Food supplements: approximation of the laws of the Member States

The Commission has presented its report on the use of substances other than vitamins and minerals in food supplements.

Directive 2002/46/EC on the approximation of the laws of the Member States relating to food supplements partially harmonises the rules applicable to the placing of food supplements on the market. The scope of the Directive covers all food supplements, with certain requirements – in particular those concerning labelling information – applying to all food supplements, regardless of their composition.

However, only the rules applicable to the use of vitamins and minerals in the manufacture of food supplements are laid down in the Directive. The use of substances other than vitamins or minerals in the manufacture of food supplements therefore continues to be subject to the rules in force in national legislation.

These principles are mentioned in Recital 8 of the Directive, which states that 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.

It is also stated that, in any event, such rules cannot be laid down until adequate and appropriate scientific data become available. In view of this, the Directive lays down that the Commission shall submit to the European Parliament and the Council a report on the advisability of establishing specific rules, including, where appropriate, positive lists, on categories of nutrients or of substances with a nutritional or physiological effect other than vitamins and minerals.

Considering all the issues described and analysed in this report, the Commission concludes that laying down specific rules applicable to substances other than vitamins and minerals for use in food supplements is not justified. Moreover, the Commission doubts the feasibility of such a measure, which, in any case, is not necessary in the short term.

Feasibility: unlike vitamins and minerals, the use of which is fairly similar throughout the Member States, the other substances correspond to very varied consumption habits. Moreover, given the available scientific information, which is essentially limited to substances that may be added for specific nutritional purposes to foods for particular nutritional uses, the Commission believes that a proposal for harmonisation in this area could only be limited to some substances, thus restricting its usefulness.

Taking account, also, of the scientific and methodological difficulties which would have to be overcome, the Commission believes that the prospect of extending Directive 2002/46/EC to substances other than vitamins and minerals could only be envisaged in the light of the experience gained when the rules on the use of vitamins and minerals were being laid down.

Necessity: according to the Commission, the conditions of use of the substances in question in foodstuffs, including food supplements, or their prohibition, can undergo harmonisation over time in the framework of the procedures provided for in those instruments. Furthermore, the legislation on novel foods is another factor likely to contribute to such harmonisation, within the limits of its specific scope.

Lastly, the Commission would point out that, in general terms, despite certain limitations, mutual recognition is a useful instrument for facilitating the free movement of the products concerned.

To conclude, the Commission believes that the existing Community legal instruments already constitute a sufficient legislative framework for regulating this area. However, since substances other than vitamins or minerals, including substances derived from plants, are now being added to ordinary foodstuffs and not only to food supplements, the Commission does not rule out the possibility, at a later state, of carrying out a supplementary analysis to this report, examining the conditions for the addition of these substances to foodstuffs in general.