Supplements in Europe – 2002 and onwards
24th July 2014
Europe created its own carve-out for food supplements back in 2002 with the EU Food Supplements Directive (FSD) (2002/46/EC). The draft law had some very worrying elements to it and so faced much opposition when it worked its way through the bureaucracy and parliamentary process in Brussels. So much so it actually inspired the formation of the Alliance for Natural Health (ANH) the same year.
European law has been big on banning everything other than those things that are specifically allowed. This approach owes its origins to the Napoleonic Code, the legal system established in France under the rule of Napoléon I in 1804, that is now firmly built into the tens of thousands of directives and regulations enacted by the European Union. In criminal law, the Napoleonic Code uses the presumption of guilt, rather than the presumption of innocence, the latter principle being seen as a fundamental right in countries like Britain that have used common law.
The FSD now supports a positive list of vitamins and minerals that can be used in the manufacture of food supplements EU-wide. Since 2010 when the list was made law, only 45 allowed forms of vitamins and 134 forms of minerals are permitted for use in food supplements, this number effectively banning around the same number again that had been used historically. It took a challenge in the High Court in London, which was then referred to the European Court of Justice (between 2003 and 2005), to establish that natural sources of vitamins and minerals were outside the scope of the FSD’s restrictive positive list. This has allowed Pukka to put its Organic Wellbeing range of food supplements on the market, in the knowledge that its natural sources of nutrients, while not being on the FSD’s positive list, are legitimate.
The debate has now moved to herbs, herbal extracts and other botanicals in food supplements. While the FSD definitely permits their use, as pre-empted in the FSD’s preamble (Recital 6), regulatory authorities are using a number of regulatory tools at their disposal to classify some plant-based ingredients either as unlicensed drugs or unauthorised novel foods. These are effectively the two main red lights the authorities can put in the way of food supplements – and both these blocks have often been used to prevent sale of botanicals in food supplements with no safety concerns. Generally, their greatest sin has been that they work, and that they interfere with sales of specific licensed medicines, conventional or herbal.
To find out more about this rapidly changing area, check out the ANH’s European website and sign up for its free weekly eAlerts. The efforts that ANH has made over the last decade have enabled many good quality, natural products to remain on the market – and ANH’s efforts have been amplified by strong support from the public, especially in the European Parliament.