BRUSSELS—The European Food Safety Authority (EFSA) should go beyond intervention trials when it determines article 13.1 claims evaluations, according to European Federation of Associations of Health Product Manufacturers (EHPM). As of now, the EHPM said ample proof shows the article 13.1 assessment is using the pharmaceutical approach, but the European Commission and member states should encourage EFSA to include all evidence.
EHPM said the trend from the EFSA opinions is that the vast majority of claims for substances other than vitamins and minerals have been rejected.
EHPM has sent extensive comments to the EFSA’s opinions, expressing its concerns. It argued that it is essential that the totality of the evidence is weighed by assessing the strength and consistency of all the available data. This will ensure that 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.
“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."
EHPM previously filed a complaint with the European Ombudsman, challenging the decision of the European Commission and EFSA to take a batch-wise approach to adopting the community list of permitted Article 13.1 health claims under the EU health claims regulation.
