C-100/96

Ministry of Agriculture, Fisheries and Food,

ex parte British Agrochemicals Association Ltd,

on the interpretation of Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ 1991 L 230, p. 1),

* Language of the case: English.

I-1521

JUDGMENT OF 11. 3. 1999 — CASE C-100/96

— the Greek Government, by Ioannis Chalkias, Legal Adviser in the State Legal Service, and by Chrysoula Vellopoulou, Adviser to the General Secretary for Community Matters, Ministry of Foreign Affairs, acting as Agents,

— the Commission of the European Communities, by Xavier Lewis and Gerard Berscheid, of its Legal Service, acting as Agents,

I - 1522

BRITISH AGROCHEMICALS ASSOCIATION

having regard to the Report for the Hearing,

after hearing the oral observations of British Agrochemicals Association Ltd, rep- resented by David Pannick and Thomas de la Mare, Barrister, the United Kingdom Government, represented by Lindsey Nicoli, assisted by Kenneth Parker, the Greek Government, represented by Ioannis Chalkias and Elli Mamouna, Secretary in the Special Department for Community Legal Affairs, Ministry of Foreign Affairs, acting as agent, and the Commission, represented by Xavier Lewis, at the hearing on 17 July 1997,

JUDGMENT OF 11. 3. 1999 — CASE C-100/96

and Food (hereinafter 'MAFF') concerning the legality of the 1994 Control Arrangements governing authorisation to place imported pesticides on the market.

3 The Directive, amended on several occasions, lays down uniform rules on the con- ditions and procedures for the grant of marketing authorisations for plant protec- tion products.

4 According to Article 2(1) of the Directive, 'plant protection products' means 'active substances and preparations containing one or more active substances, put up in the form in which they are supplied to the user' and intended for specific uses.

5 Under Article 2(10), 'any supply, whether in return for payment or free of charge, other than for storage followed by consignment from the territory of the Com- munity or disposal' constitutes 'placing on the market'. Importation of a plant pro- tection product into the territory of the Community is deemed to constitute placing on the market for the purposes of the Directive.

6 According to Article 3(1) of the Directive, 'Member States shall prescribe that plant protection products may not be placed on the market and used in their territory unless they have authorised the product in accordance with this Directive, except where the intended use is covered by Article 22'. It is apparent from the order for reference that Article 22 is not relevant to the present case.

io The 1994 Control Arrangements, which entered into force on 14 March 1994, were drawn up pursuant to the Control of Pesticides Regulations 1986 (S. I. 1986/1510).

I - 1525

JUDGMENT OF 11. 3. 1999 — CASE C-100/96

n The 1994 Control Arrangements prohibit the advertising, selling, supply, storage or use of a pesticide product in the United Kingdom unless the Minister for Agri­ culture, Fisheries and Food and the Secretary of State have jointly given in respect of it a provisional or full approval under Regulation 5 of the Control of Pesticides Regulations and all relevant conditions are complied with.

12 It is apparent from the case file that the 1994 Control Arrangements provide for the authorisation of pesticide products imported from third countries which are identical to products that have provisional or full approval under the Control of Pesticides Regulations ('the master product').

13 Under Paragraph 3(a) of the 1994 Control Arrangements, an imported product is deemed to be identical to a master product if:

is Paragraph 6 of the 1994 Control Arrangements provides that the application for approval must contain, first, a covering letter giving the name of both the master product and the imported product and the type of approval sought, secondly, three copies of the draft label and, finally, evidence that the product to be imported is identical, within the terms of these arrangements, to the master product. This may either be a sample of the original label of the product to be imported or a copy of the label of the product for which the importer is seeking approval to import.

i6 Paragraph 9 of the 1994 Control Arrangements provides:

'The registration authority may require the provision of such additional informa- tion as it considers necessary in support of an application. Where the registration authority arranges for the chemical analysis of samples provided by the applicants, the results of analyses will be confidential to the registration authority.'

17 British Agrochemicals, a limited company which represents 39 members of the agrochemical manufacturing industry, is challenging, before the national court, the legality of the 1994 Control Arrangements. It claims that those arrangements are in breach of the Directive in that they allow an imported product on to the market on the basis that it is identical to a master product already approved in the United Kingdom following tests, even though the components of the master product differ in their nature, quality and quantity from that of the imported product.

I - 1527

JUDGMENT OF 11. 3. 1999 — CASE C-100/96

' 1 . Does Directive 91/414/EEC of 15 July 1991 as amended allow a Member State to permit the placing on the market of a plant protection product imported from another EEA State or from a third country because the Member State considers that product to be identical to a master plant protection product

I -1528

BRITISH AGROCIIUMICALS ASSOCIATION

which has already been authorised by that Member State pursuant to Article 4(1) or 8(2) of the Directive, when the imported product is deemed to be iden- tical to the master product if:

(a) the active ingredient in the imported product is manufactured by the same company (or by an associated undertaking or under licence) as the active ingredient of the master product and is the same within variations accepted by the registration authority; and

(b) the formulation of the imported product is produced by the same company (or by an associated undertaking or under licence) as that of the master product and any differences in the nature, quality and quantity of the com- ponents are deemed by the registration authority to have no material effect on the safety of humans, domestic animals, livestock, wildlife or the envi- ronment generally or on efficacy?

22 It should be recalled at the outset that, according to the second recital in the pre- amble to the Directive, one of the most important ways of protecting plants and plant products and of improving agricultural production is to use plant protection products. According to the fourth recital, however, such use may involve risks and hazards for humans, animals and the environment, especially if placed on the market without having been officially tested and authorised or if incorrectly used.

23 Furthermore, the Directive introduces a set of uniform rules concerning the condi- tions and procedures for the grant of marketing authorisations for plant protection products in order, first, to ensure a high standard of protection of human and animal health and of the environment and, secondly, to eliminate within the Com- munity obstacles to trade in plant protection products and plant products arising from the existence of divergent national rules.

24 The Directive thus provides that a plant protection product may not be placed on the market of a Member State and used unless it has been duly approved in accor- dance with the Directive's provisions. Moreover, under the Directive, the importa- tion of a plant protection product into the Community is tantamount to placing it on the market.

I-1530

BRITISH AGROCHEMICALS ASSOCIATION

25 The United Kingdom Government claims that the Directive does not apply where a person is seeking to put on the market of a Member State a plant protection product imported from an EEA State or a third country which is identical to another plant protection product that is already authorised and marketed in that Member State. The Government takes the view that the Member States must adopt the definition of identicality laid down by the Court in Case 104/75 De Peijper [1976] ECR 613.

27 Furthermore, in Case C-201/94 Smith & Nephew Pharmaceuticals and Primeer own [1996] ECR 1-5819, paragraph 21, concerning the interpretation of Council Direc- tive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal prod- ucts (OJ, English Special Edition 1965-1966, p. 20), as amended in particular by Council Directive 87/21/EEC of 22 December 1986 (OJ 1987 L 15, p. 36, herein- after 'Directive 65/65'), the Court considered that that directive could not apply to à proprietary medicinal product covered by marketing authorisation in one Member State and imported into another Member State as a parallel import of a proprietary medicinal product already covered by marketing authorisation in the latter Member State, since that imported product cannot, in such a case, be regarded as being placed on the market for the first time in the Member State of importation.

I-1531

JUDGMENT OF 11, 3. 1999 — CASE C-100/96

28 It went on to explain, at paragraphs 25 and 26 of that judgment, that the competent authority in the Member State of importation must verify that the two proprietary medicinal products, which have a common origin by virtue of the fact that they are manufactured pursuant to agreements concluded with the same licensor, if not iden- tical in all respects, have at least been manufactured according to the same formula- tion, using the same active ingredient, and have the same therapeutic effects.

29 That reasoning may be applied, mutatis mutandis, to the placing of plant protec- tion products on the market.

33 It is important, however, that the competent authority should verify, apart from the existence of a common origin, that the two plant protection products, if not iden- tical in all respects, have at least been manufactured according to the same formula- tion, using the same active ingredient, and also have the same effect with due regard, in particular, to differences which may exist in conditions relating to agriculture, plant health and the environment, in particular climatic conditions, relevant to the use of the product.

34 In order to verify that those conditions are met, the competent authority of the Member State of importation has available to it, as the Court pointed out in para- graph 27 of the judgment in Smith & Nephew and Primecrown, legislative and administrative means capable of compelling the manufacturer, his duly appointed representative or the licensee for the plant protection product already covered by marketing authorisation to supply information in their possession which the authority considers to be necessary. Moreover, the competent authority may consult the file submitted in connection with the application for marketing authorisation in respect of the plant protection product already authorised.

35 Finally, Article 12 of the Directive on the exchange of information is designed to enable the competent authority of the Member State of importation to obtain the documents necessary for verification.

36 If, on completion of the examination carried out by the competent authority of the Member State of importation, the latter finds that all the abovementioned criteria are fulfilled, the plant protection product to be imported must be considered to have already been placed on the market of the Member State of importation and, accordingly, must be able to benefit from the marketing authorisation granted in respect of the plant protection product already on the market, unless that is pre- cluded by considerations concerning the effective protection of human and animal health and of the environment.

I-1534

BRITISH AGROCHEMICALS ASSOCIATION

— shares a common origin with that product in that it has been manufactured by the same company or by an associated undertaking or under licence according to the same formulation,

— was manufactured using the same active ingredient, and

— also has the same effect with due regard to differences which may exist in con- ditions relating to agriculture, plant health and the environment, in particular climatic conditions, relevant to the use of the product,

that product must be able to benefit from the marketing authorisation already granted in the Member State of importation, unless that is precluded by consider- ations concerning the protection of human and animal health and of the environ- ment.

45 The United Kingdom Government claims, however, that it would be contrary to Article 5.1 of the Agreement on Technical Barriers to Trade which appears in Annex 1A to the Agreement establishing the "World Trade Organisation, approved on behalf of the Community as regards matters within its competence by Council Decision 94/800/EC of 22 December 1994 concerning the conclusion on behalf of the European Community, as regards matters within its competence, of the agree- ments reached in the Uruguay Round multilateral negotiations (1986-1994) (OJ 1994 L 336, p . 1, hereinafter 'the Technical Barriers Agreement'), to interpret the Directive as meaning that its provisions on the procedure for granting marketing authorisation apply to the placing on the market of a plant protection product imported from a third country which is deemed by the competent authority of the Member State of importation to be identical to a plant protection product already authorised within its own territory. Article 5.1.1 of the Technical Barriers Agree- ment lays down the principle of non-discrimination with regard to the prepara- tion, adoption and application of procedures to assess conformity of products with technical regulations or standards, while Article 5.1.2 prohibits such procedures from having as their purpose the creation of unnecessary obstacles to international trade, taking account in particular of the risks non-conformity would create.

46 In that connection, it is sufficient to state that, on the grounds set out at paragraphs 43 and 44 above, to apply the conditions for the grant of marketing authorisation laid down by the Directive to a plant protection product imported from a third country but not already granted marketing authorisation in accordance therewith, cannot be considered to be discriminatory or to create an unnecessary barrier to international trade, even if the competent authority of the Member State of impor- tation may regard that product as identical to a plant protection product already covered within its territory by a marketing authorisation granted in accordance with the Directive.

Costs

so The costs incurred by the United Kingdom and Greek Governments and by the Commission, which have submitted observations to the Court, are not recover- able. Since these proceedings are, for the parties to the main proceedings, a step in the proceedings pending before the national court, the decision on costs is a matter for that court.

I-1537

JUDGMENT OF 11. 3. 1999 — CASE C-100/96

O n those grounds,

T H E C O U R T (Sixth Chamber),

BRITISH AGROCHEMICALS ASSOCIATION

t h a t product m u s t be able to benefit from the marketing authorisation already granted in the Member State of importation, unless that is precluded by considerations concerning the protection of h u m a n and animal health and of the environment.

2. The competent authority of one Member State may grant marketing a u t h o - risation for a plant protection product imported from a third country which is n o t already covered by marketing authorisation granted in accordance with the provisions of Directive 91/414 in another Member State, only under the conditions laid down by t h a t directive.

Kapteyn Hirsch Murray

Ragnemalm Schintgen

Delivered in open court in Luxembourg on 11 March 1999.