Use of Botanicals in Food Supplements

Background/Aims: In the European Union, an elaborate legal framework regulates botanical products both under food and medicinal law. The decision as to which legal framework applies to an individual product may differ between the Member States. In the case of botanical food supplements, all food law provisions apply to their manufacturing, composition and marketing, including the new claims legislation. Methods: Elements from EU and national law, scientific and other publications are brought together to investigate how to clarify the differentiation between the use of botanicals for medicinal and health-promoting purposes on a scientific basis. Results: Guidance on the safety assessment and quality evaluation of botanicals is proposed in light of the different approaches described in the scientific literature with particular attention to the concept of longterm use as an integral part of safety evaluation. Guidance on claims substantiation is also included, taking into consideration the proposed legislation, the concept of long-term Published online: December 21, 2006 P. Coppens European Botanical Forum Rue de l’Association, 50 BE–1000 Brussels (Belgium) Tel. +32 2 209 11 50, Fax +32 2 223 30 64, E-Mail [email protected] © 2006 S. Karger AG, Basel 0250–6807/06/0506–0538$23.50/0 Accessible online at: www.karger.com/anm This paper is the result of work commissioned by the European Botanical Forum and the conclusions of a workshop held in Brussels on November 30 to December 1, 2005. 1 The legal text of the European Union are easily accessible through the EURLEX website: http://europa.eu.int/eur-lex/en/ D ow nl oa de d by : 54 .7 0. 40 .1 1 11 /2 7/ 20 17 1 2: 35 :4 9 P M