EFSA J. 2021 Mar 26;19(3):e06554. doi: 10.2903/j.efsa.2021.6554. eCollection 2021 Mar.
[Table: see text] Upon request from the European Commission, the scientific and technical guidance for the preparation and presentation of an application for authorisation of a health claim initially published in 2007 and subsequently revised in 2011 and 2016 has been updated. This guidance document presents a common format for the organisation of information for the preparation of a well-structured application for authorisation of health claims which fall under Articles 13(5), 14, and 19 of Regulation (EC) No 1924/2006. This guidance outlines: the information and scientific data which must be included in the application, the hierarchy of different types of data and study designs, and the key issues which should be addressed in the application to substantiate the health claim. This guidance has been revised in 2020 to inform applicants of new provisions in the pre-submission phase and in the application procedure set out in 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, that are applicable to all applications submitted as of 27 March 2021. The 2016 version of this guidance remains applicable to applications submitted before 27 March 2021.
[表格：见正文] 应欧盟委员会要求，最初于2007年发布、随后在2011年和2016年修订的健康声称授权申请编制和提交的科学技术指南已更新。本指南文件为编制符合（欧盟）第1924/2006号条例第13(5)条、第14条和第19条规定的结构良好的健康声称授权申请提供了信息组织的通用格式。本指南概述了：申请中必须包含的信息和科学数据、不同类型数据和研究设计的层级，以及申请中为证实健康声称应解决的关键问题。本指南于2020年进行了修订，以告知申请人2002年第178/2002号条例（经关于欧盟食物链风险评估透明度和可持续性的（欧盟）2019/1381号条例修订）中预提交阶段和申请程序的新规定，这些规定适用于2021年3月27日起提交的所有申请。本指南的2016年版本仍适用于2021年3月27日前提交的申请。
