Turck Dominique, Bohn Torsten, Castenmiller Jacqueline, de Henauw Stefaan, Engel Karl-Heinz, Hirsch-Ernst Karen Ildico, Kearney John, Knutsen Helle Katrine, Maciuk Alexandre, Mangelsdorf Inge, McArdle Harry J, Naska Androniki, Pentieva Kristina, Siani Alfonso, Thies Frank, Tsabouri Sophia, Vinceti Marco, Peláez Carmen, van Loveren Henk, Gelbmann Wolfgang, Ververis Ermolaos, Turla Emanuela
EFSA J. 2024 Sep 30;22(9):e8966. doi: 10.2903/j.efsa.2024.8966. eCollection 2024 Sep.
The European Commission requested EFSA to update the scientific guidance for the preparation of notifications for authorisation of traditional 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 applicants when submitting traditional food notifications pursuant to Article 14 and traditional food applications pursuant to Article 16 of Regulation (EU) 2015/2283. The safety of a traditional food should be substantiated by data on its composition, its experience of continued use and its proposed conditions of use. Its normal consumption should not be nutritionally disadvantageous. The applicant should integrate the information on the composition and the experience of continued use and provide a concise overall consideration on how this substantiates the history of safe use of the traditional food and how this relates to the proposed conditions of use for the EU. Potential health hazards identified on the basis of compositional data and/or data from the experience of continued use should be discussed. On the basis of the information provided, EFSA will assess the safety related to the consumption of the traditional 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传统食品授权通知编制的科学指南，该指南此前是在关于新型食品的欧盟法规（EU）2015/2283通过后制定的。本指南文件就申请人依据欧盟法规（EU）2015/2283第14条提交传统食品通知以及依据第16条提交传统食品申请时需提交的科学信息提供建议。传统食品的安全性应由其成分数据、持续使用经验及其拟议的使用条件数据来证实。其正常食用不应在营养方面产生不利影响。申请人应整合有关成分和持续使用经验的信息，并就这些信息如何证实传统食品的安全使用历史以及如何与欧盟拟议的使用条件相关联提供简要的总体考量。应讨论根据成分数据和/或持续使用经验数据确定的潜在健康危害。根据所提供的信息，欧洲食品安全局将评估在拟议的使用条件下与传统食品消费相关的安全性。
