EFSA J. 2021 Mar 26;19(3):e06544. doi: 10.2903/j.efsa.2021.6544. eCollection 2021 Mar.
[Table: see text] Following a request from the European Commission in 2014, the EFSA Panel on Dietetic products, Nutrition and Allergies (NDA) was asked to provide scientific and technical guidance on foods for special medical purposes (FSMP) in the context of Article 3 of Regulation (EU) No 609/2013. The guidance presented in this document is to assist in the preparation and presentation of well-structured dossiers. It presents a common format for the organisation of the information and outlines the information and scientific data which could be included in the dossier, as well as the key issues which should be addressed in the dossier in order to assess the extent to which a food product notified as FSMP falls under the scope of Regulation (EU) No 609/2013, under the proposed use. It is intended that the guidance will be kept under review and will be further amended and updated as appropriate in the light of experience gained from the evaluation of dossiers for specific food products notified as FSMP, and in the light of future Community guidelines and legislation. The scope of this guidance is limited to FSMPs in the context of Article 3 of Regulation (EU) No 609/2013. Out of the scope of this guidance are: a) other categories of food falling under Regulation (EU) No 609/2013, such as infant formula and follow-on formula, processed cereal-based food and baby food, and total diet replacement for weight control; b) meal replacements for weight control; c) "gluten-free" and "lactose-free" foods. Upon request from the European Commission in 2020, this guidance has been revised to inform applicants of new provisions in the pre-submission phase and submission 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.
[表格：见正文] 应欧盟委员会2014年的要求，欧洲食品安全局（EFSA）的营养产品、营养与过敏专家组（NDA）被要求根据欧盟第609/2013号条例第3条，就特殊医学用途食品（FSMP）提供科学和技术指导。本文件中提供的指导旨在协助编写和提交结构良好的档案。它提出了一种信息组织的通用格式，概述了可纳入档案的信息和科学数据，以及为评估作为FSMP通报的食品在拟议用途下是否属于欧盟第609/2013号条例范围而应在档案中解决的关键问题。该指导旨在接受持续审查，并将根据对作为FSMP通报的特定食品档案评估所获得的经验，以及未来的共同体指南和立法，酌情进一步修订和更新。本指导的范围限于欧盟第609/2013号条例第3条所规定的FSMP。本指导范围之外的有：a）属于欧盟第609/2013号条例范围的其他食品类别，如婴儿配方奶粉和后续配方奶粉、谷物加工食品和婴儿食品，以及用于体重控制的全膳食替代产品；b）用于体重控制的代餐产品；c）“无麸质”和“无乳糖”食品。应欧盟委员会2020年的要求，本指导已进行修订，以告知申请人2002年第178/2002号条例（经关于欧盟食品链风险评估透明度和可持续性的2019/1381号条例修订）中预提交阶段和提交申请程序的新规定，这些规定适用于自2021年3月27日起提交的所有申请。
