The list of rejected Article 13.1 claims published alongside the permitted list in the Union Register of the European Commission is premature in light of the controversy surrounding the criteria used for their assessment, the European Federation of Associations of Health Product Manufacturers (EHPM) has said.
EHPM said that it does not object to the publication of a list of permitted claims per se. However, it said that given that the criteria used for the assessment of many non-authorised claims are not appropriate for nutrition science, there should not be a rejected list in the Union Register at this time.
The organisation also highlighted that it still awaits the decision of the European Ombusdman regarding its complaint judged valid for consideration, which argues that the assessment of Article 13.1 claims is not in accordance with the requirements of the EU Nutrition and Health Claims Regulation.
The Regulation is expected to be published in the Official Journal of the European Union in the coming days. After its publication, companies will have six months to get in compliance.
“We have consistently stated that the approach adopted by the European Food Safety Authority for the assessment of Article 13.1 claims is not in line with the proportionality foreseen by the regulation and that the pharmaceutical-type criteria it is using is not appropriate for nutrition science,” said EHPM Director of European Policy Cynthia Rousselot. “In light of the pending decision of the European Ombudsman, we believe the publication of the rejected list is premature. Non-authorised claims should be put on hold until this issue is clarified and resolved.”
EHPM also argued that the six-month transition period given for rejected Article 13.1 claims is too short and impractical for food supplement manufacturers, many of which have products with a shelf life of up to three years.
“This short timeframe will result in significant costs for SMEs because of required label changes and a lack of time to sell through their stock,” said Rousselot. “An 18-month transition period would be more proportionate. We trust that the national authorities will take into consideration the shelf life of our products when determining the timeframe for their withdrawal from the market.”