# C_2008327EN.01001601.xml

| 20.12.2008 | EN | Official Journal of the European Union | C 327/16 |
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Reference for a preliminary ruling from the Conseil d'Etat (France) lodged on 9 October 2008 — Société Solgar Vitamin's France, Valorimer SARL, Christian Fenioux, L'Arbre de Vie SARL, Société Source Claire, Nord Plantes EURL, Société RCS Distribution, Société Ponroy Santé — Intervener: 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)

(2008/C 327/27)

Language of the case: French

Referring court

Conseil d'Etat

Parties to the main proceedings

Applicants: Société Solgar Vitamin's France, Valorimer SARL, Christian Fenioux, L'Arbre de Vie SARL, Société Source Claire, Nord Plantes EURL, Société RCS Distribution, Société Ponroy Santé

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

Questions referred

| (1) | Must Directive 2002/46/EC of 10 June 2002( 1 ), and in particular Articles 5(4) and 11(2) thereof, be interpreted as meaning that, although in principle it is for the Commission to determine the maximum amounts of vitamins and minerals present in food supplements, the Member States remain competent to adopt legislation in this field so long as the Commission has not adopted the necessary Community measure? |
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| (2) | If that question is answered in the affirmative:
(a)
If the Member States are required, in order to set those maximum amounts, to comply with the provisions of Articles 28 EC and 30 EC, must they also be guided by the criteria laid down in Article 5 of Directive 2002/46/EC, including the requirement for a risk assessment based on generally accepted scientific data, in an area in which there is still relative uncertainty? (b)
May a Member State set maximum levels when it is impossible, as in the case of fluoride, to calculate precisely the intake of vitamins and minerals from other dietary sources, mains water in particular, for each consumer group and on a territory-by-territory basis? May it in that case set a zero level where risks are known to exist, without resorting to the safety procedure provided for in Article 12 of Directive 2002/46/EC? (c)
When setting maximum levels, if it is possible to take into account differences in the degrees of sensitivity of different consumer groups, as provided for in Article 5(1)(a) of Directive 2002/46/EC, can a Member State also take into account the fact that a measure addressed solely to sections of the population who are particularly exposed to risk, appropriate labelling for example, might dissuade that group from using a nutrient that would be beneficial to it in small amounts? Might taking into account that difference in sensitivity result in the application to the entire population of the maximum level appropriate for sensitive sections of the population, in particular children? (d)
To what extent may maximum levels be set in the case where no safe limits have been laid down because there is no established danger to health? More generally, to what extent and in what circumstances might the weighting of criteria to be taken into account lead to the setting of maximum levels that are significantly lower than the safe limits accepted for those nutrients? | (a) | If the Member States are required, in order to set those maximum amounts, to comply with the provisions of Articles 28 EC and 30 EC, must they also be guided by the criteria laid down in Article 5 of Directive 2002/46/EC, including the requirement for a risk assessment based on generally accepted scientific data, in an area in which there is still relative uncertainty? | (b) | May a Member State set maximum levels when it is impossible, as in the case of fluoride, to calculate precisely the intake of vitamins and minerals from other dietary sources, mains water in particular, for each consumer group and on a territory-by-territory basis? May it in that case set a zero level where risks are known to exist, without resorting to the safety procedure provided for in Article 12 of Directive 2002/46/EC? | (c) | When setting maximum levels, if it is possible to take into account differences in the degrees of sensitivity of different consumer groups, as provided for in Article 5(1)(a) of Directive 2002/46/EC, can a Member State also take into account the fact that a measure addressed solely to sections of the population who are particularly exposed to risk, appropriate labelling for example, might dissuade that group from using a nutrient that would be beneficial to it in small amounts? Might taking into account that difference in sensitivity result in the application to the entire population of the maximum level appropriate for sensitive sections of the population, in particular children? | (d) | To what extent may maximum levels be set in the case where no safe limits have been laid down because there is no established danger to health? More generally, to what extent and in what circumstances might the weighting of criteria to be taken into account lead to the setting of maximum levels that are significantly lower than the safe limits accepted for those nutrients? |
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| (a) | If the Member States are required, in order to set those maximum amounts, to comply with the provisions of Articles 28 EC and 30 EC, must they also be guided by the criteria laid down in Article 5 of Directive 2002/46/EC, including the requirement for a risk assessment based on generally accepted scientific data, in an area in which there is still relative uncertainty? | | | | | | | | |
| (b) | May a Member State set maximum levels when it is impossible, as in the case of fluoride, to calculate precisely the intake of vitamins and minerals from other dietary sources, mains water in particular, for each consumer group and on a territory-by-territory basis? May it in that case set a zero level where risks are known to exist, without resorting to the safety procedure provided for in Article 12 of Directive 2002/46/EC? | | | | | | | | |
| (c) | When setting maximum levels, if it is possible to take into account differences in the degrees of sensitivity of different consumer groups, as provided for in Article 5(1)(a) of Directive 2002/46/EC, can a Member State also take into account the fact that a measure addressed solely to sections of the population who are particularly exposed to risk, appropriate labelling for example, might dissuade that group from using a nutrient that would be beneficial to it in small amounts? Might taking into account that difference in sensitivity result in the application to the entire population of the maximum level appropriate for sensitive sections of the population, in particular children? | | | | | | | | |
| (d) | To what extent may maximum levels be set in the case where no safe limits have been laid down because there is no established danger to health? More generally, to what extent and in what circumstances might the weighting of criteria to be taken into account lead to the setting of maximum levels that are significantly lower than the safe limits accepted for those nutrients? | | | | | | | | |

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( 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 (OJ L 183, 12.7.2002, p. 51).

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