PARNUTS - Safety of food supplements - Commissioner Byrne welcomes political agreement in Council

"I am very pleased with the compromise reached today". David Byrne, the Commissioner for Health and Consumer Protection said today. "It puts consumer safety and informed consumer choice first, and will solve the problems manufacturers face in marketing their products due to the current differences in national legislation. Some people find they need food supplements to compensate for their inadequate intake of essential vitamins and minerals. Labels must give them clear information about how to use and how not to use them. We also 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. It must however be clear that a varied diet remains the best approach to achieving good health. "

The Commission presented its proposal for this Directive in May 2000 in response to an increase in the use of pills and capsules as diet supplements and to varying national rules on and attitudes to the proliferation of these products. The objective of the proposal is two-fold. First, to set out a general framework and safety rules for food supplements. As a first step detailed rules on vitamins and minerals are laid down. The Commission will within the next five years come forward with a report and appropriate measures on other types of ingredients used in food supplements. . The second objective is to give the consumer detailed information on the label to ensure consumers can make an informed choice.

Under the text as agreed today labels on, for example, bottles of vitamin pills will have to include clear instructions for daily dosage, 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.

The proposed Directive establishes a positive list of chemical substances authorised for the production of vitamins and minerals following their scientific assessment by the Scientific Committee for Food (see Annex I and II). The proposal also foresees that maximum and minimum levels of vitamin and mineral content in the daily dose of food supplements will be set by the competent regulatory committee, the Standing Committee on Food. These maximum limits are to be determined on the basis of science-based risk analysis, taking into account the intake of vitamins and minerals from other foods, as well as the 'population reference intake'. The population reference intake is the total intake of vitamins and minerals that the competent scientific committee, the Scientific Committee on Food, considers as adequate for an average person.

The Directive defines as food supplements all foodstuffs that are concentrated sources of nutrients, alone or in combination, marketed in dose form, whose purpose is to supplement the intake of those nutrients in the normal diet.. Food supplements can be sold in different 'dose forms', such as capsules, tablets, pills and other similar forms, sachets of powder, ampoules of liquids and drop dispensing bottles. The full text of the original Commission proposal of May 2000 is available at http://europa.eu.int/comm/food/fs/sfp/df_index_en.html

The proposed Directive on Food Supplements is part of the package of measures announced in the Commission's White Paper on Food safety. 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.

ANNEX I

Vitamins and minerals which may be used in the manufacture of food supplements

1. Vitamins

• Vitamin A (µg RE)
• Vitamin D (µg)
• Vitamin E (mg a-TE)
• Vitamin K (µg)
• Vitamin B1(mg)
• Vitamin B2(mg)
• Niacin (mg NE)
• Pantothenic acid (mg)
• Vitamin B6 (µg)
• Folic acid(µg)
• Vitamin B12 (µg)
• Biotin (µg)
• Vitamin C (mg)

2. Minerals

• Calcium (mg)
• Magnesium (mg)
• Iron (mg)
• Copper (µg)
• Iodine (µg)
• Zinc (mg)
• Manganese (mg)
• Sodium (mg)
• Potassium (mg)
• Selenium (µg)
• Chromium (µg)
• Molybdenum (µg)
• Fluoride (mg)
• Chloride (mg)
• Phosphorus (mg)