BRUSSELS—Just because claims have received negative opinions from the European Food Safety Authority (EFSA), does not mean the European Commission should automatically reject them, according to European Federation of Associations of Health Product Manufacturers (EHPM). Those negative opinions may have come because the claims didn't provide the information required by EFFA, not because the claims could not substantiate a cause-and-effect relationship.
“Many of the unfavorable opinions are the result of failures in the procedures, namely a lack of clarity on a number of important issues," said EHPM director of European policy Cynthia Rousselot.
The food supplement trade association made this argument in a letter to the European Commission last month, and also noted some of the article 13.1 claims dossiers received unfavorable opinions because they were not within the scope of the Nutrition and Health Claims Regulation. EHPM said these claims should be authorized under the provision of Article 10.3 of the regulation allowing reference to general and non-specific benefits if it is accompanied by a specific authorized health claim.
Further, EHPM said no guidelines were available from EFSA as to how much scientific evidence was needed or regarding its method for dossier evaluation until after the deadline for submission. The first opportunity the sector had to discuss EFSA’s assessment of the article 13 claims came three years after the claims were submitted and after EFSA had already delivered opinions on 936 claims. "We are very concerned about the large number of claims that have received negative opinions and have throughout the process called for further evaluation regarding EFSA’s assessment criteria, which we believe is not appropriate for food research," Rousselot said.
EFSA published its final batch of article 13.1 claims opinions at the end of July, which are now being considered by the European Commission as it develops a draft Union List of claims permitted for use in the EU.
EHPM has been following the 13.1 claims evaluations, previously noting if the EFSA doesn’t budge on its requirements, consumers could see a 25-percent drop in the amount of specialty nutrients (other than vitamins and minerals) they can purchase.
