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Scientific and technical guidance for the preparation and presentation of a health claim application (Revision 3)

on the Wiley Online Library

Metadata

Panel members at the time of adoption

Jean‐Louis Bresson, Barbara Burlingame, Tara Dean, Susan Fairweather‐Tait, Marina Heinonen, Karen Ildico Hirsch‐Ernst, Inge Mangelsdorf, Harry J McArdle, Androniki Naska, Monika Neuhäuser‐Berthold, Grażyna Nowicka, Kristina Pentieva, Yolanda Sanz, Alfonso Siani, Anders Sjödin, Martin Stern, Daniel Tomé, Dominique Turck, Henk Van Loveren, Marco Vinceti and Peter Willatts

This Guidance is applicable for applications submitted as of 27 March 2021

Abstract

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.