A Belgian ministerial order determined CoQ10 was safe for use in food supplements at 200mg after reviewing the available science. Previously in Belgium there was no established level for CoQ10 or non-vitamin and mineral nutrients that don’t fall under the 2002 Food Supplements Directive (FSD) such as glucosamine and choline.
The order comes into force in June, said regulatory adviser, Pieter Lagae, from Brussels-based consultancy, EAS.
“This has great potential to open up the market if principles of mutual recognition are applied,” he said, noting Denmark was considering a daily maximum level of 180mg.
Mutual Recognition recognises regulatory harmony has not been achieved across the 27-member state bloc but that single member state approval shall carry weight in other states.
He said the dose level was much greater than levels of around 30-100mg companies typically formulated at, and that the Belgian assessment process as outlined by Belgium’s Superior Health Council, was well-respected across the 27-member state bloc.
Mutual recognition may also be used to expand CoQ10 into functional and novel food areas.
Belgium has been considering reclassifying 250 herbal products from food and food supplement ingredients to medicines. Last year, the Belgian Medicines Agency (AFMPS) published detail of draft amendments to a Royal Decree that meant the classification of herbs already on market but not registered under Belgian national law that has transposed the European Union Traditional Herbal Medicinal Products Directive (THMPD) or European pharmacological regulations, must notify AFMPS.
Even those in compliance with pharmaceutical laws but which have not been brought under the remit of the THMPD must notify the AFMPS.
The Belgian Federation for Food Supplements, Dietary and Organic Products (NAREDI) said AFMPS intended to delete "ambivalent plants" from a positive list of botanicals authorised for food supplements use under a 1997 Royal decree.