Turck Dominique, Bresson Jean-Louis, Burlingame Barbara, Dean Tara, Fairweather-Tait Susan, Heinonen Marina, Hirsch-Ernst Karen Ildico, Mangelsdorf Inge, McArdle Harry J, Naska Androniki, Neuhäuser-Berthold Monika, Nowicka Grazyna, Pentieva Kristina, Sanz Yolanda, Siani Alfonso, Sjödin Anders, Stern Martin, Tomé Daniel, Vinceti Marco, Willatts Peter, Engel Karl-Heinz, Marchelli Rosangela, Pöting Annette, Poulsen Morten, Schlatter Josef, Gelbmann Wolfgang, de Sesmaisons-Lecarré Agnès, Verhagen Hans, van Loveren Hendrik
EFSA J. 2021 Mar 26;19(3):e06557. doi: 10.2903/j.efsa.2021.6557. eCollection 2021 Mar.
[Table: see text] Following the adoption of Regulation (EU) 2015/2283 on Novel Foods, the European Commission requested EFSA to develop a scientific and technical guidance for the preparation and submission of notifications for traditional foods from third countries. This guidance presents a common format for the organisation of the information to be presented by applicant for the preparation of a well-structured dossier. The safety of a traditional food should be substantiated by reliable data on its composition, its experience of continued use and its proposed conditions of use. Its normal consumption should not be nutritionally disadvantageous. This guidance is also intended to support applicants in providing the type and quality of information EU Member States and EFSA need for the assessments of traditional foods from third countries. 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. Where potential health hazards have been identified on the basis of the composition and/or data from the experience of continued use, they 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. This guidance was originally adopted by the NDA Panel in 2016. It has been revised in 2020 to inform applicants of the new provisions introduced by Regulation (EC) No 178/2002, as amended by Regulation (EU) 2019/1381 on the transparency and sustainability of the EU risk assessment in the food chain.It is applicable to allnotifications and applications submitted as of 27 March 2021. The 2016 version remains applicable to notifications and applications submitted before 27 March 2021.
[表格：见正文] 在《欧盟新型食品法规》（EU）2015/2283 通过之后，欧盟委员会要求欧洲食品安全局（EFSA）制定一份关于第三国传统食品通报编制与提交的科学技术指南。本指南提供了一种通用格式，用于组织申请人为编制结构良好的档案而需提供的信息。传统食品的安全性应以其成分、持续使用经验及拟议使用条件的可靠数据为依据。其正常食用不应在营养方面产生不利影响。本指南还旨在支持申请人提供欧盟成员国和欧洲食品安全局在评估第三国传统食品时所需的信息类型和质量。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明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。如果根据成分和/或持续使用经验数据识别出潜在健康危害，应进行讨论。欧洲食品安全局将根据所提供的信息，评估在拟议使用条件下食用该传统食品的安全性。本指南最初由新食品和食品添加剂专家委员会于 2016 年通过。2020 年进行了修订，以告知申请人《欧盟第 178/2002 号法规》（经《欧盟食品链风险评估透明度和可持续性法规》（EU）2019/1381 修订）引入的新规定。本指南适用于 2021 年 3 月 27 日及之后提交的所有通报和申请。2016 年版本仍适用于 2021 年 3 月 27 日之前提交的通报和申请。
