C-425/97

4. In some doubt as to the relevance of the legal argument advanced, the Gerechtshof, 's-Hertogenbosch, has referred the following 2. Following a check by the AID (general question to this Court for a preliminary ruling: inspection service) which revealed the pres- ence of prohibited residues 3 in the urine of cattle, their owners, Mr Albers, Mr Van den Berkmortel and Mr Nuchelmans (hereinafter 'the defendants in the main proceedings'), cattle breeders in the Netherlands, were sen- 'Does the Verordening Stoffen met sympa- tenced to fines for breaching the Verordening thico mimetische werking ( P W ) 1991, in Stoffen met sympathico mimetische werking particular Article 3(1) thereof, contain tech- nical regulations which, pursuant to Article 8 of Directive 83/189/EEC, as it stood at the * Original language: French. time when the Verordening came into force, 1 — Council Directive of 28 March 1983 laying down a procedure for the provision of information in the field of technical stan- dards and regulations (OJ 1983 L 109, p. 8). 2 — Council Directive of 22 March 1988 (OJ 1988 L 81, p. 75). 3 — Namely Clenbutcrol. 4 — Case C-194/94 [1996] ECR I-2201.

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should have been notified to the Commission 7. Article 3(1) provides: 'It is prohibited to beforehand?' keep or to have in stock, to buy or to sell fat- tening cattle to which sympathicomimetic substances referred to therein have been administered contrary to Article 2.'

The relevant Netherlands legislation

The relevant provisions of the Directive

6. Article 2 provides: 'It is prohibited to administer 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.' 9. Article 1(5) defines such regulations as 'technical specifications, including the rel- 5 — Without going into technical and scientific detail, it is clear evant administrative provisions, the obser- from the pleadings, and is not disputed, that such substances are considered an effective treatment for specific cattle dis- vance of which is compulsory, de jure or de eases (treatment of asthmatic diseases etc.) and, in prescribed • doses, can be supplied legally. However, the administration of facto, in the case of marketing or use in a this substance to young cattle in amounts exceeding the pre- Member State or a major part thereof, except scribed dose reduces the quantity of lipids and promotes an increase in the amount of muscle. It has the same effects as a those laid down by local authorities.' growth hormone and can therefore increase the value of a car- cass. The use of this substance for that purpose may pose a serious threat to the health of consumers of animal products. It is found in animals in the form of residues and the sec- ondary effects of Clenbuterol may therefore also affect con- sumers of meat from such animals (vasodilation, bron- 6 — First and second recitals of Directive 83/189. chiectasis, problems with heart rate and muscular fibrillation). 7 — Third recital.

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13. By the question it refers to this Court, the national court seeks a ruling as to whether national provisions, such as those contained in the national regulation, under which it is 11. Article 8 of the Directive requires Member prohibited to keep or to have in stock, to buy States to communicate to the Commission or to sell fattening cattle to which sympathi- any draft technical regulation, and, where comimetic substances been administered or to appropriate, the basic legislative or regulatory administer sympathicomimetic veterinary provisions. However, the first subparagraph medicines, in this case Clenbuterol, to fat- of Article 8(1) provides for a derogation from tening cattle over 14 weeks old, fall within that principle, 'where such technical regula- the scope of the obligation to notify laid down tion merely transposes the full text of an by Article 8 of the Directive. international or European standard.' In such a case information regarding the relevant stan- dard suffices.

12. Finally, Article 10 of the Directive pro- To answer that question, it must first be vides that a draft technical regulation need be ascertained whether the provisions of the national regulation are technical regulations within the meaning of Article 1 of the Direc- 8 — Which defines agricultural products as 'the products of the tive. If they are, I can go on to consider soil, of stockfarming and of fisheries and products of first- whether the obligation to notify implied by stage processing directly related to these products.' 9 — OJ, English Special Edition 1965-66, p. 20. such a definition could be waived in the 10 — OJ 1987 L 15, p. 36. present case.

Definition as a technical regulation tember 1987, 17 which sets out the character- istics which breath-analysis apparatus must exhibit, in particular so far as concerns quality, performance, testing and test methods as well as the procedures for assessing conformity, in order to be capable of being used by the police 14. The Court has been asked to rule on the for measuring alcohol content. 18 In a case components of this definition on many occa- currently pending before the Court it is asked

1990 on caretaking firms, security firms and internal caretaking services, which provided that prior approval granted by the committee established for that purpose by that law and by royal decree was necessary for the mar- keting or use of alarm systems and their com- 15. Unlike the interveners in this case, I take ponents on Belgian territory; 12 the Belgian the view that the term 'technical regulation' Ministerial Order of 24 December 1993 con- as used in the Directive has already been cerning products subject to environmental defined by the Court. 21 tax, 13 which imposed a requirement that a distinctive sign obtained from the Belgian Ministry of Finance must be affixed to all dis- posable products to be marketed on Belgian territory; 14 the Decree of 9 November 1993 of the Government of the Region of Metro- politan Brussels concerning standards of

187). 18 — Case C-226/97 Lemmens [1998] ECR 1-3711. 19 — Moniteur Belge of 29 August 1991. 11 — Judgment in Case C-69/91 Decoster [1993] ECR I-5335. 20 — See the Opinion of Advocate General Cosmas in Case 12 — CIA Security International, cited above. C-33/97 Colim pending before the Court. 13 — Moniteur Belge of 29 December 1993, p. 28903. 21 — To that effect, see Lecrenier, S., 'Le contrôle des règles tech- niques des États et la sauvegarde des droits des particuliers' 14 — Case C-13/96 Bic Benelux [1997] ECR I-1753. (The monitoring of technical regulations of States and the 15 — Moniteur Belge of 31 December 1993, p. 29194. protection of individual rights), Journal des Tribunaux de 16 — Case C-145/97 Commission v Belgium [1998] ECR I-2643. Droit Européen, 1997, p. 1.

23 — CIA Security International, cited above, paragraphs 29 and 22 — Sec point 14 of this Opinion. 30.

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in goods' 24 can be classified as a technical 24. Finally, there is no doubt that the national regulation within the meaning of the Direc- regulation at issue is binding and that failure tive. to observe it gives rise to a prohibition on marketing cattle to which substances to pro- mote growth have been administered on the national territory. Consequently it is capable of hindering directly intra-Community trade in goods. 20. The Court has, moreover, made clear that, if those criteria are fulfilled, 'a directive applies to technical regulations irrespective of the grounds on which they were adopted.' 25

25. It must therefore be concluded that the 21. Fattening cattle are the products of stock- national regulation is a technical regulation farming and are thus agricultural products within the meaning of Article 1(1) of the within the meaning of Article 38(1) of the Directive. Treaty which expressly mentions such prod- ucts.

The obligation to notify that technical regula- 22. The national regulation requires breeders tion to the Commission of fattening cattle to produce stock without using substances to promote growth such as Clenbuterol. Accordingly it lays down a spe- cific production method and procedure for an agricultural product.

27. In that judgment the Court ruled that Article 8 of the Directive had direct effect and 30. The Court pointed out that the national that individuals can rely on it before the regulations applied to the defendants in that national courts which must decline to apply case differ from those which, not having been a national technical regulation which has not notified to the Commission in accordance been notified in accordance with the Direc- with the Directive, are unenforceable against tive. In Lemmens, cited above, the Court individuals and that 'the use of the product clarified the scope of that decision. by the public authorities, in a case such as this, is not liable to create an obstacle to trade which could have been avoided if the notifi- cation procedure had been followed.' 27 The regulations in question were those which pro- hibit and penalise driving while under the influence of alcohol and require a driver to 28. In that case it fell to the Court to deter- exhale his breath into an apparatus designed mine the effect of failure to give prior notifi- to measure the alcohol content, the result of cation of a draft national order laying down that test constituting evidence in criminal pro- the required characteristics of breath-analysis ceedings. apparatus used by the police to measure alcohol content on criminal proceedings insti- tuted against drivers charged with driving with excess alcohol, evidence of whose level of alcohol had been adduced using apparatus to measure alcohol approved in accordance with the national order at issue.

32. In the case currently before the Court the technical regulation nor under an obligation national legislation at issue prohibits the mar- to provide information where they fulfil their keting of cattle whose growth has been pro- obligations as arising out of Community direc- moted through the administration of prohib- tives. ited substances. Accordingly it constitutes a direct obstacle to the free movement of goods. N o r is there any doubt that the defendants are cattle breeders who used those substances in contravention of the provisions of the national legislation at issue. It must be con- cluded that they have an interest in having the technical regulations contained in that legislation monitored on the basis of the 36. Like the Commission and the intervening Directive if that legislation falls, within the governments, I consider that the national leg- scope of the obligation to notify laid down islation at issue does not fall within the scope by Article 8 of the Directive. of the obligation to notify provided for by Article 8. In introducing the prohibition on keeping, having in stock, buying or selling fattening cattle to which sympathicomimetic substances have been administered or in pro- hibiting the administration of veterinary medi- cines with sympathicomimetic effect, in this 33. It therefore remains to be ascertained case Clenbuterol, to fattening cattle over 14 whether the national legislation falls within weeks old, the Netherlands Government ful- the scope of Article 8 or whether it is covered filled obligations as arising from two Direc- by the derogations provided for by Articles tives. 8(1) or 10 of the Directive.

38. Moreover, under Council Directive keting of such animals for both human and 86/469/EEC of 16 September 1986 concerning animal consumption if prohibited substances the examination of animals and fresh meat for are found in the animals examined. The the presence of residues, 30 Member States are national legislation at issue therefore merely to submit to the Commission a plan setting transposed the penalty laid down clearly and out the national measures to be taken to precisely by Directive 86/469. achieve the stated objective of that Directive which is to examine animals, their excrement and body fluids and tissues and fresh meat for the presence of residues. Under that direc- tive, in accordance with the final part of its 40. Finally, Clenbuterol is amongst the resi- Article 18, the national measures at issue were dues whose presence above a certain limit in notified to and examined by the Commission animals intended for human or animal con- which approved them on 30 March 1989 by sumption is prohibited 32 by that Directive. Decision 89/273/EEC. 31 There would be no point whatsoever in requiring that the national legislation at issue be notified a second time under the Directive. 41. Accordingly, although it can be classified as a technical regulation under the Directive, the national legislation adopted by the Neth- erlands authorities is not subject to the require- 39. Furthermore, Article 9 of Directive 86/469 ment to notify which the Directive imposes requires Member States to prohibit the mar- generally.

Conclusion

42. F o r the reasons given above, I p r o p o s e that the C o u r t should reply t o the q u e s - tion referred b y the Gerechtshof, V H e r t o g e n b o s c h , as follows: