EHPM urges EC to analyze negative EFSA claims opinions

Food supplement trade association EHPM has urged the European Commission (EC) not to automatically consider claims that have received negative opinions from the European Food Safety Authority (EFSA) as rejected. In a letter to the EC recently, the association said several article 13.1 claims dossiers have received unfavorable EFSA opinions not because a cause and effect was not established, but that the information provided did not meet the expectations of the EFSA – for example, the substance was not being well characterized or there being insufficient data.

The trade association said that several claims also received unfavorable opinions because they were not within the scope of the Nutrition and Health Claims Regulation, adding that they 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. EFSA published its final batch of article 13.1 claims opinions at the end of July, 2011, which is now being considered by the EC, as it develops a draft Union List of claims permitted for use in the EU.

“Claims given negative EFSA opinions should not automatically be considered as rejected,” said EHPM director of European Policy Cynthia Rousselot. “It is important to remember that no guidelines were available from the EFSA as to how much scientific evidence was needed or regarding its method for dossier evaluation until well after the deadline for submission. Many of the unfavorable opinions are the result of failures in the procedures, namely a lack of clarity on a number of important issues.”

“The first opportunity that 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,” he said.