London, England: British natural products retailers are unhappy with new wording for the European Food Supplements Directive recently agreed by the EU Council of Ministers. They are particularly concerned by the implications of several paragraphs, particularly the amended Article 5 which specifies that intakes of vitamins and minerals from other dietary sources should be taken into account when setting upper safe limits—this could affect the availability of higher potency supplements. Ralph Pike, director of UK trade body the National Association of Health Stores, told trade magazine Natural Products News: "We are now in danger of losing perfectly safe products."
In addition, the Directive is due to contain a positive list of permitted supplement ingredients and manufacturers will eventually have to submit material on the safety of any others they wish to include in their products. This would be costly and could act as a disincentive to new product development. According to industry sources, as many as 283 ingredients currently available in UK supplements are not in the existing draft of the positive list.
Along with the Netherlands, the UK supplements market is currently one of the least regulated in Europe. The newly agreed text was born out of long and sometimes bitter negotiations between the 15 Member States. Disagreements between ministers have centered on the two key areas: the legal definitions of food supplements and the criteria to be used for establishing maximum safe limits. On the issue of definition, Member States have now agreed to define supplements as those possessing a nutritional or physiological function. This is a significant development which had originally been opposed by lobbying groups for the pharmaceutical industry and some Member States, including Belgium, current holders of the EU presidency.
But the key source of disagreement throughout the progress of the proposed directive has been the issue of safety limits. Some countries have pressed for a safety-based limit while others have insisted on an approach based on reference intakes like the RDA (Recommended Daily Amount). But new wording proposed by Belgium for Article 5 of the proposed directive achieved a compromise agreement. Safety is to remain the key determinant of upper safe limits, but "due account should also be taken of reference intakes of vitamins and minerals," according to the new text.
Pedro Azua, of the European Federation of Health Product Manufacturers, described the newly agreed text as a "a very significant step towards the harmonisation of food supplement regulation in the EU. "But it is only a step on the way," he added. An enormous amount of work remains to be done to achieve the maximum benefit for the European industry."
The complex process of actually defining the maximum levels of vitamins and minerals to be allowed in supplements will not begin until after the current draft of the directive goes to the European parliament for debate in January next year. Adoption could follow as early as Spring, and enforcement within 18 months.