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Food Enzymes Approvals in EU


According to Regulation (EC) No 1332/2008 and Regulation (EU) No 562/2012, dossiers for all food enzymes currently used in food processing had to be submitted by 11 March 2015 for evaluation by the European Safety Authority (EFSA) and European commission/Member States. Food enzymes used for production of food (ingredients) imported into the EU are also in the scope of these regulations. Approved enzymes will appear on a Union List.

Regulation (EU) No 234/2011, implementing Regulation (EC) No 1331/2008, provides a list of data required for dossier submissions. Submissions contain two main parts: 1) a Risk Assessment part, which will be evaluated by EFSA, and 2) a Risk Management part, which will be evaluated by Commission and Member States (the ‘risk-managers’). Through extensive discussions with the EU authorities, Amfep acquired a clear picture of the required safety, analytical and production process documentation.

Regulation (EU) No 562/2012, amending Regulation (EU) No 234/2011, lays down the possibility to create joint dossiers for certain types of enzymes. Amfep has established working groups, open to Amfep and non-Amfep members, in order to create such joint dossiers. Amfep has submitted 16 joint dossiers before the deadline of 11 March 2015. In this context, Amfep cooperated closely with a broad range of food sectors on the risk management part of the dossiers, covering issues such as technological need of the food enzyme, use levels and processes in which the enzymes are being applied.  


A timeline for the establishment of the first EU positive list of food enzymes can be found here.