Lorene Courrege, the director of regulatory affairs at the Brussels-based trade group, the European Federation of Associations of Health Product Manufacturers (EHPM), welcomed the move and noted it had the potential to act as a “vital tool” for companies in the food supplements sector and beyond.
The rule should have a particularly liberating effect for non-vitamin and mineral substances not already covered in the Food Supplements Directive and other harmonising regulations.
Streamlined process
Courrege noted a key aspect of the regulation is the onus of proof for denying free movement of products across the EU now shifts to member states, rather than on companies to demonstrate why products should be permitted for trade across EU borders.
The regulation also clarifies rights and obligations of both the member states and industries.
“Companies have not always been willing to engage mutual recognition because many cases have ended in the European Court of Justice and it has been a time-consuming process,” she told NutraIngredients.com this morning.
“In many ways this process acted as a disincentive for companies and they didn’t want to try but now operators have the tools to fight back and have their products on-sale across the EU and this is a significant change.”
EHPM is encouraging its members to employ mutual recognition where its products are being blocked from sale in certain member states for varying reasons such as non-congruity with national health claim rules, safety reasons or due to medicinal product classifications.
Compulsory dialogue
In a statement, Courrege said the regulation established a “compulsory dialogue” between member states and companies.
“Across the EU, both within the industry and among the different national authorities, there is not much awareness of the principle of mutual recognition,” she said. “We have great hope that it will help break down barriers to trade.”
Courrege made a presentation on the topic at the Vitafoods trade show in Geneva recently and noted member states were obligated to establish Product Contact Points to provide information to companies and member state authorities about the process.
Courrege added: “This regulation is doubly important in light of the European Commission’s recently released opinion that no further harmonisation of bioactive and botanical ingredients used in food and nutritional products is necessary at this stage.
“It means companies may find barriers to trade among different member states, although ingredients lawfully marketed in one EU member state should, in principle, be accepted in all other EU markets. The new Regulation should be a useful tool to overcome these hurdles.”