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Guidance of the Scientific Panel of Food Contact Material, Enzymes, Flavourings and Processing Aids (CEF) on the Submission of a Dossier on Food Enzymes for Safety Evaluation [1]

  EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) Panel Members Arturo Anadón, David Bell, Mona-Lise Binderup, Wilfried Bursch, Laurence Castle, Riccardo Crebelli, Karl-Heinz Engel, Roland Franz, Nathalie Gontard, Thomas Haertlé, Trine Husøy, Klaus-Dieter Jany, Catherine Leclercq, Jean-Claude Lhuguenot, Wim C. Mennes, Maria Rosaria Milana, Karla Pfaff, Kettil Svensson, Fidel Toldrá, Rosemary Waring, Detlef Wölfle. Acknowledgment The European Food Safety Authority wishes to thank the members of the Working Group for the preparation of this guidance document: A. Anadón, D. Bell, T. Haertlé, T. Hallas-Møller, K.-D. Jany, P. Joudrier, P. Tobback, F. Toldrá, R. Waring and A. Pöting for assisting in the preparation of the draft guidance document under the AFC Panel mandate.
Type: Guidance of the Scientific Committee/Scientific Panel Question number: EFSA-Q-2007-080 Adopted: 23 July 2009 Published: 12 August 2009 Last updated: 24 May 2013. This version replaces the previous one/s.

No abstract available


According to Regulation (EC) No 1332/2008 food enzymes shall be subject to safety evaluation by the European Food Safety Authority (EFSA) and approval via a Community list. The inclusion of a food enzyme in the Community list will be considered by the Commission on the basis of the opinion from EFSA, taking into account also other general criteria such as technological need and consumer aspects.

The purpose of this document is to provide guidance to applicants and other interested parties in providing a dossier for safety evaluation of food enzymes. It gives guidance on the format of a formal application for the safety assessment of a food enzyme, on the administrative and technical data required, and on the range of toxicological tests generally required.

Applicants should note that the Commission will make available to competent authorities in Member States in full form any dossier submitted to the Authority for a safety assessment. Confidentiality of information provided by the applicant will be treated in accordance with Article 12 of the Regulation (EC) No 1331/2008 . Therefore applicants should mark clearly which of the information provided they wish to be treated as confidential and provide verifiable justification in such case.

Applications shall be submitted in accordance with Regulation (EC) 1331/2008 and its implementing measures referred to in Article 9 of this Regulation. All the information necessary to enable EFSA to conduct a safety assessment of a food enzyme must be provided by the applicants in the dossier. Applicants wishing to make a submission are advised to consult this Guidance.

Note: For full details, please consult the Guidance document.