Judgment of the Court (Third Chamber) of 29 April 2010 (reference for a preliminary ruling from the Conseil d’État — France) — Solgar Vitamin’s France, Valorimer SARL, Christian Fenioux, L’Arbre de Vie SARL, Source Claire, Nord Plantes EURL, RCS Distribution, Ponroy Santé, Syndicat de la Diététique et des Compléments Alimentaires v Ministre de l’Économie, des Finances et de l’Emploi, Ministre de la Santé, de la Jeunesse et des Sports, Ministre de l’Agriculture et de la Pêche

(Case C-446/08) (1)

(Directive 2002/46/EC - Approximation of laws of the Member States relating to food supplements - Vitamins and minerals which may be used in the manufacture of food supplements - Maximum amounts - Harmonisation at European Union level - None - Competence of the Member States - Rules to be complied with and criteria to take into consideration when setting those amounts - National legislation setting those amounts - Setting the amount at zero)

(2010/C 161/10)

Language of the case: French

Referring court

Conseil d’État

Parties to the main proceedings

Applicants: Solgar Vitamin’s France, Valorimer SARL, Christian Fenioux, L’Arbre de Vie SARL, Source Claire, Nord Plantes EURL, RCS Distribution, Ponroy Santé, Syndicat de la Diététique et des Compléments Alimentaires

Defendants: Ministre de l’Économie, des Finances et de l’Emploi, Ministre de la Santé, de la Jeunesse et des Sports, Ministre de l’Agriculture et de la Pêche

Intervener in support of the defendant: Syndicat de la Diététique et des Compléments Alimentaires

Re:

Reference for a preliminary ruling — Conseil d’État (France) — Interpretation of Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (OJ 2002 L 183, p. 51) and, in particular, Articles 5(4) and 11(2) thereof — Competence of Member States to determine the maximum amounts of vitamins and minerals permitted in food supplements in the absence of Community legislation on this matter — Criteria to be taken into account when setting maximum contents — Total ban on fluoride imposed by the authorities of a Member State without regard to the rules contained in Article 12 of the above Directive — Quantitative restriction on trade in breach of Articles 28 EC and 30 EC.

Operative part of the judgment

1. Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements must be interpreted as meaning that, without prejudice to the EC Treaty, the Member States remain competent to adopt legislation on the maximum and minimum amounts of vitamins and minerals which may be used in the manufacture of food supplements so long as the European Commission has not laid down those amounts in accordance with Article 5(4) of that directive.

2. In addition to the obligation to respect Articles 28 EC and 30 EC, the Member States must also be guided by the criteria laid down in Article 5(1) and (2) of Directive 2002/46, including the requirement for a risk assessment based on generally accepted scientific data in setting the maximum amount of vitamins and minerals which may be used in the manufacture of food supplements, while waiting for the European Commission to lay down the amounts pursuant to Article 5(4).

3. Directive 2002/46 must be interpreted as meaning that in a situation such as that in the main proceedings where, when setting the maximum amount of a mineral which may be used in the manufacture of food supplements, it is impossible to calculate precisely the intake of that mineral from other dietary sources, and so long as the European Commission has not laid down the maximum amounts of vitamins and minerals which may be used in the manufacture of food supplements in accordance with Article 5(4) of that directive, a Member State may, if there is a genuine risk that that intake will exceed the upper safe limit established for the mineral in question, and provided that Articles 28 EC and 30 EC are respected, set the maximum amount at a zero level without resorting to the procedure laid down in Article 12 of that directive.

4. Article 5 of Directive 2002/46 must be interpreted as meaning that the fact that appropriate labelling might dissuade the group of consumers to which it is addressed from using a nutrient beneficial to them in small doses is not a relevant criterion for setting the maximum amounts of vitamins and minerals which may be used in the manufacture of food supplements. Taking account of the varying degrees of sensitivity of different consumer groups allows a Member State to apply a maximum amount appropriate for a specific group of consumers, such as children, to the whole population only if that measure is limited to what is necessary to protect the health of the persons belonging to that group and only if that measure is proportionate to the objective it pursues, and only if that objective cannot be attained by measures which are less restrictive to trade within the European Union, which is a matter to be ascertained by the national court.

5. Directive 2002/46 must be interpreted as meaning that it precludes the setting of maximum amounts of vitamins and minerals which may be used in the manufacture of food supplements where, in the absence of a genuine risk to human health, upper safe limits have not been established for those vitamins and minerals, unless such a measure is justified in accordance with the precautionary principle, if a scientific risk assessment reveals that scientific uncertainty persists as regards the existence or extent of genuine risks to human health. After the upper safe limits have been established, the possibility of setting such maximum amounts at a level significantly lower than those limits cannot be excluded if the setting of those maximum amounts can be justified by taking into account the criteria in Article 5(1) and (2) of Directive 2002/46 and that it complies with the principle of proportionality. That assessment is a matter for the national court and must be carried out on a case-by-case basis.

(1) OJ C 327, 20.12.2008.