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Súdny dvor Európskej únie·4.2.1992

C-29/90

ECLI:EU:C:1992:51

Súd
Súdny dvor Európskej únie
IČS
61990CC0029

COMMISSION v GREECE

OPINION OF MR ADVOCATE GENERAL DARMON delivered on 4 February 1992 *

Mr President, information referred to therein 'in indelible, Members of the Court, easily legible and visible lettering'.

4. Article 7(3) provides that 'a Member 1. In the present application the State may require, for the purposes of Commission is seeking a declaration that the prompt and appropriate medical treatment Hellenic Republic has failed to fulfil its in the event of difficulties, that adequate Community obligations by requiring that and sufficient information regarding cosmetic products may be marketed only if substances contained in cosmetic products is a declaration is made accompanied by infor­ made available to the competent authority, mation and supporting documents and if a which shall ensure that this information is file is kept containing particulars which are used only for the purposes of such already printed on the packaging, containers treatment.' or labels of the products or which are not justified for the purposes of prompt and appropriate medical treatment. 5. In its judgment in Firma Eau de Cologne & Parfümerie-Fabrik Glockeiigasse No 4711 v Provide SRL 2 the Court held that 2. Council Directive 76/768/EEC of 27 July 1976 1 (hereinafter referred to as 'the directive') harmonized the national legis­ lative provisions on cosmetic products. 'the directive has provided exhaustively for Article 7(1) provides that 'Member States the harmonization of national rules on the 3 may not, for reasons related to the packaging and labelling' requirements laid down in this directive and the Annexes thereto, refuse, prohibit or restrict the marketing of any cosmetic products which comply with the and that the list of particulars required by requirements of this directive and the Article 6(1) was also exhaustive. 4 Annexes thereto.'

6. In support of its application for a declaration of failure to fulfil obligations the 3. Article 6(1) provides that cosmetic Commission claims that Greek law is products may be marketed only if their incompatible with the directive in two packaging, containers or labels bear certain respects.

* Original language: French. 2 — Judgment in Case 150/88 [1989] ECR 3891. 1 — On the approximation of the laws of the Member States 3 — Paragraph 28. relating to cosmetic products (OJ 1976 L 262, p. 169). 4 — See paragraph 17.

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OPINION OF MR DARMON —CASE C-29/90

7. It refers, in the first place, to Article 2 of (c) and (f) could, if necessary, constitute the the Presidential Decree No 532 of 23 May 'adequate and sufficient information 1981 provides that 'cosmetic products may regarding substances contained in cosmetic be marketed only after the manufacturer, or products' which the Member State may in the case of imported products, the person under Article 7(3) of the directive require to responsible for marketing, has lodged a be made available to the competent declaration with the National Drugs board authority 'for purposes of prompt and together with the following information and appropriate medical treatment in the event supporting documents: of difficulties'. However, in addition to the requirement of a declaration to the National Drugs Board, Article 2(2) of Presidential Decree No 532 provides that 'manufacturers (a) the name of the product; or those responsible for the marketing of cosmetic products are required, for the purposes of prompt and appropriate medical treatment in the event of difficulties, to (b) its form; make available to the Anti-Poisons Centre sufficient directions and information relating to the ingredients of their products. The Anti-Poisons Centre shall ensure that (c) its composition in terms of ingredients such information is used solely for thera­ and their quantities; peutic purposes.' That provision seems to constitute exercise of the option given by Article 7(3) of the directive.

(d) the name and address of the laboratory or factory where it is made;

(e) the surname and first name and address of the person responsible for marketing; 9. In my opinion, if a directive allows a Member State to require certain information to be communicated to the competent (f) the physical and chemical constants and authority for the purposes of preventing any a description of the product; impairment of public health, it is not clear that national legislation which provides for such information to be communicated to several bodies is of such a nature that it (g) a specimen of the instructions for use; should be declared incompatible with the Community legislation. The administrative organization of a Member State may justify (h) a specimen of the wording on the label two authorities, both empowered to inform or on each container, the public quickly of what should be done in the event of difficulties caused by a cosmetic product, being given the infor­ mation necessary for that purpose, and in 8. The Commission considers that that particular information relating to the provision is contrary to the directive. In my composition of the product. On the other opinion the particulars required under (a), hand, it cannot be excluded that a Member

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COMMISSION v GREECE

State which multiplies the requirements of a opinion, require to be settled by the Court declaration to various bodies, even for today. reasons to do with public health, may go beyond the derogation allowed by the directive from the principle of the free movement of goods. 12. The second head of incompatibility requires less time for consideration. The Commission objects to Article 5 of the Presidential Decree No 532 which requires that every manufacturer or person responsible for marketing the cosmetic 10. I do not think, however, that the Court product must keep at the undertaking's seat has to decide that delicate issue today. It is in Greece a complete file for each manu­ sufficient, in my opinion, to hold that of the factured or imported product, containing all information which must be forwarded to the particulars relating to the composition, in National Drugs Board the particulars under terms of ingredients and their quantities, the (b), (d), (e), (g) and (h) are not necessary to physical and chemical constants and the enable speedy therapeutic action in the description of the product, to the formal event of difficulties. record of the manufacture and inspection of each batch and the method adopted for such inspection, so that the manufacturer and importer may be in a position, in the event of inspection by sample, of demon­ strating the properties of the product.

11. It is true that at the hearing the Greek Government mentioned a Presidential Decree, No 40/91 of 28 February 1991, 13. In a letter from its Permanent Repre­ which revoked Decree No 532. The sentation dated 23 February 1987 the Greek Commission has not withdrawn its Government informed the Commission that application. The Court has consistently held that requirement would be revoked. that if, subsequent to an application to the Court, the substance of the default ceases to exist, this does not affect the merits of the Commission's application. 5 Irrespective of the proceedings which it has initiated, the 14. There is nothing in the directive Commission must examine the new enabling Member States to lay down such a provision of national law in order to provision. determine whether it correctly transposes the directive. It is apparent from the documents before the Court that the Greek Government proposed to remove certain of the information required in the declaration 15. It seems that Decree No 40/91, cited by to be sent to the National Drugs Board. The the Greek Government at the hearing, has delicate question which I previously raised brought Greek law into line with the may, perhaps, one day be submitted to the directive on that point. Nevertheless, the Court. As things stand, it does not, in my Greek Government did not comply with the reasoned opinion within the prescribed period and the default, in that respect, is 5 — Sec, for example, the judgment in Case 69/77 Commission v Italy [1978] ECR 17-19. established.

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OPINION OF MR DARMON —CASE C-29/90

16. I therefore conclude that the Court should:

1. declare that the Hellenic Republic has failed to fulfil its obligations under Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products

(a) by requiring that cosmetic products may be marketed only if a declaration containing information other than that which a Member State may require under Article 7(3) of the directive is lodged with the competent national authority,

(b) by requiring that every manufacturer of and person responsible for marketing a cosmetic product must keep at the seat of his undertaking in Greece a file for each manufactured or imported product, containing all particulars relating to the composition, properties and the description of the product, to the formal record of the manufacture and inspection of each batch and to the method adopted for such inspection;

2. order the Hellenic Republic to pay the costs.

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