DG Enterprise, 19 December 2003
DG Enterprise and DG Health and Consumer Protection have reflected on several current issues connected to the Community legislation on residues of veterinary medicinal products in food. This discussion paper presents points that need to be considered and debated with a view to reassess and modify the legislation to better serve the needs of all stake holders in this sector. The goal is to determine new means to balance consumer protection, animal health and welfare as well as trade requirements concerning residues of pharmacologically active substances used in veterinary medicinal products in food producing animals.
On the basis of the comments and suggestions received, the Commission will present a proposal for new legislation both on the evaluation of residues of pharmacologically active substances and their control in food.
The following is the introduction to the Paper. The full paper is available on this site - click here (pdf file)
Reflection Paper on Residues in foodstuffs of animal origin
This discussion paper presents points that need to be considered and debated with a view to reconsider and modify Community legislation concerning residues of veterinary medicinal products. The goal is to determine new means to balance consumer protection, animal health, welfare and trade requirements concerning residues of pharmacologically active substance used in veterinary medicinal products in food producing animals.
Existing legislation on pharmacologically active substances used in veterinary medicinal products greatly increased consumer protection but also significantly contributed to the decreased availability of medicines for uses in food producing animals in the European Community. Moreover its construction has lead to various problems related to the implementation and enforcement of legislation related to the control of residues in foods of animal origin. These have also lead to difficulties in the functioning of the Single Market and in international trade.
This paper analyses the reasons for these difficulties and seeks to propose alternative ways to achieve a high level of consumer protection coupled with continued availability and development of veterinary medicinal products for the European market. It does, however, not intent to address every detail of the legislation in force.
The authors of this document are aware of the fact that there are certainly overlaps in respect to current legislation on residues of feed additives and of plant protection products (pesticides). As recent proposals to modify the legislation governing the authorisation and control of residues of these products have been made by the Commission, it is not feasible to cover these areas in this document. It should however be borne in mind that a number of pharmacologically active substances used in veterinary medicinal products are also used as pesticides or feed additives and a co-ordinated approach in supervision of residues in foodstuff should be one of the goals for future legislation.
On the basis of the comments received, the Commission will present a proposal for new legislation on the evaluation of residues of pharmacologically active substances and for their control. This exercise should also bring the relevant legislation in line with the principles of Regulation 178/2002 ('Food Law') and would include modification of the relevant legislative instruments, i.e. Regulation (EEC) No 2377/90, and Directive 96/23/EC. The ultimate goal is to have a more consistent approach for the risk analysis and control of residues of pharmacologically active substances, which may appear in food produced in or imported into the European Union.
The main questions on which comments and proposals are solicited are the following:
1. Structures for the appropriate differentiation of risk assessment and risk management for the evaluation and control of residues in food of animal origin
2. Procedures for extrapolation of maximum residue limits
3. Procedures for provision of reference points for control purposes
4. Procedures for precautionary measures for substances in imported foodstuffs
5. Procedures for short-term risk assessments in crisis situations
6. Procedures for the evaluation of Third Countries residue control measures
7. Procedures for the nomination of Community reference laboratories
8. Procedures for the establishment of plans for monitoring and targeted controls
9. Financing of measures of interest to the Community related to food safety
10. Residue control specific enforcement measures
The Commission has asked for comments no later than 20 March 2004