Herbals/Botanicals

What are the EU rules for Botanicals and herbs?

Herbal extracts and whole herbs are used as ingredients in food supplements as well as traditional herbal medicines. In the European Market two legal statuses for Botanicals coexist:

  1. Botanicals as Traditional Herbal Medicinal Products
  2. Botanicals as Foods/Food Supplements.

The justification for the existing situation lies in the long Tradition of Use (ToU) of Botanicals for health-related effects. The distinction between the classification as food supplement or medicinal product depends on the specific conditions of use for each product and the effect (therapeutic or a physiological) to be delivered. Many factors are thus taken into account in the classification of a product (e.g. intended use, labelling, preparations and dosages).

Basic legislation

  • Directive 2004/24/EC of the European Parliament and of the Council of 31 March 2004 amending, as regards traditional herbal medicinal products,Directive 2001/83/EC on the Community code relating to medicinal products for human use
  • Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements

How do botanicals link to general food supplements law and health claims?

Botanicals products are marketed in several ways and European and National legislation confirm both realities, as only a partial level of harmonisation has been achieved to date at EU level. Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods regulates the use of health claims in advertising, presentation and labelling of Foods/Food Supplements. The assessment process for Botanicals under the Health Claims Regulation is currently on hold.

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EHPM represents the interests of specialist health product manufacturers and distributors in Europe. It works towards developing an appropriate regulatory framework throughout the EU for its members' products, and promotes industry best practices for product quality and safety.

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