General scientific guidance for stakeholders on health claim applications (Revision 1)

Abstract

[Table: see text] The general guidance for stakeholders on the evaluation of Article 13(1), 13(5) and 14 health claims was first published in March 2011. Since then, the Panel on Dietetic Products Nutrition and Allergies (NDA) has completed the scientific assessment of Article 13(1) claims except for claims put on hold by the European Commission, and has assessedadditional health claim applications submitted pursuant to Articles 13(5), 14 and also 19. In addition, comments received from stakeholders indicate that general issues that are common to all health claims need to be further clarified and addressed. This guidance document aims to explain the general scientific principles applied by the NDA Panel for the scientific assessmentof all health claims and outlines a series of steps for the compilation of applications. The general guidance document represents the views of the NDA Panel based on the experience gained to date with the scientific assessment of health claims, and it may be further updated, as appropriate, when additional issues are addressed.The document also aims to inform applicants of newprovisionsin the pre-submission phase and in the application procedure set out in the General Food Law, as amended by the Transparency Regulation. These new provisions are applicable to all applications submitted as of 27 March 2021. The version of this guidance published in 2016 remains applicable for applications submitted before 27 March 2021.

Keywords: applications; general principles; guidance; health claims; scientific aspects.