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Health Claim Submission Procedure

EFSA published a guidance document to assist all applicants in preparing and presenting their applications for authorisation of Articles13(5), 14, and 19 of Regulation (EC) No 1924/2006.

Articles 13(5), 14, and 19 applications

This guidance applies to health claims related to the consumption of a food category, a food, or its constituents (including a nutrient or other substance, or a fixed combination of constituents). The guidance 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. Adhesion to the guidance will help the Panel on Nutrition, Novel Foods, and Food Allergens to deliver its scientific opinion in an effective way and avoid delay in the scientific assessment process.

Transparency and sustainability of the EU risk assessments

The guidance was revised in 2020 to inform applicants of new provisions in the preā€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. It is intended that the guidance will be further updated as appropriate in the light of experience gained from the evaluation of health claims.

Implementation of the transparency regulation

The implementation of the Transparency Regulation in March 2021 introduced new services, processes and provisions that have strongly impacted the lifecycle and renewal procedure for applications. EFSA launched a webinar titled “Webinar on application procedure for health claims” to explain how the new requirements affect applicants in the area of health claims. The webinar provides a step-by-step explanation of the application process, from account creation to risk assessment, adoption, and publication, including a live demonstration of the E-Submission Food Chain Platform (ESFC). It also sheds light on new requirements related to confidentiality and public consultations.

EFSA’s guidance toolkit

The EFSA applications toolkit provides an overview of all EFSA portals and tools that may be of interest to applicants, including the pre-submission activities gateway, the e-submission system, and EFSA’s portal for information on its scientific assessment work.