Royal decree threatens Belgian botanicals

The draft Royal decree issued by the Belgian Medicines Agency (AFMPS) seeks to introduce the 2004 European Union Traditional Herbal Medicinal Products Directive (THMPD) into the Belgian legislature but its "medicinal tone"​ has raised fears among Belgian industry that an anti-supplements program may result. Member states have been transposing the THMPD into their legislatures on varying timeframes since its 2004 inception. Nathalie Guillaume, secretary general at the Belgian Federation for Food Supplements, Dietary and Organic Products (NAREDI), said there were several threatening aspects of the legislation. The decree gives companies only six months to apply to notify products with AFMPS from the date of publication which could be as early as June this year. The THMPD gives companies until the end of 2011 to gain registrations where required. Guillaume questioned the legality of the draft decree's six-month timeframe and was therefore advising NAREDI members to ignore the call to register products, a process that costs up to €2500 per product. "These products, such as valerian and about 250 other botanicals, have been classified under Belgian food law since 1997,"​ Guillaume told NutraIngredients.com. "Now it seems there is a desire to reclassify them as medicines. We do not understand where this is coming from." ​ NAREDI said AFMPS intended to delete "ambivalent plants" - those used in both foods and supplements such as valerian - from the positive list of botanicals authorised for food supplements use under the 1997 Royal decree. Garlic ​ This was because for many of them, like garlic, European Medicines Evaluation Agency (EMEA) monographs existed and were therefore being considered by AFMPS as 'medicinal by function' as specified in the THMPD. However, in September 2007 the German government was ordered by the European Court of Justice (ECJ) to classify garlic supplements under food law after its medicinal treatment of them was challenged by the European Commission. The ECJ found that Germany's position was an unfair barrier to trade within the bloc and also that "the intended use" of the product was not medicinal and therefore garlic supplements should not be classified as such. "Many of the botanicals AFMPS considers as being 'ambivalent' are consumed in exactly the way and available for purchase in the same was as garlic supplements are in Germany, so we think there is a case for their classification remaining under food law if the government pursues the line it is taking with this,"​ she said. However she declined to highlight examples and said NAREDI was lobbying to have the decree amended.