ERNA Warns EFSA Against Medicalisation of Food

The analysis, developed with fellow associations European Health Products Manufacturers (EHPM) and the European Botanical Forum (EBF), has been published in time for the Claims meeting EFSA has organised on 1 of June.

20 May 2010 --- European Responsible Nutrition Alliance (ERNA) has published its analysis of the European Food Safety Authority’s (EFSA) scientific opinions on article 13.1 claims of the Claims Regulation.

The analysis, developed with fellow associations European Health Products Manufacturers (EHPM) and the European Botanical Forum (EBF), has been published in time for the Claims meeting EFSA has organised on 1 of June.

“This analysis of the second batch of opinions confirms our concerns”, ERNA Vice-chair Keith Legge said. “Except for vitamins and minerals, we do not see positive opinions on any of the other food components that we have submitted under the article 13 list process. We believe this is highly questionable and we intend to question EFSA on this divergence at the 1st June meeting”.

The analysis written by ERNA and fellow associations, observes that within EFSA’s first and second batch of opinion, it has delivered un-favourable opinions on the scientific substantiation of well recognised food components, including glucosamine, chondroitine, alpha-lipoic acid, lutein, beta-carotene, to name a few. ERNA’s analysis of the opinions shows that for claims relating to substances other than essential nutrients, only those that actually relate to the reduction of a disease risk have received positive opinions.

“The regulation foresees three different procedures, reflecting the different nature of the claims. We see that all claims are now considered in the same way and that only claims that show improvements of disease related end points have a chance of being considered positively. This was not the intention of the law and there is an urgent need to reconsider this before any decisions are taken.”, Mr. Legge said.

ERNA fears that the current process leads to a fundamental medicalisation of food and will remove much useful information on the contribution that food components may have for health. Removing such information will ultimately result in reduced consumer choice, according to ERNA. ERNA has developed a model for the scientific substantiation of function claims related to the maintenance of health, which it intends to submit again to EFSA for a fundamental discussion.

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

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.