2019-6654 Final Report of an Audit Carried out In

Ref. Ares(2019)7826731 - 19/12/2019

EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY

Health and food audits and analysis

DG(SANTE) 2019-6654

FINAL REPORT OF AN AUDIT CARRIED OUT IN BELARUS FROM 13 TO 24 MAY 2019 IN ORDER TO EVALUATE THE CONTROL OF RESIDUES AND CONTAMINANTS IN LIVE ANIMALS AND ANIMAL PRODUCTS INCLUDING CONTROLS ON VETERINARY MEDICINAL PRODUCTS Executive Summary

This report describes the outcome of an audit carried out in Belarus from 13 to 24 May 2019 as part of the European Commission’s Directorate-General for Health and Food Safety planned work programme. The objective of the audit was to evaluate the effectiveness of official controls on residues and contaminants in live animals and animal products eligible for export to the European Union (EU). The audit assessed the implementation of the residue monitoring plan and also covered the authorisation, distribution and use of veterinary medicinal products, given that these areas have an impact on the monitoring of residues. Attention was also paid to examining the implementation of corrective actions indicated in response to specific recommendations made in the report of the previous residues audit to Belarus. The planning of the residue monitoring largely follows the principles of Directive 96/23/EC and covers for the most part an appropriate range of substances. The plan is nevertheless weakened by the fact that action levels for several substances across all commodities (including those for which listing has been requested) are not aligned with EU maximum residue limits, thus the plan would not be sufficient to demonstrate that commodities eligible for export to the EU would comply with such limits where they are lower that national limits. Implementation of sampling and testing is timely but some aspects of the sampling strategy weaken the effectiveness of the plan, for example, the exclusion of significant parts of the national production of pigmeat and honey from sampling, failure to ensure the analytical and legal integrity of milk samples and pooling of muscle samples from individual animals in one slaughter lot into a single test sample. Follow-up of non-compliances is supported by detailed staff instructions but is nevertheless weakened by factors such as pre- notification of operators of follow-up inspections and limited (or inappropriate) implementation of follow-up sampling. With regard to the laboratory, the fact that it is accredited, has effective internal quality control measures in place, is equipped with state of the art equipment, is analysing samples promptly and, for the matrices for which method validation has been performed, has demonstrated those methods' fitness for purpose by its successful participation in external proficiency tests, collectively provides confidence in the reliability of results. However, work remains to be done as there are still several methods for which there is a lack of validation data and some analyte/matrix combinations for which there are no methods established to date. With regard to veterinary medicinal products and official controls thereof, notwithstanding differences with the EU concerning the list of authorised veterinary medicinal products, the legal framework and official control system governing the authorisation, distribution and use of veterinary medicinal products in general underpin the guarantees on residues monitoring required by Directive 96/23/EC. There is however one exception to this; the possibility to use 17-beta oestradiol and its derivatives for the treatment of female cattle means that Belarus would not be in a position to sign the EU health certificate in the event that beef was being exported to the EU and this precludes the listing of Belarus in the Annex to Decision 2011/163/EU for this commodity. The report contains recommendations to the Belarusian competent authorities aimed at rectifying the shortcomings identified and enhancing the implementing and control measures in place.

i TABLE OF CONTENTS

1. INTRODUCTION ...... 1 2. OBJECTIVES OF THE AUDIT AND AUDIT CRITERIA ...... 1 3. LEGAL BASIS FOR THE AUDIT ...... 2 4. BACKGROUND ...... 2 4.1. Country status in relation to EU-approval of residue monitoring plans ...... 2 4.2. Summary of the previous residue audit ...... 2 4.3. Rapid Alert System for Food and Feed (RASFF) notifications since 2014 ...... 2 4.4. Production, trade information and specific import requirements ...... 3 5. FINDINGS AND CONCLUSIONS ...... 3 5.1. Residue monitoring...... 3 5.2. Veterinary medicinal products...... 14 6. OVERALL CONCLUSION ...... 19 7. CLOSING MEETING ...... 19 8. RECOMMENDATIONS...... 20 Annex 1 – Legal References

ii ABBREVIATIONS &DEFINITIONS USED IN THIS REPORT

AITS Animal Identification Traceability System BSCA Belarusian State Centre for Accreditation BSVC Belarusian State Veterinary Centre DVFS Department of Veterinary and Food Supervision EaEU Eurasian Economic Union ELISA Enzyme-linked immuno-sorbent assay EU European Union EURL European Union Reference Laboratory GC-MS/MS Gas Chromatography-(Tandem) Mass Spectrometry GFAAS Graphite Furnace Atomic Absorption Spectrometry Group A, B Categories of substances listed in Annex I to Council Directive 96/23/EC ISO International Organization for Standardization LC-MS/MS Liquid Chromatography-(Tandem) Mass Spectrometry MAF Ministry of Agriculture and Food ML Maximum Limit MRL Maximum Residue Limit MRPL Minimum Required Performance Limits PCBs Polychlorinated biphenyls RASFF Rapid Alert System for Food and Feed Safety Plan Plan for laboratory testing of products of animal origin on safety indicators

iii 1. INTRODUCTION

The audit took place in Belarus from 13 to 24 May 2019 as part of the Directorate- General for Health and Food Safety planned work programme. An opening meeting was held on 13 May with the respective departments of the Ministry of Agriculture and Food (MAF). At this meeting, the objectives and the itinerary of the audit were confirmed and the control systems were described by the authorities. Representatives from the central competent authorities accompanied the audit team during the whole audit.

2. OBJECTIVES OF THE AUDIT AND AUDIT CRITERIA

The objective of the audit was to evaluate the effectiveness of official controls on residues and contaminants in live animals and animal products eligible for export to the European Union (EU). It assessed:  the planning and implementation of the residue monitoring plan for equidae (live horses for slaughter in the EU), aquaculture, milk and eggs listed in the Annex to Commission Decision 2011/163/EU;  the planning and implementation of the residue monitoring plan for cattle, pigs, poultry and honey for which Belarus has requested to be listed in the Annex to Commission Decision 2011/163/EU.  the reliability of the guarantees in ensuring that the commodities eligible for export to the EU do not contain residues of veterinary medicinal products, pesticides and contaminants exceeding EU maximum limits;  the measures taken in response to the report of the last audit (DG(SANCO)/2014- 7032 1, hereafter the 2014 report) in which residue monitoring and identification of equidae were evaluated. Since the national rules governing the authorisation, distribution and use of veterinary medicinal products (including those administered via feed) have an impact on residue monitoring, the control systems in these areas were also part of the audit. The principal audit criteria against which fulfilment of the above objective were assessed comprised Council Directive 96/23/EC and Directive 2001/82/EC of the European Parliament and of the Council. The following table lists the sites visited and meetings held in order to achieve the audit objective.

MEETINGS/VISITS n COMMENTS Opening and closing meetings with the relevant Central 2 departments of MAF. COMPETENT Veterinary Departments within Committees of AUTHORITIES Regional 2 Agriculture and Food of Regional Executive Boards in Minsk and Brest.

1 Available at: http://ec.europa.eu/food/audits-analysis/audit_reports/details.cfm?rep_id=3436

1 MEETINGS/VISITS n COMMENTS Meetings with District Veterinary Services on farms, Local 4 processing establishments and with representatives of several district veterinary stations. LABORATORIES 2 The Belarusian State Veterinary Centre (BSVC) 1 pig farm, 1 poultry farm, 1 dairy farm, 1 bee farm, FARMS 5 1 aquaculture farm producing finfish. 1 slaughterhouse for bovine and pigs, 1 ESTABLISHMENTS 4 slaughterhouse for poultry, 1 honey processing establishment, 1 dairy processing establishment. 1 wholesaler and 1 retailer of veterinary medicinal OTHER SITES 2 products.

3. LEGAL BASIS FOR THE AUDIT

The audit was carried out under the general provisions of EU legislation, and in particular Article 46 of Regulation (EC) No 882/2004 of the European Parliament and of the Council.

4. BACKGROUND

4.1. Country status in relation to EU-approval of residue monitoring plans

Belarus is listed in the Annex to Commission Decision 2011/163/EU with a residue monitoring plan approved in accordance with Directive 96/23/EC for equine, aquaculture milk and eggs. In addition to these commodities, in 2018 Belarus requested to be listed for cattle, pigs, poultry and honey.

4.2. Summary of the previous residue audit

The 2014 report concluded that the guarantees provided by the residue control system for eggs, aquaculture products and milk were, with some exceptions, broadly equivalent to those foreseen by EU legislation. Nevertheless, the effectiveness of the residue monitoring plan was undermined by the lower than required number of samples tested for Group A substances, the use of unvalidated analytical methods and the lack of participation of certain laboratories in proficiency tests. With regard to the controls on the use of veterinary medicinal products in food-producing animals the report mentioned that the use of pharmacologically active substances which are prohibited in the EU and in Belarus (nitroimidazoles and nitrofurans) had been identified in poultry. In addition, the report indicated that a system for equine identification and traceability equivalent to that in the EU had not been implemented in practice as there had been no exports of live horses for direct slaughter in the EU since 2012 and no establishments were registered to export such horses.

4.3. Rapid Alert System for Food and Feed (RASFF) notifications since 2014

From January 2014 to May 2019, there was one notification made under the RASFF for residues of veterinary medicinal products in carp (aquaculture).

2 4.4. Production, trade information and specific import requirements

In 2018, Belarus exported 1,171 tonnes milk and dairy products and 1,507 tonnes of aquaculture products. No eggs for human consumption or horses for direct slaughter were exported to the EU. Since January 2018, four aquaculture processing establishments are listed to be eligible to export their products to the EU and since November 2018, nine dairy processing establishments are EU-approved. With regard to the commodities for which Belarus requested to be listed in the Annex to Decision 2011/163/EU with an approved residue monitoring plan, MAF informed the audit team that at the time of the audit, 31 slaughterhouses, 31 cutting and processing establishments for red meat, 23 cutting establishments for poultry meat and 34 honey collection establishments are considered to be eligible for EU-approval as a pre-requisite for export to the EU.

5. FINDINGS AND CONCLUSIONS

5.1. Residue monitoring

5.1.1. Competent authorities

1. The Department of Veterinary and Food Supervision (DVFS) within MAF, is responsible for the planning, implementation and supervision of the residue monitoring plan. Under the authority of DVFS, the Belarusian State Veterinary Centre (BSVC), the veterinary departments of the six Committees on Agriculture and Food of the Regional Executive Boards (hereafter, the Regions) and the district veterinary stations (hereafter, the Districts) take part in the planning and implementation of the residue monitoring plan for all commodities.

5.1.2. Planning of residue monitoring

Legal Requirements Article 29 of Directive 96/23/EC. References to the Union legislation applicable in the EU Member States are provided as footnotes for informative purposes. Findings 2. Both the legal basis and the annual planning process of the residue monitoring plan remain as described in the 2014 report. Similar to what happens in the EU 2, before the end of each calendar year, the BSVC requests the regions and districts to prepare and submit their draft residue monitoring plans for the year to come. These draft plans are based on the annual production in the previous year. A list of veterinary medicinal products used in the past year must also be submitted by each of the districts. This information is collated by the BSVC and consolidated into the annual national residue monitoring plan, which is approved, based on national legislation 3, at the beginning of the calendar year, by order of MAF.

2 Article 7 of Directive 96/23/EC. 3 Resolution of the Ministry of Agriculture and Food No 18, dated 28 March 2012.

3 3. The 2019 residue monitoring plan covers cattle, pigs, poultry, horses, aquaculture, milk, eggs and honey. For each of these commodities the selection of substance groups as well as the levels and frequencies of sampling are largely similar to those that would be expected in the EU 4 with the total number of samples planned for each commodity meeting the minimum required by EU legislation.

4. Action levels/decision limits are lower than EU Minimum Required Performance Limits (MRPLs) 5 and largely take into account maximum residue limits (MRLs) and maximum levels (MLs) applicable in the EU 6. Nevertheless, for certain substances action levels follow national and Eurasian Economic Union (EaEU) legislation 7 and are higher than those applicable in the EU:  Pigs: for halofuginone (B2b), the action level in muscle is set at 10 µg/kg while the EU MRL is 3 µg/kg;  Poultry: the action levels for streptomycin and dihydrostreptmycin (B1) in muscle are set at 100 µg/kg (limit of detection) while there is no MRL for these substances in poultry muscle in the EU (EU MRLs are set for other species);  Aquaculture: the action levels for several B1 substances (e.g. apramycin - 400 µg/kg; kanamycin - 40 µg/kg; streptomycin and dihydrostreptomycin - 100 µg/kg) do not take into account the fact that there are no EU MRLs for these antibiotics in finfish and therefore the relevant action levels should be set as low as possible, preferably at the method quantification level. For some contaminants (B3a and B3c), the action levels are higher than the applicable EU MLs (e.g. cadmium - 200 µg/kg 8 (50 µg/kg in the EU); polychlorinated biphenyls (PCBs) indicators - 125 µg/kg (EU ML is 75 µg/kg);  Milk: the action levels for several antibiotics (e.g. apramycin - 400 µg/kg; ofloxacin and norlfloxacin - 100 µg/kg; clindamycin -150 µg/kg) do not take into account the fact that there are no EU MRLs for these in milk so method quantification limits should apply. Action levels are higher than those applicable in the EU 9 for diclofenac (B2e), some organochlorine compounds (B3a) (e.g. DDT and its metabolites -50 µg/kg (EU MRL is 40 µg/kg); hexachlorobenzene - 10 µg/kg (EU MRL is 5 µg/kg) and aflatoxin M1 (B3d) (0.5 µg/kg in the plan (EU ML is ten-fold less at 0.05 µg/kg).  Eggs: the levels of action for several antibiotics (e.g. apramycin - 400 µg/kg; paromomycin - 200 µg/kg; spectinomycin - 100 µg/kg; streptomycin and dihydrostreptomycin - 500 µg/kg; gentamycin - 20 µg/kg; kanamycin - 40 µg/kg; clindamycin - 50 µg/kg) do not take into account the fact that there are no EU MRLs for these in eggs so similarly to milk, method quantification limits should apply. For certain organochlorine compounds (B3a), the levels of action are

4 As laid down in Article 5 and Annex II, Article 6 and Annex IV to Directive 96/23/EC and in Annex to Decision 97/747/EC. 5 Annex II to Decision 2002/657/EC. 6 Regulation (EU) No 37/2010, Regulation (EC) No 396/2005, Regulation (EC) No 1881/2006, Regulation (EC) No 124/2009. 7 Decision of Eurasian Econnomic Komission No 28 of 13 February 2018. 8 Base on Technical Regulation No 21 of the EaEU. 9 Article 1 and Table 1 of the Annex to Regulation (EU) 37/2010.

4 higher than the applicable EU MLs (e.g. DDT and metabolites, 100 µg/kg (EU MRL is 50 µg/kg); hexachlorobenzene, 20 µg/kg (EU MRL is 10 µg/kg).  Honey: for the most of aminoglycosides (B1), the levels of action are between 100 and 400 µg/kg (based on detection limits of analytical methods). No residues for these substances are allowed in honey in the EU and the recommended method detection levels are lower than 50 µg/kg. 5. The range of substances covered by all residue monitoring plans, including those for commodities which listing has been requested, is generally fit for purpose as the most of the veterinary medicinal products seen used on the farms visited and those traded by the wholesaler and retailers visited are included (see section 5.2.2).

6. The plans for poultry and milk, however, do not include testing for B1 substances levofloxacin, nisin and polymyxin B which were seen to have been used on the respective farms visited by the audit team. None of these antibiotics are authorised in the EU for use in food-producing animals. Also the residue monitoring plan for milk does not include testing for macrocyclic lactones (avermectins, B2a) to verify that such substances are used in accordance with their terms of authorisation. Similar to the EU 11, such substances are not authorised for use in dairy cows in Belarus.

7. While, similar to the EU 10, non-compliant results from previous years had been taken into account in the planning of the 2019 residue monitoring plans for nearly all commodities, this was not the case for aquaculture. Despite several non-compliant results for the presence of dyes in aquaculture fish (4 in 2017, 5 in 2018), the number of samples planned to be taken in 2019 had been reduced in the two regions visited, although the quantities of fish produced had remained constant. According to DVFS, the number of samples for dyes had been reduced to introduce, additional samples for carbamates.

Conclusions on planning of residue monitoring 8. The planning of the residue monitoring largely follows the principles of Directive 96/23/EC and covers for the most part an appropriate range of substances, though there are exceptions. Nevertheless the fact that action levels for several substances across all commodities (including those for which listing has been requested) are not aligned to EU MRLs and MLs means that the plan would not be sufficient to demonstrate that commodities exported to the EU would comply with EU MRLs and MLs, thus weakening the effectiveness of the plan.

5.1.3. Implementation of the residue monitoring plan

Legal Requirements Article 29 of Directive 96/23/EC. References to the Union legislation applicable in the EU Member States are provided as footnotes for informative purposes.

10 Article 7 (last indent) of Directive 96/23/EC.

5 Findings 9. National legislation 11 provides the legal basis for the implementation of the residue monitoring plan as well as instructions for sampling, transport and storage of samples, as would be the case in the EU 12. 10. In the regions visited, there was evidence that the annual residue monitoring plan had been received from DVFS and that sampling had been allocated to the district services in a timely manner. Similar to the situation in the EU 13, while taking into account the seasonality of production, samples were distributed over the year. 11. Sampling sites were selected by the regions on the basis of the number of animals farmed and the processing capacity of establishments present in the districts in the previous calendar year. However this rule was not always followed as in one of the regions visited, 55% of samples planned to be taken for poultry in 2019 had been allocated to slaughterhouses representing only 20% of the regional production. This was corrected during the audit by redistributing the samples according to the throughput of the slaughterhouses. In this region, spent hens were not planned to be sampled as these are slaughtered at their places of breeding, for which no samples had been allocated in the 2019 residue monitoring plan. 12. Although the residue monitoring plan is based on the whole national production, contrary to what happens in the EU 14, some farms and processing establishments were excluded from monitoring, and this was not justified on the basis of risk. In one of the regions visited, one large pig farm (producing up to 100 000 pigs a year) had started operating in 2018 but had not been included in either the 2018 and 2019 residue monitoring sampling although it is the only pig farm of this size in the district and represents a significant percentage of the regional production of pigs. In another region visited, the district with the largest share in regional honey production (30% of the regional honey production) was not allocated any samples in 2019 and it was not sampled in 2018. Similarly, two of the districts with large pig populations were neither subject to sampling in 2017 and 2018, nor allocated any samples in 2019. 13. In the regions visited, while samples were usually spread over a number of different farms and processing establishments, the audit team found that contrary to what is expected in the EU 15, large numbers of samples were collected from a few farms or slaughterhouses. In one of these regions, all Group A samples to be taken at farms from cattle were allocated to a very limited number of farms, without any risk-based justification. In the same region, all samples from group A1 to A5 were taken in one of the two slaughterhouses (for cattle and pigs) while none were planned to be collected at

11 Resolution of the Ministry of Agriculture and Food No 18, dated 28 March 2012 (Resolution No 18), Appendix 4 to the Rules for the arrangement of laboratory studies (tests) under veterinary control (supervision), approved by the Decision of the Council of the Eurasian Economic Commission No. 80 of November 10, 2017, Annex 1 to the Regulation on a unified procedure for joint inspections of facilities and sampling of goods (products) subject to veterinary control (supervision), approved by the Decision of the Council of the Eurasian Economic Commission No. 94 of October 9, 2014. 12 Article 1 and the Annex to Decision 98/179/EC. 13 Point 2.1 of the Annex to Decision 98/179/EC. 14 Annex III to Directive 96/23/EC. 15 Points 2.1, 2.2, 2.3.2 and 2.3.3 of the Annex to Decision 98/179/EC.

6 the other slaughterhouse. Such multiple sampling led to the issuing of Recommendation No 2 in the 2014 report. 14. Both the 2018 and 2019 residue monitoring plans had been strictly adhered to in terms of number of samples taken and their distribution between the different species and subgroups. In some of the cases where there had been delays in taking the samples, justifications had been provided by the district services and samples were taken shortly after. 15. All officials carrying out sampling and the operators met confirmed that, similar to the situation in the EU 16, sampling was conducted without prior notice being given to the operator. The officials met were knowledgeable about sampling techniques and familiar with the relevant instructions and equipment to be used. Once collected, samples were promptly delivered to the BSVC by officials. 16. Similar to what is required in the EU 17, official samples are sealed. However, at the dairy establishment visited, milk samples were collected in bottles with a single use cap, wrapped in plastic and sealed with stamped sticky paper. Once collected and prior to their dispatch to the laboratory for analyses, such samples were kept in a fridge which could have been accessed by staff of the dairy plant. The audit team noted that both the paper and plastic wrap could easily be removed without showing signs of tampering and that the single use cap could be replaced once opened. 17. The sampling instructions used by officials 18 are broadly similar to those followed in the EU except for samples of cattle and pig muscle. Contrary to what applies in the EU 19, muscle samples are taken from several carcasses (at least three carcasses) picked from a batch of slaughtered animals and pooled into a final sample thus causing a "dilution" of analyte in case of residues violation after individual treatment of animals. In addition, at the slaughterhouse visited (cattle and pigs), based on the sampling reports examined, the samples taken could be traced back to the farm of origin of the animal but, for cattle, they could not be linked to the animals sampled, as information on the identification of animals is not required in the sampling protocol and is not collected during sampling. Such information has been available from the traceability system in place at the slaughterhouse visited. 18. In most cases, sampling was carried out taking into account the substances to be tested for and the type of animals. However, different to what is expected in the EU 20, some samples were inappropriately targeted, hence not fulfilling the objectives of the residue monitoring plan. For example at the aquaculture farm visited, samples for subgroup B1 were only taken from fish that were not to be placed on the market for several months.

16 Article 12 of Directive 96/23/EC and point 2.1 of the Annex to Decision 98/179/EC. 17 Point 2.6 of the Annex to Decision 98/179/EC. 18 Resolution No 18. 19 Points 2.3.2.1 and 2.3.3.1 of the Annex to Decision 98/179/EC, in combination with Article 2(e) of Directive 96/23/EC. 20 Points 2 and 3 of Annex III to Directive 96/23/EC.

7 Conclusions on implementation of residue monitoring 19. The residue monitoring plan is implemented in a timely manner and in line with planned arrangements. Nevertheless, certain aspects of the sampling strategy weaken the effectiveness of the plan, namely the exclusion of significant parts of national production of pigmeat and honey from sampling, clustering of samples (cattle and pigs), inappropriate targeting of sampling (aquaculture), and not ensuring the analytical and legal integrity of milk samples. 20. As cattle and pigs can be treated on a single animal basis, pooling samples of muscle taken from different animals from one slaughter lot into a test sample risks noncompliances not being detected (due to 'dilution' of analytes) and for these commodities weakens the effectiveness of the plan.

5.1.4. Other residue monitoring programmes

Legal Requirements Article 29 of Directive 96/23/EC. References to the Union legislation applicable in the EU Member States are provided as footnotes for informative purposes.

Findings 21. National legislation 21 obliges food business operators (processing establishments) to carry out in-house controls of food safety, including testing for residues in raw materials and (finished) food products. This legal requirement is implemented through the DVFS annual "Plan for laboratory testing of products of animal origin on safety indicators" (known as the Safety Plan) by the State Institution Veterinary Surveillance. This testing is at the expense of the food business operators and is designed to control food safety indicators established in the Technical Regulations of the EaEU. 22. Under the Safety Plan, milk and dairy products, meat and meat products, fish, fishery and egg products are tested for chloramphenicol, nitroimidazoles, tetracyclines, penicillin, streptomycin, bacitracin, chemical elements (As, Pb, Cd, Hg), certain pesticides, mycotoxins, and radionuclides with mandatory notification of the non-compliance to the DVFS and the producer. Honey samples are tested for chloramphenicol, tetracyclines, sulphonamides, tylosin, organochlorine and organophoshorus pesticides including coumaphos and malathion. 23. There were 11,918 and 12,187 tests carried out under this programme in 2017 and 2018, respectively with 23 and 16 non-compliant results identified during each of these years. These included 34 cases of tetracycline (B1) in meat and meat products, 2 of metronidazole (A6) in dry milk products, 2 cases of tetracycline (B1) in cheese and 1 of cadmium (B3c) in meat products. These non-compliances had been followed-up applying the same principles as for the residue monitoring plan including recall actions by the food business operators.

21 Article 11 of the Law No. 217-З "On the quality and safety of food raw materials and food products for human consumption, dated 29.06.2003.

8 24. Similar to the EU 22, food business operators carry out own checks regarding residues. The slaughter establishment for large animals carried out quarterly checks for chloramphenicol (A6), tetracyclines, bacitracin (B1) chemical elements (B3c), hexachlorocyclohexane, DDT (B3a) and dioxins (on request only) in an accredited foreign laboratory. Similar testing was carried out biannually by the poultry slaughterhouse visited. 25. The dairy establishment visited checked each tank of delivered milk with a screening test for chloramphenicol (A6), beta-lactams, tetracyclines and streptomycin (B1). Every 10 days such a test was carried out for macrolides and quinolones (B1). The establishment operated also twice a year Enzyme-linked immuno-sorbent assay (ELISA) testing for the same analytes and quarterly for nitrofuran metabolites (A6). 26. Under the Safety Plan, dairy establishments test biannually raw milk for chloramphenicol (A6), beta-lactams, tetracyclines and streptomycin (B1), chemical elements (B3c), aflatoxin M1 (B3d). 27. The audit team found that in all of the establishments visited, the traceability systems allowed them to trace back products to the farm of origin in the event of a potential RASFF notification for a consignment exported to the EU.

Conclusions on other residue monitoring programmes 28. The other official residue monitoring programmes and the establishments’ own-checks support the guarantees offered under Article 29 of Directive 96/23/EC.

5.1.5. Follow-up of non-compliant results

Legal Requirements Article 29 of Directive 96/23/EC. References to the Union legislation applicable in the EU Member States are provided as footnotes for informative purposes. Findings 29. Between January 2014 and May 2019, there was one RASFF notification (dated 28 September 2018) for residues of leuco-malachite green (B3e) in aquaculture (live carp). The DFVS stated that it did not receive this RASFF notification as it was not forwarded by the Ministry of Health, which is the Belarussian focal point for the RASFF. Since February 2019, an agreement between the Ministry of Health and the DVFS is in force in order to ensure the forwarding of all relevant notifications to the DFVS for follow-up. 30. In 2017, there had been 46 non-compliant results (0.4%) in the residue monitoring plan of which 3 were detected in milk (chloramphenicol, metronidazole and ketoprofen), 11 in eggs (coccidiostats), 5 in pig muscle (chloramphenicol, antibiotics, coccidiostats and metronidazole), 2 in bovine muscle (antibiotics), 2 in bovine urine (thiouracil), 12 in poultry muscle (coccidiostats, chloramphenicol and metronidazole), 6 in poultry plasma (metronidazole and ronidazole) and 5 in aquaculture (dyes and metronidazole).

22 Article 9(b) of Directive 96/23/EC.

9 31. In 2018, there were 96 non-compliant results (0.7%): 6 in bovine muscle (albendazole, ketoprofen, metamizole and amprolium) and 4 in bovine urine (taleranol, stilbenes), 6 in pig muscle (chloramphenicol, doxycycline, ketoprofen and albendazole) and 1 in porcine urine (thiouracil), 39 in poultry muscle (coccidiostats) and 3 in poultry plasma (metronidazole), 5 in aquaculture (dyes), 1 in milk (metronidazole), 29 in eggs (coccidiostats and antibiotics). 32. The increase in number of non-compliant results compared to 2017 was mainly caused by the entry into force in 2018 of the EaEU MRLs for coccidiostat residues in poultry muscle which are set stricter than in the EU. With a few exceptions, the vast majority of the 39 non-compliant results for coccidiostats reported in 2018 in poultry muscle would not be considered as exceeding EU limits. 33. Official staff have instructions 23 for the follow-up of non-compliant results. These instructions are broadly equivalent to the standard applicable in the EU 24, except that in case of suspected use of prohibited substances, the owner of the animals sampled is notified of the testing results at the same time as the official services that will be carrying out the follow-up investigations. In the cases examined by the audit team, such investigations were carried out up to one month after communication of the results by the laboratory, giving, contrary to what is expected in the EU 25, ample pre-notification to the operator that a follow-up investigation and follow-up sampling would be carried out. 34. The audit team reviewed follow-up activities and looked in detail at eight follow-up files for non-compliant results in 2017 and 2018: chloramphenicol (A6) in pig muscle, clopidol (B2a) in eggs, brilliant green and crystal violet (B3e) in aquaculture fish, taleranol (A4) in bovine urine, ketoprofen (B2e) in bovine muscle and toltrazuril sulphone (B2b) in poultry muscle. Once collected, all samples had been swiftly delivered to the laboratory and in all cases, except one (taleranol in bovine urine), laboratory results were obtained within 30 days. Follow-up investigations were carried out in all cases, however: a) for the taleranol case, actions were not adequately documented as, based on the inspection report, it could not be verified if the inspectors had checked the presence of unauthorised products on the farm and the existence and content of treatment records for the relevant period; b) for the toltrazuril case, the follow-up inspection only started three weeks after notification of the non-compliance by the laboratory, thus decreasing the possibility to recall or withdraw the affected poultry meat from the market. There was no evidence that the investigation had covered the full scale of the incident as the audit team noted that a total of 22 houses (1 200 tonnes of meat) had been treated with the same coccidiostat, while only two houses (42 tonnes of meat) were mentioned in the follow-up report.

23 Decree 18, Clause 4 of Article 5 of the Technical Regulations of the Customs Union 'On food safety' TR CU 021/2011 and Clauses 116 and 129 of the Regulation on a unified procedure for joint inspections of facilities and sampling of goods (products) subject to veterinary control (supervision), approved by the Decision of the Council of the Eurasian Economic Commission No. 94 of October 9, 2014. 24 Articles 16 to 19 of Directive 96/23/EC. 25 Article 12 of Directive 96/23/EC.

10 35. As regards follow-up samples, contrary to what is expected in the EU 26, these had been taken in some cases only. In the three cases for dyes in aquaculture fish which were reviewed no follow-up samples were taken because there were no fish to sample during the time of the investigation visit. In such cases, water (or soil) from the pond had not been sampled even though dyes, once used, are persistent in the environment in which they can be detected and cause further contamination of fish when repopulating the pounds. In the toltrazuril case in poultry muscle, follow-up samples had been taken but were inappropriately targeted, having been collected from poultry reared in a house that had not been treated with toltrazuril.

Conclusions on follow-up of non-compliant results 36. Notwithstanding that there is a system in place for investigating non-compliances supported by detailed staff instructions, overall the system is weakened by factors such as pre-notification of operators of follow-up inspections and limited (or inappropriate) implementation of follow-up sampling.

5.1.6. Laboratories

Legal Requirements Article 29 of Directive 96/23/EC. References to the Union legislation applicable in the EU Member States are provided as footnotes for informative purposes.

Findings 37. All testing under the residue monitoring plan and Food Safety Plan is carried out at laboratories of the BSVC which has been visited. Similar to what is expected in the EU 27, the laboratory is accredited by the national accreditation body, the Belarusian State Centre for Accreditation (BSCA), and has a number of methods used for the residue monitoring plan included in its scope of accreditation. The BSCA is an associate member of European Cooperation for Accreditation and International Laboratory Accreditation Cooperation. 38. As described in the 2014 report and different to standards applicable in the EU 28, the BSCA has a policy of not requiring in-house verification/validation of methods which are published as State Standards of the Russian Federation or Methodological Instructions. Therefore some accredited methods used for testing residue monitoring samples have not been validated or verified in the BSVC. 39. The laboratory operates a Laboratory Information Management System and is equipped with the state of the art instrumentation. Also software for calculation of method performance parameters purchased from an EU Member State is in operation and allows for the calculation of method performance parameters which would be relevant in the EU 29.

26 Article 13(b) and Article 18 of Directive 96/23/EC. 27 Point 1.2 of the Annex to Decision 98/179/EC. 28 Article 3(c) and Annex I to Decision 2002/657/EC. 29 Decision 2002/657/EC.

11 40. There were adequate procedures and instructions for sample reception and handling and residue monitoring samples are stored in monitored conditions. 41. A target turn-around time (period between sample reception and analysis) of 30 days is established and monitored. The audit team confirmed that only 7.7% and 3.4% of samples received in 2018 and 2019 to date, respectively, were tested after the 30 day deadline. 42. Whilst method validation for antithyroid agents (A2) in urine (all species) and in bovine plasma, for resorcylic acid lactones (A4) in bovine urine and for aflatoxin M1 in milk was in progress during the time of the audit, some other methods used for the residue monitoring plan have not yet been validated: a) steroids A3 in urine and in kidney fat/muscle, resorcylic acid lactones (A4) in urine of different species – all by Liquid Chromatography-(Tandem) Mass Spectrometry (LC-MS/MS), b) colistin and bacitracin (B1) in all matrices by ELISA, c) benzimidazoles and ivermectins (B2a) by LC-MS/MS in all matrices except milk, d) permethrin (B2c) and coumaphos (B3c) by Gas Chromatography-(Tandem) Mass Spectrometry (GC-MS/MS) and lead (B3c) by Graphite Furnace Atomic Absorption Spectrometry (GFAAS) in honey, e) chemical elements (B3c) in muscle of certain species and ochratoxin A|(B3d) by in kidney of all animal species. 43. There are no methods available for deltamethrin and carbamates (B2c) in honey, no confirmatory methods for colistin and bacitracin (B1) in all relevant matrices and no method for streptomycin (B1) in honey. 44. Several analytical methods, including the screening ELISA for steroids (A3) in urine from all animal species, the LC-MS/MS method for nitroimidazoles (A6), quinolones (B1) in all relevant matrices, coccidiostats (B2b) in eggs, the GC-MS/MS method for PCBs (B3a) in fish and the GFAAS method for cadmium (B3c) in fish were examined by the audit team and with regard to method validation the audit team noted: a) method validation plans were available for each method but provided only definitions without any criteria for method performance parameters being established. Thus it remains unclear on which basis methods are deemed suitable for testing. Whilst the scopes of validations are largely similar to what would be applied in the EU 30 ruggedness and stability studies were not always carried out during the validation phase (noted for the majority of methods); b) the sensitivity of the analytical methods in use is comparable to what is expected in the EU 31; c) the method for four steroids (A3) in urine by ELISA was validated in 2012 at a concentration level of 0.8 μg/kg, which satisfies the level of interest in the EU as recommended by European Union Reference Laboratories and various methods'

30 Annex I to Decision 2002/657/EC. 31 Table 1 of the Annex to Regulation (EU) No 37/2010, Article 4 and Annex II to Decision 2002/657/EC or the levels recommended by the European Union Reference Laboratories (EURL).

12 performance parameters including CC-beta value had been established. However, no verification was carried out on urine from other species (pigs, horses) covered by the residue monitoring plan; d) the method for nine nitroimidazoles (A6) was validated in pig, poultry and fish muscle, milk, eggs and honey but no verifications had been carried out in samples of bovine and equine muscle. e) the method for quinolones (B1) was validated in milk, in cattle, pig, poultry and fish muscle, but not in equine muscle. Its fitness for purpose was largely demonstrated but not in case of perfloxacin, ofloxacin and nalidixic acid in milk, for which the target concentration of 100 µg/kg is considered too high given that there are no EU MRLs in milk 32 for these three antibiotics; f) the method for PCBs was validated in bovine muscle taking into consideration the guidelines used by laboratories in the EU 33 and its performance in fish was verified at one concentration level of 5 μg/kg. No verifications were carried out in either pig or poultry muscle which are tested using this method; g) the method for cadmium in fish was originally validated at a concentration level over ten times higher than the EU ML thus not demonstrating its equivalence to standards applicable in the EU 34. The method was re-validated during the time of the audit at four concentration levels spanning the EU ML and its established limit of detection and limit of quantification demonstrated adequate sensitivity. The method performance parameters (recovery, precision, repeatability) were calculated at 200 μg/kg, the national ML for cadmium in fish which is much higher than that in the EU. 45. With regard to quality control the audit team noted: a) quality control plans are in place for all analytical methods in operation except for quinolones in muscle. The plans include, inter alia, criteria for the calibration coefficient of a calibration curve, the inclusion of control samples in each analytical run and participation in proficiency tests. Similar to what happens in the EU 35 spiking concentration levels are set at the lowest calibration points which are lower than MRPLs/MRLs/MLs 36 applicable in the EU and lower (better) than those suggested by the EU reference laboratories. Control charts allow for long term trends in the method performance to be seen; b) for PCBs, quality control samples spiked at 5 μg/kg for three selected PCBs are included in each analytical run but different to what is recommended in EU guidelines, no rolling programme is in use to include the remaining PCBs. Also, no actions/justification had been undertaken when the acceptable recovery range of 70- 120% had not been met for control samples;

32 Regulation (EU) No 37/2010. 33 Document No SANCO/10684/2009 Quality control procedures for pesticide residues analysis in food and feed. 34 Regulation (EC) No 1881/2006, Regulation (EC) No 333/2007. 35 Article 5 of Decision 2002/657/EC and Chapter 5.9 of ISO 17025. 36 Annex II to Decision 2002/657/EC, Table 1 of the Annex to Regulation (EU) No 37/2010, Regulation (EC) No 1881/2006, Regulation (EC) No 396/2005.

13 46. Standards (including internal standards), stock and working standard solutions were of adequate quality and were properly handled. The laboratory noted difficulties in acquisition of standards for different steroids in 2019. 47. Similar to what would be expected in the EU 37, since 2014 the laboratory has participated in several proficiency tests: sulphonamides (B1) in pig muscle and tetracyclines in pig kidney, quinolones (B1) (oxolinic acid) in poultry muscle, organochlorides and PCBs (B3a) in animal fat, chloramphenicol (A6), quinolones, macrolides, oxytetracycline (B1), mercury (B3c) in fish, nitrofuran metabolites (A6) and amphenicols in shrimp, beta-lactams (B1), non-steroidal anti-inflammatory drugs (B2e), albendazole (B2a), pesticides (B3am B3b), aflatoxin M1 (B3d) in milk, sulphonamides (B1) and coccidiostats (B2b) in rabbit muscle, sedatives in muscle, quinolones and macrolides in honey. All results were satisfactory. 48. Result reporting routines are largely similar to those applicable in the EU 38 and refer to nationally established MRLs which are sometimes higher than those applicable in the EU 39 (see finding 4).

Conclusions on laboratories 49. The fact that the laboratory is accredited, has effective internal quality control measures in place, is equipped with state of the art equipment, is analysing samples promptly and, for the matrices for which method validation has been performed, has demonstrated those methods' fitness for purpose by, inter alia, the quality of its validation files and its successful participation in external proficiency tests, collectively provide confidence in the reliability of results and thus underpin the guarantees provided for by the residue monitoring plan. However, this is still a work in progress with several methods for which there is a lack of validation data and some analyte/matrix combinations for which there are no methods established to date.

5.2. Veterinary medicinal products

5.2.1. Competent authorities

50. MAF is responsible for licencing the manufacture of veterinary medicinal products. 51. The registration of veterinary medicinal products takes place after a favourable decision of the Council on Veterinary Medicines is granted based on the dossier prepared and evaluated by the BSVC. The DVFS within MAF is responsible for administrative registration of veterinary medicinal products and medicated premixes and the maintenance of the state register of veterinary medicinal products. 52. The Veterinary Department is responsible for registration of manufacturers, wholesalers and retailers and for controls on the distribution and use of veterinary medicinal products. Routine controls are carried out by State Veterinary Inspection from the District, who may be accompanied by colleagues from the Regional or Central levels where required. 37 Point 1.2 of the Annex to Decision 98/179/EC. 38 Article 6 of Decision 2002/657/EC. 39 Council Directive 96/22/EC and Table 2 of the Annex to Regulation (EU) No 37/2010.

14 5.2.2. Authorisation, distribution and use

Legal Requirements Article 29 of Directive 96/23/EC. References to the Union legislation applicable in the EU Member States are provided as footnotes for informative purposes. Findings 53. Similar to what applies in the EU 40, national legislation 41 describes the legal provisions and procedures for the registration, distribution and use of veterinary medicinal products. A list of all registered veterinary medicinal products was made available to the audit team. 54. Similar to the situation in the EU 42, national legislation 43 provides for the prohibition of manufacture and import of certain pharmacologically active substances 44. 55. Similar to what applies in the EU 45, both the EaEU and national legislation 46 provides for the establishment of MRLs for pharmacologically active substances used in veterinary medicinal products. The MRLs established in legislation applicable in Belarus are for certain substances higher than the respective EU MRLs or MLs (see also finding 4). 56. Different to the prohibition applicable in the EU 47, in Belarus, 17-beta oestradiol and its derivatives are authorised for the treatment of female cattle. 57. Different to what applies in the EU 48, a number of pharmacologically active substances are authorised in Belarus, mainly for cattle and partly for pigs and poultry, which, at the time of the audit, were not authorised for use in food-producing animals in the EU. These include metamizole (B2e) and a range of antibacterial substances: diminazene/diminacene, azithromycin, nosiheptide (also for laying hens), ofloxacin (poultry), rifampicin, clindamycin, kitamycin, levofloxacin, enramycin/enduracidin, nisin, halquinol, norfloxacin, quinoxaline derivatives: olaquindox, mequindox, dioxydin, carbadox and meldonium. Some of these are covered by the residue monitoring plan. With the exception of nisin/polymyxin and levofloxacin, none of these substances, were seen to be used on the farms visited or sold by the wholesalers and retailers visited.

40 Articles 30-40 of Regulation (EC) No 726/2004. 41 Articles 25 of the Law of the Republic of Belarus No 161-3 of 2 July 2010 “On Veterinary Activities, Decree of the Council of Ministers No 317 of 28 April 2017. 42 Council Directive 96/22/EC and Table 2 of the Annex to Regulation (EU) No 37/2010. 43 Annex 11 to the Veterinary and sanitary rules for the use, sale and storage of veterinary drugs in the Republic of Belarus No 16 of 17 March 2011, Decree of the Ministry of Agriculture and Food No. 16, of 17 March 2011. 44 Beta-agonists, carbadox, chloramphenicol, chloroform, chlorpromazine, colchcine, dapsone, nifursol nitrofurans, nitroimidazoles, olaquindox, stilbenes, resorcilic acid lactones, substances having a thyreostatic, estrogenic, progestagenic and androgenic effect. 45 Table 2 of the Annex to Regulation (EU) No 37/2010, Regulation (EC) No 396/2005, Regulation (EC) No 1881/2006, Regulation (EC) No 124/2009. 46 Decision of the Customs Union Commission No 299 of 28 May 2010, Customs Union Technical Regulations TR TS 021/2011, TR CU 033/2013, TR CU 034/2013, TR EEU 040/2016, Decision of the Eurasian Economic Commission No 28 of 13 February 2018 “On the maximum permissible levels of residues of veterinary medicinal products which can be present in unprocessed food products of animal origin, including in raw materials, and on methods for their detection”. 47 Article 5 of Directive 96/22 /EC. 48 Table 2 of the Annex to Regulation (EU) No 37/2010.

15 58. Similar to the situation described in the 2014 report, some substances (e.g. olaquindox) are authorised in Belarus for export purposes only. Although products containing these substances appear on the register of authorised veterinary medicinal products, their instructions for use specify that they are prohibited from use in Belarus. 59. Under the current arrangements in place, veterinary medicinal products authorised/registered in any member of the EaEU may be freely circulated in Belarus. Rules to regulate the circulation of veterinary medicines within the EAEU territory are at the final stage of the approval process. 60. Similar to the situation in the EU 49, national rules 50 include labeling requirements such as, registration number, expiry date, targeted species, withdrawal period for different species and precautions for use. 61. Different to the situation in the EU 51, a veterinary prescription is not obligatory to procure medicines for food-producing animals. Medicines for farmed animals may be purchased from wholesalers and retailers based on an order from a veterinarian. 62. Similar to the situation in the EU 52, national legislation requires:  veterinary medicinal products to be distributed only by veterinary product wholesalers, pharmacies and veterinary stations;  wholesalers and retailers to be licenced for their activity;  specific labelling of veterinary medicinal products 53;  personnel, facility and record keeping requirements for wholesalers and retailers of veterinary medicinal products. 63. Similar to what applies in the EU 54 off-label use of medicines is not prohibited but national rules recommend the use of medicines in line with their registration status and label indications. 64. Different to what is expected in the EU 55, no specific license is required for the production of medicated feed. However, such production is allowed only for aquaculture and poultry (coccidiostats) and is subject to official control. 65. Similar to the situation in the EU 56, national provisions in place 57 require all farms to keep treatment records for food-producing animals.

49 Article 58 of Directive 2001/82/EC. 50 Clause 19 of the Veterinary and sanitary rules for the use, sale, storage and production of veterinary medicinal products in the Republic of Belarus, approved by Decree No. 16 of 17 March 2011. 51 Article 67(aa) of Directive 2001/82/EC. 52 Articles 44, 58, 65 and 66 of Directive 2001/82/EC, Regulation (EU) No 470/2018. 53 MAF Decree No 16 of 17 March 2011. 54 Article 11 of Directive 2001/82/EC. 55 Directive 90/167/EEC. 56 Article 10 of Directive 96/23/EC. 57 Decree of the Councils of Ministers No 1102 of 29 December 2015.

16 Conclusions on authorisation, distribution and use of veterinary medicinal products 66. The possibility to use 17-beta oestradiol and its derivatives for the treatment of female cattle means that Belarus would not be in a position to sign the health certificate in the event that beef was being exported to the EU. 67. With the exception of oestradiol, notwithstanding differences with regard to the list of authorised veterinary medicinal products and the requirements for a veterinary prescription to purchase veterinary medicinal products, the legal framework governing the authorisation, distribution and use of veterinary medicinal products generally supports the adherence to the guarantees required by Article 29 of Directive 96/23/EC.

5.2.3. Official controls

Legal Requirements Article 29 of Directive 96/23/EC. References to the Union legislation applicable in the EU Member States are provided as footnotes for informative purposes. Findings 68. As described in the 2014 report, national legislation 58 determines the frequency of official controls on the distribution and use of veterinary medicinal products: one control every three years. 69. According to the information provided by the DVFS, in 2018, 4,443 cattle farms, 1,638 pig farms, 325 poultry farms, 143 aquaculture enterprises, and 634 manufacturers or distributors were inspected. In 2018 and the first quarter of 2019, the official controls resulted in 107 warnings or recommendations and 20 administrative procedures, mainly related to the presence of expired veterinary medicinal products, shortcomings in record- keeping requirements or storage conditions, no instructions for use, as well as use of drugs not in line with the instruction of the veterinarian or contrary to the instruction on the label. 70. An Animal Identification Traceability System (AITS) is being implemented. To that effect, based on national legislation 59, a database AITS.BY was put in operation with the following benchmarks for its implementation: products of animal origin -2016, veterinary safety – 2017, electronic veterinary certificates and data exchange with the Russian Federation - from July 2018. 71. To date all cattle and pigs are identified and over 20,000 horses are microchipped. The system is operated by the Inter-Branch Scientific and Practical Centre for Identification Systems and E-bussiness Operations of the National Belarusian Academy of Science and, once fully implemented, will allow the traceability of (medicinal) treatments provided to animals. 72. On 13 May 2019 there were 19,898 horses registered in the AITS.BY. The system allows the generation of electronic horse passports.

58 Decree of the President of the Republic of Belarus No. 510, dated 16 October 2009. 59 Law of the Republic of Belarus No 287-3 of 15 July 2015.

17 73. At the wholesaler, retailer, farms and bee keeper visited, the audit team noted that officials had carried out official controls in line with national rules and instructions and the outcome of these controls had been based on national legislation on and recorded in the checklists/reports developed for this purpose. The farmers and the bee keeper had recorded treatments in the respective record templates provided to them. 74. The wholesaler and the retailer had the nationally required records and documents available and no veterinary medicinal products in stock were identified which did not meet national requirements. 75. Retailers are obliged to check prior to selling, that veterinary medicinal products are authorised in Belarus. At the retailer visited records on the type and quantity of veterinary medicinal products purchased and sold were kept, including the manufacturer batch number. Based on these records, the audit team could reconcile the quantities ordered, sold and left in stock. 76. All veterinary medicinal products checked by the audit team at pharmacy/wholesale and in storage facilities on farms, held a registration number, had target species and withdrawal times indicated and were within the expiry date. 77. At the poultry farm visited, antimicrobials 60 and anticoccidials 61 used for prophylactic treatment, were administered to broilers up to 12 days before slaughter, taking into account the longest applicable withdrawal period of any of the substances used. In case of therapeutic treatment, in addition to the aforementioned substances, other substances 62 were used and, with the exception of levofloxacin (not covered by the residue monitoring plan), all are authorised in the EU for poultry. 78. At the aquaculture farm visited, several substances (covered by the residue monitoring plan) were used for treatment of fish 63. Aside from ciprofloxacin and enrofloxacin, none of these substances are authorised for aquaculture fish in the EU. These were, however, administered at the latest several months before the fish is placed on the market, hence limiting the risk of detectable residues in the final product. 79. At the dairy farm visited, several antimicrobials 64 (largely covered by the residue monitoring plan) were used for prophylactic and treatment purposes in dairy cows and young calves 65. There was no use of anthelmintics as cows are constantly kept in stables and not pasture fed. 80. At the retailer visited, in line with the instructions of the State Institution Veterinary Supervision, inspections had been carried out on an annual basis. The outcome of these inspections was documented and the corresponding reports included a list of non- conformities with a deadline for addressing them. The scope of the checks carried out covered structural and hygienic requirements, record keeping and absence of prohibited substances.

60 Enrofloxacin, sulfadimethoxine, trimethoprim, tilmicosin, amoxicillin. 61 Narasin, nicarbazin. 62 Sulphonamides, colistin, levofloxacin, florfenicol, toltrazuril. 63 Albendazole, fenbendazole, praziquantel, ciprofloxacin, enrofloxacin, ofloxacin. 64 Gentamycin, penicillin, ampicillin, cloxacillin, nisin, polymyxin B1, kanamycin, ceftiofur. 65 Sulphonamides, trimethoprim, mequindox.

18 81. The bee keeper visited did not use veterinary medicinal products other than flumethrin which is authorised for honey bees in the EU without an MRL being required.

Conclusions on official controls 82. The official control system in place on the distribution and use of veterinary medicinal products underpins the guarantees required by Article 29 of Directive 96/23/EC

6. OVERALL CONCLUSION

The planning of the residue monitoring largely follows the principles of Directive 96/23/EC and covers for the most part an appropriate range of substances. The plan is nevertheless weakened by the fact that action levels for several substances across all commodities (including those for which listing has been requested) are not aligned with EU maximum residue limits, thus the plan would not be sufficient to demonstrate that commodities eligible for export to the EU would comply with such limits where they are lower that national limits. Implementation of sampling and testing is timely but some aspects of the sampling strategy weaken the effectiveness of the plan, for example, the exclusion of significant parts of the national production of pigmeat and honey from sampling, failure to ensure the analytical and legal integrity of milk samples and pooling of muscle samples from individual animals in one slaughter lot into a single test sample. Follow-up of non- compliances is supported by detailed staff instructions but is nevertheless weakened by factors such as pre-notification of operators of follow-up inspections and limited (or inappropriate) implementation of follow-up sampling. With regard to the laboratory, the fact that it is accredited, has effective internal quality control measures in place, is equipped with state of the art equipment, is analysing samples promptly and, for the matrices for which method validation has been performed, has demonstrated those methods' fitness for purpose by its successful participation in external proficiency tests, collectively provides confidence in the reliability of results. However, work remains to be done as there are still several methods for which there is a lack of validation data and some analyte/matrix combinations for which there are no methods established to date. With regard to veterinary medicinal products and official controls thereof, notwithstanding differences with the EU concerning the list of authorised veterinary medicinal products, the legal framework and official control system governing the authorisation, distribution and use of veterinary medicinal products in general underpin the guarantees on residues monitoring required by Directive 96/23/EC. There is however one exception to this; the possibility to use 17-beta oestradiol and its derivatives for the treatment of female cattle means that Belarus would not be in a position to sign the EU health certificate in the event that beef was being exported to the EU and this precludes the listing of Belarus in the Annex to Decision 2011/163/EU for this commodity.

7. CLOSING MEETING

A closing meeting was held on 24 May 2019 with representatives of the competent authority. At this meeting, the audit team presented the main findings and preliminary

19 conclusions of the audit. The competent authority stated that they would undertake the corrective actions required to address the findings made during the audit.

8. RECOMMENDATIONS

The competent authorities are invited to provide details of the actions taken and planned, including deadlines for their completion ('action plan'), aimed at addressing the recommendations set out below, within 25 working days of receipt of this audit report.

No Recommendation

1 To ensure that the planning of the residue monitoring plan and the sampling strategy employed takes into account relevant risk factors, appropriate targeting criteria and the Maximum Residue Limits/Maximum Levels applicable in the EU, in order to provide the guarantees required under Article 29 of Directive 96/23/EC. Recommendation based on conclusions:8, 19 Associated findings: 4, 6, 7, 18.

2 To ensure that the residue monitoring plan covers the whole national production, avoids pooling of carcase samples and clustering of samples from a small number of producers and guarantees the analytical and legal integrity of milk samples in order to provide the guarantees required under Article 29 of Directive 96/23/EC. Recommendation based on conclusions: 19, 20 Associated findings: 11, 12, 13, 16, 17.

3 To ensure that follow-up actions are not pre-announced and that appropriate follow-up samples are taken to support the guarantees required under Article 29 of Directive 96/23/EC. Recommendation based on conclusions: 36 Associated findings: 33, 35.

4 To ensure that analytical methods are available for all substance-matrix combinations included in the residue monitoring plan and that only analytical methods which are validated to a standard equivalent to that laid down in Article 3 of Commission Decision 2002/657/EC are used. Recommendation based on conclusion: 49. Associated findings: 42, 43, 44.

The competent authority's response to the recommendations can be found at:

http://ec.europa.eu/food/audits-analysis/rep_details_en.cfm?rep_inspection_ref=2019-6654

20 ANNEX 1 – LEGAL REFERENCES

Legal Reference Official Journal Title Audits by Commission Services

Reg. 882/2004 OJ L 165, 30.4.2004, Regulation (EC) No 882/2004 of the p. 1, Corrected and European Parliament and of the Council of re-published in OJ L 29 April 2004 on official controls performed 191, 28.5.2004, p. 1 to ensure the verification of compliance with feed and food law, animal health and animal welfare rules

Food Law

Reg. 178/2002 OJ L 31, 1.2.2002, p. Regulation (EC) No 178/2002 of the 1-24 European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety

Reg. 852/2004 OJ L 139, 30.4.2004, Regulation (EC) No 852/2004 of the p. 1, Corrected and European Parliament and of the Council of re-published in OJ L 29 April 2004 on the hygiene of foodstuffs 226, 25.6.2004, p. 3 Reg. 853/2004 OJ L 139, 30.4.2004, Regulation (EC) No 853/2004 of the p. 55, Corrected and European Parliament and of the Council of re-published in OJ L 29 April 2004 laying down specific hygiene 226, 25.6.2004, p. 22 rules for food of animal origin

Reg. 854/2004 OJ L 139, 30.4.2004, Regulation (EC) No 854/2004 of the p. 206, Corrected and European Parliament and of the Council of re-published in OJ L 29 April 2004 laying down specific rules for 226, 25.6.2004, p. 83 the organisation of official controls on products of animal origin intended for human consumption

Monitoring and sampling of residues in food of animal origin

Dir. 96/23/EC OJ L 125, 23.5.1996, Council Directive 96/23/EC of 29 April 1996 p. 10-32 on measures to monitor certain substances and residues thereof in live animals and animal products and repealing Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/EEC and 91/664/EEC Dec. 97/747/EC OJ L 303, 6.11.1997, 97/747/EC: Commission Decision of 27 p. 12-15 October 1997 fixing the levels and frequencies of sampling provided for by Council Directive 96/23/EC for the monitoring of certain substances and residues thereof in certain animal products

Dec. 98/179/EC OJ L 65, 5.3.1998, p. 98/179/EC: Commission Decision of 23 31-34 February 1998 laying down detailed rules on official sampling for the monitoring of certain substances and residues thereof in live animals and animal products

Approval of residue monitoring plans submitted by third countries

Dec. 2011/163/EU OJ L 70, 17.3.2011, 2011/163/EU: Commission Decision of p. 40-46 16 March 2011 on the approval of plans submitted by third countries in accordance with Article 29 of Council Directive 96/23/EC

Validation of analytical methods for residues and Minimum Required Performance Limits

Dec. 2002/657/EC OJ L 221, 17.8.2002, 2002/657/EC: Commission Decision of 12 p. 8-36 August 2002 implementing Council Directive 96/23/EC concerning the performance of analytical methods and the interpretation of results

Bans on the use of hormones and beat-agonists for growth promotion in food producing animals

Dir. 96/22/EC OJ L 125, 23.5.1996, Council Directive 96/22/EC of 29 April 1996 p. 3-9 concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of beta- agonists, and repealing Directives 81/602/EEC, 88/146/EEC and 88/299/EEC

Maximum Residue Limits for phamacologically active substances in food of animal origin Reg. 470/2009 OJ L 152, 16.6.2009, Regulation (EC) No 470/2009 of the p. 11-22 European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council

Reg. 37/2010 OJ L 15, 20.1.2010, Commission Regulation (EU) No 37/2010 of p. 1-72 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin

Reg. 2017/880 OJ L 135, 24.5.2017, Commission Regulation (EU) 2017/880 of 23 p. 1–5 May 2017 laying down rules on the use of a maximum residue limit established for a pharmacologically active substance in a particular foodstuff for another foodstuff derived from the same species and a maximum residue limit established for a pharmacologically active substance in one or more species for other species, in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council

Reg. 2018/470 OJ L 79, 22.3.2018, Commission Implementing Regulation (EU) p. 16–18 2018/470 of 21 March 2018 on detailed rules on the maximum residue limit to be considered for control purposes for foodstuffs derived from animals which have been treated in the EU under Article 11 of Directive 2001/82/EC

Maximum Levels for contaminants in food

Reg. 1881/2006 OJ L 364, Commission Regulation (EC) No 1881/2006 20.12.2006, p. 5-24 of 19 December 2006 setting maximum levels for certain contaminants in foodstuffs

Maximum residue Levels of pesticide residues in food of animal origin Reg. 396/2005 OJ L 70, 16.3.2005, Regulation (EC) No 396/2005 of the p. 1-16 European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC

Authorisation of veterinary medicinal products

Dir. 2001/82/EC OJ L 311, Directive 2001/82/EC of the European 28.11.2001, p. 1-66 Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products

Reg. 726/2004 OJ L 136, 30.4.2004, Regulation (EC) No 726/2004 of the p. 1-33 European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency

Dir. 2006/130/EC OJ L 349, Commission Directive 2006/130/EC of 11 12.12.2006, p. 15-16 December 2006 implementing Directive 2001/82/EC of the European Parliament and of the Council as regards the establishment of criteria for exempting certain veterinary medicinal products for food-producing animals from the requirement of a veterinary prescription

Reg. 2018/782 OJ L 132, 30.5.2018, Commission Regulation (EU) 2018/782 of 29 p. 5–30 May 2018 establishing the methodological principles for the risk assessment and risk management recommendations referred to in Regulation (EC) No 470/2009

Medicated feedingstuffs and additives

Dir. 90/167/EEC OJ L 92, 7.4.1990, p. Council Directive 90/167/EEC of 26 March 42-48 1990 laying down the conditions governing the preparation, placing on the market and use of medicated feedingstuffs in the Community

Reg. 1831/2003 OJ L 268, Regulation (EC) No 1831/2003 of the 18.10.2003, p. 29-43 European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition Reg. 183/2005 OJ L 35, 8.2.2005, p. Regulation (EC) No 183/2005 of the 1-22 European Parliament and of the Council of 12 January 2005 laying down requirements for feed hygiene

Sampling methods and methods of analysis for contaminants in foodstuffs

Dir. 2002/63/EC OJ L 187, 16.7.2002, Commission Directive 2002/63/EC of 11 p. 30-43 July 2002 establishing Community methods of sampling for the official control of pesticide residues in and on products of plant and animal origin and repealing Directive 79/700/EEC

Reg. 401/2006 OJ L 70, 9.3.2006, p. Commission Regulation (EC) No 401/2006 12-34 of 23 February 2006 laying down the methods of sampling and analysis for the official control of the levels of mycotoxins in foodstuffs

Reg. 333/2007 OJ L 88, 29.3.2007, Commission Regulation (EC) No 333/2007 p. 29-38 of 28 March 2007 laying down the methods of sampling and analysis for the control of the levels of trace elements and processing contaminants in foodstuffs

Reg. 2017/644 OJ L 92, 6.4.2017, p. Commission Regulation (EU) 2017/644 of 5 9–34 April 2017 laying down methods of sampling and analysis for the control of levels of dioxins, dioxin-like PCBs and non-dioxin- like PCBs in certain foodstuffs and repealing Regulation (EU) No 589/2014