Food enzymes are either authorised as processing aids, which account for most authorisations in France, or as food additives.
In both cases, food enzymes are subject to standard European regulations that are currently being implemented. There are two main regulatory texts and several additional regulations:
- a Regulation on food additives, food enzymes and food flavourings (Regulation (EC) No 1331/2008);
- a specific Regulation (Regulation (EC) No 1332/2008).
These EU regulations provide for a common evaluation and authorisation procedure leading to the establishment of a list of approved food enzymes within the European Union. Until this list is published, national legislation currently in effect concerning marketing and use of food enzymes, and of foodstuffs produced with food enzymes, remain applicable in the various Member States.
In France, food enzyme authorisations fall within the scope of the Decree dated 10 May 2011, stipulating the conditions for authorisation and use of processing aids. A list of approved food enzymes and conditions of authorisation are provided in the Ministerial Order dated 19 October 2006, as amended.
The role of the Agency
Applications for authorisation to use food enzymes are submitted by applicants to theGeneral Directorate for Competition Policy, Consumer Affairs and Fraud Control (DGCCRF), which then makes a formal request to ANSES. In accordance with Article 1 of the Ministerial Order dated 7 March 2011 , these applications must be prepared as per the EFSA Guidance on submission of a dossier on food enzymes for safety evaluation.
The Agency then has a period of 4 months, which can be extended under certain conditions, to review the dossier and to issue an opinion on use of a food enzyme for a specific technical application in food intended for human consumption (Decree of10 May 2011).
 Decree No. 2011-529 dated 10 May 2011 stipulating the conditions for authorisation and use of processing aids that can be used in the manufacture of food intended for human consumption.
 Ministerial Order dated 19 October 2006 regarding the use of processing aids in the manufacture of certain food products.
 Ministerial Order dated 7 March 2011 regarding guidelines for compilation of authorisation applications concerning processing aids for use in food intended for human consumption
 EFSA Guidance of the Scientific Panel of Food Contact Material, Enzymes, Flavourings and Processing Aids (CEF) on the Submission of a Dossier on Food Enzymes. The EFSA Journal (2009) 1305, 1-26