This document provides guidance to applicants submitting applications for the authorisation of food enzymes in the European Union within the scope of Regulation (EC) No 1332/2008 and according to a common authorisation procedure for food additives, food enzymes and food flavourings, established by Regulation (EC) No 1331/2008 and Regulation (EU) No 234/2011, as amended. It complements the European Commission (EC) “Practical guidance for applicants on the submission of applications on food additives, food enzymes and food flavourings” and focuses on the criteria applied for the suitability check of food enzymes applications, as assessed by the European Food Safety Authority (EFSA), according to Article 12(3) of Regulation (EU) No 234/2011. The suitability checklist, included as Appendix to this document, reflects the data requirements for applications on food enzymes, as outlined in the EFSA “Guidance of the Scientific Panel of Food Contact Material, Enzymes, Flavourings and Processing Aids on the Submission of a Dossier on Food Enzymes” and in the EFSA “Explanatory Note for the Guidance of the Scientific Panel of Food Contact Materials, Enzymes, Flavourings and Processing Aids on the Submission of a Dossier on Food Enzymes”. EFSA recommends applicants to use the suitability checklist during the preparation of a technical dossier on food enzymes, to ensure that the criteria for the suitability of the data for risk assessment are met. This EFSA administrative guidance also describes the lifecycle of an application for the authorisation of food enzymes, from the reception of an application to the adoption and publication of EFSA scientific opinion.
12 June 2014
25 July 2014