Regulation on the classification of medicinal plants.

This Regulation defines the classification of medicinal plants for oral use. Medicinal plants within the meaning of this Regulation are fresh or dried plants or parts of plants, whole or fragmented up to a sieve grade of 355/180 Ph.Eur. (pulvis grossus) in natural and processed form.
Medicinal plants, may also be used as food, see article 3 for details; for products containing highly concentrated and highly purified extracts from plants object of this text, the opinion of the competent authority for medicinal products should be obtained. Novel foods referred to in the same article must fulfill the conditions laid down in the Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients.
Medicinal plants are classified in the following categories: category H, category Z, category ZR, and other or ND category (see Annex containing the classification list).