EFSA Issues Suitability Checklist on Food Enzymes

28 Jul 2014 --- New guidance from EFSA includes a checklist of all the information that must be submitted as part of an application to put a food enzyme on the market in the European Union (EU).

The suitability checklist is designed to be used by applicants to ensure EFSA receives all the necessary administrative and scientific data to carry out its assessment of a food enzyme application. In addition, the document sets out when and how applicants can contact EFSA staff during the evaluation process.

The procedures and timelines for processing these applications under European law are also included in the short guidance.

The suitability checklist is the latest initiative developed by EFSA as part of its ongoing customer-oriented approach to applicants of regulated products. The programme is designed to strengthen the support EFSA provides to applicants and streamline the risk assessment process.

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.