The European Food Safety Authority has kicked off the eagerly awaited health claim assessment process with a slew of claim rejections signalling a hard line methodology that may see thousands of claims submissions binned.
Of eight assessed claims, EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) rejected seven for failing to demonstrate causality between consumption of specific nutrients or foods and intended health benefits.
Patrick Coppens, the secretary-general of the Brussels-based industry group, the European Responsible Nutrition Alliance (ERNA), said the claim rejections cast an ominous first stone in a process that will see around 2800 claims assessed by January 31, 2010.
“This will come as a shock to industry and a blow to companies that have had their applications rejected. The potential economic damage is vast,” he told NutraIngredients.com. “These opinions make it clear it is not going to be easy for companies to have claims approved.”
Only Unilever’s plant sterol submission outlining cholesterol lowering potential and reduction in the risk of coronary heart disease was approved, accompanied by tightly defined claim wording.
Seven of the claims fell under article 14 of the health and nutrition claims regulation, which governs disease reduction and children’s claims. Five of these related to children’s health.
One claim under article 13 (which governs more generic nutrition and health claims) related to weight management was rejected. It was submitted by French cosmetics company, Pierre Fabre Dermo Cosmetique.
Coppens did not dispute the logic behind the rejections, noting that it appeared the dossiers “were not strong”.
“From a scientific perspective they have done a good job but it will make many companies stop and think about whether they want to risk going into the procedure or not,” he said. “This indicates EFSA is applying very high standards on the reduction of disease claims.”
Article 13, 14
Expressing a long-held ERNA and industry concern, Coppens wondered how appropriate it was to apply the same article 14 criteria regarding “substance characterisation” and observational and intervention trials to article 13 claims.
Coppens highlighted two rejected claims submitted by the Irish National Dairy Council linking dairy product consumption with ideal body weight and reduced incidence of dental carries in children.
EFSA took issue with these claims because causality was not proven but also because the kind of dairy products in question were not sufficiently defined.
“The big worry is that they might use the same standards for all article 13 claims,” Coppens said. “If every substance has to be characterised, then that presents a major problem for generic claims because for most of them the substance, by its very generic nature, is not characterised.”
“If the same criteria applied here for dairy products are applied to fruits and vegetables then no fruits and vegetables will be able to make health claims. Which is preposterous.”
Lobbying work to convince EFSA that different criteria are required for the two types of claims continues.
An EFSA spokesperson told NutraIngredients.com that official guidance on the matter is still being formulated.
There are 220 claims on EFSA’s article 14 list and about 2500 on its article 13 list.
Other rejected claims included a cactus fibre-derived blood lipid-lowering claim from French supplier Bio Serae; a probiotic children’s immunity claim submitted by enzyme.pro.ag and a soy-derived bone density claim from Israeli firm Se-Cure Pharmaceuticals.
However, Bio Serae asserted the opinion was not a rejection of its ingredient.
“It does not call into question any of the scientific data which was submitted,” said president Olivier Houalla. “It is a request for further information, or more precise details. This proves that we are advancing in the right direction and that we will now be working on the finer details of our request.”
Despite the fact that only one of its claims was approved, Unilever’s UK-based vice president of foods external affairs, Dick Toet, said the company was pleased its science had been accepted in both instances.
Its dossier relating ALA (alpha-linolenic acid) and LA (linoleic acid) consumption to healthy growth and development in children, had its scientific backing accepted but EFSA deemed that children already receive enough ALA and LA in their regular diets.
EFSA concluded that the “evidence provided does not establish a benefit” of additional fortification.
“The verdict on the ALA/LA claim is strange in that the benefit is accepted so we feel that a scientifically substantiated statement should be accepted,” he said. “We will be submitting our comments to the European Commission during the 30-day public consultation period that exists now.”
He said, and Coppens agreed, that the EC and Member States acting as risk managers may yet approve the claim as EFSA’s opinions are not binding.
Unilever has also submitted other claims awaiting assessment.
Professor Albert Flynn, chair of the EFSA NDA Panel, said: “All of the data provided to us in the dossiers submitted by the applicants to justify their claims have been evaluated according to uniform criteria. The Panel’s opinions reflect the quality of the evidence submitted and provide the scientific advice needed for the risk managers”.
To access EFSA’s opinions click here .