Turck Dominique, Bohn Torsten, Castenmiller Jacqueline, de Henauw Stefaan, Hirsch-Ernst Karen Ildico, Maciuk Alexandre, Mangelsdorf Inge, McArdle Harry J, Naska Androniki, Pentieva Kristina, Siani Alfonso, Thies Frank, Tsabouri Sophia, Vinceti Marco, Aguilera Gómez Margarita, Cubadda Francesco, Frenzel Thomas, Heinonen Marina, Neuhäuser-Berthold Monika, Peláez Carmen, Poulsen Morten, Prieto Maradona Miguel, Schlatter Josef Rudolf, Siskos Alexandros, van Loveren Henk, Ackerl Reinhard, Albert Océane, Azzollini Domenico, Fernández Dumont Antonio, Gelbmann Wolfgang, Germini Andrea, Glymenaki Maria, Kass Georges E N, Kouloura Eirini, Laganaro Marcello, Matijevic Leonard, Mendes Vânia, Noriega Fernández Estefanía, Nuin Garciarena Irene, Precup Gabriela, Roldán Torres Ruth, Rossi Annamaria, Turla Emanuela, Valtueña Martinez Silvia, Ververis Ermolaos, Knutsen Helle Katrine
EFSA J. 2024 Sep 30;22(9):e8961. doi: 10.2903/j.efsa.2024.8961. eCollection 2024 Sep.
The European Commission requested EFSA to update the scientific guidance for the preparation of applications for authorisation of novel foods, previously developed following the adoption of Regulation (EU) 2015/2283 on novel foods. This guidance document provides advice on the scientific information needed to be submitted by the applicant towards demonstrating the safety of the novel food. Requirements pertain to the description of the novel food, production process, compositional data, specifications, proposed uses and use levels and anticipated intake of the novel food. Furthermore, information needed in sections on the history of use of the novel food and/or its source, absorption, distribution, metabolism, excretion, toxicological information, nutritional information and allergenicity is also described. The applicant should integrate and interpret the data presented in the different sections to provide their overall considerations on how the information supports the safety of the novel food under the proposed conditions of use. Where potential health hazards have been identified, they are to be discussed in relation to the anticipated intake of the novel food and the proposed target populations. On the basis of the information provided, EFSA will assess the safety of the novel food under the proposed conditions of use.
欧盟委员会要求欧洲食品安全局更新关于新型食品授权申请准备工作的科学指南，该指南此前是依据关于新型食品的欧盟法规（EU）2015/2283制定的。本指南文件就申请人为证明新型食品的安全性而需提交的科学信息提供建议。要求涉及新型食品的描述、生产工艺、成分数据、规格、拟用用途及使用水平以及新型食品的预期摄入量。此外，还描述了新型食品及其来源的使用历史、吸收、分布、代谢、排泄、毒理学信息、营养信息和致敏性等章节所需的信息。申请人应整合并解读不同章节中呈现的数据，以就这些信息如何在所提议的使用条件下支持新型食品的安全性提供总体考量。若已识别出潜在健康危害，则应结合新型食品的预期摄入量和提议的目标人群进行讨论。根据所提供的信息，欧洲食品安全局将在所提议的使用条件下评估新型食品的安全性。
