EFSA’s Panel of Food Contact Material, Enzymes, Flavourings and Processing Aids Panel (CEF) has adopted a 'Scientific Opinion on Guidance on the Submission of a Dossier on Food Enzymes' on 23 July 2009. In this guidance document the data required to conduct a risk assessment for food enzymes are described. It was requested by the Regulations (EC) No 1331/2008 on a common authorisation procedure for food additives, food enzymes and food flavourings of the European Parliament and of the Council. Commission Regulation (EU) No 234/2011 of 10 March 2011 implementing Regulation (EC) No 1331/2008 lays down the content of a dossier as well as the procedure to file a dossier for the safety evaluation of a food enzyme.
In order to assist applicants to compose a technical dossier, EFSA issues the updated Explanatory Note for the CEF Panel guidance giving more examples of scientific data need. The Explanatory Note is likely to be updated if needed to incorporate new examples.