The commission's plan to unify these levels across the board, under both regulation directive 2002/46/EC (supplements) and 1925/2006/EC (fortified foods), has already caused some alarm among the industry as countries have differed over what limits they would find acceptable. There have been fears that cutting allowable levels would deliver a blow to the industry, particularly in lenient markets such as the UK and The Netherlands. But the suggested exemptions could help mitigate some of the perceived threat. The orientation paper, from the Directorate General Health and Consumer Protection, stated: "One of the criteria … are the upper safe levels of vitamins and minerals established by scientific risk assessment." The commission requested the Scientific Committee on Food (SCF) and the European Food Safety Authority (EFSA) to provide scientific opinions on tolerable upper intake levels. The orientation paper takes into account 58 responses from members after a discussion paper was issued last summer. Their opinions have differed over establishing maximum levels for nutrients which have an extremely low or non-existent toxicity even at high doses of intake, and the discussion papers talks about whether it would be "necessary" to include one. The commission concluded that "overall the position not to establish maximum amounts for nutrients for which there are no evident safety concerns would seem a proportionate approach… national levels could not be set for those vitamins and minerals which no limits have been set at EU level." Nutrients for which setting maximum levels could be waived are vitamin B1, vitamin B2, vitamin B12, biotin, panthothenic acid, chromium (III) vitamin K. The commission does suggest, however, that a "priority review system" to be set up in case new scientific date becomes available for these. The European Responsible Nutrition Alliance has praised the document, which outlines the results of safety studies by groups including the European Food Safety Authority, for taking a scientific data for setting maximum levels. Gert Krabichler, ERNA chairman, said: "We welcome the approach that the European Commission has taken in the orientation paper on setting maximum and minimum amounts for vitamins and minerals in foodstuffs. "It reflects the relevant European Court of Justice rulings and is based on the scientific risk assessment carried out by the European Food Safety Authority. It is a balanced view that takes both the legal aspects and scientific elements into account. It emphasises the safety approach and reflects the legal interpretation of the Food Supplement Directive and the Fortified Food Regulation." However, not all reactions have been as positive. The Whitehouse Consultancy, a public and parliamentary specialists group, said today: "The Orientation Paper leaves considerable grounds for concern as to what actual figures might yet be proposed by the Commission (and/or finally agreed by Council). Many higher potency supplements remain under threat." A working party made up of representatives from across the EU is due to discuss the ideas voiced in the discussion paper next month. The situation across Europe is complex, with countries differing radically on their maximum and minimum levels. A study last month by the Association of the European Self-Medication Industry (AESGP) brought these differences to the forefront once more. It 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.
