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March 2015

Food Enzymes Approvals

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.

Have a look at the timeline for the establishment of the first EU positive list of food enzymes.

AMFEP Joint Food Enzymes Dossier

Over the last three years, AMFEP has established a framework for cooperation for food enzymes producers in order to prepare joint dossiers for enzymes extracted from plant and animal tissues and for enzymes produced by fermentation of microorganisms. Where there was enough interest from food enzyme producers (minimum three companies, including AMFEP members as well as non-AMFEP members), a working group for the submission of a joint dossier was created. Consequently, AMFEP has submitted 16 Food Enzymes Dossiers before the deadline of 11 March 2015 for various applications for food enzymes obtained from:

  1. edible parts of plants or animals which have a documented history on the safety of the source of the food enzymes demonstrating no adverse effects on human health; or
  2. micro-organisms having the status of Qualified Presumption of Safety; or
  3. micro-organisms which have been used in the production of food enzymes that have been evaluated and authorised by the competent authorities in either France or Denmark in accordance with the SCF guidelines of 1992.

Read more about the AMFEP Joint Food Enzymes Dossier

16 Joint Food Enzymes Dossier submitted by AMFEP

AMFEP has created the following Working Groups to prepare joint dossiers or food enzymes in accordance with the Terms of Reference. If you are a food enzyme producer, formulator and/or distributor and you wish to join any of the Working Group, please let us know.

Please note that in accordance with art 2.13 of the Terms of Reference, joining a Working Group without having to pay the entrance fee is possible within two months after the creation of the Working Group.

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