Regulatory aspects on feed enzymes
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.