Companies must improve EFSA dossiers, expert warns

The European Commission risks putting legions of small- and medium-sized companies out of business if it doesn't relax its hard-line stance on health claims, a leading expert has warned.

The European Food Safety Authority (EFSA) is in the process of evaluating the scientific evidence for thousands of claims under the Nutrition & Health Claims Regulation, which will make it illegal to make a claim for a product unless it has been authorised.

But Nigel Baldwin, senior scientific and regulatory consultant at Cantox Health Sciences International, believes such a black-and-white approach — coupled with the credit crunch — will make life hard for those marketing functional products for which the evidence is promising but not conclusive.

"There are many small- and medium-sized enterprises out there that have some pretty good evidence to back their claims, but the evidence is only sufficient to say 'may' or 'might'," he said. "As things are, however, this isn't enough, because the EFSA's brief from the European Commission is simply to look at each dossier to see if there is a cause-and-effect relationship, not to state whether there may be a relationship. The problem is that in order to get the money to do more studies, companies need to borrow money. But where is that money going to come from?"

The nature and scale of the problem is illustrated by the fact that the EFSA has issued negative opinions on about 80 per cent of the applications it has evaluated so far, he said, and this could have far-reaching consequences for the health food industry.

"There has to be a discussion at some point on the levels of evidence required because if there isn't, the realistic outcome is that a high percentage of the industry will fail in the next year."

Baldwin doesn't blame the EFSA. "They have been asked by the commission to say yes or no, and if they can't say yes, they have to say no," he said. Instead, he believes the commission must relax its attitude to claims by allowing them to be made with caveats where the evidence is good but not yet 100 per cent conclusive.

"You don't want to mislead consumers, but there has to be some sort of halfway house. … The industry has to put pressure on the politicians to say, we need something with a bit more flexibility, otherwise we are going to kill R&D and all the SMEs. If that happens, then all the research in universities, and all the other positive things about the health-food industry will just die."

Despite this pessimistic view of the claims regime, Baldwin said companies should not be deterred from submitting applications. But he warns that they must do so correctly to increase their chances of success. Many, however, are making fundamental mistakes in their dossiers, he said.

"If you look at every negative opinion that has come out of the EFSA you can see why they have issued that negative opinion. There is quite a lot of basic stuff: the studies involve the wrong kind of subjects; the studies are poorly designed; many of the studies submitted actually don't show a positive effect — they are either neutral or negative.

"Some companies are not being tough enough on themselves beforehand. You really do have to do it very objectively and look at the totality of the evidence. Be hard on yourself, rather than taking the list of studies your marketing people have always talked about in seminars and dress them up nicely."

Toronto-based Cantox which has offices worldwide, has analysed all unsuccessful health-claims applications so far and will present its findings at a seminar in March. "We'll help companies understand what they need to do to make submissions that can at least be reviewed with a view to success," Baldwin said.

European Health Claim Submissions: Mistakes Made and Lessons Learned takes place on 24 March in Geneva, Switzerland.