Maximum level models not fit for purpose, scientists claim

By Alex McNally

- Last updated on GMT

Related tags: Vitamin, European union

Methods the European Commission has looked at for calculating
maximum levels for vitamins and mineral are scientifically flawed,
the Alliance for Natural Health (ANH) has said.

The ANH outlined in an 18-page document a series of flaws with various methods for working out what upper levels should be - and called on the Commission to reconsider its approach. Under the 2002 Food Supplements Directive and the fortified foods regulation upper and lower levels for both nutrients would be harmonised across the bloc. However, the proposal has caused concern across members states who currently differ radically on what are acceptable levels. The idea of the directive is to create upper safe levels of vitamins and minerals established by science, but the precise manner by what criteria is to be used in determining the levels is not set in law. As the Commission has not yet proposed what method it will follow, ANH's announcement comes at a time when discussions over the levels are still to be held. The Commission has not set a deadline for implementing the rules. In July the Commission published an orientation paper which outlined possible methodology for calculating the maximum permitted level. But yesterday ANH said: "Existing proposals for maximum permitted levels are gravely at risk of acting as a disproportionate risk management measure, which could seriously interfere with consumer freedom of choice and prevent people from ingesting levels of particular vitamins and minerals that are well known to be beneficial." ​ The ANH, a UK-based non-governmental organisation founded in 2002, highlights limitations of risk assessment models performed by the EU Scientific Committee on Food, UK Expert Group on Vitamins and Minerals and the US Institute of Medicine. The group compiled a list of reasons why these methodologies were flawed, which included claims these were selective, and levels were determined even though there was no adequate dose response data in humans. They said: "It is evident that the models are erroneous when the model outputs (maximum permitted levels) are compared with known responses to a wide range of vitamin and mineral dosages." ​ The Commission has already indicated that upper levels could be waived for vitamin B1, B2, B5, B12 and Biotin along with chromium (III) and vitamin K in the summer orientation paper. ANH said in the dossier that: "There are other nutrients that could equally be considered low risk because effects at high dosages are mild and reversible, e.g. vitamin C, niacinamide."​ Scientists and doctors who compiled the report for ANH also said that upper levels being considered for nutrients such as beta-carotene could be exceeded by eating two carrots. Dr Robert Verkerk, who is the director of ANH, said: "We believe a new model should be developed within an independent, academic setting rather than being subject to the often conflicting pressures of industrial stakeholders and political processes. "We are hoping that concerns about the European Commission's proposed approach will help it to drastically alter its proposed approach to the determination of maximum levels, which would otherwise be disproportionate in its effect and may in turn be subject to legal challenge."​ The Commission was not available for comment prior to publication. Across Europe levels for minerals and vitamins differ radically from country to country. A study by the Association of the European Self-Medication Industry (AESGP) found Belgium, for example, had maximum levels which varied between 1.5 and three times the recommended daily allowance (RDA) with a minimum level of 1.5 per cent RDA. By comparison Denmark varied on the maximum level from 1.8 to 1300 times RDA, and a higher minimum level of 30 to 33 per cent of RDA. Some countries had no minimum level, including Estonia, which had a maximum level inline with RDA. The UK and The Netherlands are traditionally two of the most lenient markets. High dose products account for 12 to 15 per cent of the £220m (€325m) UK vitamin and mineral market, and the UK industry would suffer a severe blow if the EU legislation were to proscribe the sale of high dose products.

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