The European Federation of Associations of Health Product Manufacturers (EHPM) letter says certain negative opinions that were down to technicalities such as non-chracterisation of substances or insufficient data, need to be reappraised by EC members.
EHPM has been a consistent and vocal critic of the EU nutrition and health claims regulation (NHCR) and has written several long letters to the EC outlining its concerns about the way the regulation is being manifested; activities that contributed to the EC withdrawing botanical submissions from the process until the methodology for their assessment can be revisited at some point in the future.
In its latest missive EHPM pointed out that certain submissions that have been deemed by EFSA’s health claims panel as outside the scope of the regulation should in fact be permitted under article 10.3 of the NHCR which allows general and non-specific claims if they are accompanied by a specific, authorised claim.
The trade association said that some claims also received unfavourable opinions because they were not within the scope of the Nutrition and Health Claims Regulation, adding that these should be authorised 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 authorised health claim.
Negative opinions, law making, procedural failure
“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 EFSA as to how much scientific evidence was needed or regarding its method for dossier evaluation until well after the deadline for submission.”
Rousselot added: “Many of the unfavourable 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.”
The EC has said it the 2700+ article 13 list should pass into EU law books in the first quarter of 2012. About 80% of those claim submissions have drawn negative opinions from EFSA’s health claim assessment panel.
EHPM said in August it was encouraged by the number of MEPs that are taking an interest in the health claims process and expressing concerns about how healthy food and supplements messaging may be severely compromised by the NHCR.