The Scientific Committee of the European Food Safety Authority has issued proposals for the safety assessment of botanicals and botanical preparations not already covered under specific regulations (such as novel foods or genetically modified organisms). Although primarily intended for food supplement use, it will also be relevant to food and animal feed uses. Under the proposals, further testing is not required for botanical products or extracts with a long history of safe use in food in Europe, if the intended levels of intake from supplements are similar to those historically consumed. For those botanicals or preparations known to contain toxic substances, support for the presumption of safety may be sought using the acceptable daily intake value (if available) or a Margin of Exposure approach after considering exposure from all sources. Toxicity data are required if the proposed level of intake of the botanical or its chemical constituents is higher than that estimated from historical use, or if a long-term safe history of food use cannot be established. Any potential pharmacological and/or adverse side effects should also be considered. The Committee has issued two lists of botanicals used in food for which possible safety concerns have been expressed by some Member States. Compendium 1, which contains over 800 entries, presents those that contain toxic, addictive or psychotropic substances, while Compendium 2, almost 400 entries, lists those that also have a medicinal use.

[Safety assessment of botanicals and botanical preparations intended for use as food supplements. Draft Guidance document of the Scientific Committee (Question No. EFSA-Q-2005-233). Intermediate document adopted for public consultation on 19 November 2007. This document is available, together with the two compendia, via on the internet. Those wishing to comment on the proposed approach are invited by EFSA to do so by 15 February 2008.] {173835}

The above item is taken from the February 2008 issue of Toxicology and Regulatory News which is sent automatically to members of bibra (click here for more details).

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