Aug 25 2011 --- Article 13.1 claims evaluations should not be finalised until a framework is in place to assess the totality of the evidence, European trade association The European Federation of Associations of Health Product Manufacturers (EHPM) has said.

Commenting on the final batch of opinions published recently by the European Food Safety Authority (EFSA), EHPM said that there is ample proof that the article 13.1 assessment process is breaching the proportionality of the claims Regulation and that European Commission and Member States should reassess the criteria to ensure that all of the available data is considered, and not accept the pharmaceutical approach with the reliance on intervention trials which appears to be followed by EFSA.

EHPM has sent extensive comments to the European Commission on the European Food Safety Authority (EFSA)’s opinions, expressing their concerns.

It argued that to ensure that both consumers have access to information on a variety of products and that manufacturers can continue to provide them with a choice of products that can benefit their health, it is essential that the totality of the evidence is weighed by assessing the strength and consistency of all the available data.

“Surely when an approach like the one adopted by EFSA is not capable of confirming that a diet rich in fruit and vegetables promotes heart health despite many health recommendations expressing the contrary, this should at least raise questions about its appropriateness,” said EHPM Chairman Peter van Doorn. “We have consistently voiced concern over the way in which the claims assessment process is being carried out, not least because of inappropriate criteria being used to evaluate article 13.1 claims which does not weigh or take into account the totality of the available data.”

“The outcome of the process shows we have been right and we hope that the authorities will seriously consider the implications for both consumers and market innovation of the EFSA approach and halt the establishment of the article 13.1 list until a proper framework is put in place that is able to assess all health effects of food components and not only those that are equivalent to medical interventions,” he added.

The trend from the EFSA opinions is that the vast majority of claims for substances other than vitamins and minerals have been rejected.