Politics / Law
Sector calls for more transparency
Parma/Brussels – Four years ago, the EU Council and European Parliament adopted the Health Claims Regulation to ban food claims that could mislead consumers. At the end of October, members of the Federation of European Specialty Food Ingredients Industries (ELC) were questioning whether the Regulation is meeting that goal. Prior to the ELC statement, the EFSA announced that it has now evaluated 1,745 claims from a list of 4,637 generic health claims, as well as about 100 out of 300 claims on disease prevention. “Only 5 % of the claims received a positive opinion,”said ELC president Prof. Dr. Markwart Kunz. “A rejection rate of 95 % calls into question whether the criteria applied are appropriate.”
Criticism from scientists and companies also grew louder after the latest evaluation round, when only 75 out of 808 pooled health claims received positive evaluations from the EFSA’s NDA panel. While the body said the high attrition rate was attributable to the poor quality of applications, even companies whose health claims were granted said there was a lack of transparency about the criteria for evaluation. “We are evaluating case-by-case,” explained an EFSA spokesman. However researchers from Cognis, which received approvals for two health claims in the latest evaluation round, told EuroBiotechNews that there are currently no defined criteria concerning either the number of clinical studies required for approval, or their minimum size and design. They added that “there is a lot of uncertainty in the industry, and many companies hope this will improve with the publication of guidelines that say more than that every claim is to be analysed case-by-case.” Food expert Andreas Hahn from the University of Hanover said that health claims are being evaluated on a very high level at EFSA. “It’s a matter of debate if the level of evidence demanded by EFSA is appropriate for the approval of an advertising claim,” he said. According to Hahn, the current evaluation practice poses a threat to most SMEs developing functional foods, because when it comes to innovative approaches, the success rate at the EFSA is very low.
Innovation not rewarded
Currently, the British SME Provexis is the only exception. Its 12 employees recently licensed their Fruitflow® tomato extract to DSM Nutritional Products following the approval of the claim that the functional ingredient prevents platelet aggregation. According to COO Steve Morrison, platelet aggregation was a very specific endpoint that could be determined accurately. In cases where hard endpoints like heart infarction or neurological degeneration can’t be determined, companies have to rely on surrogate markers. “It is very difficult to correlate biomarkers with a health effects,” said Werner Klaffke, Director of Nutrition & Health at Unilever, “even for large companies.”