EFSA rebuffs dossiers on cholesterol and dental caries

EFSA rebuffs dossiers on cholesterol and dental caries

The European Food Safety Authority (EFSA) has delivered two new scientific opinions, rejecting applications Cargill and Loc Troi group for Article 13.5 and Article 14 health claims.

The new scientific opinions, published by the EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA Panel), conclude that dossiers relating to Vibigaba (germinated brown rice) and ‘contribution to the maintenance of normal blood cholesterol concentration’ and sugar-free hard confectionery with at least 90% erythritol and ‘reduction of dental plaque, which reduces the risk of caries’ do not provide satisfactory evidence for an authorised claim.

In its opinion relating to Cargill’s Article 14 claim application for sugar-free hard confectionery and dental caries, the EFSA Panel noted that while food proposed as the subject of the health claim is sufficiently characterised, a cause-and-effect relationship could not be established form the evidence provided.
“The applicant identified two human intervention studies (reported in four publications) as being pertinent to the claim, of which only one study investigated the effect of consuming sugar-free hard confectionery with 90% erythritol on the incidence of dental caries,” the EFSA opinion states.

“In weighing the evidence, the Panel took into account that one human intervention study (reported in three publications) with some methodological limitations (e.g. data analysis in completers only) did not show an effect of sugar-free hard confectionery with at least 90% erythritol on the incidence of dental caries in children on either mixed or permanent dentition,” it said – noting that on the basis of the evidence provided in the dossier by Cargill a cause and effect relationship has not been established.

Cholesterol rejection

A second EFSA opinion from the NDA Panel rejected an application from Loc Troi group for an Article 13.5 health claim relating to Vibigaba (germinated brown rice) and ‘contribution to the maintenance of normal blood cholesterol concentrations.’

According to EFSA the scope of the application was proposed to fall under a health claim based on newly developed scientific evidence.

“The Panel notes that the applicant did not perform a comprehensive literature search to identify human intervention studies which could be pertinent to the claim other than the one provided by the applicant,” wrote the Panel. “The applicant did not reply to a specific request from the European Food Safety Authority (EFSA) to provide this information.”

The opinion noted that only one human trial was identified in the dossier, and that the EFSA Panel identified ‘important methodological limitations’ in that trial.

“The Panel considers that no conclusions can be drawn from this study for the scientific substantiation of the claim,” said EFSA. “On the basis of the data provided, the Panel concludes that a cause and effect relationship has not been established between the consumption of Vibigaba (germinated brown rice) and maintenance of normal blood cholesterol concentration.”

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