"We must be clear that a varied diet remains the best solution for a healthy development and life," said David Byrne, EU Commissioner for Health and Consumer Protection. "These food supplements mainly serve to compensate for inadequate intake of essential nutrients by certain people or specific population groups, or, for some, to increase their intake of such nutrients. Labels on these products must give consumers adequate and clear information about how to use and how not to use them. For those who find they require supplements, we must make sure that the chemical substances used to produce vitamins and mineral supplements are safe and subject to independent scientific assessment. These principles of food safety and transparent information as outlined in the White Paper on Food Safety apply here as they do to all other food products."
Under the newly proposed rules, labels on, for example, bottles of vitamin pills will have to include a recommendation for a daily dose, a warning about possible health risk in case of excess use, and a statement that the pills should not be used as a substitute for a varied diet. Claims that the product can prevent, treat or cure illness are prohibited. Any language suggesting that a varied diet does not provide the necessary amounts of essential nutrients is equally prohibited. Pills sold in packaging, which resembles that of pharmaceutical products, must carry the statement "This is not a medicinal product".
The proposed Directive includes a positive list of chemical substances authorised for the production of vitamins and minerals following their scientific assessment by the Scientific Committee for Food. The proposal also foresees that maximum and minimum levels of vitamin and mineral content in the daily dose of food supplements will be set.
The proposal for a Directive on Food Supplements is part of the package of measures announced in the Commission's White Paper on Food safety adopted earlier this year. It is based on article 95 and has to be agreed by the European Parliament and the Council of Ministers in co-decision. It is intended to enter into force on 31 May 2002, allowing the marketing of products complying with the directive as of June 2002 and prohibiting the marketing of products which do not respect its rules by June 2004 at the latest.
BACKGROUND
Definitions for the purposes of this Directive
(a) "food supplements" means foodstuffs that are concentrated sources of nutrients as specified in (b), alone or in combination, marketed in dose form, whose purpose is to supplement the intake of those nutrients in the normal diet; (b) "nutrients" means the following substances: (i) vitamins listed in point 1 of Annex I, (ii) minerals listed in point 2 of Annex I; (c) "dose form" means forms such as capsules, tablets, pills and other similar forms, sachets of powder, ampoules of liquids and drop dispensing bottles.
ANNEX I - Vitamins and minerals which may be used in the manufacture of food supplements
1. Vitamins
2. Minerals