EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL

Ref. Ares(2011)254205-08/03/2011 EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Directorate F - Food and Veterinary Office DG(SANCO) 2010-8509 - MR FINAL FINAL REPORT OF A MISSION CARRIED OUT IN SERBIA FROM 19 TO 29 OCTOBER 2010 IN ORDER TO EVALUATE THE OPERATION OF CONTROLS OVER THE PRODUCTION OF FRESH MEAT AND MEAT PRODUCTS INTENDED FOR EXPORT TO THE EUROPEAN UNION AS WELL AS CERTIFICATION PROCEDURES

Executive Summary The report describes the outcome of a mission carried out by the Food and Veterinary Office (FVO) in Serbia from 19 to 29 October 2010. The objectives of the mission were to evaluate the operation of controls over the production of fresh meat and meat products destined for export to the European Union (EU), as well as certification procedures. It was the follow up to the mission DG (SANCO)/2007-7480. Member States are currently authorised to import from Serbia to the EU fresh bovine meat and meat products, and pork meat products which have undergone treatment D as defined in Commission Decision 2007/777/EC. The Serbian Competent Authorities made a considerable effort to improve standards related to official controls. They have also achieved considerable progress in developing and amending their legislation in order to include EU requirements relevant for the scope of this mission (in general, with the view of future EU accession). The official controls are frequent and well documented; however, they did not identify all the relevant deficiencies found by the mission team in the establishments and holdings visited. Also, for deficiencies identified, the enforcement was not always efficient. Four out of six establishments visited were found to be largely compliant with EU requirements, with a limited number of deficiencies. In one, more substantial deficiencies were found, and one was found not to be in compliance, having been closed since July 2009. During visits to the national bovine database and to five pig and bovine holdings, some deficiencies in animal registration and identification, including registration of movements, were found, which indicate that the databases are not fully reliable in relation to animal movements. The certification procedures were found to be adequate. Some deficiencies in the application of animal welfare rules were found in five slaughterhouses (SH) seen in operation, indicating inadequate training and official supervision. Serbia largely meets the requirements for export of fresh meat and meat products to the EU. The Serbian Competent Authorities confirmed action in relation to two establishments that were not in compliance with EU requirements (suspension of approval and delisting). Out of the 10 recommendations made in the mission report DG (SANCO)/2007-7480, relevant to the scope of the current mission, two have been satisfactorily implemented whilst eight have not been fully or have only been partly implemented. At the final meeting, the Central Competent Authority (CCA) provided information about the action taken or planned to be taken in the establishments visited, including a proposal to suspend the certification to the EU for one, and to suspend or withdraw approval for another. A number of recommendations have been made to the CCA with a view to addressing the deficiencies identified during this mission. I

Table of Contents 1 INTRODUCTION...1 2 OBJECTIVES OF THE MISSION...1 3 LEGAL BASIS FOR THE MISSION...2 4 BACKGROUND...2 5 FINDINGS AND CONCLUSIONS...2 5.1 LEGISLATION AND COMPETENT AUTHORITIES...2 5.1.1 LEGISLATION...3 5.1.2 COMPETENT AUTHORITIES...3 5.2 HOLDING REGISTRATION, ANIMAL IDENTIFICATION...8 5.3 LABORATORY SERVICES...11 5.4 LISTING OF ESTABLISHMENTS...12 5.5 OFFICIAL CONTROLS AT ESTABLISHMENT LEVEL...13 5.5.1 ANTE-MORTEM INSPECTION...14 5.5.2 POST-MORTEM INSPECTION...14 5.5.3 GENERAL AND SPECIFIC HYGIENE REQUIREMENTS...15 5.5.4 HACCP-BASED SYSTEMS...16 5.5.5 MICROBIOLOGICAL TESTING...17 5.5.6 TRACEABILITY AND IDENTIFICATION MARKING...18 5.5.7 ANIMAL WELFARE AT THE TIME OF SLAUGHTER OR KILLING...18 5.5.8 DOCUMENTATION OF OFFICIAL CONTROLS...19 5.6 OFFICIAL CERTIFICATION...20 6 OVERALL CONCLUSIONS...21 7 CLOSING MEETING...21 8 RECOMMENDATIONS...22 ANNEX 1 - LEGAL REFERENCES...23 II

ABBREVIATIONS AND DEFINITIONS USED IN THIS REPORT Abbreviation AV CA(s) CCA(s) CCP(s) CSF DG(SANCO) DVO EC EU FBO(s) FVO HACCP Explanation Authorised Veterinarian Competent Authority(ies) Central Competent Authority(ies) Critical Control Points Classical Swine Fever Health and Consumers Directorate General District Veterinary Office (Okružna Kancelarija Veterinarske Inspekcje). Also District Veterinary Officer. European Commission European Union Food Business Operator(s) Food and Veterinary Office Hazard Analysis Critical Control Points Hygiene Package Regulations (EC) No 852/2004, (EC) No 853/2004 and (EC) No 854/2004 NRL OV SH VI National Reference Laboratory Official Veterinarian Slaughterhouse Veterinary Inspector III

1 INTRODUCTION The mission took place in Serbia from 19 to 29 October 2010 as part of the planned mission programme of the FVO. The mission team comprised four inspectors from the FVO, and one observer from DG (SANCO) Unit D 4 (first week only). The mission team was accompanied during the mission by representatives from the CCA, the Veterinary Directorate (Uprava za Veterinu) which is a part of the Ministry of Agriculture, Forestry and Water Economy. The opening meeting was held on 19 October 2010 with the CCA in Belgrade. At this meeting the mission team confirmed the objectives of, and itinerary for the mission, and additional information required for the satisfactory completion of the mission was requested 2 OBJECTIVES OF THE MISSION The objectives of the mission were to evaluate the official controls related to production and storage of food of animal origin in Serbia and imports to the EU with regard to: competent authority (CA) organisation and operation; official controls over food business operators (FBO) compliance with general and specific rules on the hygiene of food of animal origin; the correct implementation of the chain of certification. In particular, controls over meat of domestic ungulates (pigs and bovine animals) and meat products in the framework of Regulations (EC) No 178/2002, No 852/2004, No 853/2004, No 854/2004 and No 882/2004 was subject to this evaluation. In pursuit of these objectives, the mission itinerary included the following: COMPETENT AUTHORITIES Competent authorities Central 1 District (okrug) 3 Local COMMENTS On the spot in the establishments visited FOOD PRODUCTION / PROCESSING / DISTRIBUTION - ACTIVITIES Slaughterhouses 6 Cutting plant / Meat products 5, 3 Integrated with slaughterhouses Laboratories 1 Pig holdings 1 Bovine holdings 5 1

3 LEGAL BASIS FOR THE MISSION The mission was carried out under the general provisions of Community 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 legal references are provided in Annex 1. Legal acts quoted in this report refer, where applicable, to the latest amended version. 4 BACKGROUND The previous mission concerning the safety of food of animal origin in Serbia in the context of export of meat and meat products was carried out from 11 to 22 June 2007 the results of which are described in report DG (SANCO)/2007-7480 MR Final (hereafter referred to as the previous mission report). This report is accessible at: http://ec.europa.eu/food/fvo/index_en.cfm. The action plan received from the Serbian authorities in response to the previous mission report's recommendations provided satisfactory guarantees in relation to 11 of the 13 recommendations and unsatisfactory responses to two, one of which is relevant for the scope of the current mission (see section 5.1.2.3). Three recommendations were not relevant for the scope of the current mission. The implementation of the guarantees received has been reviewed during this mission. Where relevant, the reference to these recommendations will be made in the relevant sections of the report. Serbia is currently allowed to export to the EU fresh bovine meat and meat products, and pork meat products which have undergone treatment D as defined in Commission Decision 2007/777/EC. Vaccination of pigs against classical swine fever (CSF) is still carried out. The CCA indicated that January 2011 is the expected date to stop vaccination. Export of meat and meat products from Serbia to the EU is currently quite limited (865 tonnes of fresh meat and 21 tonnes of meat products from January to September 2010). 5 FINDINGS AND CONCLUSIONS 5.1 LEGISLATION AND COMPETENT AUTHORITIES Legal basis Article 46 of Regulation (EC) No 882/2004 stipulates that Community controls in third countries shall verify compliance or equivalence of third country legislation and systems with Community feed and food law and Community animal health legislation. These controls shall have particular regard to points (a) to (e) of the aforementioned Article. Point (f) is covered in Sections 5.2 to 5.7 of this report. Findings 2

5.1.1 Legislation In the previous mission's report the following recommendation was made: 8.1 To ensure that future legislation includes relevant EU requirements for export of certain live animals and products of animal origin within the scope of this mission. The response of the CCA to address the recommendation was found to be satisfactory at the evaluation of the action plan 2007. The essential elements of the Serbian veterinary and food legislation have been described in the mission report reference number DG(SANCO)/2010-8505. The mission team was informed that a number of legal acts relevant for the scope of the mission have been adopted or entered into force recently, i.e. after the mission DG(SANCO)/2010-8505, which took place in February 2010, and in particular: the amended Veterinary Law (Official Journal of the Republic of Serbia, OJRS, No 91/2005, 30/2010), applicable from 30 May 2010; Rulebook on conditions for food hygiene (OJRS, No 73/10) transposition of Regulation (EC) No 852/2004, will enter into force on 1 June 2011, which was set up as the common date for entry into force of the whole Hygiene Package in Serbia; Rulebook on general and particular conditions for food hygiene (OJRS, No 72/10, entering into force 30 September 2010) and Instruction on microbiological criteria of hygiene process and food safety, entering into force on 2 August 2010 transposition of Regulation (EC) No 2073/2005; Rulebook on the procedures for the issuing of international veterinary certificates (OJRS, No 76/10) containing some relevant elements of Council Directive 96/93/EC, and in particular Articles 3.2. and 3.3; two Rulebooks on animal welfare rules have been adopted, one of them transposing Council Directive 93/119/EC, see section 5.5.7. In addition, a Rulebook on the official controls, transposing Regulation (EC) No 882/2004, is in preparation. It is planned to have it adopted by the end of November 2010, and a draft was provided to the mission team. Awaiting the entry into force of the Hygiene Package, the old legislation, partly in line with Regulations (EC) No 852/2004 and (EC) No 853/854, namely Regulations OJRS 11-2008 (Rulebook on veterinary health conditions in establishments) and 44-2007 (Regulation on health mark and health certificates), still remains in force. 5.1.2 Competent Authorities In the previous mission's report the following recommendation was made: 3

8.2. To guarantee that efficient and effective co-ordination is ensured between all CAs at all levels, in the areas within the scope of this mission equivalent to the requirements of Article 4(3) of Regulation (EC) No 882/2004 The response of the CCA to address the recommendation was found to be unsatisfactory at the evaluation of the action plan 2007. 5.1.2.1 Organisation of Competent Authorities The latest changes in the structure of the CA have been described in the mission report DG(SANCO)/2010-8505. The CCA confirmed that, several months after the creation of the Audit Unit, no audits of the CA have yet been carried out. The CCA said they were waiting for the entrance into force of the Rulebook on the official controls. The mission team noted a lack of co-ordination between the Units of the Veterinary Directorate dealing with listing of establishment "F" approved for export to the EU (see section 5.4). 5.1.2.2 Competent Authorities' powers, independence and authority for enforcement The powers of the CCA are laid down in the Veterinary Law as amended and in particular Articles 146 and 147. The CCA stated that they have sufficient powers, independence and authority to enforce legislation. During the visits on-the-spot evidence was seen, that the official veterinarian (OV) in charge of one EU export approved establishment prohibited production for three days because of non compliant results of water examination. In another establishment, evidence was seen that the OV prohibited the production (slaughter, cutting and production of meat products) for 15 days because of maintenance and hygiene deficiencies. 5.1.2.3 Supervision In the previous mission's report the following recommendation was made: 8.4. To strengthen the controls on veterinarians of veterinary stations and certain veterinary practitioners involved in the execution of the annual animal health control programme and those involved in issuing animal health certificates in order to achieve proper implementation of the health control programme. The response of the CCA to address the recommendation was found to be satisfactory at the evaluation of the action plan 2007. 4

The supervision rules are laid down in Section XVI of the Veterinary Law, as amended. In particular the supervision of the veterinary inspectors by the Ministry of Agriculture and the supervision of veterinary stations and other veterinary organisations by the veterinary inspectors is mentioned. As already indicated in the report DG(SANCO)/2010-8505, the inspection visits by central and district levels, in the establishments approved for export to the EU, are in fact control visits, i.e. visits on the FBO performance, and not supervision of the activity of the CA at lower level by a higher level. There is no system of supervision by the CCA of the District Veterinary Offices (DVOs) by means of audits or inspections. There is an established system of annual evaluation of the veterinary inspectors within each DVO, carried out by the direct manager, the head of the District Veterinary Inspection Unit. It includes an interview and checking of the reports. The DVO undergoes an annual evaluation by the Head of the Veterinary Inspection. This is a personal individual evaluation and not a complex evaluation of the DVO's activities. There is an established system of annual inspections by the DVO of the Veterinary Stations in charge of the performance of the Annual Animal Health Monitoring Plan, and/or responsible for issuing of animal movement documents and Health certificates. Several deficiencies were found by the CA during these checks, mostly in the issuing or in the completion of these documents. In 2010 the CCA carried out targeted actions in several districts and also required general checks in all districts (see section 5.2.1). Despite this fact, the mission team found several deficiencies in animal movement documents and health certificates in the farms visited, selected for visit by the CCA (see section 5.2). 5.1.2.4 Training of staff in performance of official controls In the previous mission's report the following recommendation was made: 8.3.To ensure that appropriate training is provided to veterinary inspectors equivalent to the requirement Article 6 of Regulation (EC) No 882/2004. Special attention should be given to the traceability of raw material and product. The response of the CCA to address the recommendation was found to be satisfactory at the evaluation of the action plan 2007. As indicated in the mission report 2010-8505, training on Hazard Analysis Critical Control Points (HACCP) and on certification principles in line with the requirements of Council Directive 96/93/EC has been provided to the officials by the CA. 5

The CCA provided evidence of several training sessions for officials which were carried out in 2010: two TAIEX workshops on animal welfare during stunning and slaughter (two days, 45 officials) and on microbiological criteria for food as laid down in Regulation (EC) 2073/2005 (two days, 30 officials), training on Salmonella testing in food hygiene (one day, two officials), a workshop on the residue programme (one day, 28 officials), two workshops on check lists for inspectors (three days, 19 officials two days, 12 officials). In 2010 a total of 1 116 officials attended training. The mission team noted that amongst the training sessions in 2010, at least seven, with 97 participants concerned specific issues which were relevant to EU export controls: these related to certification principles for milk and dairy products, fish and fishery products, HACCP implementation in the dairy industry (73 participants), the EU requirements and certification principles for meat and meat products (19 participants). Amongst the training sessions held in 2009, the mission team noted five one-day sessions with 142 participants concerning the identification of bovine animals, four one-day sessions with 173 participants concerning animal welfare and three one-day sessions with 96 participants concerning the implementation of the removal of animal by-products (ABP). The CCA provided a training plan scheduled for February-April 2011, in which it is foreseen to carry out workshops on the audit on veterinary inspection and official controls, on animal welfare at transport and animal health issues. No evidence of training in traceability, as recommended in the previous mission report, has been provided. Despite extensive training related to animal welfare, significant deficiencies in this matter were noted on the spot, see section 5.5.7. 5.1.2.5 Resources The CAs have adequate resources to carry out their tasks. The budget of the Veterinary Directorate for 2010 has been increased by 80 % compared to 2009 (from 14 500 000 to 24 000 000 ). 5.1.2.6 Organisation of control systems The CCA informed the mission team about changes in the organisation of control systems in Serbia since the adoption of the Food Safety Law and the amended Veterinary Law. In particular: the compulsory full time presence of the OVs (OV, in Serbian legislation Veterinary Inspectors (VI)) in the establishments is abolished, except for ante- and post-mortem inspection in the SHs. They are cleared of other duties in order to check all documents for the loading and un-loading of meat as it is now an FBO obligation; 6

the frequency of official controls is now based on the principle of risk assessment; the OV are no longer responsible for internal shipments of products, except for export; Article 148 of the Veterinary Law as amended describes official tasks which may be delegated to Authorised Veterinarians (AV). Among these tasks, the performance of anteand post-mortem inspection is listed. The CCA stated that the AV are now dealing only with animal health issues and with the registration and identification of animals including animal movement controls. All veterinarians in the meat establishments are now VIs; the frequency of official controls in food establishments is established in monthly plans by the CCA (Head of the Veterinary Inspection) for export establishments, and by the Heads of the DVO for national establishments. For EU approved meat establishments, the frequency was set to two visits per year by the CCA, with the exception of establishment "F", which ceased its activities in June 2009 (one inspection only). In practice, the inspections in the EU approved meat establishments are much more frequent. The inspections by the CCA are normally joint inspections with the DVOs. In addition, the DVOs carry out their own inspection, when they believe it is necessary. Since April 2010, there are no veterinary checks at the border on commodities exported to the EU. All checks are carried out at the place of loading, in the establishments of origin. 5.1.2.7 Documented control procedures The mission team noted that the CCA has issued specific instructions for official controls and certification for fish and fishery products (February 2010), for official controls for milk and dairy products (May 2009, amended January 2010), for the principles of completing the model of veterinary certificate for the export of milk and dairy products to the EU (September 2010), for the principles of completing the model of veterinary certificate for the export of fresh bovine meat to the EU (January 2009). However, there is no instruction for the official controls for meat and meat products, and no certification instruction for meat products. General check lists intended for OVs in different food establishments, including SHs of ungulates, were developed by the CCA for daily documentation of FBO compliance and official controls, including general hygiene, stunning, HACCP monitoring, ante- and postmortem checks, labelling and ABP handling. In practice it may take a week to complete them as different sections are completed on different days. Specific check lists for periodic controls in holdings, dairy plants and meat establishments were developed by the CCA. The check list for meat establishments reflects the requirements of Regulation (EC) No 852/2004, and some of the requirements of Regulation (EC) No 853/2004. The evaluation of compliance is given on completion of the control (compliant, conditionally compliant with deadlines for the correction of deficiencies, non compliant with suspension of activities). 7

At every inspection, a report is drafted, and a copy provided to the FBO. In case of non conformities, a decision is taken, with a corrective action request and deadline. 5.1.2.8 Import of live animals and fresh meat The CCA stated that no animals for slaughter are imported to Serbia. According to data provided to the mission team 2 697 animals were imported into Serbia in 2009, mostly cattle and pigs from the EU, Canada, Switzerland and Norway. The figures for 2010 were 558. All animals were imported for breeding, with the exception of some 60 fattening bovine animals imported in 2009 and 2010 from Hungary. Concerning fresh meat, the CCA stated that all pig and bovine meat imported as raw material into the EU export approved establishments originated from EU Member States, or EU approved establishments in other countries. This could also be confirmed on the spot during visits to establishments, during which only meat of national or EU Member States origin was seen. Conclusions The Serbian CCA has established a system of official controls which ensures compliance with, or equivalence to the relevant EU requirements, in line with the requirements laid down in Article 46 of Regulation (EC) No 882/2004. The mission team noted deficiencies mainly relating to coordination within the CA, supervision of Veterinary Stations in charge of animal movement documents, scope and efficiency of training provided. Recommendation 8.1 of the previous mission report has been satisfactorily implemented. Recommendations 8.2, 8.3. and 8.4 of the previous mission report have not been fully or only partly implemented. 5.2 HOLDING REGISTRATION, ANIMAL IDENTIFICATION In the previous mission report the following recommendation was made: 8.6. To address the weakness identified in the system for the control of animal movement and to ensure that appropriate action is taken when animals for slaughter arrive with incomplete animal health certificates The response of the CCA to address these recommendations was found to be satisfactory at the evaluation of the action plan 2007. For this section, also recommendation 8.4, referred to in section 5.1.2.3 is relevant. Legal requirements The veterinary certification requirements for the introduction into the EU of fresh meat are laid down in Regulation (EU) No 206/2010. Point II.2 of the model certificates in Part 2 of Annex II to the Regulation sets out the animal health requirements to be met, including the requirement for the CA to have system(s) in place for holding registration and animal identification. 8

Findings The approved veterinary stations and the AVs they employ are in charge of animal identification, registration and movement control. The CCA stated that the Rulebook on identification and registration of bovine animals (OJRS No 57/2009, 14/2010) is harmonised with Regulation (EC) No 1760/2000 and (EC) No 911/2004. The CCA stated that all bovine and pig holdings are registered in the database. Currently, there are about 250 000 bovine holdings and 1 000 000 bovine animals in Serbia registered in the database, all identified with double ear tags. The tagging and registration of pigs has been finalised. The movement control of pigs will start when vaccination against CSF will be stopped. All holdings visited by the mission team were registered in the database. According to the national rules, all bovine animals have to be notified to the database within seven days of arrival/purchase, birth or departure. Currently, the owners notify the database via a Veterinary Station. The mission team noted that, due to this, the delay for notification in practice is increased from seven to 14 days (seven days for the owner and seven days for the Veterinary Station). The CCA stated that the current database has insufficient capacity and launched a tender for new hardware. The mission team noted that in a number of cases, departures or arrivals of bovine animals are not introduced in the database and are classified by the system as "illegal trade". Although the database identifies this fact no automatic action is started. The CCA can get information about these animals in two ways: via manual checks in the database or on the spot checks at farms. The CCA stated, that, in a couple of months, an automated facility will be provided whereby letters are sent to request notification. The CCA provided the information that currently, 84 225 bovine animals are registered in the database with arrival not reported, i.e departed without any indication of destination or arrival not confirmed within 14 days ("floating animals"). This constitutes approximately 8,2% of bovine animals registered in the database. In 2009, the CA carried out the first official controls of animal registration in holdings. 10 % (25 000) holdings were selected for controls according to the following criteria: size, number of animals, number of animal movements, percentage of late notifications, percentage of "floating animals", changes of owners/keepers. The CA managed to visit 2 050 holdings (<1%). In one DVO visited, the mission team noted that the CA had no data about numbers and results of the checks carried out at their territory and the database did not allow this data to be extracted. A list of facilities to be checked could be provided via manual checks but not the overview of the situation. An individual file selected by the mission team indicated that 9

the control revealed serious deficiencies to which no documented follow up could be shown. The Veterinary Stations are under the supervision of the DVO. Normally one annual visit is foreseen. The controls in 2009 indicated serious deficiencies in completing animal health certificates and movement documents, in particular in two districts. In response to this information, the CCA carried out a targeted action in these districts, with the participation of central and district inspectors, and the police. Moreover, in the Summer of 2010, the CCA requested all DVOs to check all of the Veterinary Stations approved to issue animal health certificates and movement documents. According to the CCA, in all 25 districts, deficiencies were found in 34 approved Veterinary Stations (out of 56 in the country). They were related to poor register keeping, deficiencies in issuing animal movement documents, veterinarian not present at the animal market, as requested, deficiencies in animal movement (departure arrival) notifications. 184 decisions requesting corrective action were issued. No information was available about a follow up to these decisions. In the holdings visited, the following was noted: in the pig holding, there was a significant discrepancy between the figure in the database (45 000) and in the farm register (17 036); the annual visit by the VI was not documented; In two bovine holdings, a discrepancy was found between the number of animals in the holding register and the database, indicating late notifications; delays in issuing passports (up to four months); in some cases, incorrectly completed movement documents and health certificates (treatment not mentioned, Tuberculosis results not completed, documents not signed by the veterinarian): expired drugs kept on the farm. None of these deficiencies was identified by the VI during the official checks. On one of these farms, 381 animals were registered in the database, but 25 less in the farm journal. In one bovine holding, a number of animals with a lost tag was seen, and one animal had lost both tags. Information provided to the mission team by the AV about re-tagging was confusing, as the number of replacement tags presented did not match the number of animals in the registers shown. The possible impact of deficiencies in animal movement controls on the certification for export to the EU, in particular the confirmation of three months of residency on the Serbian territory was raised by the mission team. The CCA provided the following clarification: according to the national legislation, an animal without an accompanying health certificate cannot be slaughtered. The passport is not mentioned, but an animal, to be moved, as stipulated in Article 93 of the Veterinary Law, must be identified, registered, come from a registered holding and be accompanied by an identification document, which for bovine animals is a passport. In this document all data about an animal's whereabouts are indicated. For pigs, the identification document is the animal movement document. As stipulated in Article 98 of the Veterinary Law, animals not identified or without an identification document, a health certificate or with an invalid certificate, as well as all 10

imported animals, have to be placed in quarantine. The CCA provided the information in relation to the number of animals placed in quarantine due to deficiencies or a lack of identification: in 2009: 70 bovine animals, horses and sheep; in 2010: 1 542 bovine animals, swine and sheep. According to the CCA, the period of stay in the quarantine is 30 days, after which a new passport can be issued. The CCA stated that the OV are aware of the requirement of the EU export certificate, according to which the bovine animals must remain on the Serbian territory since birth or at least three months before slaughter, and that currently no animals for slaughter are imported to Serbia. In the SH visited, the health certificates and animal movement documents for pigs and bovine animals, as well as passports for bovine animals, seen by the mission team, were correctly completed. As indicated in section 5.5.6, no evidence of export to the EU of meat of non eligible animals could be found. Conclusions Serbia has a system in place for holding registration and animal identification. However, numerous deficiencies exist in the animal movement controls which could put at risk the animal health declaration in Point II.2 of the certificate laid down in Regulation (EU) No 206/2010. Action taken by the CA to remedy the situation to date has not been successful mainly due to a lack of proper follow up. However, the mission could not find evidence of export to the EU of meat on noneligible animals. 5.3 LABORATORY SERVICES Legal requirements The veterinary certification requirements for the introduction into the EU of fresh meat are laid down in Regulation (EU) No 206/2010. Point II.1. of the model certificates in Part 2 of Annex II to the Regulation sets out the public health requirements to be met, including the requirement to satisfy the relevant microbiological criteria set out in Regulation (EC) No 2073/2005, the special guarantees concerning Salmonella for consignments to Finland and Sweden, and the specific rules on official controls for Trichinella set out in Regulation (EC) No 2075/2005. Findings 5.3.1.1 Laboratories testing against criteria for foodstuffs The Institute of Meat Hygiene and Technology is designated as a national reference laboratory (NRL) for food safety control by the Ministry of Agriculture, Forestry and Water Management since 1999. The laboratory is accredited since 2002 according to ISO 17 025 for a wide range of parameters including the relevant parameters of Regulation (EC) No 2073/2005 and for Trichinella examination according to the Magnetic Stirring Method. At District level a laboratory network of 14 laboratories are carrying out testing for different parameters including the relevant parameters of Regulation (EC) No 2073/2005. 11

According to Article 19 of the Law on Food Safety a new Directorate should take over the supervisory function as a NRL. However, this has not yet been implemented. In the laboratory visited validated methods for testing of the relevant parameters were available. The laboratory had participated successfully in one inter-laboratory ring test for the parameters, total viable counts, Enterobacteriaceae, Salmonella, and L. monocytogenes. The CCA has approved the laboratory to carry out supervisory ring-tests for official laboratories and monthly confirmatory tests for FBO laboratories carrying out tests according to Regulation (EC) No 2073/2005. The outcome was considered as satisfactory up to now. 5.3.1.2 Laboratories for Trichinella testing The NRL had participated in one ring test in 2008 for the performance of the Magnetic Stirring Method with a satisfactory result. The equipment for laboratory testing was adequate taking into account Regulation (EC) No 2075/2005. Operators carrying out the Trichinella examination in the SHs have to pass a test after participation in a training course. No supervision of the Trichinella laboratories is carried out and there are no proficiency tests to ensure that a sufficient performance has been implemented. In the establishment procedures were in place for the detention of carcasses until the result was obtained and for situations where positive results were detected in line with Regulation (EC) No 2075/2005 The laboratory facilities for Trichinella examination were sufficient, the operators were trained and the test results were documented. Conclusions A laboratory network is in place that can ensure the certification of point.ii.1.6 of the certificates for bovines and pigs as laid down in Regulation (EC) No 2073/2005. There is a system in place for Trichinella examination in line with Regulation (EC) No 2075/2005. 5.4 LISTING OF ESTABLISHMENTS Legal requirements 12

Article 12 of Regulation (EC) No 854/2004 requires that products of animal origin may be imported into the Community only if they have been dispatched from, and obtained or prepared in, establishments that appear on lists drawn up, kept up-to-date and communicated to the Commission. Findings : One establishment of six currently appearing on the list for Serbia mentioned in Article 12 of Regulation (EC) No 854/2004, establishment "F", a SH and a cutting plant, has ceased operations in June 2009. It has not resumed its activities since that date. Despite this fact, it still remains on the list and the FVO was informed, informally, by the CCA about the ceasing of activities only in September 2010, when the mission itinerary had been drafted. During the visit on the spot, the mission team found that the establishment was not in compliance with the relevant EU requirements, in particular those of Regulation (EC) No 853/2004. Moreover, it was found that the establishment was approved by the CCA, in the approval letter of 4 June 2007, without any reference to compliance with the relevant EU requirements. A general export approval had been granted and no other decision could be provided that the establishment was ever evaluated according to EU requirements. The latest CA inspection before the FVO visit, took place on 22 July 2010, and the report mentioned that all of the equipment was properly maintained and functional, with water and electricity supply. However, it did not mention the fact that the plant, abandoned for more than one year, was not in compliance with EU requirements. However, when asked by the mission team, the officials clearly confirmed the fact of non compliance. The DVO in charge of this establishment informed the CCA about ceasing of operations in a letter dated 13 August 2009. There was no follow up to this letter, in particular the CCA did not withdraw or suspend its approval. The mission team noted that there was a lack of proper communication between the different units within the CCA in charge of this issue. In three other EU approved establishments, the approval decisions mentioned commodities and products which are not eligible for export to the EU (such as fresh pig meat and fermented sausages made of pig meat) as allowed. It was however noted that both the CA and the FBO were well aware of the rules in force and no indication of such exports were noted. Conclusion In the case of one establishment, the rules for listing, laid down in the Article 12 of Regulation (EC) No 854/2004 were not respected. 5.5 OFFICIAL CONTROLS AT ESTABLISHMENT LEVEL Legal requirements Article 12 of Regulation (EC) No 854/2004 lays down that the CA of the 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 13

handling raw material of animal origin used in the manufacture of the products of animal origin concerned, complies with the relevant Community requirements, in particular those of Regulation (EC) No 853/2004, or with the requirements that were determined to be equivalent and that an official inspection service supervises the establishments and has real powers to stop the establishments from exporting to the Community in the event that the establishments fail to meet the relevant requirements. The animal and 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 the product specific Commission Regulations. In the previous mission's report the following recommendations were made: 8.8. To ensure that all approved establishments meet the general and specific hygiene requirements of Regulations (EC) No 852/2004 and (EC) No 853/2004, particularly relating to operational hygiene, traceability of raw material and products, HACCP based procedures and own checks. 8.10. To ensure that the follow-up and the actions taken in case of non compliance are sufficient to ensure that the FBO remedies the situation, in a manner equivalent to the requirements of Regulation (EC) No 882/2004, Article 54. The response of the CCA to address these recommendations was found to be satisfactory at the evaluation of the action plan 2007. Findings 5.5.1 Ante-mortem inspection Ante-mortem inspection is carried out by an OV. All animal were examined within 24 hours of arrival. Sufficiently detailed records were kept by the OV of ante-mortem inspection. The transport documentation included a statement by the owner concerning the use of medicine, a transport document and an animal health certificate issued by the AV at the Veterinary Station. The documentation covered the information required by the provisions for food chain information as laid down in Regulations (EC) No 853/2004 and (EC) No 854/2004. The documentation was checked by the OV. 5.5.2 Post-mortem inspection Post-mortem examination is carried out by an OV. Several deficiencies were noted at post-mortem inspection of bovine animals and pigs in the SH visited, and in particular: 14

in SH "A", at the pig slaughter line the OV palpated the offal but did not open any hearts. The post-mortem on the bovine line was performed satisfactorily; in SH "B" the layout of the area where the post-mortem of pigs was carried out did not allow for a proper performance of the examination (facilities for the examination not properly designed, poor light, lack of space, permanent crossing of flows of personnel and equipment including the movement of containers between clean and soiled zone); the post-mortem in the presence of the mission team was carried out by three OVs in an establishment where normally there are two, and one of them is supposed to deal with ante-mortem inspection. They did not look familiar with the tasks; a number of pigs' hearts were either not opened or not opened correctly; on the bovine line, the facilities for the examination of red offal were not properly designed. The OV did not open the trachea at inspection; in SH "C" the mandibular lymphnodes of pigs' heads were not incised. In some cases the examination of the intestines of bovine and pigs was inadequate (lack of palpation and visual examination); in SH "D", the masseters of bovine animals were not incised correctly; in SH "E", the lungs of pigs were not palpated when condemned. 5.5.3 General and specific hygiene requirements The general and specific hygiene conditions in establishment "F" were not respected, and in particular: the changing rooms looked as if they had been abandoned urgently with dirty working clothes and personal belongings left in lockers. Damp and mould was seen throughout the establishment. in the SH, generally very used structures and equipment were noted, damaged insulation in places and flaking paint on the ceiling were seen, some rooms were not clean, the ceiling was leaking with subsequent damage to the insulation. These facts were not fully reflected in the CA reports. In establishment "A", substantial deficiencies were found which related mainly to: poor maintenance in the slaughter hall and in the chilling rooms (with chilling equipment so used that could not be maintained in an acceptable state of repair), 15

Inadequate layout and frozen raw materials kept in freezers which were of an unacceptable standard, inadequate hygiene procedures (sterilisers operating below 82 degrees C, rubbish and cigarette ends amongst wooden chips in the smoke generator), ABP placed in non-identified containers. These deficiencies were not mentioned in the CA reports. The check-lists used did not contain any relevant remarks. The maintenance plan prepared by the FBO was not clear enough, and there was no evidence of follow up or corrective action requested by the CA. The mission team requested action to be taken by the CCA in relation to establishments A and "F". This action was confirmed at the final meeting. The other four establishments were found to be compliant with the relevant EU requirements, with a number of deficiencies, and in particular: In establishment "B", in addition to some animal welfare and post-mortem deficiencies (see relevant sections) inadequate hygiene procedures were noted by the mission team, and in particular: in the SH, minor faecal contamination of bovine carcasses, In the meat processing plant, cigarette ends amongst the wooden chips in the smoke generator, In establishment "C, a layout deficiency in the SH (crossing of flows between the clean and soiled zones) was noted as well as insufficient protection again pests. In establishment "D", some deficiencies were found in relation to microbiological testing and animal welfare issues (see relevant sections). In establishment "E" the SH sterilisers operated under 82 degrees (corrected on the spot); the ventilation was also not sufficient in places. In the meat processing plant, some equipment was worn, difficult to clean and to keep clean. In the cannery, some specific deficiencies were noted (cans rinsed after filling but still dirty, cans still wet after heat treatment touched with bare hands). These deficiencies were not mentioned in the CA reports. At the final meeting, the CCA provided information about action taken in these establishments. 5.5.4 HACCP-based systems All establishments are required to have HACCP procedures in place since January 2009. 16

In all establishments visited HACCP-programmes and own-check procedures were available and implemented. The HACCP programmes were largely organised as required by Article 5 of Regulation (EC) No 852/2004. Nevertheless, shortcomings were noted with regard to implementing a correct hazard analysis according to international standards resulting in a few cases incorrectly defined CCPs. In addition, inadequate measures were included to ensure and document segregation between the slaughter of EU eligible and non-eu eligible animals and between cutting and processing into meat products of EU-eligible and non-eu-eligible meat were inadequate. Likewise, no procedures were in place, documenting the removal of nervous and lymphatic tissues, exposed during the deboning process of bovine meat. In establishment "B", evidence was seen, on how the CA reviewed the HACCP system, recommending the limiting of the number of Critical Control Points (CCP) from an initial 21 (finally, six CCP were kept). In establishment "A" evidence could not be provided that the checks on canned products (double seam evaluation) were performed as described for the mission team, (i.e. performed on filled cans). In all establishments producing meat products, adequate procedures were in place to monitor and record heat treatment conditions, with automatic and parallel manual registration of time, temperature and pressure (for canned products). Evidence of official supervision was seen in the records. However, in one cannery visited (establishment "A") no thermo indicator was used and in another (establishment "E") the way it was applied was not easy to see; this increased the risk that a batch could accidentally not undergo heat treatment. 5.5.5 Microbiological testing In the previous mission's report the following recommendation was made: 8.9. To ensure that the methodology for bacteriological sampling of carcasses is carried out in a manner equivalent to the requirements of Regulation (EC) No 2073/2005 in EU approved establishments. The response of the CCA to address this recommendation was found to be satisfactory at the evaluation of the action plan 2007. Testing of carcasses, final products and water in the establishments visited was in line with the relevant EU requirements, with exceptions: In establishment "D", carcasses were not tested for Salmonella. Moreover, the FBO reduced the frequency of sampling without informing the CA. 17

5.5.6 Traceability and identification marking Traceability procedures were in place in all operating establishments visited, but their design varied. In one establishment, the products could be traced to the farm of origin, this, however, due to the fact that there was only one supplier of the fresh meat, as the system would not work with more. In most cases, however, the product could be traced back to one day's slaughter but sometimes only to eight days' slaughter. The products were prepared according to general export procedures, and not specifically for the EU. However, during the traceability exercises carried out by the mission team no evidence of export of non-eligible products could be found. In establishment "E" in most cases, the only information on the labels affixed to the trolleys or racks with raw material or intermediate products was the type of meat (for example: shoulder) and date of cutting. The system was based on the anticipation that, if the origin is not mentioned the meat comes from the own SH and is EU eligible. However, this principle was not described in the procedure. In one case, the mission noted that, when imported raw material was used, the country of origin was displayed as Belgium, but in reality it was Germany. In none of the establishments visited, as also mentioned in section 5.5.8, has the FBO put in place clear procedures about separate storage, identification and processing of EU-eligible raw materials and final products. This fact has not been identified by the CA. A similar situation to that described in relation to raw materials and final products was noted in relation to live animals. No clear written procedures could be provided by the CA in relation to eligibility checks of animals for slaughter for export to the EU. In addition, the mission team noted, as indicated in section 5.1.2.7 that instructions about official controls exist for other commodities exported to the EU, as fish and fishery products and milk and dairy products, but not for meat and meat products. However, during the visits in the SHs, the mission team could not find any evidence of export to the EU of meat from non-eligible animals. 5.5.7 Animal welfare at the time of slaughter or killing In the previous mission's report the following recommendation was made: 8.11. To ensure that the animal welfare conditions at the time of slaughter or killing are in accordance with Council Directive 93/119/EC in EU approved establishments. The response of the CCA to address the recommendation was found to be satisfactory at the evaluation of the action plan 2007. The CCA indicated that an instruction in accordance with Council Directive 93/119/EC would be issued in October 2007. Whilst the instruction above was not issued, new framework animal welfare legislation was adopted in June 2009 (Rulebook No 41/2009), and legislation transposing Council Directive 18