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 Grażyna, Pentieva Kristina, Sanz Yolanda, Sjödin Anders, Stern Martin, Tomé Daniel, Loveren Henk Van, Vinceti Marco, Willatts Peter, Fewtrell Mary, Przyrembel Hildegard, Titz Ariane, Martínez Silvia Valtueña
EFSA J. 2021 Mar 26;19(3):e06556. doi: 10.2903/j.efsa.2021.6556. eCollection 2021 Mar.
[Table: see text] Following a request from the European Commission, EFSA was asked to provide scientific and technical guidance for the preparation and presentation of a dossierfor evaluation of an infant and/or follow-on formula manufactured from protein hydrolysates. This guidance document addresses the information and data to be submitted to EFSA on infant and follow-on formulae manufactured from protein hydrolysates with respect to the nutritional safety and suitability of the specific formula and/or the formula's efficacy in reducing the risk of developing allergy to milk proteins. The guidance will be further reviewed and updated with the experience gained from the evaluation of specificdossiers, and in the light of applicable Unionguidelines and legislation. The guidance was adopted by the Panel on Dietetic Products, Nutrition and Allergies on 5 April 2017.Upon request from the European Commission in 2020, it has been revised to inform food business operators of the new provisions in the pre-submission phase and in the procedure set out in the General Food Law, as amended by the Transparency Regulation. This revised guidance applies to all dossiers submitted as of 27 March 2021 and shall be consulted for the preparation of dossiers intended to be submitted from that date onwards. For dossiers submitted prior to 27 March 2021, the previous guidance, published in May 2017 remains applicable.
[表格：见正文] 应欧盟委员会的要求，欧洲食品安全局（EFSA）被要求为编制和提交一份关于评估由蛋白质水解物制成的婴儿配方奶粉和/或后续配方奶粉的档案提供科学和技术指导。本指导文件涉及就由蛋白质水解物制成的婴儿配方奶粉和后续配方奶粉向EFSA提交的信息和数据，内容涉及特定配方奶粉的营养安全性和适用性，以及该配方奶粉在降低对牛奶蛋白过敏风险方面的功效。将根据对特定档案评估所获得的经验，并参照适用的欧盟指南和法规，对本指导文件进行进一步审查和更新。该指导文件于2017年4月5日由营养产品、营养和过敏问题小组通过。应欧盟委员会2020年的要求，对其进行了修订，以告知食品经营者在提交前阶段以及经《透明度条例》修订的《一般食品法》规定的程序中的新规定。本修订后的指导文件适用于自2021年3月27日起提交的所有档案，在编制自该日起提交的档案时应参考本文件。对于在2021年3月27日之前提交的档案，2017年5月发布的先前指导文件仍然适用。
