(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,
Having regard to the proposal from the Commission(1),
Having regard to the opinion of the Economic and Social Committee(2),
Acting in accordance with the procedure laid down in Article 251 of the Treaty(3),

Whereas:

(1) There is an increasing number of products marketed in the Community as foods containing concentrated sources of nutrients and presented for supplementing the intake of those nutrients from the normal diet.

(2) Those products are regulated in Member States by differing national rules that may impede their free movement, create unequal conditions of competition, and thus have a direct impact on the functioning of the internal market. It is therefore necessary to adopt Community rules on those products marketed as foodstuffs.

(3) An adequate and varied diet could, under normal circumstances, provide all necessary nutrients for normal development and maintenance of a healthy life in quantities which meet those established and recommended by generally acceptable scientific data. However, surveys show that this ideal situation is not being achieved for all nutrients and by all groups of the population across the Community.

(4) Consumers, because of their particular lifestyles or for other reasons, may choose to supplement their intake of some nutrients through food supplements.

(5) In order to ensure a high level of protection for consumers and facilitate their choice, the products that will be put on to the market must be safe and bear adequate and appropriate labelling.

(6) There is a wide range of nutrients and other ingredients that might be present in food supplements including, but not limited to, vitamins, minerals, amino acids, essential fatty acids, fibre and various plants and herbal extracts.

(7) As a first stage, this Directive should lay down specific rules for vitamins and minerals used as ingredients of food supplements. Food supplements containing vitamins or minerals as well as other ingredients should also be in conformity with the specific rules on vitamins and minerals laid down in this Directive.

(8) Specific rules concerning nutrients, other than vitamins and minerals, or other substances with a nutritional or physiological effect used as ingredients of food supplements should be laid down at a later stage, provided that adequate and appropriate scientific data about them become available. Until such specific Community rules are adopted and without prejudice to the provisions of the Treaty, national rules concerning nutrients or other substances with nutritional or physiological effect used as ingredients of food supplements, for which no Community specific rules have been adopted, may be applicable.

(9) Only vitamins and minerals normally found in, and consumed as part of, the diet should be allowed to be present in food supplements although this does not mean that their presence therein is necessary. Controversy as to the identity of those nutrients that could potentially arise should be avoided. Therefore, it is appropriate to establish a positive list of those vitamins and minerals.

(10) There is a wide range of vitamin preparations and mineral substances used in the manufacture of food supplements currently marketed in some Member States that have not been evaluated by the Scientific Committee on Food and consequently are not included in the positive lists. These should be submitted to the European Food Safety Authority for urgent evaluation, as soon as appropriate files are presented by the interested parties.

(11) The chemical substances used as sources of vitamins and minerals in the manufacture of food supplements should be safe and also be available to be used by the body. For this reason, a positive list of those substances should also be established. Such substances as have been approved by the Scientific Committee on Food, on the basis of the said criteria, for use in the manufacture of foods intended for infants and young children and other foods for particular nutritional uses can also be used in the manufacture of food supplements.

(12) In order to keep up with scientific and technological developments it is important to revise the lists promptly, when necessary. Such revisions would be implementing measures of a technical nature and their adoption should be entrusted to the Commission in order to simplify and expedite the procedure.

(13) Excessive intake of vitamins and minerals may result in adverse effects and therefore necessitate the setting of maximum safe levels for them in food supplements, as appropriate. Those levels must ensure that the normal use of the products under the instructions of use provided by the manufacturer will be safe for the consumer.

(14) When maximum levels are set, therefore, account should be taken of the upper safe levels of the vitamins and minerals, as established by scientific risk assessment based on generally acceptable scientific data, and of intakes of those nutrients from the normal diet. Due account should also be taken of reference intake amounts when setting maximum levels.

(15) Food supplements are purchased by consumers for supplementing intakes from the diet. In order to ensure that this aim is achieved, if vitamins and minerals are declared on the label of food supplements, they should be present in the product in a significant amount.

(16) The adoption of the specific values for maximum and minimum levels for vitamins and minerals present in food supplements, based on the criteria set out in this Directive and appropriate scientific advice, would be an implementing measure and should be entrusted to the Commission.

(17) General labelling provisions and definitions are contained in Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs(4), and do not need to be repeated. This Directive should therefore be confined to the necessary additional provisions.

(18) Council Directive 90/496/EEC of 24 September 1990 on nutrition labelling for foodstuffs(5) does not apply to food supplements. Information relating to nutrient content in food supplements is essential for allowing the consumer who purchases them to make an informed choice and use them properly and safely. That information should, in view of the nature of those products, be confined to the nutrients actually present and be compulsory.

(19) Given the particular nature of food supplements, additional means to those usually available to monitoring bodies should be available in order to facilitate efficient monitoring of those products.

(20) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(6),

HAVE ADOPTED THIS DIRECTIVE: