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Document 52012SA0014
Special Report No 14/2012 ‘Implementation of EU hygiene legislation in slaughterhouses of countries that joined the EU since 2004’
Special Report No 14/2012 ‘Implementation of EU hygiene legislation in slaughterhouses of countries that joined the EU since 2004’
Special Report No 14/2012 ‘Implementation of EU hygiene legislation in slaughterhouses of countries that joined the EU since 2004’
Special Report No 14/2012 ‘Implementation of EU hygiene legislation in slaughterhouses of countries that joined the EU since 2004’
ABBREVIATIONS BTSF : Better Training for Safer Food Agriculture and Rural Development DG : Directorate-General for Agriculture and Rural Development Health and Consumers DG : Directorate-General for Health and Consumers EAFRD : European Agricultural Fund for Rural Development EAGGF : European Agriculture Guidance and Guarantee Fund EAHC : Executive Agency for Health and Consumers ECDC : European Centre for Disease Prevention and Control EFSA : European Food Safety Authority FBO : food business operator FVO : Food and Veterinary Office HACCP : hazard analysis and critical control points MANCP : multiannual national control plan OLAF : European Anti-Fraud Office RDP : rural development programme Sapard : special accession programme for agriculture and rural development GLOSSARY Better Training for Safer Food (BTSF) : "Better Training for Safer Food" (BTSF) is a Commission initiative aimed at organising a Community (EU) training strategy in the areas of food law, feed law, animal health and animal welfare rules, as well as plant health rules. Training is designed for all staff of competent authorities of Member States involved in official control activities so as to keep them up to date with all aspects of Community law in the areas specified above and ensure that controls are carried out in a more uniform, objective and adequate manner in all Member States [1]. Cold chain : food business operators must provide throughout the food production process, from animal slaughter until the dispatch of products to the final consumer, an uninterrupted chain of suitable temperature-controlled handling and storage conditions of sufficient capacity for maintaining foodstuffs at appropriate temperatures. These temperatures are intended to maintain and extend the shelf life of fresh products by preventing the growth and multiplication of microorganisms. Critical control points (CCP) : these are the step or steps at which control is essential to prevent or eliminate a hazard or to reduce it to acceptable levels (see HACCP). Hazard analysis and critical control points (HACCP) : food business operators have to put in place, maintain and apply procedures based on HACCP principles in their activity: identifying any hazards that must be prevented, eliminated or reduced; identifying the critical control points at the step or steps at which control is essential to prevent or eliminate a hazard or to reduce it to acceptable levels; establishing critical limits at critical control points which separate acceptability from unacceptability; establishing and implementing effective monitoring procedures at critical control points; establishing corrective actions when monitoring indicates that a critical control point is not under control; establishing procedures to verify that the measures mentioned above are working effectively; establishing documents and records to demonstrate the effective application of the measures [2]. Microbiological testing : food business operators shall ensure that foodstuffs comply with the relevant microbiological criteria, and to take specific samples from carcasses and meat, as required by Regulation (EC) No 2073/2005 [3]. Multiannual national control plan (MANCP) : Member States shall enforce food law, and monitor and verify that the relevant requirements of food law are fulfilled by food and feed business operators. For that purpose, they have to maintain a system of official controls [4]. In order to ensure the effective implementation of these requirements, each Member State has to prepare a single integrated multiannual national control plan that contains general information on the structure and organisation of the systems of feed and food control, and of animal health and animal welfare control in that Member State. The MANCP is designed to promote a consistent, comprehensive and integrated approach to official controls and to identify risk-based priorities and criteria for the risk categorisation of the activities concerned and the most effective control procedures [5]. Own control programme : food business operators at each stage of food production, processing and distribution have to take samples to ensure that the production process is functioning at acceptable levels and the contamination level does not require corrective measures. Sampling frequencies of carcasses at slaughterhouses are set in Annex I to Regulation (EC) No 2073/2005. Samples also need to be taken from processing areas and equipment used in food production. Sampling by food business operators (own control programme) is differentiated from the sampling performed by Member States’ veterinarians in the framework of the multiannual national control plans. EXECUTIVE SUMMARY I. Slaughterhouses are a crucial step in the food processing chain. Under the European Union’s hygiene legislation, food business operators (FBOs) in charge of slaughterhouses must have appropriate conditions and procedures in place to ensure food safety. EU funds were allocated to slaughterhouses in countries that joined the EU from 2004 onwards, to facilitate their compliance with the provisions of the legislation. As the requirements were generally more onerous than existing national requirements, this was a major challenge. The associated upgrading of slaughterhouses was supported by EU contributions under the special accession programme for agriculture and rural development (Sapard) and later by the European Agricultural Guidance and Guarantee Fund (EAGGF) and the European Agricultural Fund for Rural Development (EAFRD). II. The audit of the Court examined whether the Commission and the Member States concerned took the necessary steps to ensure that slaughterhouses were brought up to the EU hygiene standards. This involved an examination of the supervision, guidance, implementation and funding of measures relating to hygiene requirements (paragraphs 1 to 21). III. The audit revealed weaknesses in the application of the rules and procedures in the Member States visited which are summarised below. These weaknesses do not call into question the overall design of the systems but demonstrate the need for increased rigour in the application of checks at all levels to mitigate risks and avoid potentially serious problems for food safety (paragraph 51). IV. The implementation of the requirements of the applicable hygiene regulation was partially reviewed by the Commission’s Food and Veterinary Office (FVO) in the Member States (paragraphs 22 to 25). Weaknesses were found in the implementation by Member States of the multiannual national control plans (MANCPs) (paragraphs 26 to 27). The supervision by national competent authorities did not prevent problems occurring with the implementation of hygiene requirements by FBOs (paragraphs 28 to 35). V. While the Commission published guidance documents in order to facilitate the implementation of hygiene requirements, some of the Member States involved did not produce national guidelines (paragraphs 36 to 38). VI. There was a lack of systematic consultation between the Commission and the Executive Agency for Health and Consumers concerning the initiative (paragraph 39) and a lack of appropriate procedures in the Member States to disseminate results of the BTSF initiative (paragraphs 40 to 44). VII. The contribution of EU funds to facilitating the implementation of hygiene requirements at slaughterhouses was affected by weaknesses related to the sustainability and selection of projects (paragraphs 45 to 50). VIII. The Court recommends that the Commission improve supervision and guidance of hygiene implementation of newly acceding Member States. Considering the use of EU funds for the implementation of the hygiene requirements in those Member States, the Commission is recommended to effectively supervise the implementation of the related programmes and evaluate the impact of these EU funds. INTRODUCTION 1. Maintaining high levels of food safety at a reasonable cost, by addressing key risks and ensuring effective implementation of food safety legislation, is a key priority of the Commission [6]. A series of crises concerning food and feed (for example, bovine spongiform encephalopathy, dioxin) have highlighted weaknesses in the design and implementation of food regulations in the European Union (EU). Since the "White Paper on food safety" of 2000 [7], the Commission has taken steps towards a comprehensive overhaul of EU legislation on food hygiene and veterinary issues. 2. The European Parliament and Council adopted a regulation concerning food safety [8] in 2002. Specific regulations concerning hygiene and food safety in slaughterhouses and the monitoring of their implementation were adopted by the Hygiene Package of 2004, which came into force in January 2006 and included: (a) rules on foodstuff hygiene [9]; (b) specific hygiene rules for food of animal origin [10]; and (c) specific rules for the organisation of official controls on products of animal origin intended for human consumption [11]. 3. Official controls [12] are performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules. In maintaining a high level of food safety, slaughterhouses [13] are a crucial step in the food processing chain. The main hygiene and food safety requirements to be applied in slaughterhouses [14] are set out in Annex I. 4. Member States joining the EU from 2004 faced particular challenges in meeting the new requirements of the Hygiene Package, compared with the existing Member States which had already been applying EU hygiene legislation. EU funds were therefore allocated to slaughterhouses in newly acceding Member States to facilitate their compliance with the legislation. 5. At December 2011, 2154 slaughterhouses had been approved by the national authorities of these Member States (see Table in paragraph 45) as respecting the EU hygiene regulations. RESPONSIBILITIES 6. The hygiene package assigns responsibilities for hygiene and food safety between the Commission, Member States, and food business operators. THE COMMISSION 7. The Commission (Health and Consumers Directorate-General (DG)) is responsible for developing the EU’s food safety policy, and in particular for risk management concerning food safety. It is assisted by two agencies in this task. The European Food Safety Authority (EFSA), based in Parma, provides expert opinions on food safety issues which serve as the scientific basis for EU measures. The European Centre for Disease Prevention and Control (ECDC), based in Stockholm, has also a scientific and risk assessment role, but with a greater focus on human health. 8. The Commission verifies the implementation of the EU’s food safety policy by Member States, notably by checking whether Member States develop a system of national official controls in compliance with EU law. This verification is carried out by a specific Directorate of the Health and Consumers DG, the Food and Veterinary Office (FVO), which performs audits of Member States’ national official controls. The Health and Consumers DG also develops food safety training for Member States under the BTSF programme. These training courses are administered by the Executive Agency for Health and Consumers (EAHC), based in Luxembourg. THE MEMBER STATES 9. Each Member State has a competent authority charged with implementing the Hygiene Package of 2004, and for verifying compliance by FBOs with its requirements. The main tasks of the competent authorities include: (a) development and dissemination of national guidelines; (b) approval of slaughterhouses; (c) preparing a single multiannual national control plan (MANCP) to describe their system of official controls and other activities to enforce the application of food safety requirements by FBOs at all stages of the food chain; (d) preparing MANCP implementation reports; (e) performance of official controls, (in addition to those of the official veterinarians (OV) located in the slaughterhouse) of FBOs in accordance with the MANCP; (f) promoting training of officials performing controls; (g) arranging for the designation of national reference laboratories; (h) carrying out audits of the official control systems to ensure that they are achieving the objective of Regulation (EC) No 882/2004. 10. Member States report annually to the Commission on the results of their controls and audits of the previous year. FOOD BUSINESS OPERATORS 11. FBOs are responsible for ensuring that all stages of production, processing and distribution of food under their control satisfy the relevant hygiene requirements. FBOs which manage slaughterhouses in Member States are responsible for ensuring adherence to requirements relating to: (a) providing appropriate facilities and equipment to allow the official veterinarian to perform ante-mortem and post-mortem inspections; (b) traceability of the animal products; (c) sampling for microbiological contamination; (d) separation of activities in space or time to avoid cross-contamination; (e) maintenance of the cold chain and appropriate wrapping or packaging and dispatch; (f) correct disposal of all waste resulting from the operations carried out in the slaughterhouses’ premises. 12. All food hygiene procedures should be based on the hazard analysis and critical control point (HACCP) principles [15], which is the international standard methodology for managing food related risks. SPECIFIC FUNDING FOR NEWLY ACCEDING MEMBER STATES 13. Member States acceding to the EU from 2004 had to ensure that their slaughterhouses met the EU’s hygiene requirements. As these requirements were generally to a much higher standard than existing national requirements, EU funds were provided to modernise slaughterhouses in order to facilitate their compliance with hygiene requirements. 14. The special accession programme for agriculture and rural development (Sapard programme) [16] provided around 117 million euro to 241 slaughterhouses under the measure "Improving the processing and marketing of agricultural and fishery products" [17]. This measure provided funds to help Member States deal with the structural adjustment in their agricultural sectors and rural areas, including the hygiene legislation relating to slaughterhouses. It focused on the priorities identified in the accession partnership agreements where details for each country are set down in a rural development plan. 15. Sapard funding was spent on aid such as the construction of slaughterhouse premises, the purchase of equipment, the refitting of production rooms using hygienic materials (for example no normal wall painting allowed), sterilisation and cleaning installations to meet the hygiene standards. 16. Slaughterhouses were then supported by the European Agriculture Guidance and Guarantee Fund (EAGGF) [18] under the measure "Improving the processing and marketing of agricultural products" and subsequently the European Agricultural Fund for Rural Development (EAFRD) [19] under the measure "Adding value to agricultural and forestry products". These funds are managed by the Directorate-General for Agriculture and Rural Development (Agriculture and Rural Development DG) and the Member States. AUDIT SCOPE AND APPROACH 17. The objective of the audit was to examine whether the Commission and the Member States that received funds from the Sapard, EAGGF and EAFRD programmes [20] took the necessary steps to ensure that slaughterhouses brought themselves up to the European Union (EU) hygiene standards. This involved examining the following questions: (a) Was there adequate supervision by the Commission and competent authorities in the Member States of the implementation of the hygiene requirements applicable to slaughterhouses? (b) Was there adequate guidance and training to support the implementation of the hygiene requirements applicable to slaughterhouses? (c) Were there adequate procedures to implement hygiene requirements at slaughterhouses? (d) Were the procedures for the provision of EU funding to slaughterhouses, for the implementation of the EU hygiene and food safety requirements, effective? 18. The audit included visits to relevant services of the Commission, the EAHC and EFSA. Five of the above mentioned newly acceding Member States (Czech Republic, Hungary, Poland, Romania and Slovenia) were visited and 25 slaughterhouses that benefited from EU funding (five in each Member State) were audited on the spot. 19. The audit work at the Commission services responsible for food safety included an examination of documentation and procedures concerning food safety audit and inspection missions, the management of training programmes and relevant guidelines for use by FBOs and competent authorities. 20. At the Commission services responsible for funding, the audit included the examination of documentation concerning the rural development programmes (RDPs) through the pre-accession funds (Sapard), EAGGF and EAFRD and examination of relevant documentation concerning the implementation of the programmes in the Member States visited during the audit. 21. In the Member States, the audit focused on the examination of the management systems for implementing the EU hygiene legislation in slaughterhouses, and included a review of the contribution of EU-funded programmes to this end. The audit at slaughterhouses examined the application of the related procedures. OBSERVATIONS SUPERVISION OF THE IMPLEMENTATION OF HYGIENE REQUIREMENTS 22. The audit examined the Commission’s supervision of the actions taken in Member States and the Member States’ supervision of FBOs’ activities. The Court’s audit found that overall, the design of systems for supervision of hygiene requirements by the Commission and the competent authorities in the Member States visited (paragraph 18) was adequate, but that there was scope for improvement of their implementation in a number of important respects as set out hereunder. 23. The implementation of hygiene requirements had not yet been completely reviewed by the Commission (paragraphs 24 to 25). At the level of the Member States audited, there were weaknesses in the implementation of the MANCPs (paragraphs 26 to 27) and the performance of veterinary controls (paragraph 28). THE COMMISSION HAS ONLY PARTIALLY REVIEWED THE IMPLEMENTATION OF THE 2004 HYGIENE PACKAGE IN THE MEMBER STATES 24. The Health and Consumers DG checks the implementation of hygiene requirements in Member States through inspections carried out by its FVO Directorate. The FVO performs some 250 inspection missions per year, of which more than one third are carried out in third countries. The Health and Consumers DG establishes priorities for their inspections on an annual basis, and considers risk, regulatory factors, current strategy and previous inspection results. Sector-specific inspections [21], general follow-up inspections and specific follow-up inspections are performed. 25. In 2006, the FVO reviewed the implementation of the requirements of the 2004 hygiene package (paragraph 8) concerning the red meat sector in all the Member States that joined the EU since 2004. A follow-up of unsatisfactory levels of implementation identified during that review was being completed at the time of the audit in 2011. In the poultry meat sector, however, the review started only in 2008. At the time of the audit in 2011 (five years after the deadline for implementation of the hygiene requirements), this review and its subsequent follow-up were also still in progress [22]. SHORTCOMINGS IN THE IMPLEMENTATION OF MULTIANNUAL NATIONAL CONTROL PLANS (MANCP) BY THE MEMBER STATES AUDITED 26. The implementation of Member States’ MANCPs (paragraph 9 and Glossary) is evaluated by the FVO during general follow-up audits. Weaknesses in that implementation [23] were identified by the FVO in the MANCPs of three of the newly adhering Member States visited (Hungary, Romania and Slovenia), which reduced their suitability as a basis for the performance of official controls. 27. In addition, the Court’s audit found that in Romania the controls planned by the MANCP for 2009 had not been fully implemented. WEAKNESSES IN IMPLEMENTATION OF MEMBER STATES’ VETERINARY CONTROLS 28. Member State competent authorities should carry out official veterinary controls in slaughterhouses in accordance with documented procedures [24]. Effective controls require these procedures to be clearly established and correctly implemented (see Annex II). The audit found that in general there were suitable procedures in place to comply with the requirements. However, specific shortcomings were detected. These related to problems with coordination and the documentation of sampling programmes and control results (see Box 1). IMPLEMENTATION OF HYGIENE AND FOOD SAFETY REQUIREMENTS IN SLAUGHTERHOUSES BY THE FBOS 29. The Court examined the implementation by the FBOs of hygiene and food safety requirements at slaughterhouses, under the supervision of Member States’ competent authorities. The audit found that overall there were suitable procedures in place in FBOs to comply with the requirements. Nevertheless the following observations show that the implementation of hygiene and food safety requirements by the FBOs still requires a reinforced verification by the national competent authorities and a close supervision of the latter by the Commission. BOX 1 WEAKNESSES IN OFFICIAL VETERINARY CONTROLS In Poland, the audit of official veterinary controls by the competent authorities was, at the time of the Court’s audit, performed under the responsibility of the same inspection services which perform veterinary controls. This poses a risk to the independence of the work. In Romania one report of an inspection carried out by the competent authorities to verify the performance of the official veterinarian’s tasks contained findings regarding the activity of the slaughterhouse and the implementation of own controls which are in fact the responsibility of the FBO. Member States’ veterinary services check whether the design and implementation of FBOs’ HACCP systems meet regulatory requirements. In Hungary, however, the central veterinary services did not have an overview of the application of HACCP. Furthermore, the information concerning shortcomings frequently identified was not sufficiently collated. Consequently, it was not possible to supervise the overall application and implementation of the HACCP system. In Slovenia there was a lack of clear guidelines and standard documentation for reporting veterinary control results, resulting in differences in the reporting of controls. This created a risk to their quality and completeness. In some of the small slaughterhouses visited during the audit, there was an inadequate demarcation between the responsibilities of the FBO and those of the official veterinarian. This may affect the independence of official controls. SHORTCOMINGS IN IMPLEMENTATION OF HYGIENE REQUIREMENTS 30. The audit noted weaknesses in the implementation of hygiene requirements in nine of the 25 slaughterhouses visited. These related to inappropriate cleaning, disinfection and stunning equipment, the separation of "clean" from "dirty" areas and a lack of adequate storage facilities for meat declared unfit for human consumption (see Box 2). BOX 2 SHORTCOMINGS IN THE IMPLEMENTATION OF THE HYGIENE REQUIREMENTS Although the flow of production in slaughterhouses should be designed to prevent cross-contamination, in one slaughterhouse visited in Romania staff could move freely from dirty to clean areas and the audit team had to go back on the flow from the dirty area to the clean area because no other exit was available. In a second Romanian slaughterhouse the meat from the storage facilities had to be brought back to the cutting plant to be labelled for dispatch. In both slaughterhouses, the lack of separation in space or time of activities in the slaughterhouse may present a risk of cross-contamination. In a third slaughterhouse, knives were not stored properly during the slaughtering operation. In a fourth slaughterhouse, staff handled pig carcasses immediately after cleaning the floors without first washing their hands. In a slaughterhouse visited in the Czech Republic, facilities for cleaning hands and boots were not appropriate to ensure that all staff actually used them before entering the clean areas. In this case and in a second slaughterhouse, there was no clear separation between different areas, allowing free access to facilities without taking appropriate disinfection measures. In a third slaughterhouse visited, cages used to transport live chickens were not completely cleaned after the unloading of the birds, which could lead to a risk of cross-contamination. In one slaughterhouse visited in Poland, the stunning equipment used did not function properly, causing unnecessary distress to the animals as replacement equipment was not readily available to finish the stunning in a reasonable time. In another slaughterhouse visited in Poland there were no available separate cooling facilities for the storage of meat unfit for human consumption. INSUFFICIENT ASSURANCE RELATED TO THE HAZARD ANALYSIS AND CRITICAL CONTROL POINTS (HACCP) SYSTEM 31. Appropriate documentation (for example, concerning the cold chain) forms an essential part of HACCP systems [25]. The HACCP plans of the slaughterhouses visited provided for the recording of monitoring activities of critical control points (CCPs). However, in five of the slaughterhouses visited, HACCP procedures were not applied for CCPs related to temperature and the documentation of CCP checks was incomplete and/or unreliable (see Box 3). This reduced the assurance of the reported critical control. BOX 3 INCOMPLETE CHECKS ON CRITICAL CONTROL POINTS In a slaughterhouse visited in Slovenia, the maximum temperature of meat before dispatching fixed by the regulations (7oC) was used as a limit for CCP, and temperature readings were systematically taken. If a temperature reading found that meat ready for dispatch was not cold enough, it should be chilled further. However the audit noted documented deliveries of meat from the slaughterhouse with temperature readings over 8oC without further chilling. In a slaughterhouse visited in Hungary, the temperature in chilling rooms was subject to a CCP. However the temperature monitoring system did not give sufficient warnings in case of temperature deviations from levels set in the HACCP plan. In another slaughterhouse visited, the documentation for CCPs was only completed when problems occurred. No documentary evidence of temperature readings within permitted levels was available. In one slaughterhouse visited in Romania, the temperature records in chilling rooms were not considered reliable. The same temperature was consistently recorded in these records for temperature readings taken four times a day over several weeks by the same person. In a second slaughterhouse visited in Romania, the temperature records were filled in advance showing always "C" for "compliant". DEFICIENCIES IN THE IMPLEMENTATION OF THE OWN CONTROL PROGRAMME 32. The legislation requires FBOs to perform an own control programme involving sampling of carcasses for microbiological contamination at least once per week, except in certain cases where the veterinary authorities may allow sampling to be performed on a fortnightly basis. In five of the slaughterhouses visited in three Member States, the sampling frequency or the handling of samples was not carried out in accordance with the requirements. In four cases, where the veterinary authorities approved sampling on a fortnightly basis, the actual sampling was performed at less frequent intervals. In one case the results of the testing were not available (see Box 4). BOX 4 SAMPLING OF CARCASSES NOT ALWAYS CARRIED OUT IN ACCORDANCE WITH THE RULES The FBOs of slaughterhouses shall take samples for microbiological analysis at least once a week. In two slaughterhouses visited in Romania, sampling for salmonella by the FBO was reduced below the legal requirements without appropriate prior approval by the veterinary authorities. In addition, the official veterinarian took the samples although this is the responsibility of the FBO. In one slaughterhouse visited in Poland, sampling by the FBO was reduced in some cases to once a month. In another slaughterhouse, there was no evidence that all the required tests are carried out. In one slaughterhouse visited in the Czech Republic, while the FBO complied with the sampling frequency, samples were only sent to the laboratory once a month or even less. This practice constituted a risk to production process hygiene as it would have been impossible to take immediate corrective measures in case positive sample results of microbiological analysis were not known quickly. LACK OF COMPLIANCE WITH TRACEABILITY REQUIREMENTS 33. Food and feed which may be sold in the EU should be adequately labelled or identified to facilitate its traceability, through relevant documentation or information [26]. The audit noted weaknesses in six of the 25 slaughterhouses visited. These related to inappropriate systems for the identification of carcasses and flocks and incomplete systems to trace the processing of live animals to carcasses in the food chain (see Box 5). BOX 5 LACK OF TRACEABILITY INFORMATION Slaughterhouse operators must not accept animals on the slaughterhouse premises unless they have been provided with relevant food safety information contained in the records kept at the holding of origin. In two slaughterhouses visited in Poland, no food chain information was available for cows slaughtered during the visit. In two pig slaughterhouses visited in Romania, and one in the Czech Republic, the rules regarding the identification of the carcasses, in view of ensuring traceability, were insufficient. In both Romanian cases, the FBO stated that the date of slaughter was the batch number. In the cold storage room of the first slaughterhouse, pig heads with no identification were seen during the on-the-spot visit. The absence of specific information for the identification of the parts of carcasses or the batch could then represent a risk to assuring traceability. In the case for the Czech Republic, the carcasses were numbered only with the order number of the slaughter and the date of slaughter was not recorded. This would hinder the rapid traceability of meat to farm in the event of a crisis. In two poultry slaughterhouses visited in Poland, there was no reconciliation between the number of delivered and slaughtered birds. In one of the slaughterhouses there were differences between the number of birds confirmed for slaughter by the ante-mortem veterinary inspection on the farm holding, and the number of birds delivered to the slaughterhouse. In the second slaughterhouse, there was not a physical count of slaughtered birds. Furthermore, in this case, the identification documents accompanying birds for slaughter identified the farm but information regarding the identification of the flock was missing. Where farms have more than one flock this leads to a lack of traceability between the flock checked and the flock slaughtered. A similar lack of identification of flocks was noted at a poultry slaughterhouse visited in Hungary. INCOMPATIBILITY OF RULES REGARDING FLEXIBILITY 34. As outlined in paragraph 11, FBOs are required to perform microbiological sampling at slaughterhouses. The legislation [27] provides for exemptions from the sampling frequencies in the case of small slaughterhouses, provided a risk analysis is performed which indicates that the reduction is justified. 35. There is no definition of small food businesses in the EU hygiene legislation. Furthermore, there is an inconsistency in the requirement that all establishments, irrespective of their size, have to apply the hygiene legislation in force and Regulation (EC) No 2073/2005 which allows derogations for small slaughterhouses. GUIDANCE AND TRAINING 36. The audit examined whether the Commission and Member States developed relevant guidelines and promoted appropriate training for the interested stakeholders. While guidelines are established at Commission level, few guidelines for hygiene practices at slaughterhouses were developed by the national professional sectors (paragraphs 37 to 38). The training programme organised by the Commission was considered by the Member States visited as very useful, but the audit noted that there was scope for improvement (paragraphs 39 to 44). LIMITED GUIDANCE BY THE MEMBER STATES ON THE IMPLEMENTATION OF LEGISLATION 37. The Commission is required by the food safety regulations to establish guidelines for official controls [28] and guides to good practice [29] for hygiene and for the application of HACCP principles, and should ensure that they are developed and disseminated. For that purpose the Commission publishes and updates relevant guidelines after consultation with Member States and other stakeholders. 38. Member States should also encourage the development by food business sectors of national guides to good practice for hygiene and for the application of HACCP principles [30]. These guides would be an important tool to prevent the situations described in the Court’s audit findings at Member State level, as well as weaknesses identified by the FVO inspections. However, in three Member States audited (Poland, Romania, Slovenia), no such guides had been established by the national professional associations. LACK OF SYSTEMATIC CONSULTATION BETWEEN THE HEALTH AND CONSUMERS DG AND THE EAHC 39. Topics for training and the design of BTSF training courses are selected by the Health and Consumers DG and provided in a very detailed manner to the EAHC. For the period under review (based on audit visits up to January 2011), there was a lack of systematic consultation between the EAHC and the Health and Consumers DG on the design of these training courses, which created a risk that the knowledge which the agency has gained in implementing the programmes was not exploited. SHORTCOMINGS IN THE IMPLEMENTATION OF THE BTSF 40. In order to harmonise official veterinary controls by Member States, the Commission may organise training courses for Member States’ staff [31]. The BTSF training initiative was developed by the Health and Consumers DG and is implemented by the EAHC. In order to ensure better communication with the Member States, regular meetings are organised between the Commission and Member States’ national contact points. 41. One basic principle of the BTSF training courses is not to replace national training programmes or to train all staff of competent authorities but to promote a "train-the-trainer" approach whereby Member States should pass on the information received by participants at BTSF training sessions to their veterinary services. The "train-the-trainer" approach is not yet fully implemented at EU level. Currently there is no common framework for the manner in which the dissemination activities are to be performed and no criteria for monitoring the dissemination results at Member State level in order to carry out a follow-up of these activities. 42. In Hungary and Romania, the role of the national contact points of the BTSF is limited to the transmission of information about the progress of the actions to the Commission and is not sufficient to monitor the training programme, provide feedback and disseminate the related information. 43. The intermediate evaluation of BTSF [32] showed that the participants consider that the training activities were too theoretical and lacked sufficient practical demonstrations. Furthermore the Court’s audit in Member States noted that the dissemination of information in Member States after participation on BTSF courses lacked sufficient practical demonstrations which would improve the results and impact of dissemination activities at Member State level (see Box 6). 44. A subsequent evaluation of the BTSF, which was initially planned for 2011, was delayed and is expected to be completed in 2012. BOX 6 TRAINING IMPROVEMENTS NEEDED In the Member States visited during the audit, the competent veterinary authorities consider the BTSF initiative very useful, although they suggested improvements regarding: (a) renewal of topics for BTSF training, as most of their central level inspectors already participated in existing training courses and there were other topics relating to current issues that needed to be covered to ensure a harmonised approach of official controls; (b) revision of training languages, as the training courses are normally provided only in English, French or German. The authorities underlined the difficulty in finding inspectors with sufficient language skills to participate in these courses. Moreover, not all the establishments selected to be visited by the participants in training courses were considered compliant with current hygiene requirements or provided examples of best practices. In Romania and Hungary, due to lack of exchange of information between the national contact point and the veterinary authorities, proposals for improvements to training courses were not considered. PROCEDURES FOR THE USE OF EU FUNDS 45. The audit examined the procedures to provide EU funding to slaughterhouses in order to facilitate the implementation of hygiene requirements. The Court identified weaknesses related to the sustainability and selection of projects (paragraphs 46 to 50). The Table shows the financing made available by Sapard to slaughterhouses aimed at bringing them up to EU hygiene standards. These operations are currently being supported by the measure "Adding value to agricultural and forestry products" of the EAFRD [33]. TABLE SAPARD — MEASURE "IMPROVING THE PROCESSING AND MARKETING OF AGRICULTURAL AND FISHERY PRODUCTS" Sources: Member State | Number of slaughterhouses supported by Sapard under the measure | Amount of EU contribution for slaughterhouses financed by Sapard under the measure (million euro) | Average amount of EU contribution per slaughterhouse (million euro) | Number of approved slaughterhouses at 31.12.2011 | (A) | (B) | (C) | (D)=(C)/(B) | (E) | Bulgaria [6666] | 42 | 29 | 0,69 | 108 | Czech Republic [7777] | 30 | 4 | 0,13 | 239 | Estonia [7777] | 4 | 1 | 0,25 | 60 | Latvia [6666] | 4 | 1 | 0,25 | 78 | Lithuania [6666] | 9 | 12 | 1,33 | 78 | Hungary [7777] | 13 | 3 | 0,23 | 283 | Poland [7777] | 77 | 22 | 0,29 | 1003 | Romania [7777] | 51 | 40 | 0,78 | 156 | Slovenia [7777] | 4 | 3 | 0,75 | 61 | Slovakia [7777] | 7 | 2 | 0,29 | 88 | Total | 241 | 117 | 0,49 | 2154 | 46. The national programmes contained general provisions for their implementation, including management, monitoring and controls. This was required before the Commission approved Sapard programmes. 47. The 2008 annual activity report of the Commission’s Agriculture and Rural Development DG included a reservation concerning the management and control system for Sapard in Romania and Bulgaria. The reservation was serious enough to cause the Commission to interrupt payments to those Member States. In Romania (where the problems were more severe), out of 197 Sapard projects supported under the measure "Improving the processing and marketing of agricultural and fishery products", 104 had already been investigated by the European Anti-Fraud Office (OLAF) by the time of the Court’s audit, following concerns over public procurement procedures. Serious irregularities were found for 64 projects, with recommendations for the total recovery of public aid. For 60 of these projects, fraud was suspected and the appropriate judicial authorities informed. WEAKNESSES RELATED TO THE SUSTAINABILITY OF FUNDED PROJECTS 48. One criterion for financing under Sapard was that projects should meet the new standards in terms of hygiene and food safety by the end of realisation of the investment. Project sustainability was also an objective. Funded projects should be maintained at target levels of activity for at least five years after the end of the investment. 49. The audit noted that EU funds contributed to the restructuring of slaughterhouses to facilitate compliance with the EU’s hygiene standards, and to maintain economic activity. The impact of the funded investments on meeting the new hygiene standards was not subject to a specific evaluation by the Commission services. The audit noted cases in each Member State visited where either the five-year minimum period of activity was not achieved, or where the targeted levels of activity were not achieved (see Box 7). This diminished the impact of the funds used to facilitate compliance with hygiene requirements in the slaughterhouses. INAPPROPRIATE AWARD CRITERIA FOR SAPARD PROJECTS 50. In the Czech Republic, the award criteria for Sapard sub-measure "Assistance in the introduction of hazard analysis and critical control points (HACCP)" included the existence of a HACCP team. Applicants who already had a HACCP team in place and were already well advanced in the application of HACCP were therefore selected over those which had made less progress and in fact required more assistance. This was not consistent with the objective of encouraging the implementation of HACCP. In the case of two of the slaughterhouses visited by the auditors benefiting from this sub-measure the only award criteria applied for the selection of these two slaughterhouses were the existence of a HACCP team and ISO certification. Therefore, Sapard funds’ contribution to the implementation of EU hygiene legislation was limited as establishments which were already developing the procedures to comply with these requirements were more likely to be selected. BOX 7 EXAMPLES WHERE THE PLANNED LEVEL OF ACTIVITY WAS NOT ATTAINED OR SUSTAINED In Romania two of the five slaughterhouses visited (0,9 million euro of Sapard funds) had not achieved their targeted level of slaughter activity. This was due to a combination of weaker than expected demand for their meat products, and lower than expected supply of suitable animals. In Poland one of the funded slaughterhouses initially selected to be visited (0,7 million euro of Sapard funds) ceased its activity in 2010 due to lack of economic performance. In Hungary one of the sites visited had a pig slaughterhouse supported by Sapard in 2003 (60 000 euro) which had been inactive since 2006. The FBO transferred slaughter activity to another of its slaughterhouses. While the paying agency recovered the Sapard funds due, the objectives of the EU funding were not achieved. CONCLUSIONS AND RECOMMENDATIONS 51. The Court’s audit found that overall, the design of systems for supervision of hygiene requirements by the Commission and the competent authorities in the newly acceding Member States were adequate. The audit revealed a number of weaknesses in the application of the rules and procedures in the Member States visited. In addition the audit found weaknesses related to the sustainability and selection of the funded projects. While the weaknesses detected do not individually or collectively call into question the overall design of the systems to ensure that hygiene requirements are applied, they demonstrate the need for increased rigour in the application of checks at all levels to mitigate the risks which could lead to serious food safety problems. 52. Implementation of hygiene requirements in the countries that joined the EU from 2004 onwards had not yet been completely reviewed by the Commission (paragraphs 24 to 25). At Member State level, weaknesses were noted in the implementation of the MANCPs, veterinary controls (paragraphs 26 to 28) and implementation of hygiene requirements by FBOs (paragraphs 29 to 35). RECOMMENDATION 1 Concerning the supervision of the implementation of the hygiene requirements, the Commission should: (a) complete the follow-up by the FVO of its earlier recommendations to the Member States resulting from the review of the implementation of the 2004 hygiene package; (b) improve its guidance and supervision of Member States’ preparation and implementation of the MANCPs in order to assure an effective system of official controls; (c) encourage Member States to effectively perform their veterinary controls, mainly through training, FVO inspections and review of Member States’ reports. (d) improve its supervision of Member States’ controls in order to minimise the weaknesses detected by the Court’s audit. 53. The Court’s audit found insufficient support and guidance to the FBOs and certain shortcomings in the implementation of the BTSF (paragraphs 36 to 44). RECOMMENDATION 2 Concerning guidance and training, the Commission should: (a) encourage Member States to develop national guides that can contribute to prevent the shortcomings identified by the Court’s audit; (b) consider actions to improve training actions and complete the evaluation of the BTSF initiative; (c) ensure that there is appropriate effective communication between its services to improve training actions; (d) encourage Member States in promoting increased guidance and training addressed to FBOs. 54. While EU funds contribute to the implementation of the EU hygiene requirements, there were problems with the selection and sustainability of funded projects (paragraphs 45 to 50). RECOMMENDATION 3 Concerning the use of EU funds for the implementation of hygiene requirements in slaughterhouses in countries that joined the EU from 2004 onwards, the Commission is recommended to: (a) provide guidance to Member States to encourage the effective use of EU funds, in particular concerning the effective selection of sustainable projects; (b) evaluate the impact of the EU funds allocated to the implementation of the hygiene standards and food safety; (c) consider, on the basis of that evaluation, whether further actions should be taken in order to assure a high level of hygiene standards in slaughterhouses. This report was adopted by Chamber I, headed by Mr Ioannis SARMAS, Member of the Court of Auditors, in Luxembourg at its meeting of 25 July 2012. For the Court of Auditors +++++ TIFF +++++ Vítor Manuel da Silva Caldeira President [1] Source: Executive Agency for Health and Consumers http://ec.europa.eu/eahc/food/about.html [2] Article 5 of Regulation (EC) No 852/2004. [3] Annex I to Regulation (EC) No 2073/2005. [4] Article 17 of Regulation (EC) No 178/2002. [5] Title V of Regulation (EC) No 882/2004. [6] http://ec.europa.eu/food/intro_en.htm [7] COM(1999) 719 final of 12 January 2000. [8] 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 (OJ L 31, 1.2.2002, p. 1). [9] Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs (OJ L 139, 30.4.2004, p. 1, Corrigendum OJ L 226, 25.6.2004, p. 3). [10] 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 (OJ L 139, 30.4.2004, p. 55, Corrigendum OJ L 226, 25.6.2004, p. 22). [11] 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 (OJ L 139, 30.4.2004, p. 206, Corrigendum OJ L 226, 25.6.2004, p. 83). [12] According to 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 (OJ L 191, 28.5.2004, p. 1), "official control" means any form of control that the competent authority or the Community performs for the verification of compliance with feed and food law, animal health and animal welfare rules. [13] According to the definition of Regulation (EC) No 853/2004, a slaughterhouse is an "establishment used for slaughtering and dressing animals, the meat of which is intended for human consumption". [14] Article 3 of Regulation (EC) No 852/2004. [15] See Glossary for a definition of these principles. [16] Regulation (EC) No 1268/1999 on Community support for pre-accession measures for agriculture and rural development in the applicant countries of central and eastern Europe in the pre-accession period (OJ L 161, 26.6.1999, p. 87). [17] This measure had a total allocation of 1025 million euro. The amount of 117 million euro for slaughterhouses is an estimate by the Court based on available information at the Commission and Member States.Levels of assistance under Sapard were determined and recorded at "measure" level. As there was not a measure specifically for slaughterhouses, there is a lack of reliable and complete information on their funding. Assistance under Sapard was available until 2006. If projects undergo a substantial modification during the five years after the date of final payment of the Sapard contribution, recoveries may be made by Member State competent authorities before the closure of the programme. In practice a Sapard programme will be closed after a maximum of seven years after final payment is made to the projects. For the Member States which joined the EU in 2004, recoveries may therefore be made until 2013. For Bulgaria and Romania the last declaration of expenditure was submitted in 2009, and recoveries may be made until 2016. [18] Council Regulation (EC) No 1257/1999 of 17 May 1999 on support for rural development from the European Agricultural Guidance and Guarantee Fund (EAGGF) and amending and repealing certain Regulations (OJ L 160, 26.6.1999, p. 80). [19] Council Regulation (EC) No 1698/2005 of 20 September 2005 on support for rural development by the European Agricultural Fund for Rural Development (EAFRD) (OJ L 277, 21.10.2005, p. 1). [20] Bulgaria, Czech Republic, Estonia, Latvia, Lithuania, Hungary, Poland, Romania, Slovenia and Slovakia. [21] E.g. "Food Hygiene — food of animal origin" audits carried out in 2006 in all Member States. [22] Estonia and Romania had not yet been covered. [23] E.g., in Hungary, the MANCP did not provide sufficient information on specific aspects relating to the poultry sector; responsibilities of approved veterinarians; the risk assessment; and the system used to establish the frequency of the official controls.In Romania, the MANCP did not provide sufficient information on whether sanctions were effective, proportionate and dissuasive; the prioritisation of official controls was not detailed in a harmonised way; and the plan did not cover the procedures for verifying the work of official veterinarians.In Slovenia, the MANCP did not provide sufficient information on procedures to ensure impartiality and consistency of official controls; and the plan was incomplete. [24] Article 8(1) of Regulation (EC) No 882/2004. [25] Article 5 of Regulation (EC) No 852/2004 (see also the Glossary). [26] Article 18(4) of Regulation (EC) No 178/2002. [27] Annex I to Commission Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs (OJ L 338, 22.12.2005, p. 1). [28] Article 8(4) of Regulation (EC) No 882/2004. [29] Chapter III of Regulation (EC) No 852/2004. [30] Article 7 and Article 8 of Regulation (EC) No 852/2004. [31] Article 51(1) of Regulation (EC) No 882/2004. [32] Intermediate evaluation of the "Better Training for Safer Food" training activities, final report, food chain — Evaluation Consortium, for the Health and Consumers DG, 4 April 2009. [33] Article 28 of Regulation (EC) No 1698/2005. In total this measure contributed 1025 million euro to 1936 projects. [6666] Sapard annual implementation reports and ex post evaluations available. [7777] Information sent to the Court by Member States’ paying agencies. -------------------------------------------------- ANNEX I HYGIENE AND FOOD SAFETY STANDARDS TO BE APPLIED BY FOOD BUSINESS OPERATORS FBOs shall place products of animal origin manufactured in the EU on the market only if they have been prepared and handled exclusively in authorised establishments that meet the relevant requirements of food law (Regulation (EC) No 853/2004 laying down specific hygiene rules for food of animal origin). The procedures put in place by the FBO must guarantee that animals accepted onto the slaughterhouse premises are properly identified. Slaughterhouses must have adequate and hygienic lairage facilities. There must be a separation in space or time of the operations. Slaughter lines must allow constant progress of the slaughter process and avoid cross-contamination between the different parts of the slaughter line. Slaughterhouses must have facilities for disinfecting tools with hot water supplied at not less than 82 °C, or an alternative system having an equivalent effect. There must be lockable facilities for the refrigerated storage of detained meat and separate lockable facilities for the storage of meat declared unfit for human consumption. The layout, design, construction, sitting and size of food premises must allow for: (a) adequate working space to allow for the hygienic performance of all operations and to permit good food hygiene practices, including protection against contamination; (b) suitable temperature-controlled handling and storage conditions; and (c) an adequate number of washbasins, suitably located and designated for cleaning hands (Regulation (EC) No 852/2004 on the hygiene of foodstuffs). There must be an adequate supply of potable water, which is to be used whenever necessary to ensure that foodstuffs are not contaminated. Every person working in a food handling area must maintain a high degree of personal cleanliness and wear suitable, clean and, where necessary, protective clothing. Salmonella should be absent in fresh meat; requirements concerning other microbiological criteria and sampling requirements should be observed. Training should be ensured for food handlers and for persons responsible with the implementation of the HACCP system. -------------------------------------------------- ANNEX II SPECIFIC REQUIREMENTS FOR OFFICIAL VETERINARY CONTROLS Annex II, Chapter II of Regulation (EC) No 882/2004 specifies the requirements for official veterinary controls. 1. The organisation of the competent authority and the relationship between central competent authorities and authorities to which they have delegated tasks to carry out official controls. 2. The relationship between competent authorities and control bodies to which they have delegated tasks related to official controls. 3. A statement on the objectives to be achieved. 4. Tasks, responsibilities and duties of staff. 5. Sampling procedures, control methods and techniques, interpretation of results and consequent decisions. 6. Monitoring and surveillance programmes. 7. Mutual assistance in the event that official controls require more than one Member State to take action. 8. Action to be taken following official controls. 9. Cooperation with other services or departments that may have relevant responsibilities. 10. Verification of the appropriateness of methods of sampling, methods of analysis and detection tests. 11. Any other activity or information required for the effective functioning of the official controls. --------------------------------------------------