Food Law News - EU - 2002
FSA Consultation Letter, 28 March 2002
FEED - Proposed EC additives regulation - Phasing out of antibiotic growth promoters
The European Commission has recently published a proposal for a new Regulation controlling the use of additives in animal nutrition. It contains a number of provisions relating to the authorisation of these substances including one on the phasing out of antibiotic growth promoters. A copy of this proposal is available on the FSA web site.
Feed additives such as vitamins, trace elements, binders, preservatives etc are currently controlled by Directive 70/524/EC which was last substantially amended by Directive 96/51/EC. This also includes the use of antibiotics used as growth promoting feed additives and coccidiostats as feed additives (coccidiostats are substances added to feed to kill or inhibit the growth of certain parasites mainly in poultry). Basically only additives on an authorised list can be used in animal feeds according to certain conditions of use. New additives are included on the list only after an assessment for safety, quality and efficacy. The controls cover additives used in pet foods.
The Commission considers that certain changes are needed in order to rationalise and consolidate existing rules and to clarify procedural aspects of feed additive authorisations. The overall intention of the new proposal is to protect consumers of livestock products from animals fed feedingstuffs containing additives.
Main Features of the Proposal
Some of the provisions in the proposal reflect existing controls in Directive 70/524/EC. For example, the principle of a permitted list of feed additives based on safety, quality and efficacy is retained. The FSA have indicated below, the main provisions of the proposal including certain new measures they have identified. The Explanatory Memorandum presented with the proposal sets out the Commission's reasons and objectives for the measures.
- Scope (Article 2). The scope of the Regulation covers additives incorporated in feedingstuffs and added to drinking water. However the scope does not appear to extend to other 'non-feed uses' of additives such as boluses (slow release capsules) and pastes. It has been put to the FSA that these products are important in animal nutrition and their uses should be continued, subject to proper authorisation procedures.
- Conditions for authorisation (Article 6). Amongst other things, this article indicates that in future, antibiotics shall not be authorised as feed additives. The authorisations for a number of antibiotic feed additives (notably avoparcin, tylosin phosphate, spiramycin, virginiamycin and zinc bacitracin) have already been withdrawn. In addition, the Commission proposes to phase out the remaining authorised antibiotic growth promoters (sodium monensin, sodium-salinomycin, flavophospholipol and avilamycin). This phasing out is provided for in Article 12. The reason cited is the potential risk of transfer of antimicrobial resistance from microorganisms of livestock origin to human pathogens. The prohibition will come into effect from 1 January, 2006 to give time to replace these substances by alternative products.
- Categories of additives (Article 7). The Regulation defines various 'categories' of additives. These are further divided into 'functional groups' according to their principal function (Annex I). Silage agents, which are additives used in the ensilage process of grass or forage, now come within the scope of the Directive and are listed as preservatives. Our understanding of the implications of this is that for continued use, all silage agents currently marketed will be subject to the authorisation procedures for new additives (under Articles 8-10, see below) and must gain authorisation by the time the Regulation comes into force - possibly in two or three years time. However, the proposed Regulation provides no details of how these authorisations might be carried out in this relatively short time frame. Some bioprotein products currently subject to Directive 82/471/EC on the marketing of certain protein products, such as amino acids and their derivatives will come within the scope of the new Regulation.
Additives are to be categorised by their principal function. For example, an additive that makes more than one claim, such as an organic acid that acts as a preservative but at higher levels of use provides growth promoting effects, would only be listed once. An alternative approach would be to list such additives in each of the functional groups where an effect was claimed.
- Application for Authorisation, Opinion of the Authority, Authorisation by the Community (Articles 8, 9, and 10). The current authorisation procedures for new additives require companies or other applicants to provide a dossier of information for assessment, via a Member State rapporteur. The Member State rapporteur presents the dossier which contains data on the safety, quality and efficacy of the additive for consideration by other Member States for EC authorisation. The Commission often consults its Scientific Committee on Animal Nutrition. The new Regulation if adopted will change this procedure principally as follows:
- dossiers will be provided for assessment to the new European Food Safety Authority (EFSA), provided full information has been given in the dossier;
- within three months of receipt of a positive EFSA opinion, the Commission will prepare a draft Regulation for adoption;
- authorisations will be awarded to successful applicants for a period of 10 years (currently this type of product authorisation only applies to certain types of zootechnical additives eg antiobiotic growth promoters and coccidiostats); and
- authorisations will be renewable after ten years.
- Status of existing products (Article 11). Many additives permitted for use in feedingstuffs were authorised a number of years ago before the latest guidelines on assessment were drawn up. The Commission therefore proposes to evaluate these many scores of substances according to updated criteria. This evaluation would cover many 'generic' substances, eg vitamins and trace elements, and the eventual authorisations would be specific to authorisation holders. The timetable laid down would allow up to seven years after the Regulation comes into force for this process: any such substances which have not gained authorisation during that period could not be marketed.
Although coccidiostats are classified as feed additives, consideration has been given to whether these substances should be classified as veterinary medicines. In the current proposal the Commission has decided to retain their status as feed additives but requires their re-evaluation within four years of the Regulation coming into force.
- Labelling of Feed Additives and Premixtures (Article 16). These requirements are mainly as set out in Directive 70/524/EC. However the FSA understand the requirements for the declaration of additives on labels of compound feeds additives are to be covered in a separate amendment to the Compound Feeds Directive (90/44/EC).
The FSA would be grateful for any comments on the above and other provisions in the proposed EC Regulation. It is difficult to fix a firm deadline because the Spanish Presidency has indicated that it intends to proceed promptly with this proposal and may hold a first Council working group during April. The FSA will certainly need comments by mid- May, so have indicated a deadline of 15 May.
The Agency will forward comments relating to antibiotic growth promoters, coccidiostats and other zootechnical additives to the Veterinary Medicines Directorate.
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