C-473/98

TOOLEX

OPINION OF ADVOCATE GENERAL MISCHO delivered on 21 March 2000 *

I — The question 1985:426') provides that the Swedish Gov- ernment, or the administrative authority appointed by it, may prohibit the treat- ment, import or export of a chemical product if there are specific health or 1. By order of 17 December 1998, the environmental protection reasons for doing Kammarrätten i Stockholm (Administrative so. Court of Appeal, Stockholm) referred the following question to the Court for a preliminary ruling under Article 177 of the EC Treaty (now, after amendment, Article 234 EC):

'Having regard to its aim, is a prohibition 3. In the exercise of that power, the Swed- against the industrial use of trichloroethy- ish government enacted Regulation lene as described in the order for reference 1991:1289 on certain chlorinated solvents consistent with Article 36 of the EC Treaty (hereinafter 'the regulation'). 2 and its application in Community law, even if it contravenes Article 30 of the Treaty?'

II — The main proceedings 4. Article 2 of that regulation prohibits the sale, transfer or use, for industrial pur- poses, of chemical products composed 2. Paragraph 12 of Swedish Law 1985:426 wholly or partially of methyl chloride or on chemical products 1 (hereinafter 'Law trichloroethylene.

* Original language: French. 2 — Forordningen (1991:1298) om vissa klorerade losningsme- del, replaced by Regulation 1998:944 concerning prohibi- 1 — Lagen (1985:426) om kemiska produkter, replaced bv the tion and other provisions applicable to certain situations Environmental Code (Miljobalken 1998:808) which entered where chemical products are treated, imported and into force on 1 January 1999. exported, which entered into force on 1 January 1999.

3 — Chemicals Inspectorate. 4 — Kemikalieinspektionen föreskrifter om undantag fran för- 12. Finally, Article 5 of KIFS 1995:6 pro- bud i fördordningen (1991:1289) om vissa klorerade lösningsmedel, KIFS 1995:6. vided that the Chemicals Inspectorate

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would publish a decision setting out the reasons' arises where the applicant under- cases in which the uses of trichloroethylene taking can show that: specified in pursuance of Article 2 might also be authorised after 31 December 1996.

'1. it is continuing to investigate feasible alternatives;

13. KIFS 1995:6 was amended in 1996 and 1997 by KIFS 1996:8 and 1997:3. 5

21. Following the appeal lodged by the 18. It was one of 220 or so undertakings, Chemicals Inspectorate, the Kammarrätten which applied in 1996 for permission to referred the question now in issue to the continue using trichloroethylene after Court of Justice for a preliminary ruling. March 1997.

22. fts I have just explained, the Swedish rules on the use of trichloroethylene were 19. By decision of 18 June 1996, the Che- amended on several occasions whilst the micals Inspectorate rejected Toolex's appli- main proceedings were pending. cation, essentially on the ground that, like 90% or so of the other applicant under- takings, it was unable to submit a plan showing how and above all when the use of trichloroethylene would be discontinued.

23. After the provisions relating to exemp- tions were amended on 1 April 1997 pur- suant to KIFS 1997:3, several undertakings, including Toolex, whose applications had had to be rejected in 1996, reapplied for, 20. Toolex brought an action against that and were subsequently granted, authorisa- administrative decision before the Länsrät- tion under the new rules to use trichlor- ten i Stockholmslän (County Administra- oethylene after March 1997.

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27. I too am unable to share the Commis- A — Appraisal in relation to secondary sion's view. There is nothing in the docu- Community law ments in the case or in the submissions made at the hearing to show that the Swedish legislature prohibited the use of trichloroethylene on grounds relating to notification, classification, packaging or labelling of that substance. 25. The Commission submits, first, that the Kingdom of Sweden prohibited the use of trichloroethylene for industrial purposes with a view to introducing a more rigorous reclassification of that substance than that afforded by Council Directive 67/548/EEC of 27 June 1967 on the approximation of 28. Furthermore, Article 112 of the Act laws, regulations and administrative provi- concerning the conditions of accession of sions relating to the classification, packa- the Republic of Austria, the Republic of ging and labelling of dangerous sub- stances 6 (hereinafter 'the classification 7 — Articles 30 and 31 of the classification directive were introduced by Council Directive 92/32/EEC of 30 April 1992 amending for the seventh time Directive 67/548 6 — OJ, English Special Edition 1967, p. 234. (OJ 1992 L 154, p. 1).

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30. It submits that the classification and marketing directives, together with the 33. The question is therefore whether the harmonisation introduced with regard to 8 — OJ 1994 C 241, p. 21 and OJ 1995 L 1, p. 1. 9 — OJ 1999 L 199, p. 57. 10 — OJ 1976 L 262, p. 201. 11 — OJ 1993 L 84, p. 1. 12 — Case 278/85 [1987] ECR 4069.

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dangerous substances has any bearing on 37. However, the exhaustive provisions of the right of Member States to prohibit the the classification directive cover a very use of trichloroethylene for industrial pur- clearly defined area, namely the notifica- poses. tion, classification, packaging and labelling of dangerous substances. As regards the use of such substances, the classification direc- tive merely requires that their packaging bear safety recommendations designed to inform the public of the particular care that should be taken when handling the sub- 34. The Court has consistently held that stances in question. although Article 36 of the EC Treaty (now, after amendment, Article 30 EC) allows the maintenance of restrictions on the free movement of goods, justified on grounds which constitute a fundamental require- ment recognised by Community law, recourse to Article 36 is no longer possible where Community directives provide for harmonisation of the measures necessary to 38. That directive does not harmonise the achieve the specific objective which would conditions under which dangerous sub- be furthered by reliance upon that provi- stances may be marketed or used in the sion. 13 manufacturing process.

preparations listed in the Annex to the 44. In 1991, the Council adopted Directive marketing directive. 91/173/EEC of 21 March 1991 amending for the ninth time Directive 76/769, 16 which modified the marketing directive by introducing rules relating to PCP. Member States were required to bring into force the laws, regulations and administrative provi- sions necessary to comply with the directive before 1 July 1992. That directive provided 41. Does it therefore follow that the mar- that, with some exceptions, PCP, its salts keting directive precludes national legisla- and esters were not to be used in a tion imposing restrictions on the use of concentration equal to or greater than 0.1% by mass in substances or prepara- trichloroethylene ? tions placed on the market. However, the Federal Republic of Germany continued to apply its more stringent national provision. The national court asked in essence, whe- ther the limit value established in Annex I to the marketing directive, as amended by Directive 91/173, was applicable only to PCP, its salts and esters and to preparations 42. The elements of a reply to that question produced from those substances, or whe- may be inferred from the judgment in ther that limit also applied to products Burstein, 15 which prefigures the present treated with those substances or prepara- case in that the Court was asked to tions. interpret the marketing directive in a simi- lar case concerning pentachlorophenol (hereinafter 'PCP').

47. Nor, finally, does the risks evaluation regulation preclude the Member States from exercising such a power. Its objective is to establish a procedure for evaluating B — Appraisal in relation to Article 30 of the risks associated with existing sub- the EC Treaty (now, after amendment, stances and identifying priority substances Article 28 EC) and Article 36 of the Treaty which, because of their potential effects on man and the environment, require immedi- ate attention at Community level. It is intended to assist in the management of such risks at Community level. 18 However, the risks evaluation regulation does not impose obligations with regard to the use 49. The Swedish Government maintains that, according to the case-law of the 18 — Sec Arntle 1(1)(b). Court, in particular the judgments in

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Frans-Nederlandse Maatschappij voor Bio- duced in Sweden, it constitutes an obstacle logische Producten, 19 Sandoz 20 and to the free movement of goods. Brandsma, 21 in the absence of harmonisa- tion, it is for the Member States to decide what degree of protection of the health and life of humans they intend to assure, having regard however for the requirements of the free movement of goods. It considers that Member States should be allowed a wide 52. The parties agree that the Swedish margin of discretion in that regard. legislation constitutes a measure having an effect equivalent to a quantitative restric- tion within the meaning of Article 30 of the Treaty.

53. According to the wording of the judg- ment in Dassonville, 22 'all trading rules 50. The Commission acknowledges that in enacted by Member States which are cap- the absence of any Community rule gov- able of hindering, directly or indirectly, erning trichloroethylene, the Member actually or potentially, intra-Community States are free to determine independently trade' are to be considered as measures the degree of protection that is to apply, having an effect equivalent to quantitative provided always that the protective mea- restrictions. sures are necessary and proportionate.

59. The Swedish Government explains that on the basis of the scientific data available 57. Article 36 permits national laws tò in the 1980s, in 1988 trichloroethylene was derogate from the principle of the free classified as harmful and carcinogenic in movement of goods to the extent to which category care, cat III R40 under the classi- such derogation is and continues to be fication directive. justified for the attainment of the objectives referred to in that article. 24 Those objec- tives preclude the protection of health and life of humans, animals or plants. In accordance with the second sentence of Article 36 of the Treaty, prohibitions or restrictions must not constitute a means of 60. The following definition applies to that category: 'substances which are of concern 23 — See Case 215/87 Schumacher [1989] ECR 617, paragraph to humans because of their possible carci- 15, Case C-369/88 Delattre [1991] ECR I-1487, para- graph 4 8 , Case C-347/89 Eurim-Pharm [1991] ECR nogenic effects, but which cannot be satis- I-1747, paragraph 26, Case C-62/90 Commission Germany v [1992] ECR I-2575, p a r a g r a p h , 10, Case' factorily evaluated on the basis of the C-317/92 Commission v Germany [1994] ECR I-2039, information available. There is information paragraph 14, and Case C-320/93 Ortscheit [1994] ECR I-5243, paragraph 14. See also the judgments in Motte, from appropriate animal studies but this is paragraph 16, and Muller and Others, paragraph 14, cited above and Case C-42/90 Bellon [19901 ECR I-4863, paragraph 10. 24 — See, in particular, Case 35/76 Simmenthal [1976] ECR 25 — See judgments in Case C-62/90 Commission v Germany, 1871, paragraph 14, and Case 5/77 Tedeschi [1977] ECR cited above, paragraphs 10 and .11, a n d Case C-320/93 1555, paragraph 34. Ortscheit, cited above,.paragraphs 16 and 17.

62. The Swedish Government also submits that, in recent years, concern has been 64. It points out that the legislation is part mounting. In particular, the International of a government programme to prevent Cancer. Research Agency, set up by the discharges of trichloroethylene. The legis- World Health Organisation, has produced lation is justified within the meaning of evidence — to a limited extent from epide- Article 36 of the Treaty, as it is necessary to miological tests carried out on people, and prohibit the use of trichloroethylene for more fully from experiments carried out on industrial purposes in order to achieve the animals — that trichloroethylene is a car- objective of the programme. Its aim is to cinogen. Trichloroethylene is currently reduce as far as possible the risks connected being assessed for risks under the procedure with the use of trichloroethylene, particu- introduced by the risks evaluation regula- larly those associated with the use of tion. Most scientific experts in the Member trichloroethylene for degreasing and drying States consider that there should be a more in the manufacture of machinery, without stringent classification of trichloroethylene. burdening undertakings with requirements However, the committee chaired by the beyond what is reasonable in each case. Commission has been unable to reach Moreover, the prohibition is not absolute, agreement on an evaluation. since exemptions are granted provided that the use of the substance does not entail unacceptable exposure and that there is no acceptable alternative solution. The objec- tive of the programme could be achieved only by means of individual authorisation taking into account the specific nature of each case and enabling the actual use of the 63. The Swedish Government adds that a product to be verified and controlled, with threshold for the carcinogenic effect of a view to finding an alternative solution.

69. What are the merits of these various arguments?

67. Article 36 of the Treaty also precludes 70. I note, first, that there is no suggestion the exemptions provided for under the that the Swedish legislation is based on Swedish legislation, as the criteria for considerations other than the protection of granting authorisation for use are not health and life of humans or protection of sufficiently objective and give the adminis- the environment. It also follows from the tration a very wide discretion. The criteria classification of trichloroethylene on the could be described as objective only if the basis of the relevant directive that the authorisation for use were subject to a dangerous nature of that product is genuine

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and is acknowledged at Community level. using a harmful substance may be justified The possibility that the Swedish legislation under Article 36 of the Treaty. is introducing a means of arbitrary discri- mination or a disguised restriction on trade between Member States under the pretext of a rule to protect interests recognised by Article 36 of the Treaty can therefore be ruled out.

74. There is all the more reason for that to be so in the case of a prohibition on use coupled with a system of exemptions, if the conditions for granting exemption also fulfil the proportionality requirement laid 71. The case-law relating to the justifica- down in Article 36 of the Treaty. tion of national measures under Article 36 of the Treaty on grounds of public health is particularly abundant.

77. Let us now examine these conditions in 12 June 1989 on the introduction of mea- the light of the requirements of the princi- sures to encourage improvements in the ple of proportionality. safety and health of workers at work, 27 Council Directive 90/394/EEC of 28 June 1990 on the protection of workers from the risks related to exposure to carcinogens at work (Sixth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC), 28 Council Directive 98/24/ EC of 7 April 1998 on the protection of the health and safety of workers against the 78. The Swedish Government has dwelt at risks related to chemical agents at work length on the reasons which led the Swed- (fourteenth individual Directive within the ish legislature to draw up the legislation at meaning of Article 16(1) of Directive issue which was based on what the Swedish 89/391/EEC), 29 and Council Directive Government called the 'principle of sub- 1999/13/EC of 11 March 1999 on the stitution', the idea being that the use of limitation of emissions of volatile organic trichloroethylene for industrial purposes is compounds due to the use of organic to be gradually but completely abolished, solvents in certain activities and installa- by substituting less harmful products. tions. 30

81. None of those directives applies to the 79. Toolex is the only party which chal- present case, though all of them require the lenges the principle underlying the legisla- employer to introduce measures for the tion at issue. It wonders why the Swedish protection of workers, on the basis of Government chose that particular sub- general principles of prevention including stance and complains of the costs to avoiding or reducing risks and replacing the Swedish undertakings and their loss of dangerous by the less dangerous substance. competitiveness compared with companies established in Member States where there is free use of trichloroethylene.

84. Without entering into a detailed analy- sis of the scientific papers produced by the Swedish Government, suffice it to say that 87. It cannot therefore be maintained that trichloroethylene has been found to be a to make the granting of exemption subject danger to health and the environment at to a requirement that the applicant seek an Community level. None of the parties alternative solution or to refuse to grant dispute that. They differ only on the degree exemption if there is an alternative product of danger posed by that substance. that is less dangerous, would be dispropor- tionate in relation to the objectives pursued by Article 36 of the Treaty.

85. Although the Commission argues that the Swedish legislation goes beyond what is

31—See, in particular, Joined Cases C-13/91 and C-113/91 Debus [1992] ECRI-3617,paragraph 18, and the case-law 88. Furthermore, according to settled case- cited therein. 32 — See, in particular, the judgments in Muller and Others, law, 'in so far as there are uncertainties in cited above, paragraph 26, Bellon, cited above, paragraphs the present state of scientific research, it is 16 and 17, and Case C-344/90 Commission v France [1992] ECR I-4719, paragraphs 9 and 10. for the Member States, in the absence of

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harmonisation, to decide what degree of istrative authorisation must be readily protection of the health and life of humans accessible to traders. It must be completed they intend to assure, having regard, how- within a reasonable time and, if it leads to a ever, to the requirements of the free move- rejection by the competent administrative ment of goods within the Community.' 33 authorities, that rejection must be open to challenge before the courts. 35

91. It follows from those judgments that 94. Moreover, the Swedish Government the principle of proportionality requires points out that all the applications for that the procedure for issuing prior admin- exemption made on the basis of the new provisions have been accepted and that 150 undertakings are at present authorised to 33 — See, in particular, the judgments in Bellon, cited above; use trichloroethylene. Case 97/83 Melkunie [1984] ECR 2367, paragraph 18, and Case C-375/90 Commission v Greece [1993] ECR I-2055, paragraph 19. 34 — See the judgments in Motte, cited above, paragraph 25, 35 — See also judgments in Case 222/86 Heylens and Others Muller and Others, cited above, paragraph 26, Bellon, [1987] ECR 4097, paragraphs 14 to 17, Case C-340/89 cited above, paragraphs 16 and 17 and Commission v Vlassopoulou [1991] ECR I-2357, paragraph 22, and Case France, cited above, paragraphs 9 and 10. C-19/92 Kraus [1993] ECR I-1663, paragraph 4 1 .

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98. If that complaint is to be understood as 36 — See, in particular, Case 54/85 Mirepoix [1986] ECR 1067, an objection to any charge for granting an paragraph 16 and Case 406/85. Cofette and Gilliard individual exemption, it is unfounded. [1987] ECR 2525, paragraph 10.

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IV — Conclusion

102. In the light of the foregoing considerations, I propose that the Court reply to the question referred by the Kammarrätten i Stockholm to the effect that Articles 30 (now, after amendment, Article 28 EC) and 36 (now, after amend- ment, Article 30 EC) of the EC Treaty must be interpreted as meaning that they do not preclude a Member State from prohibiting the use of trichloroethylene for industrial purposes in its territory and making the granting of individual exemption subject to three conditions: the obligation to seek an alternative solution which is less harmful to the environment and public health; the absence of such an alternative solution at present; and the absence of instances of unacceptable exposure to the substance, provided that such exemption can be obtained through a readily accessible procedure, that it does not depend on the payment of excessive administrative fees and that rejection of an application for exemption may be challenged before the courts.

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