Scientific Guidance for the submission of dossiers on Food Enzymes

Abstract Following a request from the European Commission, EFSA developed an updated scientific guidance to assist applicants in the preparation of applications for food enzymes. This guidance describes the scientific data to be included in applications for the authorisation of food enzymes, as well...

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Autores principales:	EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (EFSA CEP Panel), Claude Lambré, José Manuel Barat Baviera, Claudia Bolognesi, Pier Sandro Cocconcelli, Riccardo Crebelli, David Michael Gott, Konrad Grob, Evgenia Lampi, Marcel Mengelers, Alicja Mortensen, Gilles Rivière, Inger‐Lise Steffensen, Christina Tlustos, Henk Van Loveren, Laurence Vernis, Holger Zorn, Boet Glandorf, Lieve Herman, Jaime Aguilera, Magdalena Andryszkiewicz, Ana Gomes, Natalia Kovalkovicova, Yi Liu, Sandra Rainieri, Andrew Chesson
Formato:	article
Lenguaje:	EN
Publicado:	Wiley 2021
Materias:	food enzymes guidance applications Nutrition. Foods and food supply TX341-641 Chemical technology TP1-1185
Acceso en línea:	https://doaj.org/article/70ee69f46e64439eb0c47c74ca71674d
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spelling	oai:doaj.org-article:70ee69f46e64439eb0c47c74ca71674d2021-11-23T08:30:52ZScientific Guidance for the submission of dossiers on Food Enzymes1831-473210.2903/j.efsa.2021.6851https://doaj.org/article/70ee69f46e64439eb0c47c74ca71674d2021-10-01T00:00:00Zhttps://doi.org/10.2903/j.efsa.2021.6851https://doaj.org/toc/1831-4732Abstract Following a request from the European Commission, EFSA developed an updated scientific guidance to assist applicants in the preparation of applications for food enzymes. This guidance describes the scientific data to be included in applications for the authorisation of food enzymes, as well as for the extension of use for existing authorisations, in accordance with Regulation (EC) No 1331/2008 and its implementing rules. Information to be provided in applications relates to source, production and characteristics of the food enzyme, toxicological data, allergenicity and dietary exposure estimation. Source, production and characteristics of the food enzyme are first considered only for enzymes of microbial origin and subsequently for those enzymes derived from plants and for enzymes from animal sources. Finally, the data requested for toxicology, allergenicity and dietary exposure applies to all food enzymes independent of the source. On the basis of the submitted data, EFSA will assess the safety of food enzymes and conclude whether or not they present a risk to human health under the proposed conditions of use.EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (EFSA CEP Panel)Claude LambréJosé Manuel Barat BavieraClaudia BolognesiPier Sandro CocconcelliRiccardo CrebelliDavid Michael GottKonrad GrobEvgenia LampiMarcel MengelersAlicja MortensenGilles RivièreInger‐Lise SteffensenChristina TlustosHenk Van LoverenLaurence VernisHolger ZornBoet GlandorfLieve HermanJaime AguileraMagdalena AndryszkiewiczAna GomesNatalia KovalkovicovaYi LiuSandra RainieriAndrew ChessonWileyarticlefood enzymesguidanceapplicationsNutrition. Foods and food supplyTX341-641Chemical technologyTP1-1185ENEFSA Journal, Vol 19, Iss 10, Pp n/a-n/a (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	food enzymes guidance applications Nutrition. Foods and food supply TX341-641 Chemical technology TP1-1185
spellingShingle	food enzymes guidance applications Nutrition. Foods and food supply TX341-641 Chemical technology TP1-1185 EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (EFSA CEP Panel) Claude Lambré José Manuel Barat Baviera Claudia Bolognesi Pier Sandro Cocconcelli Riccardo Crebelli David Michael Gott Konrad Grob Evgenia Lampi Marcel Mengelers Alicja Mortensen Gilles Rivière Inger‐Lise Steffensen Christina Tlustos Henk Van Loveren Laurence Vernis Holger Zorn Boet Glandorf Lieve Herman Jaime Aguilera Magdalena Andryszkiewicz Ana Gomes Natalia Kovalkovicova Yi Liu Sandra Rainieri Andrew Chesson Scientific Guidance for the submission of dossiers on Food Enzymes
description	Abstract Following a request from the European Commission, EFSA developed an updated scientific guidance to assist applicants in the preparation of applications for food enzymes. This guidance describes the scientific data to be included in applications for the authorisation of food enzymes, as well as for the extension of use for existing authorisations, in accordance with Regulation (EC) No 1331/2008 and its implementing rules. Information to be provided in applications relates to source, production and characteristics of the food enzyme, toxicological data, allergenicity and dietary exposure estimation. Source, production and characteristics of the food enzyme are first considered only for enzymes of microbial origin and subsequently for those enzymes derived from plants and for enzymes from animal sources. Finally, the data requested for toxicology, allergenicity and dietary exposure applies to all food enzymes independent of the source. On the basis of the submitted data, EFSA will assess the safety of food enzymes and conclude whether or not they present a risk to human health under the proposed conditions of use.
format	article
author	EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (EFSA CEP Panel) Claude Lambré José Manuel Barat Baviera Claudia Bolognesi Pier Sandro Cocconcelli Riccardo Crebelli David Michael Gott Konrad Grob Evgenia Lampi Marcel Mengelers Alicja Mortensen Gilles Rivière Inger‐Lise Steffensen Christina Tlustos Henk Van Loveren Laurence Vernis Holger Zorn Boet Glandorf Lieve Herman Jaime Aguilera Magdalena Andryszkiewicz Ana Gomes Natalia Kovalkovicova Yi Liu Sandra Rainieri Andrew Chesson
author_facet	EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (EFSA CEP Panel) Claude Lambré José Manuel Barat Baviera Claudia Bolognesi Pier Sandro Cocconcelli Riccardo Crebelli David Michael Gott Konrad Grob Evgenia Lampi Marcel Mengelers Alicja Mortensen Gilles Rivière Inger‐Lise Steffensen Christina Tlustos Henk Van Loveren Laurence Vernis Holger Zorn Boet Glandorf Lieve Herman Jaime Aguilera Magdalena Andryszkiewicz Ana Gomes Natalia Kovalkovicova Yi Liu Sandra Rainieri Andrew Chesson
author_sort	EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (EFSA CEP Panel)
title	Scientific Guidance for the submission of dossiers on Food Enzymes
title_short	Scientific Guidance for the submission of dossiers on Food Enzymes
title_full	Scientific Guidance for the submission of dossiers on Food Enzymes
title_fullStr	Scientific Guidance for the submission of dossiers on Food Enzymes
title_full_unstemmed	Scientific Guidance for the submission of dossiers on Food Enzymes
title_sort	scientific guidance for the submission of dossiers on food enzymes
publisher	Wiley
publishDate	2021
url	https://doaj.org/article/70ee69f46e64439eb0c47c74ca71674d
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Scientific Guidance for the submission of dossiers on Food Enzymes

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