EFSA News Story, 16 June 2009
Experts from EFSA's Panel on Dietetic products, nutrition and allergies (NDA) met health claims applicants and industry experts in Brussels on 15 June for an exchange of views on the presentation of applications for health claim authorisations.
The meeting was an opportunity to further explain the claims evaluation process to applicants and provide additional guidance in the light of experiences gained so far with the assessment of claim applications related to Article 14 and 13(5) claims of the Regulation on nutrition and health claims.
Professor Albert Flynn, Chair of EFSA's NDA Panel said: “This has been a very successful public consultation on EFSA's evaluation of health claims. Our discussions with industry on guidance and new communications procedures will help applicants for the authorisation of claims and will also benefit the overall efficiency of EFSA's evaluation process.”
EFSA has decided to further develop procedures for communication with applicants while claims are being evaluated including greater use of the “stop the clock” procedure when NDA experts consider it necessary to request additional information regarding an application. This will help ensure that there is a shared, mutual understanding between the panel and the applicant of the claim to be evaluated prior to adoption of the final opinion. The NDA Panel may request supplementary information from applicants to clarify in particular the object of the claim (e.g. whether it relates to a component of the foodstuff or the product itself) or the claimed health relationship.
Up to now, these issues would be addressed with applicants only before the application was accepted by EFSA and before evaluation started. Experience has shown that some of these questions only become apparent during the assessment of the application and this can have a significant bearing on the evaluation.
Participants discussed various aspects of the process such as how the Panel decides whether a claim is substantiated and how the evidence is weighted, what are the data requirements and pertinent studies to be included, and on what basis EFSA proposes for the wordings of claims. EFSA will review and seek to improve transparency of the opinions with respect to these aspects.
Before the meeting, EFSA published on its website a document, in the form of Frequently Asked Questions (FAQ), highlighting the areas needing further clarification. Participants were asked to comment on the document ahead of the meeting. The NDA Panel will take into account comments received through this consultation, and those expressed during the meeting, with a view to finalising an FAQ document to complement the guidance document. This is a living document which will be updated regularly in the light of experience gained.
EFSA aims to publish the revised version of the FAQ, an overview of comments received during the consultation and a report of the technical meeting on its website in the autumn.