EU FOOD SUPPLEMENTS DIRECTIVE
In the UK all foods, including food supplements, are subject to the provisions of the Food Safety Act 1996 and amendments. Other EU Member States, however, have varying levels of food supplement regulation and differing interpretations of the food/medicine boundary. The EU Food Supplements Directive (FSD) was welcomed in 2002 as an instrument to assure a high level of consumer protection and to harmonise the internal market in food supplement products. While the Commission has stated they currently have no intention of extending the FSD to regulate substances other than vitamins and minerals, other Member States have begun preparing both positive and negative lists of substances such as botanicals, amino acids, essential fatty acids and other substances with a nutritional or physiological effect. Two areas are of particular concern to the UK natural healthcare industry:
- Vitamin and mineral formulations. Instead of adopting a negative list, disallowing specific formulations, the FSD produced a positive list which was criticised as it derived from existing lists of vitamins and minerals assessed for use in infant formula and Foods for Particular Nutritional Uses (PARNUTS). No account was taken of many years' safe use of a number of forms, including many found in natural whole foods. By not following the history of safe use precedent set for Novel Foods regulation, the natural health food industry accused the Commission of misapplying the precautionary principle, and of taking disproportionate action. The Alliance for Natural Health, a UK-based lobbying group, won a case in the European Court of Justice in 2005 that aimed to limit the scope of the FSD and resulted in the EU Advocate General declaring that the FSD was fundamentally flawed and contravened EU law. Nevertheless, the Commission has continued to press ahead with the FSD.
- The setting of maximum levels for vitamins and minerals in food supplements. The Commission is due to set maximum levels which the Directive states should take into account safe upper levels established by scientific risk assessment. However, the deeply split nature of Member States' opinions on risk assessment has made it a complex subject which has not significantly moved forward over the years since the inception of the FSD. At the same time genomic research has moved apace and the extent of variation in the population is such that in 2007 the UK Committee on Toxicity stated that for vitamins and minerals "variability in the response of individuals has the potential to result in a situation which a given level of exposure could be essential for some but toxic for others".
Nutritional therapy practice is intended to support and improve health through recognising biochemical and genetic individuality and optimising nutritional status, which often includes the use of high dose food supplements. The setting of maximum levels for vitamins and minerals is of significant concern to BANT.
1. Ames BN, Elson-Schwab I & Silver EA (2002) High-dose vitamin therapy stimulates variant enzymes with decreased coenzyme binding affinity (increased K(m)): relevance to genetic disease and polymorphisms. American Journal of Clinical Nutrition 75, 616-658.
2. Committee on Toxicity (2007) Variation and Uncertainty in Toxicology of Chemicals in Foods, Consumer Products and the Environment. Committee on Toxicity.
3. Fenech M (2007) Genome health nutrigenomics and nutrigenetics – diagnosis and treatment of genome damage on an individual basis. Food Chem Toxicol 46(4) 1365-1370
4. Verkerk RHJ & Hickey S (2009) A critique of prevailing approaches to nutrient risk analysis pertaining to food supplements with specific reference to the European Union. Toxicology http://dx.doi.org/10.1016/j.tox.2009.12.017
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