delivered on 10 July 2007 1

Joined Cases C‑260/06 and C‑261/06

Ministère public

Daniel Escalier and Jean Bonnarel

(Reference for a preliminary ruling from the Cour d’appel de Montpellier (France))

Directive 91/414/EEC – Scope – Article 28 EC – Marketing authorisation of a parallel import – Plant protection product imported from a Member State of the European Economic Area or from a third country – Whether identical to a plant protection product already authorised by the Member State of importation – Conditions for authorisation of importation – Respect for the principle of proportionality)

I – Introduction

II – Legal background

A – Community law

3. Article 28 EC provides that ‘[q]uantitative restrictions on imports and all measures having equivalent effect shall be prohibited between Member States’.

4. Article 30 EC provides that ‘[t]he provisions of [Article 28] shall not preclude prohibitions or restrictions on imports, exports or goods in transit justified on grounds of public morality, public policy or public security; the protection of health and life of humans, animals or plants; the protection of national treasures possessing artistic, historic or archaeological value; or the protection of industrial and commercial property. Such prohibitions or restrictions shall not, however, constitute a means of arbitrary discrimination or a disguised restriction on trade between Member States’.

5. Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (2) (‘Directive 91/414’) harmonises the legislation of Member States in relation to the authorisation, placing on the market, use and control of plant protection products.

8. However, Directive 91/414 contains no provision governing the conditions for the grant of marketing authorisation to parallel imports, in other words when a trader seeks to import a product which is authorised in one State into another State in which a similar product has already been authorised.

B – National law

9. Under Article L-253-1 of the Code rural (Rural Code), ‘placing on the market, use and possession by the end user of plant protection products are prohibited if those products lack marketing authorisation’.

11. Decree No 2001-317 of 4 April 2001 establishes a simplified procedure for marketing authorisations for plant protection products from the European Economic Area. (4) Under Article 4, ‘[t]he marketing authorisation of the product introduced into national territory may be refused or withdrawn … on grounds of protection of human and animal health and of the environment; … where there is no identity, within the meaning of Article 1, with the reference product …’.

12. The annex to the Order of 17 July 2001 on the application of Decree No 2001-317 establishing a simplified procedure for marketing authorisations for plant protection products which are parallel imports (5) states that any applicant for marketing authorisation must provide, inter alia, ‘the trade name to be used in France for the product for which application is made’.

III – The main proceedings and the reference for a preliminary ruling

13. The main proceedings have their origin in legal actions brought by the DRAF against wine growers in Languedoc-Roussillon, a region on the Spanish border.

A – Case of Mr Escalier (Case C-260/01)

14. On 6 May 2003 officials of the DRAF carried out an inspection of premises for the storage of pesticides originating in Spain for agricultural use on land farmed by Mr Escalier and drew up an official report of offences of use and possession with intent to use such products when there was no marketing authorisation for them. On 7 January 2004 the DRAF decided to bring criminal proceedings against Mr Escalier. On 15 June 2005 the Tribunal de grande instance de Carcassonne (Regional Court, Carcassonne) convicted Mr Escalier of those offences and fined him EUR 1 500, with stay of payment. The court also ordered extracts from the judgment to be published in the regional newspapers at the defendant’s expense. Mr Escalier then brought an appeal against that judgment before the Cour d’appel de Montpellier.

B – Case of Mr Bonnarel (Case C-261/01)

15. On 17 April 2003 officials of the DRAF carried out an inspection of premises for the storage of pesticides originating in Spain for agricultural use on land farmed by Mr Bonnarel and drew up an official report for the impounding of such products that lacked marketing authorisation. On 2 July 2003 an official report of the offences of possession of those products with intent to use them was drawn up. The DRAF then decided to bring criminal proceedings against Mr Bonnarel. On 15 June 2005 the Tribunal de grande instance de Carcassonne convicted Mr Bonnarel of that offence and fined him EUR 1 500, with stay of payment. The court also ordered extracts from that judgment to be published in the regional newspapers at the defendant’s expense. Mr Bonnarel brought an appeal against that judgment before the Cour d’appel de Montpellier.

C – Questions referred for a preliminary ruling

16. The Cour d’appel de Montpellier made the following findings: the objective of the marketing authorisation procedure established by the French legislature is to ensure that products which present any risk or danger to humans, animals or the environment are not placed on the market; the objective of the simplified authorisation procedure is to reconcile the principle of free movement of goods within the Community with the need to allow each Member State the ability to ensure the protection of public health and the environment while taking into account in particular any specific local factors; Directive 91/414 makes no distinction between parallel imports for commercial purposes and those by individuals for private purposes which are for strictly personal use; the Court of Justice held, in Case C‑212/03 Commission v France, (6) that it is for the French authorities, in relation to personal imports of medicinal products, as distinct from commercial imports, to adopt an authorisation procedure adapted to the specific nature of those imports; the Court of Justice, in Case C‑100/96 British Agrochemicals Association, (7) stated in paragraph 31 that where a plant protection product covered by a marketing authorisation granted in accordance with the provisions of Directive 914/14 in one Member State is imported into another Member State as a parallel import of a plant protection product already covered by a marketing authorisation in the Member State of importation, the provisions of the Directive on the procedure for the grant of marketing authorisation do not apply. The Cour d’appel de Montpellier accordingly considered it necessary to stay the proceedings and refer the following questions to the Court of Justice:

(1) Where a Member State subjects the importation of a plant protection product from another Member State in which the product already has a marketing authorisation issued in accordance with Directive [91/414] to a simplified marketing authorisation procedure in order to verify that the product imported meets the identity requirements laid down in [British Agrochemicals Association], is that Member State entitled to make an operator subject to that simplified authorisation procedure where:

– the importer is a farmer who is importing the product solely for the needs of his farm, which are manifold but limited in quantity, and is therefore not placing it on the market in the commercial sense which that concept implies;

– the simplified marketing authorisation procedure constituting import authorisation is personal to each operator/distributor, who is required to give the product imported his own brand name and is subject to a charge of EUR 800?

(2) If the reply to the first question is negative, can the judgment [in Commission v France] on personal imports of medicinal products by individuals be applied to the case of plant protection products imported by farmers solely for the needs of their farms?

IV – Observations submitted to the Court

A – The first question referred for a preliminary ruling

17. Mr Escalier and Mr Bonnarel consider that the French legislation is contrary to the judgment of the Court in Kohlpharma (8) in so far as it requires that that imported plant protection products are manufactured by the same company as that which manufactures the reference products in France.

18. They submit that the requirement of an individual marketing authorisation for personal imports by farmers solely for the needs of their own plant production is disproportionate having regard to the conditions imposed on obtaining that authorisation, particularly when no distinction is made between parallel imports for commercial purposes and personal imports, and when there are imposed on farmers the same obligations as are imposed on distributors to pay a fee of EUR 800 and to register a new trading name.

19. The methods employed by the French authorities to determine that the product for which marketing authorisation is sought and the reference product are identical are all the more disproportionate in that there is no plant protection product which is authorised in another Member State, and particularly in Spain, which could not be used in France on the grounds of specific agricultural, plant health or environmental – particularly climatic – conditions, or on grounds of ensuring protection of human and animal health and the environment. The Commission of the European Community thus produced, on 12 July 2006, a proposal for a Regulation (9) which would replace the concept of national marketing authorisation with the concept of zonal marketing authorisation by means of compulsory application of the principle of mutual recognition by all Member States in the same zone.

21. The French Government, and also the Finnish Government, submit that the fact that farmers who import plant protection products for use on their own farms are subject to a simplified marketing authorisation procedure such as that laid down in France by the Decree of 4 April 2001 is clearly justified having regard to the objectives of protection of human and animal health and protection of plants and the environment. There is no difference between those farmers who import plant protection products for use on their own lands and commercial undertakings who import such products. The checks which have to be made on an imported product in order to be satisfied that it is identical to the reference product are exactly the same. It is essential that those products which are potentially dangerous are not used until a check has been made that they do not cause harm, how they are to be applied, what their conditions for use are, and whether they are duly labelled in French, as permitted by Article 16(5) of Directive 91/414. The effects of those products are not restricted solely to the surface area of a farmer’s lands, but extend beyond the boundaries of his lands and can spread throughout neighbouring areas. Further, those products are applied to plants which are then supplied for human or animal consumption beyond the boundaries of the farm. In addition, a product which is authorised in one Member State is not necessarily authorised on the same conditions in France, since each product presents specific dangers according to the biotope (biological community) into which it is introduced.

22.Without the simplified marketing authorisation procedure, it would be impossible to be satisfied that the products imported by a farmer solely for the needs of his farm did not present a risk to public health and to the environment. Moreover, the requirements of the simplified procedure at issue are not excessive. As regards the payment of a fee of EUR 800, that is justified by the fact that the competent authority systematically examines every case and makes checks of material held by its foreign counterparts.

23.In the opinion of the French and Netherlands Governments, the national court is wrong, in its first question, to refer to an obligation on the part of the importer to attach his own brand name to the product. The annex to the Order of 17 July 2001 confines itself, under the heading ‘French identification of import’, to requesting provision of ‘the trade name to be used in France for the product for which application is made’.

24.The Finnish, Greek and Netherlands Governments, referring to Article 3(1) or (4) of Directive 91/414, consider that a Member State is entitled to insist on application of a simplified marketing authorisation procedure in the case of the parallel import of plant protection products for the needs of a farm.

25.The Finnish and Netherlands Governments refer to paragraphs 26 to 31 of <i>British Agrochemicals Association, </i> which, they argue, state that, although Directive 91/414 does not apply to parallel imports, the same objectives of protection of human and animal health and of the environment which governed the adoption of the directive also hold good for parallel imports.

26.The Greek Government submits that, in the light of the first subparagraph of Article 9(1) of Directive 91/414 and the case-law of the Court, a provision of national legislation which systematically imposes on a farmer the marketing authorisation procedure for a plant protection product which has already successfully undergone that procedure, in conjunction with the high cost, might be considered to infringe the principle of proportionality.

27.In the opinion of the Netherlands Government, the national court’s observation that the farmer does not place the product on the market in the commercial sense that that concept implies is beside the point. ‘Placing on the market’ must be understood as ‘any supply, whether in return for payment or free of charge’ (Article 2(10) of Directive 91/414), especially as part of the product can be resold. Unlike medicinal products supplied on prescription, it will be difficult to monitor the quantity of plant protection products which a farmer does in fact use for his own needs.

28.As to a possible infringement of the principle of proportionality, the Netherlands Government submits that assessment by the Member State of importation, firstly, is necessary for the system of authorisations established by Directive 91/414 to work and for the monitoring obligation incumbent on the Member States under Article 17 to be effective, and, secondly, is permitted by the judgment of the Court in <i>British Agrochemicals Association</i>. The national court should assess whether the amount of the actual expenses is not excessive and whether there is a reasonable balance between the fee and the service provided. In the present case, it is not obvious that that the sum of EUR 800 represents a heavy imposition by comparison with the advantages of the parallel imports, namely a saving of 30 to 40% on respectively EUR 30 000 or EUR 12 000 per annum, the more so when the authorisation is valid for several years.

29.The Commission proposes that the Court’s reply should be that Article 28 EC precludes the requirement that the parallel import of a plant protection product be subject to a prior authorisation procedure when that plant protection product has already received an authorisation as a parallel import issued to another economic operator. The safety, effectiveness and quality of products which already have a marketing authorisation issued to another party have already been established. A prior authorisation procedure ought not to be applied to every batch of plant protection products which are parallel imports, but ought to cover a group of actual import transactions. The monitoring of each actual import transaction cannot be other than limited.

30.The Commission recognises that use of a plant protection product may harm not only the person who uses it – like a medicinal product – but also other persons, animals and the environment. That consideration may possibly justify, in certain cases, the fact that personal importation, and accordingly use, of plant protection products is subject to a prior authorisation system slightly stricter than that which may be applied to personal importation of medicinal products for human use, when the plant protection product is not covered by a marketing authorisation in the Member State of importation. However, that is not the situation in the cases before the Court. In the case of plant protection products as in the case of medicinal products for human use, personal importation, in a limited quantity, is less likely to be harmful than commercial importation. It is therefore absolutely logical, when dealing with personal importation of plant protection products as with personal importation of medicinal products for human use, to apply a system of prior authorisation, when it is justified, which is markedly less onerous than that applied to commercial importations.

31.The mere requirement of a prior authorisation at the time of a personal parallel importation of plant protection products is a measure of equivalent effect within the meaning of Article 28 EC, since it prevents the intended importation until the prior authorisation is obtained, and entails an administrative cost likely to deter the potential importer from proceeding with the transaction. That is even more true when, as in the present case, the procedure for the person resorting to it is costly, and even likely to cancel out the economic advantage of the transaction.

B – The second question referred for a preliminary ruling

32.The French Government proposes that the second question referred by the national court should be answered in the negative, having regard to the specific nature of plant protection products and the fact that imports made by a farmer solely for the needs of his own farm cannot be regarded as imports for personal purposes but as imports for commercial purposes. The French Government points out that <i>Commission</i> v <i>France</i>, to which the question refers, concerns imports of medicinal products for human use prescribed by a doctor, the use of which is strictly personal. The effects of those products accordingly remain limited to the person who consumes them. On the other hand, in the case of plant protection products, no prescribing doctor or pharmacist takes responsibility for use of the product, which could carry risks not only for the farmer but also for other human beings and for animals, plants and the environment. Further, that judgment made a distinction between imports of medicinal products for commercial objectives and imports for personal objectives. Unlike an individual who imports medicinal products for personal purposes, a farmer who imports plant protection products solely for the needs of his own farm does so for commercial purposes. Moreover, if it becomes necessary to withdraw or recall those products, it will be particularly difficult to trace them if the Court were to extend that case-law to plant protection products.

33.The Greek and Netherlands Governments consider that no reply should be given to the second question. In any event, both they and the Finnish Government agree with the reflections of the French Government as to the differences between medicinal products which are prescribed by a doctor, the use of which is strictly personal, and plant protection products which present a danger both to the environment and to the consumer of the treated products.

34.The Commission considers that the second question referred for a preliminary ruling is the same as the first.

V – Preliminary observations

35.Under Article 28 EC, quantitative restrictions on imports and all measures having equivalent effect are prohibited in trade between Member States. A measure having equivalent effect is a measure capable of hindering, directly or indirectly, actually or potentially, intra‑Community trade. However, Article 30 EC allows the possibility of prohibitions or restrictions which are justified on grounds of ‘protection of health and life of humans, animals or plants’. The Court has stated that protection of the environment is a mandatory requirement which may restrict the scope of Article 28 EC. However, the principle of proportionality, which underpins the last sentence of Article 30 EC, requires that the power of Member States to prohibit importation of products from other Member States be restricted to what is necessary for the attainment of legitimately pursued health protection objectives.

36.As stated above (point 8), Directive 91/414 does not contain any provision which specifically governs the conditions for the granting of marketing authorisation for plant protection products in the context of parallel imports. That that directive does not apply to parallel imports was clearly stated by the Court in Case C‑400/96 <i>Harpegnies</i>, confirmed, as the national court has observed, in <i>British Agrochemicals Association</i>.

37.According to the latter judgment, where two marketing authorisations are granted in conformity with Directive 91/414, the objectives which the directive pursues as to protection of human and animal health and of the environment do not call for the same treatment. In such a situation, application of the directive’s provisions concerning the procedure for the grant of a marketing authorisation would go beyond what is necessary to achieve those objectives and could, without justification, run counter to the principle of the free movement of goods laid down in Article 28 EC.

38.The Court then stated in that judgment under what conditions such a simplified authorisation procedure as regards the placing on the market of plant protection products is permissible. In addition to the existence of a common origin in the sense that they have been manufactured by the same company or by an associated undertaking or by one working under licence according to the same formulation, the two plant protection products at issue, if not identical in all respects, must have at least been manufactured according to the same formulation, using the same active substance, 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.

39.Following that judgment a simplified procedure was set up by the French Government by Decree No 2001-317, taking up those conditions of permissibility, and by the Order of 17 July 2001.

VI – Assessment

A – The first question referred for a preliminary ruling

40.The first part of the first question referred for a preliminary ruling aims to establish whether a Member State may impose a simplified marketing authorisation procedure on a farmer who imports a plant protection product when that farmer has imported the product only for the exclusive needs of his farm.

41.According to the Commission, that requirement is a measure of equivalent effect within the meaning of Article 28 EC inasmuch as it imposes an administrative charge which is likely to deter such an importer.

42.However, as it has just been stated, French law, by requiring the general rule of a simplified marketing authorisation procedure, merely puts into effect what was stated in <i>British Agrochemicals Association </i> to be necessary, namely the checking whether the product for which importation is sought and the product which already has marketing authorisation in the Member State of importation have a common origin.

43.Mr Escalier and Mr Bonnarel for their part claim, inter alia, that the French legislation infringes the Court’s judgment in <i>Kohlpharma </i> by imposing the requirement that the imported plant protection products are manufactured by the same company as that which manufactures the reference products in France.

44.It must be stated, although the national court does not ask the Court for guidance on the criteria of identification of the product for which importation is sought and the reference product, that the scope of that case, which states that the fact that an already authorised medicinal product and another medicinal product for which marketing authorisation is sought do not have a common origin cannot, in itself, be a ground for refusal of marketing authorisation to the second medicinal product, cannot be extended to plant protection products. While a medicinal product is prescribed by a doctor and ingested solely by a single patient, a plant protection product such as that in these proceedings, namely a pesticide, is likely to spread into the countryside environment, both through the air and through the ground. What is more, those pesticides are designed to be used on plants which are intended for sale and for human or animal consumption.

45.There is no doubt that plant protection products are dangerous. To be persuaded of that, one need only read the Sixth Environment Action Programme which aims inter alia to reduce the risks associated with the use of pesticides, improve controls on the use and distribution of pesticides and promote replacement of the more dangerous active substances by safer substances such as non‑chemical substitutes, or peruse the academic literature on the subject.

46.Accordingly, a State is justified in requiring that an importer, even in the case of a wine grower who will use the product only for spreading on his own fields, apply for a simplified marketing authorisation. True, the product is not directly marketed, since it is not resold, but it is certainly part of a commercial process, since the plant products on which the pesticide is spread will subsequently be marketed. The Court, in <i>British Agrochemicals Association</i>, did not moreover distinguish according to the objective of the importation or the status of the applicant, since the risks which flow from the use of plant protection products remain the same.

47.As regards the argument of Mr Escalier and Mr Bonnarel to the effect that there is no plant protection product which is authorised in another Member State, and in particular in Spain, which cannot be used in France, and that the European Commission has produced a proposed regulation which will replace the concept of a national marketing authorisation with the concept of a zonal marketing authorisation, the response can be given that, on any view, the concepts of ‘national’ and ‘zonal’ marketing authorisation cannot be identical. A zonal marketing authorisation, which covers a much wider territory, implies that the specific factors of the areas covered are taken into account, while a national marketing authorisation takes into account only the characteristics of its own territory.

48. The second part of the first question referred for a preliminary ruling aims to establish whether the simplified importation authorisation procedure must be personal, and whether the importer can be compelled to attach his own brand name to the imported product and to pay a fee of EUR 800. That raises the issue of the proportionality of what may be asked of a farmer who imports a plant protection product for his personal needs, when there already exists an authorised reference product in the State of importation.

(a) The need for personal authorisation

49. The potential dangers of plant protection products to which reference has been made are the justification of the requirement that every import be covered by a declaration and an authorisation even if the latter is addressed to a single user. Responsibility for the use of such a product cannot be left to the assessment merely of a user but must be covered by authorisation by the public authorities.

50. In addition, a Member State must be aware of all the plant protection products to be found on its territory, particularly because it must, under Article 12(1) of Directive 91/414, ‘[w]ithin a period of one month at the end of each quarter at least, … inform [other Member States] and the Commission in writing of any plant protection products authorised or withdrawn … indicating at least: the name or business name of the holder of the authorisation – the trade name of the plant protection product, – the type of preparation, – the name and amount of each active substance which it contains … where relevant, the reasons for withdrawal of an authorisation’. Article 12(2) also provides that ‘[e]ach Member State shall draw up an annual list of the plant protection products authorised in its territory and shall communicate that list to the other Member States and the Commission’. Further, authorisations are granted only for a fixed period not exceeding 10 years (Article 4(4)), and the authorisations can be reviewed at any time (Article 4(5)). A Member State can in addition authorise products only for a provisional period (Article 8). Moreover, if a Member State decides to withdraw a plant protection product, it is very necessary that it be aware of all similar products on its territory so that it can have them all withdrawn.

51. The Finnish and Greek Government have stated in their observations on these proceedings that they consider that a Member State may justifiably require the operation of a simplified marketing authorisation procedure in the case of parallel importation of plant protection products for the needs of a farm, from which one can infer that their respective legal systems impose such an obligation. The same is also true for example in the United Kingdom and in Slovenia.

(b) The proportionality of the obligation to specify a trading name

52. While the importation of pesticides by wine growers, for spreading on their plant products which are intended for sale, falls incontestably into the category of commercial activity, it must be stated that in such circumstances the pesticides are not themselves intended for sale. Accordingly, the specification of a trading name appears to lack any justification.

53. In that regard, it is of interest to observe that such a specification is not for example obligatory in the United Kingdom, where the importer need only use the trading name under which the product is registered in the State of exportation.

54. In these proceedings, the Finnish, Greek and Netherlands Governments do not contend that the specification of a trading name for an import intended for strictly personal use is necessary.

55. The French Government, supported on this point in particular by the Netherlands Government (see point 23 above), argues on the other hand that French law does not at all impose that obligation in such circumstances. The national court is said to have misinterpreted the matter of naming the imported product.

(c) The proportionality of the obligation to pay a fee of EUR 800

56. The obligation to pay a fee which is overly high prior to importation of a plant protection product may be a deterrent. It may therefore hinder, directly or indirectly, actually or potentially, imports and therefore the effectiveness of Article 28 EC. The Netherlands Government calculates that the sum of EUR 800 does not represent too heavy an imposition in relation to the savings that the importation may allow to be made. That calculation is however of little use, given that the fee in question is proportional not to the savings which may potentially be made, but to the costs of the checks which the State authorities must carry out in order to establish the similarity of the product for which importation is sought to the reference product. But there is no question, in the case of a parallel import, of carrying out scientific tests, only of checking that the product is identical to the reference product. To respect the principle of proportionality, such a fee should not exceed the actual cost of checking that the product for which importation is sought is identical to the reference product.

57. The French Government contends that the sum of EUR 800 is justified by the fact that the authorities check documents held by their foreign counterparts. However, the very principle of parallel importation implies that the identity of the product sought to be imported is checked not against the original product but against the ‘reference product’, which is to say, the product already imported.

58. By way of comparison, it is interesting to observe that in the United Kingdom, the charges differ according to whether the parallel import is for personal use or for commercial use. In Slovenia, while the charges are the same whatever the purpose of import, the charges, although annual, amount to only EUR 17.73.

59. The reply to the first question must therefore be that a Member State is entitled to subject a farmer who imports a plant protection product as a parallel import solely for the needs of his farm to a simplified authorisation procedure. That authorisation, personal to each importer, cannot however be conditional on the naming of the imported product with a brand name specific to the importer and cannot be subject to a fee which exceeds the real costs of checking that the product for which importation is sought is identical to the reference product.

B – The second question referred for a preliminary ruling

62. As has been argued in points 44 and 45 above, medicinal products, prescribed by a doctor for a single patient, cannot be compared to plant protection products used on plant products which are designed to be sold.

63. The answer to the second question must therefore be that Commission v France, which relates to personal imports of medicinal products by individuals, is not capable of being applied to plant protection products imported by farmers solely for the needs of their farms.

VII – Conclusion

64. In the light of the foregoing reflections, I suggest that the Court reply as follows to the questions referred by the Cour d’appel de Montpellier:

(1) A Member State is entitled to subject a farmer who imports a plant protection product as a parallel import solely for the needs of his farm to a simplified authorisation procedure. That authorisation, personal to each importer, cannot however be conditional on the naming of the imported product with a brand name specific to the importer and cannot be subject to a fee which exceeds the real cost of checking that the product for which importation is sought is identical to the reference product.

(2) The judgment of the Court in Case C‑212/03 Commission v France, which relates to personal imports of medicinal products by individuals, is not capable of being applied to plant protection products imported by farmers solely for the needs of their farms.

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(1) Original language: French.

(2) – OJ 1991 L 230, p. 1.

(3) – Journal officiel de la République française, 7 May 1994, p. 6683.

(4) – Journal officiel de la République française, 14 April 2001, p. 5811. Text consolidated in Articles R.253-52 to R.253-55 of the Code rural.

(5) – Journal officiel de la République française, 27 July 2001, p. 12091.

(6) – Case C‑212/03 [2005] ECR I‑4213.

(7) – Case C‑100/96 [1999] ECR I‑1499.

(8) – Case C‑112/02 [2004] ECR I‑3369.

(9) – 2006/0136 (COD) – COM (2006) 388 final. Annex 1 concerning the definition of zones for the authorisation of plant protection products defines a Zone C – South to include both France and Spain as well as Portugal, Greece, Italy, Cyprus and Malta.

(10) – Case 8/74 Dassonville [1974] ECR 837, and Case 120/78 Rewe-Zentral (‘Cassis de Dijon’) [1979] ECR 649.

(11) – Case 302/86 Commission v Denmark 1988 [ECR] 4607, paragraph 9. Thus, the obligation imposed by national legislation on manufacturers and importers, as part of a system under which the marketing of beer and soft drinks is authorised only in re-usable containers, to establish a deposit-and-return system for empty containers must be regarded as necessary to achieve the objectives pursued in relation to the protection of the environment, so that the resulting restrictions on the free movement of goods cannot be regarded as disproportionate (paragraph 13).

(12) – Case 174/82 Sandoz [1983] ECR 2445, paragraph 18. National legislation or practice cannot benefit from the derogation laid down in Article 30 EC when the health and life of humans can be protected equally effectively by measures less restrictive of intra-Community trade (see, inter alia, Case C‑172/00 Ferring [2002] ECR I‑6891, paragraph 34, and Case C‑15/01, Paranova Läkemedel and Others [2003] ECR I‑4175, paragraph 24).

(13) – On the subject of placing plant protection products on the market, see Kraus, V., Die Zweitanmelderproblematik im Pflanzenschutzrecht, Diss., Frankfurt am Main 1993, pages 1-5; by the same author, Nationale Marktzugangsbeschränkungen für Pflanzenschutzmittelimporte, Europäische Zeitschrift für Wirtschaftsrecht 1997, Heft 11, pages 331-334; Fluck, J., Konsequenzen der europäischen Wirkstoffzulassung für bestandkräftige deutsche Pflanzenschutzmittel-Zulassungen, Europarecht 1999, Heft 5, pages 687-696; Fischer, K., Ursprungsidentität bei Arzneimittelzulassung, Europäische Zeitschrift für Wirtschaftsrecht 2004, Heft 17, pages 530-533, and Die Erteilung einer Verkehrsfähigkeitsbescheinigung beim Parallelimport von Pflanzenschutzmitteln, Berlin 2006; Köpl, C., and Fredel, A., Parallelimport von Pflanzenschutzmitteln, Neue Zeitschrift für Verwaltungsrecht 2004, Heft 5, pages 569-572; Quart, P. E., EU-Parallelimporte von Pflanzenschutzmitteln, Wettbewerb in Recht und Praxis 2005, Heft 3, pages 323-330; Koof, P., Welche gesetzlichen Rahmenbedingungen braucht der Pflanzenschutz- und Generikahandel in der Europäischen Union unter den Anforderungen des globalen Marktes?, Agrar- und Umweltrecht 2005, Heft 11, pages 349-357; Bouveresse, A., Commentaire, Autorisation de mise sur le marché, Revue mensuelle LexisNexis JurisClasseur, 2005, pages 19-20; Berr, C.-J., Retrait d’une autorisation de mise sur le marché, Revue trimestrielle LexisNexis JurisClasseur 2006, pages 678-679; Erlbacher, F., Neueste Rechtsprechung der Europäischen Gerichte in den Bereichen Landwirtschaft, Fischerei, Tiergesundheit und Pflanzenschutz (2. Halbjahr 2006), Agrar- und Umweltrecht 2007, Heft 2, page 46.

(14) – Case C‑400/96 Harpegnies [1998] ECR I‑5121, paragraph 8, relating to products which have not yet been placed on the market in the Member State of importation: ‘Both the procedure established by Article 4 and that established by Article 8 are concerned solely with the first application in a Member State for authorisation of a plant protection product which has not yet been authorised in that Member State’.

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15 – Paragraph 31.

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16 – Paragraph 32.

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17 – Paragraph 40.

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18 – It is to be noted that the concept of criteria for identification is the subject of an action for failure to fulfil obligations, Case C‑201/06 Commission v France. In that case, currently pending before the Court, the Commission considers that the French Republic has failed to fulfil its obligations under Article 28 EC by requiring that the plant protection product which is a parallel import and the reference product have a ‘common origin’ (identity of manufacture).

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19 – Kohlpharma, paragraph 21.

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20 – Directive 91/414 thus states in the ninth recital in its preamble that ‘the provisions governing authorisation must ensure a high standard of protection, which, in particular, must prevent the authorisation of plant protection products whose risks to health, ground water and the environment [have not been properly investigated; the protection of] human and animal health [and of the environment] should take priority over the objective of improving plant production’ (the English language version of this recital is defective).

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21 – Article 7(2)(c) of Decision No 1600/2002/EC of the European Parliament and of the Council of 22 July 2002 laying down the Sixth Community Environment Action Programme (OJ 2002 L 242, p. 1). The Communication of the Commission on that sixth programme (COM 2001, 31 final; page 47) states that ‘One group of chemicals that requires particular attention is pesticides (i.e. plant protection products and biocides). They can affect human health via their contamination of groundwaters, soils, food and even the air. Gaps in the current data on the issue make it difficult to be precise about the scale and trends of the problem but there is sufficient evidence to suggest it is serious and growing. The contamination of groundwaters is of particular concern. On average, 65% of European drinking water is supplied from groundwaters and, even after remedial action has been taken to prevent further contamination, they often take a long time to recover to acceptable quality levels. Also of concern is the contamination of our foodstuffs and evidence of continuing accumulation of certain pesticides in plants and animals with associated impacts on their health and ability to reproduce’.

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22 – Thus, in relation to French territory, we note that an article in the newspaper Le Monde (M. Auzanneau, 12 June 2007) provides the following information: according to F. Veillerette (co-author of Pesticides, Fayard, 2007): ‘Almost 900 pesticide molecules are used in France. They are to be found everywhere; everyone eats them on a daily basis. Because they are so ubiquitous, scientists have difficulty in identifying the precise sources of risk – as distinct from a restricted problem such as asbestos’; according to I. Baldi (Lecturer at the University of Bordeaux), who stresses the lack of scientific results in relation to the possible dangers linked to consumption of pesticides present within foods, ‘There are some 30 studies in the world which all show an increased risk of cerebral tumours, and some tens of others which are evidence to an increased frequency of other pathologies’. Moreover, according to French research, farmers who are heavily exposed to pesticides, but also people who use pesticides on plants within the home, are statistically twice as likely to develop brain tumours (Occupational and Environmental Medicine, http://oem.bmj.com) [30 May 2007].

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23 – The proposed regulation is intended to replace Directive 91/414. It aims in particular to restrict the use of chemicals in the composition of plant protection products.

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24 – In Germany however, as the law now stands, this point is uncertain. The Verwaltungsgerichtshof Baden-Württemberg (Higher Administrative Court of Baden-Württemberg) (VGH Baden-Württemberg, judgment of 23.1.2007 – Az. 4 S 1379/04 –, Juris) has however ruled that on a literal interpretation of the Law on Plant Protection (Pflanzenschutzgesetz (PflSchG)) a personal parallel import also requires a simplified marketing authorisation procedure, so that the standards of safety laid down by Directive 91/414 are maintained.

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25 – The Plant Protection Products Regulations 2005 (Statutory Instrument 2005/1435).

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26 – Article 32a of the Zakon o fitofarmacevtskih sredstvih (Law on plant protection products), Uradni list Republike Slovenije 35/2007, page 5017).

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27 – Regulation 19 of the Plant Protection Products Regulations 2005.

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28 – That is moreover clearly stated in French law since the Decree of 4 April 2001 provides, in its first article, that: ‘Identification of the product introduced into national territory with the reference product shall be assessed on the basis of …’

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29 – In Germany, the costs of a simplified marketing authorisation vary from EUR 160 (for mere checking of a document) to EUR 1 840 (Article 2(1) of the PflSchG, and Anlage Gebührenverzeichnis (Annex: List of fees) No 5700 to the Verordnung über Kosten des Bundesamtes für Verbraucherschutz und Lebensmittelsicherheit und der Biologischen Bundesanstalt für Land- und Forstwirtschaft im Pflanzenschutzbereich) (Pflanzenschutzmittel-Gebührenverordnung – PflSchMGebV) in the version of the notice of 9 March 2005, BGBl. I p. 744, amended on 12 March 2007, BGBl. I p. 319). The subject of the cost of parallel importation of a product for strictly personal use is however not clearly defined.

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30 – The charges are however high: just over EUR 700 for a parallel import for personal use, and even more expensive for a parallel import intended for trading (about EUR 1 600) as well as possible specification of a trading name (about EUR 450 additionally). The charges are explained in the Plant Protection Products (Fees) Regulations 2007, which came into force on 1 March 2007 (http://www.opsi.gov.uk/SI/si2007/uksi_20070295_en.pdf).

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31 – Article 4 of the Uredba o stroških v zvezi z registracijo fitofarmacevtskih sredstev, ocenjevanjem aktivnih snovi in izdajo dovoljenj za fitofarmacevtska sredstva (Regulation on costs relating to authorisation of plant protection products, analysis of active substances, and issuing of permits for plant protection products), Uradni list Republike Slovenije 36/2005.