On April 30, 2004, three important new regulations on food hygiene and veterinary controls were published in the Official Journal of the EU. These regulations came into force on May 20th and will come into effect on January 1st, 2006. This completes a year-long reform process that has fundamentally changed the concept of established hygiene law and brought it into a new legal framework. The declared goal of bringing together the entire community hygiene and veterinary law and making it clearer, simpler and more coherent has been achieved. At the same time, by including agriculture, the "farm-to-fork approach" is implemented in a contemporary manner, taking into account the principles and basic concepts of the EU basic regulation 178/2002.

After a total of almost four years of deliberations, the goal of publishing the new regulations before May 1, 2004 was also achieved, although in the end, when the Council, EP and Commission reached a consensus, a more extensive discussion in favor of the quality of the texts would have been desirable. It is already necessary to immediately republish the legal acts (see below) published in the Official Journal of the EU No. L 139 of April 30.4.2004, XNUMX in a corrected form, since they contain serious editorial errors. This should be done by the end of June.

The background to this redesign was that the food hygiene law, which has grown steadily since the 60s, included countless independent, specific and detailed legal provisions for the individual hygiene-sensitive areas of food production (meat, fish, milk, eggs...). In addition, in 1993 came the generally formulated Directive 93/43 EEC on food hygiene, which applied to all food companies after the original production - implemented in the national "Regulation on Food Hygiene" - which introduced new concepts and the approach to deregulation. However, the developments led to a situation of confusion, inconsistencies and excessive regulations, which was denounced for a long time and many times.

The new regulations:

• Regulation (EC) No. 852/2004 of the EP and the Council of April 29.4.2004, XNUMX on food hygiene
• Regulation (EC) No. 853/2004 of the EP and the Council of April 29.4.2004, XNUMX with specific hygiene regulations for food of animal origin
• Regulation (EC) No. 854/2004 of the EP and of the Council laying down specific procedural rules for the official controls of products of animal origin intended for human consumption

At the same time, the repeal directive was discussed (to be published) with which the hygiene guidelines to be replaced will be repealed and the member states will be asked to adapt the respective national law.

Summary of the innovations in the catalog of regulations

• Legal form; they are EU regulations with immediate effect
• There is a general basic hygiene regulation for all companies in the food chain - including primary production 
• no longer a priority special right
• special regulations for food of animal origin (only) supplementary
• Implementing regulations with microbiological criteria and temperatures follow
• All food companies are obliged to "enter" / register with the authorities
• General demand for the equivalence of all food from third countries
• The concept of voluntary guidelines for good hygiene practice is being upgraded
• Documentation obligations (of HACCP measures)
• For the animal food sector:
• Approval for operation, controls, identity marking and third-country regulations based on uniform principles
• Modernized and flexible system of veterinary controls
• No more differentiation between artisanal and industrial companies

The new regulations in detail:

Regulation (EC) No. 852/2004 of April 29.4.2004, 1 of the European Parliament and of the Council on food hygiene ("HXNUMX")

The content of the regulation is based on the concept of Directive 93/43/EEC on food hygiene and will represent a general basic regulation of food hygiene for all companies in all areas of the food chain, including primary production. It will also apply to the previously separately regulated areas (meat, fish, milk...). The regulation contains

• the general hygiene requirement and the obligation to adequately observe the general hygiene regulations listed in the appendices - separately for primary production and further processing;
• the obligation for self-control according to the principles of the HACCP concept according to Codex Alimentarius (except for the primary production) including the obligation to document the HACCP-related measures;
• a general (notification) notification or registration obligation, to which all companies are subject; Approval obligation (only) for companies that process food of animal origin;
• the requirement that food establishments in third countries supplying to the Community have to meet the same requirements;
• the process for the development and review of sectoral national or community voluntary "guidelines to good hygiene practice";
• Annexes with general hygiene regulations separated by primary production and all other production sites.

Regulation (EC) No. 853/2004 of April 29.4.2004, 2 of the European Parliament and of the Council on specific hygiene regulations for food of animal origin ("HXNUMX")

This regulation contains specific hygiene rules for companies that process food of animal origin; it applies in addition to the above-mentioned general hygiene regulation H1.

• The regulation only applies to unprocessed products of animal origin (including honey) and to foodstuffs resulting from the primary processing of unprocessed animal products. "Processed products" containing ingredients of both animal and vegetable origin are not subject to this specific rule. Also excluded are retail establishments and collective catering establishments.
• Food businesses that are subject to these specific regulations are subject to licensing. The approval is independent of the product according to a uniform procedure. The previous dichotomy between businesses of certain sizes with a local market that are subject to registration and businesses that are subject to approval under meat and poultry meat hygiene law will no longer exist in favor of more flexibility and risk-oriented assessment of the approval.
• Approved companies receive a sector-independent identity mark. For the purpose of traceability, foodstuffs from companies subject to approval must be marked with the identification number of the company. This identity marking for end products will replace and standardize the previous practice of health marking in the areas of meat, fish, milk and egg products. There is a health mark (to be carried out exclusively by the official veterinarian) for slaughtered animal carcasses and fresh red meat.
• The specifications for operating approval and identity marking for third-country imports are summarized and reorganized independently of the product.
• In addition, the ordinance in the appendices contains detailed hygiene regulations to the necessary extent for, among other things, the meat, fish milk and egg processing plants, in which the most important provisions from the currently applicable special law for the individual areas have been included. Quantitative parameters such as temperatures or germ counts were generally not adopted with the aim of scientific verification and are newly regulated in supplementary implementation regulations (see below).

Regulation (EC) No. 854/2004 of April 29.4.2004, 3 of the European Parliament and of the Council laying down rules for the official controls of products of animal origin intended for human consumption ("HXNUMX")

In addition to regulation H2 and in accordance with the new general monitoring regulations of the community, the veterinary control system will also be newly regulated; The ordinance summarizes the procedures currently set out by the supervisory authorities in the existing product-specific regulations for business approvals, specific business controls, ante-mortem and meat inspections and the issuance of health certificates, etc. In the future, the specific official controls and verification measures in all companies subject to the H2 regulation will be carried out according to uniform principles. At the same time, the official controls, such as the meat inspection, are being streamlined and modernized and allow for new organizational forms.

Directive (…..) of the European Parliament and of the Council repealing certain directives on food hygiene and hygiene requirements relating to the manufacture and placing on the market of certain products of animal origin intended for human consumption ("H5")

With this directive, 16 product-specific directives as well as Annex II of Directive 92/118/EEC are repealed; pending the adoption of microbiological and temperature criteria by the committee procedure, the relevant criteria and requirements set out in the regulations to be repealed should continue to apply.

A supplementary EU regulation with microbiological criteria is in preparation; in it, criteria for sampling, examination and evaluation are legally fixed for certain pathogenic germs and hygiene indicator germs and thus specifications for the validation of the operational HACCP concepts at all levels.

The new EU hygiene regulations, as directly applicable regulations, will have a significant impact on the existing national hygiene law: They will - among other things - replace the "Food Hygiene Regulation", largely the meat and poultry hygiene law, the fish hygiene regulation and the milk regulation - and numerous other regulations (e.g. Transport Container Ordinance, Import Control Ordinance, Inspector Ordinance, etc.). The legal transition from national regulations to EU regulations will still be an enormous task for the national legislature by the deadline of January 1.1.2006, XNUMX.

Source: Bonn [bll]