61994C0293

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Introduction

1 A national system of authorization for the sale of biocides, justified on public health grounds under Article 36 of the Treaty establishing the European Community (hereinafter `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 ensuing prosecution of Mrs Brandsma, the manager of the store, the Belgian Court of First Instance has referred two questions concerning the interpretation of Articles 30 and 36 of the Treaty. The judgment of the Court in 1981 in Frans-Nederlandse Maatschappij voor Biologische Producten (1) (hereinafter `Biologische Producten') should provide assistance in answering these questions.

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 Netherlands, but had only two, at the material time, in Belgium. In practice, most of the goods sold by the group in Belgium are provided by Dutch suppliers, who sell to HEMA on favourable terms related to sales volume.

3 Subsequent to a visit to the supermarket on 12 March 1993 by a pharmaceuticals inspector, criminal proceedings were commenced against Mrs Brandsma before the Rechtbank van Eerste Aanleg, Turnhout, for the unlawful sale of an unauthorized algicide, HEMA Tegelreiniger (tile cleanser), contrary to Article 8 of the Royal Decree of 5 June 1975 on the possession, sale and use of pesticides and plant-protection products (hereinafter `the Royal Decree'). This product, whose active ingredient is didecyldimethyl ammonium chloride in the concentration of 6g/L, prevents the formation of algae on walls and tiles.

4 The product was imported from the Netherlands, where it is marketed pursuant to a Dutch authorization, but no corresponding authorization had been obtained in Belgium. Indeed, HEMA has never applied for such an authorization. Counsel for Mrs Brandsma, who was assisted by a legal adviser to HEMA at the oral hearing, in response to questions from the Court, explained this decision as being based in part on cost and in part on HEMA's view that its Dutch authorization should suffice. He was not in a position, however, to give any clear information regarding the costs actually likely to be involved. This general absence of information regarding the practical application of the Belgian authorization procedure arises, presumably, from HEMA's decision to stand aloof from that procedure in reliance on its Dutch authorization. The product's package bears the Dutch authorization number.

5 Article 8 of the Royal Decree provides for a mandatory authorization process. It makes it an offence to trade in, to acquire, offer, expose or put on sale, stock, prepare, transport, dispose of either for valuable consideration or otherwise, import or use pesticides for non-agricultural use which have not previously been authorized by the Minister responsible for public health.

6 Article 10 of the Royal Decree provides for the specification by the Minister of a fixed application fee, and of the scientific tests to be performed at the expense of the applicant. Article 12 provides that applications for authorization should be made on a standard form set out in Annex I to the Royal Decree. Article 13 states that the Minister may require certain scientific tests to be performed before authorization is granted, and may specify the standards with which the product should comply. Article 14 provides that the Minister, acting on the advice of the Erkenningscomité (Authorization Committee) or of the Hoge Gezondheidsraad (Superior Council on Public Health), may specify the conditions under which an authorized product is marketed and used. Article 16 of the Royal Decree provides an appeal procedure against refusal of authorization.

7 Counsel for Mrs Brandsma stated at the oral hearing that the Belgian authorization procedure is identical to the procedure under which HEMA Tegelreiniger was approved for sale in the Netherlands, as set out in a Netherlands law of 1962. (2) However, there is no evidence before the Court that identical or comparable substantive safety standards were specified, or applied in practice, in Belgium and the Netherlands in respect of algicides. Nor has the Court been provided with any information as to standards specified by the Belgian Minister for Health under Article 13 of the Royal Decree. As I have already indicated, HEMA has chosen not to test that procedure.

8 Mrs Brandsma argued in her defence before the national court that the provision in question was contrary to the superior rule contained in Article 30 of the Treaty which prohibits, between Member States, quantitative restrictions on imports and all measures having equivalent effect. The product, she claimed, was lawfully marketed in the Netherlands and complied with all applicable European Community directives.

9 By an order of 20 October 1994, the Fifth Chamber of the Rechtbank van Eerste Aanleg (Court of First Instance), Turnhout, stayed the proceedings, and referred the following questions to the Court for a preliminary ruling under Article 177 of the Treaty:

`1. Must the national legislation of a Member State prohibiting pesticides for non-agricultural use which have not been previously authorized by the Minister for Health from being brought into circulation, acquired, offered, put on display or sale, kept, prepared, transported, sold, disposed of for valuable consideration, or imported or used free of charge, be regarded as a quantitative restriction or a measure having equivalent effect within the meaning of Article 30 of the Treaty, where under that national measure a pesticide for non-agricultural use lawfully marketed in another Member State may not be offered for sale on importation into the first-mentioned Member State so long as no prior authorization has been obtained from the Minister for Health in the first-mentioned State?

2. If the answer to the first question is affirmative and such measure conflicts with Article 30 of the EEC Treaty, may the first-mentioned Member State in the circumstances set out above lawfully rely on the exception from the prohibition contained in Article 30 on grounds of public health as provided for in Article 36 of the EEC Treaty?'

Observations

10 Written observations were submitted by the defendant in the main proceedings, Mrs Brandsma, by the Commission, and by the Austrian, Netherlands, Swedish and United Kingdom Governments. Mrs Brandsma, the Commission and the Swedish Government were also represented at the oral hearing on 1 February 1996.

11 As regards the first question, there was, not surprisingly, a consensus among those who submitted observations that Article 8 of the Royal Decree constitutes a measure having equivalent effect to a quantitative restriction on imports within the meaning of Article 30 of the Treaty, by reference to the tests set out in Procureur du Roi v Dassonville, (3) and in Rewe v Bundesmonopolverwaltung fuer Branntwein (`Cassis de Dijon'). (4)

12 As regards the second question, Mrs Brandsma submitted that the product HEMA Tegelreiniger had been authorized in the Netherlands, and complied in all respects with the applicable European Community directives. She cited in this regard a number of directives on the classification, labelling and marketing of dangerous preparations, (5) and on the marketing and use of certain dangerous substances and preparations. (6) She argued that the application of Article 36 was excluded because there was complete harmonization of marketing requirements at Community level; she also contended (in the alternative, it would appear) that, as public health in Belgium was sufficiently protected by the Dutch testing and authorization process, it would be disproportionate to require a similar process in Belgium, which would, inter alia, require different packaging bearing a Belgian authorization number. The Belgian Government bore the burden of demonstrating otherwise.

13 The Commission, and the Austrian, Netherlands, Swedish and United Kingdom Governments all argue for an affirmative response to the second question. They contend that harmonized Community rules do not yet exist for the authorization of algicide products such as HEMA Tegelreiniger, which fall into the general category of biocides. (7) 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 protection of public health or of the environment. They analyse the directives cited by Mrs Brandsma, and say that harmonized rules on such matters as packaging and labelling do not suffice to address these concerns. At the oral hearing, the agent for the Commission pointed out that these directives, which harmonize rules on labelling and packaging, do not affect the question of authorization to place a product on the market. The Commission pointed out, further, that Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (8) does not cover products of the type at issue in this case. Some of the Member States also contend that mutual recognition of national authorizations would tend to favour the lowest level of protection in the Community, since producers would be likely to seek approval in the Member State applying the least exacting standards. They relied in particular on the judgment of the Court in Biologische Producten, (9) in which it was pointed out that it was for each Member State to decide on the level of protection of these interests required in its territory, although it must avoid duplication and take account of the available results of tests in other Member States which satisfy its own standards.

Analysis

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 Treaty. The Court set out a general test in Procureur du Roi v Dassonville, (10) that `[a]ll trading rules enacted by Member States which are capable of hindering, directly or indirectly, actually or potentially, intra-Community trade are to be considered as measures having an effect equivalent to quantitative restrictions'. The Court, in one of many recent examples, summarized this test as it has been expressed in the subsequent case-law:

`It is established by the case-law beginning with "Cassis de Dijon" (Case 120/78 Rewe v Bundesmonopolverwaltung fuer Branntwein [1979] ECR 649) that in the absence of harmonization of legislation, obstacles to the free movement of goods which are the consequence of applying to goods coming from other Member States where they are lawfully manufactured and marketed, rules that lay down requirements to be met by such goods (such as those relating to designation, form, size, weight, composition, presentation, labelling, packaging) constitute measures of equivalent effect prohibited by Article 30.' (11)

15 The list of such measures in parenthesis merely gives examples of the range of regulations to which the marketing of products is subject, and which fall within the scope of Article 30 of the Treaty. It is implicit in the judgment of the Court in Biologische Producten that a national requirement, prior to marketing, of an authorization from the health authorities of a Member State satisfies the criteria for addition to that list. (12) Such a requirement can hinder intra-Community 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 requirement of authorization is a measure of equivalent effect to a quantitative restriction on imports prohibited by Article 30.

16 I must consequently address the second question, whether the Kingdom of Belgium can rely on an exception from that prohibition, namely the protection of public health, found in Article 36 of the Treaty. (13) It is first necessary to establish whether harmonized 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 they do not. Mrs Brandsma referred in her observations to three items of Community legislation. One (Council Directive 76/769/EEC (14)) simply establishes restrictions on the marketing and use of a number of specified chemical substances (which do not include didecyldimethyl ammonium chloride). The other two (Council Directives 67/548/EEC and 78/631/EEC (15)) concern the manner in which dangerous products are presented on the market - classification, packaging and labelling - rather than the prior question, whether the marketing of those products is acceptable in the first place. (16) The same is true of another measure mentioned by the United Kingdom Government in its observations, Council Directive 88/379/EEC. (17) It also appears that a product of which the active ingredient is didecyldimethyl ammonium chloride does not fall within the material scope of these measures. (18)

17 Even if the product, HEMA Tegelreiniger, did fall within the field of application of any of these Community measures, the fact that it was marked with the appropriate warning `irritant', and with the corresponding symbol, the cross of St Andrew, would establish no more than that the product is a non-corrosive preparation which, through immediate, prolonged or repeated contact with the skin or mucous membrane, can cause inflammation; (19) this is unrelated to other qualities which may be of relevance to public health, and does not establish that it is consistent with the protection of public health to market the product in Belgium, with its active ingredient (didecyldimethyl ammonium chloride), in its present concentration (6g/L), for the indicated purpose (the cleaning of walls and tiles), to be used in accordance with the instructions indicated on the package, and in the range of conditions of use which can be anticipated.

18 It is also clear that the product in question is not governed by the harmonized rules on authorization contained in Directive 91/414/EEC concerning the placing of plant-protection products on the market, as it is also outside its material scope. (20) In any event, that Directive establishes a procedure for national authorization, which was not sought in this case, and which it requires to be accorded to a product already authorized in another Member State only where all the product's active substances are listed in Annex I to the Directive. The product at issue here does not satisfy this requirement. (21) A similar regime has been proposed in respect of products such as that at issue, in the draft Directive concerning the placing of biocidal products on the market, (22) but has not yet been adopted.

19 In the absence of such a harmonized authorization regime, designed to reconcile the general interests in the free movement of goods and in the protection of public health, the Member States remain free to adopt measures designed to safeguard public health, including a system of national authorization of potentially harmful products. As the Court stated in Biologische Producten, it is for the Member States to decide, in such circumstances, what degree of protection of public health they intend to assure and, in particular, the strictness of the checks to be carried out. (23) As the Court indicated in Heijn, a case concerning residues in food, the regulations adopted by different Member States in respect of a product may legitimately vary from one country to another according to climatic conditions, the population's state of health, and its normal diet. (24) The Netherlands Government suggested a number of other possible considerations in respect of biocidal products such as that at issue: the manner of production and use of the product, the presence of the active substance in the environment, the degree to which a Member State is industrialized, the density of its population. I believe that these are all factors which might possibly lead to legitimate differences in the authorization standards adopted by different Member States in the absence of a harmonized regime. In the absence of any information about these, I cannot comment on their possible relevance to any comparison of the respective Belgian and Dutch regimes.

20 For the particular purposes of the proceeding before the national court, it may be enough to answer the second question on the basis of the preceding paragraph. Firstly, that proceeding is a prosecution of Mrs Brandsma for breach on a particular date of a national law; it is not a civil proceeding in which HEMA seeks to obtain an authorization of its product. Secondly, the offence alleged is the selling of the product without an authorization, in circumstances where no authorization was sought, nor any serious attempt made to establish the especially onerous, unfair or costly features of the Belgian law or its application. (25) Indeed, counsel for Mrs Brandsma, who, as I have already 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 results.

21 Thus, once it is accepted in principle that Belgium is entitled to maintain a system of product authorization grounded on public health protection, it is not easy to see how it can assist the national judge to be informed of the obligations of the Belgian authorities to deal fairly with an entirely hypothetical application. On the other hand, it might give a false impression to provide an unqualified answer to the question regarding Article 36 of the Treaty. It is, in the final analysis, a matter for the national court to apply the answers given by the Court and for it alone to assess their relevance to the particular issue it has to decide. I will turn, therefore, to the important qualifications to the power of Member States which can be found in Article 36 and which have been developed in the case-law of the Court.

22 The policy of the Member States in applying Article 36 derogations remains subject to the conditions found in the text. Article 36 states that prohibitions or restrictions on imports, exports or goods in transit may be justified (26) on grounds of, inter alia, the protection of health and life of humans, animals and plants, (27) and continues: `[s]uch prohibitions or restrictions shall not, however, constitute a means of arbitrary discrimination or a disguised restriction on trade between Member States'. This means that restrictions on the marketing of products `must be restricted to what is actually necessary to secure the protection of public health'. (28)

23 This condition of necessity relates both to the standards adopted by Member States and to the authorization procedure employed to ensure observance of those standards. This means that Member States are at all times required, to the maximum degree that is consistent with the objective of the protection of public health, `to assist in bringing about a relaxation of the controls existing in intra-Community trade'. (29) As regards substantive standards, the Court has indicated that the Member States are free to choose their own standard `in so far as there are uncertainties at the present state of scientific research, ... having regard however for the requirement of free movement of goods within the Community'. (30) Thus, in the context of food additives, the Court has concluded 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 particular of the work of the Community's Scientific Committee for Food, the Codex Alimentarius Committee of the Food and Agriculture Organization of the United Nations and the World Health Organization, and, on the other hand, of the eating habits prevailing in the importing Member State, the additive in question does not present a risk to public health and meets a real need, especially a technical one'. (31)

24 As regards the authorization procedure, the Court held in Commission v Germany that `by virtue of the principle of proportionality, traders must also be able to apply, under a procedure which is easily accessible to them and can be concluded within a reasonable time, for the use of specific additives to be authorized', (32) and added that `it must be open to traders to challenge before the courts an unjustified failure to grant authorization'. (33) In such circumstances, it is for the competent national authorities to demonstrate that the prohibition is justified on grounds of protection of public health, in the light of national habits and with due regard to the results of international scientific research. (34)

25 Furthermore, in the course of a national authorization procedure for a product already authorized in another Member State, Member States `are not entitled unnecessarily to require technical or chemical analyses or laboratory tests where those analyses and tests have already been carried out in another Member State and their results are available to those authorities, or may at their request be placed at their disposal. For the same reasons, a Member State operating an approvals procedure must ensure that no unnecessary control expenses are incurred if the practical effects of the control carried out in the Member State of origin satisfy the requirements of the protection of public health in the importing Member State.' (35)

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 necessary of the free movement of goods, does not unnecessarily duplicate tests carried 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 individual cases of refusal of authorization.

(1) - Case 272/80 [1981] ECR 3277.

(2) - It is not clear whether this is the Bestrijdingsmiddelenwet (Law relating to plant-protection products), 1962, which was at issue in Biologische Producten, cited in footnote 1 above, in Case 94/83 Heijn [1984] ECR 3263, and in Case 125/88 Nijman [1989] ECR 3533.

(3) - Case 8/74 [1974] ECR 837, paragraph 5 of the judgment.

(4) - Case 120/78 [1979] ECR 649, paragraph 8 of the judgment.

(5) - Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions 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 to the classification, packaging and labelling of dangerous preparations (pesticides); OJ 1978 L 206, p. 13.

(6) - Council Directive 76/769/EEC of 27 July 1976 on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations; OJ 1976 L 262, p. 201.

(7) - The Commission made a proposal for a European Parliament and Council Directive concerning the placing of biocidal products on the market, on 27 July 1993; OJ 1993 C 239, p. 3, as amended on 24 July 1995; OJ 1995 C 261, p. 5. Biocidal products are defined in Article 2 of the draft Directive.

(8) - OJ 1991 L 230, p. 1.

(9) - Case 272/80, cited in footnote 1 above.

(10) - Case 8/74, cited in footnote 3 above, paragraph 5 of the judgment.

(11) - Case C-293/93 Houtwipper [1994] ECR I-4249, paragraph 11 of the judgment.

(12) - Case 272/80, cited in footnote 1 above, paragraphs 10, 11 and 16 of the judgment.

(13) - Two Member State Governments, those of Sweden and the United Kingdom, also mentioned the possibility of derogation on grounds of environmental protection. This was not adverted to in the question referred by the national court, but can probably be subsumed into the public health ground in this case, as the environmental damage which can result from ill-advised use of biocidal products, in the form of pollution of water and soil, and of the passage of toxins into the food chain, is such as to pose a threat to health.

(14) - Cited in footnote 6 above.

(15) - Cited in footnote 5 above.

(16) - This logical distinction is reflected in the Royal Decree: Chapter II deals with authorization, and Chapter III with labelling and packaging.

(17) - Council Directive 88/379/EEC of 7 June 1988 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations; OJ 1988 L 187, p. 14.

(18) - The agent for the Commission indicated at the hearing that this active ingredient does not appear in the list of dangerous substances in Annex I to Directive 67/548/EEC, cited in footnote 5 above, which defines the material scope of that Directive and of Directives 78/631/EEC, cited in footnote 5 above (see Article 1(3) thereof), and 88/379/EEC, cited in footnote 17 above (see Article 2 thereof).

(19) - Article 2(2)(h), Directive 67/548/EEC, cited in footnote 5 above.

(20) - Article 2.1 of Directive 91/414/EEC, cited in footnote 8 above, defines plant-protection products. An algicide could arguably be deemed to be a preparation intended to destroy undesired plants, within the meaning of Article 2.1.4 of the Directive, as botanists differ on whether algae (or at least certain algae) should be classified as plants. This is certainly the case if one is simply concerned with distinguishing the plant from the animal kingdom. Under a more complex approach, dividing life into five kingdoms (in order of complexity, monera, protista, fungi, plantae, animalia), multi-cellular algae are counted as plants by some authorities (e.g. T. Elliot Weier, Botany: An Introduction to Plant Biology, 6th ed. (John Wiley and Sons, 1982), at pages 8 to 10), but are confined to the kingdom of protista by others (e.g. Raven, Biology and Plants 4th ed. (1986, Worth Publishers), at pages 160 to 162, who classes algae as photosynthetic protists). However, any doubts about whether HEMA Tegelreiniger comes within the material scope of the Directive can be dispelled by reference to the clear objective of regulating products for use in agricultural (rather than domestic) contexts, as indicated by the alternative criteria in Article 2.1, and in the second, third and fourth recitals in the preamble to the Directive.

(21) - Article 10 of Directive 91/414/EEC, cited in footnote 8 above.

(22) - Cited in footnote 7 above. The first and second recitals show that the proposal concerns non-agricultural pesticides. Annex I to the draft Directive also contains a list of active substances, agreed at Community level for inclusion in biocidal products. Member States are responsible for the authorization of such products for their respective markets (Article 3(1)). Mutual recognition of Member State authorizations is prescribed in respect of products whose active substances appear in Annex I (Article 3(3), Article 4(1)), while derogation from this obligation is permitted where environmental circumstances different from those of the Member State of first authorization mean that the product would be either ineffective or dangerous (Article 3(4)).

(23) - Case 272/80, cited in footnote 1 above, paragraph 12 of the judgment.

(24) - Case 94/83, cited in footnote 2 above, paragraph 16 of the judgment.

(25) - For example, it was not demonstrated that the need for products exported to Belgium to bear a Belgian authorization number would inevitably raise packaging costs, as a common package could presumably bear authorization numbers from both countries, clearly indicated as such.

(26) - Emphasis added.

(27) - It seems that the protection of the health and life of humans is the dominant justification for the Belgian authorization regime, in view of the role of the Minister responsible for public health, and his obligation to consult the Hoge Gezondheidsraad.

(28) - Case 178/84 Commission v Germany [1987] ECR 1227, paragraph 44 of the judgment; see also Case 174/82 Sandoz [1983] ECR 2445; Case 247/84 Motte [1985] ECR 3887; Case 304/84 Ministère Public v Muller [1986] ECR 1511.

(29) - Case 272/80 Biologische Producten, cited in footnote 1 above, paragraph 14 of the judgment.

(30) - Case 174/82 Sandoz, cited in footnote 28 above, paragraph 16 of the judgment.

(31) - Case 178/84 Commission v Germany, cited in footnote 28 above, paragraph 44 of the judgment (emphasis added).

(32) - Case 178/84, cited in footnote 28 above, paragraph 45 of the judgment. This statement paraphrases paragraph 26 of the judgment in Case 304/84 Ministère Public v Muller, cited in footnote 28 above, but adds a specific reference to the principle of proportionality.

(33) - Case 178/84 Commission v Germany, cited in footnote 28 above, paragraph 46 of the judgment.

(34) - See paragraph 26 of the judgment in Case 304/84 Ministère Public v Muller, cited in footnote 28 above.

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