Lambré Claude, Barat Baviera José Manuel, Bolognesi Claudia, Cocconcelli Pier Sandro, Crebelli Riccardo, Gott David Michael, Grob Konrad, Lampi Evgenia, Mengelers Marcel, Mortensen Alicja, Rivière Gilles, Steffensen Inger-Lise, Tlustos Christina, Van Loveren Henk, Vernis Laurence, Zorn Holger, Glandorf Boet, Herman Lieve, Aguilera Jaime, Andryszkiewicz Magdalena, Gomes Ana, Kovalkovicova Natalia, Liu Yi, Rainieri Sandra, Chesson Andrew
EFSA J. 2021 Oct 21;19(10):e06851. doi: 10.2903/j.efsa.2021.6851. eCollection 2021 Oct.
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.
应欧盟委员会要求，欧洲食品安全局制定了一份更新的科学指南，以协助申请人准备食品酶的申请。本指南描述了根据（欧盟）第1331/2008号条例及其实施规则，食品酶授权申请以及现有授权用途扩展申请中应包含的科学数据。申请中需提供的信息涉及食品酶的来源、生产和特性、毒理学数据、致敏性和膳食暴露评估。食品酶的来源、生产和特性首先仅针对微生物来源的酶进行考虑，随后针对植物来源的酶以及动物来源的酶进行考虑。最后，毒理学、致敏性和膳食暴露所需的数据适用于所有食品酶，无论其来源如何。欧洲食品安全局将根据提交的数据评估食品酶的安全性，并得出它们在拟议的使用条件下是否对人类健康构成风险的结论。
