Keywords

Summary



Keywords

1. Approximation of laws — Food supplements — Directive 2002/46 — Prohibition on trade in food supplements containing certain vitamins or certain minerals — Measure aimed at improving the functioning of the internal market — Legal basis — Article 95 EC — Need to ensure a high level of human health protection

(Art. 95 EC; European Parliament and Council Directive 2002/46, Arts 3, 4(1) and 15(b), and Annexes I and II)

2. Free movement of goods — Quantitative restrictions — Measures having equivalent effect — Prohibition, arising from a Community measure, on marketing food supplements containing certain vitamins or certain minerals — Not permissible — Justification — Protection of public health — Conditions

(Arts 28 EC and 30 EC; European Parliament and Council Directive 2002/46, Arts 3, 4(1), 4(5) and 15(b), and Annexes I and II)

3. Common commercial policy — Regulation by the Community institutions — Regulation No 3285/94 — Purpose — Liberalisation of imports from non-member States — Effect on the conditions for placing the imported products on the market — None — Effect

(Council Regulation No 3285/94)

4. Approximation of laws — Food supplements — Directive 2002/46 — Harmonisation measures — Prohibition on marketing food supplements containing certain vitamins or certain minerals — Infringement of the principle of subsidiarity — None

(Arts 5, second subpara., EC and 95(3) EC; European Parliament and Council Directive 2002/46, Arts 3, 4(1) and 15(a) and (b))

5. Approximation of laws — Food supplements — Directive 2002/46 — Harmonisation measures — Prohibition on marketing food supplements containing certain vitamins or certain minerals — Infringement of the principle of equal treatment — None

(European Parliament and Council Directive 2002/46, 11th recital, Arts 3, 4(1) and 15(a) and (b), and Annex II)

6. Approximation of laws — Food supplements — Directive 2002/46 — Harmonisation measures — Prohibition on marketing food supplements containing certain vitamins or certain minerals — Failure to respect the private and family life of consumers — None

(Art. 6(2) EU; European Parliament and Council Directive 2002/46, Arts 3, 4(1) and 15(b))

7. Community law — Principles — Fundamental rights –– Right to property –– Freedom to pursue a trade or profession –– Restrictions –– Prohibition, arising from a Community measure, on marketing food supplements containing certain vitamins or certain minerals –– Breach of the right to property –– None –– Breach of the right of manufacturers of those products freely to pursue a trade or profession –– Whether permissible –– Restriction justified by the general interest –– Breach of the principle of proportionality –– None

(European Parliament and Council Directive 2002/46, Arts 3, 4(1) and 15(b))

Summary

1. When there are obstacles to trade, or it is likely that such obstacles will emerge in the future, because the Member States have taken, or are about to take, divergent measures with respect to a product or a class of products, which bring about different levels of protection and thereby prevent the product or products concerned from moving freely within the Community, Article 95 EC authorises the Community legislature to intervene by adopting appropriate measures.

Consequently, Article 95 EC constitutes the only appropriate legal basis for Articles 3, 4(1) and 15(b) of Directive 2002/46 relating to food supplements, owing to the differing national rules to which they were subject before the adoption of the directive and the inherent risk of their free movement being impeded, which may have a direct impact on the functioning of the internal market in this field.

Similar provisions must, however, respect both Article 95(3) EC, which explicitly requires that, in achieving harmonisation, a high level of protection of human health should be guaranteed, and the legal principles referred to in the Treaty or identified by the case‑law, in particular, the principle of proportionality. Thus, the fact that human health considerations played a part in the decision to prohibit marketing food supplements containing the vitamins, minerals or other vitamin or mineral substances which are not included in the lists annexed to that directive, resulting from the combined provisions of Article 3, 4(1) and 15(b) of Directive 2002/46, cannot invalidate the foregoing assessment.

(see paras 31-32, 35, 40, 42)

2. The provisions of Articles 3, Article 4(1) and 15(b) of Directive 2002/46 relating to food supplements constitute a restriction on the free movement of goods between Member States for the purposes of Article 28 EC. By prohibiting the marketing in the Community of food supplements containing vitamins, minerals, or vitamin and mineral substances not included on the lists annexed to that directive, those provisions are capable of restricting the free movement of food supplements within the Community. Such a measure, adopted on the basis of considerations related to the protection of human health, can nevertheless be justified, pursuant to Article 30 EC, provided that it is necessary and proportionate in relation to the objective pursued.

In order to satisfy the requirement of proportionality, the prohibition on marketing products containing substances not included on the positive lists laid down in the applicable legislation must be accompanied by a procedure designed to allow a given substance to be added to those lists and the procedure must comply with the general principles of Community law, in particular the principle of sound administration and legal certainty. Such a procedure must be accessible in the sense that it must be expressly mentioned in a measure of general application which is binding on the authorities concerned. It must be capable of being completed within a reasonable time. An application to have a substance included on a list of authorised substances may be refused by the competent authorities only on the basis of a full assessment of the risk posed to public health by the substance, established on the basis of the most reliable scientific data available and the most recent results of international research. If the procedure results in a refusal, the refusal must be open to challenge before the courts.

The procedure referred to in Article 4(5) of Directive 2002/46, which allows a vitamin, a mineral, or a vitamin and mineral substance to be added to the lists mentioned above, fulfils those conditions.

(see paras 48-51, 72-74, 89)

3. The objective of Regulation No 3285/94 on the common rules for imports and repealing Regulation No 518/94 is to liberalise imports of products originating in non-member States. However, it does not aim to liberalise the placing on the market of those products, which takes place after import. It follows that that regulation is of no relevance for the purpose of assessing the legality of Community measures whose effect is to prohibit the placing on the market within the Community of products imported from non-member States which do not satisfy the conditions laid down for such placing on the market for reasons relating to the protection of human health.

(see paras 95-96)

4. Articles 3, 4(1) and 15(b) of Directive 2002/46 relating to food supplements do not infringe the principle of subsidiarity laid down in the second subparagraph of Article 5 EC.

The prohibition, under those provisions, on marketing food supplements which do not comply with Directive 2002/46, supplemented by the obligation of the Member States under Article 15(a) of the directive to permit trade in food supplements complying with that directive, has the objective of removing barriers resulting from differences between the national rules on vitamins, minerals and vitamin or mineral substances authorised or prohibited in the manufacture of food supplements, whilst ensuring, in accordance with Article 95(3) EC, a high level of human-health protection. To leave Member States the task of regulating trade in food supplements which do not comply with Directive 2002/46 would perpetuate the uncoordinated development of national rules and, consequently, obstacles to trade between Member States and distortions of competition so far as those products are concerned. Thus, the objective pursued by Articles 3, 4(1) and 15(b) of the directive cannot be satisfactorily achieved by action taken by the Member States alone and requires action to be taken by the Community.

(see paras 105-108)

5. Articles 3, 4(1) and 15(b) of Directive 2002/46 relating to food supplements do not infringe the principle of equal treatment.

The prohibition, under those provisions, on marketing food supplements containing the vitamin and mineral substances which are not included on the positive list in Annex II to Directive 2002/46 is based on the fact that the substances had not, at the time when that directive was adopted, been subject to a scientific evaluation by the competent authorities so as to ensure their conformity with the criteria of safety and bioavailability referred to in the 11th recital of the preamble to the directive, unlike the substances which are included in it. That difference in situations therefore permits a difference in treatment, and an infringement of the principle of equal treatment cannot be successfully pleaded.

(see paras 116, 118-119)

6. The fact that Articles 3, 4(1) and 15(b) of Directive 2002/46 relating to food supplements may deprive people of the right to consume food supplements which do not comply with that directive cannot be regarded as amounting to a breach of respect for their private and family life within the meaning of Article 8 of the European Convention on Human Rights.

(see paras 123-124)

7. The right to property, and likewise the freedom to pursue an economic activity, form part of the general principles of Community law. However, those principles are not absolute but must be viewed in relation to their social function. Consequently, the exercise of the right to property and the freedom to pursue an economic activity may be restricted, provided that any restrictions in fact correspond to objectives of general interest pursued by the Community and do not constitute in relation to the aim pursued a disproportionate and intolerable interference, impairing the very substance of the rights guaranteed.

In that respect, the prohibition on marketing and placing on the Community market food supplements which do not comply with that directive, which arises from the provisions of Articles 3, 4(1) and 15(b) of Directive 2002/46 relating to food supplements, in no way calls property rights into question. No economic operator can claim a right to property in a market share, even if it held it at a time before the introduction of a measure affecting the market, since such a market share constitutes only a momentary economic position exposed to the risks of changing circumstances.

Conversely, that prohibition is capable of restricting the freedom of manufacturers of food supplements to carry on their business activities. However, in the light of the public interest objective of the protection of human health pursued by the prohibition, such a restriction cannot be found to constitute a disproportionate impairment of the right to exercise the business activities of these manufacturers.

(see paras 126-129)