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1 EUROPEAN COMMISSION HEALTH & CONSUMER PROTECTION DIRECTORATE-GENERAL Directorate F - Food and Veterinary Office DG(SANCO)/7712/2005 MR Final FINAL REPORT OF A MISSION CARRIED OUT IN BRAZIL FROM 23 NOVEMBER TO 1 DECEMBER 2005 CONCERNING THE EVALUATION OF THE CONTROL OF RESIDUES AND CONTAMINANTS IN LIVE ANIMALS AND ANIMAL PRODUCTS, INCLUDING CONTROLS ON VETERINARY MEDICINAL PRODUCTS Clarifications provided by the Brazilian Competent Authorities are given as footnotes, in bold, italic type, to the relevant part of the report. The response from the Competent Authorities is published on the website of the European Commission s Health and Consumer Protection Directorate-General and can be accessed as an annex to this report. 18/04/

2 EXECUTIVE SUMMARY This report describes the outcome of a mission carried out by the Food and Veterinary Office (FVO) in Brazil, from 23 November to 1 December The mission was part of a series of FVO missions on residue controls in third countries. The overall objective of the mission was to evaluate the control of residues and contaminants in live animals and animal products, including the controls on the distribution and use of veterinary medicinal products (VMPs) and feed additives, the use of which may give rise to residues in such products. The evaluation was based on the standards set out in Council Directive 96/23/EC, and other relevant Community legislation in this field, including legislation on the control and distribution of VMPs. The mission assessed the performance of the competent authorities and other officially authorised entities involved in residues and VMP controls and the legal and administrative measures put in place to give effect to the relevant Community requirements with regard to import of food of animal origin into the EU. In particular, attention was focussed on the implementation of corrective actions and guarantees given by the Brazilian authorities in response to the recommendations made in the 2003 FVO residues mission report (DG(SANCO)/9047/ 2003). The report concludes that most of the deficiencies found in 2003 have still not been rectified and many of the promised actions did not in fact happen. Consequently the present system of residues and veterinary medicine control is not adequate and can not be judged to offer guarantees equivalent to those provided for in Community legislation. Major shortcomings in the design, scope and implementation of the national residues control plan remain. The official residues laboratory network is not capable of delivering the quality and breadth of analytical service require to meet even the limited scope of the existing national residues control plan. The continued free availability of the majority of veterinary medicines, the absence of any requirement for maintenance of medicines records on farm, the absence of official controls on farm in this respect and a lack of testing for residues of the many veterinary medicines which are unauthorised for use in food producing animals in the EU but which are freely available for use in Brazilian livestock production, individually and cumulatively undermine confidence in the residue status of several commodities exported to the EU. The export of honey to the EU in the absence of any testing, the export of eggs in the absence of any Commission approval of a residue control plan for this commodity, and the finding (outside the scope of the mission), that pig meat has been continuously exported to the EU (as ships supplies) throughout 2005 in contravention of Community animal health requirements, undermine confidence in the ability of the CCA to guarantee that exported food of animal origin complies with Community requirements. The report makes a number of recommendations to the Brazilian competent authorities, aimed at rectifying the shortcomings identified and enhancing the implementing and control measures in place. ii


4 ABBREVIATIONS & SPECIAL TERMS USED IN THE REPORT AMOZ AOZ CA CCα CCβ CCA CCRC CGAL CRL DES DG DFIP DIPOA DSA 5-methylmorpholino-3-amino-2- oxazolidione (a marker residue for the nitrofuran furaltadone) 3-amino-2-oxazolidinone (a marker residue for the nitrofuran furazolidone) Competent Authority Decision limit Detection capability Central Competent Authorities Coordenação de Controle de Resíduos e Contaminantes Co-ordination of the control of residues and contaminants Coordenação Geral de Apoio Laboratorial General Coordination of Laboratories Community Reference Laboratory Diethylstilbestrol Directorate General Departamento de Fiscalização de Insumos Pecuários Department of Livestock Input Inspection Departamento de Inspecao de Produtos de Origem Animal - Department of Inspection of Products of Animal Origin Departamento de Saude Animal - Department of Animal Health Group A, B HPLC EC European Community ISO INMETRO EEC European Economic Community LANAGRO EU European Union LC-MS/MS EUROSTAT Statistical Office of the European Communities LOD Categories of substances listed in Annex I to Council Directive 96/23/EC: A1 Stilbenes A2 Thyrostats A3 Steroids A4 Zeranol A5 A6 B1 Beta-agonists Substances listed in Annex IV to Council Regulation (EEC) No 2377/90 Inhibitors (antimicrobials) B2a Anthelmintics B2b Coccidiostats B2c Carbamates and pyrethroids B2d Sedatives B2e NSAIDs B2f Others (e.g. corticosteroids) B3a Organochlorines including PCBs B3b Organophosphorus compounds B3c Chemical elements B3d Mycotoxins B3e Dyes B3f Others High Pressure Liquid Chromatography Instituto Nacional de Metrologia, Normalização e Qualidade Industrial Brazilian National Accreditation Body International Standardisation Organisation Laboratório Nacional Agropecuário National Animal and Plant Laboratory Liquid Chromatography Tandem Mass Spectrometry Limit of Detection FVO Food and Veterinary Office LOQ Limit of Quantification GC-MS Gas Chromatography Mass Spectrometry MAPA Ministério da Agricultura, Pecuária e Abastecimento Ministry of Agriculture, Livestock and Food Supply GMP Good Manufacturing Practice ML Maximum Level iv

5 MRL Maximum Residue Limit SEDESA MRPL Minimum Required Performance Limit SEFAG NRCP National Residue Control Plan SEM POM Prescription-only medicine SFA PT Proficiency Test SIF Serviço de Defesa da Sanidade Agropecuária Service of Protection of Animal and Plant Health Serviço de Fiscalização Agropecuária Service of Animal and Plant Inspection Semicarbazide a marker residue for the nitrofuran nitrofurazone Superintendencia Federal de Agricultura, Pecuária e Abastecimento - Federal Superintendence of Agriculture, Livestock and Food Supply Serviço de Inspeção Federal Federal Inspection Service RASFF Rapid Alert System for Food and Feed SOP Standard Operating Procedure RIA Radioimmunassay TLC Thin Layer Chromatography SDA Secretaria de Defesa Agropecuaria Secretariat of Animal and Plant Protection VMP Veterinary Medicinal Product CONVENTIONS USED IN THE REPORT Bullet points marked thus indicate findings made by the mission team on the basis of observations on the spot or assessment of information received. v

6 1. INTRODUCTION The mission took place in Brazil from 23 November to 1 December The mission team comprised two inspectors from the Food and Veterinary Office (FVO) and one national expert. The mission was undertaken as part of the FVO's planned mission programme, evaluating control systems and operational standards in this sector. Representatives from the central competent authorities (CCA) accompanied the inspection team during the whole mission. An opening meeting was held on 23 November 2005 with the CCA. At this meeting, the objectives of, and itinerary for, the mission were confirmed by the inspection team and the first discussions with the CCA officials were held. 2. OBJECTIVES AND SCOPE OF THE MISSION The objective of the mission was to evaluate the implementation of national measures, aimed at the control of residues and contaminants in live animals and animal products, including the controls on the distribution and use of veterinary medicinal products (VMPs) and feed additives, the use of which may give rise to residues in such products. The evaluation was based on the standards set out in Council Directive 96/23/EC 1 and other relevant Community legislation in this field, including legislation on the control and distribution of VMPs. The mission focused on the role of the competent authorities (CA), the legal and administrative measures in place to give effect to the relevant EU requirements with regard to import of food of animal origin into the EU, controls with regard to residues and VMPs and their operation, and the performance of residue laboratories. Particular attention was paid to examining the implementation of corrective actions promised by the CA in response to recommendations made in the report of the previous FVO residues mission to Brazil (DG(SANCO)/9047/2003). The following sites were visited and meetings were held with: COMPETENT AUTHORITY VISITS Competent Authorities LABORATORY VISITS Reference and routine laboratories FARMS Comments Central 3 Opening and closing meetings and a separate meeting on inter alia the follow-up of non-compliant results and on VMP authorisation and control at the Ministry of Agriculture, Livestock and Food Supply (MAPA) Regional 1 One State Office. Furthermore, meetings took place with representatives from two other State Offices when establishments located in their States were visited. Comments 3 LANAGRO/MG, LANAGRO/SP, LANAGRO/RS (all official laboratories involved in residues testing, belonging to MAPA) Comments Poultry production site 1 One major poultry farm Cattle production site 1 One major cattle farm Establishments Comments Honey processing plant 1 One major honey processing plant, exporting honey and honey products. OTHER SITES Comments Veterinary wholesaler 1 One major wholesaler dealing with VMPs. Retailer/Pharmacy 1 One veterinary pharmacy dealing with VMPs. 1 EU legal acts quoted in this report refer, where applicable, to the last amended version. 1

7 3. LEGAL BASIS FOR THE MISSION The mission was carried out under the general provisions of Community legislation and, in particular: Council Directive 96/23/EC, Commission Decision 98/140/EC 2 of 4 February 1998 laying down certain detailed rules concerning on-the-spot checks carried out in the veterinary field by Commission experts in third countries. A full list of the legal instruments referred to in this report is provided at Annex I. 4. BACKGROUND 4.1. COUNTRY STATUS IN RELATION TO SUBMISSION OF RESIDUES CONTROL PLANS Commission Decision 2004/432/EC 3, indicates that the Brazilian National Residues Control Plan (NRCP) is approved in accordance with Council Directive 96/23/EC for bovine, ovine/caprine (only casings), swine, equine, poultry, aquaculture products, milk, farmed game, and honey. In January 2005 the Brazilian authorities asked the Commission Services for eggs to be listed. At the moment there are no EU approved establishments in Brazil for pig meat. The 2005 NRCP was submitted at the beginning of January 2005 to the Commission Services. The evaluation of this NRCP by the Commission Services revealed substantial deficiencies (e.g. many relevant substance groups not included in the plan), which were communicated to the CCA by letter in September SUMMARY OF PREVIOUS MISSION RESULTS A previous residues mission to Brazil was undertaken from 30 June to 10 July 2003 (DG(SANCO)/9047/2003), the report of which has been published on the Health and Consumer Protection Directorate General web site at: The report identified a number of deficiencies in several key areas of the NRCP (design, scope and implementation) and in the authorisation and control system for VMPs. The Brazilian authorities subsequently submitted a detailed action plan to the Commission services intended to address the shortcomings identified RAPID ALERT SYSTEM FOR FOOD AND FEED (RASFF) NOTIFICATIONS FOR CONSIGNMENTS FROM BRAZIL CONCERNING RESIDUES In 2003 a total 39 findings of nitrofuran residues (mainly AMOZ and SEM) in poultry meat imported from Brazil were reported under the RASFF. Most of these notifications were reported between January and August 2003, with one further AMOZ notification from November Besides these findings in poultry meat, there was one SEM notification in egg white powder and one streptomycin finding in honey in In SEM residues findings in consignments from Brazil were notified under the RASFF (in shrimps, chicken nuggets and breaded chicken 2 Official Journal L 038, 12/02/1998 p Official Journal L 154, 30/04/2004 p.44 as corrected in Official Journal L 189, 27/5/2004 p.33 2

8 products) 4. In 2005 (up to November) there was one RASFF report of AMOZ in bovine intestine PRODUCTION AND TRADE INFORMATION Detailed information on the quantities of food commodities (of animal origin) exported to the EU in 2004 and 2005 (January October) was supplied by the Brazilian Ministry of Development, Industry and Trade. These can be summarised as follows: Export to the EU (tons) Commodity * Bovine meat 287, ,721 Poultry meat and products (incl. turkey) 369, ,973 Horse meat 17,382 13,691 Pig meat 19,808 ** Other meat products Offals of ovine/caprine Bladder and stomachs from animals 16,377 10,702 Casings 12,492 13,434 Shrimps and products (aquaculture and wild caught) 41,615 33,404 Aquaculture fish 3,338 2,481 Honey 16,664 8,447 Eggs Milk and milk products 39 1 * January October 2005 ** no data presented for 2005 According to EUROSTAT data, in 2004 Brazil was the largest exporter of bovine and poultry meat to the EU, and the second largest exporter for horse meat. 5. MAIN FINDINGS 5.1. NATIONAL RESIDUE CONTROL PLAN Planning The Ministry of Agriculture, Livestock and Food Supply (MAPA) is the responsible authority for the control of inter alia residues in live animals and animal products. Within MAPA, in the Secretariat for the Protection of Livestock (SDA) the new body Co-ordination of the control of residues and contaminants (CCRC) has started its operation in March 2005 (on the legal basis of Presidential Decree N from ). CCRC acts as a central co-ordination body and is responsible for inter alia the planning, co-ordination, supervision and follow-up of the annual NRCP. 4 In their response to the draft report the Brazilian Competent Authorities stated that for all 3 SEM cases detailed technical reports by DIPOA had shown that that nitrofurans were not used in these cases. 3

9 The mission team noted that: all responsible authorities are involved in the planning of the NRCP, e.g. the Department of Inspection of Products of Animal Origin (DIPOA), Department of Animal Health (DSA), Federal Inspection Service (SIF) and the General Coordination of Laboratories (CGAL); most of the relevant data and information are taken into account for the planning. However, the usage pattern and consumption figures for VMPs are in general not available, thus the scope of the NCRP i.e. the range of analytes tested is only based on the availability of analytical methods and the capability of the responsible laboratories; the NRCP 2005 was officially published via Ordinance No. 1 at the 7 January 2005 and sent in parallel to the Commission Services. The results of the NRCP 2004 were officially published in July However, this publication is only a summary and gives no details about the non-compliant results; the NRCP 2005 was issued for the following commodities: bovine (including live sampling), pigs, equidae, poultry, milk, eggs, and aquaculture; there is no plan for honey, in spite of the fact that Brazil is listed for honey and has been regularly exporting honey to the EU. The CCA informed the mission team that up to now honey has never been sampled or tested. According to information given by CCRC, honey sampling will start in December 2005 (only for tetracyclines and sulphonamides) and it is planned to include honey in the NRCP ; there is no plan for farmed game. Brazil is listed for this commodity although there are no exports to the EU at present; a plan for eggs was submitted. Brazil is not listed for this commodity, but has asked the Commission Services for listing of eggs 6 ; the provision of a plan for sheep and goat meat was promised by the Brazilian authorities in the action plan to the FVO report 2003, however no plan for this commodity was submitted 7 ; Volume 3 of the Codex Alimentarius forms the basis for the number of samples in the Brazilian NRCP. For cattle, pigs and poultry, 460 samples are selected at random and are analysed for several substance groups. On the assumption that each of these populations is homogenous, testing this number of samples should allow an actual residue violation prevalence of 1% to be detected with a confidence level of 99%. Compared to the NRCP 2003, the sample figures have been significantly increased; many analyte group/commodity combinations specified in Council Directive 96/23/EC are not covered in the NRCP : 5 In their response to the draft report the Brazilian Competent Authorities stated that: Sampling of honey had commenced in late November 2005 and by the end of January 2006, 119 samples had been tested for tetracyclines and sulphonamides. For the NRCP 2006 honey will be tested for heavy metals, sulphonamides and tetracyclines. 6 In the NRCP egg samples were tested for chloramphenicol and 155 samples for nitrofurans. All were compliant and the Competent Authority is considering making an official request to the Commission Services to approve the residues plan for this commodity. 7 At the moment there is no intention to apply for the listing of sheep/goat. 4

10 bovine: A6 (nitroimidazoles are missing but other A6 compounds are covered), B2b (anticoccidials), B2c (carbamates/ pyrethroids), B2d (sedatives), B2e (NSAIDs), B3b (organophosphates), B3d (mycotoxins); swine: A1 (stilbenes), A2 (thyrostats), A3 (steroids), A4 (zeranol), A5 (betaagonists), A6 (nitroimidazoles are missing but other A6 compounds are covered), B2b (anticoccidials), B2c (carbamates/ pyrethroids), B2d (sedatives), B2e (NSAIDs), B3b (organophosphates), B3d (mycotoxins); equine: A1 (stilbenes), A2 (thyrostats), A3 (steroids), A4 (zeranol), A5 (beta-agonists), A6 (nitroimidazoles are missing but other A6 compounds are covered), B2b (anticoccidials), B2c (carbamates/ pyrethroids), B2d (sedatives), B2e (NSAIDs), B3b (organophosphates), B3d (mycotoxins); poultry: A2 (thyrostats), A3 (steroids), A6 (nitroimidazoles are missing but other A6 compounds are covered), B2c (carbamates/pyrethroids), B2e (NSAIDs), B3d (mycotoxins); aquaculture: A1 (stilbenes), A3 (steroids), B1 (antimicrobials), B2a (anthelmintics), B3a (organochlorines), B3d (mycotoxines), B3e (dyes malachite green) (aquaculture products are foreseen to be tested only for nitrofuran metabolites, chloramphenicol and mercury) milk: A6 (chloramphenicol, nitrofurans, nitroimidazoles), B2e (NSAIDs), B3b (organophosphates), B3c (heavy metals) (milk is foreseen to be tested only for tetracyclines, anthelmintics, organochlorine compounds and M1) eggs: B1 (antimicrobials), B2b (anticoccidials), B3a (organophosphates); several relevant substance groups and important compounds are totally lacking: nitroimidazoles, B2c (carbamates/pyrethroids), B2d (sedatives), B2e (NSAIDs), B3b (organophosphates), and malachite green; there is no testing planned for the detection of residues of some substances which are expressly banned from use in food producing animals in the EU (e.g. boldenone, ractopamine) but which are authorised in Brazil for use in animals which may enter the food chain 9. Similarly there is no testing for residues of many substances, authorised for use in food producing animals in Brazil, but which do not have Community MRLs and thus have no EU authorisation (see also chapter 5.3.1); in addition, the scope of several substance groups in the NRCP is very limited: steroids - only trenbolone is tested only in bovine, beta-agonists - only clenbuterol and salbutamol are tested only in bovine and poultry, sulphonamides - only four of more than ten authorised substances are tested, and anticoccidials - only nicarbazin in poultry meat is tested; no chemical confirmation is planned for the screening tests of antimicrobials (B1) which are among the most frequently used veterinary medicines in animal 8 In their response to the draft report the Brazilian Competent authorities stated that: Testing for sulphonamides and tetracyclines in honey, tetracyclines in milk, chloramphenicol in cattle, pigs, poultry, fish, shrimp and eggs and nitrofuran metabolites in horses has started. Furthermore, nitromidazoles, carbamates, carbadox, olaquindox, cyromazine, spectinomycin, flubendazole, clopidol, lasalocid, spiramycin and tylosin are already on both the CCRC and CGAL s priority list for inclusion in the NRCP 2006 as soon as the techniques have been validated and the laboratories accredited by CGAL to participate in the NRCP 2006 have been authorised. 9 Boldenone and ractopamine are also priorities for testing under the NRCP

11 production worldwide. Thus screened positive findings can not be confirmed and the substance can not be unambiguously identified; most of these gaps and deficiencies detailed above were also observed in the NRCP After the FVO mission in June 2003, the CCA produced an action plan stating that most of the missing substance groups would be included in the NRCP However, this did not happen 10 and, during the present mission the CCA stated that the continuing NRCP deficiencies are due to a lack of analytical methods in the laboratories. The Commission Services wrote to the Brazilian authorities in September 2005 highlighting the substantial deficiencies in the NRCP 2005, however, to date, the plan has not been amended and the deficiencies remain Implementation After planning of the NRCP is completed, DIPOA draws on a random basis using a computer application, the establishments to be sampled and one week before sampling, informs the responsible SIF officials in each of the States. Also the type of sample (species, matrix etc.) and analytes to be tested are given by this application. All sampling is done by SIF inspectors, primarily in the EU-approved establishments. The residues laboratories have access to this computer databank and after receipt and analysis of the samples the sample data are completed. Lost samples or samples unacceptable for analysis are replaced by new samples drawn by DIPOA. An annual sampling plan for live animals is prepared centrally by DSA and submitted to the State offices (Service for the Protection of the Health of Livestock, SEDESA). This plan is restricted to urine sampling on cattle farms. The regional offices of SEDESA select the farms to be sampled, which are mostly feed lots. Sampling is performed by SEDESA officials. The mission team noted that: all samples are taken randomly either in the establishments or on farm. Samples are sealed and are appropriately transported directly to the relevant laboratories; concerning milk samples, the SIF inspectors decide themselves whether samples are taken on farm or from corporative/transport tanks. Traceability back to the farm is not always guaranteed 11. In addition, the possibility of detecting noncompliant residues is decreased when pooled samples are taken from bulk transport tanks; aquaculture samples are only taken in processing establishments after harvest, thus there is no sampling on farm, at all production stages which is a requirement under Council Directive 96/23/EC In their response to the draft report the Brazilian Competent Authorities stated that: Several actions were taken following the announcement of the present mission (April 2005). Inspectors may collect samples from collective tanks. The establishment must provide a list of the names of all producers contributing to this collective milk so that traceability (to the farm of origin) is ensured in the event of a non-compliant result. 6

12 Supervision of implementation The CCRC is responsible for the over-all supervision of the implementation of the NRCP. The CCRC has access to the DIPOA databank. The mission team noted that: for the NRCP 2004 only about 80% of the planned meat, milk and urine samples (according to the official NRCP) were received and analysed in the laboratories. There were several reasons for this shortfall e.g. samples were received in the laboratories, but were rejected for analysis, mostly due to thawing, samples were lost during the transport by post or samples were not taken at all; none of the planned chloramphenicol samples were taken or tested in 2004, due to the absence of an appropriate analytical method and an approved testing laboratory for this method; 923 poultry samples were planned in the NRCP 2004 for the analysis of nitrofurans, however no samples were tested. The CA informed the mission team, that the private laboratories involved in nitrofuran analysis were accredited; however they were approved for this analysis only at the end of 2004 by the authorities. The CA stated that only approved methods could be used in the scope of the NRCP; for the NRCP 2005, a total of 11,800 samples (out of a planned 18,800) had been received in the residues laboratories and registered in the DIPOA databank at the time of the mission; for 2005, 2300 samples were planned for chloramphenicol analysis but no samples have been taken up to now, due to the lack of an appropriate analytical method. The analytical method for chloramphenicol is now validated in a private laboratory and sampling will start after the final approval by CGAL (probably in December 2005). The CA expects that the plan will be not realised for chloramphenicol in 2005; the CA informed the mission team that no horse meat samples for nitrofuran analysis were taken up to now due to the lack of a validated method; from 100 planned milk samples for mycotoxins for 2005, 6 samples have been taken to date and 20% of the milk samples foreseen for tetracycline analysis have been sampled to date 8 ; the mission team received an unofficial internal plan from the DIPOA with reduced samples figures for several substance group/commodity combinations for 2005 (an over-all reduction of 4860 samples). DIPOA stated that this reduced plan will be fulfilled in However, this plan has not been officially announced to the Commission Services Follow-up of non-compliant results The CCRC is the responsible body for co-ordination and supervision of the followup of non-compliant results. Non-compliant results are sent from the laboratories to the CGAL which transfers this information to the CCRC. The CCRC sends this information further to DIPOA, DSA and the Department of Livestock Input 12 In their response to the draft report the Brazilian Competent Authorities stated that there had been a mistake in the official publication of the NRCP for 2005 which was given to the mission team. This mistake had subsequently been realised and the sample numbers corrected accordingly. At the closure of the 2005 NRCP, more than 2000 tests in excess of the number provided to the mission team in November 2005 had been carried out, a 17% increase compared to

13 Inspection (DFIP) within SDA in order to initiate the follow-up procedure. DIPOA marks non-compliant results from slaughterhouses in its databank so that SIF is able to resample the next 2 deliveries from the same farm. Furthermore, SEDESA performs on farm investigation. The measures taken are residue-dependent. For example, after a first non-compliant result for stilbenes the whole herd is destroyed. In the case of other prohibited substances, the herd is blocked (i.e. not permitted to send animals for slaughter for human consumption or to sell animals to other farms) for additional sampling. If this result is positive there will be no destruction of the herd but a further blockage of six months after which the herd is sampled again. In case of a further noncompliant result the herd is again blocked, up to a compliant analysis result. Farm investigations are always performed in non-compliant cases. Samples on farm are taken from live animals sampling of feedstuffs or drinking water is not foreseen. In 2004 non-compliant results for AOZ (one finding in pig muscle), ivermectin, abamectin, sulphamethazine, and heavy metals were reported. In 2005, up to the end of October, the number of non-compliant results (in total 24 results) had increased compared to The 2005 results included zeranol (two findings in bovine urine), SEM (two findings in poultry muscle), sulphonamides, abamectin, ivermectin, doramectin and heavy metals. The follow-up files of these noncompliant cases are kept at central level (DIPOA). The mission team noted that: a manual of procedures for the follow-up of non-compliant results was issued in an internal official communication ( Memo ) by DIPOA in January In addition, a manual for follow-up procedures including forms and checklists was drafted by DFIP, which will probably be implemented in Thus at the moment there are two manuals for follow-up procedures; in the follow-up files studied at central level the mission team found that all responsible bodies were informed in a timely fashion and the turnaround times from sample receipt to reporting were sufficiently short to facilitate effective follow-up investigation. However, some files were still not completed several months after the second sampling, due inter alia to an absence of documents from SEDESA. The CCRC has no power to force the States for the timely completion of the files; the follow-up file of the RASFF alert notification (SEM in shrimps) was studied in detail by the mission team. A comprehensive study was performed by all responsible bodies. No evidence for the illegal use of nitrofurans could be found Other residues control programmes Nitrofurans monitoring programme for poultry meat Details about this monitoring programme are described in the report of the residues mission 2003 (DG(SANCO)/9047/2003). Since 2003, 405 samples per week have been taken from all of the establishments exporting poultry to the EU. Up to now in 8

14 total 54,000 samples have been analysed in two accredited private laboratories. There were 85 non-compliant results in 2003 and none in 2004 and In addition to this monitoring programme, 1982 poultry samples were planned to be taken in the scope of the NRCP In the NRCP programme 2 non-compliant results for SEM were obtained in The mission team noted that: the private laboratories involved in the nitrofurans monitoring programme were approved for this analysis by the authorities only at the end of Auto-control system for honey before export In the honey collection centre visited, honey was tested before export for residues of VMPs, when requested by the importer. The samples were taken officially and the analysis reports were annexed to the health certificates. The honey samples were analysed for residues in private laboratories. The mission team noted that: in most analysis reports studied by the mission team the methods used and analytical limits of detection were not adequate to ensure compliance with Community MRLs Implementation of the guarantees given in the action plan after the FVO residues mission 2003 regarding the NRCP During the residues mission in 2003 several substantial deficiencies were found in the design of the NRCP 2003 and in its implementation. In the action plan sent by the Brazilian authorities to the European Commission in October and December 2003 numerous detailed guarantees regarding the NRCP were given. These included inter alia: 15 the submission of an NRCP including honey and sheep/goat meat; 7 the inclusion of several specific substances in the NRCP, present in authorised veterinary medicinal products in Brazil, which are either expressly banned in the EU or are not authorised for use in food producing animals in the EU; the adoption of the EU MRLs for veterinary drugs and the EU MLs for contaminants in the NRCP; a general increase in the number of substance groups covered by the NRCP, particularly the addition of the following: carbamates and pyrethroids in general; steroids, NSAIDs and mycotoxins for poultry; stilbenes, zeranol and NSAIDs for equines; steroids, anthelmintics and dyes for aquaculture In their response to the draft report the Brazilian Competent Authorities stated that: Since February 2003 a total of samples have been tested in this programme, with 86 noncompliant results. On the basis of these results MAPA has suggested that it may be possible to terminate this specific programme and to continue these tests in the context of the annual NRCP. These non-compliant results were from establishments not authorised for export to the EU. Nevertheless, appropriate follow-up was performed. A number of actions were carried out a detailed description and the rationale used is documented in the response to the draft report which is annexed to this report. 9

15 Whilst the numbers of samples foreseen to be taken from certain commodities did increase, the findings detailed in the present report indicate that most of the undertakings listed above were not implemented as promised Export of pig meat and eggs to the EU According to data provided by the CCA pig meat has been continuously exported to the EU. The CCA stated that this meat is destined for ships supplies. Brazil does not comply with Community animal heath requirements for export of pig meat to the EU as it is not listed in Part 1 of Annex 2 to Council Decision 79/542/EEC 16. Furthermore there are no EU-approved establishments for production of pig meat in Brazil. The ships supplies issue was also detected during the FVO residues mission in The CCA informed the mission team that no health certificates were issued for pig meat and that these data derived from sales figures to ship suppliers 17. The mission team noted that: according to Commission Decision 2005/92/EC 18, from 1 January 2005 consignments of certain products of animal origin entering free zones, free warehouses or premises of ship suppliers have to comply with Community animal health requirements and shall be accompanied by appropriate animal health certificates ensuring this compliance. The CCA was not aware of this legislation. According to the data provided by the CCA, eggs have been exported to the EU with a significant increase in The mission team noted that: Brazil is not listed for this commodity in Commission Decision 2005/233/EC 19. This issue was also already detected during the FVO residues mission in LABORATORIES General description The General Coordination of Laboratories (CGAL) was created in 2005 by the Presidential Decree N from 21 January 2005, as a body under the SDA in MAPA. CGAL was formed by merging two previous co-ordination bodies: the coordination of Laboratories for Animal Products and the Co-ordination of Laboratories for Plant Products. CGAL is inter alia responsible for planning, standardisation, co-ordination and supervision of the laboratory network and provides equipment, training, proficiency tests (PTs) etc. for the laboratories. The following four official MAPA laboratories are approved by CGAL for the analysis of NRCP samples: LANAGRO/MG in Pedro Leopoldo, LANAGRO/SP in Campinas, LANAGRO/RS in Porto Alegre and LANAGRO/PE in Recife. In Official Journal L 146, 14/06/1979 p 15 In their response to the draft report the Brazilian Competent Authorities stated that DIPOA is investigating this issue and that appropriate legal measures will be implemented to stop this practice. Official Journal L 31, 04/02/2005 p.62 Official Journal L 72, 18/03/2005 p.30 10

16 addition four private laboratories are approved by CGAL for special sophisticated analysis (e.g. analysis of nitrofuran metabolites, beta-agonists). The mission noted that: none of the four LANAGRO laboratories for the NRCP are accredited according to ISO The mission team was informed that CGAL will apply to be certified as an accreditation body by a foreign organisation. It is then planned to accredit the LANAGRO laboratories up to the end of 2006 by CGAL 20. In contrast, the four private laboratories involved are accredited by external accreditation bodies, mostly by the national accreditation body INMETRO; CGAL plan to audit the LANAGRO laboratories every 6 months - within CGAL a department for auditing of the LANAGRO laboratories will be set up. To date LANAGRO/SP and LANAGRO/RS have not been audited by CGAL 21. The management of LANAGRO/MG stated that an external audit was performed by CGAL; however an audit report was not available for the mission team. In contrast, the private laboratories involved in official testing are audited by CGAL together with experts from the LANAGRO laboratories before their approval. In addition the use of new analytical methods in the private laboratories needs a CGAL audit before official approval by CGAL; the LANAGRO laboratories have not participated in international PTs to date 22. LANAGRO/MG has started the organisation of national PTs for the LANAGRO laboratories. In October 2005 a PT for sulphonamides and heavy metals in liver was organised, using fortified samples; there are few and infrequent scientific contacts to EU or American residues laboratories; CGAL has initiated a tender for several relevant instruments for residues analysis (e.g. LC-MS/MS, GC-MS, and HPLC) and it is expected that this equipment will be installed in April 2006 in the LANAGRO laboratories visited. LANAGRO/SP has acted as technical co-ordinator for this tender. Up to now there are no action plans with specific deadlines and priorities available in the LANAGRO laboratories for the use of these instruments in order to develop lacking analytical methods. 23 Also CGAL - as central coordination body - informed the mission team that there is no concrete central action plan available. A meeting about this topic with all involved residue control laboratories (LANAGRO and private laboratories) is planned for December In their response to the draft report the Brazilian Competent Authorities stated that: The international recognition of CGAL as an accrediting body is still ongoing and that the date of accreditation of the LANAGRO laboratories (end of 2006) is only an anticipated one. The external auditing process in the LANGRO laboratories has started and CGAL is monitoring the implementation of corrective actions after the audits. In December 2005 LANAGRO-PE received samples as part of an international PT promoted by the Pan-American Health Organisation. Several LANAGRO laboratories participated in a technical co-operation programme with Italian institutes. Samples for PTs of chloramphenicol, nicarbazin, sulphamethazine and oxytetracycline in poultry, and aflatoxin M1 in milk, have been promised to be supplied in the scope of this programme for the first half of In addition, contacts have been established with IRMM/JRC in Geel /Belgium and the CRL Fougères. A plan of action for the rational use of equipment is being drawn up under the auspices of the Geral de Apoio Laboratorial, further to a meeting held in December 2005 in which validation of new methods for the 2006 NRCP was also planned. 11

17 several validation documents from two private laboratories were studied by the mission team. The validation files of the RIA assays for diethylstilbestrol (DES), zeranol, salbutamol and clenbuterol in liver were available and adequate. The files for the analysis of chloramphenicol in samples from cattle, pigs, poultry, eggs, shrimps and fish were studied. There are no method and validation files available for chloramphenicol in equidae (460 samples foreseen in the NRCP 2005). The method has an appropriate sensitivity; however CCα and CCβ were not determined although this was promised in the action plan from Furthermore, the method was not capable of confirmation of chloramphenicol. The choice of florfenicol as an internal standard may be problematical since this substance is an active principle in authorised VMPs in Brazil On the spot visits in the LANAGRO laboratories Three LANAGRO laboratories were visited during the course of the mission LANAGRO/MG in Pedro Leopoldo, LANAGRO/SP in Campinas, LANAGRO/RS in Porto Alegre LANAGRO/MG in Pedro Leopoldo The mission team noted that: a quality system was in place, including a quality manager and the availability of a quality manual. Internal audits were regularly performed; reports and correction files of these audits were available. The quality manual and the written procedures were quite comparable with the ISO system. Training files of the laboratory staff were available and general SOPs for calibration and maintenance of instruments were in place. An SOP for method validation was available and the approach described was comprehensive. However, several validation elements of the Commission Decision 2002/657/EC were lacking (and in the action plan of 2003 the CCA had undertaken to validate methods to this standard); all methods studied by the mission team had written SOPs and validation files; some equipment was out of order and the only GC-MS system has not been running since July 2005 due to missing spare parts. The samples had been sent for analysis to a private laboratory; logbooks for the equipment were in place; however it was not registered when the GC-MS system went out of working order; thyrostats are screened by gravimetric determination of the thyroid glands in the slaughterhouses. This procedure is not validated and is not state-of-the-art. To date one sample screened non-compliant, however this screening result was not confirmed by the TLC method available in LANAGRO/MG. Furthermore, the TLC method for confirmation is not sufficiently sensitive and specific to detect the potential illegal use of thyrostats; the validation file for the analysis of anabolic substances in urine was reviewed. The file was comprehensive and many data had been collected, however the method was not fit for the purpose of confirmation. For several of these analytes the LOD was identical with the LOQ. 12

18 LANAGRO/SP in Campinas According to NRCP 2005, LANAGRO/SP has to analyse NRCP samples for anabolics (DES and zeranol), beta-agonists, mycotoxins (M1 in milk), nitrofuran metabolites in pigs and equidae, heavy metals and organochlorines. The mission team noted that: due to a lack of methods and instruments most of the obligatory analyses have been outsourced to either private laboratories (screening of anabolics and betaagonists by radioimmunoassay (RIA), nitrofuran metabolites in pork and horse muscle by LC-MS/MS) or LANAGRO/MG (analysis of M1 in milk); a quality manual was in place but it did not fulfil several of the requirements laid down in ISO An internal audit is performed once a year; LANAGRO/SP is responsible for the confirmation of screening non-compliant samples for beta-agonists and anabolics, screened by RIA assays in a private laboratory. While there were no such samples in 2004 or 2005 to date, the laboratory does not have authorised written SOPs for the analysis of anabolics and beta-agonists. For the determination of DES in liver a condensed method is described in the the validation study. Validation of a GC-MS method for the analysis of DES in bovine liver was ongoing. With regard to other substances with an anabolic action, no validation data were available for the determination of zeranol or of the beta-agonists clenbuterol and salbutamol in liver; an SOP was not available for the analysis of nitrofuran metabolites, only a summary of the method was given in the validation file. The method for the determination of nitrofuran residues was validated for pork muscle for three of the four nitrofuran marker residues (SEM was not included) but not for horse muscle. Due to these gaps in validation the method was not used routinely in the NRCP 2005 for any matrix and samples were outsourced to a private laboratory; for the LC-MS/MS system no maintenance records were available. Since its installation in June 2003 no routine samples had been analysed with this system; a validation file for the determination of organochlorine residues was available. The method was not validated for polychlorinated biphenyls. Furthermore, no re-validation for the range of organochlorine pesticides detected had been performed after a major change of the analytical equipment LANAGRO/RS in Porto Alegre The mission team noted that: a quality manager and a quality manual were in place. However, internal audits had not been performed and the analytical methods approved were not listed in the quality manual; In their response to the draft report the Brazilian Competent Authorities stated that: SOPs are now available for beta-agonists and anabolics and that the validation process for zeranol has started. Maintenance records for the LC-MS/MS system are now available. The organochlorine method will be reassessed. The LARA/RS handbook of methods is quoted and referred to in the Quality Manual. 13

19 written SOPs were available for the methods checked by the mission team. Validation records were available for the HPLC method for nicarbazin in poultry muscle and the TLC method for sulphonamides. The adopted procedure was adequate; there is a system adopted for the storage and identification of reference standards and the preparation of stock standard solutions; no maintenance records were available for the equipment used; the microbiological screening test for antimicrobials (2-plate test) in muscle was not validated with regard to sensitivity and scope. This method is used throughout Brazil for antibiotic screening. In this laboratory no non-compliant results had been detected to date, no chemical methods are available for confirmation. Such a screening method is not state-of-the-art and is unlikely to detect a broad range of antibiotic residues at relevant concentrations; four sulphonamides are included in the TLC method for liver (more than ten different sulphonamides are authorised as active principles in VMPs for food producing animals). The method in place is not selective for the sulphonamides tested because three out of four substances are not clearly separated on the plate. Positive screened samples are sent for confirmation to LANAGRO/MG; however this laboratory also has only a TLC method for sulphonamide analysis Implementation of the guarantees given in the action plan after the FVO residues mission 2003 regarding laboratories Many problems in the operation of the network of governmental residue laboratories were documented in mission report DG(SANCO)/9047/2003. The subsequent action plan from the CA submitted to the Commission in October 2003 stated that there would be, inter alia: implementation of a quality system based on ISO 17025; implementation of independent audits in the official laboratories to comply with the standards of ISO 17025; establishment of analytical performance criteria as specified in Commission Decision 2002/657/EC; participation of official laboratories in EU-organised PTs; provision of regular information to the Commission Services on the progress of the implementation of the quality system in the official laboratories. The findings of the present mission show that most of the guarantees concerning quality systems and accreditation in the LANAGRO laboratories have not been implemented. 26 In their response to the draft report the Brazilian Competent Authorities stated that screening and confirmation of sulphonamides will be replaced by more sensitive and comprehensive methods. For antibiotics, the FAST screening test will be employed (see followed by a seven plate bioassay and confirmation using LC-MS. 14

20 5.3. VETERINARY MEDICINAL PRODUCTS (VMPS) AND MEDICATED FEEDINGSTUFFS Authorisation of VMPs DFIP within SDA under MAPA is the national authority responsible for the marketing authorisations of VMPs. DFIP was created in February 2005 in connection with the restructuring of MAPA. According to Normative Instruction 36, 7 July 2002, only 17 VMPs (psychotropic, sedative and anabolic VMPs) are designated as prescription-only medicines (POMs). Consequently, the vast majority of VMPs (e.g. antibiotics, antiparasitics) are freely available for the farmer, without prescription by a veterinarian. Hormones and anabolic substances are banned from use in cattle in Brazil. Furthermore, hormones are banned in all feedingstuffs and for the production of poultry. However, the use of anabolic substances via e.g. injection or implant is not expressly prohibited for horses, pigs and sheep. (This was also the case in 2003) The use of chloramphenicol and nitrofurans is forbidden in VMPs and feedingstuffs intended for use in food producing animals. Arsenicals, penicillins, tetracyclines, sulphonamides, carbadox and olaquindox are forbidden as feed additives. This situation is comparable with the situation in the EU. The mission team noted that: about 8,000 VMPs have marketing authorisations in Brazil. No official list with all registered VMPs is publicly available. There is an internet databank of VMPs created by the pharmaceutical industry association; however this list is not complete. The CA stated that an official web application software is under development but that the withdrawal times and species are not planned to be included in this list of VMPs; only VMPs registered by DFIP are allowed to be distributed or used in Brazil. All authorised products must carry a DFIP marketing authorisation number; changes in the registration of VMPs are announced in the official gazette and via circular letters; it is compulsory to have information on withdrawal times either on the outer package or label or insert. Although many VMPs have this information only in the insert, the CA stated that newly authorised VMPs already have this information on the label and that the labelling requirements will be amended in the renewed authorised products; Examination of the database on VMPs revealed that: VMPs containing nitroimidazoles are no longer authorised for use in food producing animals (as they were in 2003); the following substances banned in the Council Directive 96/22/EC are authorised in Brazil: boldenone is approved for equidae as a POM with the remark not for food producing animals. However, there is no horse identification system which would allow sport horses (which could be legally treated with boldenone) to be differentiated from horses destined for the food chain; the beta-agonist ractopamine is approved as feed additive for pigs, without any withdrawal time; 15