Keywords
Summary

Keywords

1. Approximation of laws – Food supplements – Directive 2002/46

(European Parliament and Council Directive 2002/46, Art. 5(4))

2. Approximation of laws – Food supplements – Directive 2002/46

(Arts 28 EC and 30 EC; European Parliament and Council Directive 2002/46, recitals 13 and 14, and Art. 5(1)(2) and (4))

3. Approximation of laws – Food supplements – Directive 2002/46

(Arts 28 EC and 30 EC; European Parliament and Council Directive 2002/46, Art. 12)

4. Approximation of laws – Food supplements – Directive 2002/46

(Art. 30 EC; European Parliament and Council Directive 2002/46, Art. 5)

5. Approximation of laws – Food supplements – Directive 2002/46

(European Parliament and Council Directive 2002/46, Art. 5(1) and (2))

Summary

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

(see para. 24, operative part 1)

2. In addition to the obligation to observe 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 on the approximation of the laws of the Member States relating to food supplements, including the requirement for a risk assessment based on generally accepted scientific data in setting the maximum amount of vitamins and minerals that may be used in the manufacture of food supplements, while waiting for the Commission to lay down the amounts pursuant to Article 5(4).

Although the Member States remain competent to adopt legislation on those amounts so long as the Commission has not set them in accordance with Article 5(4) of that directive, the fact remains that, in the exercise of that competence, they must comply with the law of the European Union. The result prescribed by Directive 2002/46 would not be achieved if the Member States failed to take account of the criteria laid down in Article 5 thereof. Article 5(1) and (2) of Directive 2002/46 constitutes a fundamental provision with respect to setting the maximum amounts of vitamins and minerals which may be used in the manufacture of food supplements, since it lists the criteria which must be taken into account in order to set those amounts. Those criteria are derived from a risk analysis, within the meaning of Regulation No 178/2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety, which, according to Article 1(2) thereof, is intended to apply to all measures concerning food safety, including those taken by the Member States. Furthermore, it is clear from Article 5(1) and (2) of Directive 2002/46, read in conjunction with Recitals 13 and 14 thereof, that setting the maximum amounts of vitamins and minerals which may be used in the manufacture of food supplements on the basis of those criteria is intended to protect human health.

(see paras 26, 28-32, operative part 2)

3. Directive 2002/46 on the approximation of the laws of the Member States relating to food supplements must be interpreted as meaning that in a situation in which, 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 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.

Given that the application of Article 12 of Directive 2002/46 is subject to the implementation of that directive and, in particular, to Article 5 thereof, that is to say, to the laying down of the maximum amounts by the Commission referred to by the latter, and that the Commission has not yet laid down the maximum amounts, Article 12 is not applicable. In that context, it is not inconceivable that the taking into account of one or more of the criteria in Article 5(1) and (2) of Directive 2002/46 may lead to the maximum amount of a vitamin or mineral which may be used in the manufacture of food supplements being set at a very low level or even at zero, despite the fact that that vitamin or mineral is one which may be used in the manufacture of food supplements listed in Annex I to that directive.

(see paras 41-42, 44, 48, operative part 3)

4. Article 5 of Directive 2002/46 on the approximation of the laws of the Member States relating to food supplements 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 that 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 in order 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 less restrictive of trade within the European Union, which is a matter to be ascertained by the national court.

In exercising their discretion relating to the protection of public health, the Member States must observe the principle of proportionality. Furthermore, it is for the national authorities to show in each case, in the light of national nutritional habits and in the light of the results of international scientific research, that their rules are necessary in order effectively to safeguard the interests referred to in Article 30 EC and, in particular, that the marketing of the products in question poses a real risk for public health. In that context, it is for the national court to examine, in particular, whether appropriate labelling informing consumers about the nature, the ingredients and the characteristics of the food supplements concerned constitutes a measure sufficient to ensure the protection of the health of those persons, in particular in order to avoid the harmful effects relating to an excessive consumption of the nutrients concerned.

(see paras 54-55, 57, 61, operative part 4)

5. Directive 2002/46 on the approximation of the laws of the Member States relating to food supplements 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 when, 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 real risks to human health. After the upper safe limits have been established, it is not impossible that such maximum amounts should be set at a level significantly lower than those limits, 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 if it observes the principle of proportionality. That assessment is a matter for the national court and must be carried out on a case-by-case basis.

(see para. 73, operative part 5)