Health rules: animal by-products and derived products not intended for human consumption

PURPOSE: to lay down health rules as regards animal by-products not intended for human consumption.

PROPOSED ACT: Regulation of the European Parliament and of the Council.

BACKGROUND: in response to several crises linked to products of animal origin which threatened the

safety of public and animal health (TSE, dioxin, FMD), the Community introduced a comprehensive legislative framework to maintain a high level of safety along the whole production and distribution chain, from "farm to fork". In this context, Regulation (EC) No 1774/2002 laying down health rules concerning animal by-products not intended for human consumption was adopted. The Regulation, which has been applicable since 1 May 2003, consolidated and recast the various existing rules covering animal by-products (ABP).

The Commission presented a report in October 2005 reflecting the experience of all 25 Member States in applying the legislation. In addition, the Commission's Food and Veterinary Office (FVO) carried out a round of inspections in all 25 Member States throughout 2004 and 2005 to assess the level of compliance of the Member States.

The following major issues emerged from consultations on the report as meriting reconsideration:

a)      the basic framework of safeguards applicable to all ABP should be maintained;

b)      the scope of the rules on ABP should be adjusted;

c)      the interaction of the rules on ABP with other Community legislation should be clarified;

d)     a more risk-based approach for the categorisation of ABP, as well as controls, should be introduced.

CONTENT: the proposal takes into account the results of the review carried out on Regulation and re-enacts the reviewed provisions, as well as the remaining part of the enacting provisions, in a single text. In the light of the practical and scientific experience gained and the outcome of the consultation, the main elements of the proposal are to maintain a high level of food and feed safety and consumer protection, and at the same time to provide:

1) Clarification

• anend point in the life-cycle of ABP is being introduced so as to clarify the point from which ABP cease to be covered by the requirements of the Regulation along the manufacturing chain. This point can be fixed at various stages, depending on the nature of ABP used, the characteristics of a treatment process or the intended end use of the product manufactured on ABP basis;
• with respect to legal uncertainties regarding the scope of the rules on ABP from wild game, potential sanitary gaps are being closed by introducing parallel provisions to the legislation on food hygiene;
• with regard to the interaction with other Community legislation, the approval of establishments and the performance of official controls, duplication between requirements is being avoided insofar as the objectives protected by one legislative framework can be considered to be covered sufficiently by another legislative framework.

2) A more risk-based approach

• theprimary responsibility of operators to ensure that the requirements of the Regulation are met, in line with the approach adopted in Community legislation on food and feed hygiene, is being reinforced. This should allow the competent authorities to focus resources on verifying compliance of operators with this obligation;
• in particular regarding the manufacture of products based on ABP without direct relevance to the safety of the (food and) feed chain (other than those produced as feed to farmed animals or as organic fertilisers), operators are entrusted with increased responsibility for the placing on the market of safe products. Provided they use safe raw materials for the production, develop safe manufacturing processes or use ABP for end purposes which are on balance safe, ABP of all categories may be used. Further details regarding this option may be laid down by way of implementing rules;
• new products, which have been proven to pose only limited risks, should be introduced into the classification of ABP. At the same time, the precautionary provision, whereby any ABP which are not expressly classified fall under Category 2 and may not be used in feed to farmed animals, should be maintained.
• current derogations regarding the exceptional burial and burning on site in cases of disease outbreaks should be clarified and extended to situations in which recovery operations in accordance with the  general rules of the Regulation become practically very difficult, such as during natural disasters.

The provisions laid down in the Annexes to the Regulation, as well as provisions laid down in separate Community acts implementing or derogating from that Regulation, such as Regulations (EC) No 811/2003, 79/2005, 92/2005 or 181/2006, will be re-enacted in an implementing Regulation, under the comitology procedure. This will be prepared in parallel, so as to enter into application simultaneously with the current proposal.