Feed Additive Regulation in the EU
Feed additives are an integral part of modern animal husbandry which aims to enhance animals' nutrition with dietary supplements to prevent vitamin and nutrient deficiencies and ultimately improve their production and performance.
Feed additives need to be authorised prior to placing on the European market. Authorisation can only be granted after a scientific evaluation proving that the additive has no harmful effects on human and animal health and on the environment. The scientific evaluation is conducted by the European Food Safety Authority (EFSA) with assistance of the nominated EU Reference Laboratories for Residues of Pesticides (EURL) specialised on feed additives used in animal nutrition.
The approval procedure, labelling and use are laid down by the Feed Additives Regulation (EC) 1831/2003 and related directives, such as the most recent Commission Implementing Regulation (EU) No 2020/1773, amending Regulation (EC) No 429/2008 and providing detailed rules on how Regulation (EC) No 1831/2003 to be implemented, and the current Regulation (EU) No 2019/1381 on the transparency and sustainability of the EU risk assessment in the food chain. All amendments have been integrated in the original Regulation (EC) No 1831/2003.
Our Expertise
Based on our hands-on knowledge of the national and international regulatory and scientific framework, we have successfully submitted more than 50 re-authorisation dossiers for feed additives since 2001. We provided continuous support for numerous authorisations of new feed additives and successfully defended already filed authorisations due to additional requests from EFSA. We have vast experience in developing effective waiving strategies, tackling GMO-related challenges and dealing with toxicity concerns related to feed and food additives, including processing aids.
Our Services
We provide a wide range of technical and regulatory consulting services for feed additives, including:
- Comprehensive support on all relevant issues related to Regulation (EC) No 1831/2003
- Preparing application dossiers
- Establishing optimal portfolios of expert statements for your products
- GLP-certified archiving of GLP documentation and samples