Commission lifts lid on draft EU health claims list

Commission lifts lid on draft EU health claims list

Consisting of 118 pages of approved claims, Owen Warnock, partner at UK law firm Eversheds, predicts it will be "the most significant set of health claims for many years to come.” Some companies like DSM may get approval while others like Valio will find that their benefit claims cannot be included on their labeling.

The European Commission has published a draft version of the list of generic structure-function claims that will be permitted for use by anybody under the EU’s controversial Nutrition & Health Claims Regulation.

The draft list contains claims evaluated and approved by the European Food Safety Authority (EFSA) through the notorious Article 13.1 process. The document runs to 118 pages and includes almost 250 claims for a range of substances from activated charcoal to zinc.

As well as indicating which claims will be permitted for use, the list signals that the day is coming closer when hundreds of other claims rejected during the health claims evaluation process by EFSA will be banned.

It is expected the list of permitted generic claims will be finalized by the end of this year and officially adopted some time in the spring. Then, after a six month transition period, companies using claims which are not on the list—and which are not covered separately by Article 13.5 and 14 approvals—will be forced to remove claims from their labels, advertising and marketing materials.

Owen Warnock, partner at UK law firm Eversheds, said the list of permitted health claims would have “great commercial significance for food manufacturers.” He added: “This is a key moment in the tortuous process leading to the approval of health claims for food and drink products. The generic list will be the most significant set of health claims for many years to come.”

EFSA may have finished evaluating claims through the Article 13.1 channel, but it continues to evaluate claims submitted via the Article 13.5 process (for claims based on proprietary and newly emerged science) and the Article 14 route (for disease risk reduction claims and claims relating to children’s health).

Ingredients supplier DSM has just won a positive opinion from EFSA for an Article 14 disease risk reduction claim relating to vitamin D and a reduction in falls and fractures among the elderly.

EFSA approved the claim “Vitamin D may reduce the risk of falling. Falling is a risk factor for bone fractures.” It concluded that, in order to obtain the claimed effect, 800IU (20μg) of vitamin D from all sources should be consumed daily by the target population of men and women 60 years of age and older.  

However, EFSA has rejected an Article 13.5 submission from Valio relating to maintenance of normal blood pressure by the peptides IPP and VPP after finding the 21 human intervention studies provided did not demonstrate cause and effect. It’s another blow for the Finnish company, which, in the summer, had an Article 13.5 gut health claim for its probiotic LGG rejected.

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