EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL

Transcription

1 Ref. Ares(2012) /07/2012 EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Directorate F - Food and Veterinary Office DG(SANCO) MR FINAL FINAL REPORT OF AN AUDIT CARRIED OUT IN URUGUAY FROM 05 TO 16 MARCH 2012 IN ORDER TO EVALUATE THE OPERATION OF CONTROLS OVER THE PRODUCTION OF MEAT PRODUCTS, MINCED MEAT AND CASINGS DESTINED FOR EXPORT TO THE EUROPEAN UNION, AS WELL AS CERTIFICATION PROCEDURES

2 Executive Summary The report describes the outcome of an audit carried out by the Food and Veterinary Office (FVO) in Uruguay from 5 to 16 March The purpose of the audit was to evaluate the operation of controls over the production of meat products, minced meat and casings destined for export to the European Union (EU), as well as certification procedures. Twenty-two meat product and casings establishments exported to the EU in 2011 (8 267 tonnes) and 18 in 2010 (4 849 tonnes). The Central Competent Authority (CCA) explained that the drop in the export figures is due to a reduction in the number of bovines slaughtered in the country (due to drought) and partly the re-direction to other markets (USA). The FVO audit team visited seven establishments during the audit, all major exporters in 2010 and In Uruguay the raw material for the production of meat products and casings for export to the EU must originate from a national EU approved establishment, except for bovine and horse casings (imports from Argentina takes place). The situation concerning the organisation of official controls remains largely as described in the FVO audit report DG(SANCO)/ This organisation is adequately structured for the completion of the requirements laid down in the relevant export certificates. However, the CCA failed to identify a number of significant issues, and in particular the shortcomings in relation to certification. The situation in the establishments visited (food business operators' (FBO) obligations and official controls, in particular, related to the product treatment and record keeping) was found to be generally satisfactory, with some deficiencies noted. The most important concerns a minced meat product facility with poor maintenance and cleanliness. It has not been in activity for a long time and has never exported. This deficiency was not identified by the Competent Authority (CA) despite frequent documented checks. Traceability systems are in place in all establishments visited and traceability exercises forward and backward were satisfactory. A number of deficiencies of a general character was found concerning export certification, testing of water and micro-sampling and validation of processes in Hazard Analysis Critical Control Points (HACCP) programmes. Despite the shortcomings noted by the FVO audit team, the system for official controls in Uruguay is in general capable of providing the guarantees laid down in the export certificates currently in force (Commission Regulation (EU) No 206/2010, Commission Decisions 2007/777/EC and 2003/779/EC.) The CCA took immediate action to address the deficiencies found and provided satisfactory guarantees for most of them. A number of recommendations have been made to the CA with a view to addressing the deficiencies identified during this audit. I

3 Table of Contents 1 INTRODUCTION OBJECTIVES LEGAL BASIS BACKGROUND FINDINGS AND CONCLUSIONS NATIONAL LEGISLATION AND COMPETENT AUTHORITIES LEGISLATION COMPETENT AUTHORITIES APPROVAL OF ESTABLISHMENTS OFFICIAL CONTROLS AT ESTABLISHMENT LEVEL GENERAL HYGIENE REQUIREMENTS WATER TESTING CONTROLS OF INGREDIENTS HACCP-BASED SYSTEMS MICROBIOLOGICAL TESTING IDENTIFICATION MARKING AND LABELLING TRACEABILITY SYSTEMS AND ELIGIBILITY OF RAW MATERIALS OFFICIAL CERTIFICATION OVERALL CONCLUSIONS CLOSING MEETING RECOMMENDATIONS...10 ANNEX 1 - LEGAL REFERENCES...11 II

4 ABBREVIATIONS AND DEFINITIONS USED IN THIS REPORT Abbreviation CA(s) CCA(s) CCP(s) COTE DG(SANCO) DGSG DIA DILAVE Explanation Competent Authority (ies) Central Competent Authority(ies) Critical Control Point (s) Internal Transfer Certificate (Certificado oficial de transferencia de exportación) Health & Consumers Directorate General Directorate General of Livestock Services (Dirección General de Servícios Ganaderos) División Industria Animal a unit within the Central Competent Authority in charge for official controls on meat and meat products Division Laboratorios Veterinarios is the National Reference Laboratory (NRL) for the microbiological testing methods EC EU FBO(s) FVO HACCP European Community European Union Food Business Operator(s) Food and Veterinary Office Hazard Analysis of Critical Control Points Hygiene Package Regulations (EC) No 852/2004, No 853/2004 and No 854/2004 MGAP Ministry of Livestock, Agriculture and Fisheries (Ministerio de Ganadería, Agricultura y Pesca). NRL OV National Reference Laboratory Official Veterinarian III

5 1 INTRODUCTION The audit took place in Uruguay from 5 to 16 March 2012 as part of the planned audit programme of the FVO. The FVO audit team comprised two auditors from the FVO. The FVO audit team was accompanied throughout the audit by a representative from the CCA, the Directorate General of Livestock Services (Dirección General de Servícios Ganaderos, DGSG) of the Ministry of Livestock, Agriculture and Fisheries (Ministerio de Ganadería, Agricultura y Pesca, MGAP). The opening meeting was held on 5 March 2012 with the CCA in Montevideo. At this meeting the FVO audit team confirmed the objectives of, and itinerary for the audit, and additional information required for the satisfactory completion of the audit was requested. 2 OBJECTIVES The objective of the audit was to evaluate the official controls related to the production and storage of food of animal origin in Uruguay and exports to the EU with regard to: CA organisation and operation, official controls over FBOs' compliance with general and specific rules on the hygiene of food of animal origin, and the correct implementation of the chain of certification of meat products, minced meat and casings in relation to the requirements of Council Directive 96/93/EC. In particular, controls over the production of meat products, minced meat and treated stomachs, bladders and intestines including those controls necessary for certification in accordance with the requirements of Commission Regulation (EU) No 206/2010, Commission Decisions 2000/572/EC, 2003/779/EC and 2007/777/EC in the framework of Regulations (EC) No 178/2002, No 852/2004, No 853/2004, No 854/2004 and No 882/2004 as well as Council Directives 92/118/EC and 97/78/EC were subject to this evaluation. In pursuit of these objectives, the audit itinerary included the following meetings and visits: Competent Authorities Comments Competent Authorities Central 1 Opening and Closing meetings Regional Local 7 In the establishments visited Food Production/Processing/Distribution - Activities Meat product establishments 5 Casings establishments 2 Minced meat establishments 1 Certification office 1 1

6 3 LEGAL BASIS The audit was carried out under the general provisions of EU legislation and, in particular Article 46 of Regulation (EC) No 882/2004 of the European Parliament and of the Council on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules. Full EU legal references are provided in Annex 1. Legal acts quoted in this report refer, where applicable, to the latest amended version. 4 BACKGROUND The CCA provided the FVO audit team with following statistics : Quantity exported to the EU (Thousand tonnes) Casings Meat Products The CCA explained that the drop in the export figures is due to a reduction in the number of bovines slaughtered in the country (due to drought) and partly the re-direction to other markets (USA). In Uruguay, following the national requirements, the raw material for the production of meat products and casings for export to the EU has to originate from the national EU approved establishments, except for bovine and horse casings (imports from Argentina takes place). In Uruguay exported to the EU the following meat products: cooked bovine stomachs, cooked and frozen bovine meat, corned beef (2010 only), meat extracts, beef jerkey, tasajo (dried cured beef). Uruguay is a member of the World Organisation of Animal Health (OIE) and is recognised by the OIE as free of foot and mouth disease with vaccination. EU Member States are authorised to import meat products and treated stomachs, bladders and intestines from the whole territory of Uruguay if the requirements of the certificate laid down in Annex III to Commission Decision 2007/777/EC are satisfied and, in particular, for products made of bovine meat, treatment "C", or, for biltong/jerkey and pasteurised meat, treatment "E". EU Member States are authorised to import casings from Uruguay if the requirements of the certificate laid down in Annex IA to Commission Decision 2003/779/EC are satisfied. The previous audits carried out in Uruguay on the safety of food of animal origin in Uruguay were: fresh meat of bovine animals and meat of wild leporidae from 3 to 13 March 2011, the results of which are described in report DG(SANCO)/ MR Final (hereafter referred to as the previous audit). fresh meat and meat products of domestic ungulates and wild leporidae as well as casings from 3 to 13 March 2009 the results of which are described in report DG(SANCO)/ MR Final. These reports are accessible at: 2

7 The action plan received from the Uruguayan authorities in response to the recommendations of the previous audit provided satisfactory guarantees in relation to Recommendation No 4 which was relevant for the scope of the current audit ( To ensure that the frequency of water testing and the physic-chemical and microbiological parameters tested are in line with the requirements of Council Directive 98/83/EC ). 5 FINDINGS AND CONCLUSIONS 5.1 NATIONAL LEGISLATION AND COMPETENT AUTHORITIES Legal requirements Article 46.1 of Regulation (EC) No 882/2004 stipulates that official controls by Commission experts in third countries shall verify compliance or equivalence of third country legislation and systems with EU feed and food law, and EU animal health legislation. These controls shall have particular regard to points (a) to (e) and (g) of the aforementioned Article Legislation The main piece of Uruguayan legislation relevant for the scope of the mission is the Ministerial Regulation for Veterinary Inspection of products of animal origin No 369/983 of 7 October The requirements for the production of minced meat intended for export to the EU are laid down in the Circular of 1 July Since the last audit, changes have been made for water testing updating the rules in force by Circular 1/2012 concerning the number of samples and frequency of sampling for microbiological and physical chemical parameters of water Competent Authorities Organisation of Competent Authorities There were no changes in the organisation of the CA since the previous audit report Competent Authorities' powers, independence and authority for enforcement There were no changes in the CA powers, independence and authority since the previous audit report. It is considered to be sufficient to carry out the official controls relevant for the scope of the audit Supervision There were no changes in the supervision procedures since the last audit report. The records provided to the FVO audit team were found to be satisfactory. Observations: Training of staff in performance of official controls The official veterinarian (OV) in the establishments visited, when asked about training related to 3

8 official certification issues, referred to training in EU related matters, which was said to have taken place in However, no records could be provided concerning the scope of this training or to confirm the participation of the official concerned in this training event Resources In the offices and establishments visited the FVO audit team noted that the number of official staff was adequate to carry out the official controls foreseen by the procedures in place Organisation of official controls The official controls of the approved establishments are carried out by the supervisors from the DIA. (División Industria Animal) a unit within the CCA in charge for controls on meat and meat products. Each supervisor is in charge of a number of establishments in a given geographical zone. Two divisions of the DIA are relevant for the scope of the audit: for the slaughterhouses, Departamento de establecimientos de faena, and for the meat product establishments, Departamento establecimientos industrializadores. The controls on processed stomachs and minced meat are carried out together with slaughterhouses. The control visits take place once a month or more often, if necessary Documented control procedures Documented control procedures have been described in the previous mission reports and they apply also for the scope of the current audit Official controls on imports On the basis of a Circular of 6 December 1999 under no circumstances is it allowed to import into Uruguay live animals, meat and other products of animal origin not complying with the requirements of export markets having specific conditions, including the EU market. The only commodity relevant for the scope of this audit which was imported to Uruguay was the raw materials from Argentina for the production of casings. Each import takes place on the basis of an individual import permit issued by the CA. Observations The consignment of salted casings imported from Argentina seen by the FVO audit team was accompanied by a certificate satisfying the requirements of the certificate laid down in Annex IA to Commission Decision 2003/779/EC. The consignment was subject to official checks at random (verification of ph and organoleptic characteristics) before being released for free use Enforcement Documented examples of the enforcement procedures were seen in the establishments visited. The enforcement measures can be considered as satisfactory with the exception of one establishment where significant non-conformities were not identified by the CA (see Section 5.3.1) and, in general, in the certification procedures (see Section 5.4). Conclusions The control system in Uruguay has the potential to provide satisfactory assurances regarding compliance with, or equivalence to, EU requirements as required by Article 46.1(h) of Regulation (EC) No 882/

9 5.2 APPROVAL OF ESTABLISHMENTS Legal Requirements Article 12 of Regulation (EC) No 854/2004 lays down that the CA of a third country of origin has to guarantee that establishments placed on the list of establishments from which imports of specified products of animal origin to the EU are permitted, together with any establishments handling raw material of animal origin used in the manufacture of the products of animal origin concerned, complies with the relevant EU requirements, in particular those of Regulation (EC) No 853/2004, or with requirements that were determined to be equivalent. Findings The procedure for listing of establishments for export to the EU was described in the previous audit's report. The policy of the CCA is that an establishment listed may remain on the list for an unlimited time even if it doesn't export, on condition that it fulfils the relevant requirements. The FVO audit team noted, however, that the list of casings establishments is kept up to date, i.e. only establishments actually exporting to the EU remain on the list. This is not the case for the meat product and minced meat establishments. In particular, the minced meat establishment which has not been in activity for a long time and has never exported to the EU, was not in compliance with the relevant EU rules. This fact has not been identified by the CA despite frequent documented checks. Conclusions The approval of establishments to be included on the list of authorised establishments to export to the EU takes place according to the procedures in place. However, in one case an establishment was listed contrary to the requirements of Article 12 of Regulation (EC) No 854/2004, although the requirements for listing were not met. 5.3 OFFICIAL CONTROLS AT ESTABLISHMENT LEVEL Legal Requirements Article 12 of Regulation (EC) No 854/2004 lays down that the CA of a third country of origin has to guarantee that establishments placed on the list of establishments from which imports of specified products of animal origin to the EU are permitted, together with any establishments handling raw material of animal origin used in the manufacture of the products of animal origin concerned, complies with relevant EU requirements, in particular those of Regulation (EC) No 853/2004, or with requirements that were determined to be equivalent. It also lays down that an official inspection service supervises the establishments and has real powers to stop the establishments from exporting to the EU in the event that the establishments fail to meet the relevant requirements. The animal and public health and veterinary certification requirements and certification models for the introduction into the EU of products of animal origin intended for human consumption are laid down: for minced meat, in Commission Regulation (EU) No 206/2010, for meat products and treated stomachs, bladders and intestines, in Commission Decision 2007/777/EC, and for casings, in Commission Decision 2003/779/EC. Findings 5

10 5.3.1 General hygiene requirements The FVO audit team has visited 7 establishments listed for export to the EU: 2 casings (out of 3 currently listed) and 5 meat product plants (out of 26 listed), all major exporters in 2010 and According to the procedures in place, the OV has to carry out pre-operational and operational hygiene checks, good manufacturing practices and maintenance checks. The regional supervisor has to carry out monthly supervision visits which include verification of compliance with the general and specific hygiene requirements of EU legislation. The efficiency of official controls can be considered as satisfactory, in particular, with regard to the product treatment and record keeping. However, some deficiencies not identified by the CA were noted. In particular: in one casings establishment maintenance deficiencies were not properly assessed and action evaluated as completed was in fact incomplete (flaking of paint was corrected but elsewhere, plaster was falling off a brick wall over an area where exposed product was stored. This deficiency was noted by the FBO and containers were covered with plastic film). In the same establishment a leaking roof in the storage rooms for the final product was not identified by the official controls. in one meat product and minced meat establishment, which had not been in activity for several months, substantial deficiencies in cleaning and maintenance were found. The meat grinder had not been cleaned after it had last been used. It was full of meat and rust. Some other equipment was dirty and not easy to clean. Cold store walls were damaged because of the infiltration of condensation water. When identified by the FVO audit team, the cleaning deficiencies were corrected immediately. However, deficiencies in this facility were not identified by the CA despite frequent documented checks and the facility was maintained on the list despite the fact that it did not fulfil all the relevant EU requirements. In one canning plant visited, the main processing room did not provide adequate working space to allow for the hygienic performance of all operations which took place there (cooking, filling, seaming, rinsing of cans, double seam evaluation) Water testing In all seven establishments visited official sampling takes place, replacing FBO sampling. A Circular was issued in February 2012 in response to Recommendation No. 4 of the previous audit report in order to ensure compliance with the requirements of Council Directive 98/83/EC. It has been decided to replace FBO sampling with official sampling in order to comply with the Directive. However, the issue of volume of water consumption in relation to establishing the sampling frequency for microbiological parameters is not addressed. In addition, the specification of microbiological testing methods are not detailed enough to establish if they are equivalent to the methods described in the Directive. The FVO audit team was informed that action would be taken to address this issue. Findings In the establishments visited the following was noted: Not all chemical parameters as listed in Council Directive 98/83/EC are analysed for since the national laboratories are unable to carry out examinations for such specific parameters. Specifically, the FVO audit team was informed that Uruguay does not have the analysing 6

11 capacity for Polyaromatic Hydrocarbones (PAH), Tetratchloroethene, Trichlorethene, Trihalomethanes and Vinylchloride. Sampling and testing for E.coli was established and takes place with a fixed frequency that is higher than the one indicated in the Directive. Sampling and testing for Enterococci was implemented in all seven establishments visited, however not with the frequency established in the Directive, which is based on water consumption. The FVO audit team was informed that action would be taken to address this issue Controls of ingredients Controls on suppliers were in place for ingredients of non-animal origin including suppliers' declarations for food grade of the products used for the production of dried and cured products. In most cases analytical certificates with regard to microbiological and chemical specifications were also available HACCP-based systems In the establishments visited the HACCP programmes were in general adequately documented and designed. A proper hazard analysis and identification of CCPs was carried out. In all establishments visited the CCPs were validated. Observations In the two casings establishments visited, the validation of the salting process was not fully adequate, since it was not demonstrated if the actual process would destroy or deactivate all bacterial species present (Clostridium spores). In one establishment visited the method of the measuring of the core temperature in cooked meat was not adequate in order to guarantee that it actually was the core temperature of the meat that was measured (the thermometer probe was inserted into the bag with cooked meat but not into the piece of meat itself). The validation of the CCPs: the cooking temperature (80 C), the drying process and the salting time for salted and dried products in one establishment and of the cooking temperature of cooked and chilled meat in two other establishments visited, was adequate Microbiological testing The DILAVE is the National Reference Laboratory (NRL) for the microbiological testing methods used to ensure compliance with Regulation (EC) No 2073/2005. Sampling programmes for microbiological examination in order to comply with Regulation (EC) No 2073/2005 were in place in the establishments visited where it was relevant, e.g. for minced meat and Ready-to-Eat meat products. No specific provisions are in place to give effect to the Regulation. Nevertheless, the FBOs are instructed to ensure compliance with Regulation (EC) No 2073/2005. Observations In an establishment listed for the export of minced meat to the EU, a sampling programme was in place in line with the requirements of Regulation (EC) No 2073/2005 as regards sampling frequency and parameters to be examined for. Methods validated against the reference method in accordance with the standards of the Regulation were in place for 7

12 Aerobic Colony Count and E. coli. However, this issue could not be demonstrated for testing for Salmonella. The testing was planned to be carried out in the FBO laboratory, which was approved by the DIA. In another establishment producing Ready-To-Eat meat products, including both products supporting the growth of L. monocytogenes and products not supporting this growth, sampling programmes were in place and implemented in line with Regulation (EC) No 2073/2005, including the products and the environment. Testing for L. monocytogenes was carried out in the FBO laboratory using a detection method that was validated against the reference method of the said Regulation. The laboratory did not participate in proficiency tests to ensure the reliability of the results but carried out comparison tests of samples with another private laboratory accredited according to ISO There is no official supervision of the private laboratories testing for compliance with Regulation (EC) No 2073/2005 by the DIA or by the DILAVE. A weekly official sampling programme for L. monocytogenes has been implemented in order to verify the sampling and testing programmes of the FBOs. A pooled sample was taken, however, it could not be demonstrated if the criteria as laid down in the Regulation for control of compliance were complied with. Moreover, it was not demonstrated if the method used had been validated against the reference method in the Regulation Identification marking and labelling The FVO audit team did not identify deficiencies related to identification marking and labelling Traceability systems and eligibility of raw materials Traceability systems are in place in all establishments visited and traceability exercises forward and backward carried out by the FVO audit team were satisfactory, as also was the eligibility of raw materials. All raw materials for the production of meat products originated mainly from their own establishments, or their own group establishments' slaughterhouses. All raw materials for casings that were verified by the FVO audit team had originated in Uruguayan or Argentinian establishments. Conclusions The efficiency of official controls at establishment level can generally be considered as adequate to satisfy the requirements laid down in the export certificates in force (Commission Regulation (EU) No 206/2010, Commission Decisions 2003/779/EC and 2007/777/EC). The CA has identified most but not all of the deficiencies found by the FVO audit team. These deficiencies concern maintenance and other shortcomings in individual establishments, and, in particular, in a minced meat producing facility, and deficiencies of a general character in most of the establishments visited: The water testing regime is not fully in line with the requirements of Council Directive 98/83/EC since the testing frequency of enterococcus was not linked to the water consumption, the equivalence of methods used for microbiological examinations with the methods of Council Directive 98/83/EC were not guaranteed and also due to the fact that not all chemical parameters of Annex I of the Directive were analysed for. The sampling and testing for microbiological criteria were not fully in line with the requirements of Regulation (EC) No 2073/2005 as regards validation of methods and as regards the application of criteria for L. monocytogenes. 8

13 5.4 OFFICIAL CERTIFICATION Legal Requirements Council Directive 96/93/EC lays down the general rules to be observed by third countries in issuing certificates required for exports to the EU, according to the specific EU veterinary legislation. The specific animal health, public health and veterinary certification requirements for the introduction into the EU of products of animal origin intended for human consumption, are laid down in Commission Decision 2007/777/EC (see point 5.3). Findings The export veterinary certificates are issued centrally in a Certification Office located in the Port of Montevideo, the shipping port. The consignments to be exported are sent from establishments of origin to the port, accompanied by an internal transfer document named Certificado official de transferencia de exportación (COTE), signed by an OV. In Section 2.2 of this document, "Special certification", reference has to be made to the specific certificate requirements of the EU. For meat products, in the examples seen by the FVO audit team (in most cases cooked bovine stomachs), the COTE did not contain all of the relevant information necessary for the issuing of the export certificate at the port, i.e. information in its Section 2.2 referred to the Animal Health Declaration, but not to the Public Health (both Animal and Public Health Declarations are integral parts of the certificate laid down in Annex III to Commission Decision 2007/777/EC). The Declaration to be used for certification of meat products for the EU was provided in the official instruction of 29 March On the basis of this incomplete information, export certificates were issued certifying data which cannot be ascertained by the certifying officer, and this is contrary to Article 3.3 of Council Directive 96/93/EC. Moreover, for cooked stomachs, most, but not all of the COTE seen by the FVO audit team, also contained a reference to the Fresh Meat Declaration according to Regulation (EU) No 206/2010. This confusing declaration was not foreseen by the official certification instruction. Transfer documents for other commodities (casings, fresh meat) seen by the FVO audit team contained a correct reference to the relevant parts of the certificates laid down in Commission Decision 2003/779/EC and Regulation (EU) No 206/2010. However, the FVO audit team saw one document, in which the COTE for a consignment of fresh meat did not have any Declaration, however, an export certificate had still been issued. In two establishments visited the OV met were not aware of the correct wording of the declaration required for the certificate or of the official instruction. In the Declaration for Meat Products in the COTE, three commodity options are available: meat products, stomachs, bladders and intestines; according to the instruction, the non-applicable should be deleted. In the documents seen by the FVO audit team, this was not done in the majority of cases. One OV when asked, if the non-applicable should not be deleted, answered, that this was not the case. The shortcomings in the instruction and the certification procedures had not been identified by the CA. When these were found by the FVO audit team, the CCA proposed immediately to amend their procedures in order to address the deficiencies concerned. In particular, a new correct version of the certification instruction for the meat products was presented before the final meeting. Moreover, the FVO audit team found that the certificates carried the date of the loading in the port of Montevideo but in reality were signed two days later. The CCA did not provide a satisfactory 9

14 explanation for this procedure but undertook to change it, i.e. to sign the certificate on the day of loading. Conclusions The export certificates for meat products from Uruguay were issued on the basis of transfer documents containing incomplete and sometimes confusing information. The principles of certification set out in Council Directive 96/93/EC, and in particular in Articles 3 and 4.1 were not respected. The CCA took immediate action to address the deficiencies found by the FVO audit team. 6 OVERALL CONCLUSIONS Despite the shortcomings identified during the audit in relation to controls over listing of establishments, product and water testing and export certification the Uruguayan control system is in general capable of providing the guarantees laid down in the export certificates currently in force (Commission Regulation (EU) No 206/2010, Commission Decisions 2003/779/EC and 2007/777/EC). The CCA took immediate action to address most of the deficiencies found during the FVO audit. 7 CLOSING MEETING A closing meeting was held on 16 March 2012 with the CCA, the DGSG. At this meeting the FVO audit team presented the findings and preliminary conclusions of the audit. The representatives of the CCA acknowledged the findings and conclusions presented by the FVO audit team. 8 RECOMMENDATIONS An action plan, describing the actions taken or planned in response to the recommendations of this report and setting out a timetable to correct the deficiencies found, should be presented to the Commission with 25 working days of receipt of the report. N. Recommendation 1. To take action in order correct deficiencies found in the establishments visited in order to provide the guarantees of Article 12 of Regulation (EC) No 854/ To correct the certification procedures in order to bring them in line with the relevant requirements of Council Directive 96/93/EC, in particular the provisions of Articles 3 and 4 of Council Directive 96/93/EC. 3. To continue the action already initiated in order to bring water testing procedures fully in line with the requirements of Council Directive 98/83/EC. 4. To carry out validation methods for microbiological testing in order to bring them fully in line with the requirements of Regulation (EC) No 2073/

15 The competent authority's response to the recommendations can be found at: 11

16 ANNEX 1 - LEGAL REFERENCES Legal Reference Official Journal Title Reg. 178/2002 OJ L 31, , p Reg. 852/2004 OJ L 139, , p. 1, Corrected and re-published in OJ L 226, , p. 3 Reg. 853/2004 OJ L 139, , p. 55, Corrected and re-published in OJ L 226, , p. 22 Reg. 854/2004 OJ L 139, , p. 206, Corrected and re-published in OJ L 226, , p. 83 Reg. 882/2004 OJ L 165, , p. 1, Corrected and re-published in OJ L 191, , p. 1 Reg. 2073/2005 OJ L 338, , p Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules Commission Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs 12

17 Legal Reference Official Journal Title Reg. 2074/2005 OJ L 338, , p Reg. 2075/2005 OJ L 338, , p Reg. 1162/2009 OJ L 314, , p Reg. 206/2010 OJ L 73, , p Dir. 92/118/EEC OJ L 62, , p Commission Regulation (EC) No 2074/2005 of 5 December 2005 laying down implementing measures for certain products under Regulation (EC) No 853/2004 of the European Parliament and of the Council and for the organisation of official controls under Regulation (EC) No 854/2004 of the European Parliament and of the Council and Regulation (EC) No 882/2004 of the European Parliament and of the Council, derogating from Regulation (EC) No 852/2004 of the European Parliament and of the Council and amending Regulations (EC) No 853/2004 and (EC) No 854/2004 Commission Regulation (EC) No 2075/2005 of 5 December 2005 laying down specific rules on official controls for Trichinella in meat Commission Regulation (EC) No 1162/2009 of 30 November 2009 laying down transitional measures for the implementation of Regulations (EC) No 853/2004, (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council Commission Regulation (EU) No 206/2010 of 12 March 2010 laying down lists of third countries, territories or parts thereof authorised for the introduction into the European Union of certain animals and fresh meat and the veterinary certification requirements Council Directive 92/118/EEC of 17 December 1992 laying down animal health and public health requirements governing trade in and imports into the Community of products not subject to the said requirements laid down in specific Community rules referred to in Annex A (I) to Directive 89/662/EEC and, as regards pathogens, to Directive 90/425/EEC 13

18 Legal Reference Official Journal Title Dir. 96/22/EC OJ L 125, , p. 3-9 Dir. 96/23/EC OJ L 125, , p Dir. 96/93/EC OJ L 13, , p Dir. 97/78/EC OJ L 24, , p Dir. 98/83/EC OJ L 330, , p Dec. 79/542/EEC OJ L 146, , p Dec. 2000/572/EC OJ L 240, , p Dec. 2003/779/EC OJ L 285, , p Council Directive 96/22/EC of 29 April 1996 concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of ß-agonists, and repealing Directives 81/602/EEC, 88/146/EEC and 88/299/EEC Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products and repealing Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/EEC and 91/664/EEC Council Directive 96/93/EC of 17 December 1996 on the certification of animals and animal products Council Directive 97/78/EC of 18 December 1997 laying down the principles governing the organisation of veterinary checks on products entering the Community from third countries Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption 79/542/EEC: Council Decision of 21 December 1976 drawing up a list of third countries from which the Member States authorize imports of bovine animals, swine and fresh meat 2000/572/EC: Commission Decision of 8 September 2000 laying down animal and public health conditions and veterinary certification for imports of minced meat and meat preparations from third countries and repealing Decision 97/29/EC 2003/779/EC: Commission Decision of 31 October 2003 laying down animal health requirements and the veterinary certification for the import of animal casings from third countries 14

19 Legal Reference Official Journal Title Dec. 2007/777/EC OJ L 312, , p /777/EC: Commission Decision of 29 November 2007 laying down the animal and public health conditions and model certificates for imports of certain meat products and treated stomachs, bladders and intestines for human consumption from third countries and repealing Decision 2005/432/EC 15