Presenting a paper at a conference organised by the Food & Health Forum of the Royal Society of Medicine, Professor Hans Verhagen, who is also head of the Centre for Nutrition and Health at the National Institute for Public Health and Environment (RIVM) in The Netherlands, dismissed a suggestion that the new rules, which govern the claims that can appear on foods, would impede companies from successfully marketing new products.
“I do not agree that it will stifle innovation,” Verhagen replied to a question about the likelihood of the regulation stopping manufacturers coming up with new products because the approvals process was too tortuous and insufficiently cost effective.
“Consumers do not make a real distinction in their perception between a simple nutrition claim, a general function claim or a disease risk reduction claim. For consumers all they say is, ‘is it good for me, yes or no?’” said Verhagen.
Verhagen added: “There are about two dozen nutrition claims that are allowed via the regulation. You can take any nutrition claim [from the approved list] that you want to make and put it on your product, provided that a product is there [which meets the conditions of the claim]. You can also use the accepted list of generally based health claims.”
Competing on a different level
He said that companies using health claims would have to compete on the basis of what had been substantiated. “You will not be able to make claims that have not been substantiated; but neither can your competitors,” he added. “I think innovation will go more for presentation, for taste, for whatever. In the future [supermarket] shelves will not be empty, but they will look different.”
EFSA’s NDA panel has come under intense criticism from some sections of the food industry over the past year for its failure to approve many product dossiers submitted for health claims approval. The panel comprises 21 independent scientists from across the EU who deliberate across seven working groups looking at different health claim areas.
While EFSA is charged with carrying out the scientific assessment of submissions, it will be ultimately up to the European Commission and Member States to manage the regulation’s implementation. It is unlikely that EFSA will complete its assessment of its huge backlog of submitted dossiers for Article 13 general function and emerging science health claims until the end of 2011.
Why submissions fail
Verhagen explained that many submissions had been refused because they failed on a number of counts. These ranged from them not providing sufficient human intervention data; showing benefits for patients rather than “healthy” individuals within a product’s target population; for not defining and characterising bioactive ingredients sufficiently; and for poor scientific references. “Human studies are pivotal,” he claimed.
He noted that the quality of scientific references in a number of dossiers was often very poor. Among the 39,500 references from 2118 claims being considered, he cited frequent references to papers in languages other than English and references that were too vague to check. In one submission there was even a reference made to the Holy Bible. “This is not the sort of thing you would expect in a scientific document,” said Verhagen. “The quality of the literature is far from optimal.”
Next week, EFSA will be holding a meeting in Parma, Italy, to discuss developments in the health claims process. The June 1 meeting is the first opportunity for stakeholders to discuss Article 13 claims with the risk assessor, which industry groups say has come too late.
"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," said Peter Van Doorn, chairman of the European Federation of Health Product Manufacturers.