to inaccuracies in the overall assessments of the results of monitoring and rabies surveillance.

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them a) the BFSA is currently assessing the options for purchasing new equipment and a GIS system enabling the real-time official control of the flights and the distribution of the baits (currently a link with real-time online tracking of the flights is available to the BFSA). Further a training of the official vets responsible for the controls on the oral vaccination on the field will be carried out (estimated timeframe ­ autumn 2019 (pending on the purchase)). b) The sampling, packing and delivery to NRL procedures are described in a Standard operational procedure No.13 and its Annex (available here: providing template for systematic collection of data on the samples submitted and the results obtained. Training on that SOP is provided to the heads of the regional AH units of the BFSA, together with the outcomes of the implementation of the programme is regularly provided (at least once per year). In order to guarantee the compatibility of the samples submitted vs. their classification in the NRL action was taken by the NRL and the AH unit in BFSA for sending data to the RFSD on the samples received and tested on a monthly basis. The protocols with the results of the tetracycline

BFSA is currently assessing the options for a) Software (GPSLClient) for online real-time purchasing new equipment and a GIS system enabling tracking of the aircrafts and the bait drop was the real-time official control of the flights and the provided by the IT services of the contractor distribution of the baits (currently a link with real-time implementing the vaccination. The programme online tracking of the flights is available to the BFSA). was installed to the computers of all official Further a training of the official vets responsible for the veterinarians appointed to control the aerial controls on the oral vaccination on the field will be distribution of the vaccine on the airfields and to carried out (estimated timeframe ­ autumn 2019 computers in BFSA HQ. Further, a training was (pending on the purchase). provided on 25.10.2019, before the estimated start of the autumn campaign, together with b) The sampling, packing and delivery to NRL written instruction for the users of the system. procedures are described in a Standard operational Assessment of the real-time control on the aerial distribution with the provided software will be procedure No.13 (available here: SOP-13

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Hunted foxes and golden jackals, as well as the occasional wolf, from areas outside the ORV areas are subject to rabies testing under a national active rabies surveillance programme. The BFSA has previously informed the Commission services that, until 2017 these tests were included in the applications for co-funding from the EU, but this would not be the case in the application for co-funding of the 2018 programme. In 2017, rabies tests were carried out under the national active surveillance programme on 444 foxes, 926 golden jackals and 1 wolf in total from 12 RFSDs outside the ORV area, and 2 hunted wolves from one RFSD within the ORV area. In 2018, the laboratory carried out rabies tests under the national active surveillance programme on 144 hunted foxes, 179 hunted golden jackals in total from 5 RFSDs outside the ORV area and five hunted wolves from one RFSD within the ORV area. In the 13 RFSDs (2018) where only part of the territory is covered by rabies vaccination, foxes and golden jackals hunted outside the ORV area have also been tested for rabies under the co-financed monitoring programme. 5.1.4 Verification of the monitoring and surveillance programmes

Each sample submission form indicates the geolocation of where the animal was shot or found. Neither the BFSA, nor the RFSD or the laboratory had used these data to indicate/determine if the tests carried out on the sample are eligible for co-funding under the monitoring programme or not. 14

The sampling for the monitoring of vaccine uptake and population immunity has improved since the previous audit. However, the uneven coverage, the lack of serological results from the regions added to the programme in 2018, the inclusion of samples from outside the vaccinated territories, the large proportion of golden jackals in the material and the deficiencies in the laboratory (see 5.4) weaken the reliability and representativeness of the results presented to the Commission.

There is a reasonable level of awareness among hunters but the authorities have made limited efforts to maintain a high awareness of rabies among the public, who might see rabies as a risk of the past. This is evident from the very few suspect cases and the limited numbers of samples submitted for passive surveillance to the local competent authorities. However, the passive surveillance has been under-reported by ca 50% to the Commission so the coverage has been better than reported, but it is still poor in certain important border areas where the competent authority considers the risk for incursion of rabies to be high. 15

The sample registration, and tests carried out, in the laboratory are sometimes not appropriate for the category of the sample due to a lack of clear categorisation of the samples on the submission form. Therefore, the summary results provided to the BFSA and the Commission have been misleading. The submission form used by the official veterinarians is the same irrespective of whether the sample is for the monitoring programme, for active surveillance outside the ORV area, or for the passive surveillance (suspect cases, animals killed in road traffic, animals found dead). A description of the sampled animal in free text on the submission form intends to guide the laboratory's classification of the sample. When official veterinarians had incorrectly submitted a blood sample (only required for the monitoring programme) with the animal's head (required for surveillance), the laboratory had handled the submission as if it belonged to the monitoring programme, also when the free text implied that it was not. There is no requirement for RFSDs with only part of their territory covered by ORV to indicate clearly if a sample originates from inside or outside of the ORV area. Consequently, the NRL has reported the results from animals hunted outside the vaccination area as if they belonged to the monitoring programme and were eligible for co-funding. Due to the miss-classification of passive surveillance samples, the NRL had not prioritised the samples for rapid rabies diagnostic tests, carried out over 100 unnecessary tests for biomarker and serology, and the total number of samples reported to the BFSA as passive surveillance was less than the actual numbers received and tested in the NRL.

Through the misclassification of samples and results, due to unclear information on the submission forms, the NRL has provided the competent authority with misleading results for rabies surveillance and monitoring of the effectiveness of the oral vaccination.

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order to facilitate the correct submission of registers the collected samples and their classification by oved the NRL, an amended template of submission was introduced by the BFSA. The form ides clear visibility of the type of surveillance he territory where it was collected from.. lease see the response to pt. i) the testing of the samples which were nating from areas outside the vaccinated ones h was related to the accreditation rements of the NRL) was addressed by an ial letter of the BFSA to the NDRVI and the ith instruction only blood samples from nated areas to be serologically tested. ns were taken so that quality manuals are able to the NRL constantly (action ongoing). were amended so that signatures are able on each page, reference to the OIE mended method was updated accordingly te also of the certificate is foreseen). er ELISA diagnostic kit was registered n by the NDRVI.

order to facilitate the correct submission of the A follow-up letter was sent on 10.10.2019 to the llected samples and their classification by the NRL, an NRL with particular instruction applicable for amended template of submission form was introduced the TMTesting. by the BFSA. The form provides clear visibility of the type of surveillance and the territory where it was collected from. (the template is attached to the current file ). ease see the response to pt. i) the testing of the samples which were originating from areas outside the vaccinated ones (which was related to the accreditation requirements of the NRL) was addressed by an official letter of the BFSA to the NDRVI and the NRL (enclosed ) with instruction only blood samples from vaccinated areas to be serologically Page: 2 ecommendations received on 29 October 2019 ubmitted by the competent authorities of Bulgaria in response to Report ref. 25 March 2019 to 29 March 2019 in order to evaluate the implementation and Action Proposed by the competent authority BFSA Response of 29/10/2019 tested. Actions were taken so that quality manuals are available to the NRL constantly (action ongoing). SOPs were amended so that signat

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In 2017 and in 2019 (to date) the national reference laboratory for rabies (NRL) only tested less than half of the samples submitted for detection of antibodies. The NRL and the BFSA indicated that this problem had been linked to the procedures for procurement of test kits and was likely to continue into the next three-year period (2019-2021). In 2018, all 800 samples submitted for serological testing were analysed. In 2017, the NRL tested only 39% (317) of the 817 blood samples they had received. In 2019, the NRL tested the first 100 blood samples to arrive but samples arriving later have been stored frozen pending procurement of test kits. The laboratory expects that, although financial means have been made available in the budget,, the procurement rules may restrict the purchase to 900 tests, out of the ca 2,281 listed in the approved programme for 2019.

The basic methods of relevance for the rabies eradication programme are available in NRL. However, there is no confirmatory method for rabies, which is important e.g. if a person has been bitten by a potentially rabies-infected animal and the result of the initial FAT test of the biting animal is negative or inconclusive.

The FAT for rabies diagnosis and the tests for biomarker detection and age determination use methodology recommended by the EURL. However, the test used for detection of rabies antibodies is not the method recommended in international standards, has not been evaluated in international comparative tests, and does not meet the requirements in point (5)(f) of the Annex to Commission Decision 2008/341/EC. The acceptance criteria in the tender for purchase of ELISA kits for the detection of rabies antibodies are so specific that only the currently used commercial ELISA kit is eligible. The criteria include a requirement for validation for certain domestic species even though the NRL will use it for wildlife samples only. In published studies, the EURL and an OIE reference laboratory have shown that the commercially available ELISA used in the NRL is not sensitive enough and therefore not suitable for monitoring the effectiveness of rabies vaccination in foxes. A study from the EURL suggests that if this ELISA is used, the cut-off for deeming a test result positive needs to be lowered to increase the sensitivity of the method, compared to what is recommended in the instructions accompanying the test kit. The NRL has made no such adjustments to the method. 17 The performance of the commercial ELISA on sera from foxes had not been verified in the NRL, nor did the NRL take part in the 1st inter-laboratory study on rabies antibody detection in wildlife samples organised by the EURL in 2016. No information is available, from the manufacturer or from validation carried out in a manufacturer-independent laboratory, on the performance of this test on samples from golden jackals, which in 2018 represented 38% of the tested animals.

The NRL did not have sufficient test material to carry out serological analyses on a large proportion of the blood samples they received for the monitoring in 2017 and 2019. In addition, the low sensitivity of the serological method used in the NRL provides the competent authority with results that likely err towards a lower sero- prevalence in foxes(4). These weaknesses undermine the evaluation by the competent authority of the effect of the oral vaccination on the immunity of the target animal (fox) population. In addition, the laboratory does not have any confirmatory test method for rabies, which may delay important test results, especially in cases of suspect human exposure.

Despite the lack of sufficient supplies of test kits, the NRL used many of the available kits to analyse samples from golden jackals, a species for which the method's reliability is unknown. It is therefore not possible for the competent authority to investigate the possible reasons for the low sero-prevalence but high bait uptake reported by the NRL for golden jackals. 4 In their comments to the draft report the competent authority noted that in 2019 there is a new tender for diagnostic tests for serological analyses and FAT. 19

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tasks Following the audit findings, actions were taken to amend the technical specification related to the c procurement procedure for purchasing ELISA kits. The possibility of further investigation of the low seropositivity rates vs. the high % of the uptake in jackals was communicated with the EURL, information on the findings will be included in the following reports of the programme implementation to the EC. PCR testing will be added as confirmation method, such will be included in the scope of the next accreditation verification of the NRL by the Bulgarian Accreditation Service (estimated timeframe ­ October or November 2019)

g the audit findings, actions were taken to Under the previous programme period, one amend the technical specification related to the public contractor was directly assigned to supply rabies procurement procedure for purchasing ELISA kits diagnostic kits, as well as kits for diagnosis of (please find enclosed document). The possibility of influenza due to an emerging epizootic situation. further investigation of the low sero-positivity rates vs. In this case, the provisions of the Public the high % of the uptake in jackals was communicated Procurement Low do not allow direct with the EURL, information on the findings will be negotiation of kits above the value at which both diagnostics were purchased. Because of the fact included in the following reports of the programme that part of the allowed funds was used to implementation to the EC. purchase influenza kits too, the funds was not enough to purchase the rabies kits. PCR testing will be added as confirmation method, such will be included in the scope of the next accreditation Currently, following an "open" procurement verification of the NRL by the Bulgarian Accreditation procedure with a subject: "Delivery of vaccines Service (

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In 2018, the variation among the 22 RFSDs in the ORV area was substantial as illustrated in Figure 1. The poor and patchy implementation of the blood sampling makes it difficult to assess the seroprevalence in the target animal population. As regards submissions of animals for testing for rabies virus, bait contact and age determination, the mean among RFSDs was 4.49 animals/100 km2, the median was

As described in the 2014 audit report, there are no routines in the BFSA to check the progress of sampling and testing during the year, which would make timely corrective actions possible. Although each RFSD has the responsibility for verifying that the number of monitoring samples submitted meets the target set for the ORV area, there were examples of both extreme over-sampling and substantial under-sampling in 2018. The BFSA was aware of the seemingly poor passive surveillance, but it was not until this audit that the incorrect classification of samples in the laboratory became evident. Unless the laboratory diagnoses rabies, the BFSA would not notice any non- compliance regarding sampling or testing until they receive the annual results from the laboratory at the beginning of the following year, in preparation for the annual report to the Commission. The NRL, the BFSA, or the responsible RFSDs had not taken any (documented) actions e.g. to address the lack of, or poor implementation of, blood sampling in several RFSDs, including the seven regions added to the ORV in 2018. 5.1.5 Analysis of the effectiveness of the rabies eradication programme

The sampling for the monitoring of vaccine uptake and population immunity has improved since the previous audit. However, the uneven coverage, the lack of serological results from the regions added to the programme in 2018, the inclusion of samples from outside the vaccinated territories, the large proportion of golden jackals in the material and the deficiencies in the laboratory (see 5.4) weaken the reliability and representativeness of the results presented to the Commission.

There is a reasonable level of awareness among hunters but the authorities have made limited efforts to maintain a high awareness of rabies among the public, who might see rabies as a risk of the past. This is evident from the very few suspect cases and the limited numbers of samples submitted for passive surveillance to the local competent authorities. However, the passive surveillance has been under-reported by ca 50% to the Commission so the coverage has been better than reported, but it is still poor in certain important border areas where the competent authority considers the risk for incursion of rabies to be high. 15

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Please see the response to the recommendation e 3b). Additional training for the AH units and representatives of the hunting organizations and xecutive Forestry Agency will be carried out (dates to be confirmed, estimated timeframe ­ autumn 2019).

e the response to the recommendation 1b). A template was introduced together with the tional training for the AH units and representatives NRL to cross-check the samples submitted by f the hunting organizations and Executive Forestry the RFSD and received by the NRL on a gency will be carried out (dates to be confirmed, monthly basis. Any incompliances are to be stimated timeframe ­ autumn 2019). communicated between the RFSD, NRL and HQ BFSA. Page: 4

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The Instruction of animal welfare during animal depopulation was updated on 29.07.2019 , as provides the option for applying erogation from one or more of the provisions of this Regulation e the CA considers that compliance is likely to affect human health or significantly slow down the process of eradication of a disease (in exceptional circumstances). The derogation (if applied) will be reported to EU via the annual report (as laid down in art.18 Regulation (EC) No 1099/2009). Culling method by lethal injection was not used in poultry. The National contingency plan has also been updated in line with the above mentioned Instruction. he new draft for amending the national veterinary legislation (Law of veterinary activity) requires the owner to draw up a plan for the implementation of emergency measures for detecting infectious disease in the nimal holding.

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On 27-28.06.2019, a training on AW during depopulation and emergency killing was organized for Heads of Animal Health Unit of all regions. It was desktop training updating and improving the knowledge about AW requirements and methods for killing of animals for emergency purposes. event of a widespread disease outbreak, services and additional personal will be contracted for depopulation, disposal, cleaning isinfection which will ensure that the outbreak eradication procedures are carried out without delay. Moreover, the new draft for amending the national veterinary legislation (Law of veterinary activity) requires the owner and local authorities (mayor) to cooperate and contribute to the eradication procedure , following the instruction of official veterinarians, which will ensure the effective and timely response, Page: 1 r 2019 rt ref. DG(SANTE)/2019-6600-MR of the audit carried out from 10 June evention and control of avian influenza on Proposed by the competent authority icularly in the event of a widespread disease outbreaks s foreseen that the faculties of veterinary medicine and essional training centers to organize courses related to the isition of knowledge and competence

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ans of legislation and educational tools will be used to awareness among owners of poultry kept in backyard ldings. ducational video for improvement awareness campaign among backyard owners is published on the website of BFS, and it is oaded especially for Avian influenza with more details on emiology, pathology and how and to whom to report lems and suspicions. This video is available on following k: ://bfsa.bg/bg/Page/Influenza/index/Influenza/%D0%98%D0% 1%84%D0%BB%D1%83%D0%B5%D0%BD%D1%86% 0%20%EF%BF%BD national veterinary legislation is going to be amended. The t lays down the rules of routine visits by private veterinarians a frequency specified in a procedure approved by the utive Director of the BFSA. For backyard holdings once h per at least.These visits will ensure the effectiveness of the Page: 2 r 2019 rt ref. DG(SANTE)/2019-6600-MR of the audit carried out from 10 June evention and control of avian influenza ion Proposed by the competent authority trol measures against AH in particular early detection, orting without delay of any signs of the disease, enhance reness and knowledge by the owners. early warning of suspected disease the new draft of Law of erinary activity p

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epidemiological inquiry is carried out at the time of suspicion hout delay, in accordance with the contingency plan for the ase. Some delays were observed during the epidemic in ginning of 2017 due to the increased number of outbreaks. Such ys were avoided due to the further measures taken in the rest 2017 and next epidemic in 2018 and 2019. s it was explained during the audit, the national poultry database tem has a number of weaknesses that make difficult the process epidemiological investigation. planned enhancements of the used systems will facilitate this cess. system will be inserted allowing access to GEO information poultry holding (in term of findings (55)) itionally, the epi protocol will re ­ designed to allow a prehensive epidemiological investigation and full risk essment.

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ional Diagnostic Science-and-Research Veterinary ical Institute (NDSRVMI) has planned a procedure for asing equipment for virus sequencing and pathotyping. The cedure is planned to be completed in March 2020. The ipment will be used by the NRL for AI 2020, the NDSRVMI has planned two more national oratories (within the BFSA structure) to be accredited for the Page: 3 r 2019 rt ref. DG(SANTE)/2019-6600-MR of the audit carried out from 10 June evention and control of avian influenza on Proposed by the competent authority ose of AI diagnostic, which will ensure the capacity to ond to the high testing demands in case of large outbreaks and emic of HPAI.

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laboratories involved in testing to detect the presence of avian influenza will be designated by Order of the Executive Director of e BFSA. Order requires the coordination of these laboratories, lar verification procedures of quality and reliability of their testing vities, via inter-laboratory comparative tests to be done by the

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PAI is confirmed in a poultry holding, without any delay ection and surveillance zones are established. emiological commissions consisting representatives from different institutions (local authorities including private sector as eterinarians) take place at municipal level. Within these meetings ll restriction measures are enforced. Special focus is given, in particular in relation to backyard holdings - counting of back s, communication and awareness campaign in cooperation the local authorities (mayor) and private veterinarians. disease surveillance activities are targeted in the zones rding to the risk of circulation and spread of the HPAI virus ed on the types of holdings. restrictions are lifted by means of Order of the Executive ctor of BFSA having considered the risk analysis and omes of the results from the surveillance activities.

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ventive culling as a specific additional measure to accelerate Page: 4 r 2019 rt ref. DG(SANTE)/2019-6600-MR of the audit carried out from 10 June evention and control of avian influenza Action Proposed by the competent authority the eradication of HPAI and prevent its further transmission in as with a high density of poultry has been arranged. Preventive culling has been used in 2017 (ADNS 2017/67) following the rules of Directive 2005/94/EC.

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The derogations for poultry movement has been granted by means of Order of the Executive director of BFSA for any particular movement since the start of epidemic. Based on the risk assessment and epidemiological situation the appropriate restrictive measures were taken including pre movement testing r any particular movement. As it was observed and noted in the audit report, having considered the development of the epizootic situation the BFSA s assessed and addressed this issue. The routine surveillance and testing have been enhanced ( including pre movement testing to prevent eventually silent spread of the disease)

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e see the comments in point 1 and 2 Page: 5 r 2019 rt ref. DG(SANTE)/2019-6600-MR of the audit carried out from 10 June evention and control of avian influenza on Proposed by the competent authority

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Despite the above, the audit team noted in the holdings visited ­ which had been subject to official controls - that the records of these controls did not show that the following issues (which were seen by the audit team during the audit) had been identified: a. In two out of four holdings visited, operators had not: (i) recorded in holding registers, (ii) notified, and (iii) identified newborn calves; (for example, in one holding visited, 17 cows had 17 calves in the last 12 months, none of which had been registered). 6 b. In two out of four holdings visited, animals that had died on farm (fallen stock) and/or were emergency slaughtered had not been recorded as such in the holding register and thus appeared in the records as still "alive". c. In two out of four holdings visited, the number of animals in the registers did not reflect the actual number of animals on the holding.

In the holdings visited, the audit team noted that there had been significant delays in applying individual ear tags or retagging animals that had lost their identification, and there were frequent non-compliances with record keeping and reporting requirements. For example: a. Contrary to Article 4a of Regulation (EC) No 1760/2000 which requires identification of bovine animals within a maximum of 20 days from the birth of the animal and in any event before the animal leaves the holding on which it was born, in one of the holdings visited, six bovine animals out of 43 kept had no ear tags, and approximately 50% of those remaining ones had only one tag; b. Contrary to Article 7 of Regulation (EC) No 1760/2000 - which requires that each animal keeper (except transporters) reports to the competent authority all movements to and from the holding and all births and deaths of animals in the holding, along with the dates of these events, within a period fixed by the Member State of between three and seven days of the event occurring - in three animal holdings visited, the keepers selling calves aged between one to two weeks old to other locations did not: (i) notify the birth of calves, (ii) record the birth and the sale in the holding registers, (iii) keep movement documents allowing to trace the calves to the holding of origin and link them with their mothers, and (iv) could not otherwise demonstrate that prior to movement, calves had been identified with individual ear tags. None of these non-compliances had been detected during the official controls on these holdings. The above-mentioned non-compliances with Regulation (EC) No 1760/2000 in the holdings visited call into question the suitability and effectiveness of official controls and subsequent measures taken by the competent authorities. Another practical consequence is also a breach of Article 22 of Regulation (EC) No 1760/2000. 5.2.3 Bovine passports

While checking the bovine identification documents in the visited premises, the audit team noted that there had been significant delays in issuing passports. In particular, in one of the slaughterhouses visited, bovine animals presented for slaughter were accompanied by passports that had been issued (for the first time) on the day prior to slaughter or on the day of slaughter. These animals were aged between 18 and 24 months. 7

The audit team analysed the data on the location and the number of bovine passports issued in comparison with the location and the number of registered new-born calves born in the country and noted a lack of correlation between the figures. In nine regions, differences between passports issued and animals born ranged from approximately 1,000 to almost 9,000. The officials in charge of conducting official controls did not pay attention to these discrepancies, which could indicate non-compliances related to animals' individual identification and movements, namely unregistered movements of unidentified young calves (see findings: 18.a, 24 and 25). 5.2.4 Computerised database

According to the data from VetIS, in the period from 2014 to 2018, the population of bovine animals has steadily increased from approximately 721,000 to 765,000. However, the audit team noted that there was a large cohort of bovine animals missing from the database. For example in 2018, the difference between the number of animals born and traded (into Bulgaria) and the number of animals slaughtered, dead, traded and exported (out of Bulgaria), resulted in a surplus of approximately 34,000 animals, without a known (confirmed) history (3). This represents approximately 4.5% of the bovine population in the country.

The owners of bovine holdings visited stated that their main activity is production of milk, and their cows calve every year. The audit team noted that except for two regions where the numbers of new-born calves registered in VetIS were plausible, in the remaining 26 regions registered calves represented from 17% to 30% of the expected number.

In one of the holdings visited, the owner stated that there were 17 calves born within the last 12 months ­ all were sold aged one to two weeks old. In another holding visited, the animal keeper confirmed that his cows calved annually and that he retained a few heifer calves for rebuilding the herd. The audit team cross-checked the situation on that holding with the VetIS data and noted that: a. The calf retained in the herd had no ear tags and was not identified by any other means. b. For 17 cows, ranging in age from 14 to 19 years old, only one to three calves per cow had been notified in VetIS during the entire cows' lives; the owner retained the notified calves in the herd, and during the audit they were presented as adult cows.

The BFSA has granted access to VetIS to officials from the central and regional level, official veterinarians in slaughterhouses and to registered veterinarians. One person at central level (VetIS administrator) has access to all the information, whilst other users are only allowed to see information limited to an individual animal or a holding. These users have limited possibilities to correct or edit data in the event they see a non-conformity. Slaughterhouse operators, those collecting and disposing of fallen stock and animal (3) Data by BFSA (VetIS) and from TRACES. 8 keepers, have no access to VetIS. The BFSA stated that it is preparing a new functionality for animal keepers to allow them to notify relevant events via smartphones and tablets.

In light of the above, VetIS does not meet the requirements of Article 5 of Regulation (EC) No 1760/2000 as it neither reflects the actual population of bovine animals in Bulgaria nor does it facilitate the supply of the required items of information set out in Article 14 of Council Directive 64/432/EEC.

While official controls on the identification and registration of bovine animals are carried out as planned and identified shortcomings are subsequently followed up, these controls have, to date, not identified some non-compliances related to the identification of bovine animals and notification of births of calves at holdings.

A lack of effective action by the competent authority to enforce the operators' obligations to notify all events at holdings has contributed to a situation where the information in the national database for registration and identification of bovine animals is unreliable. In addition, due to limitations in the database's functionality, information that would be relevant for the planning and implementation of official controls on BSE and ABP cannot be easily extracted. Overall, these deficiencies cumulatively undermine the reliability of the BSE monitoring programme.

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ng to ensure the compliance with the bovines identification requirements the following actions re foreseen: 1. Regulatory changes: The requirements of a deadline (of 7 days) for submission of notifications in the case of fallen or becoming unreadable means of official identification, as well as for affixing (within 14 days) the replacing identifier(s), are both laid down in Art. 132, para. 1, item 4a and item 4b of the Law on Veterinary Activities (LVA) and are in force as of 14.02.2020 (the date of their publication in the State Gazette (SG), issue 13 of 14.02.2020). These amendments have been introduced in order to improve control, since prior to laying down these texts in the LVA, they had been applicable for the control according to an instruction issued by the competent authority (BFSA). According to the LVA, farmers must notify the veterinarian serving their holdings in writing within the time limits specified in Art. 132, para. 1 of the LVA. From the other side, veterinarians practicing veterinary practice, under the deadlines specified in Art. 39, para. 2, item 14 of this same law, must enter into the BFSA IIS (the VetIS) the information about the new events with animals, s

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The audit team noted that the information provided by the competent authorities on monitoring in this sub-population is incomplete. There are significant discrepancies between the number of bovine animals from the sub-population of emergency slaughtered animals and found sick at ante mortem inspection reported by FCD and AHFCD (see Appendix, Tables 6 and 7). Data presented by FCD, AHFCD and those sourced from the BSE testing laboratories differ and cannot be reconciled (see Appendix, Tables 8 to 10, and Tables 16 to 18).

The audit team saw evidence of situations where cows emergency slaughtered at holdings had been classified as healthy/slaughtered for own consumption. The opposite was the case in one of the BSE testing laboratories visited where all bovine animals sampled for BSE and notified as healthy/slaughtered for own consumption had been reclassified by the laboratory to the sub-population of emergency slaughtered. In this laboratory, the approach has been in place for at least four years and concerned samples were collected from eight regions.

Due to the limited availability of testing kits, BFSA decided that samples collected from fallen bovine animals were of a low priority and delayed their testing. This resulted in a situation where samples from a group, which would ordinarily be considered as being a high risk (of BSE), were kept for several months before being tested (see findings 55 and 56).

The NRL-TSE is responsible for ensuring that there is a sufficient availability of BSE diagnostic tests for itself and for the regional BSE laboratories. The audit team noted that the arrangement for acquiring tests did not work effectively in 2018 as the regional laboratories and the NRL-TSE did not have sufficient tests available. This resulted in over 18,000 collected BSE samples (and an additional 11,000 for Scrapie) not being analysed. Due to this shortage of testing kits since August 2018, the samples from the sub- populations of bovine animals slaughtered at holdings as healthy, in emergency and dead were categorised as low priority and collected, but not tested. Only for the sub-population of healthy bovine animals slaughtered in slaughterhouses, have the laboratories carried out tests continuously without any interruption. In 2019, the BFSA outsourced the testing of stored samples to an external laboratory.

With respect to the arrangements for BSE testing, the audit team noted that the NRL-TSE did not overcome difficulties in ensuring availability of sufficient BSE test kits in 2019 and the backlog of untested samples is growing. At the time of this audit, there were 6,500 samples awaiting BSE testing (and 5,500 for Scrapie).

Samples of brainstem seen in the laboratories visited were placed in individual sampling containers, which were identified by either labels or a consecutive sequential number written with a marker. While the information from labels (date of slaughter, the 15 slaughterhouse number and the slaughter number of the animal or the ear tag number) could ensure traceability to the bovine animal sampled, the sole consecutive sequential number could not; especially if more samples with the same number were delivered for examination. This is not compliant with the provisions of Point 1 of Chapter C of Annex X to Regulation (EC) No 999/2001, which requires that the samples should be marked correctly as to the identity of the sampled animal and Article 11(7) of Regulation (EC) No 882/2004 requiring that samples must be handled and labelled in such a way as to guarantee both their legal and analytical validity.

The quality and quantity of samples, once collected, are able to ensure sufficient material for BSE testing. However, the method of identifying samples does not guarantee to trace back to the sampled animal in the event of a positive result.

Despite the fact that the NRL-TSE and regional BSE laboratories are accredited to EN ISO/IEC 17025, use the approved test kits listed in the Regulation (EC) No 999/2001 and have performed satisfactorily in proficiency tests for BSE, both the competent authority and the NRL-TSE have consistently failed to ensure the availability of a sufficient number of diagnostic tests to analyse all the samples taken. This has resulted in an unsatisfactory situation where large numbers of samples from high-risk sub- 16 populations have either not been analysed or their analyses had been delayed for months, further weakening the reliability of the BSE monitoring results.

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The following actions are proposed in order to ensure that the samples are to be correctly marked: f 1. Establishing a procedure to manage the dispatch, reporting and control of BSE samples, comprising the following aspects: esponsibilities of RVs in the taking and sending samples from large ruminants - Responsibilities of OVs of the AH departments of RFSDs to control BSE sampling done in respective area; - responsibilities of NRL and accredited laboratories in the classification and reporting of samples Page: 15 ulgaria to the recommendations of report ref. DG(SANTE) 2019-6634 of the audit carried out from 21 October te the implementation of the monitoring and eradication measures for bovine spongiform encephalopathy (BSE), ken to address recommendations from previous audits on BSE and animal by-products (ABP) posed by the competent authority - templates of cover letters, reporting tables, instructions for entering sample taken into , VetIS, etc. waits the changes in the VetIS system to be made, so that those could be introduced in the e relevant templates of cover letters. gs on the procedure referred to in Item 1 above for the: AH departments; ) training of RFSD's OVs/official v

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The analysis of the available data on the sub-population of bovine animals slaughtered as healthy (aged over 30 months) (4), shows that: a. The number of BSE samples taken in slaughterhouses is lower than the number of healthy bovine animals eligible for BSE testing, and the discrepancy between these numbers is increasing (see Appendix, Table 1). b. The number of slaughterhouse samples tested for BSE is lower than the number of animals sampled. On average, approximately 30% of the samples taken have been tested (see Appendix, Table 2). c. A significant number of bovine animals is slaughtered at holdings and, in some years, the number of such animals is approximately double that slaughtered in slaughterhouses (see Appendix, Tables 3 and 4). d. The cumulative number of all healthy slaughtered bovine animals eligible for BSE testing, slaughtered both in slaughterhouses and at holdings, is much higher than the number of all tests actually carried out for this sub-population (see Appendix, Tables 4 and 5). The above findings are not in line with Point 2.2 of Part I of Chapter A to Annex III to Regulation (EC) No 999/2001, which requires that all bovine animals slaughtered normally for human consumption as healthy and aged over 30 months are to be tested for BSE. 5.3.2 BSE monitoring in the sub-population of animals emergency slaughtered and found sick at ante mortem inspection

The audit team noted that the information provided by the competent authorities on monitoring in this sub-population is incomplete. There are significant discrepancies between the number of bovine animals from the sub-population of emergency slaughtered animals and found sick at ante mortem inspection reported by FCD and AHFCD (see Appendix, Tables 6 and 7). Data presented by FCD, AHFCD and those sourced from the BSE testing laboratories differ and cannot be reconciled (see Appendix, Tables 8 to 10, and Tables 16 to 18).

The audit team saw evidence of situations where cows emergency slaughtered at holdings had been classified as healthy/slaughtered for own consumption. The opposite was the case in one of the BSE testing laboratories visited where all bovine animals sampled for BSE and notified as healthy/slaughtered for own consumption had been reclassified by the laboratory to the sub-population of emergency slaughtered. In this laboratory, the approach has been in place for at least four years and concerned samples were collected from eight regions.

The analysis of the available data on the sub-population of bovine animals, aged over 24 months, found sick at ante mortem inspection and emergency slaughtered shows that: a. The number of animals notified as emergency slaughtered and eligible for BSE testing is significantly higher for those slaughtered at holdings than in slaughterhouses (see Appendix, Table 11). A small proportion of these emergency slaughtered at holdings is reported in VetIS ­ again demonstrating the unreliability of the data in this system. b. Reporting on the number of animals found sick at ante mortem inspection is limited to one region, and even in this case the collected samples were not tested (see Appendix, Table 12.). c. The number of bovine animals from the sub-population of emergency slaughtered and found sick at ante mortem inspection reported as sampled is lower than the number of samples tested. The above findings are not in line with Point 2.1 of Part I of Chapter A to Annex III to Regulation (EC) No 999/2001, which requires that all bovine animals, aged over 24 months old, emergency slaughtered and found sick at ante mortem inspection are to be tested for BSE. 5.3.3 BSE monitoring in the sub-population of dead animals (fallen stock)

The population of bovine animals aged over 30 months in the last five years in Bulgaria amounts to approximately 0.5 million heads (VetIS: 521,759 animals in 2018). In its TSE monitoring and eradication programme submitted to the Commission, the BFSA estimated that the number of fallen bovine animals eligible for BSE testing should amount to at least five thousand, representing 1% of this population. The audit team noted that apart from this estimate, there are no countrywide data on mortality at holdings and accordingly, the BFSA has no information on the number of bovine animals from the sub- population of dead bovine animals aged over 24 months. Thus, 12 the BFSA cannot verify if the number of collected samples reflects the entire sub- population eligible for testing (5).

The analysis of the available data on the sub-population of dead bovine animals eligible for BSE testing shows that: a. The number of fallen bovine animals reported as eligible for BSE testing is approximately 80 times lower than the amount estimated by the BFSA in its TSE monitoring and eradication programme, and is also much lower than the lowest average values from the EU statistics (see Appendix, Table 19). (5) The audit team requested information on the number of fallen bovine animals reported in VetIS but this information has not been provided. 13 b. The number of bovine animals sampled remains constantly low and until 2018, on average, represented 30% of the bovine animals collected as eligible for testing (see Appendix, Table 15). c. The number of samples tested does not match the number of the ones collected (see Appendix, Tables 14 and 15); moreover, there are significant delays in testing due to a shortage of test kits and assigning low priority to this sub-population (see findings 55 and 56). The above findings are not in line with Point 3.1 of Part I of Chapter A of Annex III to Regulation (EC) No 999/2001 which requires BSE testing of all dead bovine animals aged over 24 months (6). 5.3.4 BSE monitoring in the sub-population of BSE suspects

The samples are not taken from all animals that should be tested in the relevant sub- population. A significant proportion of eligible healthy bovine animals, mainly slaughtered outside slaughterhouses, which should have been tested for BSE, have not been sampled. Likewise, sampling of eligible animals emergency slaughtered or found sick at ante mortem inspection is limited to very few regions, whereas the majority of such animals have not been notified or sampled. In comparison with other Member States and even with the competent authority's own estimates, the number of fallen bovine animals sampled remains extremely low.

The audit team noted that, with regard to this recommendation: a. There had been no changes in the system of official controls on holdings aimed at addressing the issue of the BSE monitoring, in particular to verify that all eligible bovine animals from relevant sub-populations had been sampled and tested (one exception to this was the system put in place in one of the regions visited ­ see finding 29). Controls at holdings that would be relevant to verify the effectiveness of BSE monitoring are carried out in the framework of controls on animal identification. However, these do not cover aspects related to BSE monitoring (i.e. whether animals that had been slaughtered or died at holdings were eligible for sampling and testing). b. While collecting the BSE samples, the BFSA focuses on slaughterhouses. Sampling at holdings of all types from relevant sub-populations was inconsistently applied resulting in an underrepresentation of samples from eligible bovine animals that were slaughtered or died at holdings (see findings in section 5.3). c. Significant delays in testing samples from the risky sub-populations of bovines emergency slaughtered or found dead further undermine the effectiveness of the BSE monitoring programme (see conclusions in section 5.3). d. Official controls (through VetIS) on the work of registered veterinarians are almost non-existent, partially due to issues with the database's functionality and accuracy (see finding 27).

The audit team noted that, whilst the BFSA had issued practical guidance to animal keepers (8), none of the holdings visited had a container for collection of SRM or a (8) Available at: http://babh.government.bg/uploads/File/Zdraveopazvane/Zarazni_bolesti/TSE/13_Luda%20krava- praktichesko%20rakovodstvo%20za%20fermerite.pdf 20 separate, dedicated place for storage of dead animals. These deficiencies had neither been noted by the competent authority in the reports of their official controls nor resulted in any measures being taken.

The CAs have not demonstrated that they have put in place actions that would effectively address recommendation 4 of audit report DG(SANCO)2011-8944. This additionally undermines Bulgaria's request for a relaxation of the frequency of testing for BSE.

The implementation of the actions to address recommendation 6 of audit report DG(SANCO)2011-8944 has not been effective. Collection of SRM produced as a result of on-farm slaughtering of bovine animals in backyard holdings continues to be inexistent.

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mended Law on Veterinary Activities entered into force on 14.02.2020. One of the objectives of the new texts was to ensure sustainable veterinary supervision and correct implementation of the veterinary rammes in all types of holdings and settlements, including strengthening the TSE samples llection and the official control on these activities. exts in Art. 137a are providing for obligation of the owners of holdings, other than backyards, to have contract with a registered veterinarian which has a contract with the RFSD for the implementation of the veterinary programmes. . Texts 137b are providing for obligation of the Bulgarian Veterinary Union to appoint at least one egistered veterinarian to each settlement with whom the RFSD would have a contract for the Page: 17 ulgaria to the recommendations of report ref. DG(SANTE) 2019-6634 of the audit carried out from 21 October te the implementation of the monitoring and eradication measures for bovine spongiform encephalopathy (BSE), ken to address recommendations from previous audits on BSE and animal by-products (ABP) by the competent authority of veterinary programmes in backyard holdings (including the BSE/TSE surveillance , progra

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The audit team noted that the BFSA had organised a meeting with operators of the ABP plants and agreed that the operators would collect blood from slaughterhouses on the basis of a bilateral contract for the collection and disposal of ABP (signed individually with each slaughterhouse). The BFSA did not however specify how it would strengthen official controls on legal and natural persons to ensure collection and disposal of ABP, including dead animals.

The operators and the competent authority had no information on the quantity/volume of blood collected. If only bovine animals were slaughtered and even if the quantity of Category 1 and Category 3 ABP (from the table above) only represented collected blood, this quantity is still much lower than would be expected, considering the number of bovine animals slaughtered in slaughterhouses.

The actions implemented to address recommendation 4 of audit report DG(SANCO)2011-8949 were not sufficient to demonstrate that the CAs have a comprehensive overview on the ABP situation in the country, which prevents an effective official control system along the ABP chain.

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or the enforcement of adequate ABP collection system, the following actions are implemented and foreseen: nt Page: 20 ulgaria to the recommendations of report ref. DG(SANTE) 2019-6634 of the audit carried out from 21 October te the implementation of the monitoring and eradication measures for bovine spongiform encephalopathy (BSE), ken to address recommendations from previous audits on BSE and animal by-products (ABP) on Proposed by the competent authority . The latest regulatory changes with the amendments to Ordinance No 44 of 2006 on animal health requirements to livestock sites (SG No. 5 of 17.01.2020) and the amendment of the LVA (SG No. 13 of 2.2020) BFSA has taken measures to ensure compliance with the requirements to the existing sites registration of new ones under Art. 137 of the LVA (including a campaign for registration of ckyard farms with the assistance of mayors). The BFSA shall carry out enhanced checks to comply animal health requirements at livestock establishments, including biosecurity requirements, tification of animals, veterinary care and notification of dead animals and on farm slaughter, as well ollection and hand over for the disposal of ABPs. Penalties sh

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The CA informed the audit team about the activities regarding the monitoring of the consumption and use of food additives, as required by Article 27 of Regulation (EC) 1333/2008 and the monitoring of the consumption and use of flavourings as required by Article 20 of Regulation (EC) 1334/2008. Currently, no monitoring in these areas has been carried out by the National Centre for Public Health and Analyses, a research institute under the Ministry of Health, responsible for these activities. Conclusions on Competent Authority

Bulgaria does not comply with the requirements of Article 27 of Regulation (EC) 1333/2008 and Article 20 of Regulation (EC) 1334/2008.

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Backyard holdings are legally obliged to register and the authorities highlighted this requirement during an awareness campaign. At the time of the audit, only a small percentage complied with this requirement. All 24 backyard holdings where outbreaks (1) In their response to the draft report, the BFSA noted that Ordinance No 44 had already been amended as of January 2020 and is in force. It allows non-commercial holdings to keep up to three fattening pigs, and provides for a range of biosecurity requirements for each pig farm category. 4 have been detected up to 3 October 2019, were not registered. In one region visited, nine backyard holdings registered after an awareness campaign, but a census carried out in the region revealed 505 backyard holdings, keeping 919 pigs. One backyard farmer visited expressed certain reluctance, as this would imply costs for the registration, for ear tags and a compulsory contract with a veterinarian. The competent authorities declared the costs as being very low and explained a certain general reluctance of backyard farmers to comply with the registration requirements. Competent authorities do not grant unregistered holdings compensation in the case of depopulation in order to motivate the farmers to register.

By decision of Central Epizootic Council, the Ministry of Agriculture, Food and Forestry (MAFF), took up this initiative in the summer of 2019 and sent out a letter to the Governors to be implemented in their respective regions. The authorities asked keepers of backyard holdings situated in a 20 km radius of industrial holdings, slaughterhouses, main roads and in areas defined as high-risk to voluntarily slaughter their pigs early and before the end of August 2019. They also asked the keepers to sign declarations that they would not replace the pig for at least one year and that they would disinfect their holdings. In return, they received compensation of 300 Leva (approximately 150 Euro) for cleaning and disinfection activities per holding. Official veterinarians from other RFSD checked a sample of 15 % of the backyard holdings to verify compliance with this requirement. In the region mentioned above, 797 farmers signed the mentioned declaration.

Nearly all regions in Bulgaria implemented this campaign: 31,242 backyard holdings stopped keeping pigs and approximately 50,000 pigs were slaughtered.

The owner of one backyard holding visited, which had been affected by ASF, admitted to the following non-compliances: a. no registration of the holding; b. no identification of animals, no register of pigs kept; c. keeping a sow for breeding; d. movement of animals without notification (boar of neighbouring holding for insemination); e. swill feeding; 5 f. no notification of the registered veterinarian within 24 hours of the change of the status of the animals (including home-slaughter), although this is required under national law. In general, the competent authorities reported frequent and major non-compliances in the unregistered backyard holdings, which they identified during the census.

In one region, RFSD highlighted that registered veterinarians authorised to register holdings and who had been contacted by farmers willing to register their holdings did not register the holding nor did they encourage farmers to register. Private veterinarians providing services to unregistered holdings do not inform the veterinary authorities on the existence of the holdings.

In one region visited, the competent authority informed about a holding where four wild boar are kept for training hunting dogs. Under the current legislation, dog-training areas do not have to be registered as a pig holding, which represents a weakness in the control of all pig holdings by the competent authority.

Despite a legal requirement and an intensive awareness campaign since 2015, only a limited number of non-commercial holdings are registered which makes it difficult for the authorities to detect promptly the disease and to control its spread. The proactive measures taken by the authorities to depopulate backyard holdings in high-risk areas are likely to significantly reduce the risk of disease introduction and spread. However, there is uncertainty about how this limitation of the risk will be maintained when the defined period for the non-population expires, and about how the authorities will monitor these holdings in particular when they are going to restock.

Private registered veterinarians are complicit in maintaining the unregistered pig population as they do not actively support the registration of non-commercial holdings but rather continue to provide service to unregistered holdings.

Two positive cases of ASF were confirmed in pigs that had been dumped on a public road; the origin of these pigs could not be traced. When the campaign for the early slaughter of pigs in non-commercial holdings was initiated in the summer of 2019, MAFF ordered a permanent supervision of slaughterhouses by the veterinary authorities in cooperation with the police forces in order to avoid an illegal commercial slaughter of pigs from unregistered holdings. 5.4.3 Wild boar

Despite the recent efforts to reduce the number of non-commercial holdings and to bring them into compliance with biosecurity requirements, it is very likely that there still exits a considerable number of unregistered backyard holdings in the country. The absence of reliable data on the location and movement of pigs within the non-commercial sector means that it is often not possible to trace animals that could have carried ASF virus to or from outbreak holdings. It also means that it is difficult for the veterinary authorities to enforce the prohibition to dispatch live pigs originating from the areas included in the Part III territory in the case of non-commercial holdings. This surely contributes to the spread of the disease and makes its containment very difficult.

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According to national legislation (Ordinance No 44 of 20 April 2006), pig holdings are categorised according to their size and biosecurity standards. Commercial holdings with high biosecurity standards include industrial holdings and family farms type "A" holdings. In addition, some outdoor farms in the Eastern part of the country raise free- roaming East Balkan pigs, a local breed. The current legislation allows non-commercial holdings to keep up to five pigs for own consumption, but not breeding sow or boars. This classification is broadly in line with the ASF strategy of the EU. (1) Type of pig holding Number of holdings as Number of pigs of September 2019 Industrial 65 538,000 Family farm type "A" 192 30,000 East Balkan pig 46 3,600

The owner of one backyard holding visited, which had been affected by ASF, admitted to the following non-compliances: a. no registration of the holding; b. no identification of animals, no register of pigs kept; c. keeping a sow for breeding; d. movement of animals without notification (boar of neighbouring holding for insemination); e. swill feeding; 5 f. no notification of the registered veterinarian within 24 hours of the change of the status of the animals (including home-slaughter), although this is required under national law. In general, the competent authorities reported frequent and major non-compliances in the unregistered backyard holdings, which they identified during the census.

Officials use a specific checklist to verify the level of biosecurity of the commercial holdings. The requirements, which the officials have to check, are broadly in line with those established in the strategic approach to the management of ASF for the EU. The authorities indicated the following key findings: a. The level of biosecurity in industrial holdings was, in general, quite good, but there are numerous backyard holdings in close proximity to industrial holdings; b. Non-compliances with certain biosecurity requirements, e.g. the structure of the buildings and the installations were not in line with established standards, but mainly with regard to operational measures, e.g. weak record keeping of visitors, no clear distinction within the holding of "clean" and "dirty" sections.

The authorities introduced additional biosecurity measures pursuant to order PR 11- 1813 of the BFSA as of 30 August 2019 in light of the evolution of the disease. They also prepared awareness material targeted at family farms and backyard holdings. Those additional measures included a ban on live pigs markets in the whole country and a ban on pork meat sale in farmers markets. 5.1.2 Wild boar

The competent authorities have issued stricter operational rules in order to rectify shortcomings in the biosecurity rules in commercial holdings. These would likely further increase the level of biosecurity.

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The audit team reviewed the epidemiological inquiries carried out for several outbreaks. In the industrial holdings, the veterinary authorities had investigated the possible sources of infection to or from the holdings to a certain extent, but in most cases had not finalised the epidemiological inquiry, and the cause for the infection was not really followed up. The authorities indicated that this was due to time constraints, i.e. the fact that they were involved in depopulation activities and several other outbreaks. In the backyard holdings, the competent authorities focused on the depopulation of unregistered holdings in the protection zones rather than on determining the cause for the infection.

The lack of thorough epidemiological inquiries, and the fact that due to time constraints the staff are faced with they were not able to finalise epidemiological investigations in commercial holdings, means that opportunities are missed to intercept possible transmission of the virus via vectors or fomites or contaminated products to previously uninfected areas

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The agreement between the veterinary authorities and the EFA, together with the enforcing support of EFA and the application of innovative measures such as trapping and silent hunt out of the season is likely to reduce the density of the wild boar 9 population and thus to help slowing down the transmission of ASF from it. However, the lack of systematic checks by the veterinary authorities prevents the authorities to demonstrate that the measures are in fact implemented as planned.

The veterinary authorities do not receive regularly the information from EFA on the numbers of wild boar shot and therefore they cannot check the hunting records against the sample submission records to determine whether all hunted wild boar have in fact been tested for ASF. The obligation to use the hunting module (see finding 36) in the hunting season 2019/2020 within the infected area should provide information about all wild boar shot and allow a crosscheck on the number of wild boar sampled. 5.2.3 Laboratory network

In the case of one outbreak, the BFSA established surveillance zone restrictions on a pig fattening holding located at a distance of 7.2 km in a straight line from the outbreak. This decision was subsequently re-assessed by the RFSD and BFSA headquarters. The reassessment took into account that the fattening holding was located in a different municipality and that the distance by road to the outbreak was 12, 5 km. On this basis, the RFSD decided to lift the restrictions four days later. This decision was not in line with the requirements set out in Article 9 of Directive 2002/60/EC, which requires the surveillance zone to cover all holdings within a "radius of at least 10 kilometres". During the period when other pig holdings within the surveillance zone remained under restriction, this fattening holding was allowed to slaughter pigs in a slaughterhouse located in the same region and the meat was placed on the national market. However, the holding was subject to official supervision with the collection and testing of samples to rule out ASF presence before it was allowed to resume normal trading. In addition, during the lifting of the restrictions in the 10 km surveillance zone, samples for ASF were taken on this fattening holding with a negative result.

The central veterinary authorities have established a clear chain of command that is supported by written instructions, regular trainings and meetings and reporting arrangements, in line with Annex VI(c) of Directive 2002/60/EC. RFSDs have to report on a weekly basis to the BFSA on the measures taken with regard to ASF eradication. While BFSA staff are regularly present in the regions during the confirmation of positive cases, they do not systematically supervise the regions to verify the correct implementation of instructions.

The authorities at central level do not carry out a systematic supervision of the implementation of measures related to ASF control neither on veterinary authorities nor with regard to the requirements in hunting grounds. Therefore, they do not become aware of shortcomings in the implementation of measures and cannot correct them. (5)

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Concerning the rotation of the staff, exceptions and some flexibility are allowed in specific circumstances (e.g. remote areas, availability of personnel). It is up to the RFSD to decide when and if the rotation should take place: in one region staff rotates every six months and in another one every year. The CA of the latter region explained that the frequency of rotation of staff working in slaughterhouses involved in exports is lower as the knowledge required for this sector and the language skills are very important.

A training system aimed to ensure that official staff is able to carry out their tasks properly is in place. However, the audit team noted that the system does not take into account if training is needed for those officials rotating and dealing with new tasks they are not familiar with.

There is a training system in place aimed to ensure that official staff carry out their tasks adequately,and as regards the new rules introduced in the cow milk sector, it appears effective. However, the system in place does not take into account that new tasks can be assigned to official staff within the rotation system in place and therefore there are no guarantees that they will undertake these new duties competently.

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A series of training events (including theoretical and practical part,(on-site in dairy establishments) are planned to take place. Besides the general requirements for carrying out official controls, inspectors will be acquainted with the ROC (Regulation on official Controls) to be entered into force on 14.12.2019 Deadline of execution: 06.2019 - 12.2019 There is a special Order (of ref. No RD11-649 of 28 March 2019) signed by the BFSA Executive Director to provide for that each inspector (Official Veterinarian = OV) appointed to carry out official controls in dairy plant(s) (after rotation of the inspectors performed), when s/he has not exercised official controls similar kind of sites must be individually trained locally by an experienced inspector from the relevant Regional Food Safety Directorate = RFSD). During this training, the inspector concerned will have to fully informed (on the spot, in a diary plant) of the specifics of the inspections at the establishments producing dairy products and the specific details of processing processes that have to ensure the production of safe products. Each such training must be documented in a special ,,protocol". Deadline of execution: 0

ARES(2019)2331510 dated In addition to the actions we have already informed you about, we could add the following details: 01/04/2019 (received in EN). A series of training events 1. In order have more adequate and effective actions taken (including theoretical and practical by all the RFSDs to address this recommendation, the CCA part (on-site in dairy have required for and received the names of two employees establishments), are planned to take per each Food Control" Unit of each of the 28 RFSDs. These place. Besides the general are officials of profound knowledge of the dairy production requirements for carrying out technology and experience in performing official controls on official controls, inspectors will be dairy establishments, as well as auditing of their self-control acquainted with the ROC systems. These 56 RFSD`s inspectors, together with 5 (Regulation on official Controls) to experts from the ,,Food Control" Directorate (of the BFSA be entered into force on Central Office i.e., the CCA) are included in the expert working group at national level. 14.12.2019. Deadline of execution: 2. By the end of 2019, there is to be a special training of this 06.2019 - 12.2019 exper

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Whilst information and instructions are provided to the BIP and DPEs/DPI staff to support the implementation of the import controls the lack of sufficiently detailed guidance has resulted in situations where the official controls were not performed correctly and having a consistent approach. In addition, the national administrative provisions on animal health requirements for the importation of live animal species which are not regulated by EU legislation have not been established, therefore there is a possibility that such consignments would be accepted for importation without due consideration of the risks they may pose. 5

The audit team checked in total 11 files related to import of live animals and noted the following errors in documentation which did not elicit an appropriate response from the authorities: A consignment of birds (one parrot imported for non-commercial use) had been imported with an appropriate model veterinary certificate, but the applicable parts of the health certificate had not been filled in, contrary to the requirements of Annex II to Commission Decision 2007/25/EC. In one BIP, a consignment of horses had been imported with an appropriate model veterinary certificate (for re-entry) but some applicable parts of the health certificate (owner declaration) had not been filled in, as required by Annex II of Commission Decision 93/195/EEC. 6 In another BIP, several consignments of horses had been imported with an appropriate model veterinary certificate (for temporary admission) but some applicable parts of the health certificate (owner declaration) had not been filled in, as required by Annex II(E) of Commission Decision 92/260/EEC. 5.2.2 DOCUMENTARY CHECKS ON PRODUCTS OF ANIMAL ORIGIN

In one BIP, the competent authority considered that the time limit of 60 days applicable to rejected consignments, with a view to their re-dispatch, started from the moment of arrival of the consignment in the port. This interpretation is not in line with Article 21(2) of Regulation (EC) No 882/2004.

In the majority of the cases reviewed by the audit team during the BIP visits, consignments of food of animal origin were accompanied by prerequisite documents. In other cases the audit team identified a number of non-compliances in accompanying documents: In one BIP several consignments of wild fish were accepted for importation despite the fact that the health attestation referring to farmed stock was not crossed out. The competent authority stated that the health certificate was 7 checked against the catch certificate. The latter was not available for examination by the audit team. A consignment of casings was accepted for importation despite the fact that the non-applicable parts in the health attestation were not crossed out. 5.2.3 DOCUMENTARY CHECKS ON PRODUCTS OF NON-ANIMAL ORIGIN Findings

The competent authority incorrectly allowed the importation of a consignment of groundnuts from Argentina since the analytical report was issued after the signature of the health certificate.

In one DPE, several rejected consignments of groundnuts from different non-EU countries were not re-dispatched within the time limit of 60 days of the decision of the competent authority. This is not in line with the requirements of Article 21(2) of Regulation (EC) No 882/2004. The audit team noted that in these cases the re-dispatch took place up to three months after the signature of part II of the CED. Conclusion on the implementation of documentary checks

For the most part, the implementation of documentary checks is carried out correctly in BIPs and DPEs and performed using all available information. Nevertheless the audit team's identification of errors in documentation accompanying consignments which were ultimately imported, indicate that improvements are required in the implementation of documentary checks and subsequent decisions on importation.

The audit team noted a number of errors in the documentation in TRACES as follows: Two consignments of different products (farmed fish and animal by-products) were incorrectly declared by the person responsible for the load as transhipments in box 17 of part I of the CVED instead of definitive imports. The competent authority did not take any action to rectify these deficiencies during the documentary check. The competent authority correctly rejected a consignment of farmed fish due to a failure in the identity check, but the results of the identity check were recorded incorrectly as satisfactory in box 27 of part II of the CVED. There was no information in box 41 of part II of the CVED for confirmation of receipt from the local veterinary unit for two reimported consignments. However, the audit team noted that the BIP received a letter from the local veterinary units of destination confirming receipt of the consignments. For one rejected consignment of collagen for human consumption, the date of re- export was not recorded in box 35 of part II of the CVED as is required in the Notes 9 for guidance for the CVED certificate in Annex III to Commission Regulation (EC) No 136/2004. One consignment of wild fish had been incorrectly declared by the person responsible for the load as farmed stock in box 12 of part I of the CVED instead of wild fish as described in health certificate. This had not been spotted by the competent authority during the documentary check. Conclusion on the use of TRACES

The audit team noted that no audits or supervision activity had been carried out by the central level in BIPs/DPEs from 2015 until the time of this audit.

The audit team noted that no supervision activity had been performed at the local level with the exception of BIP Sofia airport where a regular supervision activity has been carried out at the local level since 2014. This is not in line with the requirements of Article 4(2)(a) and 4(4) of Regulation (EC) No 882/2004. Conclusion on the verification of compliance of import controls

Lack of verification activities undermines the capacity of the central competent authority to ensure that official controls are performed correctly. Thus the competent 10 authority has not used relevant mechanisms to ensure that the official controls are appropriate and effective.

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erification of official controls There is a special Order (of BFSA ref. No 11-1609 02.09.2016) signed by the BFSA Executive Director (ED) (please see the attached pdf file, which approves and enacts the Standard Operational Procedure (SOP) titled: "Procedure for performing check of the effectiveness of Official Controls performed by Bulgarian Food Safety Agency" (also enclosed as a pdf file), together with relevant annexes to Part B, its "specialized part". 11-1609-1.pdf 11-1609-2.pdf Annex 10 (also enclosed as a pdf file) to this SOP is titled "Verification of the effectiveness of the official border veterinary controls, carried out by the BIP departments (actually the border inspection posts) within the Border Control Directorate at the BFSA Central Office". Annex 11 (also enclosed as a pdf file) to this SOP is titled "Verification of the effectiveness of official controls on the imports of foodstuffs of non-animal origin and of food contact materials and articles". A full revision of the above-mentioned procedure will be completed by 01.06.2018 and, accordingly, there is to be a revised and updated version, which will be approved and enacted, to correct those issues, where the v

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In line with Article 8(1) of Regulation (EC) No 882/2004, the BCD has established procedures, guidance and instructions for implementing import controls. The audit team noted the following: a. The BCD has developed a general manual for the BIPs, last updated in 2012. Instructions for the control of products of animal origin and live animals were produced in 2014. One instruction (on animal welfare during transport) was updated by the central competent authority in 2017 and others are at a draft stage (e.g. controls on customs warehouses, pet animals and instructions for veterinary checks). b. The instructions prepared by the BCD do not include sufficiently detailed information to support the work of the officials responsible for conducting documentary checks and to ensure a consistent approach in relation to: - actions to be taken in the event of non-compliances related to documentary checks being identified. The audit team noted that several errors in records it selected at random for examination had been accepted by the officials (see finding 31); - implementation of the time limits applicable for rejected consignments with a view to their re-dispatch (see findings 24 and 29). c. Since 2014, the BCD has developed procedures and working instructions for controls on food of non-animal origin. These were updated in 2017.

There are no administrative provisions (procedure) in place to establish animal health requirements for the importation of live animal species which are not regulated by EU legislation. This is not in line with Article 5(f) of Directive 91/496/EEC (see finding 18).

Whilst information and instructions are provided to the BIP and DPEs/DPI staff to support the implementation of the import controls the lack of sufficiently detailed guidance has resulted in situations where the official controls were not performed correctly and having a consistent approach. In addition, the national administrative provisions on animal health requirements for the importation of live animal species which are not regulated by EU legislation have not been established, therefore there is a possibility that such consignments would be accepted for importation without due consideration of the risks they may pose. 5

In one BIP, the competent authority considered that the time limit of 60 days applicable to rejected consignments, with a view to their re-dispatch, started from the moment of arrival of the consignment in the port. This interpretation is not in line with Article 21(2) of Regulation (EC) No 882/2004.

In the majority of the cases reviewed by the audit team during the BIP visits, consignments of food of animal origin were accompanied by prerequisite documents. In other cases the audit team identified a number of non-compliances in accompanying documents: In one BIP several consignments of wild fish were accepted for importation despite the fact that the health attestation referring to farmed stock was not crossed out. The competent authority stated that the health certificate was 7 checked against the catch certificate. The latter was not available for examination by the audit team. A consignment of casings was accepted for importation despite the fact that the non-applicable parts in the health attestation were not crossed out. 5.2.3 DOCUMENTARY CHECKS ON PRODUCTS OF NON-ANIMAL ORIGIN Findings

For the most part, the implementation of documentary checks is carried out correctly in BIPs and DPEs and performed using all available information. Nevertheless the audit team's identification of errors in documentation accompanying consignments which were ultimately imported, indicate that improvements are required in the implementation of documentary checks and subsequent decisions on importation.

When non-compliances are identified during documentary checks the decision on further action is taken by the official and depending on the case, after internal consultation. However, the instructions provided by the BCD did not provide enough detailed information to the officials to support their decision contrary to Article 8(1) of Regulation (EC) No 882/2004. Conclusions on the action taken in case of non-compliances related to documentary checks

When the DPE and BIP officials identify non-compliances during the documentary check, they take action, although not always the appropriate action. The lack of sufficiently detailed instructions from the competent authority hampers correct decision- making.

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Not later than end of March 2018, a special Order to be signed by the BFSA ED is to establish and set up a working group designated to update the current standard operating procedures for official controls and to develop detailed guidance for carrying out documentary checks, together with relevant actions to be performed in case of deficiencies identified.

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The audit team noted several deficiencies in Sofia airport BIP related to the requirements of Article 4 of, and the Annex to, Commission Decision 2001/812/EC1: i. The equipment for sampling frozen products in both human and not for human consumption areas was missing and some sampling equipment had not been cleaned; ii. The storage room for frozen products located within the not for human consumption section, was not working; iii. A general lack of cleanliness in all rooms of the facility and a leaking roof in the not for human consumption area; iv. A lack of hot water since a week before the time of the audit.

The airport BIP and the control point/DPI facility visited are in general suitable for undertaking the necessary checks; however, the conditions found at the BIP Sofia airport undermine the hygienic handling of the food and feed. 1 The competent authority provided additional information on 16 October 2017 that it took some measures to rectify most, but not all, of the deficiencies described in finding 44. 12

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The procedures for cleaning, washing and disinfecting the premises have been updated and the results of these activities as actually performed are to be recorded /documented/ in an especially dedicated for the purpose checklist. Experts from the department named "Organisation and Management of Border Controls" with the Border Control Directorate at central BFSA level are to perform an on-spot check (in the beginning of March 2018) to verify the effectiveness of this procedure. Page: 3

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There were significant variations between regions in the implementation of the programme. The audit team noted that significant underperformances in certain regions did not have an adequate adequately followed up and thus, they were not addressed. The authorities confirmed that, at central level, there was no expert group in charge of epidemiological analysis of CSF data collected in order to assess non-compliances with 3 the programme and underperformances in certain regions, and to prioritise corrective actions.

The structure, organisation and competencies of the authorities involved in the CSF surveillance programme are well defined. There is a system in place for verification and supervision of official controls.

At industrial holdings, the team noted that although there were significant number of pigs (e.g. sows, piglets, weaners, fattening pigs, etc.) kept in several distinct sub-units, sampling was always carried out considering the whole holding as one epidemiological unit; i.e. in this type of holding, 14 blood samples have to be taken every year in order to detect at least a 20% prevalence of CSF antibodies with 95% confidence. The wrong categorisation of pig holding (e.g. holding classified as backyard farm instead of type A or type B holding), as mentioned in paragraph 15 also affects the implementation of the CSF surveillance programme, as instructions for clinical examinations and sampling of pigs are significantly different between these two types of holding.

The results of the last three years' surveillance programme in wild boars, which requires sampling for serological and virological testing, were provided to the team. 13

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assess non-compliances with the programme and underperformances of certain regions and to prioritise corrective actions in accordance with the requirements laid down in Directive 2001/89/EC. By letter from 06.10.2017 and Order No RD 11-2008 from 11.10.2017 by the end of 2017, the data for all types of holdings (industrial, type A, type B and personal holding) on the territory of the country was updated in the information system. The above- mentioned letter points out obligatory registration of all types of pig holdings under Art. 137 of the LVA. By Order No RD 11-322/22.02.2018 competent authority obliges owners of A and B type pig holdings to identify with individual ear marks all newborn pigs up to 20 days of age and 20 March 2018 and all adult pigs of type A and type B are also to be identified with individual ear tags. These actions taken by the competent authority are aimed at preventing movements of unidentified pigs from unregistered holdings, which in turn will guarantee the health status of the animals in relation to CSF and ASF. The primary objective of the competent authority by letter from 06.10.2017 is to close the type B farms which are the main risk factor for the sp

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All the holdings visited by the audit team had holding registers, in the format initially designed by the competent authority: In all family holdings visited, the holding register did not contain a section to record births and deaths. Therefore, the register did not necessarily state the exact number of animals present on the holding as requested by Article 4 of Directive 2008/71/EC. Traceability of movements of animals not yet identified 6 could not be ensured. The authorities informed the team that the owner/keeper should notify all births to the authorised veterinarian within three days. tThis requirement was not implemented, checked or enforced in the holdings visited during the audit. In one type B holding, with 22 sows, the number of offspring identified and recorded in the register (respectively 155 and 29 in 2016 and 2017) was very low. In two family holdings, a large number of pigs were slaughtered on farm (e.g. up to 50 pigs in six months in one type A holding; 15 pigs in four days in one type B holding); the slaughter was mentioned in the holding register, but no other evidence was available to substantiate this information.

Bulgaria can ensure adequate traceability of identified pigs. Hoewever, the lack of records of births and deaths in the holding registers do not allow the control of production parameters. 7

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ild boar sampled in 2017 n order to ensure adequate traceability of the pigs and to know the exact number of nimals in the site, according to the requirements of Art. (4) of Directive 2008/71/EC, the ompetent authority has developed a model document for 'Birth and mortality in pigs of ype A and type B' (Approved by Order No RD 11-320/22.02.2018), which in turn is ompulsory an application to the holding register already kept on the holding. Also by rder No RD 11-322/ 2018, all pigs present on Type A and Type B sites must be ndividually marked until March 20, 2018 and all newborn pigs individually marked up to 0 days of age. rder 11-320/22.02.2018

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Based on the data provided by the competent authority, they surpassed the total target set for industrial and type A holdings where animals had to be clinically examined, but not all regions achieved the targets set for them. In 2015, authorised veterinarians had to inspect 100% and official veterinarians 10% of backyard farms; in 2016, the surveillance scheme changed to 10% and 5% respectively.

Although with regional variations, the active surveillance programme for domestic pigs provides substantial guarantees that the CSF virus is not circulating in commercial holdings. The system gives more limited guarantees for holdings with low biosecurity, where shortcomings in holding registration and records undermine the ability to fully assess the CSF epidemiological situation but the sharp drop in the number of backyard holdings following comprehensive verification by the competent authority mitigates the significance of this weakness.

The team noted the following: The active surveillance system for wild boars has significantly improved since guidelines on the targeted sampling of wild boars have been issued and implemented. In 2016, 49 wild boars were tested seropositive: all seropositive animals were tested negative by PCR. Age and location (oral vaccination in previous years) of each seropositive wild boar were compatible with the assumption that seropositivity was due to previous vaccination. However, no procedures are in place to confirm this assertion and discard other possible hypothesis (circulation of virus in the area). Therefore, appropriate measures to confirm or rule out the presence of the disease in wild boar when the disease is suspected, were not taken according to the requirements laid down in Article 15 of Directive 2001/89/EC (taking into account the recommendations of the CSF diagnostic manual: point B (3) and (7) of Chapter VII of Annex to Decision 2002/106/EC). The authorities issued new instructions regarding surveillance in wild boars in 2016 (No 6106 of 17 October 2016) requesting the sampling and testing (ASF and CSF) of all shot wild boars (ASF strategy to prevent or detect early the introduction of ASF in Bulgaria) and the request was renewed for the 2017 hunting season (letter dated 11 October 2017). These instructions have not been taken into account in two Regional Directorates visited during the audit. In addition, the 2016 and 2017 programmes have not been updated to take into consideration this new strategy, which would have led to a significant increase in testing expenses (about 90,000 wild boars were tested in 2016). The testing capacity of the laboratory has not been checked and assessed beforehand. The competent authority stated that the intention of these instructions was to raise the 14 awareness of hunters and develop the habit of systematic sampling, but that they had no intention to test all samples. In one region visited, the audit team noted under-implementation of the active surveillance programme in wild boars: e.g. respectively in 2015 and 2016, only 63 and 20 shot wild boars were sampled and tested, while the planned number of samples was 147. The region, where a vaccination programme was implemented until the end of 2015, was considered at risk, as it border a country with an unknown CSF status. The competent authority had an explanation for this situation, but no corrective action was initiated. The laboratories did not perform PCR testing for CSF since April 2017, due to a lack of test kits. According to the National reference laboratory, samples have been frozen pending further testing.

The active surveillance system for wild boars has significantly improved since the authorities issued guidelines on the targeted sampling of wild boars for the CSF surveillance programme in 2013. The programme, as implemented, has adequate sensitivity for confirming absence of CSF virus circulation in wild boars. The significant under-performances in some regions lead to uncertainty regarding the disease status of these zones, especially for peripheral regions, where a vaccination programme has been implemented until recently. There are no procedures in place to confirm or rule out the presence of the disease when a wild boar is tested seropositive.

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ee actions proposed for recommendation 1. rder No. RD 11- 2008/ 11.10.2017 was in force and in the meeting with the heads of the nimal health departments of 28 regional food safety directorates in January again ttention was paid to its implementation. Page: 2 h 2018 f report ref. DG(SANTE)/2017-6113-MR of the audit carried out from 07 November ogramme for the control and monitoring of classical swine fever roposed by the competent authority

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The team noted that: According to the central authority, since 2015 to date, only two occurrences of suspicion of CSF in domestic pigs were subject to laboratory tests. CSF was ruled out after getting negative results from the National reference laboratory 10 following the criteria laid down in the EU diagnostic manual for CSF. However, differential diagnosis with ASF was not carried out. Conclusions on surveillance, controls on domestic pigs

Passive surveillance in domestic pigs remains very weak and, as such, does not provide a sufficient level of confidence that CSF is being continuously ruled out as a potential cause of pig illness or mortality. This results in uncertainty regarding the effectiveness of the CSF early detection system. Furthermore, differential diagnosis with ASF is not carried out in cases of suspicion of CSF in domestic pigs.

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RD 11-322/22.02.2018 obligates sampling and testing for CSF and ASF of pigs ad, pigs showing signs of neurological disease or other suspect cases.

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The team noted that: According to the central authority, since 2015 to date, only two occurrences of suspicion of CSF in domestic pigs were subject to laboratory tests. CSF was ruled out after getting negative results from the National reference laboratory 10 following the criteria laid down in the EU diagnostic manual for CSF. However, differential diagnosis with ASF was not carried out. Conclusions on surveillance, controls on domestic pigs

Passive surveillance in domestic pigs remains very weak and, as such, does not provide a sufficient level of confidence that CSF is being continuously ruled out as a potential cause of pig illness or mortality. This results in uncertainty regarding the effectiveness of the CSF early detection system. Furthermore, differential diagnosis with ASF is not carried out in cases of suspicion of CSF in domestic pigs.

The team noted the following: The active surveillance system for wild boars has significantly improved since guidelines on the targeted sampling of wild boars have been issued and implemented. In 2016, 49 wild boars were tested seropositive: all seropositive animals were tested negative by PCR. Age and location (oral vaccination in previous years) of each seropositive wild boar were compatible with the assumption that seropositivity was due to previous vaccination. However, no procedures are in place to confirm this assertion and discard other possible hypothesis (circulation of virus in the area). Therefore, appropriate measures to confirm or rule out the presence of the disease in wild boar when the disease is suspected, were not taken according to the requirements laid down in Article 15 of Directive 2001/89/EC (taking into account the recommendations of the CSF diagnostic manual: point B (3) and (7) of Chapter VII of Annex to Decision 2002/106/EC). The authorities issued new instructions regarding surveillance in wild boars in 2016 (No 6106 of 17 October 2016) requesting the sampling and testing (ASF and CSF) of all shot wild boars (ASF strategy to prevent or detect early the introduction of ASF in Bulgaria) and the request was renewed for the 2017 hunting season (letter dated 11 October 2017). These instructions have not been taken into account in two Regional Directorates visited during the audit. In addition, the 2016 and 2017 programmes have not been updated to take into consideration this new strategy, which would have led to a significant increase in testing expenses (about 90,000 wild boars were tested in 2016). The testing capacity of the laboratory has not been checked and assessed beforehand. The competent authority stated that the intention of these instructions was to raise the 14 awareness of hunters and develop the habit of systematic sampling, but that they had no intention to test all samples. In one region visited, the audit team noted under-implementation of the active surveillance programme in wild boars: e.g. respectively in 2015 and 2016, only 63 and 20 shot wild boars were sampled and tested, while the planned number of samples was 147. The region, where a vaccination programme was implemented until the end of 2015, was considered at risk, as it border a country with an unknown CSF status. The competent authority had an explanation for this situation, but no corrective action was initiated. The laboratories did not perform PCR testing for CSF since April 2017, due to a lack of test kits. According to the National reference laboratory, samples have been frozen pending further testing.

Regarding passive surveillance, the audit team noted the following: Instructions for sampling of wild boars were not correctly implemented in two Regional Directorates visited, as the authorities did not understand that samples of wild boars killed on the road have to be sent to the laboratory. Since April 2017, no PCR testing for CSF has been performed in the framework of passive surveillance because of the lack of availability of test kits. ASF differential diagnosis was not performed on samples forwarded to the laboratory, even when requested by the competent authority. 15 Conclusions on surveillance in wild boars

The absence of PCR testing of wild boars since April 2017 (due to a lack of test kits) seriously undermines the ability of the Bulgarian authorities to identify the possible introduction of the CSF virus through wild boars at an early stage. For wild boar found dead, Bulgaria is not performing differential diagnosis with ASF.

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cree of the Council of Ministers of the Republic of Bulgaria at the end of 2017, 000 was granted to provide the NRL with supplies, reagents, diagnostic kits, tants, protective clothing, etc., to ensure preparedness to deal with the disease re and after entering the country. ollection is enhanced from wild boar found dead, wild boar killed in road traffic s and those with atypical behaviors and cachectic were increased to be tested in for CSF and ASF.

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The team noted the following: The active surveillance system for wild boars has significantly improved since guidelines on the targeted sampling of wild boars have been issued and implemented. In 2016, 49 wild boars were tested seropositive: all seropositive animals were tested negative by PCR. Age and location (oral vaccination in previous years) of each seropositive wild boar were compatible with the assumption that seropositivity was due to previous vaccination. However, no procedures are in place to confirm this assertion and discard other possible hypothesis (circulation of virus in the area). Therefore, appropriate measures to confirm or rule out the presence of the disease in wild boar when the disease is suspected, were not taken according to the requirements laid down in Article 15 of Directive 2001/89/EC (taking into account the recommendations of the CSF diagnostic manual: point B (3) and (7) of Chapter VII of Annex to Decision 2002/106/EC). The authorities issued new instructions regarding surveillance in wild boars in 2016 (No 6106 of 17 October 2016) requesting the sampling and testing (ASF and CSF) of all shot wild boars (ASF strategy to prevent or detect early the introduction of ASF in Bulgaria) and the request was renewed for the 2017 hunting season (letter dated 11 October 2017). These instructions have not been taken into account in two Regional Directorates visited during the audit. In addition, the 2016 and 2017 programmes have not been updated to take into consideration this new strategy, which would have led to a significant increase in testing expenses (about 90,000 wild boars were tested in 2016). The testing capacity of the laboratory has not been checked and assessed beforehand. The competent authority stated that the intention of these instructions was to raise the 14 awareness of hunters and develop the habit of systematic sampling, but that they had no intention to test all samples. In one region visited, the audit team noted under-implementation of the active surveillance programme in wild boars: e.g. respectively in 2015 and 2016, only 63 and 20 shot wild boars were sampled and tested, while the planned number of samples was 147. The region, where a vaccination programme was implemented until the end of 2015, was considered at risk, as it border a country with an unknown CSF status. The competent authority had an explanation for this situation, but no corrective action was initiated. The laboratories did not perform PCR testing for CSF since April 2017, due to a lack of test kits. According to the National reference laboratory, samples have been frozen pending further testing.

Regarding passive surveillance, the audit team noted the following: Instructions for sampling of wild boars were not correctly implemented in two Regional Directorates visited, as the authorities did not understand that samples of wild boars killed on the road have to be sent to the laboratory. Since April 2017, no PCR testing for CSF has been performed in the framework of passive surveillance because of the lack of availability of test kits. ASF differential diagnosis was not performed on samples forwarded to the laboratory, even when requested by the competent authority. 15 Conclusions on surveillance in wild boars

The active surveillance system for wild boars has significantly improved since the authorities issued guidelines on the targeted sampling of wild boars for the CSF surveillance programme in 2013. The programme, as implemented, has adequate sensitivity for confirming absence of CSF virus circulation in wild boars. The significant under-performances in some regions lead to uncertainty regarding the disease status of these zones, especially for peripheral regions, where a vaccination programme has been implemented until recently. There are no procedures in place to confirm or rule out the presence of the disease when a wild boar is tested seropositive.

During the visit of the national reference laboratory, the team noted that: The laboratory has no laboratory information management system system, and therefore it was rather difficult to find the requested documents. Moreover, the laboratory has no crisis management plan as it had been running under crisis mode for the past couple of years (lumpy skin disease, avian influenza outbreaks). At reception level, in the absence of specific instructions, certain requests for testing were deliberately modified or not taken into account: e.g. even when requested by the authorities, ASF testing was not performed; in 2016, following a request for differential diagnosis (CSF, ASF and foot-and-mouth disease) on a wild boar sample coming from a region neighbouring Turkey, only CSF testing was performed. Moreover, since April 2017, incoming samples from wild boars found dead were not registered at reception: the laboratory explained to the team that this was applied in order to avoid impact on the turn-around time, which could affect its accreditation. The laboratory had only two pieces of PCR testing equipment at the time of the audit, of which one was not operational; consequently, the testing capacity of the laboratory was clearly deficient. The laboratory informed the team that two additional PCR devices will be purchased by the end of 2017; so that ASF testing can be performed on a routine basis. The only certified test for CSF virus detection is PCR. From April 2017, the national reference laboratory has not performed any PCR test , due to a lack of availability of test kits. The laboratory explained to the team that this was due to issues related to public procurement. o An alternative method (ELISA antigen), for which the laboratory is no longer accredited, was used in the pre-slaughter surveillance of East Balkan pigs. The central authorities were orally informed. o Regarding wild boar, since April 2017, all samples have been frozen and they are kept in cold storage until the PCR test is available again. In 2017, serological ELISA testing has been performed according to the surveillance scheme. However, in 2016, an internal audit carried out on the implementation of the CSF programme clearly identified in one region that 17 serological ELISA testing was not performed because the reference laboratory had run out of kits. Virus isolation and virus neutralisation for CSF are no longer accredited tests, and the laboratory hasn't been in a position to perform a virus neutralisation test since 2014. Currently, there is no agreement with the EURL for support in confirmation of positive samples by virus isolation and virus neutralisation. Virus neutralisation was not performed on ELISA seropositive wild boars. Therefore, appropriate measures to confirm or rule out the presence of the disease in wild boar when the disease is suspected, were not taken in accordance with EU requirements.

The significant shortcomings in the CSF national reference laboratory and one regional laboratory visited - mainly due to shortage of resources and inadequate organisation ­ impact negatively on the capacity of the authorities to early detect CSF.

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rm suspicious and positive results obtained with serological and virological tics of CSF by appropriate virus-neutralization technique and by means of techniques, action will be taken to reach an agreement with the EU RL in many.

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During the visit of the national reference laboratory, the team noted that: The laboratory has no laboratory information management system system, and therefore it was rather difficult to find the requested documents. Moreover, the laboratory has no crisis management plan as it had been running under crisis mode for the past couple of years (lumpy skin disease, avian influenza outbreaks). At reception level, in the absence of specific instructions, certain requests for testing were deliberately modified or not taken into account: e.g. even when requested by the authorities, ASF testing was not performed; in 2016, following a request for differential diagnosis (CSF, ASF and foot-and-mouth disease) on a wild boar sample coming from a region neighbouring Turkey, only CSF testing was performed. Moreover, since April 2017, incoming samples from wild boars found dead were not registered at reception: the laboratory explained to the team that this was applied in order to avoid impact on the turn-around time, which could affect its accreditation. The laboratory had only two pieces of PCR testing equipment at the time of the audit, of which one was not operational; consequently, the testing capacity of the laboratory was clearly deficient. The laboratory informed the team that two additional PCR devices will be purchased by the end of 2017; so that ASF testing can be performed on a routine basis. The only certified test for CSF virus detection is PCR. From April 2017, the national reference laboratory has not performed any PCR test , due to a lack of availability of test kits. The laboratory explained to the team that this was due to issues related to public procurement. o An alternative method (ELISA antigen), for which the laboratory is no longer accredited, was used in the pre-slaughter surveillance of East Balkan pigs. The central authorities were orally informed. o Regarding wild boar, since April 2017, all samples have been frozen and they are kept in cold storage until the PCR test is available again. In 2017, serological ELISA testing has been performed according to the surveillance scheme. However, in 2016, an internal audit carried out on the implementation of the CSF programme clearly identified in one region that 17 serological ELISA testing was not performed because the reference laboratory had run out of kits. Virus isolation and virus neutralisation for CSF are no longer accredited tests, and the laboratory hasn't been in a position to perform a virus neutralisation test since 2014. Currently, there is no agreement with the EURL for support in confirmation of positive samples by virus isolation and virus neutralisation. Virus neutralisation was not performed on ELISA seropositive wild boars. Therefore, appropriate measures to confirm or rule out the presence of the disease in wild boar when the disease is suspected, were not taken in accordance with EU requirements.

During the visit to one regional laboratory involved in CSF testing, the team noted that: The laboratory, which is ISO 17025 certified since 2008 for CSF ELISA Antibody detection, has a quality manager and a biosafety manager. The laboratory has a standard operating procedure based on the manual of the commercial kit. There was no operating procedure for numbering or document control. The templates of the working sheets used in the laboratory were not included in the standard operating procedure. It was difficult to make an irrefutable link between the working sheet with the sample disposal and the ELISA reader printout. On the working sheet the incubation time is mentioned but the room temperature is not measured. Conclusions on laboratories

The significant shortcomings in the CSF national reference laboratory and one regional laboratory visited - mainly due to shortage of resources and inadequate organisation ­ impact negatively on the capacity of the authorities to early detect CSF.

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logical diagnostics, the NRL and the two regional laboratories are covered by a concluded after a public procurement contract for implementation of the National ive program 2016-2018. For virological diagnostics, measures have been taken to bids and purchase diagnostic quantities sufficient for NRL.

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Bulgaria sends live pigs to other Member States accompanied by the appropriate Intra- Union trade certificate, signed on the basis of the current surveillance scheme. No specific instruction had been issued when Decision 2013/764/EU was modified in 2016 to introduce this derogation, and no specific check-list was developed to verify compliance with the provisions of Article 2a of this Decision. Live pigs certified for trade did not meet the requirements of Decision 2013/764/EU, as: The holding was not subjected at least every four months to inspections by the competent authority. Live pigs were introduced into the holding during the 30-day period immediately prior to the date of dispatch. The sampling and testing of the pigs was not performed within one month prior to movement to the slaughterhouse; 19 The testing was performed as per the annual plan, allowing for detection of 20% prevalence, while the requirement is that the testing should be performed according to the standard laid down in point F.2 of Chapter IV of the Annex to Decision 2002/106/EC (10% seroprevalence with 95% confidence (5% for sows) in pigs in each sub-unit in the holding). Conclusions on Animal health controls on meat production and EU trade

The authorities certify and dispatch to other Member States live pigs, fresh pig meat, meat products and meat preparations which do not comply with the requirements set for Bulgaria for intra-Union trade.

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to ensure that live pigs dispatched to other Member States with the relevant g certificate within the Union comply with the requirements laid down in Art. 2a 2013/764 / EC, the competent authority has developed an order stating that Page: 3 h 2018 f report ref. DG(SANTE)/2017-6113-MR of the audit carried out from 07 November ogramme for the control and monitoring of classical swine fever posed by the competent authority ch from the Republic of Bulgaria to the other EU Member States of live pigs g only in holdings of the type of industrial farms subject to strict conditions o in the Decision. al of these establishments for trade with Member States shall be made after an n by the farm owner to the relevant RFSD and providing to Animal health and d feed control directorate at the Central level by the relevant RFSD of an urveillance plan. The order was sent for approval to the Ministry of e, Food and Forestry and is expected to be issued by 10 March 2018.

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Fresh pig meat, meat preparations and meat products are dispatched to other member States accompanied by the appropriate Intra-Union trade certificate, signed on the basis of the current surveillance scheme. This scheme does not fully meet the requirements laid down in Decision 2013/764/EU and in particular the one relating to the absence of introduction of live pigs into the holding, or separate production unit, during the 30-day period immediately prior to the date of dispatch to the slaughterhouse.

In two industrial holdings visited, the audit team noted that live pigs were introduced into the holdings on a daily basis, without confirmation by the official veterinarian that the absence of introduction would only apply to separate production units, contrary to the requirements in Decision 2013/764/EU (i.e. the structure, size and distance between the production units and the operations carried out are such that the production units provide completely separate facilities for housing, keeping and feeding, so that the virus cannot spread from one production unit to another). The annual sampling plan was performed on the basis of the whole holding and not for each separate production unit (see paragraph 23), which incurs that the official veterinarian actually considered that the virus could spread among production units.

The authorities certify and dispatch to other Member States live pigs, fresh pig meat, meat products and meat preparations which do not comply with the requirements set for Bulgaria for intra-Union trade.

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o ensure that pig meat, meat preparations and meat products dispatched to other tes with the relevant marketing certificate within the Union comply with the rements laid down in Article 4 of Decision 2013/764 / EC in the order referred to in tion 8. It is noted that the pigs destined for slaughter are transported directly olding to the immediate slaughterhouse and only batches of pigs which comply onditions set out in the Decision. Page: 4

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There has been no systematic vaccination of calves since 15 July 2016. The policy to vaccinate calves was amended at a meeting between the CCA and all RFSD's in December 2016 when the age limit was reduced from 6 to 4 months of age. However, apart from the minutes of the meeting no specific instruction was issued to RFSD's and at the time of this audit, no systematic vaccination of calves had commenced.

As there has been no systematic vaccination of calves since 15 July 2016, there is a serious risk of an ever increasing number of susceptible animals in Bulgaria which could become infected if/when virus circulates. This risk would be addressed if the instruction issued on 13 February to vaccinate all calves over 4 months of age with immediate effect and to continue this on a weekly basis is implemented.

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The audit team confirmed with inspectors met during the audit, that they had undergone training as described by the BFSA. However, the audit team noted that two inspectors at Sofia Airport, who had recently completed their induction training, did not carry out an effective inspection of basil (see section 5.4.4 below). All other staff met by the audit team appeared to be fully technically competent.

Two staff at Sofia Airport, responsible for performing import checks for plant health, are not technically competent and cannot therefore be considered as qualified, at least to perform plant health checks, which is not in line with Article 1 of Directive 98/22/EC, in particular Point 2 of the Annex to that Directive. 4

The BFSA stated that they have issued official work instructions (see section 5.1.3 below) to ensure that, if followed, controls are performed appropriately and in line with Directive 2000/29/EC. However, at least in the case of sampling (see section 5.1.3) and dealing with soil attached to imported produce (see section 5.1.6 below), staff were generally not aware of these work instructions. The lack of awareness of official work instructions means that staff are not necessarily able to ensure the proper application of the Directive, and cannot therefore be considered as qualified, which is not in line with Article 2(1)(i) of Directive 2000/29/EC.

Whilst observing an inspection of cut basil (Ocimum sp.) from Israel, inspectors stated that they were unaware of any interceptions having been notified on this trade elsewhere in the EU. In fact, at the time of the audit, basil was the second most frequently 6 intercepted commodity from Israel which in turn was the non-EU country with the fourth highest number of interceptions for harmful organisms in the EU1. These inspectors did not have available information on interceptions made by other Member States. This is not in line with Point 1 of the Annex to Commission Directive 98/22/EC. 5.1.4 Planning of official controls

The audit team noted that, at least in the case of fruits, vegetables and cut flowers, the work instructions on sampling are generally not applied in practice (see section 5.1.3 above). It was also noted by the audit team that RFSD inspectors operating at approved places of inspection were not aware of sampling instructions for fruits, vegetables and cut flowers. The senior official from the region concerned confirmed that she was aware of such instructions but considered them to be out of date and no longer relevant. The BFSA later confirmed that the instructions were current and should have been known by the RFSD.

Two newly recruited staff at Sofia Airport are not technically competent to carry out plant health checks, as a result, their checks cannot be considered as reliable. The same staff were unaware of interceptions made in other Member States. Furthermore, whilst staff are familiar with most official instructions, there are instructions on certain topics, which inspectors are generally unaware of. As a result, plant health checks are not always carried out in line with the BFSA's work instructions which, compromises the reliability of these checks. The system of internal audits has not been effective in identifying and addressing this.

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so, in At present, all border inspectors are of higher (University) lar education, i.e. MS degree in Agronomy and a specialty in plant such protection, as per the requirements laid down in Ordinance No. 8 y on the Phytosanitary Control, Article 4, Paragraph 2 thereof.- Each official Border Inspection Phyto-sanitary Posts (BIPP) within the BIPs are provided with official instructions for work and training of the inspectors. The necessary steps will be taken to involve border inspectors carrying out border phytosanitary controls in both EU and national training, as well as in additional training so that these inspectors could regularly improve their knowledge and skills to work with EUROPHYT. As for the newly appointed staff, there shall be initial introductory training carried out as a basis for the further subsequent specialized training events in which they will be included. All official documents are provided to all BIPP at the BIPs. BFSA will take the appropriate measures in the following areas: - Regular updating inspectors' knowledge of the official instructions for work and timely notification of the newly adopted ones; - Monthly provision of information to the BIPPs (within

esent, all border inspectors are of higher (University) education, i.e. MS degree in In order to increase knowledge, skills and Agronomy and a specialty in plant protection, competencies of all border inspectors as per the requirements laid down in performing the phytosanitary control, they Ordinance No. 8 on the Phytosanitary will be a priority nominated to participate Control, Article 4, Paragraph 2 thereof.- in: - training activities under the initiative Each official Border Inspection Phyto- BTSF of the European Commission. In sanitary Posts (BIPP) within the BIPs are addition to the existing themes, the Border control Directorate has given proposals for provided with official instructions for work 2 new themes in this area, to be included in and training of the inspectors. the BTSF 2018-2020 training calendar. BFSA has been involved in an organized The necessary steps will be taken to involve consultation (by e-mail) by the organizers of border inspectors carrying out border the program with proposals for two thematic phytosanitary controls in both EU and topics: national training, as well as in additional Europhyt network System training so that these inspectors could Quarant

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The audit team noted that, if applied, the sampling rates in the work instructions would, according to ISPM 31, provide an appropriate probability of detecting harmful organisms in small and large lots of fruits, vegetables and cut flowers, and plants intended for planting. However, for mid-sized lots, the sample size would, in many cases, provide a confidence level significantly below 80% of detecting even a 5% level of infestation and this reduced level of confidence was not justified based on risk. The work instructions on sampling do not therefore provide for a sample which 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 the work instructions on sampling are not generally applied in practice in the case of fruit, vegetables and cut flowers. All inspectors met by the audit team, other than those at Sofia Airport who followed the work instructions on sampling, stated that they sample 200 individual fruit, vegetables or stems, selected at random from 10 boxes, which is not in line with the work instructions.

The audit team observed an inspection of citrus from Turkey and noted that: the lot consisted of 2 200 boxes, each weighing 10 kilograms; the BCD inspectors selected 10 boxes from five different pallets and inspected 20 fruit from each box; according to the work instructions, the sample size should have been 88 boxes. The sample size taken in this case was therefore lower than that provided in the work instructions, which already provides for too low a confidence level. The sample was not therefore representative of the lot, which is not in line with Article 13a(1)(b)(iii) of Directive 2000/29/EC.

The work instructions provide for sample sizes which, in some cases, are too small to be considered representative of the lot and the sample sizes applied in practice are sometimes even smaller. Therefore, the resulting checks are not reliable in determining the pest status of the lot.

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health The currently applied sampling methodology during the checks, with which is outlined in the monitoring programs developed by o experts of the Central Laboratory on Plants Quarantine (CLPQ) and the `Plant Health and Quality Controls of Fresh Fruits and Vegetables' Directorate (within the BFSA Central Office) will be appropriately reviewed, revised and updated in the context of IPPC Standard 31, in order to be always able to have a reasonable and grounded conclusion that the particular batch is not contaminated with any pests. Following approval and adoption such new sampling methodology, the latter is to be immediately distributed to all BIPP within the BIPs.

currently applied sampling methodology The methodology has been developed by during the checks, which is outlined in the experts of the Central Laboratory on Plants monitoring programs developed by experts of Quarantine (CLPQ) and is currently being tested on some Phytosanitary BIPs. It is Page: 2 received 7 November 2017 ed by the competent authorities of Bulgaria in response to Report ref. DG(SANTE)/2017-6143- 2017 in order to evaluate the system of import controls for plant health Action Proposed by the competent authority Action Proposed by the Competent Authority (updated) e Central Laboratory on Plants Quarantine expected by December 2017, to be approved (CLPQ) and the `Plant Health and Quality by the Executive director of the Bulgarian Controls of Fresh Fruits and Vegetables' Food Safety Agency. Directorate (within the BFSA Central Office) Deadline: December 2017 will be appropriately reviewed, revised and updated in the context of IPPC Standard 31, in order to be always able to have a reasonable and grounded conclusion that the particular batch is not contaminated with any pests. Following approval and adoption such new sampling methodology, the latter is to be immediately

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Facilities at the land border crossing and seaports visited by the audit team were generally in line with EU requirements, although the lighting at the seaports was not appropriate as the light source was fixed behind the location where inspectors stand whilst carrying out their visual examinations, casting a shadow over the inspection area.

At Sofia airport, the audit team noted that the inspection facility lacked appropriate lighting and the inspection table was located immediately adjacent to the loading bay of the warehouse facility where there was a significant level of forklift traffic. This was not a suitable area for inspection since it did not provide any protection from the risk or noise of industrial traffic. This facility does not therefore meet all of the minimum conditions for carrying out plant health checks specified in the Annex to Directive 98/22/EC as required by Article 1 of the same Directive.

Inspection facilities are of a good standard, although with somewhat inadequate lighting. However, the facility at Sofia Airport did not meet all of the minimum conditions for carrying out plant health checks. These shortcomings make it difficult for inspectors to carry out appropriate checks.

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ch meet All necessary measures will be taken to ensure that all places where plant health checks are carried out strictly comply with the minimum requirements set out in the Annex to Directive 98/228/EC and Ordinance No 8 on Phytosanitary Controls. * The lighting equipment in the facilities of the Inspectorate of Ports has been duly corrected at the time of the audit.

l necessary measures will be taken to sure that all places where plant health All places strictly comply with the minimum checks are carried out strictly comply with requirements set out in the Directive the minimum requirements set out in the 98/228/EC Annex to Directive 98/228/EC and Ordinance No 8 on Phytosanitary Controls. * The lighting equipment in the facilities of the Inspectorate of Ports has been duly Page: 3 received 7 November 2017 ed by the competent authorities of Bulgaria in response to Report ref. DG(SANTE)/2017-6143- 2017 in order to evaluate the system of import controls for plant health tion Proposed by the competent authority Action Proposed by the Competent rrected at the time of the audit. Authority (updated)

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At Sofia Airport, BCD inspectors stated that they work daily with the Customs Services in the passenger channels. Customs officers identify passengers for inspection and in the event that they are carrying any quantity of plant material, BCD inspectors are engaged to determine whether the material is compliant with import requirements. BCD inspectors stated that, at the time of the audit, two seizures had resulted from these passenger baggage controls so far in 2017, in both cases the quantities detected were in excess of the small quantity concession and no accompanying phytosanitary certificate was present. The BCD inspectors stated that they do not notify such interceptions through the EUROPHYT system because they are 'non-commercial' consignments. The BFSA stated that they considered 'non-commercial' consignments to include those sent by postal or courier modes and goods contained in travellers' personal baggage. The BFSA confirmed that the national policy was only to notify interceptions of 'commercial' consignments (see section 5.6 below). 5.3.6 Checks for non-regulated articles and for non-regulated harmful organisms

The audit team studied notifications submitted by Bulgaria and noted the notification procedures laid down in Commission Directive 94/3/EC are generally complied with. However, the BFSA do not notify interceptions related to passenger baggage (see section 5.3.5 above). Failure to notify these interceptions is not in line with the requirements of Article 2 of Directive 94/3/EC.

Interceptions of 'non-commercial' consignments, in particular those imported in passengers' luggage, are not notified to the Commission and other Member States. This does not enable the Commission and other Member States to evaluate and potentially mitigate the risk posed by such imports.

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ission Additional instructions will be given to all inspectors carrying out ant the border phytosanitary controls to outline their obligations to 'non- promptly notify the EUROPHYT System about all cases of he same detention of plants, plant products and other objects imported as ,,non-commercial" consignments as this is required by Article 2 of Commission Directive 94/3/EC. Page: 2

ditional instructions will be given to all rs carrying out the border ytosanitary controls to outline their There will be given instructions to all head ligations to promptly notify the of BIPs units within Border control ROPHYT System about all cases of Directorate to notify through the tention of plants, plant products and other EUROPHYT System all cases of ,,non- commercial"consignments with quarantine jects imported as ,,non-commercial" pests. nsignments as this is required by Article 2 Deadline: 30 November 2017 Commission Directive 94/3/EC. Page: 4

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For 2014, 2015 and 2016, the sampling programme covered almost all the bacterial species and food producing animal populations and food combinations compulsory in Decision 2013/652/EC. In 2015, the competent authorities did not test Salmonella isolates (see point 19). This will most likely be rectified for 2016 since some isolates were gathered at the NRL and are planned to be tested and reported.

With regard to the fulfilment of the minimum number of samples and isolates to be tested, the situation was as follows: Salmonella ­ all available isolates gathered under the Salmonella National Control Programme (SNCP) were tested as required by the Decision. This was not the case for the isolates gathered in the context of Regulation (EC) No 2073/2005, for 2015 (see point 19). 4 E. coli - 85 isolates were gathered from caecal samples each year. Whilst for 2014 the necessary 85 isolates had been tested, for 2015 only 21 were tested due to lack of microdilution plates available as a result of budget constraints. This situation will most likely be resolved for 2016, since 424 E. coli isolates were gathered from broiler caecal samples and the audit team noted that the laboratory availed of a sufficient number of plates to test the required 85 isolates. C. jejuni­ The minimum 85 isolates tested was exceeded for 2014 and will most likely be achieved for 2016, since 90 C. jejuni isolates were gathered and are currently under testing. ESBL- or AmpC-producing E. coli ­ The required number of samples to be tested was achieved for 2015 and largely exceed for 2016. Isolates from samples collected at poultry primary production

According to information provided by the competent authority, no positive samples were gathered from the food business operator own-checks in the last 3 years and this was the case in the slaughterhouses visited. It was noted however, that the competent authority could not ensure that if such isolates are gathered at private laboratories, they are communicated or made available to the NRL. For instance, in none of the slaughterhouses visited, were there provisions in place to ensure these isolates are preserved, communicated and if necessary made available to the NRL (as is the case for isolates gathered for food safety criteria). Isolates gathered from caecal samples collected at slaughter

The competent authority has documented procedures in place to support the implementation of most of the provisions laid down in the legislation. However, shortcomings were noted that undermine the representativeness of data obtained, in particular the lack of an even distribution of sampling during all months of the year, the sampling of repeated epidemiological units. The measures in place to gather Salmonella isolates from food business operator own checks were also insufficient to achieve the objectives of Decision 2013/652/EU. 5.2.2 OFFICIAL LABORATORIES Legal requirements Article 10 of Directive 2003/99/EC; Article 4 and Annex Part A.5 of Decision 2013/652/EU. Article 33 of Regulation (EC) No 882/2004. Findings

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to For the whole 2016 there were a total of 21 isolates obtained and typed as Salmonella nt 2.2 of Part spp. under the programs for monitoring of salmonellas in poultry, all these being tested that when and entered under the EFSA reporting document. In addition, there were 5 isolates e subject obtained and typed as Salmonella spp. ones originating from broiler carcasses that have d, all been sampled and tested for verification of the compliance in accordance with Chapter 2, be subject to paragraph 2.1.5 of Annex I to Regulation (EC) No 2073/2005. Those have been tested and entered under the EFSA reporting document. Consumables assured, provided and supplied in 2016 were sufficient to perform the test for detection of antimicrobial resistance. The isolates of Campylobacter jejuni, which are ready for reporting, are more than 85, the commensal Escherichia coli are more than 85, having also sufficient number of isolates of E. coli, which are producing ESBL, AmpC or carbapenemases originating of cecum samples collected at slaughter of broilers. All quantitative criteria in conducting compulsory part of the monitoring study will be satisfied and the results for 2016 will be reported in

whole 2016 there were a total of 21 isolates The Program for Monitoring and Reporting of Antimicrobial Resistance of obtained and typed as Salmonella spp. under the Zoonotic and Commensal Bacteria in the Republic of Bulgaria in 2017 lays rams for monitoring of salmonellas in poultry, all down the requirement that when salmon isolates are detected, both from these being tested and entered under the EFSA official control samples and from own monitoring samples, the respective ng document. In addition, there were 5 isolates laboratory (government or private) shall send the isolates for typing in the and typed as Salmonella spp. ones originating "Salmonella, Campylobacter, Staphylococci and Antimicrobial Resistance" oiler carcasses that have been sampled and NRL with the National Food Safety Centre (NFSC) with the National fication of the compliance in accordance Diagnostic-and-research Veterinary Medical Institute (NDRVMI) in Sofia ith Chapter 2, paragraph 2.1.5 of Annex I to ation (EC) No 2073/2005. Those have been In order to meet this requirement, there was an e-mail sent on 22 March 2017 sted and entered under the EFSA reporting to the directors of and heads of the Food Control De

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The AMR monitoring programme clearly specifies the relevant rules to be observed during sampling activities. Whilst continuous improvements had been made since the inception of the programme in 2014, some issues still need to be brought fully in line with EU requirements, as follows: The monitoring programme allows samples to be tested up to 72 hours after sampling. This flexibility is not fully in line with point 4.1 of Part A of the Annex to Decision 2013/652/EU, since it is not aligned with the maximum of 48 hours defined under the European Union Reference Laboratory (EURL) detection protocol. It requires also that samples are gathered from national or EU produced meat, thereby excluding non EU meat which is contrary to the point 2.3.3 of Part A of 3 the Annex to Decision 2013/652/EU that requires that samples should not be pre- selected based on the origin of the food. The number of samples to be taken annually has been defined based on the number of samples or isolates (as applicable) subject to EU co-financing, which is not in line with the requirements of point 2.2 of the Annex to Decision 2013/652/EU. This approach has resulted in a considerable delay in the implementation of the monitoring programme (see point 21) and in a significantly higher number of samples being tested than required by the Decision. For instance, 426 samples tested under the ESBL protocol (instead of the required 150) for the 2016, since the competent authority was mistakenly trying to get 150 presumptive ESBL- or AmpC- producing E. coli isolates. No instructions were included in the monitoring programme to ensure that Salmonella isolates submitted to the NRL from the regional laboratories are properly identified (see point 15). 5.2.1.2 Sampling design Legal requirements Articles 1 to 3 of Decision 2013/652/EU; Article 4 to 7 of Directive 2003/99/EC. Findings 5.2.1.2.1 Sampling framework

Whilst in one of the regional offices visited the audit team noted that isolates were regularly submitted to the NRL, these isolates were in general poorly identified. For instance, for some isolates verified at the laboratory, no information was available on the epidemiological unit of origin, matrix and sampling context. This prevented the competent authority from ensuring that repeated epidemiological units were reported, as required by point 2.3.2 of part A of the Annex to Decision 2013/652/EU. Isolates from carcass samples collected at slaughter

Contrary to the requirements set out in point 2.3.1 of part A of the Annex to Decision 2013/652/EU, the caecal samples gathered under the AMR monitoring programme were not evenly distributed over each month of the year. Instead, monthly sampling took place only from May to December in 2015 and from June to December in 2016. The 6 main reason for these delays was the fact that the competent authority waited for the financial grant decision to define the number of samples to be collected.

The competent authority has documented procedures in place to support the implementation of most of the provisions laid down in the legislation. However, shortcomings were noted that undermine the representativeness of data obtained, in particular the lack of an even distribution of sampling during all months of the year, the sampling of repeated epidemiological units. The measures in place to gather Salmonella isolates from food business operator own checks were also insufficient to achieve the objectives of Decision 2013/652/EU. 5.2.2 OFFICIAL LABORATORIES Legal requirements Article 10 of Directive 2003/99/EC; Article 4 and Annex Part A.5 of Decision 2013/652/EU. Article 33 of Regulation (EC) No 882/2004. Findings

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ive, as The program was developed in February 2017 (before the promulgation of the co- financing decision, thus not been bound with it). It was based on the requirements laid of down in Decision 2013/652/EC and was approved under the Order of ref. No RD 11- units 356/20.02.2017 of the BFSA Executive Director. Immediately after this approval it was id sent for implementation by its stakeholders and, as by now, the time schedule is for the implemented without deviations. been evenly distributed in all the next months of the year starting February December inclusive. Distribution of sampling was based on the thorough ade in 2016 to cover number of farms that supply each pig slaughterhouse, hat the number of the sampling planned would correspond to the number of ng animals for slaughter. ram lays down that sampling of cecum content shall be subject to random t only from slaughtered pigs reared locally, the planning of sampling must ionate to the annual capacity of the slaughterhouse and consistent with the Technical specifications on randomised sampling for harmonised antimicrobial resistance in zoonotic and commensal bacteria (EFSA 12 (5): 3686). aken from pre-packaged chilled meat of

re that sampling at slaughterhouses is representative, as required by Article 2(1) of Part A of BFSA foresees to have a working group established in November 2017 under e Annex to Decision 2013/652/EU, by evenly an order of the BFSA Executive Director to collect the data needed and to tributing samples over each month of the year and develop the Program for 2018, which has to be approved by 30.12.2017 by avoiding sampling repeated epidemiological units BFSA ED. This new 2018 Program is to provide that samples will be allocated d by point 2.3.1 of part A of the Annex to the for implementation within the whole year, i.e. January - December 2018. id Decision. In particular, information available llow for the exclusion of repeated . iological units. dation based on conclusion No 28. The template (form) established is an annex to the Program and serves as ssociated findings No 8, 17, and 21 to 23. accompanying letter to sample movements, i.e. transfer of samples to the laboratory to be test, and/or transporting the isolate to the NRL for typing. The letter is used by official controls and by the laboratories within the BFSA structure. The samples for the self-control are taken in accord

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For the reasons detailed in point 21, significant delays were also noted in the implementation of the sampling plan at retail level (only the second semester of the year was covered in both 2015 and 2016). These delays can hamper the representativeness of the data collected and are not in line with which was recommended under the EFSA technical specifications 3.

Although the allocation of samples to the regions was in general proportional to its population, it only covered eight regions accounting for 60% of the Bulgarian population. This is not in line with the 80 % recommended under the above-mentioned technical specifications. The competent authority informed the audit team that there are plans to extend the geographical area to cover 90% of the population.

At regional level, retail establishments are selected randomly for sampling, following the requirements of the sampling programme. However, samples are not selected randomly, as required by point 2.3.3 of Part A of the Annex to Decision 2013/652/EU, as EU and domestically produced meat are targeted in the sampling plan. 3 http://www.efsa.europa.eu/en/efsajournal/pub/3686.htm 7 Conclusions on national measures and sampling design

The competent authority has documented procedures in place to support the implementation of most of the provisions laid down in the legislation. However, shortcomings were noted that undermine the representativeness of data obtained, in particular the lack of an even distribution of sampling during all months of the year, the sampling of repeated epidemiological units. The measures in place to gather Salmonella isolates from food business operator own checks were also insufficient to achieve the objectives of Decision 2013/652/EU. 5.2.2 OFFICIAL LABORATORIES Legal requirements Article 10 of Directive 2003/99/EC; Article 4 and Annex Part A.5 of Decision 2013/652/EU. Article 33 of Regulation (EC) No 882/2004. Findings

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equired by The Program was drafted in February 2017 and was approved by Order of ref. No RD 11- ision 356/20.02.2017 of the BFSA Executive Director. It includes provision for the allocation he planned samples to be taken at the stage of retail. Immediately after its approval, ed on it was sent for execution at regional level. lays down a requirement to the directors of each RFSDs, included in sampling from commercial sites for retail of foodstuffs, that they must ent persons to be responsible for implementing the Program and the nsible for sampling (titular and deputy). They shall also establish an rocedure for taking, collecting and dispatching the samples into the NRL pylobacter, Staphylococcus and Antimicrobial Resistance" with the ny undue delay. mples from pig and bovine meats that must be taken for testing in the han 150 for each type of meat, their allocation being in accordance with et out in the 2017 Program. ersons responsible for sampling are required to personally take the of samples of chilled meat of pigs and bovines. Sampling is spread over ry to December 2017, included to be performed under an approved ogram contains a table developed to specify this schedule (month

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Laboratory procedures were available on-the-spot and generally followed the relevant international standards. However, some shortcomings were noted by the audit team: MIC determination Quality controls with reference strains were not run every day that the tests were performed in order to monitor the quality of test results, as detailed in ISO 20776:2006 and CLSI M07-A10. Instead, the reference strain was only run for 9 specific situations such as for the verification of new batches of testing microdilution plates or broth and for the performance of proficiency tests. There were no procedures in place to ensure that implausible test results are adequately challenged and investigated before being reported to EFSA. For instance, some isolates were reported showing resistance to cephalosporins and susceptibility to ampicillin, high values of resistance to nalidixic acid and susceptibility to ciprofloxacin. Whilst improvements have been noted in the quality of data reported since the inception of the programme in 2014, there are still no documented procedures or good practices to ensure a harmonised approach during plates reading. The MIC determination procedure for Campylobacter only included the incubation time/temperature conditions of 37ºC, 48 hours although the combination 42ºC, 24 hours was also used. Therefore, the standard operating procedures were not being followed. Although manual records were kept of the working temperature for each incubator (verification twice a day to check functioning), records were neither kept of the duration of incubation nor of the identification of the incubator used to allow for correlation between the results obtained and the incubation conditions. Moreover, relevant information such as the Muller-Hinton media used for the performance of the tests was not recorded. This insufficient record keeping is not in line with point 4.13.2 of ISO 17025. There was no calibration of the multichannel pipettes used to add the inoculum to the plate wells in order to ascertain the volume used which is not in line with point 5.4.1 of ISO 17025. Moreover, no alternative methods to obtain this information (for instance, through periodic control of the weight of the filled microdilution plates) were developed. Protocols for detection of presumptive E. coli producing ESBL and AmpC enzymes Reference strains are regularly used to validate the preparation of the McConkey agar with cefotaxime. Although these plates are usually prepared for a relatively short period (2 weeks), this shelf life had neither been defined in the internal procedures nor had the validation of the medium stability for this period ever been performed. For the year 2015, despite the fact that there were 92 presumptive ESBL-, AmpC- producing E. coli isolates gathered from the caecal samples, only 72 isolates were tested later on for the MIC determination. No investigation had been performed on this unusual recovery rate. 10 5.2.2.4 Storage of the isolates

Notwithstanding the fact that the laboratory for the official monitoring of AMR is properly designated, accredited and involved in proficiency tests with satisfactory results, weaknesses in the internal quality control system have the potential to undermine the reliability of the results obtained. These refer, notably, to the lack of consistent use of reference strains and some deficiencies in record keeping at the laboratory.

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place In order to eliminate the deficiencies identified, the following measures have been taken: ic - there is a newly corrected standard operating procedure (SOP) for determining the MIC isolates of Campylobacter spp. only at a temperature of 37°C applicable to conducting the A of the testing; le 4 - quality control of testing the isolates from the monitoring program has been brought into line with the requirements of ISO 20776-1: 2006 and CLSI M07-A10 by using the relevant reference strains simultaneously with the tested isolates; - the results for MIC are recorded in a separate document for each of the tested and reference strains, then data are recorded in a separate log-book; - a post-consulting alternative calibration has been performed of the laboratory multichannel pipettes used for the work and there was determination of the quantity of liquid after 10 consecutive receivable operations performed in each of the 8 channels of the pipette. Then the liquid was transferred into 8 test tubes, and then the amount of liquid was quantified as volume in one mililitre. Pending is the pipettes to be sent for calibration by specialized company; - after the audit there was careful analy

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The results of the AMR monitoring were submitted in the form of raw isolate-based data generally in line with the requirements of the data dictionary provided by EFSA. Although some improvements were noted on the quality of the information provided from 2014 to 2015, deficiencies were noted in the most recent reporting period (data from 2015), such as: A total of 33 E. coli isolates gathered from meat samples under an investigation project out of the scope of Decision 2013/652/EU, were incorrectly reported under the "ESBL MON" programme. Similarly, the Salmonella isolates reported in 2015 under the "AMR MON" programme were instead clinical isolates which is contrary to point 1 of Part B of the Annex to Decision 2013/652/EU. Inaccuracies were noted in the mandatory reporting of the "Total units tested" and "Total units positive" under the "ESBL MON" programme that can lead to incorrect interpretation of data reported. The total number of epidemiological units reported was grouped for each monitoring programme, instead of discriminated by each given matrix and bacterial species as required under point 2 of part B of the Annex to Decision 2013/652/EU. The audit team selected randomly six isolates from the data reported in 2014 and 2015 and noted that for two isolates the MIC values reported for some antimicrobials did not match with the records available at the laboratory. The "matrix" and the "laboratory isolate code" were also incorrect for two other isolates. 11 The "sampling date" reported for all isolates resulted to be the date of arrival to the laboratory.

The collection form used for reporting data submitted to EFSA did not include the "overall description of the implementation of the AMR monitoring" contrary to points 2 and 2.1 of Part B of the Annex to Decision 2013/652/EU. Conclusion on assessment and reporting of AMR

The annual report includes all the mandatory information for each individual isolate reported under harmonised monitoring, and some information reported on a voluntary basis. There are though weaknesses in the completeness and accuracy of information provided and the lack of overall description of the implementation of AMR monitoring that undermine the quality of the data reported.

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scription In order to ensure that the information included in the general description of the g implementation of the monitoring of antimicrobial resistance as provided to the European and Food Safety Authority (EFSA) is complete and accurate, and that include "a general description of the monitoring of AMR", there is a special reporting form developed and and entered into use under the Program for monitoring and reporting of antimicrobial r to resistance in zoonotic bacteria and commensal bacteria. ken from pre-packed, chilled meat of porcine or bovine animals are taken by applying random selection at the retail stage of the food chain. tled as «Collection, Reporting and Use of Data» lays down that: tral Office collects and reports all the results of the samples tested broken ors tested and species, as this is reflected in Annex titled "Technical Part A "Framework of the actions for sampling and analysis" to Decision ; the performance of sampling for the monitoring of AMR in compliance ical requirements set out in Part A of the Annex to Decision No rily ensures collection and testing of the 2017 representative isolates of bacteria in compliance with the technical requirements set o

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Official controls undertaken at producers/processors of PDO/PGI/TSG to verify compliance with the Product Specifications, did not always include verification of every element of the Product Specification. 5.2.5 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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The CA confirmed the total equidae population to be 81,686 of which 28,262 equidae are currently identified. Data on total population is obtained from monthly returns submitted by private practitioners. The regional distribution of identified horses, provided by the CA, is illustrated below: Identification document

The total number of passports issued by the five issuing bodies for the first seven months of 2016 in Bulgaria according to the age groups was as follows: Age when issued 0 ­ 6 months 6 ­ 12 months > 12 months Number of horses 430 435 3634

The CA has a good level of knowledge of location of equidae within its territory and has developed a system for identification of equidae largely in line with EU standards. However, this system is not applied to a very significant extent. No solution is envisaged by the CA to overcome the identified reason (financial constraints) and the level of enforcement is not dissuasive.

Weaknesses exist in the system to issue equine identification documents which frequently do not contain all the required information. When equidae are identified, they are most frequently identified outside the required time limit. Despite this, they are not issued with the correct identification document which should exclude them from entering the food chain. This results in ineligible animals entering the food chain, and does not contribute to deter non-compliance.

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The total number of passports issued by the five issuing bodies for the first seven months of 2016 in Bulgaria according to the age groups was as follows: Age when issued 0 ­ 6 months 6 ­ 12 months > 12 months Number of horses 430 435 3634

The CA confirmed that they do not use the derogation foreseen in Article 12(2) of Regulation (EU) 2015/262 which requires equidae to be identified by 6 months or the calendar year of birth. Instead, equidae must be identified not later than 12 months following the date of birth and in any event before leaving permanently the holding of birth as required by Article 12(1) of Regulation (EU) 2015/262. All equidae identified after the age of 12 months should therefore be issued a duplicate identification document (if first identification document has been lost) or replacement identification document (if identified for the first time) and excluded from slaughter for human consumption. The CA and the approved bodies visited confirmed that they do not exclude equidae identified after 12 months of age from slaughter for human consumption. This is not in compliance with Articles 29(2)(c), 31(1) and 32(2)(c) of Regulation (EU) 2015/262. 5

Weaknesses exist in the system to issue equine identification documents which frequently do not contain all the required information. When equidae are identified, they are most frequently identified outside the required time limit. Despite this, they are not issued with the correct identification document which should exclude them from entering the food chain. This results in ineligible animals entering the food chain, and does not contribute to deter non-compliance.

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CA confirmed that no guidance had been issued to deal with the subject of replacement/duplicate equine identification documents. One issuing body considered duplicate and replacement passports were the same document. Few duplicate passports were available for audit team to review (for the seven first months of 2016, only 2 duplicate/replacement passports were issued). Of the 2 duplicate passports reviewed in two separate issuing bodies, one was stamped on cover page as not intended for slaughter for human consumption but neither had the section on administration of veterinary medicinal products completed to exclude them from the food chain. This is not in compliance with Article 29(2)(c) of Regulation (EU) 2015/262. Identification verification (Transponder)

Weaknesses exist in the system to issue equine identification documents which frequently do not contain all the required information. When equidae are identified, they are most frequently identified outside the required time limit. Despite this, they are not issued with the correct identification document which should exclude them from entering the food chain. This results in ineligible animals entering the food chain, and does not contribute to deter non-compliance.

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The format and content of the identification documents issued by the CA or the issuing bodies has not been updated according to the requirements of Regulation 2015/262. 4

Two weeks in advance of this audit, the CA audited the four issuing bodies for registered equidae and suspended them from issuing further identification documents. The conditions for removing the suspension include the requirement to provide BFSA with a certified copy of their identification document which complies with the format and content of the current legislation and their internal rules and procedures for issuing identification documents in compliance with Regulation (EU) No 2015/262.

An issuing body had changed five times the format and appearance of its identification documents since 2011. The differences include the colour of the covering page and different methods of binding the pages not all of which met the requirement for the passport to be indivisible as required by part 2(c) of Annex I of Regulation (EU) 2015/26. No system was in place to verify that these identification documents were all issued by the issuing body and were unique, genuine and authentic as required by Article 8(b)(i) of Regulation (EU) 2015/262.

Weaknesses exist in the system to issue equine identification documents which frequently do not contain all the required information. When equidae are identified, they are most frequently identified outside the required time limit. Despite this, they are not issued with the correct identification document which should exclude them from entering the food chain. This results in ineligible animals entering the food chain, and does not contribute to deter non-compliance.

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An issuing body had changed five times the format and appearance of its identification documents since 2011. The differences include the colour of the covering page and different methods of binding the pages not all of which met the requirement for the passport to be indivisible as required by part 2(c) of Annex I of Regulation (EU) 2015/26. No system was in place to verify that these identification documents were all issued by the issuing body and were unique, genuine and authentic as required by Article 8(b)(i) of Regulation (EU) 2015/262.

Weaknesses exist in the system to issue equine identification documents which frequently do not contain all the required information. When equidae are identified, they are most frequently identified outside the required time limit. Despite this, they are not issued with the correct identification document which should exclude them from entering the food chain. This results in ineligible animals entering the food chain, and does not contribute to deter non-compliance.

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The list of issuing bodies available to other Member States and the public on the website established by the competent authority was not up to date at the time of the audit, as it listed only 4 of the 5 issuing bodies in Bulgaria. This is not in compliance with Article 6(1) of Regulation (EU) 2015/262.

The list of issuing bodies available on the CA website is incomplete making it difficult for Member States and the public to determine if identification documents have been issued by a recognised issuing body.

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Even though the current version of the National Regulation is dated June 2014, it does not incorporate some of the requirements of Regulation (EC) No 889/2008, in force since 1 January 2014. Although it is mentioned in the National Regulation that all EU Regulations are directly applicable, this inaccuracy may cause that CBs to not include in their procedures some of the missing EU requirements, as CBs may use the National Regulation rather than the directly applicable EU legislation as a reference when drafting their procedures. This was noted to be the case by the audit team at the headquarters of one of the CBs, which referred in its procedures to the National Regulation and to Regulation (EC) No 834/2007 only. As a result, the requirement for the minimum 10% of visits carried out unannounced, established in Regulation (EC) No 889/2008, which is missing from the National Regulation, was not taken into account by the CB.

In addition, the National Regulation includes some requirements which are not in line with EU Regulations, such as the delegation to CBs of the power to grant derogations on the renewal of flocks and herds and the possibility to grant derogations on housing conditions and stocking densities, which are already phased out in the EU Regulations since 31 December 2013. Although these derogations had not been granted in recent years, they are not in line with EU Regulations.

Furthermore, some of the measures foreseen in the national sanction catalogue are not in line with the requirements in EU Regulations. Only soft measures are foreseen in the catalogue, even in cases of severe, recurrent non-compliances (see paragraphs 90-92). 3 Conclusions on Relevant National Legislation and Provisions

National laws necessary to implement legally binding European Union acts relevant to this audit have been adopted by the CA. However, the fact that the National Regulation does not incorporate all relevant EU requirements creates confusion when it comes to their implementation by CBs. In addition, some of the EU requirements further developed by the National Regulation are not in line with EU Regulations.

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1. 1 7 2013 . . , . : - , , , ; , ( , , , ); - , ­ ; : ( 01.04.2016 ., 19 11 2016 .)

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The Bulgarian Accreditation Service Executive Agency (IABSA), under the Ministry of Economy, Energy and Tourism is the national accreditation body. The IABSA is responsible for the accreditation of CBs according to the International Organisation for standardization guide ISO/IEC 17065:20121. At the time of the DG Health and Food 1 The ISO/IEC 17065:2012-Conformity assessment- Requirements for bodies certifying products, processes and services, was published in September 2012 and replaced ISO Guide 65 and EN 45011. In accordance with an 4 Safety audit, all the CBs operating in Bulgaria were already accredited to ISO/IEC 17065, having completed the transition from previous standards before September 2015. As regards the exchange of information with the CU on the results of the accreditation audits carried out on CBs, the audit team noted that the CU requested this information on 23 June 2014 but at the time of the audit it had not been provided by the IABSA. This lack of cooperation prevents the CU from effectively carrying out its supervisory activities on CBs according to Article 92(c) of Regulation (EC) No 889/2008 (see paragraph 17).

CAs are designated in Bulgaria with a clear division of responsibilities and tasks. However, cooperation between the CU and the IABSA is not adequate to ensure that the CU fulfils its supervisory activities on CBs.

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1. ,,". ,,", , . 2, 11 () 765/2008 ( ,," ). : 2016 .

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The audit team noted that the tool used by CBs has limited possibilities. CBs have to indicate whether parcels, chosen from a dropdown list, are compliant or not with the organic requirements. However, CBs cannot and do not report on non-compliances other than those affecting the organic status of products. In addition, not all parcels subject to controls can be reported as only the parcels receiving subsidies are in the system. As a result, several non-compliances and the risk thereof are not reported to the NPA. Moreover, non-compliances detected after 30th October of a given year can only be notified if the parcel receives subsidies during the following year. CBs also stated that irregularities concerning animal husbandry may not be notified as they cannot be linked to parcels in the system.

The audit team was informed that the NPA had deducted payments to six farmers in 2014 following the notification of results from CBs. However, this figure is much smaller than the total number of irregularities affecting the organic status of the product which were notified by CBs in their annual reports submitted to the CU. This indicates that results notified to the CU may differ from the results notified to the NPA. The CU does not directly notify the results to the NPA, and only the CBs do so. Therefore, the system in place in Bulgaria used by the CBs does not fully ensure that information on the results of inspections and visits is communicated to the NPA, contrary to Article 92 (6) of Regulation (EC) No 889/2008. International Accreditation Forum (IAF) decision, the implementation of the new standard was subject to a three-year transition period expiring in September 2015. 5 Conclusions on Competent Authorities, Control Authorities and Control Bodies

The system in place in Bulgaria does not fully ensure that information on the results of inspections and visits is communicated to the NPA. 5.2.1.1 Control Bodies: Approval, Supervision and Withdrawal Legal Requirements Article 5(2) and (3) of Regulation (EC) No 882/2004 Article 27(5) to (9) and (14) of Regulation (EC) No 834/2007 Article 92c of Regulation (EC) No 889/2008 Findings

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, Page: 1 s of Report ref. DG(SANTE)/2015-7357-MR of the audit carried out from 16 ems for organic production and labelling of organic products 2013 . . , 92 (6) 89/2008; 1 7 .

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However, although accreditation is a compulsory requirement for approval, the CU does not take into account the accreditation reports issued by Accreditation Bodies when carrying out the annual supervision to CBs, which is not in line with Article 92c(1) of Regulation (EC) No 889/2008. At the time of the audit, the CU had not requested any accreditation reports on the seven CBs whose headquarters are based in other MSs, nor 6 had the CU established cooperation arrangements for supervision with the CAs of those MSs. The CU requested the IABSA to provide, but had not received to date the reports on the four CBs whose headquarters are in Bulgaria (see paragraph 9).

However, the systematic shortcomings observed by the audit team, described in several sections of this report, were not noted by the CU, inter alia: CBs do not appear to have the infrastructure required and sufficient staff to adequately carry out their tasks. Timing and preparation of inspections are often not adequate Documented procedures used by CBs were very basic and checklists did not contain all relevant requirements or criteria to be checked during inspections; Risk analysis applied by both CBs did not serve as an adequate basis to determine the nature and frequency of visits; CB2 did not carry out adequate annual inspections to subcontracted operators. CB2 did not carry out any additional visits based on risk and the selection of operators for sampling was not risk-based in the majority of the cases. CBs did not immediately notify major non-compliances affecting the organic status of products, neither to the CU nor to other CBs. Such notifications take place with a great delay. Sampling procedures were not always adequate to ensure the reliability of the samples, and they were not always followed by inspectors; Inspectors systematically overlooked relevant requirements during the inspections. 7

The CU does not adequately assess the information received from CBs in their annual reports. For example, CB1 reported in 2014 that 26 samples tested positive for the presence of unauthorised PPPs, while CB2 reported no positive results. The audit team noted that 60% of the samples were taken by CB2 from the same product, and in most cases, not at operators with high risk profiles. Moreover, CB1 notified in the 2015 annual report a total number of irregularities three times higher than the number notified by CB2, which had not reported any major irregularities in at least the last three years. This obvious difference between the results of controls did not provoke any reaction from the CU.

Annual supervision is carried out by the CU on the delegated CBs. However, it is not adequate to verify the effectiveness of controls as it failed to identify and address the systematic severe shortcomings in the performance of the CBs.

Reports issued by Accreditation Bodies are not taken into account when the CU carries out supervision of CBs.

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,,". ,,", ,," , 92 (1) 89/2008. 2013 . Page: 2 s of Report ref. DG(SANTE)/2015-7357-MR of the audit carried out from 16 ems for organic production and labelling of organic products , ,,". 1 7 .

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The CU is responsible for the approval and withdrawal of CBs. Accreditation by an Accreditation Body is a prerequisite to obtain and maintain approval. CBs must be accredited to ISO/IEC 17065:2012. The validity of approval matches the period of validity of accreditation, and it is only extended by the CU if accreditation is renewed by the AB. The accreditation of two CBs to EN 45011 expired on 30 Sept 2014 and the CU extended the validity of the approval as the IABSA had also extended the validity of their accreditation to EN 45011 until 30 March 2015. The IABSA carried out an accreditation audit to both CBs in August 2014 and at the time of the audit, all four CBs were accredited in Bulgaria to ISO 17065. Approval shall be withdrawn if CBs are no longer accredited or if they cease to fulfil their obligations, in line with Article 27 (9) of Regulation (EC) No 834/2007. However, fines or any measures other than withdrawal of the approval are not foreseen, which in practice makes it difficult for the CU to impose effective measures on the CBs to correct any shortcoming detected during supervision.

The CU supervises the execution of delegated controls carried out by CBs. Supervision is carried out annually, covering all areas of the CBs activity, in line with EU provisions. Office audits with a duration of two-three days are carried out at the headquarters of the CBs. Documented procedures are checked as well as at least 1% of operator´s files. The CU also checks the background, training of inspectors and the absence of any conflict of interest. In addition, witness audits are carried out during two-three days to observe the performance of inspectors. When non-compliances are found, they are reported to the CB as well as deadlines for the CBs to implement corrective action. The audit team checked a number of supervision reports and noted that the CU had reported no shortcomings in 2014 as regards CB1 and only two and one shortcoming in 2015 as regards CB1 and CB2 respectively. The audit team noted that CB2 repeated the same shortcoming during the annual inspection carried out three months after the supervision had taken place, meaning that the CB was not implementing the adequate corrective action to remedy the situation.

Even when shortcomings are found in the performance of CBs, no effective corrective measures are in place to rectify the situation, as only withdrawal of approval, while foreseen, is not applied in practice, and other measures are not set out 5.2.2 Registration of Operators Legal Requirements Article 28(1), (2) and (5) of Council Regulation (EC) No 834/2007 Article 92(2) and 92b of Commission Regulation (EC) No 889/2008 Findings

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09-225 02.04.2015 . 19 11 . 01.04.2016 . ; 3 . 22, . 3 4 , . 3 . , ." 0/20.10.2015 . XII , , 0.10.2015 . 016 . Page: 3 s of Report ref. DG(SANTE)/2015-7357-MR of the audit carried out from 16 ems for organic production and labelling of organic products

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The CU is responsible for maintaining the list of operators subject to the control system, which is publicly available since 2012. Applications submitted by operators to notify 2 In their response to the draft report, the CA noted that "An amendment to the ZPOOPZPES was initiated by Order No RD-09-225 of 2 April 2015. The amended law was promulgated in the State Gazette (SG) No 19 of 11 March 2016 and will enter into force on 1 April 2016. The amended ZPOOPZPES introduces additional sanctions, which the CU may impose on CBs. The additional sanctions (including financial) are stipulated in Articles 22(3) and (4) and 64(3) of the ZPOOPZPES." 8 their activities are uploaded onto the list by the CU. The information on new operators subject to the control system is supplemented by CBs, who must also update any relevant changes affecting the organic status of the operators under their control. According to the National Regulation, the deadline for CBs to upload any such change is three days. However, the audit team noted several cases where this deadline was not met, which is not in line with Article 37(5) of the National Regulation. In addition, CBs do not alert the CU in case that they find any contradictory information on the list.

The audit team checked the list and noted that it shows the name and location of the operators, the CB controlling their activities and the organic status (organic or in conversion to organic production). The date when operators sign a contract is established as the starting date for the conversion period. The list may also include as an attachment the documentary evidence issued by CBs as well as Annexes with details on products and quantities certified, suppliers and clients. All relevant changes in the status of operators are kept in the system and can be easily tracked. However, at the time of the DG Health and Food Safety audit, documentary evidences were only available for a limited number of operators, not fulfilling the requirement of Article 92(b) of Regulation (EC) No 889/2008.

The CU publishes a list of registered operators and is responsible to keep it updated. The 9 lists keeps track all of relevant changes in the status of operators since the time of registration. However, the list does not include all updated documentary evidence and it is not always adequately updated in order to reflect changes in the organic status of operators.

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, 8, . 2 2013 . , 1 7 .

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When operators move CB, the relevant elements of the operators´ file and the reports referred to in the second subparagraph of Article 63(2) must be transferred from the previous CB to the subsequent CB. However, the audit team noted several cases where this relevant information was not transferred. This is not in line with Article 92 of Regulation (EC) No 889/2008. The change must also be notified to the CU by the CBs concerned. The CBs do not notify directly to the CU but by uploading the information on the operators onto the list instead. This approach was proved to be inadequate as the CU was unaware of the change. The audit team noted several cases when operators had signed a contract with a new CB without informing the original CB. As a result, the operator was officially under the control of two CBs in parallel during several months without the original CB or the CU being aware of it, even if the new CB had uploaded this information onto the list. This may allow for situations where non-compliant products decertified by one CB may still be marketed by using documentary evidence issued by the other CB.

The exchange of communication between CBs is not always adequate when operators move CB, and it is not ensured that the operator´s control file and the reports referred to in Article 63(2) of Regulation (EC) No 889/2008 are transferred from the previous CB to the subsequent CB. In addition, the notification of the changes made by CBs to the CU is not adequate as it cannot be ensured that the CU is aware of such change having taken place.

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,, ­ IV. . , Page: 4 s of Report ref. DG(SANTE)/2015-7357-MR of the audit carried out from 16 ems for organic production and labelling of organic products 18, . 2 2016 .

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Both CBs doubled the number of operators under their control in recent years. This huge increase was not accompanied by a proportionate readjustment in their resources, including staff, to carry out control and certification tasks. The ratio of inspections per inspector/year is very high, especially in certain periods in the year. The majority of operators in Bulgaria are plant producers, which narrows the timeframe to execute the inspections. As a result, a significant percentage of inspections are not carried out at the most suitable time, which renders these controls ineffective. This is not in line with Article 5(2)(b)(i) and (ii) of Regulation (EC) No 882/2004. The audit team noted several cases, including all the inspections witnessed at plant producers, when inspections had been planned after harvesting had already taken place and with no products in the 10 warehouses. In addition, CB1 does not necessarily plan visits to processors at the time when organic products are processed, with the exception of the first inspection for the approval of new operators. This is not in line with Article 27(3) of Regulation (EC) No 834/2007, which establishes that the nature of controls shall be determined based on an assessment of the risk of occurrence of irregularities and infringements as regards compliance with the requirements laid down in the same Regulation.

CBs do not necessarily require the operators to submit important compulsory information, such as on the precautionary measures, or do not adequately asses it. In addition, the number of staff available for certification and control tasks is very limited. As a result, the timing and preparation of the annual and additional visits are not always adequate, which strongly undermines the effectiveness of controls.

Medlemsstatens svar

,, 20.10.2015 . .

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CB2 does not carry out the same type of annual inspection to all operators. Subcontracted operators, which carry out important core activities such as production, are not subject to the same level of control from the CB as certified operators. The CB uses a different checklist and carries out only short inspections, with significant scope limitations, in comparison to those carried out on certified operators. The CB stated that they considered subcontracted operators less risky operators as they were under the internal control of the client to whom they sell their products. This is the approach followed by CBs when issuing certification to Producer Groups in developing countries, but in MSs this is not in line with Article 27(3) of Regulation (EC) No 834/2007, as the nature of these controls is not justified by any assessment of the risk of occurrence of irregularities as regards compliance. This is also not in line with Article 92(c)(2)(a) of Regulation (EC) No 889/2008, which establishes that the result of risk analysis shall provide the basis for determining the intensity of unannounced or announced annual inspections and visits. 11

Both CBs use risk analysis procedures to select the operators for additional visits and sampling. Several criteria are used, such as past irregularities, time in the control system, number and types of crops grown, multiple activities carried out, parallel production and processing of organic and conventional products. The criteria are put together in several groups, which may score a maximum of five points. The scoring of the different groups is aggregated, and according to the final score, operators are allocated into risk groups.

The audit team noted the following weaknesses in the risk analysis implemented by both CBs: Some operators such as small farmers who do not market, and small traders selling only pre-packed products, are not subject to risk assessment by CB2. This is not in line with Article 65(2) and 65(4) of Regulation (EC) No 889/2008, which establishes that the selection of the operators where samples have to be taken and the random control visits shall be based on the general evaluation of the risk of non-compliance with the organic production rules. Quantities produced are not taken into account, which is not in line with Article 65(4) of Regulation (EU) No 889/2008. Operators with major non-compliances in previous years may remain in lower risk categories as the maximum possible score for each group is five points, regardless of the severity and recurrence of the non-compliance. In addition, risk assessment is carried out by CB2 inspectors during the inspection and information obtained by other sources (e.g. results of samples taken during previous years) is not taken into account by the CB. This is not in line with Article 65(4) of Regulation (EC) No 889/2008. Several important criteria are put together in the same group and the individual weight of each criterion may not be taken sufficiently into account as the maximum possible score for the all the criteria together in the group is five points. Operators placed in the second lowest category by CB1 may be selected before operators placed in a higher risk category for additional visits or sampling.

At the time of the DG Health and Food Safety audit, less than 0.050% of operators under the control of CB1 and CB2 were classified in the highest risk category. The majority of operators were placed in the second lowest risk category by CB1 while CB2 only had two risk categories, meaning that more than 99,9% of operators were placed in the lowest risk category. The audit team observed a number of cases where operators with low risk profiles (e.g. small fully organic farmer with no past irregularities) were placed in the same risk category as operators with a high risk profile (e.g. large producer and processor of conventional and organic products with past irregularities). This means that the risk assessment carried out by both CBs is inadequate and does not allow for the determination of the nature and frequency of controls, which is not in line with Article 27(3) of Regulation (EC) No 834/2007. 12

Risk analysis as carried out by CBs does not serve as a good basis to determine the nature and frequency of the visits to operators. Compulsory requirements such as quantities or past records are not adequately taken into account, not all operators are subject to risk assessment and not all subcontracted activities subject to the same level of controls.

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2013 . ; . , Page: 5 s of Report ref. DG(SANTE)/2015-7357-MR of the audit carried out from 16 ems for organic production and labelling of organic products . ,, ,, , , ) () 834/2007; 1 7 .

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The inadequate timing may also be caused by insufficient knowledge of the operators to be visited. CB1 does not request the operators to submit information on all of their undertakings, but only on the parcels or units subject to organic certification. Precautionary measures, which are important prerequisites to comply with the organic production rules, are not required to be submitted to the CB either. This is not in line with Article 63(1) (a) and (d) of Regulation (EC) No 889/2008. As a result, the CB does not verify the description of the units and the precautionary measures. This is not in line with Article 63(2) of the same Regulation. CB1 had not noted that, for more than one year, one operator produced a particular variety of plant under both conventional and organic management, which is not permitted in EU Regulations. Most of inspectors from CB1 did not know basic aspects such as the risk category of the operators visited or the precautionary measures implemented by operators to reduce the risk of contamination.

CB2 receives from their operators the information referred to in Article 63(1) of Regulation (EC) No 889/2008. However, the audit team noted cases where it was not used adequately. As an example, the CB manager evaluated the information on the operator and signalled points of attention for the inspector to focus on during the inspection. The annual inspection was planned after both the organic and conventional plots had been harvested. This rendered the inspection ineffective. The inspector was requested to check that the organic operator had sold the harvest as conventional rather than focusing on the only risky point, which was the presence of a conventional neighbouring plot.

CBs do not necessarily require the operators to submit important compulsory information, such as on the precautionary measures, or do not adequately asses it. In addition, the number of staff available for certification and control tasks is very limited. As a result, the timing and preparation of the annual and additional visits are not always adequate, which strongly undermines the effectiveness of controls.

Medlemsstatens svar

20.10.2015 .

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CB1 carries out the additional visits primarily unannounced, which is in line with EU Regulations. However, the number of additional visits does not reach the minimum 10% of the total number of operators, which is not in line with Article 92c(2)(b) of Regulation (EC) No 889/2008. The total number of unannounced visits is also not reached, which is not in line with Article 92c(2)(c) of the same Regulation. Moreover, the audit team noted that most of the additional inspections carried out by CB1 in 2014 were concentrated in November and December. This undermines the effectiveness of the inspections as no relevant activity was carried out at that time in plant producers. CB2 could not provide any evidence that it carries out any additional visits based on risk, which was considered by the audit team as being the absence of a key control. In fact, the procedure for risk assessment had been implemented for the first time in 2014 and actually carried out by inspectors, meaning that all visits were planned before the categorization of operators took place. The audit checked a number of files claimed by the CB as relating to additional controls and noted that they were carried out to operators with low risk profile and by following a shortest report template. Moreover, the audit team noted that in several cases the inspection had taken place on the same day as the annual inspection. In other cases it was carried out to supplement the annual inspection. Furthermore, operators may be given a prior warning of 24 hours. All of this is not in line with Article 65(4) of Regulation (EC) No 889/2008. Conclusions on Planning and Prioritisation of Controls

The number of additional visits and unannounced visits does not meet the minimum requirements in EU Regulations. The selection of operators for additional visits and sampling is not always carried out risk-based. Moreover, additional visits are not primarily carried out unannounced in all cases and annual visits are always announced, which is not in line with EU Regulations. 13 5.2.4 Controls of Operators Legal Requirements Titles II and III of Regulation (EC) No 834/2007. Title II of Regulation (EC) No 889/2008. Title IV of Commission Regulation (EC) No 889/2008 Article 65 of Commission Regulation (EC) No 889/2008. Articles 8 and 9 of Regulation (EC) No 882/2004. Findings

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2013 . Page: 6 s of Report ref. DG(SANTE)/2015-7357-MR of the audit carried out from 16 ems for organic production and labelling of organic products 0% 10% ; ,, . , . , ". ,, . , , ­ ( ( ). . 1 7 13 . 20.10.2015 . .

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Both CBs have documented procedures to carry out controls. The main document used for the inspections is the report template, which also serves as a checklist for the inspectors. A copy of the report is given to operators, including the description of non- compliances and deadlines for the operators to apply corrective measures, which are followed-up by inspectors during the following inspection. However, the checklists used by the CBs did not provide the basis for assurance on the following important aspects as they failed to cover: Records showing the effectiveness of cleaning measures in facilities where parallel processing of conventional and organic foodstuffs take place, as required by Article 26 (4)(b)of Regulation (EC) No 834/2007. Records showing the results of verifications made on reception of organic foodstuffs, as required by Article 66(2) of Regulation (EC) No 889/2008. Operators did not keep such records and did not provide any evidence that they systematically checked the origin of products. This lack of verification was the root cause of at least one case notified from other MSs (see paragraph 97). Accounting documents showing the balance between input/output, as required by Article 66(2) of Regulation (EC) No 889/2008. No reference to the obligation of inspectors to physically inspect all conventional units run by the operator, as required by Article 66(3) of Regulation (EC) No 889/2008.

This lack of adequate documented procedures is also not in line with Article 27(6)(a) of Regulation (EC) No 834/2007, which establishes that the standard control procedure of CBs must contain a detailed description of the control measures and precautions that the body undertakes to impose on operators subject to its control.

Both CBs have documented procedures in place with the aim of ensuring consistency of controls. However, the level of detail is not adequate to provide inspectors with adequate guidance. Checklists do not include the verification of records showing the effectiveness of cleaning, the results of verification at reception and the balance between input/output. Operators are not required to keep such records and consequently, most operators do not keep them, thus not providing evidence that the relevant requirements have been complied with. In addition, units where non-organic products are produced or kept are not necessarily subject to the minimum control requirements.

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When records and accounting documents were available at the operators, inspectors did not adequately check them and other relevant requirements were often overlooked: CB1 inspectors signed and stamped the internal records checked and made a 14 reference in the report and attached a copy of these records to the report. One inspector from CB1 stated that he always stamps and signs on the records. This could be considered as a good audit practice as the performance of the inspectors can be traced back and subject to later evaluation. However, this inspector had not checked the records on the use of fertilizers and PPPs during the previous inspection, as there were no stamps or signatures on any of these. Furthermore, the control does not include checks on the official logbook filled by the official agricultural services. CB2 inspectors never leave a track of the documents checked, neither by leaving a mark on them nor by making a cross-reference in the report. In a large processor, the inspector could not document how he had calculated during the most recent annual inspection at that processor, the balance input-output for all the products processed since the previous inspection. The inspector claimed that the input of 279 tonnes of fruits had been validated only one day before the annual inspection at the processor at the wild collection area, based on estimation of harvest. The audit team checked the delivery notes and noted that all of the quantities had been delivered by one single person. The CB and the operator explained that compliance with the organic production rules is ensured by employing 16 seasonal workers who are given training and instructions to pick up the wild fruit. However, the audit team noted that each picker had collected around 300-400 kilos/day, which is unrealistic. The operator stated that these figures were not plausible and that he was aware that in practice a significant number of other pickers help in the collection and concluded that this activity was entirely out of their control. This lack of adequate verification of quantities harvested in wild collection areas could be the cause of the increasing number of irregularities notified from other MSs affecting wild collected products (see paragraph 95). The same inspector stated that he systematically verifies the records of own- checks carried out by the operator, even if no track of this verification is included in the report. However, the audit team noted that several samples taken by the operator and tested by accredited laboratories in July 2015 showed the presence of several unauthorised PPPs. The operator did not notify the positive results to the CB and the CB overlooked these results during the annual inspection carried out in September 2015. As a result, no measures were taken by the operator or by the CB to prevent the suspicious products from being marketed. This is not in line with Articles 91(1) and (2) of Regulation (EC) No 889/2008. No notification was made to the CU on the likelihood of non-compliance, which is not in line with Article 5(2)(e) of Regulation (EC) No 882/2004. Both CBs validate the quantities harvested by comparing the production declared with the estimations made by the operators. However, it remained unclear how plausibility checks, such as verification of the yield, were carried out by CBs. CBs do not use official yield data available on the website of the Ministry. The 15 data refers to conventional crops in the different regions of the country, and the CA accepts a variation of 20% in the yield when it comes to crops produced organically. In addition, only a small number of invoices for sales are usually checked, which is not representative of the total production/processing of the year. This is not in line with Article 66(2) of Regulation (EC) No 889/2008. In a small beekeeper, the CB2 inspector did not provide evidence that he had cross-checked the information on the map provided by the beekeeper during the annu

When such records or, any other document, such as maps showing the areas surrounding beehives are present, they are not adequately verified by inspectors to ensure compliance of operators with EU requirements. In addition, inspectors do not notice gross non- compliances regarding relevant requirements such as prohibited dehorning practices, inadequate husbandry and animal welfare conditions, proving such inspections to be ineffective. 5.2.5 Controls on Labelling and Traceability Legal Requirements Article 23 of Regulation (EC) No 834/2007. Article 23(1) of Regulation (EC) No 834/2007 Regulation. Title III of Commission Regulation (EC) No 889/2008. Article 27(13) of Council Regulation (EC) No 834/2007. Article 18 of Regulation (EC) No 178/2002 17 Findings Controls carried out by the CA.

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CBs approved in advance the labels used by operators. CBs receive and assess the format of the labels, which can only be used after the CB notify the operators. However, the audit team noted that in some cases, the labels used were not fully in line with the EU Regulations (e. g. blue logo used on a white background or letters difficult to read due to a transparent background). In two cases, products not satisfying the requirements of the EU Regulations bore labels including the term "bio" in the trademarks, which is not in line with Article 23(2) of Regulation (EC) No 834/2007.

CBs carry out labelling and traceability checks during inspections at operators. Checklists used by CBs contain a specific aide-memoir for labelling and traceability checks to be performed at operators. However, the audit team noted that checks were not always adequate: Inspectors did not request or did not adequately verify records on the identity checks to be performed by operators. This is not in line with Article 66 of Regulation (EC) 889/2008 which establishes that operators shall keep documentary records proving that they have performed identity checks on the purchased products to verify that the labels or invoices contain the information referred to in Article 33 of Regulation (EC) 889/2008. In several cases, operators did not keep records showing the results of verification of the raw materials purchased. Inspectors did not require the operators to keep identified at all times stored products, as required by Article 35 of Regulation (EC) No 889/2008. Neither did they require the operators to establish the links between different stages of processing, and therefore the balance between inputs and outputs could not always be fully validated for certain batches. This is not in line with Article 66(2) of Regulation (EC) No 889/2008.

Labelling and traceability controls are regularly performed by the CA and CBs. Controls carried out by the CA are overall adequate. However, controls by CBs are not always exhaustive. Inspectors do not either require the operators to keep records on the identity checks carried out or to keep the products identified at all times allowing for establishing the link between the processing steps. Nevertheless, the outcome of the traceability exercise carried out during the audit was satisfactory for the products selected. As regards labelling checks, CBs do not systematically verify that the approved labels are used on the final products and it cannot be ensured that labelling of the products complies with EU provisions. 5.2.6 Sampling and laboratory analysis Legal Requirements Article 65 (2) of Commission Regulation (EC) No 889/2008. Articles 5(2) and 12 of Regulation (EC) No 882/2004. Findings

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The selection of the operators by CB2 was not risk-based because there are only two operators in the highest risk category and the operators in the lower risk categories are randomly selected. The audit team noted several cases where samples were taken from operators with a low risk profile. In addition, around 60% of samples in 2014 and 40% in 2015 were taken from the same product, which is not representative of the activities controlled by the CB. This is not in line with Article 65(2) of Regulation (EC) 889/2008, which establishes that the selection of operators for sampling shall be based on the general evaluation of the risk of non-compliance with organic rules.

The audit team noted that in several cases, CB2 took a good number of samples at one processor on the same day and counted them as having been taken from the suppliers of the raw materials concerned. As a result of this practice, the total number of samples was artificially increased by 50% in 2014 and 2015. Without this practice, the CB did not reach the minimum number of samples required. In addition, six out of 11 CBs reported to the CA that they had taken during 2014 a number of samples which did not reach the minimum required, with two CBs not taking any sample at all. This is not in 20 line with Article 65(2) of Regulation (EC) No 889/2004, which establishes that the number of samples to be taken and analysed by CBs every year shall correspond to at least 5 % of the number of operators under its control. The insufficient number of controls (in the case of two CBs the absence of controls) raise concerns, as such controls are required in order to mitigate significant risks.

Not all CBs reach the minimum number of samples to be taken for the analysis of substances not authorised in organic production.

It cannot be ensured that the selection of the operators to be sampled is risk-based, that the quantities sent to the laboratories are sufficient and that samples are preserved, at least in the case of perishable products for the detection of PPPs. These deficiencies undermine the reliability of results. 5.2.7 Exceptional production rules and other derogations. Legal Requirements Article 29 of Regulation (EC) No 889/2008 and Annex IX of the same Regulation. Sections 2 to 4 of Chapter 6 of Title II of Regulation (EC) No 889/2008 Article 22(2) of Regulation (EC) No 834/2007. Findings

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Both CBs have sampling instructions to serve as guidance to inspectors on how samples should be collected and transported to laboratories. Instructions by CB2 refer to the fulfilment of the requirements of Directive 2002/63/EC, which establishes the methodology to be followed for the testing of PPPs, including quantities to be sent to the laboratory for each type of product and conditions for the preservation of samples. However, the audit team checked several files and noted that the CB often did not follow its own procedure. Samples were sent to laboratories in quantities smaller than indicated in the Directive. In addition, samples were not preserved, which is not in line with Section 4.6 of the Annex of the Directive 2002/63/EC. This can render these checks ineffective.

Instructions issued by CB1 specify the equipment to be used and also the techniques to ensure the representativeness of the sample. The instructions do not require that the samples of perishable products are kept cool when delivered to the laboratories, which is not in line with Section 4.6 of the Annex of Directive 2002/63/EC. The audit team observed the procedure for taking samples followed by CB1. The inspector stated that a cooling box is used to transport the samples to the headquarters of the CB. However, the sample had to be sent to a laboratory in another MS and the CB does not use specific containers to preserve the sample cooled. In addition, the inspector used a plastic jar provided by the farmer to take the sample of the product, not following the CB´s sampling procedure.

It cannot be ensured that the selection of the operators to be sampled is risk-based, that the quantities sent to the laboratories are sufficient and that samples are preserved, at least in the case of perishable products for the detection of PPPs. These deficiencies undermine the reliability of results. 5.2.7 Exceptional production rules and other derogations. Legal Requirements Article 29 of Regulation (EC) No 889/2008 and Annex IX of the same Regulation. Sections 2 to 4 of Chapter 6 of Title II of Regulation (EC) No 889/2008 Article 22(2) of Regulation (EC) No 834/2007. Findings

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Laboratories are not designated by the CU in advance and during the supervision of CBs, the CU does not check that laboratories have the appropriate scope to carry out the tests requested by CBs. The CU argued that the only requirement established in Article 5(2) of Regulation (EC) No 882/2004 is that laboratories used by CBs operate in accordance with the standards referred to in Article 12(2) of the same Regulation (ISO 17025). However, the same Article also establishes that these laboratories may only be designated by the CU if they operate and are assessed and accredited to that standard. In addition, Article 12(3) establishes that such accreditation and assessment may relate to individual tests or groups of tests, which is not cross-checked by the CU.

As the CU does not designate the laboratories analysing official samples, it does not notify them to the National Reference Laboratory, thus not ensuring that the laboratories take part in the proficiency tests organised at national level, as indicated in Article 33(2)(c) of Regulation (EC) No 882/2004.

CBs have sampling programmes in place for the detection of substances not authorised in organic production. Action is taken by CBs in all cases where analytical results show any presence of unauthorised substance. Laboratories used are accredited to ISO 17025. However, laboratories are not designated by the CU, who does not check during supervision whether the analytical scope of the laboratories used by CBs is adequate. In addition, it is not ensured that laboratories carrying out official controls take part on the proficiency tests organised by the National Reference laboratory.

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2013 . , , 2, 1 2 () 004 1 13 .

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CB1 only requests the laboratories to use multi-residues methods. This is not adequate as some PPPs commonly used in the EU (for example Glyphosate and Chlormequat) can 21 only be detected by using methods that are specific for the relevant PPP. The sample sheet used by CB2 caters for other PPPs but Glyphosate is not included either. The delegation of tasks to CBs does not describe who is responsible to decide on the range of PPPs to be tested, taking into account relevant information available. This is not in line with Article 5(2) of Regulation (EC) No 882/2004.

Both CBs use laboratories accredited to ISO Guide 17025, which establishes the general requirements for the sampling and calibrating laboratories. The audit team checked several laboratory results and noted that the scope of the laboratories was adequate for the methods used and substances tested. However, CB2 does not systematically check that the scope of the chosen laboratory is appropriate. The audit team noted that CB2 kept an old version of the accreditation certificate of the laboratory often used by the CB. The audit team also noted that in one case, the results submitted by the laboratory referred to physical-chemical analysis, which had not been requested. This was not noted by the CB and the result was filed with no further action by the CB.

In addition, the delegation of tasks to CBs does not define who is responsible to decide on the minimum range of products to be tested. As a result, the CBs do not request 22 laboratories to test PPPs which are commonly used in the EU.

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According to the National Regulation, the CU has the competence to grant derogations, except derogations on the use of conventional seeds and propagating material, which had been delegated to CBs, in line with EU Regulations. The National Regulation also includes provisions for certain derogations which, although not granted in recent years, are not in line with, or already phased out in EU Regulations. For example, CBs may grant derogations for the renewal of herds and flocks and for the introduction of non- organic female mammals, which is not in line with Article 42 of Regulation (EC) No 889/2008. The National Regulation also foresees the possibility to grant derogations on housing conditions and stocking densities, already phased out in EU Regulations since 31 December 2013.

All derogations granted by CBs concerned the use of conventional seeds. When examining applications submitted, CBs must check whether operators justify the use of the conventional seed and also prove that no organic seed was available at that time in the market. At the time of the DG Health and Food Safety audit, there were eight organic suppliers registered in the seed database to supply organic seed and other 23 propagating material (see paragraph 105). The audit team noted that in several cases, operators had used a conventional seed without applying for a derogation, contrary to Article 45(6) of Regulation (EC) No 889/2008. The audit team also noted that some derogations were granted in 2014 by CBs without operators providing any evidence that the same variety of the organic seed was not available. The CU and the CBs stated that the seed database was not operative at that time. However, operators did not either provide any evidence that there were no suppliers able to deliver the organic seed, which is not in line with Article 45(5)(b) of Regulation (EC) No 889/2008.

The National Regulation establishes the derogations and exceptions to organic rules to be granted by the CU and CBs. It also includes provisions for certain derogations which, although not granted in recent years, are not in line with, or already phased out in EU Regulations.

The CU correctly grant derogations for the applications received. However, it cannot be ensured that operators use conventional seeds only after a derogation is granted by CBs. Moreover, CBs often do not request operators to prove the unavailability in the market of the same organic variety.

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In cases where operators apply any exceptional rule, CBs must check whether they have been granted any derogation in advance, and also whether the derogation is adequately applied (e.g. to use only conventional seeds not treated with PPPs). However, the audit team noted that, in some cases, the inspectors were not aware of any derogation having been granted and did not adequately check whether operators apply any exceptional rule (see last bullet point in paragraph 48 related to systematic dehorning in a dairy farm). Conclusions on Exceptional Production Rules and Other Derogations

CBs do not adequately check that operators applying any exceptional rule have been authorised in advance, and do not check the conditions under which the rules are 24 implemented in practice. 5.2.8 Imports of Products from Organic Production Legal Requirements Article 33 of Regulation (EC) No 834/2007. Chapter 3 of Title III of Regulation (EC) No 1235/2008. Annexes II, III, V and VI of Regulation (EC) No 1235/2008. Findings

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The CU has adopted and notified to CBs a catalogue of enforcement measures to be applied in cases of non-compliances, in line with Article 92(d) of Regulation (EC) No 889/2008, although its adoption was late3. The measures are contained in Annex III to the National Regulation.4 The measures range from a simple remark or warning to total withdrawal of the operators from the system, depending on the severity of the non- compliance. However, most of the measures foreseen are not adequate to ensure compliance of operators with organic requirements. For the following non-compliances, operators will only receive warnings with no suspension of the certification, even if no corrective action is taken: Parallel conventional and organic production of the same variety of plant or of the same animal species, if conventional and organic productions were kept separately; No records at all are kept by plant producers during two consecutive years; Use of conventional seeds without prior authorisation when the same variety was available in organic form; Use of large quantities of unauthorised conventional feed; Dehorning of animals during three consecutive years without prior authorisation by the CU and without anaesthesia; Non respect of conversion period for animals exceeding the maximum number of treatments by chemically synthesised allopathic medicines; Severe infringement regarding outdoor space and housing conditions; Use of non-organic ingredients other than those authorised in Annex IX to Regulation (EC) No 889/2008 even if the same organic ingredient was available. 3 The catalogue became effective only in August 2014 as compared to the EU Requirement (1 January 2014). 4 In their response to the draft report, the CA noted that " The CU has initiated a procedure to amend the Regulation, and more specifically the catalogue of sanctions imposed for the different types of infringements." 26

The sanction catalogue does not adequately take into account the repetition of non- compliances, and for some of them (for example dehorning without prior authorisation) operators may receive a "remark" the first year, a "corrective instruction" the second and a "warning" the third. After 24 months with no repetition of the irregularity, past records are disregarded. No monetary sanctions are foreseen, even in cases where no corrective action may be taken (for example when non-compliant product has already been sold as organic and it cannot be recalled from the market).This is not in line with Article 55(1) of Regulation (EC) No 882/2004, which establishes that measures must be proportionate and dissuasive.

CBs follow the national sanction catalogue. For the non-compliances noted by the audit team during the visits at operators (see bullet points in paragraph 48) CB1 only reported remarks to the operators concerned and the certification was granted in all cases with no need of corrective measures to be applied by the operators. The CB stated that the non- compliance would be followed-up during the annual inspection in 2016.

One of the few measures found to have consequences for the operators´ certification were those applied by CB1 concerning the use of unauthorised PPPs (see paragraph 71). However, the sanction catalogue only foresees the prohibition of operators from marketing any organic products for short periods (up to 12 months) if they are found to use unauthorised substances during several consecutive years.

The CU has adopted and notified to CBs a catalogue of infringements and corresponding measures to be applied by CBs. However, most of the measures applied are neither dissuasive nor proportionate, and therefore ineffective to ensure compliance of the 28 operators with organic requirements.

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3 . , (1) () 882/2004. : 1 7 2013 .

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CBs notify the CU of the irregularities found during the year by means of their annual report. The national legislation does not require CBs to notify the risk or suspicion of non-compliance as they occur. Major irregularities affecting the organic status of the product are not immediately notified, either to the CU or to other CBs. In fact, the standards procedures of CB2 envisaged such notifications "if necessary". This is not in line with Article 30(2) of Regulation (EC) No 834/2007. The audit team noted that there are no documented procedures to ensure this exchange of communication to happen, which is not in line with Article 92(5) of Regulation 889/2008. The audit team noted that, during 2015, CB1 had already taken 35 samples which showed presence of unauthorised substances and the CU was unaware of this. The consequence of this lack of immediate notification is that the CU does not have an adequate overview of the state of compliance in the country and cannot take appropriate action to prevent non- compliant products being marketed as organic. Moreover, the CU cannot supervise the effectiveness of the actions taken by CBs. Follow-up of irregularities by other MSs.

The CU has not established documented procedures to ensure the communication of irregularities between CBs and the CU and among CBs, and irregularities affecting the organic status of the products are not immediately notified. As a result, the CU cannot take adequate action to either prevent non-compliant products being marketed or to follow-up the accuracy of the actions taken by CBs.

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,, ", 09-696/08.10.2015 . age: 13 s of Report ref. DG(SANTE)/2015-7357-MR of the audit carried out from 16 ems for organic production and labelling of organic products s of Report ref. DG(SANTE)/2015-7357-MR of the audit carried out from 16 ems for organic production and labelling of organic products

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However, the audit team noted that follow-up was not carried out to operators at all stages of production and that not all necessary documents were submitted. For example, in one of the cases observed, the actions focused exclusively on the exporter, who had only relabelled the final product. The CB visited neither the wild collection area nor the processor involved and the documents submitted did not include cleaning records from the day when the notified batch was processed. In another case, the CB had correctly determined the reason which caused the irregularity but the corrective action taken was not adequate. The operator had accepted certain raw material without adequately checking its organic origin and the supplier was not certified to sell the product. The measure proposed by the CB (to take samples from new suppliers) was inadequate as it did not tackle the root-cause of the non-compliance (inadequate identity and documentary check at reception).

The role of the CU was found by the audit team to be insufficiently active. According to the National Regulation, the CU may also carry out inspections to operators on its own initiative, but to date no such inspections have been carried out, even in cases where the same operator had been involved in several OFIS notifications. The CA waits for the CBs to submit information on the measures taken by CBs, but there is a lack of evaluation by the CU of the effectiveness of such measures. In addition, it normally takes more than 30 days for the CA to send a reply in OFIS, which is not in line with is not in line with Article 92(a)4 or Regulation (EC) No 889/2008.

OFIS cases are not always adequately followed up and the CU does not sufficiently evaluate the actions taken by CBs. In addition, the CU does not usually meet the 30 days deadline to reply in OFIS.

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1 7 013 . , ,, , .18, . 2 , ". . 64, . 3 (: 1 2016) ,, OFIS rganic farming information system), . (: 16) , , FIS , . , . . (: 1 7 2013 .) ge: 15 s of Report ref. DG(SANTE)/2015-7357-MR of the audit carried out from 16 ems for organic production and labelling of organic products

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The controls at the entry and exit BIPs on transits of non-EU goods comply with the EU requirements and provide guarantees that only eligible goods are accepted into the EU and they always leave the territory. The controls at the warehouse are weakened by the poor checks on traceability and the inadequate physical checks of the goods.

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plemented in In April and July were held meetings with representatives of Defence sion Logistics Agency (the responsible Agency for NATO's bases delivery of the consignments), USA Embassy in Bulgaria and the national Competent Authority (CA), i.e. BFSA. After the meeting in April the military bases (Romania) and Novo Selo were entered into TRACES and the issuing the CVEDs are done by the system. By the end of 2015 the BFSA is planning to organize training for official veterinarians who are engaged with the control of the custom warehouse in relation to receiving of non-complaint consignments, keeping records and TRACES usage in relation to Art. 6, letter a) of Regulation 882/2004. By the end of October 2015 will be drawn up and approved procedures for: ·performance of identification checks and acceptance of non-complaint consignments under custom control, according to requirements laid down in Decision 2000/571/EC; ·disposal of non-complaint consignments according to requirements laid down in Art.17of Directive 97/78/EC. In 2016 in Verification plan according to Art.8 (3) of Regulation 882/2004 the custom warehouse is going to be checked every quarter.

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The competent authority was unaware of the requirement to control EU goods re-entering from external transits, and controls are not done. Consignments that should not have been allowed re-entry to the Union were not rejected, even though they did not fulfil the animal health requirements, which may pose an animal health risk in the EU. 9

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entering the By the end of October 2015 will be drawn up and approved procedure ensure that only for performance of checks of consignments coming from European erritory as Union, which are re-entering the Union after transition via third 9/662/EEC and countries in order to ensure that only eligible consignments will be introduced into the Union. By the end of December 2015 BFSA is going to organize training for official veterinarians in BIPs how to perform checks in case of external transit for the purposes of the official control according to requirements laid down in Council Directive 89/662/EEA and Page: 1 o the recommendations of Report ref. DG(SANTE)/2015-7430-MR of the Audit carried out from 26 to 30 rols on consignments in transit Council Directive 90/425/EEA.

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Currently there are no national guides to good hygiene practice for the control of hazards in primary production of FNAO in Bulgaria. The CA didn't provide evidence that the development of such guides is encouraged.

The development of national guides to good practice is not encouraged as required by Article 7 and Annex 1 to Regulation (EC) No 852/2004.

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tage there are not drafted national guidelines for practices related to microbiological s of food of non-animal origin, as required by Article 7 of Regulation (EC) 852/2004

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The two inspectors checked the documentation of the company, including test results of water analysis (twice a year), results of testing the hygiene of the equipment and rooms, cleaning and disinfection using swab tests (twice a year), pest control, labelling and traceability. Personal health records of the staff were also checked.

The official control system in place for establishments selling seeds intended for sprouting or producing sprouts is not effective to ensure that seeds intended for sprouting are fit for purpose. 10 5.2.5 Official Sampling Procedures Legal Requirements Article 11 of Regulation (EC) No 882/2004 and Regulation (EC) No 2073/2005 Findings

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self-controls of the plants are under bring them in compliance with relevant requirements of Regulation (EC) No 2073/2005 and Regulation (EC) No 209/2013. Respective monitoring is already updated, including the mandatory requirement for laboratory analysis in respect of sprouts and seeds for sprouting.

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The information regarding accreditation of the laboratory and the method used for STEC were not available on the certificates provided. There was no indication that the seeds were intended for sprouting.

The official control system in place for establishments selling seeds intended for sprouting or producing sprouts is not effective to ensure that seeds intended for sprouting are fit for purpose. 10 5.2.5 Official Sampling Procedures Legal Requirements Article 11 of Regulation (EC) No 882/2004 and Regulation (EC) No 2073/2005 Findings

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this stage /currently/ there are sufficient proofs saying that the seeds obtained are for production of sprouts, are suitable for the production of sprouts. When performing their planned inspections, respective official inspectors will require to be presented the analytical results based on the Page: 1 Report ref. DG(SANTE)/2015-7457-MR of the Audit carried out from 17 imary production of food of non-animal origin riptive instructions' delivered to ensure testing of ing seeds. planned to have appropriate training performed for the rs engaged in official controls related to germs and for germinating (sprouting).

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Controls by the PPCD on farms are risk-based. The audit team was informed that at the time of the audit the risk-assessment was mainly based on the use of pesticides.

Risks of microbiological contamination in primary production were not included in the risk analysis at the time of the audit. This may compromise the ability of the CA to verify compliance with the food law due to inappropriate practices during the growing and harvesting stages. 5.2.4 Implementation of Official controls over FBO's obligations Legal requirements Article 10(2)(b)(i), Article 10(2)(c), Article 10(2)(d) and Article 15(1) of Regulation (EC) No 882/2004, Article 4(1), Article 7, Article 8 and Part B of Annex I of Regulation (EC) 7 No 852/2004, Article 18 of Regulation (EC) No 178/2002, Article 3 of Regulation (EU) No 208/2013, Regulation (EU) No 211/2013, and Annex I of Regulation (EC) No 2073/2005 Findings Cultivation

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fter entry into force (on 25-th February 2015) of the Procedure for performing official controls on general visions for hygiene of primary production of plants and ant products to eliminate contaminants", this type of l is also included as requirement for fulfilment of plans for control on usage of plant protection ts by agriculture producers. ining agriculture holdings /farms/ that are to be t to respective inspection is done after relevant risk es on microbiological contamination within primary tion. This risk analysis is done on the basis of fying appropriate indicators to identify specific farm s related risk of microbiological contamination. t to priority inspections are those farms that have been fied as such of high or medium microbiological ination risk levels. eveloped, Annual Plans for controls during the next ar year usually include priorities for inspecting the identified as more risky both on the basis of risk is concerning their usage of plant protection products imary production and the risk analysis concerning Page: 2 Report ref. DG(SANTE)/2015-7457-MR of the Audit carried out from 17 imary production of food of non-animal origin microbiological contamination.

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s, both A work and action plan (WAP) has been elaborated with the f Article objective to establish a computerized sampling system for both, official and "own/private" samples. The system is designed to sting and ensure and verify the integrity of the samples throughout the nipulation whole process, including the IT processing of laboratory results with the view to avoid manipulations of the process. In addition, the computerized system "raw milk of cows" will just be an "add-on module" to the existing VETIS database operated by the Bulgarian Food Safety Agency, holding all relevant data on the farms, animals and movement control.

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All three establishments visited by the FVO audit team have developed procedures for raw milk checks as laid down in Regulation (EC) No 853/2004. The FBOs could document all their own checks carried out in relation to raw milk supply. Nevertheless the results provided were implausible (See paragraph 40 - 42) and official controls had not identified evidence that samples submitted to the laboratories had been manipulated. 5.2.2 Traceability, labelling and identification marking Legal requirements Article 18 of Regulation (EC) No 178/2002. Article 4(6) of Regulation (EC) No 854/2004. Article 5 and Annex II, Section I to Regulation (EC) No 853/2004. Article 4(6) of Regulation (EC) No 854/2004. Regulation (EC) No 1169/2011. Article 4 of Commission Decision 2009/861/EC. Findings

Some of the results of raw milk analysis of samples taken on the holding visited were shown to the FVO audit team. For the reasons given in paragraphs 40 ­ 42 below, these cannot be considered plausible. Conclusions on Official Controls over Food Business Operator's compliance

Official controls on milk processing establishments are well organised and are risk- based and documented. While reasonable levels of compliance were observed in two of the three establishments visited, some deficiencies were detected indicating that controls were not fully effective.

Official controls were not effective in identifying the evidence that samples submitted to the laboratories had been manipulated. 5.3 SAMPLING AND ANALYSIS OF RAW MILK (SOMATIC CELL COUNT AND TOTAL PLATE COUNT) 5.3.1 Control of raw milk upon collection Legal requirements Article 8 and Annex IV to Regulation (EC) No 854/2004. Findings

The laboratories visited could provide the results for all the samples delivered to them and these were evaluated by the FVO audit team. For the reasons mentioned below, the results were not credible. Only one laboratory provided credible results. While this had been identified in a number of laboratories, only one (NRL) had documented these anomalies. However, no follow-up action had been taken by the official services and official controls had not detected problems with the lack of credibility of analysis results.

The results of the tests carried out in different public or private laboratories differed very significantly, with some public laboratories identifying high or very high numbers of unsatisfactory results, while the private laboratories identified hardly any non- compliance even when performing a high number of analyses including in the same geographical areas. The range went from zero to 30% for TPC and SCC.

In a high proportion of cases raw milk samples taken by an official or the FBO at holding level had been manipulated. They had been diluted before being submitted for analysis: this was evident when the values for fat content and/or freezing point were taken into consideration. For example, many examples were seen where the fat content was lower than 1%. This was also the case for official samples taken in the framework of the process for the classification of holdings. As a consequence the results for TPC and SCC were deemed satisfactory whereas, in reality, they would have been unsatisfactory if they had not been diluted prior to analysis.

When subjected to statistical analysis, it was found that the results of samples collected by specific FBOs on different holdings were lower than or approaching the limits of repeatability of the methods (for example 6,6 % at a level 140 000 cells where the acceptable variation limit was 10 % when analysing the same samples twice). Usually, results showing 50% to 90% (depending of the level of TPC or SCC) of variation are expected with such microbiological reference methods. This was the case for one laboratory, in particular, where a high number of analyses had been carried out. In such cases, it cannot be excluded that the sampling supposed to come from different holdings came from one single holding or that "standardised" samples had been prepared for submission for laboratory analysis. This suspicion is reinforced by implausible interval between collection of samples from different holdings (see paragraph 32 above).

Samples submitted for laboratory analysis for SCC and TPC showed evidence of having been manipulated in order to obtain satisfactory results. Contributing factors are the lack of standard procedures for collection of samples by FBOs and the absence of official controls on sample collection. The integrity of samples as required by Article

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loping The WAP takes also into account strengthening of testing raw nces and by milk on inhibitory substances in line with the official re- assessment of the milk testing laboratories including the organisation of inter-laboratory ring tests.

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All four laboratories visited during the FVO audit were accredited for the analysis carried out. Nevertheless one of the laboratories visited was accredited for the reference method (ISO 13336-1) but was using an automated variance of this reference method without any internal or external validation having been carried out.

The analytical performance of laboratories is assessed by inter-laboratories tests (Ring tests) organised by the NRL for Total Plate Count (TPC), Somatic Cell Count (SCC) and residues analysis for inhibitors. It is compulsory for the public laboratories to take part in these ring tests and all private laboratories are invited to participate. Most private laboratories do so and the four laboratories visited by the FVO audit team had participated on a regular basis or at least partially (one laboratory had not participated in 9 the ring test in relation to SCC). Ring tests are not performed sufficiently frequently to allow a reliable assessment of the performance of laboratories. In addition, no reliable controls or reference materials are used to check the accuracy and stability of results at laboratory and national levels.

Concerning inhibitors, the Bulgarian standard method was used in all laboratories visited, but its application varied between laboratories, in particular, concerning the cut off (time or acidity range) between compliant and non-compliant results. More generally, it should be noted that this method is insufficient to detect certain categories of inhibitors. This was confirmed in an evaluation carried out by the NRL and this could 10 also explain the almost complete absence of the detection of inhibitors in official and own check samples. Conclusions on Sampling and Analysis of Raw Milk (Somatic Cell Count and Total Plate Count):

The method in place for detecting inhibitors is not suitable for detecting certain categories of inhibitors which has the potential to allow non-compliant milk to enter the food chain. The number and range of laboratory ring test organised by the NRL is insufficient to provide assurance of adequate performance by laboratories.

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l purposes, As initial step the analyses are performed only in two already f accredited laboratories, the NRL Sofia and the regional laboratory tion as of the BG FSA in Haskovo. or As indicated under 2.) above all laboratories currently involved in testing of raw milk will be re-assessed taking into consideration the testing equipment available, the test methods and the quality management practiced in the laboratory. A new list of accredited laboratories will be issued in accordance with the implementation schedule of the WAP.

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The new procedure foresees setting of measurable objectives for the official import controls and indicators linked to these objectives, however at the time of the audit the strategic objectives were not developed into operational objectives. The procedure uses the verification of compliance as the basis for verification of effectiveness, and highlights the difference between the two concepts. However both concepts get mixed later in the document.

The objectives of the audit activities on official import controls are to assess the activities and their compliance with the relevant procedures. This includes an evaluation of the appropriateness of the official import controls when a shortcoming in the implementation of these controls is identified. In such a case the audit team is conducting root-cause analysis to determine if the procedure needs to be improved.

The competent authority is developing the activities for verification of effectiveness but has not yet set the relevant indicators to measure the extent to which the objectives are met. Currently the verification activities assess the appropriateness of the official import controls only when a shortcoming in the implementation of the controls is identified.

In both BIPs visited there is cooperation with Customs in respect of Customs nomenclature codes (CN codes) that do not specify the type of commodity. The heads of the BIPs hold regular meetings with Customs officials. A central supervision conducted in October 2013 in both BIPs recommended that these meetings should be documented. These meetings are documented in BIP Gjueshevo but not in BIP Kapetan Andreevo.

The new procedure specifies the measures to ensure that all consignments subject to veterinary checks are identified and presented to the BIP in line with requirements of Article 3 of Directive 97/78/EC and Article 2(1) of Regulation (EC) No 136/2004. The supervision at local level in BIP Kapetan Andreevo assesses the pre-notifications without following the checklist annexed to the new procedure and the relevant instruction for checking a percentage of CVEDs. In BIP Gjueshevo the supervision assesses the pre-notifications following the checklist and relevant instruction.

The heads of both BIPs visited were aware of how the Customs database flags the consignments, but they did not use all intelligence available (Customs documents and data), contrary to the requirement of Article 6 of Regulation 136/2004 to cross check that no import of a consignment violates the requirements of Article 4(1) of Directive 91/496/EEC and Article 3 of Directive 97/78/EC. The verification activities had not identified this shortcoming either at local (supervision) level or at central (supervision, audit) level. 5.2.2 Veterinary checks

The new procedure for the verification of effectiveness has instructions on what percentage of CVEDs should be evaluated. The heads of the BIPs are not following the instruction to select specific amounts of CVEDs to assess performance of official veterinarians. The supervisors stated that they fill the supervision checklist using the previous knowledge they have on each veterinarian's performance.

The local supervision focuses on the performance of the official veterinarians. Having no overview of the official import controls, the supervision does not detect errors by the persons responsible for the loads (pre-notification) or other BIPs and local veterinary units (LVUs) (related to follow-up of the consignments).

The audit team discussed with the competent authority several shortcomings that were not identified by the verification activities of the competent authority (see also finding 27): · First page of CVEDs not complete, or incorrect but were accepted (e.g. Article 12 warehouse accepted CVED from Burgas with an incorrect approval number), contrary to the requirements 2(e) and (h) of Annex 1 to Regulation (EC) No 136/2004 · BIP Bregovo issued CVED for a Customs warehouse, not approved under Article 12 that led to a wrong documentary check and a wrong decision contrary to the requirements of Article 13(1) of Directive 97/78/EC · In BIP Gjueshevo the officials do not unload the consignments for a physical check, contrary to the requirement of Annex III to Directive 97/78/EC. In addition, samples for laboratory testing are taken without unloading the consignment, therefore the sample is not representative of the load contrary to the requirements of Annex III to Directive 97/78/EC. The new procedure for verification of effectiveness and the checklist annexed to it do not specify the evaluation of this aspect of sampling. · In BIP Kapetan Andreevo, a case in which a consignment of pet animals (dogs) was accepted indicated a physical check in TRACES without checking all animals (one of the animals had a different microchip number than the one indicated in the CVEDA). This is not in compliance with the requirement of Article 4(4) of Directive 97/78/EC. The issue was not identified by the verification activities but notified to DG SANCO by the competent authority from the Member State of destination. 5.2.3 Controls of transit/non-EU complying consignments

Root cause analysis of the internal audit concluded that major shortcomings identified are due to the warehouse being approved and starting activities under Article 12 without ensuring availability of procedures. In addition the knowledge of the official veterinarians on their tasks relating to requirements of import legislation had not been updated. The competent authority stated that since the approval of the warehouse no written instruction was provided to the official veterinarians until the time of the internal audit in November 2013. The internal audit report recommended provision of training and documented procedures to the official veterinarians by the end of February 2014. At the time of the audit the competent authority had not implemented the actions planned to address the recommendations contrary to the requirement of Article 8(3)(b) of Regulation (EC) No 882/2004. 6

In February 2014 the competent authority conducted an unannounced supervision of the warehouse, using a new checklist that will be incorporated into the procedure referred to in finding 2. In this supervision improvements after the 2013 internal audit were confirmed and some shortcomings were identified. The competent authority stated that the checklist is at a draft stage and under review so that it can be used for both supervision from central and local level. The supervision identified the non-confirmation of exit transit in BIP Kapetan Andreevo. However no recommendation was issued and no action plan was implemented contrary to the requirement of Article 8(3)(b) of Regulation (EC) No 882/2004 (the head of the BIP was not aware of the issue when this was raised during the audit).

The competent authority does not register in TRACES CVEDs for non-complying consignments intended for other warehouses in different Member States, contrary to the requirement of Article 3(2) of Decision No 2004/292/EC.

A local supervision procedure on the warehouse was launched by the LVU in December 2013. This is not related to the procedure described in findings 2-5. This supervision has not identified major shortcomings. The officials performing the supervision are not kept up-to-date relating to official import control requirements, although this was recommended by a relevant internal audit (finding 23). This reduces the capability to identify shortcomings in the operation of the warehouse. The competent authority performed a reconciliation test for quantities of commodities handled in which they used the information in TRACES. The conclusion was that commodities examined had ensured traceability. However the audit team noted that there were cases of non-complying consignments sent to another Member State without registering of the movement in TRACES. This renders TRACES unable to be used for reconciliation activities.

The audit team identified several shortcomings that were not identified by the verification activities of the competent authorities: · Several cases of exit transit not being confirmed in Kapetan Andreevo, contrary to the requirements of Article 11(2)(d) of Directive No 97/78/EC. · For the warehouse approved under Article 12 of Directive 97/78/EC, at least four different names are mentioned in CVEDs. The address for the warehouse has at least two different addresses. This is not in line with the requirement 2(h) of Annex 1 to Regulation (EC) No 136/2004. · The competent authority accepts CVEDs with wrong warehouse registration numbers (for the same warehouse different registration numbers are used, only one being correct). This is not in line with the requirement 2(e and h) of Annex 1 to Regulation (EC) No 136/2004. · CVEDs accompanying consignments exiting the warehouse, indicated in box 37 details of a destination in a third country. This is incorrect and does not comply with Annex III to Regulation (EC) No 136/2004. · CVEDs issued in the warehouse indicated seal checks. This is not possible in the case of consignments that are imported to the warehouse and then split (issuing subsequent CVEDs) and it is not in line with the requirement of Annex III to Regulation (EC) No 136/2004. 7 Conclusion on the implementation of the verification activities

The verification activities largely ensure compliance, of the official import controls, with legal requirements and planned arrangements. For some areas the identification of non-compliances is limited by (i) incomplete scope of the verification (e.g. sampling activities are not covered), (ii) lack of implementation (e.g. there are no cross-checks with the Customs database), and (iii) limited awareness of responsible staff (e.g. the supervision of the warehouse approved under Art. 12 of Directive 97/78/EC).

The outcome of supervision is used in audit planning. The competent authority stated that supervision results are also used by audit activities to verify effectiveness. No methodology and results of this verification were available at the time of the audit.

The competent authority keeps a report of monitoring the status of corrective action plans for supervision activities. This does not include the verification activities in the Article 12 warehouse. In the case of the audit activities certain actions planned were not implemented within the deadline and not at the time of the audit (finding 23). There was no follow-up by the time of the audit, contrary to the requirement of Article 8(3)(b) of Regulation (EC) No 882/2004.

Regarding finding 22 the competent authority implemented a corrective action that required all carton boxes of non-compliant products to be stamped with the CVED number. This was applied to new arriving consignments but no to the goods already in stock. Four months after the internal audit, significant stock introduced before the audit, had no CVED identification in the carton boxes. The audit team noted that the corrective action was not effective to address the shortcoming and this is contrary to the requirement of Article 8(3)(b) of Regulation (EC) No 882/2004. 8

Regarding finding 25 although the issue was identified long before the internal audit, it is still outstanding despite communication with DG SANCO and guidance received. In addition the corrective action to the recommendation of the audit report indicated sending a letter to the Member States that receive such consignments in order to obtain the registration number of the destination warehouses. At the time of the audit the issue was not addressed contrary to the requirement of Article 8(3)(b) of Regulation (EC) No 882/2004.

The results of the verification activities are used for planning future audits. Improvements following verification on the official import controls are evident, however there are cases in which the verification activities do not ensure that corrective actions are implemented or that they are adequate.

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By Order 09-360 from 28.05.2014 the Minister of Agriculture and Food has appointed a working group to develop a new Multi-Annual National Control Plan. The new Multi-Annual National Control Plan in accordance with a Council Decision , 2007/363 / EC will include strategic and operational objectives in the implementation of import controls and indicators for measuring their achievement. Following the publication of the new Multi-Annual National Control Plan by the end of December 2014 the procedure to verify the effectiveness of official controls will include requirements for monitoring the implementation of the objectives. RD 09-360_28 05 14.pdf One of the operational objectives that will be set is "not allowing the importation of consignments that are not subject to official controls." For tracking this objective BFSA has developed from 04.04.2014 the OPAC project " Development and implementation of BFSA's information system for service and automatization of the processes for processing of the import of products of animal and non-animal origin" The system will provide the official controls and access to the Custom's system. The construction and deployment of the system to be comple

By Order 09-360 from 28.05.2014 the Minister of Agriculture and Food has appointed a working group to develop a new Multi-Annual National Control Plan. The new Multi-Annual National Control Plan in accordance with a Council Decision , 2007/363 / EC will include strategic and operational objectives in the implementation of import controls and indicators for measuring their achievement. Following the publication of the new Multi-Annual National Control Plan by the end of December 2014 the procedure to verify the effectiveness of official controls will include requirements for monitoring the implementation of the objectives. RD 09-360_28 05 14.pdf One of the operational objectives that will be set is "not allowing the importation of consignments that are not subject to official controls." For tracking this objective BFSA has developed from 04.04.2014 the OPAC project " Development and implementation of BFSA's information system for service and automatization of the processes for processing Update received 13 November 2014 After the audit measures were taken to update the procedure for verification. The procedure was divided by control systems (animal and non-animal origin) and the cus

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The competent authority stated that after information was sent to the BFSA that official controls were not carried out properly, an urgent internal audit in the approved warehouse was conducted last November. The audit identified several shortcomings (e.g. low awareness of official veterinarians on specific issues, contrary to the requirements of Article 6(a and b) of Regulation (EC) No 882/2004, a lack of documented procedures, contrary to the requirements of Articles 8(1) and 3(a) of Regulation (EC) No 882/2004, no traceability in TRACES between incoming and outgoing consignments contrary to the requirement of Annex III to Regulation (EC) No 136/2004, no identification of CVED on the carton boxes of the non-compliant consignments contrary to the requirement of Article 1(5) of Decision 2000/571/EC). For each of the shortcomings the audit report identified the root cause and requested immediate action to address them within a specified period of time.

A local supervision procedure on the warehouse was launched by the LVU in December 2013. This is not related to the procedure described in findings 2-5. This supervision has not identified major shortcomings. The officials performing the supervision are not kept up-to-date relating to official import control requirements, although this was recommended by a relevant internal audit (finding 23). This reduces the capability to identify shortcomings in the operation of the warehouse. The competent authority performed a reconciliation test for quantities of commodities handled in which they used the information in TRACES. The conclusion was that commodities examined had ensured traceability. However the audit team noted that there were cases of non-complying consignments sent to another Member State without registering of the movement in TRACES. This renders TRACES unable to be used for reconciliation activities.

The verification activities largely ensure compliance, of the official import controls, with legal requirements and planned arrangements. For some areas the identification of non-compliances is limited by (i) incomplete scope of the verification (e.g. sampling activities are not covered), (ii) lack of implementation (e.g. there are no cross-checks with the Customs database), and (iii) limited awareness of responsible staff (e.g. the supervision of the warehouse approved under Art. 12 of Directive 97/78/EC).

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eir In June 2014 the BTSF carried out a mission in order to conduct a eries of priority trainings for Bulgaria. One of the areas in which raining was requested is audits and verification of official to controls. In the closing meeting was planned training to be held in first quarter of 2015

eir In June 2014 the BTSF carried out a mission in order to conduct a eries of priority trainings for Bulgaria. One of the areas in which Report ref. DG(SANCO)/2014-7025 -MR of a/an audit carried out from 24 es in place to verify the effectiveness of the import control system. training was requested is audits and verification of official red to controls. In the closing meeting was planned training to be held in the first quarter of 2015

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The outcome of supervision is used in audit planning. The competent authority stated that supervision results are also used by audit activities to verify effectiveness. No methodology and results of this verification were available at the time of the audit.

The competent authority keeps a report of monitoring the status of corrective action plans for supervision activities. This does not include the verification activities in the Article 12 warehouse. In the case of the audit activities certain actions planned were not implemented within the deadline and not at the time of the audit (finding 23). There was no follow-up by the time of the audit, contrary to the requirement of Article 8(3)(b) of Regulation (EC) No 882/2004.

Regarding finding 22 the competent authority implemented a corrective action that required all carton boxes of non-compliant products to be stamped with the CVED number. This was applied to new arriving consignments but no to the goods already in stock. Four months after the internal audit, significant stock introduced before the audit, had no CVED identification in the carton boxes. The audit team noted that the corrective action was not effective to address the shortcoming and this is contrary to the requirement of Article 8(3)(b) of Regulation (EC) No 882/2004. 8

Regarding finding 25 although the issue was identified long before the internal audit, it is still outstanding despite communication with DG SANCO and guidance received. In addition the corrective action to the recommendation of the audit report indicated sending a letter to the Member States that receive such consignments in order to obtain the registration number of the destination warehouses. At the time of the audit the issue was not addressed contrary to the requirement of Article 8(3)(b) of Regulation (EC) No 882/2004.

The results of the verification activities are used for planning future audits. Improvements following verification on the official import controls are evident, however there are cases in which the verification activities do not ensure that corrective actions are implemented or that they are adequate.

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n the "Internal Audit" Directorate at the "Audit of official ontrol" Department was hired a new employee from May 2014, main responsibility will be monitoring the implementation f corrective and preventive actions of the conducted internal udits. n Food and Border Control Directorate, Department of "Border ontrol" has been seconded Inspector from BIP, who should rovide methodological assistance for the implementation of lanned preventive and corrective actions to the recommendations f the internal audits in the approved warehouse, as well as other nternal audits in the field of border control . Page: 2

In the "Internal Audit" Directorate at the "Audit of official n control" Department was hired a new employee from May 2014, hose main responsibility will be monitoring the implementation of corrective and preventive actions of the conducted internal audits. In Food and Border Control Directorate, Department of "Border control" has been seconded Inspector from BIP, who should provide methodological assistance for the implementation of planned preventive and corrective actions to the recommendations of the internal audits in the approved warehouse, as well as other internal audits in the field of border control . Page: 3

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rom 22.04.2014 . 30/22.04.2014 . and at de 2014 . 23.04.2014 . 2014 . 23.04.2014 . , (- ) , . , (. , ). 21.05-22.05.2014 . . , ( ). ­ e 1, ­ 2.

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( ) ­ 3 , , , . 2014 . : Page: 1 Report ref. DG(SANCO)/2014-7057 -MR of a/an audit carried out from 07 rabies eradication programme. ; ( ), ; 31.05.2014 . , ( ) , 01.06.2014 . ( ). , 01.07.2014 . 11-539 22.04.2014 . ­ e 4

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2 )

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,, " 28- ,, " . . . , . Page: 2 Report ref. DG(SANCO)/2014-7057 -MR of a/an audit carried out from 07 rabies eradication programme.

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e , ,, " I () 669/2009 . , , - . , , . , . , , .

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(). 2015 ., Page: 1 14 eport ref. DG(SANCO)/2014-7187 -MR of a/an audit carried out from 01 d of non-animal origin. ( 6070-/30.10.2014 .). . 2015 . ( 7037-/09.12.2014 .).

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31 29 2004 . . .

n An interdepartmental working group is to be set up to prepare a lated in draft Regulation amending and supplementing Regulation No 31 The intra-ministerial working group was established with of 29 July 2004 on the maximum permitted levels of Order of the Minister of health ( 09-129/05.08.2013 contaminants in food. The draft Regulation will create the .). to prepare amending regulation of Ordinance conditions for the implementation of all regulations in the area of 31/2004 , which will assure the implementation of contaminants in food and for establishing sampling and analysis Regulation 1881/2006. The draft of the Ordinance is in methods for the purposes of official controls. preparation. Instructions concerning the implementation of the provisions of the Regulation were sent to the all RFSD (with letter 653 /31.01.2013 . ), according which the provisions of the Regulation are directly implemented according to the Law on the legislative acts (State Gazette last amended 2007) point-1.pdf

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- 5.2013. ,, ". .

ges to By order of the Executive Director of the Bulgarian Food Safety The BFSA website is updated with the consolidated Agency (BFSA) No RD 11-347/03.05.2013, a procedure was laid versions of Regulation 1881/2006 and Regulation down in "Instructions for the organisation of activities in relation 252/2012 m up to to publication of information on the BFSA website". with Following the recommendation made at the final meeting of the e 6 of mission, the BFSA website was revamped, with all updated legislative documents being uploaded.

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.5 . .8 25 Page: 1 rt ref. DG (SANCO)/2013-6656-MR of an audit carried nants in food of plant origin Action Proposed by the Competent Authority 2011. - , , , : , . . , , , .

Pursuant to Article 3(1)(5) of the BFSA Act, SG No 8 of 25 To assure the laboratory resources, for which BFSA had January 2011, the Bulgarian Food Safety Agency carries out not adequate capacity, the Agency started tender procedure Page: 1 Updated action Plan received 30/8/2014 ! t Authorities of Bulgaria on 28 May in response to Report ref. ary to 01 February 2013 in order to evaluate controls of contaminants in Action Proposed by the Competent Authority Updated response received 30/8/2013 controls in accordance with the conditions, procedures and (in accordance with the Procurement law) for the selection powers set out in the special laws concerned in relation to the of external laboratories. The laboratories will be oblige to requirements applying to: raw materials and food with the perform the test for contaminants according to the criteria exception of bottled natural mineral, spring and table waters. The set out in Regulations 401 () /2006, Regulation () BFSA has not delegated control functions to other control bodies. 1881/2006, Regulation () 1882/2006 ., Efficient and effective coordination and cooperation between the Regulation () 333/2007 and Regulation(E) BFSA and the Mi

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4, , " ", ,, ".

of For the purposes of Regulation (EC) No 852/2004, the plant n protection inspectors of the Regional Food Safety Directorates No (RFSDs) carry out checks on the use of plant protection products and fertilisers, under the technical guidance of the Control of Plant Protection Products and Fertilisers Department of the Directorate for Plant Protection Products and Fertilisers.

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. Page: 2 rt ref. DG (SANCO)/2013-6656-MR of an audit carried nants in food of plant origin Action Proposed by the Competent Authority

e area of In a letter from the BFSA Executive Director, all RFSDs were The adequate equipment for sampling was provided to the ent requested to provide information on the current availability of RFSD equipment for sampling food of non-animal origin. Following iently, clarification regarding any equipment lacking at RFSDs, the Page: 2 Updated action Plan received 30/8/2014 ! t Authorities of Bulgaria on 28 May in response to Report ref. ary to 01 February 2013 in order to evaluate controls of contaminants in Action Proposed by the Competent Authority Updated response received 30/8/2013 tion on necessary actions will be taken to ensure that missing items are provided.

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25-27.06.2013 .) . ,, " " ". ( , ) ), , , . Page: 3 rt ref. DG (SANCO)/2013-6656-MR of an audit carried nants in food of plant origin Action Proposed by the Competent Authority , (). - . , , , (28 ), , , . 2013 . 3. , , , .

ols 1. The Training and Qualification Directorate is planning to hold, The approved procedure (with Order of the BFSA together with the Feedingstuffs Control Directorate, a training executive Director) for sampling of food of non-animal and course in Varna from 25 to 27 June 2013 on "Sampling methods origin is respected and the samples are laboratory tested he area to be used in official controls on animal feed", featuring a for the purpose of the official control for: separate lecture on "Interpreting results of laboratory analyses". - Presence of nitrates; s Comprising a theoretical and a practical part, the training will be - Plumbum, Cadmium, mercury, nonorganic ) No attended by 28 RFSD inspectors (one from each RFSD) who are Cilium, 3 D, PAHs; rform directly involved in animal feed controls, as well as by inspectors - mycotoxines. he same from the Border Inspection Posts (BIPs). On completion of the course, successful participants will provide cascading training in Training was conducted for the period 25-27 June in situ (at the 28 RFSDs) for all staff involved in animal-feed Varna. In the organization of the training Participated controls. "Training and qualification" Directo

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. 15- ", ,, " .. 2. 2013. ,, ", , , Page: 4 rt ref. DG (SANCO)/2013-6656-MR of an audit carried nants in food of plant origin Action Proposed by the Competent Authority .

Order of the Executive Director has been drawn up for the In development is procedure for planning of the risk based creation of a working group to prepare the planned sampling of monitoring program including the contaminants raw materials and food of non-animal origin, additives and food t materials (FCMs). Under the Order, the working group is vene every year by 15 February in order to plan laboratory ls for the year, with representatives of other BFSA orates and services taking part as necessary, including from sk Assessment Centre, the Laboratory Activities orate, and others. en the need to change the number of planned samples for a memorandum has been drawn up on the need for an n to be issued by the Risk Assessment Centre, based on an ment of the risk associated with the presence of nitrates, xins, inorganic tin and heavy metals in food consumed in ia.

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. . . 3 () . IMG_0005.pdf () 1882/2006 () 401/2006 . , Page: 5 rt ref. DG (SANCO)/2013-6656-MR of an audit carried nants in food of plant origin Action Proposed by the Competent Authority . RPK5_7_3_Afla.doc Probonabirane_nitrat RPK5_8_1_Hrani.doc i.doc 508-2 06.03.2013 . -07/2013 . . Commission Regulations (EC) No 401/2006 (mycotoxins), Commission Regulations (EC) No 1882/2006 (nitrates), Commission Regulations (EC) No 333/2007 (heavy metals), , . , / , . 2013 . , 9 . , .

he The Laboratory Testing Complex (LTC) at the Pleven Regional Page: 4 Updated action Plan received 30/8/2014 ! t Authorities of Bulgaria on 28 May in response to Report ref. ary to 01 February 2013 in order to evaluate controls of contaminants in Action Proposed by the Competent Authority Updated response received 30/8/2013 Health Inspectorate (RHI) does not accept samples whose ich has quantity fails to meet the requirements of the relevant regulations. The laboratory investigations of nitrates in children's puree take into account section B 3 of Regulation (EC) No 1882/2006 regarding sampling and analysis methods for the purposes of official checks on food for the presence of nitrates. Following on from the findings made during the mission, staff involved in the acceptance of samples have undergone training on strict compliance with the requirements of the Regulations in force. [PDF file enclosed: IMG_0005.pdf ­ see Bulgarian original] The LTC at the Plovdiv RHI operates established procedures for taking samples to be tested for mycotoxins and nitrates in accordance with the requirements set out in Regulation (EC) No 1882/2006 and Regulation (EC) No 401/2006 laying down the meth

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. 33 () 882/2004, () : URL , Page: 6 rt ref. DG (SANCO)/2013-6656-MR of an audit carried nants in food of plant origin Action Proposed by the Competent Authority . - . , 2013 . , . - , , . 06-07.06.2013 . , ELISA . 09-773/15.09.2011 . . EURL . : 1. - () . 2. , (. 2962- Page: 7 rt ref. DG (SANCO)/2013-6656-MR of an audit carried nants in food of plant origin Action Proposed by the Competent Authority /30.04.2013 . ) . 09-333/13.05.2013 . . Order lab.pdf

ls are In accordance with Article 33 of Regulation (EC) No 882/2004, The course was given on 6 and 7 June 2013 at the CLCTC EC) the CLCTC, in its capacity as National Reference Laboratory and comprise theoretical and practical training on analysis for mycotoxins, has taken the following action: of mycotoxins using liquid chromatographic and ELISA er receiving notification from the European Reference methods. Participants were from the laboratories for atory (EURL) for mycotoxins about the three PT-tests official control testing. ed for 2013, the CLCTC sent all laboratories carrying out ial controls in the Republic of Bulgaria an inquiry as to er they would be able to take part in them. the CLCTC will be taking part in the first -test in April point for determining patulin in apple juice, as the other 9-Programe-training-C atories have not applied to take part. CLCTC, jointly with the company RIADCOM and an - NRLs, the laboratories annually take part in professional t from Germany, will be conducting a training course on proficiency tests organised by the EURL. sis of mycotoxins for laboratories which perform such CLCTC, as NRL received invitations from EURL for ses for the purposes

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, () 401/2006 ( ), () 1882/2006 ( ), () 333/2007 ( ) ­ . , () 401/2006 ( ), () 1882/2006 ( ), , Page: 8 rt ref. DG (SANCO)/2013-6656-MR of an audit carried nants in food of plant origin Action Proposed by the Competent Authority - (recovery) ­ - 02/2013. -02/2013 ., 16591/87 . 1/88 ( 31.01.2013 . . 6.4. - . ( 1). - - ( 2), , . ( ), . RSD . - : - -03/2013, - 03/2013, 3 . - ( HPLC ) . Page: 9 rt ref. DG (SANCO)/2013-6656-MR of an audit carried nants in food of plant origin Action Proposed by the Competent Authority - , ,, " . - . ( ) . 02.2013 . ( , , , IRMM), . , (: z- score < 2). , FAPAS, , z- score , - . , URL . 2013 . Page: 10 rt ref. DG (SANCO)/2013-6656-MR of an audit carried nants in food of plant origin Action Proposed by the Competent Authority Prilojenie 1.rar Prilojenie 2.rar Prilojenie 3.rar

alysis Laboratory Testing Complex (LTC) at Pleven Regional Health Regarding ensuring of laboratory resources, for which nd are Inspectorate (RHI) and LTC at Plovdiv RHI there is a lacking capacity in BFSA, a tender procedure analytical methods for the analysis of official samples for has been started according to the Law on Public Page: 7 Updated action Plan received 30/8/2014 ! t Authorities of Bulgaria on 28 May in response to Report ref. ary to 01 February 2013 in order to evaluate controls of contaminants in Action Proposed by the Competent Authority Updated response received 30/8/2013 ity contaminants are validated and meet the method performance Procurement for selection of external laboratories for criteria as defined in Commission Regulation (EC) No 401/2006 testing of samples for pollutants, with criteria set (mycotoxins) Commission Regulation (EC) No 1882/2006 according to the requirements of Regulation 401 ( EU) / (nitrates) and Commission Regulation (EC) No 333/2007 (heavy 2006 , Regulation (EC ) 1881/2006 , Regulation (EC ) metals) ­ if necessary, records of the validation of the analytical 1882/2006 , Council Regulation (EC ) 333/2007 and methods can be provided. Regu

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IMG_0006.pdf IMG_0007.pdf , , . 4.4 () 401/2006 () 1882/2006. , EN ISO/I 17025. II, 4.4 () 401/2006 . Page: 11 rt ref. DG (SANCO)/2013-6656-MR of an audit carried nants in food of plant origin Action Proposed by the Competent Authority -04/2013 ( 4) 510-1/ .13 ,, ", II , . , () 1882/2006. Prilojenie 4.rar

d with LTC at Pleven RHI In the notes of the three test reports of CLCTC, RHI In the presentation of the results of testing, account is taken of Plovdiv and RHI Pleven is displayed ­ daily analytic n whether a particular result was corrected by analytical spiking, production and uncorrected result to the daily production nd its level. as well as expanded uncertainty) in accordance with Annex II, p. 4.4 of Regulation (EC) No 401/2006 closed: IMG_006.pdf, IMG_0007.pdf ­ see Bulgarian (mycotoxins) Annex to Regulation (EC) 1882/2006 (nitrates). v RHI The three laboratories provide testing protocols with equal l result is reported together with the expanded data required above. uncorrected for recovery, in compliance with point II to Commission Regulation (EC) No 401/2006 to Commission Regulation (EC) No 1882/2006. point-11-RHI.pdf point-11-CLCTC.pdf the results of the tests carried out are stated a declared uncertainty in the test reports, in th BDS N ISO/IEC 17025. For official control requirements set out in point 4.4 of Annex II to C) No 401/2006 in relation to corrections to daily Page: 10 Updated action Plan received 30/8/2014 ! t Authorities of Bulgaria on 28 May in response to R

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, , , , , . . 2. ,, ", Page: 12 rt ref. DG (SANCO)/2013-6656-MR of an audit carried nants in food of plant origin Action Proposed by the Competent Authority . Page: 13

1. At the end of each quarter, each RFSD submits to the Food Headquarters of the Bulgarian Food Safety Agency Control (FC) Directorate of the BFSA an interim report on annually prepare and send to RFSD instructions for food EC) implementation of the sampling plan. Set out on the reporting sampling, which include the type of sample, the number of template provided by BFSA Central Office, it states the type of samples, the indicators on which analysis is carried out, a food sampled, the number of samples taken from production timetable for sampling as well as priority sampling of facilities and retail premises, the food's country of origin, production establishments in the region. discrepancies and corresponding corrective actions taken in The approved in June procedures for sampling of food of accordance with current food legislation. When BFSA Central non-animal origin for laboratory testing for the official Office launches the sampling schedule it has prepared, it writes to control for content of: the RFSDs requesting that they provide this information. - nitrates, 2. Where a non-compliant result is obtained, the RFSD concerned - plumbum, cadmium, mercury, inorganic is required to

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09-1135/31.08.2012 . . 12 () 882/2004 . 32, . 1 ( 1); 11-731/11.07.2013 . . ( 2); 9391/18.07.2013 . . 9573/24.07.2013 . 11-941/10.09.2013 . . ( 3); (6-7.11.2013 .) .

/31.08.2012 of the Ministry of od implementing Article 12 of Regulation (EC) No 32(1) and (2) of the Food Act (Annex No 1); 11.07.2013 of the Executive Director Agency establishing the Programme for rms producing milk that does not comply with Annex No 2); No 9391/18.07.2013 on the national d Safety Agency's regional laboratories 7.2013 on training delivered at the 'Milk Reference Laboratory of the Regional Food (Annex No 6); 10.09.2013 of the Executive Director Agency on inter-laboratory comparative e (6-7.11.2013 .) training of laboratory an Food Safety Agency (Annex No 8).

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19.02.2008 . Page: 1 eceived 12 November 2013 Report ref. DG(SANCO)/2013-6882-MR of an audit carried ed to the safety of food of animal origin, in particular to the lk processing establishments as laid down in Commission Decision Action Proposed by the Competent Authority 44 20 2006 . . - .

modernisation and categorisation, amendments to proposed and implemented accordingly: Order laying down specific requirements for the d transportation of raw cow's milk and standards Page: 1 2013 )/2013-6882-MR of an audit carried food of animal origin, in particular to the ishments as laid down in Commission Decision oposed by the Competent Authority nd placing on the market of dairy products and Order 2006 on veterinary requirements in animal holdings. made it possible for more farms to take part in the -quality milk.

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31.07.2013 . " " . , , . 28 , ­ 451 . , .4 () 882/2004 - . L.monocytogenes, "Guidelines on sampling the food processing area and equipment for the detection of Listeria Page: 2 eceived 12 November 2013 Report ref. DG(SANCO)/2013-6882-MR of an audit carried ed to the safety of food of animal origin, in particular to the lk processing establishments as laid down in Commission Decision Proposed by the Competent Authority ogenes, Version 1 ­ 04/04/2012, Brigitte CARPENTIER and RRE, EURL for Listeria monocytogenes, Maisons-Alfort ory for Food Safety, ANSES, France". .

national meeting was held with the 'Control of f department to examine the mission findings inal meeting. The attendees paid particular attention to of the performance of official controls, documentation lysis of findings and developing appropriate remedial ing of Official Veterinarians and inspectors from the Food Control Directorate was attended by 451 , in accordance with Article 4 of Regulation (EC) No of Department will assess whether the instructions during the training have been applied correctly. er development for sampling from production ipment to identify L.monocytogenes on the basis of the pling the food processing area and equipment for the ria monocytogenes, Version 1 ­ 04/04/2012, Brigitte a BARRE, EURL for Listeria monocytogenes, 2013 )/2013-6882-MR of an audit carried food of animal origin, in particular to the ishments as laid down in Commission Decision petent Authority for Food Safety, ANSES, France". The to business operators and the official controls

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12 , - , , 17 . Page: 3 eceived 12 November 2013 Report ref. DG(SANCO)/2013-6882-MR of an audit carried ed to the safety of food of animal origin, in particular to the lk processing establishments as laid down in Commission Decision ction Proposed by the Competent Authority .

out in 12 milk production facilities visited during lished that, following closure of the audit, the dy took steps to eliminate the discrepancies found. relating to infrastructure and equipment, of condensation, mould, pests, equipment blishing the expiry date of products and roducts according to the technical reference ted. For some of the findings relating to he conduct and upkeep of self-checking he implementation of internal monitoring deadlines have not expired. With regard to the ed during the checks, seven instructions were for their elimination. ied out on the remaining 217 milk production hat 114 instructions have been given concerning ingement notice has been drawn up. The e instructions have not yet passed.

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. Page: 4

for the categorisation of milk production Page: 3 2013 )/2013-6882-MR of an audit carried food of animal origin, in particular to the ishments as laid down in Commission Decision n up and implemented. During the checks mation has been provided concerning uirements and correction of shortcomings in

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t protection has been elaborated, which of Directive 2009/128/EC. The draft law tion procedure within MAF WG 1 and WG 7. is in the process of external departmental ther ministries. nts and observations adopted in the text of the his ordination; to be submitted for approval by Council of aw to be considered and adopted by the National n of Plants to be published in the Official Gazette

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acting as zonal Rapporteur Member State lications because of lack of administrative and we are complying with the dead lines laid out evaluated plant protection product. Having said is to hire new experts who will be involved in the n order to take part of the risk assessment on he zone.

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inspectors have all the necessary information the otection Products" Department duct is been authorized summarize all remarks Page: 1 2012-6279-MR of an audit carried Competent Authority from the Council Meeting Group of experts in and the Material Safety Data Sheet (MSDS) of the o the applicant. The applicants have the obligation orrections and then resubmit them officially to labels in accordance to Regulation (EC) No uploaded in the website of the BFSA to be used and fertilizers" Department colleagues for l functions and for the public. ng a register of authorized PPP will be developed available through the BSFA website. available the following information: (now Order and certificate of authorization) Internet connection RFSDs inspectors will be ve access to current information on labels and protection and control at the sites

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action on the number of active test facilities control of pesticide residues (official of active databases has been increased ases, such as the possibilities of the laboratory 2012-6279-MR of an audit carried Competent Authority (GC-ECD, GC - NPD, GC-MS, GC-MS/MS, e residues for all active databases listed in l program of EU virgin olive oil will be used d laboratory system BFSA. ade of the national monitoring program for nd on foodstuffs of plant and animal origin in 1.6.2012, as the changes are reflected in point 1. 4 Sampling. ges is available on the BFSA website.

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ruits and vegetables, including commodities h acid content 17 (d) - Single residue methods - wo laboratories to perform official controls on n. eement and annex to it for testing in a for analysis of pesticide residues in samples of th laboratories use the same methods for sample of official control. Pleven work in close cooperation and constant and assistance. Recently a meeting of experts es was held on 11-12.06.2012, in RHI - Pleven. s discussion and assistance in relation to carried out in 2011 analysis of samples 669/2009 2012-6279-MR of an audit carried ction Proposed by the Competent Authority utes of the meeting held in both laboratories. took part in the ongoing RTs organized by the ratory for 2009-2010. MLS as official controls are carried out by f which is CLCTC. The range of tests for he official control of two different laboratories. ng up plans for coordinated monitoring e competent authority (BFSA).

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al Implementation plan for the Management of utants in Bulgaria, 2012 ­ 2020" is developed in the process of inter departmental coordination es. The Bulgarian updated NIP shall be adopted l of Ministers. The updated NIP includes a set of for final elimination/disposal of identified arian ­ Swiss Cooperation Programme a Project disposal of obsolete pesticides and other crop s been approved, which shall be implemented ­ 2019. The activities under the project include g, export, final destruction of at least 6 000 tones including the available 161 tones POPs pesticides ndane). The final destruction of obsolete age: 4 2012-6279-MR of an audit carried Competent Authority e in European licensed incineration facility within

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icial inspectors on techniques and non-animal origin: the first half of 2013. The topics will be l training plan for 2013. for mycotoxin analysis: system of quality management according 17025:2005, and draw annual Training d external) and also annual plan for are 8 trainings performed of laboratory staff ethods for mycotoxins and the monitoring been held. d: the official from CLCTC in Annual eference laboratories for mycotoxins - 7th 7.04.2012 ; he official from CLCTC in Seminar "The alysis and verification of mycotoxins in rkshop)" ­ 03-05.07.2012 IRMM rticipated in proficiency testing -(PT EU-RL Myco 2012 ­ IRMM, Geel)- expressed the interest in participation also Page: 1 293-MR of an audit carried of report DG (SANCO)/2010-8592 ion Proposed by the Competent Authority characterization ch will be held in October 2012; employees in a seminar on ds for the analysis of mycotoxins", ainings conducted of new recruits on for analysis of mycotoxins, validation, aluation of measurement uncertainty. For reports. e provided according to the plans developed in management and EN ISO/IEC 17025:2005.

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he BFSA's CEO RD 11-962/27.07.2012 FSD until 31.10.2012 to provide seals for l origin for laboratory analysis in nalytical validity of samples.

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the Embassy of the Republic of Turkey in ion of consignments for food of non- import into the EU in order to meet the 669/2009. Meetings with Turkish exporters anned locally at designated point of entry Page: 2 293-MR of an audit carried of report DG (SANCO)/2010-8592 oposed by the Competent Authority

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en instructed on the procedure rtation from designated points of ults of laboratory tests to other MS come out. detailed written about: authorities for final destination of ective action (by a competent l destination to the DPE).

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been instructed for the implementation of in relation to documentary checks entry.

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ions have been issued for completing the ocument in accordance with the Regulation 669/2009.

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ng of customs officials from the regional ses will be held at Bulgarian Customs more specifically - Border control application of Regulation 669/2009 and Page: 3 293-MR of an audit carried of report DG (SANCO)/2010-8592 tion Proposed by the Competent Authority

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e been given for completing the second part ope of Regulation 1152/2009. As number will be assigned to the ordance with Annex II of the

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s taken preventive action in implementing 4 of Annex II of Regulation 401/2006 as he test uncertainty of the results of a feature in in a recovery. cated that the declared uncertainty is extended. follows x ± U, where, the results. re not corrected for recovery, as in "Note" to ecoveries of daily analytical run, and an is not adjusted to it. effective on 05/11/2012 port is sent electronically to the team mission)

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PT DON, ZON, T-2, HT-2 PT EU-RL Page: 4 293-MR of an audit carried of report DG (SANCO)/2010-8592 sed by the Competent Authority gium, and the results were sent to the ing receipt of the final report of the PTs preparation of spiked samples to ensure control charts, validation and verification of ted during the mission. provide SRM/RM in various matrices to re- ion of the methods of analysis.

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ncluded updated test methods for ces to be officially supervised in the scope of by its certificate of accreditation by NAB- creditation certificate and order including methods that are effective 29/06/2012, valid ). quests for testing ochratoxin A in spices until re-accreditation of the laboratory (in April lab is not worthwhile, its inclusion in the was not possible to keep score in the scope of ring of mycotoxins was carried out in other test method for the characteristic Ochratoxin ch is validated and accompanied by a Page: 5 293-MR of an audit carried of report DG (SANCO)/2010-8592 by the Competent Authority ty. The inlet lab samples are being analyzed uct "spice" for ochratoxin A was presented to ission). in the application for extension of t supervision by the national accreditation

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loped and approved on the procedure for ems from non-animal origin to the final ts of the laboratory analysis.

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lth has been forwarded concerning the the creation of an roup on issues related to import controls on ncluding and the WG on EU Regulation

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iven on the procedure to non shipments origin, for which after the official checks cluding those that are subject to re-dispatch.

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n on notification to the customs Page: 6 293-MR of an audit carried of report DG (SANCO)/2010-8592 etent Authority Page: 7

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es for reliable During 20-21.06.2012 detailed inspection of the NRL for FMD was carried out ntigen in order (Order 11-784/19.06.2012 of the executive director of the Bulgarian Food Regulation Safety Agency) to detect the gaps in laboratory diagnosis and ensure reliable nnex testing of official samples for FMD virus and antigen. Each year tendering procedure is performed for supplying the laboratory with the necessary diagnostics. Pursuant to contract 60/30.12.2011 Ag ELISA kits for 1700 tests have been provided to and are available in NRL for antigen detection. Real time RT-PCR kits for 756 tests have been supplied with the support of EuFMD/EC and are available in NRL. For 2012 the laboratory has already been equipped with all necessary diagnostics for testing samples for FMD virus and antigen. If additional number of tests is needed BFSA will immediately contact the firm that won the tender and order the needed diagnostic kits to be supplied to the laboratory in time. The next tendering procedure for Ag ELISA and RT PCR is foreseen to start in February 2013 and end in April 2013. On 18-20th Sept a Tripartite meeting is going to be carried out in Istanbul organized by EuFMD Commiss

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icial samples In the framework of the 2012 (Apr ­ Dec) and 2013 FMD surveillance program rder to meet the serological samples are analyzed using NSP-ELISA test which is under the (EC) No scope of accreditation. Liquid-phase blocking ELISA (LPBE) and Ag ELISA test are additional tests to be used in the framework of the control program which are also in the scope of accreditation. The documentation to be submitted for accreditation of the real time RT PCR method is in preparation. It is expected the official documentation to be prepared and sent to the Bulgarian Accreditation Body (BAB) by the end of September 2012. Additional information concerning validation of the method and technical equipment is planned to be submitted to BAB by the end of December 2012. By the end of March 2013 internal audit is expected to be carried out. By the end of May 2013 official audit by BAB is expected. The accreditation of the real time RT PCR method is expected to be finalized in June 2013.

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h regard to The FMD Operation Manual has been amended accordingly to make sure that is not FMD virus is not transferred by persons involved in the sampling of animals and of animals the handling of sampled carcasses to meet the requirements of point 9 of Annex he XVII to Council Directive 2003/85/EC. l Directive ampling Additional point . 7.1.2. has been added to the FMD Operation manual (http://babh.government.bg/uploads/File/Zdraveopazvane/Zarazni_bolesti/Conting ens_plan/Operational_manual_FMD_BG_2012_1.pdf ) defining the bio-security measures in case of sampling of susceptible domestic and wild animals and carcasses 2 o-security measures during sampling and prepared and distributed. Website: File/Zdraveopazvane/Zarazni_bolesti/lovci/Ins pdf

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"Animal Health and Welfare" Directorate (AHWD) has developed by Instruction for performing official controls concerning salmonelloses in poultry, in particular in laying hens, breeding herds, broilers and turkey, this instruction being endorsed and entered into effect by BFSA Order of ref. No RD 11-1063/30.08.2012 signed by BFSA Executive Director. This document lays down in details the obligations of the experts of AHWD at central level, of official veterinarians in the country and of "Animal Health" Department chiefs at Regional Food Safety Directorates (RFSD) concerning the mode or procedures to be applied by them when performing inspections, when collecting and tracing the data for the performance of relevant Salmonelloses control programmes (plans) in respective poultry categories. Among the others, this Instruction enters into effect a new model form of the samples `Accompanying Letter', thus enabling the specification therein, whether the sample(s) concerned are taken from a farm or hatchery, together with the code of the herd and the age of the poultry concerned.

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by "Food Quality Management" Directorate with BFSA Central Office has unicipal developed a 5-year plan for the internal audits to be performed in lieu with salmonelloses in poultry. The first audit of these series is to be performed from 27.08 till 31.08.2012 in the administrative district (i.e. RFSD) of Pazardzhik. BFSA does not intend to use the services of external auditors. The audit team has 20 days to prepare a draft audit Page: 1 ations of Report ref. DG(SANCO)/2012-6438-MR of an audit carried ional Control Programmes in particular poultry populations (breeders, Action Proposed by the Competent Authority report and the audited entity has 20 days to develop a plan of action.

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e to By developing the Instruction mentioned herein above, the Manual on fulfil the the implementation of the national Salmonelloses control programmes (plans) in poultry and the Sampling Scheme for the implementation of these national Salmonelloses control programmes (plans) in poultry, BFSA is to ensure (and guarantee) that is has its effective procedures to verify the efficiency of relevant official controls as to comply with the requirements of Article 8 of Council Regulation (EC) 882/2004.

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re in When performing controls concerning Salmonelloses, official art A (II), veterinarian are to produce (`issue') official `prescriptive' reports e incorporating all the necessary measures recommending to the owner(s) of respective poultry farm how to ensure their bio-security. These reports lay down also relevant deadlines to complete all the corrective actions needed for the purpose of ensuring proper level of bio-security. After the date of this deadline, there is to be second inspection of the farm concerned.

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By the aforementioned Instruction for performing official controls he concerning salmonelloses in poultry, in particular in laying hens, breeding herds, broilers and turkey, the Competent Authority (i.e. Page: 2 ations of Report ref. DG(SANCO)/2012-6438-MR of an audit carried ional Control Programmes in particular poultry populations (breeders, Action Proposed by the Competent Authority ling BFSA) ensures and may guarantee that all the controls on sampling related to national Salmonelloses Control Programmes do complies with the requirements of Regulations 2160/2003 and 200/2010, in particular the ones concerning the frequency of sampling and its confirmative documents specified as control sheets. Appropriate sanctions are provided for any case of non-compliance.

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By the aforementioned Instruction developed and entered into effect, the the Central Competent Authority guarantees that monitoring and sampling performed under the national Programme for the herd monitored and tested is in accordance with the requirements of Regulation 517/2011, in particular the ones related to frequency of sampling and its confirmation thorugh control sheets.

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By its specific instructive Letter, the Central Competent Authority has with notified the Director of RFSD of Stara Zagora about his obligation to undertake all the necessary measures for ensuring complete control concerning Salmonelloses in turkey and relevant sampling and testing that should cover all relevant breeding and/or fattening herds. If those measures would not be implemented, appropriate sanctions are to be imposed. Page: 3 ations of Report ref. DG(SANCO)/2012-6438-MR of an audit carried ional Control Programmes in particular poultry populations (breeders, Action Proposed by the Competent Authority

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la National Diagnostic and Research Veterinary Institute (NDRVI) has ollow- taken corrective actions and an application (BAS QA 2.1.1.), NRTSBH ion (EC) respectively, National Reference Laboratory (NRL) "Salmonella, Campylobacter and antimicrobial resistance" to the Executive Agency "Bulgarian Accreditation Service" to expand the scope of accreditation including testing for Salmonella control and re-confirming food, feed and farm samples. Order RD 11-847/04.07.2012 of the BFSA's Executive Director for organizing and conducting as well as the inter-laboratory comparison testing has been issued. Inter-laboratory testing has been planned in October 2012 in order to schedule "Detection of Salmonella spp. in samples of food, feed and fecal samples", organized by the National Reference Laboratory (NRL) "Salmonella, campylobacter and antimicrobial resistance" to NDRVI. More specifically, inter-laboratory test to detect Salmonella spp. in fecal samples according to the method BS EN ISO 6579:2005 /A1, will be conducted with participation of laboratories "Bacterial diseases in animals" section to "Bacteriology and bacterial diseases" in NDRVI and accredited laboratories RFSD in Blagoevgrad,

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be performed an additional training for ans at the regional food safety directorates and those t points, according to the requirement of Article 16 of 2005 concerning the recording equipment for road tellite navigation system so that checks on these are the training will be covered the topics on the ey logs and the realistic journey times.

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­ ZJ dated 10.07.2012 all Directors of the Regional ctorates are informed to follow strictly the procedures iveness of official controls at the animal health and edures covered responsibilities, frequency, fectiveness and actions in case of non-compliance.

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Activity provided for increased times for animal owners and entities for failure to ments on animal welfare. The Draft is under nal Parliament of the Republic of Bulgaria on y with the requirements of Art. 54 of Regulation (EC) ial veterinarians issued a prescription act when the ance is detected. In case of the new detected non- nctions in accordance with the Law onthe Veterinary ANCO)/2012-6454-MR of an audit carried elfare on farms and during transport Action Proposed by the Competent Authority nd effective, proportionate and dissuasive

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d by the Animal Health and Welfare Directorate at instructions to all officials about the II and VI of Annex I to Regulation (EC) No as performed an additional training to all Heads 28 regional food safety directorates in order e requirements of Regulation 1/2005/EO. The ed that the official veterinarian who performed vehicle for long journey should guarantee that f the Regulation 1/2005/EO. The document is ernet address: bg/actualno-department-

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Activity provided for increased mes for animal owners and entities for failure to quirements for animal welfare. The Draft is under onal Parliament of the Republic of Bulgaria in e requirements of Art. 54 of Regulation (EC) inarians issued a prescription act when the etected. In case of the new detected non- n accordance with the Law on the the ANCO)/2012-6454-MR of an audit carried elfare on farms and during transport Action Proposed by the Competent Authority re much higher.

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ned to be organized an additional training of the staff l controls on long distance transport. oint, on 10.07.2012 all official veterinarians who are ial animal health and welfare control at RFSD and med about the route recording equipment ­ record s. As a part of the cascade training, the by an expert during the meeting of national egulation 1/2005)- 19 - 21.06.2012 held in Grange, d in Bulgarian and shared with the with the official out checks of the long distance transport. could be found on the following internet address: t.bg/bg/actualno-department- .html

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nnex III, points 2 and 3 Directive 2007/43/EC, are onal legislation- Art. 13 of Ordinance 26 of minimum standards for animal welfare and rs /promulgated in SG 72 of 15.08.2008/. ed a system for better communication of possible tors to/from slaughterhouses- official letter signed ctor of BFSA 4257-/17.07.2012. ANCO)/2012-6454-MR of an audit carried elfare on farms and during transport mpetent Authority

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of live animal consignments at the Exit point to be minimized the delays, in accordance tion (EC) No 1/ 2005. t was signed between the Veterinary Service, in order to be prioritized the live animal e lane. In accordance with the agreement the rect the transporters of live animals for any delay.

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ver the 11-1080 04.09.2012 . tably ) 17.09.2012 . 19.09.2012 . : ,, HACCP ". . : , , , , . . , " , ". , . 56, . 2, . 1 . 34 , 28 , () 6 ,, " . () Page: 1 erein are published as separate annexes 1 and 2 and can be found at :http://ec.europa.eu/food/fvo/rep_details_en.cfm?rep_id=2984 tions of Report ref. DG(SANCO)/2012-6491-MR of an audit carried for the identification of hazards and management of risks along the feed Action Proposed by the Competent Authority . , ,, " ,, ". 11-1080 04.09.2012 . . 2012 . " - " " ". " " , . , , , , 11-1355/28.10.2011 . : http://www.babh.government.bg/bg/actualno-department- training&article_id=267.html

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samples 11-1135/29.09.2012 . t the , rials in , ith the Page: 2 in are published as separate annexes 1 and 2 and can be found at :http://ec.europa.eu/food/fvo/rep_details_en.cfm?rep_id=2984 tions of Report ref. DG(SANCO)/2012-6491-MR of an audit carried for the identification of hazards and management of risks along the feed by the Competent Authority S) S) 2:2009 ,,Foods of etermination of pesticide residues using GC-MS and/or ng acetonitrile extraction/partitioning and clean-up E - QuEChERS-method" 2 - EN ISO 16050:2011; 141-2: 2000, EN 14132: 2009 in are published as separate annexes 1 and 2 and can be found at :http://ec.europa.eu/food/fvo/rep_details_en.cfm?rep_id=2984 tions of Report ref. DG(SANCO)/2012-6491-MR of an audit carried for the identification of hazards and management of risks along the feed the Competent Authority 2011 10. ncy testing s) roficiency Test for Pesticide Residues in e- lab30, Category A; uropean Proficiency Test in rice with incurred in are published as separate annexes 1 and 2 and can be found at :http://ec.europa.eu/food/fvo/rep_details_en.cfm?rep_id=2984 tions of Report ref. DG(SANCO)/2012-6491-MR of an audit carried for the identification of hazar

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the feed . 4583 ­ 31.07.2012 . ,, ues of " ,, " No , 05 . ment.bg/uploads/File/Ajtualno%20%20Furaji/Informa e%20deinosti%20koito%20podlegat%20na%20regi renie%20po%20Zakona%20za%20furagite.pdf . Page: 7 in are published as separate annexes 1 and 2 and can be found at :http://ec.europa.eu/food/fvo/rep_details_en.cfm?rep_id=2984 tions of Report ref. DG(SANCO)/2012-6491-MR of an audit carried for the identification of hazards and management of risks along the feed the Competent Authority 012 . . s and food industry). 2 . erein are published as separate annexes 1 and 2 and can be found at :http://ec.europa.eu/food/fvo/rep_details_en.cfm?rep_id=2984 tions of Report ref. DG(SANCO)/2012-6491-MR of an audit carried for the identification of hazards and management of risks along the feed by the Competent Authority n-going

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l ate 2012 . 11-1004/06.08.2012 . e: 9 erein are published as separate annexes 1 and 2 and can be found at :http://ec.europa.eu/food/fvo/rep_details_en.cfm?rep_id=2984 tions of Report ref. DG(SANCO)/2012-6491-MR of an audit carried for the identification of hazards and management of risks along the feed roposed by the Competent Authority

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cation of . 27, . 6 8(3)(a) of " " " 882/2004". 22.08.2012 . overnment.bg/uploads/File/Ajtualno%20%20Furaji/Procedu on_BABH_KF.pdf 2 12 . 20 ) 882/2004. Page: 10 erein are published as separate annexes 1 and 2 and can be found at :http://ec.europa.eu/food/fvo/rep_details_en.cfm?rep_id=2984 tions of Report ref. DG(SANCO)/2012-6491-MR of an audit carried for the identification of hazards and management of risks along the feed on Proposed by the Competent Authority

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and . 4583 ­ 31.07.2012 . ,, y by " ,, " , ,, " , () . 183/2005. 83/2005 : abh.government.bg/uploads/File/Ajtualno%20%20Furaji/Informa Page: 11 erein are published as separate annexes 1 and 2 and can be found at :http://ec.europa.eu/food/fvo/rep_details_en.cfm?rep_id=2984 tions of Report ref. DG(SANCO)/2012-6491-MR of an audit carried for the identification of hazards and management of risks along the feed Action Proposed by the Competent Authority 0vidovete%20deinosti%20koito%20podlegat%20na%20regi i%20odobrenie%20po%20Zakona%20za%20furagite.pdf . 3/2005 date: On-going

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rce uired , h.government.bg/uploads/File/Ajtualno%20%20Furaji/Informa 0vidovete%20deinosti%20koito%20podlegat%20na%20regi i%20odobrenie%20po%20Zakona%20za%20furagite.pdf 4 2012 .) 82/2004 , Page: 12 erein are published as separate annexes 1 and 2 and can be found at :http://ec.europa.eu/food/fvo/rep_details_en.cfm?rep_id=2984 tions of Report ref. DG(SANCO)/2012-6491-MR of an audit carried for the identification of hazards and management of risks along the feed Action Proposed by the Competent Authority 5, 6 () 183/2005. . () 183/2005 . ompletion date: On-going

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avoid of 13 arget . (carry over), .

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17.09. 19.09.2012 . : ,, HACCP " , Page: 13 in are published as separate annexes 1 and 2 and can be found at :http://ec.europa.eu/food/fvo/rep_details_en.cfm?rep_id=2984 tions of Report ref. DG(SANCO)/2012-6491-MR of an audit carried for the identification of hazards and management of risks along the feed the Competent Authority d the , tion . 16. nd of December 2012 Page: 14

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d , , . After the entry into force of the Act amending the Law on the veterinary activity, sanctions will be applied by official veterinarians under the provisions set out in that amended Law.

After the entry into force of the Act amending the Law on the veterinary activity, sanctions will be applied by official veterinarians under the provisions set out in that amended Law.

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ly , . . , . Instructions have been sent to the BIPs for the proper carrying out of documentary checks of consignments intended for transit and guidance ensuring traceability of the exit of transit consignments of the EU territory. A meeting was held at the local level with Macedonian official veterinarians and the gap in the veterinary certificates for shipments in transit was discussed. Macedonian competent authorities guaranteed that Page: 1 n received from CA 29 August 2012 s of Report ref. DG(SANCO)/2012-6520-MR of an audit carried aken by the Competent Authorities with regard to the import/transit n Proposed by the Competent Authority fications would be in accordance with European legislation.

ry Instructions have been sent to the BIPs for the Update received 27 September 2012 oper carrying out of documentary checks of The desired effect for the proper on consignments intended for transit and guidance implementation of veterinary checks ensuring traceability of the exit of transit (especially documentary ones for transits consignments of the EU territory. A meeting from FYROM will be made after further as held at the local level with Macedonian verifications by central competent authorities official veterinarians and the gap in the related to the BIP's activities. erinary certificates for shipments in transit s discussed. Macedonian competent authorities guaranteed that certifications would be in accordance with European legislation.

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, . , 2001/812. ant measures have been taken by the RFSD directors, managing hrough memoranda to the attention of the BFSA's CEO for ing the necessary financial means to enhance BIPs support. BFSA uarters has been informed by RFSD directors that the facilities and ment would meet the Decision 2001/812 requirements. Page: 2

Relevant measures have been taken by the Update received 27 September 2012 RFSD directors, managing BIP through The central competent authorities develop a Page: 1 Updated Action Plan received from CA 27 September 2012 the Competent Authorities of Bulgaria on 29 August in response to Report ref. from 25 to 29 June 2012 in order to evaluate the follow-up action taken by the Competent ontrol system and border inspection posts Action Proposed by the Competent Authority Updated Action proposed by the Competent Authority memoranda to the attention of the BFSA's CEO procedure to commit RFSD to carry out for granting the necessary financial means to systematic checks ensuring conditions which enhance BIPs support. BFSA Headquarters has BIP must met, in accordance with Decision been informed by RFSD directors that the 2001/812/EC. These checks will be verified facilities and equipment would meet the as adequate during planned visits at BIP by Decision 2001/812 requirements. CCA. Page: 2

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aken into account the annual sales of veterinary medicinal VMP) provided by Control of VMPs Directorate, as in the f the plan for 2013 for testing certain substances in certain well as in the plans for the development of new methods and he scope of existing ones for 2013 in order to establish the substances from VMP.

CLVCE has taken into account the annual sales of veterinary medicinal products (VMP) provided by Control of VMPs Directorate, as in the eparation of the plan for 2013 for testing certain substances in certain animals, as well as in the plans for the development of new methods and extending the scope of existing ones for 2013 in order to establish the presence of substances from VMP. Updated actions proposed by the CA ­ 13 May 2013 On the base of Order No16/26.02.2013 issued by acting executive director of CLVCE is prepared Plan for the development of method for determining residues of amitraz in honey. At the moment the preliminary literature research (available information concerning the methods) is done and Report ( 504-5/11.04.2013 ) is prepared. At the CLVSEE the necessary conditions for development of the method are available. The deadline for development and validation of the method is the end of July 2013, after which the CLVSEE will begin analyzing samples of honey amitraz.

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11-1426/26.11.2012 of the BFSA Executive Director, is that in the first quarter of each year, until the approval of the nitoring Plan for Control on Residues (NMPCR) for the r, the official control plan of residues of veterinary medicinal be implemented in accordance with the plan for the second the previous year. Thus, it is ensured that the sampling is in variable time intervals spread over the whole year in with the requirements of the Annex of Commission Decision Presently that Order ( RD 11-1426/26.11.2012) is by all official veterinarians and inspectors involved in

Order RD 11-1426/26.11.2012 of the BFSA Executive Director, is stipulated that in the first quarter of each year, until the approval of the National Monitoring Plan for Control on Residues (NMPCR) for the current year, the official control plan of residues of veterinary medicinal products to be implemented in accordance with the plan for the second Page: 1 Updated Action Plan received from CA on 13 May 2013 (Recommendations 1 and 6). s of Report ref. DG(SANCO)/2012-6524-MR of an audit carried residues and contaminants in live animals and animal products Action Proposed by the Competent Authority quarter of the previous year. Thus, it is ensured that the sampling is implemented in variable time intervals spread over the whole year in accordance with the requirements of the Annex of Commission Decision 98/179/EC. Presently that Order ( RD 11-1426/26.11.2012) is implemented by all official veterinarians and inspectors involved in sampling.

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en removed from the official website of the BFSA ing that the consumer has no access to its contents, respectively to ring plan for VMP substances. With this action, we consider e provided the element of surprise of the inspections in with Annex III to Council Directive 96/23/EC.

MPCR has been removed from the official website of the BFSA prise ensuring that the consumer has no access to its contents, respectively to the monitoring plan for VMP substances. With this action, we consider that we have provided the element of surprise of the inspections in accordance with Annex III to Council Directive 96/23/EC.

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increase the efficiency of the VMP residues control, additions Page: 1 Action Plan received from CA on 5 March 2013 ref. DG(SANCO)/2012-6524-MR of an audit carried d contaminants in live animals and animal products posed by the Competent Authority I, IX and X of Order RD 11-1537/13.11.2011 are envisaged. atory activities" Directorate (LAD) has the obligation to rification of that particular Order every three months the sampling and testing for the respective groups of on the basis of information provided by CLVCE and ood Safety Directorates (RFSD).The Order will be modified : all promptly inform LAD within HQ of BFSA for the ies of Plan implementation; ll sent to LAD information regarding the number of samples of tested samples for every substance and matrix. n regarding the identified problems in the implementation of be promptly submitted to the respective deputy executive to take appropriate corrective action. actions, and the actions taken as a response to FVO tions No. 1 and 2, we consider that we have created the conditions for effective implementation of the monitoring plan ntrol of VMP residues of and contaminants

In order to increase the efficiency of the VMP residues control, additions in points I, IX and X of Order RD 11-1537/13.11.2011 are envisaged. The "Laboratory activities" Directorate (LAD) has the obligation to onduct verification of that particular Order every three months regarding the sampling and testing for the respective groups of substances on the basis of information provided by CLVCE and Regional Food Safety Directorates (RFSD).The Order will be modified as follows: - CLVCE shall promptly inform LAD within HQ of BFSA for the possibilities of Plan implementation; - RFSD shall sent to LAD information regarding the number of samples and number of tested samples for every substance and matrix. Information regarding the identified problems in the implementation of Page: 2 Updated Action Plan received from CA on 13 May 2013 (Recommendations 1 and 6). s of Report ref. DG(SANCO)/2012-6524-MR of an audit carried residues and contaminants in live animals and animal products by the Competent Authority tted to the respective deputy executive e corrective action. actions taken as a response to FVO we consider that we have created the ective implementation of the monitoring plan ues of

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tification of equine in Bulgaria is carried out in accordance with EC) No 504/2008. For more effective implementation of the , as of April 2013 the system for identification of equine will . Until now, the identification was carried out by Municipal eterinarians, and from April 2013 the identification will be by private practicing veterinarians. According to the Law on Action Plan received from CA on 5 March 2013 ref. DG(SANCO)/2012-6524-MR of an audit carried d contaminants in live animals and animal products Action Proposed by the Competent Authority ty (SG. 7 from 25.01.2013), every owner of animals is n individual contract with private veterinarian, and both ed (according to the provisions of Law on Veterinary rding to the contract provisions) to comply with the egulation 504/2008. training of private veterinarians was conducted on the whole country on the identification of equine. aw on Veterinary Activity, the penalties for non- ed to animal identification have been significantly

ce The identification of equine in Bulgaria is carried out in accordance with egulation (EC) No 504/2008. For more effective implementation of the the system for identification of equine will dentification was carried out by Municipal from April 2013 the identification will be ing veterinarians. According to the Law on rom 25.01.2013), every owner of animals is l contract with private veterinarian, and both ng to the provisions of Law on Veterinary e contract provisions) to comply with the 04/2008. f private veterinarians was conducted on the ry on the identification of equine. inary Activity, the penalties for non- l identification have been significantly

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sting of samples according to NMPCR for which there is no laboratory capacity, BFSA organizes a procedure for selection boratory. 2 the financial resources for the implementation of the ontracts under public procurement for delivery of ables, reagents and spare parts, have been provided. Page: 3

For the testing of samples according to NMPCR for which there is no necessary laboratory capacity, BFSA organizes a procedure for selection Page: 3 Updated Action Plan received from CA on 13 May 2013 (Recommendations 1 and 6). s of Report ref. DG(SANCO)/2012-6524-MR of an audit carried residues and contaminants in live animals and animal products oposed by the Competent Authority ernal laboratory. d of 2012 the financial resources for the implementation of the CLVCE contracts under public procurement for delivery of , consumables, reagents and spare parts, have been provided. ctions proposed by the CA ­ 13 May 2013 till in the procurement procedure for selection of external ies and not selected laboratories

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back- According to art. 51 of Law on the Veterinary Activity all animal o-date as holdings are subject to obligatory registration and all animals kept in - to identification. The BFSA maintains an Integrated Information System (electronic database) ­ VetIS with all data for holdings, identified animals and animal movements. As additional guaranty that all pigs holdings including backyards are registered and the register is kept up to date a new instruction was issued (Order RD 11-365/26.03.2013 of the Executive Director of BFSA) for implementation of measures for control of classical swine fever in Bulgaria and the recommendations of the FVO Audit carried out in Bulgaria from 19 to 26.11.2012. in order to assess the measures for control of classical swine fever(DG (SANCO) /2012-6602), http://babh.government.bg/uploads/File/Zdraveopazvane/Zarazni_bolesti /Klasicheska_chuma_svine/Instruction%20CSF%20program_final.pdf In p. I of this instruction are defined the rules and timetable for the control to be applied on the registration of pig holdings and animal identification, the obligations of official veterinarians at municipal level, of Heads of Animal Health Departments at the RFSD-s

51 of Law on the Veterinary Activity all animal holdings are subject to obligatory ion and all animals kept in - to identification. The BFSA maintains an Integrated Information electronic database) ­ VetIS with all data for holdings, identified animals and animal onal guaranty that all pigs holdings including backyards are registered and the register is kept e a new instruction was issued (Order RD 11-365/26.03.2013 of the Executive Director of implementation of measures for control of classical swine fever in Bulgaria and the ations of the FVO Audit carried out in Bulgaria from 19 to 26.11.2012. in order to assess the for control of classical swine fever(DG (SANCO) /2012-6602), bh.government.bg/uploads/File/Zdraveopazvane/Zarazni_bolesti/Klasicheska_chuma_svine/Inst 0CSF%20program_final.pdf f this instruction are defined the rules and timetable for the control to be applied on the ion of pig holdings and animal identification, the obligations of official veterinarians at level, of Heads of Animal Health Departments at the RFSD-s and AHAW directorate at the BFSA as well as the sanctions in case of noncompliance with the relevant legislation. June 2013: ted there is already a legal

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to In order to ensure that all pig movements, including those to backyards, Page: 1 ndations of Report ref. DG(SANCO)/2012-6602-MR of an audit carried health controls on classical swine fever tion Action Proposed by the Competent Authority quired are recorded as required by Article 4 of Council Directive 2008/71/EC, it was ordered all guidelines of p. II of the new instruction (approved by Order of Executive Director of BFSA RD 11-365/26.03.2013.) for implementation of measures for control of classical swine fever in Bulgaria and the recommendations of the FVO Audit carried out in Bulgaria from 19 to 26.11.2012 in order to assess the measures for control of classical swine fever(DG (SANCO) /2012-6602), to be strictly followed. http://babh.government.bg/uploads/File/Zdraveopazvane/Zarazni_bolesti /Klasicheska_chuma_svine/Instruction%20CSF%20program_final.pdf According to this point the following has to be performed: 1. Official municipal veterinarians together with police officers carry out regular inspections on farms and on during the journey of animals the documentation issued for their movements. The inspections are carried out according to the timetable specified in section . p

ure that all pig movements, including those to backyards, are recorded as required by cle 4 of Council Directive 2008/71/EC, it was ordered all guidelines of p. II of the new instruction ed by Order of Executive Director of BFSA RD 11-365/26.03.2013.) for implementation of Page: 2 bmitted by the Competent Authorities of Bulgaria on 05 April in response to Report ref. rom 19 to 26 November 2012 in order to evaluate the animal health controls on classical Action Proposed by the Competent Authority es for control of classical swine fever in Bulgaria and the recommendations of the FVO Audit n Bulgaria from 19 to 26.11.2012 in order to assess the measures for control of classical er(DG (SANCO) /2012-6602), to be strictly followed. ploads/File/Zdraveopazvane/Zarazni_bolesti/Klasicheska_chuma_svine/Inst al.pdf following has to be performed: inarians together with police officers carry out regular inspections on farms f animals the documentation issued for their movements. The inspections are e timetable specified in section . p.1. th police officials are carried out in accordance with the provisions of ich determines the rules for interaction between the veterinary experts of internal aff

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ion To ensure that the requirements in Article 11(a) of Commission Decision mestic 2008/855/EC are enforced on all holdings for domestic pigs the measures under section III of the Instruction (approved by Executive Director of BFSA RD 11-365/26.03.2013) for ation of measures for control of classical swine fever in and the recommendations of the FVO Audit carried out in from 19 to 26.11.2012. in order to assess the measures for f classical swine fever(DG (SANCO) /2012-6602), bh.government.bg/uploads/File/Zdraveopazvane/Zarazni_bolesti ska_chuma_svine/Instruction%20CSF%20program_final.pdf ed: Page: 3 ndations of Report ref. DG(SANCO)/2012-6602-MR of an audit carried health controls on classical swine fever oposed by the Competent Authority pal Official veterinarian carries out checks on pig farms for ty level pursuant to Art. 11 of Ordinance 44 of April 20, nimal health requirements for holdings pal Official veterinarian carries out checks for the ation of the provisions of Ordinance 6 of 20 March 2007 nditions and procedure for pasture breeding of East-Balkans their crossbreds. pal Official veterinarian carries out checks for the ation of Order RD 09-27 / 15.01.2010 of MAF and Order

hat the requirements in Article 11(a) of Commission Decision 2008/855/EC are enforced on s for domestic pigs the following measures under section III of the Instruction (approved by ecutive Director of BFSA RD 11-365/26.03.2013) for implementation of measures for classical swine fever in Bulgaria and the recommendations of the FVO Audit carried out in om 19 to 26.11.2012. in order to assess the measures for control of classical swine fever(DG /2012-6602), .government.bg/uploads/File/Zdraveopazvane/Zarazni_bolesti/Klasicheska_chuma_svine/Inst SF%20program_final.pdf : Page: 4 bmitted by the Competent Authorities of Bulgaria on 05 April in response to Report ref. rom 19 to 26 November 2012 in order to evaluate the animal health controls on classical ion Proposed by the Competent Authority inarian carries out checks on pig farms for biosecurity level pursuant to Art. l 20, 2006 on animal health requirements for holdings inarian carries out checks for the implementation of the provisions of 07 on the conditions and procedure for pasture breeding of East-Balkans inarian carries out checks for the implementation of Order RD 09-27 / RD 11-45 / 26.01.2010. 1-3 are performed by Municipal Off

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onitoring The head of AH department at RFSD and the AHAW Directorate at the aid down, HQ of BFSA carry out periodical checks of the lower levels pursuant to ol plan the provisions of new Instruction on the check of the effectiveness of the . official control in the scope of Animal Health and Welfare in accordance 8, point 3 of Regulation 882/2004 (approved by Order RD .03.2013 of the Executive Director of BFSA) bh.government.bg/uploads/File/Zdraveopazvane/Humanno_otno struction_official%20control_AHWD_final.pdf to ensure that g and control measures for domestic pigs meet the targets laid he annual CSF control programme nal Food Safety Directorate sends to AHAW Directorate at the A report (in accordance with the template in the Annex of ram) about the checks carried out on a quarterly basis, the ance detected and the sanctions imposed for the period. escribed in p. IV of the new Instruction for implementation of for control of classical swine fever in Bulgaria and the Page: 5 ndations of Report ref. DG(SANCO)/2012-6602-MR of an audit carried health controls on classical swine fever Action Proposed by the Competent Authority recommendations of the FVO Audit carried out in Bulgaria fr

f AH department at RFSD and the AHAW Directorate at the HQ of BFSA carry out l checks of the lower levels pursuant to the provisions of new Instruction on the check of the ness of the official control in the scope of Animal Health and Welfare in accordance with art. 8, of Regulation 882/2004 (approved by Order RD 11-343/20.03.2013 of the Executive Director BFSA) vernment.bg/uploads/File/Zdraveopazvane/Humanno_otnoshenie/Instruction_official%20c nal.pdf to ensure that monitoring and control measures for domestic pigs meet the own in the annual CSF control programme ood Safety Directorate sends to AHAW Directorate at the HQ of BFSA report (in h the template in the Annex of this program) about the checks carried out on a quarterly compliance detected and the sanctions imposed for the period. bed in p. IV of the new Instruction for implementation of measures for control of classical Bulgaria and the recommendations of the FVO Audit carried out in Bulgaria from 19 to order to assess the measures for control of classical swine fever(DG (SANCO) /2012- d with Order of Executive Director of BFSA RD 11-365/26.03.2013) vernment.bg/uploads/File/Zdraveopazvane/Zarazni_bolesti/Klasicheska_chuma_

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into A new Instruction for targeted sampling of wild boar in the framework ex to of the annual CSF control program was approved by Order RD 11- 365/26.03.2013 of the Executive Director of BFSA. http://babh.government.bg/uploads/File/Zdraveopazvane/Zarazni_bolesti /Klasicheska_chuma_svine/Instruction%20CSF%20WB%20sampling_fi nal.pdf For the purpose of targeted survey of the CSF health status of wild boar in this instruction the whole territory of Bulgaria is divided into 80 zones, 15 of them (along the North and West borders) classified as high risk and the remaining 65 as low risk for CSF. The population of the wild boar in each of the zones (1 to 80) is approximately between 350 and 1,600 heads (Executive Forestry Agency, 2012). Pursuant to the Instruction a sampling scheme of 59 heads is planned for each zone (1-80) to detect the disease at 5% prevalence with 95% Page: 6 ndations of Report ref. DG(SANCO)/2012-6602-MR of an audit carried health controls on classical swine fever Action Proposed by the Competent Authority confidence for the goals of the annual CSF surveillance in wild boar. The plan is in line with the recommendations of EFSA: "Control and eradication of CSF in wild

ction for targeted sampling of wild boar in the framework of the annual CSF control was approved by Order RD 11-365/26.03.2013 of the Executive Director of BFSA. abh.government.bg/uploads/File/Zdraveopazvane/Zarazni_bolesti/Klasicheska_chuma_svine/Inst %20WB%20sampling_final.pdf argeted survey of the CSF health status of wild boar in this instruction the whole a is divided into 80 zones, 15 of them (along the North and West borders) classified remaining 65 as low risk for CSF. e wild boar in each of the zones (1 to 80) is approximately between 350 and 1,600 estry Agency, 2012). Page: 8 bmitted by the Competent Authorities of Bulgaria on 05 April in response to Report ref. rom 19 to 26 November 2012 in order to evaluate the animal health controls on classical Action Proposed by the Competent Authority t to the Instruction a sampling scheme of 59 heads is planned for each zone (1-80) to detect the at 5% prevalence with 95% confidence for the goals of the annual CSF surveillance in wild boar. n is in line with the recommendations of EFSA: "Control and eradication of CSF in wild boar". A Journal (2009) 932 pling of the wild boar population in each of the zones is planned according to t

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By Order RD 11-363/25.03.2013 of the Executive Director of BFSA a five-member expert group is nominated in line with the requirements of this Article 15(2)(a) of Council Directive 2001/89/EC to review on a regular ccination basis the results of the vaccination campaigns in wild boar as required by this Article 20(2) (k) of this Directive and to analyses their effects on the immune status of the wild boar population. The expert group submits the analysis to the CVO, specify the deficiencies found and propose corrective actions, if needed.

r RD 11-363/25.03.2013 of the Executive Director of BFSA a five-member expert group is ed in line with the requirements of Article 15(2)(a) of Council Directive 2001/89/EC to review gular basis the results of the vaccination campaigns in wild boar as required by Article 20(2) (k) rective and to analyses their effects on the immune status of the wild boar population. The t group submits the analysis to the CVO, specify the deficiencies found and propose corrective needed.

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The AHAW Directorate at the headquarter of BFSA has always reported the state of play and will report and submit for approval to the as Commission any amendment of the annual control program for CSF /EC. Page: 7 ndations of Report ref. DG(SANCO)/2012-6602-MR of an audit carried health controls on classical swine fever Action Proposed by the Competent Authority In April (16 17.04.2013) CSF TASKFORCE meeting in Bucharest, Romania, will be held and the Commission also will be present. During the session BFSA will report about the: - implementation of the CSF control programs in 2012 and 2013; - measures taken on the recommendations of the FVO Audit carried out in Bulgaria from 19 to 26.11.2012 assessed the measures for control of classical swine fever(DG (SANCO) /2012-6602); - planned targeted sampling for CSF surveillance in wild boar. Until 04/30/2013 BFSA will submit to the European Commission for approval the 2014 CSF control program.

ectorate at the headquarter of BFSA has always reported the state of play and will report Page: 9 bmitted by the Competent Authorities of Bulgaria on 05 April in response to Report ref. rom 19 to 26 November 2012 in order to evaluate the animal health controls on classical ion Proposed by the Competent Authority it for approval to the Commission any amendment of the annual control program for CSF (16-17.04.2013) CSF TASKFORCE meeting in Bucharest, Romania, will be held and the on also will be present. During the session BFSA will report about the: plementation of the CSF control programs in 2012 and 2013; asures taken on the recommendations of the FVO Audit carried out in Bulgaria from 19 to 26.11.2012 assessed the measures for control of classical swine fever(DG (SANCO) /2012- 6602); anned targeted sampling for CSF surveillance in wild boar. /30/2013 BFSA will submit to the European Commission for approval the 2014 CSF control

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les are During 26-28.03.2013, the NRL for CSF was audited by the Bulgarian he Accreditation Service (BAS) in conjunction with re-accreditation of the 004. analytical methods and the extension of the real time PCR (letter 69/227 19.03.2013 of BAS). The audit was successfully finalized with a positive evaluation and within one month from the date of the audit the Research Laboratory for Exotic and Emergency Contagious disease within the National Diagnostic and Reasearch Veterinary Institute (NRL for CSF is within its' scope) will receive an official extension from the BAS. As next step documentation will be submitted to BAS for further extension of the scope of accredited methods (which according to Bulgarian law is 30% of the already accredited methods) for VNT for Page: 8 ndations of Report ref. DG(SANCO)/2012-6602-MR of an audit carried health controls on classical swine fever oposed by the Competent Authority NT to distinguish antibodies against Bovine Viral Diarrhea ­ isease and Border disease. It is expected that the tion will be submitted to BAS by the end of September 2013 rocedure will be finalized in March 2014.

8.03.2013, the NRL for CSF was audited by the Bulgarian Accreditation Service (BAS) in ion with re-accreditation of the analytical methods and the extension of the real time PCR (letter 19.03.2013 of BAS). The audit was successfully finalized with a positive evaluation and ne month from the date of the audit the Research Laboratory for Exotic and Emergency disease within the National Diagnostic and Reasearch Veterinary Institute (NRL for CSF is ope) will receive an official extension from the BAS. step documentation will be submitted to BAS for further extension of the scope of accredited (which according to Bulgarian law is 30% of the already accredited methods) for VNT for CSF to distinguish antibodies against Bovine Viral Diarrhea ­ Mucosal Disease and Border disease. pected that the documentation will be submitted to BAS by the end of September 2013 and the e will be finalized in March 2014. Page: 10 bmitted by the Competent Authorities of Bulgaria on 05 April in response to Report ref. rom 19 to 26 November 2012 in order to evaluate the animal health controls on classical ion Proposed by the Competent Authority

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SF control Director of the National Diagnostic and Research Veterinary Institute at testing BFSA has declared the need for timely purchase of 100 doses of ed in the diagnostic kit for real time PCR (report ref. 4147/22.03.2013), which 2)(c) of will be sufficient till the completion of an ongoing tender for the of diagnostic kits expected to be finalized in May 2013. The approved by the CVO and the laboratory will be collateralized out the necessary tests. Page: 9

r of the National Diagnostic and Research Veterinary Institute at BFSA has declared the need rchase of 100 doses of diagnostic kit for real time PCR (report ref. 4147/22.03.2013), be sufficient till the completion of an ongoing tender for the purchase of diagnostic kits be finalized in May 2013. The report is approved by the CVO and the laboratory will be ralized to carry out the necessary tests. Page: 11

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01.01.2012 ., ( ) () () , . (), , , . , .

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, " " , .

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. 1 - Page: 1 ed on 23 December 2011 of Report ref. DG(SANCO)/2011-8924-MR of an audit carried carried out at border inspection posts and specific issues at selected ion Proposed by the Competent Authority : - , , ., , ; - 20.01.2012 . , - .. , , . -

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47 97 /78, . Page: 2

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ial Chapter 6 (Food Inspection) of the Foodstuffs Act BFSA is the competent authority that ts out the powers of the supervising bodies. carries out official controls on food at all These powers are conferred upon the Bulgarian Food stages of production, processing and fety Agency (BABH) by Article 3(1) and (2) of the distribution. Bulgarian Food Safety Agency Act (ZBABH) and EAFA (Executive Agency of Fisheries Article 30 of the Foodstuffs Act. and Aquaculture), which is also part of the MAF - is the competent authority to carry However, by virtue of Article 28(3) of that Act out activities in the organization, `bottled mineral, spring and table water, shall be management, usage and protection of fishery inspected by the Regional Health Inspectorates of the resources in the waters of the Republic of Ministry of Health'. Bulgaria, fish trading and trading with other aquatic organisms. Regulatory basis for this is the National legislation - 1.Law on Fisheries and Aquaculture (FAA) promulgated., SG. 41 of 24.04.2001 last amended and supplemented. SG. 77 of 09.10.2012, and 2. Ordinance 4 of 13.01.2006 on the terms and conditions for the primary sale of fish and other aquatic organisms.

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ining has been planned on the assessment of ACCP procedures in place at (i) catering facilities sales outlets, and (ii) plants processing food of -animal origin. Deadline: 15.4.2012. following guidance material has been forwarded all Provincial Food Safety Directorates (ODBH): uidelines on the verification of compliance with icle 5 of Regulation No 852/2004 on the hygiene foodstuffs and the compliance with certain visions of that Regulation; anual on the application of HACCP procedures the implementation of HACCP principles to tain food-related activities; anual on food traceability; raining manual on food safety issued by the vak Chamber of Crafts and Industry (adapted by Bulgarian Union for Free Enterprise - SSI). imum accessibility to all legislation in the area of Page: 3 Authority 22/10/2012 the Competent Authorities of Bulgaria on 02 April in response to Report ref. from 30 November to 07 December 2011 in order to assess the official control systems in and bottled water by the Competent Authority Updated Comments by the Competent Authority received 22/10/2012 h in hard copy and in electronic form, d for all state health inspectors. The lth has prepared guidelines for the new

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rovision of calibrated thermometers as needed by he Provincial Food Safety Directorates. Deadline: 4 30.6.2012. n Operating Manual for digital thermometers and hermometer probes has been issued.

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ll establishments subject to inspection by the BABH Under Chapter I, Article 1, paragraph 2 of are registered; registers can be found on the BABH the Law on Food - the requirements and rules ebsite. The re-registration of the retail and catering for wine and spirits are governed by the Law stablishments is currently being finalised (deadline on Wine and Spirits. 31.3.2012). According to Article 2, paragraph 2 of the ll producers of bottled water are registered in line Law on wine and spirits, Minister of ith Article 12 of the Foodstuffs Act and Article 31 Economy, Energy and Tourism implements f Regulation (EC) No 882/2004. The register can be the state policy on the production of ethyl ound on the website of the Ministry of Health (by alcohol of agricultural origin, distillates of Page: 9 Authority 22/10/2012 the Competent Authorities of Bulgaria on 02 April in response to Report ref. from 30 November to 07 December 2011 in order to assess the official control systems in and bottled water by the Competent Authority Updated Comments by the Competent Authority received 22/10/2012 egisters tab and then Mineral Waters agricultural origin and spirit drinks. wn menu): Under article 2, p

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meeting with professional organisations of estaurant owners and managers, chefs, bakers and confectioners is to be held to prepare a Manual for ractices in manufacturing and hygiene at ng and retail establishments. Deadline: 012. idance material listed in point 2 of these endations has already been sent to all peration with the Ministry of Health, the ian Association of Non-Alcoholic Beverage ers has issued a manual on HACCP and good ic practices in the marketing of bottled water.

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he Pursuant to Article 6(a) of Regulation (EC) No 82/2004, a training course has been given to staff of the Sofia RZI verifying compliance with the rules and regulations on the labelling and marketing of bottled l, spring and table water for human ption. Page: 12 Authority 22/10/2012 the Competent Authorities of Bulgaria on 02 April in response to Report ref. from 30 November to 07 December 2011 in order to assess the official control systems in and bottled water Proposed by the Competent Authority Updated Comments by the Competent Authority received 22/10/2012 ficial personally responsible, by order of the or of the Sofia RZI, for inspecting producers of d mineral, spring and table waters in Sofia has ed the relevant training and has been arised with the relevant procedures for tion, sampling and HACCP assessment. ry inspection inspectors must complete a list to assess the procedures concerning and good practices in manufacturing and e. They must also complete an inspection and hand a copy to the business operator.

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G SANCO's guidance document on the entation of procedures based on the HACCP inciples and on the facilitation of the implementation of the HACCP principles in the f certain food businesses has been sent to all ODBHs. e issued the 2012 Operational guidelines for ODBHs for inspections (sampling) of raw materials odstuffs of non-animal origin, additives and s entering into contact with food. llowing procedures have been put in place: ting inspections to identify pesticide residues Page: 13 Authority 22/10/2012 the Competent Authorities of Bulgaria on 02 April in response to Report ref. from 30 November to 07 December 2011 in order to assess the official control systems in and bottled water n Proposed by the Competent Authority Updated Comments by the Competent Authority received 22/10/2012 odstuffs of non-animal origin; g samples to identify pesticide residues in tuffs of non-animal origin; g samples to identify the presence of oxins in foodstuffs of non-animal origin; s response procedures in connection with food- illness. ing courses have been planned on the sment of HACCP-related procedures in catering etail establishments, and at plants processing of non-animal origin. Deadline: 1

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Suitable sampling equipment has been provided. he Instructions for handling sampling equipment are ing drafted. Deadline: 31.3.2012.

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Pursuant to Order No RD 11 1009 of 23.8.2011 Pursuant to Order No RD 11 1009 of issued by the Director-General of the BABH and in 23.8.2011 issued by the Director-General of dance with the approved timetable for 2011, the BABH and in accordance with the s national reference laboratories have carried approved timetable for 2011, BABH's nterlaboratory tests with the regional national reference laboratories have carried atories. The results can be found in the reports out interlaboratory tests with the regional Page: 14 Authority 22/10/2012 the Competent Authorities of Bulgaria on 02 April in response to Report ref. from 30 November to 07 December 2011 in order to assess the official control systems in and bottled water by the Competent Authority Updated Comments by the Competent Authority received 22/10/2012 national reference laboratories. laboratories. The results can be found in the tory tests concerning the identification reports prepared by the national reference pp. and Listeria monocytogenes were laboratories. October and November 2011. The The interlaboratory tests concerning the found in the relevant reports. identification of Salmonella spp. and Listeria timetable for inter

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e In line with the findings of the audit carried out by he the Commission's Food and Veterinary Office (FVO), a number of adjustments have been made. These are the Quality Management System for coming under the Sofia RZI in ith BDS EN ISO/IEC 17025:2006 Page: 16 Authority 22/10/2012 the Competent Authorities of Bulgaria on 02 April in response to Report ref. from 30 November to 07 December 2011 in order to assess the official control systems in and bottled water on Proposed by the Competent Authority Updated Comments by the Competent Authority received 22/10/2012 tled `General qualifications required from testing calibration laboratories'. quality procedures concerning the methods and itions under which samples are analysed have amended in accordance with Regulation (EC) 82/2004. protocols for method validation include an racy assessment, as defined in Annex II to ctive 2003/40/EC. ouse training has been organised in order to te staff on the amendments to the Management em.

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on The BABH is the national authority responsible for the inspection of plant-health activities, raw materials e and foodstuffs (with the exception of bottled mineral, ng and table water), objects coming into contact food, and compliance with EU quality standards the marketing of fresh fruit and vegetables. an for joint inspections with other competent orities in 2012 and 2013 is to be drafted by 5.2012. eting with these authorities to draft the joint Page: 17 Authority 22/10/2012 the Competent Authorities of Bulgaria on 02 April in response to Report ref. from 30 November to 07 December 2011 in order to assess the official control systems in and bottled water ction Proposed by the Competent Authority Updated Comments by the Competent Authority received 22/10/2012 lan is to be held by 30.4.2012.

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he BABH has an internal auditing mechanism in lace, which includes a procedure, document emplates and an annual audit plan approved by the irector-General of the BABH and published on the ebsite of the BABH together with the action plans f the audited entities. n audit plan has been prepared for food inspections arried out by RZIs in accordance with Commission ecision 2006/677/EC. nder this plan, the inspection bodies of the Ministry f Health are subjected to internal audits twice a year. hese are conducted in line with the relevant auditing rinciples (notification of the audited party, greement on the date and audit plan, introductory eeting, completion of a check-list outlining the udit criteria, closing meeting with discussion on the on-conformities identified, preparing a paper on the on-conformities with a deadline for remedial action, udit report, inspection of the remedial action and, epending on the outcome, enforcement).

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ursuant to Order No RD 09-113 of 7.2.2012 issued Page: 18 Authority 22/10/2012 the Competent Authorities of Bulgaria on 02 April in response to Report ref. from 30 November to 07 December 2011 in order to assess the official control systems in and bottled water Proposed by the Competent Authority Updated Comments by the Competent Authority received 22/10/2012 by the Minister of Agriculture and Food, an inter- services working group has been established to the Procedural Handbook for the Rapid Alert for Food and Feedstuffs (RASFF). The g group comprises representatives of the ry of Health, BABH, the Executive Agency of nd Wines, the Commission for Consumer tion and the Ministries of Justice , Defence and terior . The update of the procedural handbook es these three ministries in the RASFF ation exchange system. The draft updated ok is currently being coordinated at working level. ultation process is currently under way in ia concerning amendments to the Foodstuffs hese include a proposal for a Regulation on the ements concerning the establishment and ion of a Rapid Alert System for Food and uffs (RASFF). Furthermore, by Order No RD of 7.2.2012, the Minister of Agriculture and as ord