C-155/82

composed of: J. Mertens de Wilmars, President, P. Pescatore, A. O'Keeffe and U. Everling (Presidents of Chambers), Lord Mackenzie Stuart, G. Bosco, T. Koopmans, O. Due and K. Bahlmann, Judges,

Advocate General: S. Rozès Registrar: P. Heim

gives the following

COMMISSION v BELGIUM

JUDGMENT

Facts and Issues

JUDGMENT OF 2. 3. 1983 — CASE 155/82

The application shall be submitted in triplicate to the competent minister by By letter of 27 March 1981, the the person established in Belgium who is Commission commenced the procedure responsible for the marketing of the provided for under Article 169 of the phyto-pharmaceutical product or the EEC Treaty against the Kingdom of pesticide for non-agricultural use, Belgium. It claimed that Article 12 of the whether he is the manufacturer, Royal Decree of 5 June 1975 importer, proprietor or concessionnaire. constituted, in respect of the products concerned, a barrier to intra-Community By letter of 5 November 1979, the trade and infringed the requirements Commission drew the attention of the imposed by Article 30 of the EEC Government of the Kingdom of Belgium Treaty, inasmuch as it rendered the to the fact that it had received a marketing of imported products more complaint from the authorities of the difficult than that of domestic products; Federal Republic of Germany, which arguments based on public policy and considered that Article 12 of the Royal public health were not sufficient to Decree, by making the admission of the justify the measure under the provisions above-mentioned goods conditional on of Article 36 of the Treaty. having a representative in Belgium, put foreign producers at a disadvantage and In its observations of 21 May 1981, the therefore constituted a barrier to intra- Belgian Government conceded that

measures which have an effect equivalent of a dangerous nature, and were to quantitative restrictions on imports therefore regulated by the imposition of and are not covered by other provisions extremely strict rules throughout the adopted in pursuance of the EEC Treaty marketing process. It was essential that (Official Journal, English Special Edition the system of control be as effective as 1970 (I), p. 17), measures having an possible. For that system to be effective,

I I I — C o n c l u s i o n s of t h e p a r t i e s Pursuant to the first paragraph of Article 169 of the EEC Treaty, the Commission issued a reasoned opinion on 23 October The Commission claims that the Court 1981, notified to the Kingdom of should: Belgium on 30 October 1981, in which it drew attention to that State's failure to Declare that the Kingdom of Belgium, fulfil its obligations under the Treaty and by providing that only a person requested it to take the necessary established in Belgium may apply for the measures within a period of two months. approval and authorization of pesticides and phyto-pharmaceutical products, has In its reply of 18 February 1982, the failed to fulfil its obligations under Belgian Government emphasized the Article 30 et seq. of the EEC Treaty; necessity of protecting public health in the sector of pesticides for non-agri- Order the Kingdom of Belgium to pay cultural use and phyto-pharmaceutical the costs. products; the requirement that the person with responsibility for marketing The Government of the Kingdom of be established in Belgium provided in Belgium claims that the Court should : that respect a number of safeguards, whch could not be regarded as Declare the Commission's application to incompatible with the Treaty. be unfounded;

Order the Commission to pay the costs.

II — W r i t t e n p r o c e d u r e IV — S u b m i s s i o n s a n d a r g u m e n t s of t h e p a r t i e s in t h e c o u r s e By application lodged on 17 May 1982, of t h e w r i t t e n p r o c e d u r e the Commission instituted these proceed- ings pursuant to the second paragraph of Article 169 of the EEC Treaty for a The Commission does not dispute the declaration that the Kingdom of Belgium fact that numerous phyto-pharmaceutical

products and pesticides for non-agri- regarded as measures having an effect cultural use do indeed present a potential equivalent to quantitative restrictions. danger of intoxication; that fact however cannot justify the disputed provision. The restriction of the right to apply for the necessary approvals and authoriz- The Commission points out moreover ation for phyto-pharmaceutical products that it submitted to the Council on 4 and pesticides for non-agricultural use to August 1976 a proposal for a Council persons established in . Belgium directive concerning the placing of EEC- constitutes a barrier to trade. It is likely accepted plant-protection products on to hinder, directly or indirectly, actually the market (Official Journal 1976, or potentially, intra-Community trade C 212, p. 3), which provides a and therefore constitutes a measure Community solution to the question of having an effect equivalent to a establishment. That solution is quantitative restriction on imports, which incompatible with a "national" solution. is contrary to Article 30 of the Treaty The Commission has already taken unless it is covered by Article 36. action against several Member States for breaches similar to that which is the subject of the present case, particularly in The requirement of an approval or auth- the sector of medicinal products and orization for marketing is justified under phyto-pharmaceutical products. Article 36. The point at issue in,this,case is the necessity of having recourse : to' a person established in Belgium who alone From a legal point of view, it should be may apply for that approval or authoriz- noted that Article 12 (2) of the Royal ation. A comparison with the situation in Decree of 5 June 1975 imposes an other Member States shows that it imperative obligation on producers from is perfectly possible to differentiate other Member States to call upon the between an authorization and the services of an importer or distributor necessity of establishment. established in Belgium who will be "responsible for marketing" and who, as such, is the only person eligible to apply The practical effect of the disputed for the approval or authorization of their legislation is perhaps limited, inasmuch products by the appropriate minister. as the majority of the undertakings concerned have a local representative in any case for reasons of sales policy; nevertheless that consideration raises the (a) That obligation impedes com- question why Belgium considers it mercial transactions connected with necessary to retain legislation which is of importation and marketing, inasmuch as minimal effect. an exporter, who is nearly always the producer, from another Member State is prevented from himself applying for the necessary authorizations in Belgium. The There is a contradiction in the Belgian necessity of acting through the inter- Government's argument. On the one mediary of an undertaking established in hand it seeks to discount the effect on Belgium inevitably entails costs and intra-Community trade, but on the other imposes a burden which is not imposed hand emphasizes all the obligations on domestic producers. Under Directive which the applicant for approval or auth- 70/50/EEC such measures are to be orization must fulfil.

The arguments put forward by the The Belgian Government confuses the Belgian Government are founded on a application for approval and the confusion between the application for marketing of the product; there is no approval and the marketing of the logical necessity for the applicant or the product. In particular, the necessity of holder of the approval and the person providing for effective criminal penalties, with responsibility for marketing to be if it is conceded that they are indeed the same person. The obligations indispensable to ensure the protection of imposed on the holder of the approval, public health, does not automatically in particular as regards liability, might mean that such penalties must be equally well be assigned to the person enforceable against the holder of the with responsibility for marketing the approval; it is sufficient if they apply to product in question. the producer and the retailer of the product.

The authority which granted the approval or authorization is as well The fact that the majority of Member placed as anyone to provide the States dò not have legislation comparable necessary information as to the chemical to the disputed provisions is in itself composition of the product and its toxic sufficient evidence that there are other properties. means of ensuring the protection of the health and life of humans.

Moreover the possibility of initiating criminal or civil proceedings provides no As regards the argument that the justification for the disputed measure. measure in question does not constitute Within the framework of international either a means of arbitrary discrimination legal and administrative cooperation, or a disguised restriction on trade, it there are already sufficient possibilities should be pointed out that Article 52 of for prosecuting an offender, even when the Royal Decree of 5 June 1975

provides for a Benelux approval or auth- territory of the State to which the orization which enables Belgium to set application is submitted. aside not only the requirement that a person be established in Belgium but also that of a national approval or authoriz- ation, provided that a Benelux approval or authorization has been issued by the (a) The Belgian legislation in question Netherlands or Luxembourg. What is is intended to provide every possible possible within the framework of the safeguard in order to avoid accidents Benelux Economic Union should be and the extremely serious consequences possible within that of the EEC. thereof. The holder of the approval established in Belgium is unquestionably in a better position than a holder living The Government of the Kingdom of abroad, perhaps at some considerable Belgium emphasizes that phyto-pharma- distance from the place where the ceutical products and pesticides for non- product is used, to verify that the agricultural use are products which are product satisfies the requirements.

products. It is indispensable for the responsibility. In the event of an protection of the user to adopt legislative accident, it is for the holder of the measures concerning the imposition of approval, as the person who has liability. Article 12 of the Royal Decree knowledge of the total composition of of 5 June 1975 is intended to satisfy that the product and its particular toxic prop- objective. erties, to provide the doctor in attendance with the necessary infor- mation.

234). Belgium, supported by other Member States, has reaffirmed its view that it is necessary to allow Member (b) The fact that a foreign producer States to impose a requirement that the must satisfy conditions for approval, applicant for acceptance reside in the fixed in the absence of a harmonized

system of approval within the foreign undertakings would be at an Community by each Member State, and advantage, because it would be more that he must apply to each individual difficult to enforce the criminal law government to obtain the national against them than against national under- approval in itself amounts to an obstacle takings. to trade. The requirement of having a representative within the national territory is, in that respect, only one element of the system of national (d) In view of the potential danger to approval considered as a whole. public health of phyto-pharmaceutical products and pesticides for non-agri- cultural use, every attempt should be made to impose liability on the under- taking. The requirement provided for by (c) The requirement has only a slight Article 12 of the Royal Decree should be effect on trade. The foreign undertaking regarded as safeguarding a public is completely at liberty to appoint a interest which takes precedence over the representative and the expense of so demands of free trade. doing is not excessive. The fact of having a representative in the Member State may, moreover, have commercial advantages for the foreign undertaking. (e) In any event, the disputed measure In practice, even in States which do not may be justified under Article 36 of the require the establishment of a represen- Treaty on the ground of the protection tative within the national territory, all of the health and the life of humans. undertakings have a local representative. Undertakings are not required to establish a new representative in Belgium, as the application for approval The Court has held that Member States may be submitted by a concessionnaire áre entitled to adopt the necessary who is already established. measures to ensure that public health is protected effectively. For that reason, the holder of the approval must bear the consequences of the liability which he incurs by marketing products which do In any event, if there is a barrier to not conform to the specifications of the trade, it cannot be regarded as having an approval. The holder must be liable to effect equivalent to a quantitative criminal penalties, which, in addition to restriction within the meaning of Article being punitive, have a preventive effect. 30 of the EEC Treaty. Not every measure adopted by governments in connection with imports constitutes such a restriction. This case is concerned with The problem is not, as has been a measure intended to provide the best suggested by the Commission, whether it possible protection for public health. As is possible to initiate criminal pros- far as the threat of criminal prosecution ecutions. Offences committed on Belgian is concerned, the requirement of a territory are always capable of giving rise representative has the effect, not of to prosecution and in those circum- creating discrimination, but, on the stances recourse may be had to contrary, of placing a foreign under- conventions on legal cooperation in taking in the same position as a national criminal matters. Nor is there any undertaking. Without that requirement, difficulty in obtaining a judgment in

V — Oral procedure The threat of enforceable criminal penalties is the condition sine qua non for the liability which must be imposed on the person who markets the toxic The Commission, represented by R. product on national territory. Wägenbaur, and the Government of the Kingdom of Belgium, represented by R. Hoebaer, presented oral argument at the sitting on 7 December 1982. (f) Article 12 of the Royal Decree is compatible with the principle of pro- portionality. The objective consists in The Advocate General delivered her establishing the best protection for public opinion at the sitting on 19 January health, in particular, by ensuring the 1983.

COMMISSION v BELGIUM

Decision

1 By application lodged at the Court Registry on 17 May 1982, the Commission of the European Communities brought an action under Article 169 of the EEC Treaty for a declaration that, by restricting the right to apply for authorization or approval for pesticides for non-agricultural use and phyto-pharmaceutical products to persons established in Belgium, the Kingdom of Belgium has failed to fulfil its obligations under Article 30 et seq. of the EEC Treaty.

2 By the Royal Decree of 5 June 1975 on the storage, marketing and use of pesticides and phyto-pharmaceutical products (Moniteur Belge, p. 13864), Belgium made the marketing on its territory of pesticides for non-agri- cultural use and phyto-pharmaceutical products, more fully defined in the above-mentioned Royal Decree, subject to governmental authorization. Article 12 of the decree provides that authorization may be obtained only by a person established in Belgium who has responsibility for the marketing of one of those products as a producer, importer, proprietor or concessionnaire.

6 Following that statement, on 17 May the Commission brought an action under Article 169.

7 It is not disputed that the requirement imposed by the Belgian legislation constitutes an obstacle to the importation of the products concerned into Belgium, inasmuch as it compels undertakings established in other Member States to incur the cost of establishing a representative in Belgium, and that it may, as a result, make it difficult, if not impossible, for certain undertakings, in particular small or medium-sized undertakings to enter the Belgian market.

8 The Belgian Government acknowledges that the requirement constitutes an impediment to trade within the Community, but argues that it is justified on the ground of the protection of public health, as recognized by Article 36 of the Treaty.

9 It points out that there is, as yet, no harmonized system of approval at Community level in the sphere in question, so that each Member State lays down the rules for approval for its own territory. The requirement of having a representative on national territory is, in that respect, only one element of the system of national approval, taken as a whole.

io It maintains that, in view of the considerable increase in the use of the products concerned and of the high degree of toxicity of certain of them,

COMMISSION v BELGIUM

12 The principle behind the arguments put forward by the Belgian Government can not be disputed, inasmuch as each Member State is entitled to take within its territory, in particular in a sphere in which the objective of the harmonization of health control measures has not yet been achieved, appro- priate measures in order to ensure the protection of public health. However, such measures are justified only if it is established that they are necessary in order to attain the objective of protection referred to in Article 36 and that such protection cannot be achieved by means which place less of a restriction on the free movement of goods within the Community.

JUDGMENT OF 2. 3. 1983 — CASE 155/82

i3 In that connection two observations should be made concerning the arguments put forward by the Belgian Government.

H On the one hand, it seems that the objectives pursued by the Belgian Government with regard to the completion of the approval formalities, the rules on labelling, the verification of the conformity of the product marketed with the product approved and the availability of information in the event of an accident or a complaint may be fully satisfied by appropriate administrative measures taken when the application is examined and the approval is issued, without its being necessary to require the establishment of a representative on national territory.

is On the other hand, questions of criminal liability are relevant to the objective of Article 36 only in so far as the application of criminal provisions may have a preventive effect. In that respect it is clear that, as far as effective prevention is concerned, only the preliminary formalities connected with the issue of the approval and the checks carried out at that stage and, possibly, at the moment when the goods are placed on the market can provide an adequate safeguard for the attainment of the objective pursued by Article 36. Even though criminal penalties may have a deterrent effect as regards the conduct which they sanction, that effect is not guaranteed and, in any event, is not strengthened, in the case of a manufacturer in another Member State who has been issued with an approval, solely by the presence on national territory of a person who may legally represent the manufacturer.

THE COURT

hereby:

1. Declares that, by restricting the right to apply for authorization or approval for pesticides for non-agricultural use and phyto-pharma- ceutical products to persons established in Belgium, the Kingdom of Belgium has failed to fulfil its obligations under Article 30 et seq. of the EEC Treaty;

2. Orders the defendant to pay the costs.

Mertens de Wilmars Pescatore O'Keeffe Everling

Mackenzie Stuart Bosco Koopmans Due Bahlmann