C-293/94

BRANDSMA

OPINION OF ADVOCATE GENERAL FENNELLY delivered on 29 February 1996

Introduction Factual and legal context

2. Jacqueline Brandsma is the manager of a supermarket in Turnhout, which is a branch of the Dutch group HEMA . HEMA has approximately 200 branches in the Nether­ lands, but had only two, at the material time, 1. A national system of authorization for in Belgium. In practice, most of the goods the sale of biocides, justified on public health sold by the group in Belgium are provided grounds under Article 36 of the Treaty estab­ by Dutch suppliers, who sell to HEMA on lishing the European Community (hereinaf­ favourable terms related to sales volume. ter 'the Treaty'), is the subject of the present reference. The Dutch retail group, HEMA , in selling an algicide intended as a tile cleanser at a supermarket in Belgium, sought to avoid the obligation to obtain a prior authorization required by a Belgian Royal Decree by relying on its alleged equivalent, already obtained in the Netherlands. In an 3. Subsequent to a visit to the supermarket ensuing prosecution of Ms Brandsma, the on 12 March 1993 by a pharmaceuticals manager of the store, the Belgian Court of inspector, criminal proceedings were com­ First Instance has referred two questions menced against Ms Brandsma before the concerning the interpretation of Arti­ Rechtbank van Eerste Aanleg, Turnhout, for cles 30 and 36 of the Treaty. The judgment of the unlawful sale of an unauthorized algicide, the Court in 1981 in Frans-Nederlandse 1 HEMA Tegelreiniger (tile cleanser), contrary Maatschappij voor Biologische Producten to Article 8 of the Royal Decree of 5 June (hereinafter 'Biologische Producten') should 1975 on the possession, sale and use of pes­ provide assistance in answering these ques­ ticides and plant-protection products (here­ tions. inafter 'the Royal Decree'). This product, whose active ingredient is didecyldimethyl ammonium chloride in the concentration of 6g/L, prevents the formation of algae on * Original language: English. 1 — Case 272/80 [1981] ECR 3277. walls and tiles.

7. Counsel for Ms Brandsma stated at the oral hearing that the Belgian authorization procedure is identical to the procedure under 5. Article 8 of the Royal Decree provides for which HEMA Tegelreiniger was approved a mandatory authorization process. It makes for sale in the Netherlands, as set out in a it an offence to trade in, to acquire, offer, 2 Netherlands law of 1962. However, there is expose or put on sale, stock, prepare, trans­ no evidence before the Court that identical port, dispose of either for valuable consider­ or comparable substantive safety standards ation or otherwise, import or use pesticides were specified, or applied in practice, in Bel­ for non-agricultural use which have not pre­ gium and the Netherlands in respect of algi- viously been authorized by the Minister cides. Nor has the Court been provided with responsible for public health. any information as to standards specified by the Belgian Minister for Health under Arti­ cle 13 of the Royal Decree. As I have already indicated, HEMA has chosen not to test that procedure.

2 — It is not clear whether this is the Bestrijdingsmiddelenwet 6. Article 10 of the Royal Decree provides (Law relating to plant-protection products), 1962, which was for the specification by the Minister of a at issue in Biologische Producten, cited in footnote 1 above, in Case 94/83 Heijn [1984] ECR 3263, and in Case 125/88 fixed application fee, and of the scientific Nijman [1989] ECR 3533.

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BRANDSMA

10. Written observations were submitted by the defendant in the main proceedings, '1 . Must the national legislation of a Mem­ Ms Brandsma, by the Commission, and ber State prohibiting pesticides for non- by the Austrian, Netherlands, Swedish agricultural use which have not been and United Kingdom Governments. previously authorized by the Minister Ms Brandsma, the Commission and the for Health from being brought into cir­ Swedish Government were also represented culation, acquired, offered, put on dis­ at the oral hearing on 1 February 1996. play or sale, kept, prepared, transported, sold, disposed of for valuable consider­ ation, or imported or used free of charge, be regarded as a quantitative restriction or a measure having equiva­ lent effect within the meaning of Arti­ cle 30 of the Treaty, where under that 11. As regards the first question, there was, national measure a pesticide for non- not surprisingly, a consensus among those agricultural use lawfully marketed in who submitted observations that Article 8 of another Member State may not be the Royal Decree constitutes a measure hav­ offered for sale on importation into the ing equivalent effect to a quantitative restric­ first-mentioned Member State so long tion on imports within the meaning of Arti­ as no prior authorization has been cle 30 of the Treaty, by reference to the tests

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OPINION OF MR FENNELLY — CASE C-293 C-293//94

7 cides. They contend, further, that Member State Governments are entitled, pending such rules, to require a national authorization in advance of the marketing of such products on their territory, in the interests of the pro 12. As regards the second question, tection of public health or of the environ Ms Brandsma submitted that the product ment. They analyse the directives cited by HEMA Tegelreiniger had been authorized in Ms Brandsma, and say that harmonized the Netherlands, and complied in all respects rules on such matters as packaging and label with the applicable European Community ling do not suffice to address these concerns. directives. She cited in this regard a number At the oral hearing, the agent for the Com of directives on the classification, labelling mission pointed out that these directives,

9 logische Producten, in which it was pointed out that it was for each Member State to 3 — Case 8/74 [1974] ECR 837, paragraph 5 of the judgment. decide on the level of protection of these 4 — Case 120/78 [1979] ECR 649, paragraph 8 of the judgment. interests required in its territory, although it 5 — Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provi- sions relating to the classification, packaging and labelling of dangerous substances; OJ, English Special Edition 1967 (I), p. 234; Council Directive 78/631/EEC of 26 June 1978 on the approximation of the laws of the Member States relating 7 — The Commission made a proposal for a European Parlia- to the classification, packaging and labelling of dangerous ment and Council Directive concerning the placing of bio- preparations (pesticides); OJ 1978 L 206, p. 13. cidal products on the market, on 27 July 1993; OJ 1993 C 239, p. 3, as amended on 24 July 1995; OJ 6 — Council Directive 76/769/EEC of 27 July 1976 on the 1995 C 261, p. 5. Biocidal products are defined in Article 2 of approximation of the laws, regulations and administrative the draft Directive. provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and 8 — OJ 1991 L 230, p. 1. preparations; OJ 1976 L 262, p. 201. 9 — Case 272/80, cited in footnote 1 above.

14. As regards the first question, I think it is clear that the authorization requirement set out in Article 8 of the Royal Decree is within the field of application of Article 30 of the 15. The list of such measures in parenthesis Treaty. The Court set out a general test in merely gives examples of the range of regu­ 10 Procureur du Roi ν Dassonville, that '[a]ll lations to which the marketing of products is trading rules enacted by Member States subject, and which fall within the scope of which are capable of hindering, directly or Article 30 of the Treaty. It is implicit in the indirectly, actually or potentially, intra- judgment of the Court in Biologische Pro- Community trade are to be considered as ducten that a national requirement, prior to measures having an effect equivalent to marketing, of an authorization from the quantitative restrictions'. The Court, in one health authorities of a Member State satisfies 12 of many recent examples, summarized this the criteria for addition to that list. Such a test as it has been expressed in the subse­ requirement can hinder intra-Community quent case-law: trade by subjecting producers who wish to trade in more than one Member State to multiple authorization procedures, which can, even when the requirement is met, increase costs and cause delay in putting a product on the Community market. I would therefore propose that the Court answer the first question referred by the national court in the affirmative by stating that the Belgian 'It is established by the case-law beginning requirement of authorization is a measure of with "Cassis de Dijon" (Case 120/78 Rewe ν equivalent effect to a quantitative restriction Bundesmonopolverwaltung für Branntwein on imports prohibited by Article 30. [1979] ECR649 ) that in the absence of har­ monization of legislation, obstacles to the

16. I must consequently address the second not fall within the material scope of these question, whether the Kingdom of Belgium measures. can rely on an exception from that prohibi­ tion, namely the protection of public health, 13 found in Article 36 of the Treaty. It is first necessary to establish whether harmon­ ized Community rules exist in respect of the authorization of potentially harmful biocidal products such as the algicide at issue in the instant case. It is clear that 17. Even if the product, HEMA Tegelreini- they do not. Ms Brandsma referred ger, did fall within the field of application of in her observations to three items of any of these Community measures, the fact Community legislation. One (Council that it was marked with the appropriate 14 Directive 76/769/EEC ) simply establishes warning 'irritant', and with the correspond­ restrictions on the marketing and use of ing symbol, the cross of St Andrew, would a number of specified chemical substances establish no more than that the product is a (which do not include didecyldimethyl non-corrosive preparation which, through ammonium chloride). The other two immediate, prolonged or repeated contact (Council Directives 67/548/EEC and with the skin or mucous membrane, can 15 19 78/631/EEC ) concern the manner in cause inflammation; this is unrelated to which dangerous products are presented other qualities which may be of relevance to on the market — classification, packaging public health, and does not establish that it is and labelling — rather than the prior consistent with the protection of public question, whether the marketing of those health to market the product in Belgium, 16 products is acceptable in the first place. with its active ingredient (didecyldimethyl The same is true of another measure ammonium chloride), in its present concen­ mentioned by the United Kingdom Gov­ tration (6g/L), for the indicated purpose (the ernment in its observations, Council cleaning of walls and tiles), to be used in 17 Directive 88/379/EEC. It also appears accordance with the instructions indicated that a product of which the active ingredient on the package, and in the range of condi­ is didecyldimethyl ammonium chloride does tions of use which can be anticipated.

BRANDSMA

As the ized in another Member State only where Court stated in Biologische Producten, it is all the product's active substances are listed for the Member States to decide, in such cir in Annex I to the Directive. The product at cumstances, what degree of protection of issue here does not satisfy this require public health they intend to assure and, in 21 ment. A similar regime has been proposed particular, the strictness of the checks to be 23 in respect of products such as that at issue, in carried out. As the Court indicated in the draft Directive concerning the placing of Heijn, a case concerning residues in food, the

and fourth recitals in the preamble to the Directive.

20. For the particular purposes of the pro­ health protection, it is not easy to see how it ceeding before the national court, it may be can assist the national judge to be informed enough to answer the second question on the of the obligations of the Belgian authorities basis of the preceding paragraph. Firstly, that to deal fairly with an entirely hypothetical proceeding is a prosecution of Ms Brandsma application. On the other hand, it might give for breach on a particular date of a national a false impression to provide an unqualified law; it is not a civil proceeding in which answer to the question regarding Arti­ HEMA seeks to obtain an authorization of cle 36 of the Treaty. It is, in the final analysis, its product. Secondly, the offence alleged is a matter for the national court to apply the the selling of the product without an author­ answers given by the Court and for it alone ization, in circumstances where no authoriz­ to assess their relevance to the particular ation was sought, nor any serious attempt issue it has to decide. I will turn, therefore, made to establish the especially onerous, to the important qualifications to the power unfair or costly features of the Belgian law of Member States which can be found in 2 or its application. 5Indeed, counsel for Article 36 and which have been developed in Ms Brandsma, who, as I have already the case-law of the Court. indicated, was assisted at the oral hearing by a legal adviser to HEMA , was unable to provide any significant information about these matters. I would add that the similarity of the authorization procedures followed in the Netherlands and in Belgium does not establish that the Belgian regime, in this instance, constitutes a useless and burdensome formality. It is perfectly possible that different standards apply, or that comparable standards, applied in different environmental and other circumstances, would lead to different 22. The policy of the Member States in results. applying Article 36 derogations remains sub­ ject to the conditions found in the text. Arti­ cle 36 states that prohibitions or restrictions on imports, exports or goods in transit may 26 be justified on grounds of, inter alia the protection of health and life of humans, ani­ 2 mals and plants, 7and continues: '[s]uch prohibitions or restrictions shall not, how­ ever, constitute a means of arbitrary dis­ crimination or a disguised restriction on trade between Member States'. This means 21. Thus, once it is accepted in principle that that restrictions on the marketing of prod­ Belgium is entitled to maintain a system of ucts 'must be restricted to what is actually product authorization grounded on public

23. This condition of necessity relates both 24. As regards the authorization procedure, to the standards adopted by Member States the Court held in Commission ν Germany and to the authorization procedure that 'by virtue of the principle of propor­ employed to ensure observance of those tionality, traders must also be able to apply, standards. This means that Member States under a procedure which is easily accessible are at all times required, to the maximum to them and can be concluded within a reas­ degree that is consistent with the objective of onable time, for the use of specific additives 32 the protection of public health, 'to assist in to be authorized', and added that 'it must bringing about a relaxation of the controls be open to traders to challenge before the 29 existing in intra-Community trade'. As courts an unjustified failure to grant authoriz­ 33 regards substantive standards, the Court has ation'. In such circumstances, it is for the indicated that the Member States are free to competent national authorities to demon­ choose their own standard 'in so far as there strate that the prohibition is justified on are uncertainties at the present state of scien­ grounds of protection of public health, in the tific research, ... having regard however for light of national habits and with due regard the requirement of free movement of goods to the results of international scientific 30 34 within the Community'. Thus, in the con­ research. text of food additives, the Court has con­ cluded that 'the use of a specific additive which is authorized in another Member State must be authorized in the case of a product imported from that Member State where, in view, on the one hand, of the findings of international scientific research, and in par­ 25. Furthermore, in the course of a national ticular of the work of the Community's Sci­ authorization procedure for a product entific Committee for Food, the Codex Ali- already authorized in another Member State, mentarius Committee of the Food and Member States 'are not entitled unnecessarily Agriculture Organization of the United to require technical or chemical analyses or Nations and the World Health Organization, and, on the other hand, of the eating habits

Conclusion

26. I would therefore recommend to the Court that the following answers be given to the questions referred by the Rechtbank van Eerste Aanleg, Turnhout:

(1) National legislation of a Member State prohibiting pesticides for non- agricultural use which have not previously been authorized by the Minister for Health from being produced, marketed or used in any way must be regarded as a measure having equivalent effect to a quantitative restriction within the meaning of Article 30 of the Treaty establishing the European Community.

(2) A Member State may none the less rely on the exception from the prohibition contained in Article 30 provided for in Article 36 of the Treaty to justify such legislation on grounds of public health, so long as the restriction is necessary in the light of current scientific knowledge, is no more restrictive than neces­ sary of the free movement of goods, does not unnecessarily duplicate tests car­ ried out in another Member State of which the results are available, and can be the subject of an accessible appeal procedure before the national courts in indi­ vidual cases of refusal of authorization.

35 — Case 272/80 Biologische Producten, cited in footnote 1 above, paragraphs 14 and 15 of the judgment.

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