Botanical Food Supplements – Regulatory Situation in the EU

Botanicals are used as components of both food supplements and medicinal products. The European legal framework explicitly allows both products to exist in parallel. Botanical food supplements need to be in conformity with the full food legislation, including safety provisions, manufacturing requirements and labeling. In addition, Member States have national rules to assure their safe use.

Relating to the borderline, the European Court of Justice has establish rules to judge if a product should be considered as medicinal or not. It has ruled that such a decision must consider individual products, taking into consideration all of the product's characteristics. Furthermore, the definition of medicinal product by function should be interpreted restrictively and not cover substances that do not strictly modify the way in which it functions, i.e. that do not have a therapeutic effect.

In recent years the EC has put into place two new laws that may help the EU to progress towards harmonisation. It concerns the legislation on health claims under which a claim relating to the effect of a botanical on the body needs pre-marketing approval and the legislation on addition of nutrients to foods, under which a procedure has been created to deal with emerging safety issues. The claims legislation does not accept traditional use as a valid parameter for the validation of a health claim, while traditional herbal medicinal law product does. This has now created a new situation that the European Commission is reflecting upon.