Veterinary Medicines Feed additives

A new EU Regulation (EC 1831/2003), published in September 2003, describes the requirements for the registration of new and existing products used as feed additives in animal nutrition. The regulation applies to five categories of additives:
Technological additives: any substance added to feed for a technological purpose, e.g. preservatives, antioxidants, emulsifiers, stabilizers, thickeners, anticaking agents, silage additives, etc.
Sensory additives: any substance added to feed to improve or change the organoleptic properties of the feed or the visual characteristics of the food derived from animals, e.g. colorants and flavouring agents.
Nutritional additives: vitamins, amino acids, trace elements, urea.
Zootechnical additives: any substance used to affect favourably the performance of animals in good health or used to affect favourably the environment, e.g. digestibility enhancers, gut flora stabilizers, etc.
Coccidiostats and histomostats
New products must comply with the new regulation immediately after it comes into force (October 2003):
Existing feed additives must in a first step be notified by the producers, before October 2004. The second step is the submission of a full evaluation dossier, which must be submitted at the latest one year before the current registration expires or until October 2010, if the current registration is unlimited in time. If a feed additive is not notified, it will loose its marketing authorization at the end of the notification period.
Data protection:
The scientific data and other information in the application dossier may not be used for the benefit of another applicant for a period of 10 years, unless the original applicant agrees. However, data sharing is encouraged, especially for animal studies.
One difference between the registration of existing feed additives and previous re-registration programs is that many existing registration are not to a specific person or company, but are in the public domain. This means that anybody can sell the product as feed additives without a specific registration to his name. It is not completely clear, how and by whom these feed additives will be notified.
LKC Switzerland Ltd offers the following services to the Feed Additive Industry:
Notification of behalf of a manufacturer or supplier or a consortium of several companies.
Preparation of expert reports and risk assessments, especially for the chemical/pharmaceutical and toxicological summaries
Management of a consortium of interested companies. This includes collection of data, assessment of confidential information, negotiations for data and cost sharing.
Compilation of the assessment dossier, which may consists of several individual confidential parts and a joint safety assessment part.
Submission of the dossier and negotiations with the competent authorities.
Related Information
Contact LKC
LKC Switzerland Ltd
Hauptstrasse 10
P.O. Box 167
4414 Füllinsdorf
Switzerland
Phone: +41 (61) 906 8500
Fax: +41 (61) 906 8509