Opinion of Advocate General Jacobs delivered on 16 june 1993

1 Original language: English.

2 Sec Article 1(6) and (8) of the Ninth Regulation amending the Regulation on Cosmetics (Neunte Verordnung zur Änderung der Kosmetik-Verordnung), of 20 March 1985 (BGBl. 19851, p. 586).

3 Sec the Fourteenth Regulation amending the Kosmetik-Verordnung, of 2 December 1988 (BGBl. 1988 I, p. 2206).

4 Twelfth Commission Directive 90/121/EEC of 20 February 1990 adapting to technical progress Annexes II, III, IV, V and VI to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products (OJ 1990 L 71, p. 40).

5 Last amended by Council Directive 92/27/EEC of 31 March 1992 (OJ 1992 L 113, p. 8).

6 On the Community provisions governing the sale of medicinal products, see Leigh Hancher Creating the internal market for pharmaceutical medicines: An Echternach jumping procession? in Common Market Law Review 28(1991), pp. 82I-853.

7 See the amendment to Article 4 made by Article 7 of Council Directive 82/368/EEC of 17 May 1982 (OJ 1982 L 167, p. 1).

8 Cited above in note 6.

9 By Council Directive 83/574/EEC (OJ 1983 L 332, p. 38) and Council Directive 89/679/EEC (OJ 1989 L 398, p. 25).

10 OJ 197S L 13, p. 24.

11 See Anicie l(3)(b) and (4) of the Seventeenth Regulation amending the Kosmetik-Verordnung, of 21 March 1990 (BGBl. 1990 I, p. 589).

12 See Council Directive 89/341/EEC of 3 May 1989 (OJ 1989L 142, p. 11).

13 Second Council Directive of 20 Mav 1975 on the approximation of provisions laid down by law. regulation or administrative action relating to proprietary medicinal products (OJ 1975 L 147, p. 13); last amended by Council Directive 92/27/EEC of 31 March 1992 (cited above in note 4).

14 Sec the Directives cited below in paragraph 45, note 19.

15 See Council Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of medicinal products (OJ 1975 L 147, p.1), as amended by Council Directive 89/341/EEC (cited above in note 11) and last amended by Commission Directive 91/507/EEC (OJ 1991 L 270, p. 32).

16 The memorandum of the Bundesgesundhcilsanu appears to form the basis of the German Government's grounds for the prohibition of OHP given in its notification to the Commission of 16 January 1989, pursuant to Article 12 of the Cosmetics Directive. A copy of that notification is annexed to the German Government's written observations.

17 Cf. the opening paragraph of the article by Vermorkcn, Goos and Roelofs in Journal of Dermatology (1980) 102 (a copy of which is on the national file lodged at the Court), p. 695: During the last 10 years, the skin has been recognized as a major site for androgen metabolism, comparable to the prostate gland.

18 A summary of the grounds of the judgment is also available on the JURIS database: see JURIS Document No 347021.

19 In the English version of the Decision, in contrast to Article 8(2) of the Cosmetics Directive, the Committee is referred to as the Scientific Committee on Cosmetology rather than for Cosmetology; there is however no corresponding inconsistency in the French and German versions.

20 See for instance Council Directive 92/25/EEC of 31 March 1992 on the wholesale distribution of medicinal products for human use (OJ 1992 L 113, p. 1), Council Directive 92/26/EEC of 31 March 1992 concerning the classification for the supply of medicinal products for human use (ibid. p. 5), Council Directive 92/27/EEC of 31 March 1992 on the labelling of medicinal products for human use and on package leaflets (ibid. p. 8), and Council Directive 92/28/EEC of 31 March 1992 on the advertising of medicinal products for human use (ibid. p. 13).

21 Annexed to Angelopharm's reply to questions of 19 March 1993.

22 See the article by Tamm and Gauri in Ärztliche Kosmetologie May/June 1983 pp. 2-4 (a copy of which is on the national file), at p. 2, where however OHP is described as a steroid derivative rather than as a steroid. The title of that journal (Medical Cosmetology) is perhaps not without interest in the present context.

23 Cited above in paragraph 18, note 14.

24 Cited above in paragraph 16, note 10; it will be recalled that the Seventeenth Regulation in particular added OHP to the list of prohibited substances contained in Part A of Annex I to the Kosmetik-Verordnung, and deleted OHP from the list of prohibited substances contained in Part B.