Solgar Vitamin's France and Others v Ministre de l'Économie, des Finances et de l'Emploi and Others.

• Jurisdiction: European Union
• Celex Number: 62008CC0446
• ECLI: ECLI:EU:C:2009:795
• Date: 17 December 2009
• Court: Court of Justice (European Union)
• Procedure Type: Reference for a preliminary ruling
• Docket Number: C-446/08

OPINION OF ADVOCATE GENERAL

JÄÄSKINEN

delivered on 17 December 2009 ¹(1)

Case C‑446/08

Solgar Vitamin’s France

Valorimer SARL

Christian Fenioux

L’Arbre de Vie SARL

Source Claire

Nord Plantes EURL

RCS Distribution

Ponroy Santé

and

Syndicat de la Diététique et des Compléments Alimentaires, intervener,

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

(Reference for a preliminary ruling from the Conseil d’État (France))

(Food supplements – Absence of implementing measures – National legislation setting the maximum amounts of vitamins and minerals permitted in food supplements – Setting a maximum amount at zero – Application of the safeguard clause – Setting maximum amounts in the absence of safe limits)

1. In these proceedings, the Court is asked to rule on several questions relating to the existence and, where relevant, to the scope of the powers of the Member States as far as concerns food supplements, where the Commission fails to adopt implementing measures for setting the maximum amounts of nutrients present in food supplements.

2. In that regard, I note that the legislature sought to achieve complete harmonisation as regards the vitamins and minerals which may be used in the manufacture of food supplements. However, that harmonisation is incomplete in practice, since the Commission has failed to adopt the necessary implementing measures. That situation is a source of legal uncertainty for the undertakings concerned and causes problems in the application and transposition process for the competent authorities of the Member States. It is therefore for the Court to seek a balance between the requirement for the free movement of the goods in question and the need to protect public health in this unprecedented legal context.

3. The French Conseil d’État (Council of State) has posed a series of questions to the Court concerning the interpretation of Articles 5, 11(2) and 12 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 (2) (‘Directive 2002/46’), and Articles 28 EC and 30 EC.

4. This reference arises in the actions for misuse of powers brought before the referring court between 11 and 24 July 2006 by Solgar Vitamin’s France and seven other claimants, all active in the food supplements sector (‘Solgar and Others’), and in the action brought on 28 July 2006 by the Syndicat de la Diététique et des Compléments Alimentaires (‘the Syndicat’) against the interministerial order of 9 May 2006 on nutrients permitted for use in the manufacture of food supplements (‘the order of 9 May 2006’).

I – Legal framework

A –European Union law

5. According to Article 1(1) of Directive 2002/46, the Directive concerns food supplements marketed as foodstuffs and presented as such.

6. Recitals 1, 2, 5, 13, 14 and 16 in the preamble to Directive 2006/46 are worded as follows:

‘(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.

...

(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.

...

(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.

...

(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.’

7.Article 2 of Directive 2002/46 provides:

‘For the purposes of this Directive:

(a) “food supplements” means foodstuffs the purpose of which is to supplement the normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physiological effect, alone or in combination, marketed in dose form, namely forms such as capsules, pastilles, tablets, pills and other similar forms, sachets of powder, ampoules of liquids, drop dispensing bottles, and other similar forms of liquids and powders designed to be taken in measured small unit quantities;

(b) “nutrients” means the following substances:

(i) vitamins,

(ii) minerals.’

8.Article 3 of Directive 2002/46 is worded as follows:

‘Member States shall ensure that food supplements may be marketed within the Community only if they comply with the rules laid down in this Directive.’

9.Article 4(1), (2) and (4) of Directive 2002/46 provide:

‘1. Only vitamins and minerals listed in Annex I, in the forms listed in Annex II, may be used for the manufacture of food supplements, subject to paragraph 6.

2. The purity criteria for substances listed in Annex II shall be adopted in accordance with the procedure referred to in Article 13(2), except where they apply pursuant to paragraph 3.

...

4. For those substances listed in Annex II for which purity criteria are not specified by Community legislation, and until such specifications are adopted, generally acceptable purity criteria recommended by international bodies shall be applicable and national rules setting stricter purity criteria may be maintained.

…’

10.Article 5 of Directive 2002/46 is worded as follows:

‘1. Maximum amounts of vitamins and minerals present in food supplements per daily portion of consumption as recommended by the manufacturer shall be set, taking the following into account:

(a) upper safe levels of vitamins and minerals established by scientific risk assessment based on generally accepted scientific data, taking into account, as appropriate, the varying degrees of sensitivity of different consumer groups;

(b) intake of vitamins and minerals from other dietary sources.

2. When the maximum levels referred to in paragraph 1 are set, due account should also be taken of reference intakes of vitamins and minerals for the population.

3. To ensure that significant amounts of vitamins and minerals are present in food supplements, minimum amounts per daily portion of consumption as recommended by the manufacturer shall be set, as appropriate.

4. The maximum and minimum amounts of vitamins and minerals referred to in paragraphs 1, 2 and 3 shall be adopted in accordance with the procedure referred to in Article 13(2).’

11.Article 11 of Directive 2002/46 states:

‘1. Without prejudice to Article 4(7), Member States shall not, for reasons related to their composition, manufacturing specifications, presentation or labelling, prohibit or restrict trade in products referred to in Article 1 which comply with this Directive and, where appropriate, with Community acts adopted in implementation of this Directive.

2. Without prejudice to the Treaty, in particular Articles 28 and 30 thereof, paragraph 1 shall not affect national provisions which are applicable in the absence of Community acts adopted under this Directive.’

12. Under Article 12 of Directive 2002/46:

‘1. Where a Member State, as a result of new information or of a reassessment of existing information made since this Directive or one of the implementing Community acts was adopted, has detailed grounds for establishing that a product referred to in Article 1 endangers human health though it complies with the said Directive or said acts, that Member State may temporarily suspend or restrict application of the provisions in question within its territory. It shall immediately inform the other Member States and the Commission thereof and give reasons for its decision.

2. The Commission shall examine as soon as possible the grounds adduced by the Member State concerned and shall consult the Member States within the Standing Committee on the Food Chain and Animal Health, and shall then deliver its opinion without delay and take appropriate measures.

3. If the Commission considers that amendments to this Directive or to the implementing Community acts are necessary in order to remedy the difficulties mentioned in paragraph 1 and to ensure the protection of human health, it shall initiate the procedure referred to in Article 13(2) with a view to adopting those amendments. The Member State that has adopted safeguard measures may in that event retain them until the amendments have been adopted.’

13.Article 13(1) of Directive 2002/46 provides that the Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health instituted by Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 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 (3) (‘the Committee’).

14. Where reference is made to...