Public consultation on the draft scientific and technical guidance for the preparation and presentation of a health claim application

12 September 2016
Document (812.27 KB)

EFSA has launched an open consultation on its draft scientific and technical guidance for the preparation and presentation of a health claim application.

This 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 (reflecting the relative strength of evidence which may be obtained from different types of studies) and the key issues which should be addressed in the application to substantiate the health claim.

In line with EFSA’s policy on openness and transparency and in order for EFSA to receive comments from the scientific community and stakeholders, EFSA has launched a public consultation on the draft document developed by the NDA Panel of EFSA.

Interested parties are invited to submit written comments by 12 September 2016. Please use the electronic template provided to submit comments and refer to the line and page numbers. Please note that after 2 hours your working session will expire and comments submitted after that time will not be recorded and transmitted. If you would like to submit additional data to support your comments or files send an email to: NDA.PublicConsult.73 [at] Please note that comments will not be considered if they:

  • are submitted after the closing date of the public consultation;
  • are not related to the contents of the document;
  • contain complaints against institutions, personal accusations, irrelevant or offensive statements or material;
  • are related to policy or risk management aspects, which are out of the scope of EFSA's activity. 

EFSA will assess all comments from interested parties which are submitted in line with the criteria above. The comments will be further considered by the relevant EFSA Panel and taken into consideration if found to be relevant.

All comments submitted will be published. Comments submitted by individuals in a personal capacity will be presented anonymously. Comments submitted formally on behalf of an organisation will appear with the name of the organisation.

Submit comments (deadline: 12 September 2016)

18 July 2016