EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY

Ref. Ares(2017)2715469-30/05/2017 EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY Health and food audits and analysis DG(SANTE) 2017-6181 - MR FINAL REPORT OF AN AUDIT CARRIED OUT IN SOUTH AFRICA FROM 14 FEBRUARY 2017 TO 27 FEBRUARY 2017 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 a DG Health and Food Safety audit in South Africa, carried out from 14 to 27 February 2017, as part of the published DG Health and Food Safety's audit programme. This audit was carried out in parallel with an audit on public health (reference DG(SANTE) 2017-6228). The objective of the audit was to evaluate whether official controls concerning residues and contaminants in live animals and animal products offer adequate assurance that the products and animals concerned, eligible for export to the European Union (EU), do not contain residues of veterinary medicinal products, pesticides and contaminants at concentrations in excess of EU maximum limits. Since the authorisation, distribution and use of veterinary medicinal products and feed additives have an impact on the monitoring of residues, the national rules governing the control systems in these areas were also part of the audit. The report concludes that despite the largely adequate planning, sampling and follow-up activities carried out under the national residue monitoring plan, there are important deficiencies in its implementation which, cumulative, seriously question the reliability of the guarantees on the residues status of food of animal origin eligible to be exported to the EU. These deficiencies concern notably the use of analytical methods which are not demonstrably fit for purpose, failures to analyse all samples in a timely fashion, and the lack of testing for some substances indicated in the residue monitoring plan. The report contains recommendations to the competent authorities of South Africa 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...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 previous audit results...2 4.3. Rapid Alert System for Food and Feed (RASFF) notifications...3 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...11 6. OVERALL CONCLUSION...14 7. CLOSING MEETING...14 8. RECOMMENDATIONS...14 Annex 1 Legal References ii

ABBREVIATIONS & DEFINITIONS USED IN THIS REPORT Act 36 Fertilizers, Farm feeds, Agricultural Remedies and Stock Remedies Act, 1947 Act 101 Medicines and Related Substances Act, 1965 ARC-OVI DAFF ELISA EU HPLC LC-MS/MS MRL RASFF RMP SABS SOP Agricultural Research Council-Onderstepoort Veterinary Institute Department of Agriculture, Forestry and Fisheries Enzyme-linked immuno-sorbent assay European Union High Performance Liquid Chromatography Liquid Chromatography-(Tandem) Mass Spectrometry Maximum Residue Limit Rapid Alert System for Food and Feed Residue Monitoring Plan South African Bureau of Standards Standard Operating Procedure iii

1. INTRODUCTION The audit took place in South Africa from 14 to 27 February 2017 and was undertaken as part of the DG Health and Food Safety planned audit programme. An opening meeting was held on 14 February with the Department of Agriculture, Forestry and Fisheries (DAFF) and the Department of Health, the central competent authorities responsible for the monitoring of residues and contaminants in live animals and animal products as well as for the authorisation and controls on veterinary medicinal products. At this meeting, the objectives of, and the itinerary for the audit were confirmed and the control systems were described by the authorities. Representatives from the DAFF accompanied the audit team during the whole audit. 2. OBJECTIVES OF THE AUDIT The objective of the audit was to evaluate the performance of competent authorities and other officially authorised entities in their implementation of official controls concerning residues and contaminants in live animals and animal products, in order to assess whether these controls adhere to the guarantees provided by the residue monitoring plan (RMP) approved by the European Union (EU) and offer adequate assurance that the products and animals concerned, eligible for export to the EU do not contain residues of veterinary medicinal products, pesticides and contaminants at concentrations in excess of EU maximum limits. Since the authorisation, distribution and use of veterinary medicinal products and feed additives have an impact on the monitoring of residues, the national rules governing the control systems in these areas were also part of the audit. In addition, as this audit was carried out in parallel with DG(SANTE)2017-6228 audit on public health and all public health related findings are presented in that audit report. The principal audit criteria against which fulfilment of the above objective was assessed comprise: Regulation (EC) No 882/2004 of the European Parliament and of the Council; Council Directive 96/23/EC; Directive 2001/82/EC of the European Parliament and of the Council. The table below lists the sites visited and meetings held in order to achieve the audit objective. 1

MEETINGS/VISITS No COMMENTS COMPETENT AUTHORITIES Central 2 Regional/ local LABORATORIES 3 OTHER SITES 10 2 Opening and closing meetings with the competent authorities. Meeting with the state veterinary office in George. Meeting with the National Regulator for Compulsory Specifications Office in Cape Town. ARC-OVI and SABS in Pretoria, Fish Residue Laboratory in Cape Town. Three slaughterhouses for farmed/wild game, one aquaculture processing plant, one farmed game farm, one aquaculture farm, one hatchery (finfish), and three wholesalers/retailers of veterinary medicinal products. 3. LEGAL BASIS FOR THE AUDIT The audit was carried out under the general provisions of EU legislation, and in particular: Article 29 of Directive 96/23/EC; Article 46 of Regulation (EC) No 882/2004. A full list of the legal instruments referred to in this audit report is provided in Annex 1 and refers, where applicable, to the last amended version. 4. BACKGROUND 4.1. Country status in relation to EU-approval of residue monitoring plans South Africa is listed in the Annex to Commission Decision 2011/163/EU with an RMP approved in accordance with Directive 96/23/EC for farmed and wild game. In addition, in 2015, South Africa expressed an interest in exporting aquaculture products (finfish and abalone) to the EU. In April 2016, South Africa provided the 2016 RMP for farmed and wild game and in June 2016, the respective 2015 results to the Commission services, and in January 2017 an updated version of the RMP for aquaculture was sent for assessment. 4.2. Summary of previous audit results Previous Commission audits on the implementation of official controls on residues, pesticides and contaminants and on the use of veterinary medicinal products took place in 2007 (report ref. DG(SANCO) 2007-7585 MR Final) 1 and 2008 (report ref. DG(SANCO) 2008-7932 MR Final) 2. The 2008 report concluded that the overall situation regarding residue controls in farmed and wild game had improved since 2007 and guarantees given had an effect at least equivalent to those provided for by Directive 96/23/EC. 1 http://ec.europa.eu/food/audits-analysis/audit_reports/details.cfm?rep_id=1832 2 http://ec.europa.eu/food/audits-analysis/audit_reports/details.cfm?rep_id=2021 2

4.3. Rapid Alert System for Food and Feed (RASFF) notifications There were no RASFF notifications for residues of veterinary medicinal products for farmed and wild game meat products from 2009 to January 2017. 4.4. Production, Trade Information and Specific Import Requirements In 2015, the national production of slaughtered farmed ostriches / farmed crocodiles was around 8 666 / 29 tonnes of which 3 646 / 26 tonnes were exported to the EU. The national production for wild game was 161 tonnes of which 97 tonnes were exported. For the 2016 RMP, the competent authority had calculated that there were 440 registered ostrich farms exporting the meat of their animals to the EU. There are currently eight EU-approved slaughterhouses for farmed ostrich (one not operational at the time of the audit) of which four are also EU-approved for processing wild game. 5. FINDINGS AND CONCLUSIONS 5.1. Residue monitoring 5.1.1. Competent authorities The Chief Directorate of Animal Production and Health under the DAFF is the central competent authority responsible for the planning and supervision of the RMP, and the nine Provincial Veterinary Authorities are responsible for the sampling and follow-up activities under the RMP. 5.1.2. Planning of residue monitoring Legal requirements Article 29 of Directive 96/23/EC. The following list of legislation and elements thereof is provided for informative purposes, encompassing the various aspects of Union legislation applicable to this section of the report as regards the obligations of EU Member States. Articles 3 to 7 of, and Annex I and IV to, Directive 96/23/EC; Commission Decision 97/747/EC; Article 11(2) of Council Directive 96/22/EC; Article 11 of Regulation (EC) No 178/2002 of the European Parliament and of the Council; Commission Regulation (EU) No 37/2010; Regulation (EC) No 396/2005 of the European Parliament and of the Council; Commission Regulation (EC) No 1881/2006; Commission Regulation (EC) No 124/2009; Council Regulation (EEC) No 315/93; Article 4 of Commission Decision 2002/657/EC; Decision 2011/163/EU. Findings 1. Similar to what is required in the EU, the 2016 RMP for farmed and wild game covers all of the required essential subgroups 3 and the number of samples to be taken is based on the minimum number of 100 samples 4. 3 Annex II to Directive 96/23/EC. 4 Chapter 3 of the Annex to Decision 97/747/EC. 3

2. In addition to EU requirements, the RMP also includes testing: for more subgroups in wild game, which caters for the possibility of these animals having access to treatments (e.g. lick stones, dipping, medicated feed) provided to domestic animals kept on the same farm; of a) two blood samples and b) one feed sample for subgroups A1, A3, A4 and A5 taken from each of the registered ostrich farms (see section 4.4), which caters for the possibility of farmers using pharmacologically active substances for growth promotion off-label (see also finding no 40). 3. Risk criteria used for planning the RMP included production volumes and export data, similar to what is required in the EU 5, but not available information on the use of veterinary medicinal products, or non-compliant results in the previous year. As a consequence, the RMP has remained the same since 2014. Tylosin (one of the four substances of subgroup B1 used for treatment of farmed ostriches by the veterinary practitioner of one of the ostrich farmer associations visited was not included in the plan. 4. Similar to what is required in the EU 6, planning provides for a distribution of samples over the year. The RMP specifically allocates samples to the EU-approved slaughterhouses and to registered farms. 5. In general, EU maximum residue limits (MRLs) are indicated as the level of action in the RMP. This is not done though for phenylbutazone and olaquindox, for which the RMP indicates a level of action of 100 µg/kg and 50 µg/kg respectively. These substances are not authorised to be used in food producing animals in the EU 7. Conclusion on planning of residue monitoring 6. The planning of residue monitoring complies with the requirements of and largely adheres to the guarantees provided by the RMP approved by the EU, notwithstanding the fact that information on the use of veterinary medicinal products is not taken into consideration, and some levels of action do not reflect EU MRLs. 5.1.3. Implementation of the residue monitoring plan Legal requirements Article 29 of Directive 96/23/EC. The following list of legislation and elements thereof is provided for informative purposes, encompassing the various aspects of Union legislation applicable to this section of the report as regards the obligations of EU Member States. 5 Article 7 of Directive 96/23/EC and Article 3(1)(a) of Regulation (EC) No 882/2004. 6 Point 2.1 of Decision 98/179/EC. 7 Table 1 of the Annex to Regulation (EU) No 37/2010. 4

Articles 4, 5, and 12 of, and Annex IV to, Directive 96/23/EC; Decision 97/747/EC; Decision 98/179/EC; Commission Directive 2002/63/EC; Commission Regulation (EU) No 589/2014; Commission Regulation (EC) No 333/2007; Commission Regulation (EC) No 401/2006; Article 69 of Directive 2001/82/EC; Annex I, Part A III, point 8(b) to Regulation (EC) No 852/2004 of the European Parliament and of the Council; Annex II, Section III, point 3(c) to Regulation (EC) No 853/2004 of the European Parliament and of the Council; Article 5 and Annex I, Section I, chapter IIA, point 1 of Regulation (EC) No 854/2004 of the European Parliament and of the Council. Findings 7. The DAFF has issued an instruction to the nine Provinces with individual sample distribution plans for each EU-approved slaughterhouse, in order to ensure proper sampling under the RMP. 8. Nevertheless, in 2015 and 2016 the DAFF could not implement the RMP as planned, either because fewer samples were taken than planned and/or the laboratories did not analyse all samples taken (e.g. only 37% of the planned samples for wild game were taken in 2015, and the sampling rate for the different commodities and tissues varied between 67% and 90% in 2016). 9. In 2016, a number of substances indicated in the RMP, were either not analysed or there were delays in carrying out the analyses, as follows: Thyrostats, as the responsible laboratory no longer carries out these analyses. Zeranol, beta-agonists and stilbenes in serum samples of ostriches, and zilpaterol and stilbenes in ostrich feed samples. This was due to the lack of analytical methods at the laboratory Agricultural Research Council- Onderstepoort Veterinary Institute (ARC-OVI) (see finding 27). All substances in ostrich serum samples received at ARC-OVI after 27 October 2016, as no analysis took place due to a lack of qualified staff in this laboratory (see also finding 27). 10. At both local veterinary offices visited, the audit team noted the following: The officials took the blood and feed samples at all registered ostrich farms as planned under the RMP, if the farm was still active and had animals. The officials carried out on all farms the annual control for verifying that the farms comply with the registration requirements and drafted comprehensive reports on these controls; in one office, an example of withdrawal of the registration of a farm was demonstrated. 11. At the first slaughterhouse visited, the audit team noted the following: The official veterinarian took all of the samples required under the 2016 RMP for farmed ostriches. The official veterinarian distributed the samples over different farms and completed all sampling reports. In addition, the RMP sampling instructions were followed in that she did not take all samples scheduled for wild game due to the limited number of farms of origin. 5

12. At the second slaughterhouse visited, sampling under the 2016 RMP had not yet been completed but the official veterinarian (who had only been in charge for a month), had already noted that his predecessor had not duly carried out some of the necessary tasks under the RMP (for instance, he had taken 5 out of the 32 scheduled samples, had indicated for 2 samples the wrong code for the substances to be analysed for as scheduled, and had not always sent the samples the next day to the laboratory as provided for in the national instruction). 13. From the sampling reports available at ARC-OVI, the audit team noted that one EUapproved slaughterhouse had stored samples of crocodile tissues for up to 4 months before dispatch to the laboratory. This practice risks that truly non-compliant carcasses may not be identified due to time-dependent degradation of some veterinary drug residues. 14. Similar to what is required in the EU 8, officials at the slaughterhouses visited had adequately stored and packed samples, except for tamper proof sealing. As most samples are transported by public courier to the laboratory, sample integrity is not fully ensured, in contrast to what is required in the EU 9. 15. In contrast to what is required in the EU 10, the national instruction does not provide for suspect sampling. 16. In contrast to what is required in the EU 11 the official animal movement documents used for farmed ostriches did not contain information on veterinary medicinal products administered, other than the obligatory tick treatment before slaughter. Conclusions on implementation of residue monitoring 17. Failures to analyse all samples in a timely manner and, in particular, a lack of testing for several substances indicated in the RMP severely hamper the effectiveness of its implementation. This situation undermines the reliability of the guarantees on the residues status of farmed game eligible to be exported to the EU. 5.1.4. Follow-up of non-compliant results Legal requirements Article 29 of Directive 96/23/EC. The following list of legislation and elements thereof is provided for informative purposes, encompassing the various aspects of Union legislation applicable to this section of the report as regards the obligations of EU Member States. Articles 13, 16, 17, 18, 19, 23, 24, 27 and 28 of Directive 96/23/EC. 8 Point 2.9 of the Annex to Decision 98/179/EC. 9 Point 2.6 of the Annex to Decision 98/179/EC. 10 Article 24 of Directive 96/23/EC. 11 Annex II, Section III, point 3(c) to Regulation (EC) No 853/2004. 6

Findings 18. Most of the non-compliant results detected from 2014 to date relate to heavy metals. In addition, in both 2014 and in 2015, two samples of ostrich tissue contained residues of the nitroimidazole ronidazole (which is prohibited for use in food producing animals in the EU 12. Other detections of residues were monensin in crocodile tissue (2015), three screening positive results for zeranol in ostrich serum (2014), and residues of four different tetracyclines in ostrich kidney (2016). 19. Similar to what is required in the EU 13, the DAFF has issued instructions for carrying out follow-up investigations of non-compliant results. 20. The audit team examined all 17 follow-up files for 2015 to date and noted the following: In most cases, ARC-OVI needed 6 or more months after the samples were taken, to report the non-compliant results. In some cases, the analytical results, although available, had only been reported at the request of the DAFF. Due to the severely delayed turn-around times (see finding 27), the DAFF also requested follow-up investigations for non-compliant results identified via screening methods. In four of these cases, the confirmatory method did not confirm the first non-compliant result. Despite the fact that the sample report contains the registration number of the farm and the individual tag number of the ostrich sampled, the identification of the farm of origin was not always possible, due to mistakes in completing the sampling reports (see finding 12). For a number of cases, the responsible state veterinary offices had not yet delivered the requested follow-up report, most likely due to the time elapsed between sampling and reporting of the analytical results. Where follow-up investigations took place (for which a report was available), the official had undertaken a thorough investigation, including follow-up samples to identify the source of the residues detected. In one case, the detection of monensin in crocodile meat was found to be most likely caused by feeding the crocodiles with treated broilers. Conclusions on follow-up of non-compliant results 21. While follow-up investigations of non-compliant results would allow the identification of the possible source of the residues detected, the severely delayed turn-around times and the delayed reporting by ARC-OVI undermine the reliability of the guarantees provided by the approved RMP. 12 Table 2 of the Annex to Regulation (EU) No 37/2010. 13 Articles 16, 17 and 18 of Directive 96/23/EC. 7

5.1.5. Laboratory network Legal requirements Article 29 of Directive 96/23/EC. The following list of legislation and elements thereof is provided for informative purposes, encompassing the various aspects of Union legislation applicable to this section of the report as regards the obligations of EU Member States. Article 15 of Directive 96/23/EC; Point 1.2 of the Annex to Decision 98/179/EC; Articles 3, 4, 5 and 6 of Decision 2002/657/EC; Annexes to Regulation (EU) No 589/2014, Regulation (EC) No 333/2007 and Regulation (EC) No 401/2006. Findings 22. At the time of the audit, the residue laboratory network comprised three laboratories: i) ARC-OVI, a governmental laboratory designated by the DAFF to carry out analyses under the RMP and, ii) two other laboratories subcontracted by ARC-OVI, one of which is also a governmental laboratory (South African Bureau of Standards - SABS) and one is a private laboratory, responsible for analysing heavy metals. 23. Similar to what is required in the EU 14, the laboratories were accredited in accordance with the standard ISO/IEC 17025 by the national accreditation body, the South African National Accreditation Service. For the two subcontracted laboratories, the methods covered by their respective scopes of accreditation matched with the analyses carried out under the RMP. This was not the case for the accreditation certificate of ARC-OVI, which covered microbiological growth inhibition test screening in eggs and tissues and immunological screening (ELISA method) for sulphonamides. ARC-OVI voluntarily suspended its accreditation for HPLC methods, due to a shortage of qualified staff. At the time of the audit, problems with staffing had been resolved and an action plan was in place for reaccreditation of the HPLC methods and an extension of the accreditation for LC- MS/MS and GC-MS/MS methods (see finding 31). 24. The DAFF has designated ARC-OVI as the national reference laboratory, and in this function ARC-OVI audits the two subcontracted laboratories every 2 years, using a checklist, drafting audit reports and following up corrective actions by email. 25. Based on an unsigned draft agreement, SABS is responsible for analysing substances in subgroups B2c (pyrethroids only), B3a and B3b. SABS largely adheres to the 30 day turn-around time from sample receipt to analysis stipulated in the draft agreement. 26. During the visit to the SABS the audit team noted the following: The laboratory was fully equipped with instruments as well as secured walkin freezers for sample storage. Staff were documenting the operation of instruments. 14 Article 12 of Regulation (EC) No 882/2004 and Section 1.2 of the Annex to Decision 98/179/EC. 8

The screening method for organochlorine compounds (Group B3a) in fat was fully validated at appropriate levels for some species, but not for all different wild game species; however, every sample had been analysed twice, once spiked and once as received, to serve as its own control. 27. Under the RMP, ARC-OVI is responsible for most of the analyses for substances in subgroups A1, A2, A3, A4, A5, A6, B1, B2a, B2b, B2c (carbamates only), B2e, B2f, B3a, B3d and B3e. Based on a Memorandum of Understanding between the DAFF and ARC-OVI, the turnaround time for analysis is 30 days. In 2016, ARC- OVI did not achieve this turnaround time for most of the analyses. Although ostrich serum samples were taken throughout the year, ARC-OVI reported the analytical results on five occasions. For samples taken after 20 October 2016, ARC-OVI has not reported any result. In addition, ARC-OVI had only reported the results for a limited range of the substances or subgroups for which it is responsible (see finding 10), as not all substances had been analysed for. 28. The audit team noted that staff at ARC-OVI had received training for analytical methods. The training had been provided by vendors of equipment and exchange visits to other laboratories in the context of projects of the EU or the International Atomic Energy Agency. 29. ARC-OVI maintains a quality manual. The general Standard Operating Procedure (SOP) on sample reception described that "abnormalities" are one of the reasons for the rejection of samples, but staff responsible for reception of samples stated that they are not aware of when to reject a sample. The audit team noted that the laboratory had accepted samples for which the sampling report did not indicate the farm of origin or the tag number of the animal sampled (see also finding 12). Staff at the sample reception desk did not record any data on whether the samples were fit for analysis or not. 30. Another SOP of ARC-OVI described the validation process for screening methods and HPLC methods. In contrast to the validation procedures applied in the EU 15, the SOP provided for a much broader range of acceptable analytical recovery (+/- 44 %). 31. The audit team examined a number of analytical methods used at ARC-OVI for which it had reported non-compliant results. The following was noted: The HPLC-fluorescence method detected a non-compliant result for abamectin in crocodile meat, although the method was validated only for bovine and ovine liver and kidney. In the validation file, results for a 1-day validation for ovine kidney and liver was present, which is in contrast with the validation procedure in the EU 16, where a 3-day validation is used to determine in-house laboratory reproducibility. In the afore-mentioned sample, the laboratory reported the detection of 74 µg/kg of abamectin as the screening result and a detection of 1.9 µg/kg as the confirmatory result, both obtained with the same analytical method. The laboratory staff could not explain this unexpected discrepancy. 15 Table 2 of the Annex to Commission Decision 2002/657/EC. 16 Decision 2002/657/EC. 9

An un-validated LC-MS/MS method detected a non-compliant result for nitroimidazoles in ostrich tissue. In addition, from the sample sequence, the audit team could see that the non-compliant sample had been injected directly, without using a prior blank sample to minimise the possibility of carry-over from the preceding injection (after the highest point of the calibration curve). A second analysis of this sample was also recorded as non-compliant, but the audit team could see from the mass spectra that the sample was positive on only one mass transition out of three, in contrast with the confirmation criteria used in the EU 17. The respective SOP did not describe criteria for confirmatory analysis. A non-compliant result for aminoglycosides in ostrich tissue was reported following a screening positive result using the microbiological growth inhibition test (Four Plate Test). The confirmatory analysis with an experimental LC-MS/MS method, with no SOP or validation file available produced a compliant result. Several months had elapsed between the screening and confirmatory analyses which, due to the recognised timedependent instability of aminoglycoside residues, could have reduced the residue level of aminoglycosides in the sample despite it being kept frozen in the meantime. The audit team noted that in the absence of any validation for the LC-MS/MS method, the confirmatory result is unreliable. 32. All three laboratories participated in proficiency tests. While the SABS and the private laboratory achieved acceptable results (z-scores below 3), ARC-OVI had unsatisfactory results (z-scores above 3) for a number of proficiency tests with methods not under its current scope of accreditation. As ARC-OVI did not perform a root cause analysis, there was not a corresponding procedure for implementing corrective actions. ARC-OVI simply re-analysed the remaining proficiency test samples with either the same or another experimental method of analysis. For example, in a proficiency test for chlortetracycline the original z-score was 19, and the z-score was again above 3 when the analysis was repeated with LC-MS. Moreover, ARC-OVI did not report the results of a proficiency test for tetracycline in which it participated in 2016. 33. While the DAFF plans to audit ARC-OVI at least once a year, no audit had been carried out in 2015 and 2016. Conclusions on laboratories 34. At present, the competent authority cannot have confidence in the reliability of most of the results generated under the RMP, as the majority of the analytical methods used at ARC-OVI are not demonstrably fit for purpose. This and the far too long turnaround times of this laboratory severely undermine the reliability of the guarantees required under Article 29 of Directive 96/23/EC. 17 Decision 2002/657/EC. 10

5.2. Veterinary medicinal products 5.2.1. Competent authorities 35. The DAFF is the central competent authority for issuing marketing authorisations for veterinary medicinal products under Fertilizers, Farm feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36) and the Department of Health is responsible for issuing marketing authorisations under the Medicines and Related Substances Act, 1965 (Act 101). 36. Officials of the nine Provinces are responsible for official controls on the distribution and use of veterinary medicinal products. 5.2.2. Authorisation, distribution and use Legal requirements Article 29 of Directive 96/23/EC. The following list of legislation and elements thereof is provided for informative purposes, encompassing the various aspects of Union legislation applicable to this section of the report as regards the obligations of EU Member States. Articles 4, 7, 10 and 29 of Directive 96/23/EC; Articles 4, 5, 7 and 11(2) of, and Annexes II and III to Directive 96/22/EC; Articles 5-15, 21-30, 58-62, 65-71 and 83 of Directive 2001/82/EC; Articles 30-40 of Regulation (EC) No 726/2004 of the European Parliament and of the Council; Regulation (EC) No 470/2009 of the European Parliament and of the Council; Annex to Regulation (EU) No 37/2010; Annex I, Part A III, point 8(b) to Regulation (EC) No 852/2004; Annex II, Section III, point 3(c) to Regulation (EC) No 853/2004; Articles 2, 8 and 9 of Council Directive 90/167/EEC; Regulation (EC) No 1831/2003 of the European Parliament and of the Council. Findings 37. As described in the 2008 report, two national Acts (Act 36 and Act 101) contain legal provisions for the authorisation, distribution and use of veterinary medicinal products. 38. All applications for registration of a new product are assessed by the Medicines Control Council under the Department of Health, which decides whether the product will be registered under one of the schedules of Act 101 or can be exempted from Act 101 and be registered under Act 36. 39. Similar to what is required in the EU 18, products registered under Act 101 (mainly products which require a veterinary diagnosis), can be purchased only in licensed pharmacies or via the veterinary practitioner with a veterinary prescription or, for example in the case of narcotics, only be applied by a veterinarian. 40. In contrast to what is required in the EU 19, products registered under Act 36, can be purchased without veterinary prescription over the counter in licensed pharmacies or in retailers and shops. Most of the veterinary medicinal products (e.g. 18 Articles 65 to 67(aa) of Directive 2001/82/EC. 19 Article 67(aa) of Directive 2001/82/EC. 11

anthelmintics, antibiotic growth enhancing products, hormonal growth promotants) are registered under Act 36. 41. Similar to what is required in the EU 20, legal implementing provisions under Act 101 and Act 36 set out specific requirements for labelling of the products or for a package leaflet. 42. MRLs are established a) by recognising the MRLs established by the Codex Alimentarius or in the EU 21, b) by adopting own national MRLs, or c) by applying a default MRL of 50 µg/kg. 43. As described in the 2007 report, the DAFF does not maintain a register of veterinary medicinal products which is accessible to officials in the Provinces. Products on the market, registered under Acts 36 and 101, are listed in a vademecum which is published by the pharmaceutical industry. 44. With regard to the production of farmed ostriches, the audit team noted that: all farmers must apply for registration by the local veterinary offices of the Provinces before they are eligible to deliver animals to EU-approved slaughterhouses; the registration procedure requires an annual statement from the farmer, that he does not use or store hormonal growth promotants or other substances for the purpose of growth promotion on this farm; the farmer needs a veterinary prescription for the use of veterinary medicinal products which are not registered for ostriches, has to keep these prescriptions available for official controls where, in addition, the veterinary practitioner must indicate the withdrawal period for these products; farmers have to keep records of the purchase and use of veterinary medicinal products; all ostriches have to be identified with a unique electronically readable tag number, when vaccinated for the first time (at 4 months of age); and the movement of ostriches from one farm to another or to the slaughterhouse requires a permission document to be signed by the official of the local veterinary office. Conclusions on authorisation, distribution and use 45. The system for the authorisation, distribution and use of veterinary medicinal products differs substantially from what is required in the EU. That said, the requirements for the production of farmed ostriches, in this regard, satisfactorily contribute to the guarantees required under Article 29 of Directive 96/23/EC. 20 Article 58 of Directive 2001/82/EC. 21 Table 1 of the Annex to Regulation (EU) No 37/2010. 12

5.2.3. Official controls Legal requirements Article 29 of Directive 96/23/EC. The following list of legislation and elements thereof is provided for informative purposes, encompassing the various aspects of Union legislation applicable to this section of the report as regards the obligations of EU Member States. Article 10 of Directive 96/23/EC, Article 80 of Directive 2001/82/EC; Article 4(2) of Regulation (EC) No 854/2004; Directive 90/167/EEC. Findings 46. In the pharmacy visited, the audit team confirmed that it held the required veterinary prescriptions for the sale of products registered under Act 101 as required in national legislation. 47. At the wholesaler and the retailer visited, which were selling veterinary medicinal products registered under Act 36, the audit team noted the following: The responsible officials controlled all wholesalers and retailers at least once per year using checklists drafted for that purpose, drafted reports on the outcome of their controls and undertook follow-up inspections if necessary. The scope of the controls was limited to verifying the existence of a registration number, that the expiry date of medicines was not exceeded and that labelling requirements were adhered to (see findings 41 and 43). For more in-depth controls (e.g. whether the registration was still valid or expired), the official had to ask the representative of the marketing authorisation holder to present a copy of the actual registration documents. 48. At the ostrich and aquaculture farms visited, officials had verified that the farmers kept: the required records for purchase and use of veterinary medicinal products; the veterinary prescriptions indicating the withdrawal period to be respected for products which are not registered for ostriches. 49. The audit team confirmed that the local veterinary offices carry out a thorough annual control (see finding 10).on whether the farmers comply with the registration (and related requirements at ostrich farms (see finding 44). 13

Conclusions on official controls 50. The official control system in place provides largely satisfactory guarantees that the national requirements on distribution and use of veterinary medicinal products are adhered to. 6. OVERALL CONCLUSION Despite the largely adequate planning, sampling and follow-up activities carried out under the national residue monitoring plan, there are important deficiencies in its implementation which, cumulative, seriously question the reliability of the guarantees on the residues status of food of animal origin eligible to be exported to the EU. These deficiencies concern notably the use of analytical methods which are not demonstrably fit for purpose, failures to analyse all samples in a timely fashion, and the lack of testing for some substances indicated in the residue monitoring plan. 7. CLOSING MEETING A closing meeting was held on 27 February 2017 with representatives of the central competent authority. At this meeting, the audit team presented the main findings and preliminary conclusions of the audit. The authorities did not express disagreement and stated that they would take whatever actions were necessary in order to address the findings. 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 residue monitoring plan envisages the testing of all relevant substances in line with the range of veterinary medicinal products authorised and most likely used, and reflects EU maximum residue limits as levels of actions for the substances tested for, so that the guarantees provided under Article 29 of Directive 96/23/EC are effective. Recommendation based on conclusion 6. Associated findings 3 and 5. 2 To ensure that all the analytical results under the residue monitoring plan are obtained with analytical methods demonstrably fit for purpose and reported in a sufficiently timely manner, so that the guarantees provided under Article 29 of Directive 96/23/EC are effective. Recommendation based on conclusions 17, 21 and 34. Associated findings 8, 9, 20, 23, 27, 30, 31 and 32. 14

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=2017-6181 15

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