Europe “clarifies” basis for health claims
European food manufacturers continue to file thousands of petitions for approval of health claims for their products. The European Food Safety Authority (EFSA) takes a dim view of most of them, arguing that the claims are poorly substantiated by scientific evidence, if at all.
Now EFSA is attempting to clarify what manufacturers have to do to gain approval for their claims. I say “attempting” because EFSA’s statements often are models of bureaucrat-speak.
EFSA, for example, says it is willing to consider evidence for claims based on studies performed in people with a particular disease:
For studies in groups (e.g. subjects with a disease) other than the target group (e.g. general population) for a claim EFSA considers whether scientific conclusions can be drawn for the substantiation of the claim on a case by case basis…For example, for claims on reducing gastro-intestinal discomfort (in the general population) evidence in patients with irritable bowel syndrome may be accepted.
OK. I get that. Then it offers further clarification:
For claims on maintenance of normal joints (in the general population, evidence in osteoarthritis patients is not accepted as osteoarthritis patients are not considered to be representative of the general population with regard to the status of the joint tissues. In its evaluation, EFSA considers that where a health claim relates to a function that may be associated with a disease, subjects with the disease are not the target for the claim.
EFSA explains its overall philosophy for deciding which claims to approve. It does not use a pre-established formula for the type or number of studies. Instead, it weighs:
All the evidence from the pertinent studies (i.e, studies from which scientific conclusions can be drawn for substantiation of the claim)…with respect to its overall strength, consistency and biological plausibility, taking into account the quality of individual studies and with particular regard to the population group for which the claim is intended and the conditions of use proposed for the claimed effect.
As with all scientific evaluations, EFSA’s judgments are subjective. It considers animal studies, but grants more weight to studies in humans. These, it says, are “central for the substantiation of the claim.”
Food manufacturers also view the evidence subjectively, but tend to be less scientifically rigorous in their interpretation of benefit, especially when their own products are involved. Hence: conflict.
At the moment, EFSA is holding a hard line on health claims. FDA: take notice!

Comments
[...] de dossiers (44 000 !) pour approbation des allégations nutritionnelles et de santé. Selon Food Politics, le groupe scientifique des produits diététiques, nutrition et allergies (NDA) de l’EFSA n’a [...]
even with their problems it appears that EFSA has more teeth than the FDA.
By the way, fortunately EFSA stands for European Food Safety Authority and not only European Food Standards Agency.
Excellent. Looking forward to seeing the same standards apply to anti-GMO claims. That should eliminate a lot of that badly done animal data.
Manuel, Barbara and Marion, in theory EFSA has more teeth, but here in Sweden health claims and ‘green-washing’ is very common.
A manufacturer can have any health claim without approval from EU for up to one year, so they another company wont steal their ‘idea’. Applying for a health claim grant is voluntarly, and usually they don’t until costumers complain to consumer care authority.
It all look very pretty on the paper, but thruth is that the swedish spike mat still can treat everything from cancer to depression, a year after people sent in the first few complaints on false advertising.
I do think that things are a bit better here than in US though, but probably because Scandinavians are generally sceptical to new things, no matter what
Pardon my typos- having problems with my spellcheck