Dialogue Absolutely Vital on Article 13 Claims, Says EHPM

European Federation of Health Product Manufacturers (EHPM) have expressed their extreme disappointment that no proper dialogue has been held on the assessment of the list of generic health claims, in its comments published today.

The comments on the European Food Safety Authority’s (EFSA) assessment of its second batch of opinions on the generic health claims (article 13 claims) pursuant to the EU’s Claims Regulation, were published in collaboration with the European Responsible Nutrition Alliance (ERNA) and the European Botanical Forum (EBF) in the run up to EFSA’s meeting on claims in Parma on 1 June.

“We are disappointed that the first opportunity to discuss EFSA’s assessment of the article 13 claims, comes as late as 3 years after claims were submitted in 2007, and, after EFSA has delivered its 2 batches of opinions for 936 out of 4000” said Peter Van Doorn, the Chairman of EHPM. “We are very concerned with the large number of claims that have received negative opinions to date and have throughout the process called for discussion with EFSA on its assessment, which we believe is not appropriate for food research”.

According to EHPM, the second batch of EFSA’s opinions yields much the same results as its first batch of opinions, approving a very small number of claims mostly relating to vitamins and minerals and rejecting almost all other claims relating to the role of other substances have been rejected by EFSA.

“It is clear that EFSA’s approach is not adapted to current food research and will have a serious impact of stifling innovation” said Peter Van Doorn. “The Regulation clearly provides for different types of assessment for the types of claims subject to substantiation. However EFSA has applied the same assessment procedure for all claims which has resulted in the assessment of Article 13 claims better suited for medicinal products rather than food”.

EHPM hopes EFSA and the European Commission will take all these comments into consideration, and it intends to make sure that these are raised in the June 1st meeting of stakeholders. However, EHPM is concerned that given the number of participants, there will not be enough time to discuss all issues and that this will not be conductive of the kind of in depth dialogue that is required.