C-246/98

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grounds of protecting the health and life of technical regulation merely transposes the humans and animals are authorised. full text of an international or European standard ...'. In that case, information regarding the relevant standard will suffice.

5. However, according to the second sen- tence of Article 36 of the Treaty, those prohibitions or restrictions may not consti- tute a means of arbitrary discrimination or 8. Article 10 of Directive 83/189, amended a disguised restriction on trade between by Directive 88/182, provides that a draft Member States. technical regulation does not need to be either notified to or sent to the Commission where '... Member States honour their obligations arising out of Community Directives'. 6. Council Directive 83/189/EEC of 28 March 1983 laying down a procedure for the provision of information in the field of technical standards and regulations 3 as amended by Council Directive 88/182/EEC of 22 March 1988 4 is aimed at preventing any technical barriers to intra-community 9. Directive 86/469 6 is designed to facil- trade in products resulting from diversity itate the free movement of goods by between the legislation of the various approximating the divergent rules of the Member States. 5 The third recital in the Member States which lead to obstacles in preamble to Directive 83/189 therefore intra-Community trade and to a distortion states that a procedure requiring Member in the conditions of competition between States to notify the Commission of techni- products that are the subject of common cal standards and rules prior to their organisations of the market. adoption is established.

12. Article 9(3)(b) of Directive 86/469 requires the competent authorities to ensure that, if the examination of an official sample 'reveals the presence of prohibited substances, the animals may 15. Article 2 of the Netherlands Regulation not be placed on the market for human or provides that it is prohibited 'to administer animal consumption'. sympathicomimetic veterinary medicines containing Clenbuterol to fattening cattle over 14 weeks old or to authorise the administration of such veterinary medicines to such fattening cattle'. 13. Directive 86/469 lists in Annex I the groups of residues which fall within the scope of Article 9, referred to above. Clen- buterol falls within Point B of Annex I, headed 'Specific Groups', Group I: 'Other medicines', sub-group (c): 'Other veterinary 16. Article 3(1) provides: 'It is prohibited medicines'. to keep or to have in stock, to buy or to sell fattening cattle to which sympathicomi- metic substances referred to therein have been administered contrary to Article 2'.

The Netherlands legislation

Factual and procedural background 14. Article 1 of the Verordening Stoffen met sympathico mimetische werking (PW) 1991 (Regulation on sympathicomimetic substances; referred to below as 'the Neth- 17. The order for reference shows that the presence of clenbuterol was recorded in 8 — Article 2(c) of Directive 86/469. urine samples taken from four cattle at the

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farms of the defendants in the main pro- 20. They have further stated that the Neth- ceedings, Berendse-Koenen M.G. and erlands Regulation has the effect of prohi- Berendse H.G. Maatschap. They were biting the use of that type of veterinary therefore prosecuted for infringement of medicinal product, whereas other Member the Netherlands Regulation. States do not impose such a prohibition. In their submission, that inequality of treat- ment between Netherlands operators and other Community operators has the effect of creating distortions in competition pro- hibited by Community law.

9 —[1996] ECR I-2201. 10 — It is common ground that the veterinaty medicinal product called 'Ventipulmin' contains clenbuterol, and that, when 11 — Page 4, paragraph 2 of the English translation of the order lawfully prescribed in authorised doses, it can effectively for reference. treat asthmatic illnesses of cattle. 12 — OJ 1981 L 317, p. 1.

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relation to the defendants. However, the 2. Does the Verordening Stoffen met court wishes to obtain confirmation of its sympathico mimetische werking proposed interpretation of Directive (PW) 1991 and, more particularly, 83/189 for the purposes of ruling on the Articles 2 and 3 thereof, contain provi- compatibility of its national law with the sions which constitute obstacles to latter. freedom of trade for the purposes of Article 30 of the EC Treaty?'

22. Concerning the defendants' second 24. By letter of 11 June 1999, the national plea, the national court expresses no opi- court indicated to the Court of Justice that, nion, but questions whether it is well in the light of the judgment of 11 May founded. 1999 in Case C-425/97 Albers and Others, 1 3it no longer wished to proceed with the first question.

26. The wording of the question referred by the national court shows that the Court of Justice is not being asked to rule on the validity of Directive 86/469 in the light of Article 30 of the Treaty, 16 but has to assess the compatibility, with regard to that Treaty provision, of a rule of domestic 28. It is settled case-law that measures law such as that laid down by Article 3(1) having equivalent effect to quantitative of the Netherlands Regulation read in restrictions on imports within the meaning combination with Article 2 thereof. of Article 30 of the Treaty are defined as obstacles to free movement of goods which, in the absence of harmonisation of legisla- tion, are the consequence of applying to goods coming from other Member States, where they are lawfully manufactured and marketed, conditions with which such goods must comply, even if those rules apply without distinction to all products, 27. It might legitimately be asked what unless their application can be justified by a need there is to reformulate the second public-interest objective taking precedence question in so far as the national court over the free movement of goods. 19 decided to withdraw the first, having taken cognisance of the Albers judgment which — it should be remembered — held that the national measures in dispute did not constitute measures adopted unilater- ally by the Netherlands State but were internal measures for transposing Directive 86/469 which, in accordance with Arti- cle 10 of Directive 83/189, escape the notification obligation laid down by Arti- 29. Measures such as those adopted by the disputed national provisions were, as 16 — That is confirmed by the reasons given for the decision to already mentioned, regarded by the Court refer (see p. 4 of the English translation of that decision), by the letter of 11 June 1999 in which the national court indicated to the Court of Justice that it was withdrawing its first question, by the written observations submitted in 17 — Paragraphs 23 and 24. these preliminary ruling proceedings (paragraphs 43 to 49 of the Commission's observations, paragraph 46 of the 18 — It is settled case-law that 'the prohibition of quantitative Netherlands Government's observations; paragraphs 29 to restrictions and of all measures having equivalent effect 31 of the Irish Government's observations), by the further applies not only to national measures but also to measures arguments of the latter and of the parties to the main adopted by the Community institutions' (Case C-284/95 proceedings at the hearing before the Court of Justice, and Safety Hi-Tech v S & T [1998] ECR I-4301, paragraph by the replies given to the Court's questions during that 63). hearing. 19 — Keck and Mithouard, cited above.

33. It follows from the above that, in so far as rules such as those laid down by the Netherlands Regulation, and in particular by Articles 2 and 3 thereof read in combi- nation, have been enacted by Member States not to protect interests of their own but in order to comply with the decision of the Council in the general interest of the Community, the question of the compat- 30. It must be concluded that provisions ibility of those national rules with Arti- such as those in Article 3(1) of the Nether- cles 30 and 36 of the Treaty no longer lands Regulation, read in combination with arises. Article 2 of that regulation, do not consti- tute unilateral measures designed to protect the own interests of the Member State 22 — See the judgment in Keck and Mithouard, referred to above. enacting them, but were adopted to comply 23 — See, for example, Case 72/83 Campus Oil v Minister for with the decision of the Council in the Industry and Energy [1984] ECR 2727, paragraph 27; Case 148/85 Direction Générale des impôts v forest general interest of the Community. [1986] ECR 3449, paragraph 14; Case C-5/94 R v MAFF ex parte Hedley Lomas [1996] ECR I-2553, paragraph 18; Case C-l/96 R v MAFF ex parte Compassion in World Farming [1998] ECR I-1251, paragraph 4 1 . 24 — They claim, in particular, that the legislation effectively 20 — See Article 9(3)(b) of Directive 86/469. prohibits the marketing in national territory of cattle to 21 — I emphasised in my Opinion in Albers (footnote 5) how the which medicines prescribed for therapeutic purposes and presence of clenbuterol in excess of the authorised doses containing clenbuterol in authorised doses have been presents real dangers for human health. administered.