1 NEW LEGISLATIVE FRAMEWORK OF FOOD HYGIENE IN THE EUROPEAN UNION FORMER SITUATION Historically, the regulation of food hygiene has been a basic part of European Community’s legislation from the very beginings. According to that time development of the Community, the legislations were sectorial, related to products, product groups resulting in a mainly vertical regulatory pattern of directives with consequent inhomogeneity on Community level (Directives are not legally bound in their entirely, National laws must only comply with Directives). In order to regulate the hygiene condition and control of food production and trade in the European Union during the last four decades, 1 horisontal and 17 vertical Directives were released. WHY REMODELLING IS NECESSARY The vertical character carries several overlappings in legislation and this is further complicated by countless modifications generating growing inhomogeneity on EU level. In contrast, there is a principally free movement of products in the EU internal market against a inhomogenously complex legislation. The food-chain has also been getting more complex and its elements are changing. The food borne hazards, therefore, are also changing and new risk types are emerging. Consumers are reacting with leaking confidence. Evaluating the situation, European Commitee decided (1999) to reform food safety regulation making it bound homogenously along the entire food chain, food sectors and member states. The necessary basic principles and detailed executive plan were summarized in the „White Book on Food-Safety” (COM(1999)719-Final). 2 CONSTRUCTION AND IMPLEMENTATION OF THE NEW FOOD HYGIENE REGULATION (NEW HYGIENE PACKAGE) Following the law making plan laid down in the White Book, the European Committee lanced the new food hygiene regulations (so called Hygiene package) for discussion and finally, those were entered into force. The package involved 5 regulations and directives as follows: 1. General food hygiene rules: 852/2004/EU (Members’ implementation: 2006) 2. Special hygiene prescriptions for food of animal origin: 853/2004/EU (Members’ implementation: 2006) 3. Official control of food of animal origin intended for human consumption: 854/2004/EU (Members’ implementation: 2006) 4. Animal health rules related to food of animal origin intended for human consumption: 2002/99/EU (Members’s implementation: 2005l) 5. List of Directives overruled by the new rules: 2004/41/EU (Members’ adoption: 2006) Ad 1-3 are are regulations, 4 and 5 are Directives. In 2002, the European Parlament and the Committee accepted the regulation (178/2002/EC) on The general principles and requirements of food-law The procedures corresponding to food-safety and The establishment of European Food Safety Office This is not part of the New hygiene package but the rules of the package closely connected to this basic regulation that may be considered as the Food Law of EU. Further regulations and directives: The 882/2004/EU regulation is dealing with the official food and feed control (It is in close relationship with 854/2004/EU) The regulation of 2160/2003/EU and the directive of 2003/99/EU on protection against, monitoring of salmonellas and other zoonotic causatives, respectively. 3 SHORT DISCUSSION OF THE RELEASED REGULATIONS AND DIRECTIVES General regulation of food hygiene The 852/2004/EU Regulation replaced the 93/43/EEC Directive. It covers all food commodities and food undertakings. Concerning traditional product manufacturing methods and distribution and geographically hardly approachable production sites, the Regulation is flexible and allows their regulation on the National level without violating basic hygiene principles. Exempts are primary production for own use, low volume products sold directly to final consumer by a local trader. In contrast to 93/43/EEC, 852/2004/EU regulate also the primary production, thereby the whole food-chain is involved („field to table”). It declares that it is the producer/distributor who is responsible for food safety and safety can be ensured in framework of HACCP by applying all the 7 principles. In respect of small undertakings, it is flexible and in case of production without identifiable CCP, GHP might substitute CCPrelated safety assurance and the administrative work is also suggested to be kept on reasonable measure. In primary production, the application of all principles of HACCP is not mandatory but compulsory the introduction of GHP and the elaboration of related hygiene guidelines are suggested. In order to facilitate the appropriate practical application of HACCP principles in other segments of food chain, the regulation suggests the elaboration of GHP guidelines both on EU and National levels. The general part of the Regulation contains 2 attachments. The first one summarizes the the hygiene requirements of the primary production, the second one (similarily to Directive 93/43/ECC) regulates the general hygiene conditions of production and distribution. Special hygiene prescriptions for food of animal origin In order to ensure a higher safety of food of animal origin that carry more severe microbiological and chemical hazard for health of consumer than other food, the EU elaborated special hygiene rules in form of Regulation of 853/2004/EU. The regulation describes (similarily to the 852/2004/EU): The tasks of food-enterpreneurs The special hygiene prescriptions for production and distribution of fresh and processed food of animal origin (excluded products containing of food of plant origin) 4 It is valid only for whole-sale distribution. In retail distribution, the application of general hygiene rules are sufficient (852/2004/EU) The flexibility in enforcement and fields of National regulations are the same as listed in 852/2004/EU, the latter is supplemented with possible National regulation of low quantity game-meat intended for selling to final consumer or retailer by hunters, as well as the prohibition or restriction of direct marketing for human consumption of fresh milk and cream. Most important food-enterpreneur and miscellenous product related prescriptions are Approval and record keeping of production and distributor establishments Mandatory identification or approval for human consumption (meat stamp) of food of animal origin Requirements for importing products originated from third countries Availability of so called food-chain information Only approved food production or distributor establishment may operate (if they produce/distribute food of animal origin which are listed in Attachment III). Exempts are those establishments which perform only primary production, only transportation, only storage without need of temperature control or retail distributor units supplying direct/final consumers, this latter must, however, be registered For ensuring tracebility, only food of animal origin having identifier marking is allowed to be marketed. Two permitted forms of marking are existing, namely identification marking and the meat-stamp. How meat stamp must be applied coupled with meat inspection, is regulated by 854/2004/EU. If this regulation actualy does not order the use of stamp, the food must be labelled by identfication mark. This mark is oval in European Union establishments and shows the abbreviated (according to ISO standard) name of the member state, the approval number of the establishment and the abbreviation of the European Union (EU). The site of marking is the product itself, or its individual or collective package. The label might be printed on sticking-tape or on plastic or metal plate. An important new element is the food-chain information. It indicates the animal health status of flock/herd of the slaughter animals and health status of the actually slaughtered animals. According to the regulation, the slaughterhouse may accept of entering slaughter animals if the related food-chain information from the farm is in hand 24 hours before arrival of animals and if it is made available for the official veterinarian. 5 The farm must describe/declare the animal-health-status of the herd/flock in question (with special regard to the possible presence of zoonotic carriers that clinically nondetectable and might lead to cross-contamination at slaughter and with special regard to the absence of veterinary drug residue over the corresponding MRL: observing withdrawal time). Further demand is the description of possible diseases and treatment occurred, results of earlier ante mortem inspections, production indices of the herd/flock, name and availability of the responsible veterinarian. The official veterinarian must be informed before the ante mortem inspection on any data that indicate public health risk or if the slaughter animals are without this food chain information (or if it is not complete). In this case the official veterinarian will make the appropriate decision. The animal health authority may give permission of giving/accepting the the food chain information at time of arrival of the slaughter animals in case of pig, poultry and farmed game if the ante mortem inspection was carried out at the farm and the animals proved to be healthy, furthermore in case of solipeds or emergency slaughter. Attachment III of the regulation contains description of special hygiene requirements for the production and marketing of the following products: meat of slaughter animals (solipeds), poultry meat, meat of farmed game and game meat, ground meat, meat-products, mechanically recovered meat, live bivalve molluscs, fish, fishery products, fresh milk, milk products, egg and egg products, thigh of frog, snail, animal fat, gastric and intestinal preparations, gelatin, collagen. Actualy, these items are regulated by 14 EU Directives which will be overruled by Directive 2004/41/EU from 01 January 2006. The third important Regulation of the „Hygiene package” is the 854/2004/EU dealing with the official control of food of animal origin. The official control has 3 main aspects: Public health Animal health Animal welfare This regulation is coupled to regulation of 882/2004/EU on official control of food and animal feed(ingstuff). One of the most important part of the regulation is the description of the official control of fresh meat. It discusses in detail the tasks of official veterinarian and technician and requirements of their professional education/knowledge. Declared important tasks are the meat-stamping at slaughterhouses and meat plants that reflects meat inspection judgement, furthermore the survaillance of control of establishment hygiene and corresponding HACCP system including verification in framework of self-control. 6 Minimum 1 official vet must be present during both ante and post mortem meat inspection at slaughterhouses, and at post mortem inspection in game-depots. The regulation is flexible in the following specified cases: A) Not obligatory the presence of official slaughterhouse-site ante mortem inspection if vet during The ante mortem inspection was carried out at the farm by official (or charged offical) vet, the offcial vet checked the food chain information and then, the results of these were given to the official slaughterhouse technicians Having the information, the official technicians decide if the slaughter of animals is without food safety risk and the body and health condition of the animals are appropriate or not The official vet regularly controls if the above described duties of official technicians are properly-done B) Not obligatory the presence of official vet during post mortem inspection if The post mortem inspection is carried out by official technicians and the abnormal organs (parts) altogether with the belonging carcase are detained The detained meat is inspected by the official vet (not obligatory in case of poultry) The official technician documents his work according to the directions of the official vet The above described flexible procedure must not be applied in case of emergency slaughter or at slaughters when potential public health risk case emerged, or if the slaughter of cattle, sheep or goat is intended from herd/flocks that are noneradicated of tuberculosis or brucellosis, furthermore in case of (other) notifiable diseases. Member states may permit that at poultry or hare slaughter the work of official technicians are carried out by professional technicians of the slaughterhouse, supposing that the slaughterhouse run a HACCP system for 12 months altogether with the application of GHP, the salughterhouse professionel technicians must have education comparable to the official technicians, and the work of official technicians must be done under the control of official vet. If a member state wants apply this possibility, it has to be reported to the European Committee. 7 Beside task determination, the regulation defines the necessary personnel professional requirements. Official vet must have a wide-range of theoretical knowledge (exam is demanded but based on graduate or postgraduate education authority may give escape) and at least 200 hours practice under the control of an official vet. Requirements of part-time official vets are determined by the member states. Official technicians must have at least 500 hours theoretical and 400 hours practical education and must have exam on topics determined in the regulation. The Regulation details the meat inspection. The new aspect is that member states may permit of carrying out the ante mortem inspection of pig by official or charged official vet at the farm and this is followed by a simplified inspection (identification and observation) of animals. Also in national regulatory framework, the simplified (only observation) post mortem inspection of pigs, which are coming from well controlled integrated production systems, may be permitted. Following this, the regulation describes the official control of production and distribution of live bivalve molluscs, fishery products and in brief, fresh milk and milk products. 8 SUMMARY OF THE NEW FOOD HYGIENE SAFETY REGULATION IN THE EUROPEAN UNION 178/2002/EU Regulation HYGIENE 852/2004/EU Regulation CONTROL 853/2004/EU Regulation FeedHygieneRegulation 854/2004/EU Regulation 882/2004/EU Regulation ZOONOSES ANIMAL HEALTH 2160/2003/EU Regulation 2002/99/EU Directive 2003/99/EU Directive (under preparation) IMPLEMENTATIVE RULES (COMMITTEE DECISIONS) NATIONAL REGULATION 9 FORMER FOOD HYGIENE DIRECTIVES OF THE EUROPEAN UNION AND THEIR HARMONISED HUNGARIAN EQUIVALENTS (Reflects the sectorial, vertical structure of the former food related legislation) Regulated field General hygiene EU Directive* 93/43/EEC Fresh meat Fresh poultry meat Game-meat, hare 64/433/ EEC 71/118/ EEC 91/495/ EEC, 92/45/ EEC 91/493/ EEC 91/492/ EEC 89/437/ EEC 92/46/ EEC 77/99/ EEC 94/65/EU Fishery products Sea molluscs Egg products Milk, milk products Meat products Cut, ground meat Meat and distribution meat product Hungarian Rules 90/2003. FVMESzCsM 100/2002. FVM 70/2002. FVM 9/2002. FVM 40/2002. FVM 80/2004. FVM 23/2002. FVM 1/2003. FVM 20/2003. FVM 77/2002. FVMESzCsM 79/2003. FVM 80/215/ EEC 72/461/ EEC 91/494/ EEC Trichinella examination 77/96/ EEC 69/2002. FVM * = Number of the original directive FVM = Ministry of Agriculture and Country-Development ESzCsM = Ministry of Health