Consumer demand for food supplements has long surpassed the scope of just vitamins and minerals. Market data shows that in 2005 supplements containing ingredients other than vitamins and minerals made up 43 percent of the total European Union (EU) dietary supplement market, and a significant increase is expected by 2010.
The EU defines food supplements as 'concentrated sources of nutrients or other substances with a nutritional or physiological effect', but besides vitamins and minerals, it does not actually name the ingredients that are permitted for use. In theory this can be advantageous for manufacturers, because in principle they can use any safe ingredient which has a physiological or nutritional effect. In practice however, the different EU countries (Member States) tend to apply their own rules and request specific supporting documentation.
Regulation for the use of herbs and other bioactive substances such as amino acids, glucosamine and probiotics can be complex because these ingredients are not yet harmonised across the EU and many of them are classified differently across the Member States.
In some countries such as Italy, France, Latvia and Romania positive and negative lists of ingredients exist. These lists are invaluable tools for the industry, offering easy access to clearly defined rules. However in other countries, such as Cyprus and Poland, nothing like this exists. Instead the authorities rely on case by case evaluations, clearly making it more difficult for manufacturers to foresee possible restrictions. In this case, key factors that will play a decisive role in a positive determination of the product as a food supplement are ingredient levels, the full product composition, and product presentation.
In terms of the future use of herbs in food supplements, the European Food Safety Authority (EFSA) has drafted a document on the safety assessment of botanicals. It includes two draft compendia listing herbs that contain natural compounds which may need further research for food use. The compendia provide useful indications and specific comments from Member States regarding toxic, addictive or psychotropic substances, or the reported medicinal use of botanicals.
When facing barriers in specific Member State markets, a recourse for manufacturers can lie in the EU's principle of mutual recognition (free movement of goods). It means that a simplified authorisation process may apply for substances not authorised in one Member State if it can be proven that the product is legally on the market in another Member State. The European Commission's recent victory when it took Germany to court over its refusal to allow 'garlic extract powder capsules' on the German market is testament to the fact that this principle has some clout. The German authorities had claimed that the capsules constituted a medicinal product, but the European Court of Justice judged that the product did not correspond to the definition of a medicinal product by either presentation or function.
Discussions are underway within the EU to further harmonise food supplement legislation, but progress continues to be slow. What is clear however, is that the Member States are keen to resolve the ongoing divergences in the classification of ingredients in food supplements across the EU.
Article by Pieter Lagae, Regulatory Adviser, EAS, 50 Rue de l'Association, 1000 Brussels, Belgium. Tel: (+32 2) 218 14 70, Fax: (+32 2) 219 73 42, email [email protected], visit www.eas.eu.
Market data collected from Euromonitor International