Scientific Guidance for the submission of dossiers on Food Enzymes.
Scientific Guidance for the submission of dossiers on Food Enzymes.
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DOI：
10.2903/j.efsa.2021.6851
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发表时间：
2021-10
期刊：
影响因子：
--
通讯作者：
Chesson A
中科院分区：
文献类型：
--
作者：
EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (EFSA CEP Panel);Lambré C;Barat Baviera JM;Bolognesi C;Cocconcelli PS;Crebelli R;Gott DM;Grob K;Lampi E;Mengelers M;Mortensen A;Rivière G;Steffensen IL;Tlustos C;Van Loveren H;Vernis L;Zorn H;Glandorf B;Herman L;Aguilera J;Andryszkiewicz M;Gomes A;Kovalkovicova N;Liu Y;Rainieri S;Chesson A
应欧盟委员会的要求，EFSA制定了最新的科学指南，以帮助申请人准备食品酶的申请。本指南描述了根据第1331/2008号法规（EC）及其实施规则，食品酶授权申请以及现有授权使用扩展申请中应包含的科学数据。申请中提供的信息涉及食品酶的来源、生产和特性、毒理学数据、过敏性和膳食暴露估计。食品酶的来源、生产和特性首先只考虑微生物来源的酶，然后考虑植物来源的酶和动物来源的酶。最后，要求提供的毒理学、致敏性和饮食接触数据适用于所有食品酶，而与来源无关。根据提交的数据，EFSA将评估食品酶的安全性，并得出结论，在拟议的使用条件下，它们是否对人类健康构成风险。本出版物链接到以下EFSA支持出版物文章：http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2021.EN-6850/full
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. This publication is linked to the following EFSA Supporting Publications article: http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2021.EN-6850/full
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作者：
Auch AF;von Jan M;Klenk HP;Göker M
通讯作者：
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