Protection of human health: hygiene of foodstuffs

The Council is pleased to note that the Commission accepts its common position and that the draft Regulation is consistent with many of the amendments that the European Parliament adopted at first reading. Moreover, even when the Council and the Commission could not fully accept the Parliament's amendments, the common position is often closer to the Parliament's position than the Commission's original proposal. The main amendments introduced by the Council are as follows: - Scope : the Council agrees that it is not appropriate for Community legislation to lay down hygiene rules for the direct supply of small quantities of primary products to the final consumer and local retail establishments. However, the common position makes clear that direct supply means supply by the primary producer; direct supply to local retail establishments covers only shops and restaurants (and not wholesale or processing operations); and Member States must establish national rules for such direct supply that ensure the same level of food safety as the Regulation. It also contains an exemption for collection centres and tanneries that carry out no operations related to food production other than the storage of raw material for the production of collagen or gelatine. The Regulation laying down specific hygiene rules for food of animal origin contains appropriate rules for such establishments. - HACCP : the Council does not believe that it would be practicable, in the short term, to apply the principles of hazard analysis and critical control points (HACCP) to primary production. It agrees, however, that the Commission should review this issue and report on its conclusions within five years of entry into force of the Regulation, as part of its report on the implementation of the Regulation. The Council also agrees that HACCP requirements for other food business operators need to be flexible, so as to be practicable for all types of establishments. In particular, the Council agrees that it should be possible in certain establishments to use procedures contained in guides rather than carrying out a full application of HACCP principles. To ensure that this possibility does not undermine food safety objectives, however, it is appropriate to regulate the use of guides through comitology. - Comitology : the Council agrees that it would not be appropriate for Article 4 to impose a duty on food business operators to comply with the provisions of Annexes that could be added to the Regulation through comitology. It does not accept, however, that there should be no scope for granting exemptions or for amending the existing Annexes through comitology. The common position maintains this possibility, but contains criteria specifying the circumstances in which the Annexes could be amended. - Guides to good practice : the Council agrees that it is desirable to emphasise that all stakeholders should be involved in the development of guides to good practice for food hygiene or for the application of the HACCP principles. It also accepts the need for regular reviews of Community guides. However, since food business operators would use guides on a voluntary basis, it does not agree that it would be appropriate to establish a hierarchy between Community and national guides. - Flexibility : the Council agrees that there should beflexibility for Member States to adopt national measures adapting the detailed requirements laid down in Annex II, if this does not compromise the objectives of the Regulation. It also agrees that it is appropriate to enhance the transparency of the procedure through which Member States would exercise this flexibility, to ensure that all envisaged measures undergo a proper review. However, the Council does not believe that it is appropriate to extend the procedure to Annex I, which sets general objectives rather than laying down detailed requirements. - Date of application : the common position provides for the Regulation to apply eighteen months after the date on which all elements of the package are in force, but not before 1 January 2006. - Requirements for primary producers (Annex I) : the Council agrees that the rules for primary producers should not just apply to primary production but also to certain operations intimately associated with primary production. These operations should include: operations carried out at the place of production that do not substantially alter the nature of primary products; the transport of live animals; and the delivery of products of plant origin, fishery products and wild game from the place of production to another establishment. - Technical requirements for operations after primary production (Annex II): The common position incorporates a number of technical modifications to Annex II. Key among these are stricter equipment requirements; simpler rules on heat treatment and the transfer and generalisation of requirements that used to be specific to heat treatment; and deletion of specific rules on salting and smoking, since they did not add anything to the general requirements.�