Public consultation on the draft Guidance on the scientific requirements for health claims related to the gastro-intestinal tract, the immune system, and defence against pathogenic micro-organisms.

Privacy statement(159.17 KB) 

EFSA has launched an open consultation on its updated draft Guidance on the scientific requirements for health claims related to the gastro-intestinal tract, the immune system, and defence against pathogenic micro-organisms.

This document takes into account the outcome of a previous public consultation on a discussion paper together with new scientific evidence available to the NDA Panel and the experience gained to date with the evaluation of health claim applications in the areas of the gastro-intestinal tract, the immune system, and defence against pathogenic micro-organisms. The Guidance presents examples drawn from evaluations to illustrate the approach of the NDA Panel in the evaluation of health relationships and outcome variables which may be acceptable in these areas, as well as the conditions under which they may be acceptable. A better understanding of the NDA Panel approach could help applicants in preparing applications on health relationships and related outcome variables.

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 second public consultation on the draft document developed by the NDA Panel of EFSA.

Interested parties are invited to submit written comments by 23 March 2015. Please use the electronic template provided to submit comments and refer to the line and page numbers. If you would like to submit additional data to support your comments or file send an email to: NDA.PublicConsult.44 [at] efsa.europa.eu (NDA[dot]PublicConsult[dot]44[at]efsa[dot]europa[dot]eu).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.