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