Food safety: additive in feedingstuffs and in drinking water for animal nutrition

PURPOSE: To consolidate EU provisions on additives for use in animal nutrition. CONTENT: Existing provisions on the regulation of additives for use in animal nutrition stem from a variety of (frequently outdated) Directives. So far, the basic legislation (Directive 70/524/EEC) has undergone five major amendments and numerous modifications of the annexes (over 100). The Directive has never been consolidated and provisions for authorisation contain many faults. Recognised problems include, no clear separation for risk evaluation or risk management, too much dependence on Member States who tend not be impartial and time-consuming, intransparent procedures. In light of these short comings the general objective of this proposed Regulation is to re-haul the entire regulatory process taking into account new products, feeding techniques and the short-coming of existing legislation. The Regulation will incorporate additives in feeding-stuffs and drinking water as well as the use of additives in silage. Only those additives which do not present a risk to human health, animal health or the environment may be included. Importantly, responsibility for authorisation will rest in the hands of the European Food Safety Authority (EFSA). The advantages are that the EFSA will provide a single framework for dossier evaluation for all feed additives, will bring clarity through guidelines which will be updated and adopted to various types of additives, efficiency through a single evaluation and transparency through the adoption of an assessment report and public consultation. Specifically, the Regulation contains the following elements: - In terms of scope the Regulation seeks to define "feed additives" Processing aids and veterinary medicines will not be covered by the Regulation. Only additives covered by an authorisation under the terms of the Regulation will be allowed to be put on the market, used or processed. Further, the borderline between veterinary medicinal products and feed additives is clarified. Thus, antibiotics are not authorised as feed additives. The use of coccidiostats as feed additives will be given limited authority depending on strict Maximum Residue Limits (MRLs). - The list of authorised additives will be divided into a restricted number of categories including technological additives; sensory additives; nutritional additives; zootechnical additives; coccidiostats. Additionally, a number of antibiotic feed additives will be withdrawn including avoparcin, tylosin phosphate, spiramycin, virginiamycin and bacitracin zinc. The Scientific Steering Committee recommends that the use of anti-microbials as growth promoting agents should be phased out as soon as possible and ultimately abolished. - In terms of registration, a positive list is maintained whereby only the additives listed in a register are allowed to be placed on the market, used or processed. Strict guidelines on the authorisation procedure are outlined. - On labelling rules the following will be required: the labelling of all additives; the name of the additive, the name and address of the person responsible for placing the product on the market, the net weight of the active component, directions for use and safety recommendations. The labelling will also indicate whether the additive is intended to be incorporated in feeding-stuffs or in drinking water. Lastly, the Commission will be responsible for implementation in accordance with Council Decision 1999/468/EC.�