Masterarbeit
The new regulatory framework for authorisation and reevaluation of feed additives by the European Food Safety Authority in the European Union
Monika Merfels (2004)
After many food alerts and crises in the recent years (for example bovine spongiform encephalophaty) the central goal of the European Commission is the achievement of the highest possible level of health protection for the consumers of Europe`s food.
Background of the changes regulating food additives is the White Paper on Food Safety, adopted January 2000, building up on the consultation arising from the Commission`s Green Paper on Food Law in 1997.
The White Paper sets out a major programme of legislative reform as well as the establishment of the new European Food Safety Authority.
The proposals in the White Paper of Food Safety are the most radical and far-reaching ever presented in the area of food safety.
One major topic is the regulatory framework concerning feed additives in the European Union which has been taken under revision. The Council Directive 70/524/EEC was superseded by the new Regulation 1831/2003/EC on additives for use in animal nutrition, which is applicable from 18 October 2004 on.
Several categories of feed additives and two different types of authorization are covered in the new regulation. This is often reason for tension and confusion in industry and needs explanation.
The status of the existing products authorised according Council Directive 70/524/EEC is described in this thesis, as well as the procedures of reevaluation, renewals and new authorization of a feed additive in demarcation to the veterinary medicinal products. The main topic here is the fate of antibiotics, coccidiostats and histomonostats and finally the growth promotors. These are relevant substances used in animal nutrition and are added for many reasons always taking into consideration animal health, agriculture, consumer health and the impact on the environment.
Since phasing-out of the antibiotics as feed additives is already determined and the fate of coccidiostats and certain growth promotors seem to face into the same direction, new paths in industry have to be treaded. Described are the possibilities and the dossier requirements for antibiotics and similar substances vs. feed additives in case industry intends to seek for an authorisation as veterinary medicinal products for these products. The comparable process in the European Union is the centralised procedure for veterinary medicinal products at the European Medicines Agency. Relevant national aspects have to be considered. Another interesting aspect for global operating industry is the view over the ocean since feed additives used in animal nutrition in the United States are handled different compared to the European Union.
An important task for all persons involved with this subject is to watch carefully that at first place a high level of protection of consumer and animal health is ensured. The European Food Safety Authority is asked to review the progress achieved in the development of alternative substances and alternative methods of management, feeding, hygiene etc. before 1 January 2005 and the planned actions are introduced.
Pages: 60, Appendices: 44 pages