European Botanical Forum Proposes Regulatory Model for Botanicals in Food Supplements

Experts from the European Botanical Forum have recently developed a safety evaluation model they hope will be used in the future regulation of botanicals under food law.

The model, which was recently featured in Annals of Metabolism and Nutrition, is based on the current legal framework and the recently published legislation on food claims and fortification. It provides the possibility of classifying botanicals into four categories under food law.

The model will incorporate a European-wide negative list of botanicals not to be used in foods because of safety concerns. The list is currently being developed, based on lists already in practice in Spain, the UK, Sweden, Finland, Latvia, Belgium, The Netherlands, Italy, Hungary, and the Czech Republic.

“Safety is key,” stated Dr Manfred Ruthsatz, Chairman of the European Botanical Forum. “The aim of the negative list is to provide a document that is widely acceptable across the 27 EU member states to allow safe applications under food law on the principle that if there is no safety risk there should be any regulation. The inclusion of botanicals into negative lists, however, should be considered with care since it would preclude use of the botanical entity for all food applications whereas the safety of derivatives, extracts or isolates can be frequently demonstrated.”

Botanicals include fruit and vegetables, herbs and spices, herbal teas and infusions, herbs added to foods and beverages for taste or functional purposes and botanical food supplements. Many botanicals however, also have medicinal uses, making the task of determining which legal framework applies to which product difficult.

The European Botanical Forum was set up in 2004 by the European Responsible Nutrition Alliance (ERNA) and the European Federation of Associations of Health Product Manufacturers (EHPM) as a discussion platform for scientific and regulatory issues related to the use of herbs in food supplements.

It encourages debate among industry, government and the scientific community on scientific and regulatory issues relating to botanical food supplements, in terms of the regulatory approaches of existing member states, the extension of the 2002 Food Supplement Directive with botanical ingredients, and the Implementation of the 2004 Traditional Herbal Medicinal Product Directive. It has organized several workshops with experts from academia and national authorities in the course of the preparation of the model.

“The model was extensively discussed at our recent workshop organised early December,” said Patrick Coppens, Secretary of the European Botanical Forum. “The Forum is invited to a hearing by the Council of Europe working group on food supplements later this month and will share its expertise and knowledge with their experts”.
For more information contact Patrick Coppens, European Botanical Forum, 50 Rue de l’Association, 1000 Brussels, tel: (+32) (0)2 209 11 50.


The European Botanical Forum aims to consolidate the efforts undertaken by national associations and individual companies to work to protect national systems currently in place, contribute to the creation of appropriate national systems where not currently in place, and build a pan-European system for the trade of herbs under food law.
The article was published with following title: The Use of Botanicals in Food Supplements. Regulatory Scope, Scientific Risk Assessment and Claims Substantiation; Ann Nutr Metab 2006;50:538-554 (DOI: 10.1159/000098146).

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