Feed enzymes - regulatory aspects
Enzymes which are used in animal nutrition (feed enzymes), are considered as feed additives. Production and marketing of feed additives – and thus feed enzymes – are regulated by the following texts:
- Regulation 1831/2003 on feed additives.
- Guidelines for feed additives (Regulation 429/2008).
- Regulation 183/2005 on feed hygiene, supplemented by codes of practice such as FAMI-QS.
- Regulation 767/2009 on the marketing of feed.
In 2012, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) of the European Food Safety Authority has published a set of guidance documents, some of which, like the document on zootechnical additives, are applicable to feed enzymes.
An explicit EU authorization needs to be obtained before placing a feed enzyme on the market. For this, a comprehensive dossier - demonstrating that the product is safe for the users, target animals, consumers and the environment and efficient - needs to be submitted to EFSA and the European Commission for approval. EFSA reviews the dossier and publishes a scientific opinion. The final authorization is issued by means of a Commission Regulation (after consulted formal vote of the Member States). This authorization is valid ten years. A public list of authorized feed additives is published by the Commission (feed additive register).
Note that CLP is also applicable to feed enzymes, except when in the finished state intended for the final user.