EFSA expands on article 13.1 health claim methods

By Shane Starling

- Last updated on GMT

Related tags Efsa European commission European union

Health claims backed by studies carried out on non-healthy populations are capable of winning positive opinions according to an EFSA assessment of its own methods sent to the European Commission and member states and published this week.

Although many European Food Safety Authority (EFSA) opinions such as those for chondroitin and glucosamine and joint health, have paid little heed to studies carried out on niche or diseased populations, EFSA offered hope for a more a inclusive scientific approach.

"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,” ​EFSA wrote.

“For example, for claims on reducing gastro-intestinal discomfort (in the general population) evidence in patients with irritable bowel syndrome may be accepted."

Such guidance was well received by at least one probiotics supplier. “I believe the good news is that EFSA has now opened for use of a trail population that is not healthy,”​ said Svend Laulund, external affairs manager at probiotics giant, Chr. Hansen. But he said there were few revelations in the guidance that can be found here.

However, EFSA specifically noted that such an inclusive approach would not be applied to the joint health area.

“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 said about 2000 claims that had been sent back to the EC and member states for clarification were still being clarified.

The EC has advised EFSA not to assess 223 product-specific claims along with 37 other claims, as they are being scrutinised by member states. The Commission added an addendum of up to 500 claims may added to the list of claims EFSA must assess.

Gold standards

In regard to EFSA’s acceptance of all the evidence presented to it in various dossiers, something it has been criticised over for alleged preferences for clinical, pharma-style data, EFSA affirmed its methodology.

“All the evidence from the pertinent studies (i.e, studies from which scientific conclusions can be drawn for substantiation of the claim) is weighed 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,”​ it wrote

“A grade is not assigned to the evidence. While studies in animals or in vitro may provide supportive evidence, human data are central for the substantiation of the claim…There is no pre-established formula as to how many or what type of studies are needed to substantiate a claim. However, the NDA panel considers what the accepted norms are in the relevant research fields and EFSA consults experts from various disciplines, as appropriate.”

EFSA affirmed that the European Commission had a role in claim wording modification, which may, “need to take into account aspects other than agreement with the scientific evidence, e.g. understanding by consumers.”

EFSA said, for example in the area of digestive health, that “gut health”​ is too general, but “transit time”​ was more likely to be measurable.

Ways to meet EFSA’s scientific standards will be discussed at the NutraIngredients Health Claims​ 2010​ conference to be held in Brussels on 10th December. In addition, ERNA and the likes of Danone and Unilever will discuss the regulation. For more information and to register, please click here ​.

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