Food and Chemical Toxicology. 2003;41(12):1625-1649; ILSI Europe Report Series
There is a growing interest by both consumers and industry for the development of food products with ‘functional’ properties, or health benefits. These products may take the form of dietary supplements or of foods. The health benefits are generated from particular ingredients, and, in many cases, these are derived from botanicals. The variety of plants providing these functions are large, ranging from staple food sources such as cereals, fruits and vegetables, to herbals as used in traditional medicine. The food or ingredient conferring health properties may consist of the plants themselves, extracts thereof, or more purified components. The scientific literature is abundant with articles not only on the beneficial properties, but also on possible adverse health effects of plants and their components.
The Guidance for the Safety Assessment of Botanicals and Botanical Preparations for use in Food and Food Supplements was elaborated by an expert group of the Natural Toxin Task Force of ILSI Europe and discussed with a wider audience of scientists at a workshop held on 13-15 May 2002 in Marseille, France. The report discusses the data required to determine the safe use of these types of ingredients, and provides advice on the development of risk assessment strategies consistent with due diligence under existing food regulations. Product specifications, composition and characterisation of standardised and authentic materials, documented history of use and comparison to existing products (taking into account the effect of industrial processing), description of the intended use and consequent exposure are highlighted as key background information on which to base a risk evaluation. The extent of experimental investigation required, such as in-vitro animal, and/or human studies, depends on the adequacy of this information.
The ultimate safety in use depends on the establishment of an adequate safety margin between expected exposure and identified potential hazards. Health hazards may arise from inherent toxicities or contaminants of the plant materials, including the mechanism of the intended beneficial effect. A lower safety margin may therefore be expected than for food ingredients or additives where no physiological effects are intended. In rare cases, post launch monitoring programmes may be envisaged to confirm expected exposures and adequacy of the safety margin.
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