Planta Med 2013; 79 - WS1
DOI: 10.1055/s-0033-1351803

Health claims for botanical food supplements: approach and consequences for the regulatory framework

P Coppens 1
  • 1European Botanical Forum, Brussels, Belgium

In the EU, the use of botanicals for nutritional or physiological purposes in food supplements is covered under food law since 2002 (Directive 2002/46). The use of botanicals for therapeutic or preventive purposes has been harmonised by the Traditional Herbal Medicinal Product Directive (THMPD, Directive 2004/24). The Court of Justice of the European Union (CJEU) has established the following principles:

  • Member Sates must determine the status based on a case-by-case assessment of all of the product's characteristics.

  • All products that are presented as having therapeutic or preventative effects should be subject to medicinal law.

  • Products having an effect on the human body, but which do not significantly affect the metabolism and thus do not strictly modify the way in which it functions are not medicinal products.

The EU Nutrition and Health Claims Regulation (Regulation 1924/2006) requires scientific studies to prove health benefits, while for botanicals most of the knowledge has been gained through use and experience over time. This was explicitly recognised by the THMP legislation. The requirements for demonstrating simple health effects for food are therefore more demanding than for therapeutic effects for medicinal products. For this reason the European Commission (EC) stopped the process of claims assessment for botanicals in September 2010.

In August 2012 the EC published of a discussion document for the Member States, asking for input on one of two options:

  • Option 1: EFSA to continue the assessment of claims for botanicals as originally foreseen, which would likely reject all health claims for botanicals.

  • Option 2: Address the specificities of botanicals in specific legislation, taking into consideration traditional use and potentially also safety and quality.

The responses by the Member States diverge and vigorous opposition to option 2 has been expressed by many pharmaceutical stakeholders. Until a decision is taken THMPs and food supplements can continue to be marketed in parallel.