One of the decrees will provide a distribution benefit by allowing a broad range of botanicals to be sold in non-pharmacy outlets such as supermarkets and health food stores for the first time.
The other recognises that botanical products have a somewhat unique status and can be sold as both food supplements and medicines.
Until now almost all botanical products except basic ‘spice rack’ herbs and a few others could only be sold in France as medicines in pharmacies.
Jacques Karlsson, the general secretary of the French food supplements trade association, Synadiet, said while the decrees were yet to become law as detail required further resolution, the French government move was significant.
Important step
“This is a very important step because it recognises herbal products for what they are rather than mis-grouping them all together as medicines and restricting their access,” Karlsson told NutraIngredients.com.
“But it is not yet written in law and we have not seen the final text so we wait for that.”
He said the Traditional Herbal Medicines Product Directive (THMPD) had not yet been transposed into the French legislature.
Most botanical products have been classified as medicines in France since the enactment of a 1941 law and hence restricted to pharmacies.
According to Patrick Coppens, the secretary-general of the Brussels-based industry group, the European Responsible Nutrition Alliance (ERNA), the French decrees were a step toward lifting “the pharma monopoly” that had existed in France for so long.
“The legislation is not complete but this is a move in the right direction,” he said. “With the application of the principles of mutual recognition there could soon be a lot more botanical products sold in non-pharmacy markets on the French market.”
Belgium
The move follows potentially restrictive activity in Belgium in May.
The Belgian Medicines Agency (AFMPS) published detail of draft amendments to a Royal Decree that may switch the classification of 250 herbal products from food and food supplement ingredients to medicines.
The amendments state that those 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.
These are plants that have both medicinal and other uses such as food ingredients. Garlic is an example. The THMPD gives companies until the end of 2011 to gain registrations where required but the Belgian laws may require action within six months.
The THMPD was in part designed to create a specialist category for herbal products across the EU's 27 member states that fell between medicines law and food law, but its long lead-times and procedural uncertainty have meant its transposition into member state law has not been consistent.
Governments in other member states such as Poland have announced intentions to take matters into their own hands by similarly classifying a host of herbal products as medicines.