Food Enzymes Approvals in EU

Amfep is establishing a framework for cooperation of food enzymes producers in order to prepare joint dossiers for enzymes extracted from plant and animal tissues and produced by fermentation of certain types of microorganisms.

The initial submission window for food enzyme dossiers, foreseen by the FIAP regulations, has started on 11 September 2011.

Through extensive discussions with the EU authorities, Amfep acquired a clear picture of the safety and analytical documentation – as well as production process description – that will need to be reviewed by the European Safety Authority (EFSA) in food enzyme dossiers. We are presently clarifying remaining elements of the risk management that will be reviewed by the Commission and Member States – in particular the demonstration of technological need of food enzymes.

Amfep is currently establishing a framework for preparation and submission of joint dossiers for food enzymes obtained from:

(a) 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

(b) micro-organisms having the status of Qualified Presumption of Safety; or

(c) 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.

Are you a food enzyme producer or formulator? Do you import food enzymes into the European Union? Join Amfep now – and use our unique extensive knowledge of food enzymes approvals!