Criminal proceedings against Daniel Escalier (C-260/06) and Jean Bonnarel (C-261/06).
Date: 2007-11-08
24. Accordingly, under the principles set out in the Directive, in particular in Article 3(1), and notwithstanding the rules of the EC Treaty relating to the free movement of goods, no plant protection product can be placed on the market and used in a Member State unless a prior marketing authorisation has been issued by the competent authority of that State in accordance with the Directive. That requirement has the same force even when the product concerned already has a marketing authorisation issued by the competent authority of another Member State, given that the Directive requires that prior authorisation be obtained from the competent authority of each Member State in which that product is placed on the market and used (see, to that effect, Case C‑400/96 Harpegnies  [1998] ECR I‑5121, paragraph 26).
25. However, when there is presented in one Member State a marketing authorisation application for a plant protection product already authorised in another Member State, under Article 10(1) of the Directive the former State must, subject to certain conditions and allowing for certain exceptions, refrain from requiring the repetition of tests and analyses already carried out in that other State, which permits thereby a saving of time and money involved in gathering the required information.
26. It follows that the obligation under the Directive for the importer of a plant protection product to obtain, prior to making the product available to third parties in a Member State, a marketing authorisation issued in accordance with the Directive, cannot as a general rule constitute a restriction on intra-Community trade which is prohibited by Article 28 EC (see, in relation to pharmaceutical products, Case C‑322/01 Deutscher Apothekerverband  [2003] ECR I‑14887, paragraphs 48, 52 and 53, and Case C‑150/00 Commission  v Austria  [2004] ECR I‑3887, paragraphs 56 and 57). That conclusion applies also to the prohibition of using, on the territory of the Member State of importation, a product which has not first been authorised.
28. On the other hand, where a plant protection product covered by marketing authorisation granted in accordance with the provisions of the Directive in one Member State is imported into another Member State as a parallel import of a plant protection product already covered by marketing authorisation in the Member State of importation, the provisions of the Directive on the procedure for the issue of marketing authorisation do not apply (see, in relation to pharmaceutical products, Case C‑201/94 Smith & Nephew and Primecrown  [1996] ECR I‑5819, paragraph 21, and, in relation to plant protection products, British Agrochemicals Association , paragraph 31). None the less, such a situation falls within the scope of the provisions of the EC Treaty on the free movement of goods.
29. Member States must however determine whether the import of a plant protection product which has a marketing authorisation in another Member State is a parallel import by reference to a product which already has a marketing authorisation in the Member State of importation, since they are obliged to ensure that the obligations and prohibitions laid down by the Directive are complied with (see, to that effect, British Agrochemicals Association , paragraph 33).
30. If the plant protection product concerned must be regarded as having already been authorised in the Member State of importation, the competent authorities of that State must allow the product concerned to have the benefit of the marketing authorisation issued to the plant protection product already on the market, unless that is precluded by considerations relating to the effective protection of human and animal health and of the environment (see, to that effect, Smith & Nephew and Primecrown , paragraphs 29 and 32, and British Agrochemicals Association , paragraph 36). Accordingly, a plant protection product introduced into the territory of a Member State as a parallel import cannot, automatically or absolutely and unconditionally, have the benefit of a marketing authorisation issued to a plant protection product already on the market of that State.
31. If the plant protection product cannot be regarded as having already been authorised in the Member State of importation, that State may issue a marketing authorisation for that product, but only if the conditions laid down in the Directive are complied with (see Smith & Nephew and Primecrown,  paragraph 30, and British Agrochemicals Association , paragraph 37) or may prohibit its being placed on the market and used.
32. It follows from the foregoing that Member States are obliged to submit the imports of plant protection products into their territory to a procedure of examination, which can, as in the present case, take the form of a ‘simplified’ procedure, the purpose of which is to verify whether a product requires a marketing authorisation or whether it should be treated as already having been authorised in the Member State of importation. In that regard, it is for the competent authorities of the Member State of importation to examine, when requested by parties concerned, whether they can allow the product concerned to have the benefit of a marketing authorisation issued in favour of a plant protection product already on the market of that State.
37. As regards whether the circumstances that a marketing authorisation issued following a simplified procedure is personal and that an importer is obliged to name with his own brand name the product which is a parallel import and to pay a charge of EUR 800 under such a procedure are in compliance with Community law, it must be stated that it is for the competent national authorities to ensure that the primary objective of the Community legislation, namely the safeguarding of human and animal health and of the environment, is fully complied with. Nevertheless, the principle of proportionality requires that, in order to protect the free movement of goods, the legislation in question be applied within the limit of what is necessary in order to achieve the aim of protection of the environment and of human and animal health that is legitimately being pursued (Case C‑172/00 Ferring  [2002] ECR I‑6891 paragraph 34, and Case C‑112/02 Kohlpharma  [2004] ECR I‑3369, paragraph 14).
– The fact that a marketing authorisation is personal
38. In that regard, as stated by the Advocate General in points 49 and 50 of her Opinion and as observed by the Netherlands and Finnish Governments, taking account of the dangers of plant protection products and the risks associated with their use, the need effectively and reliably to verify compliance with the requirements of the Directive can justify the fact that a marketing authorisation is personal.
39. The objective that no use of plant protection products can take place on the territory of a Member State unless they have undergone a procedure of control carried out by the competent authorities of that State, such use being subject to the conditions laid down in the marketing authorisation, can be achieved only if each operator is obliged to undergo a simplified marketing authorisation procedure, whether it is his intention to make the imported product available to third parties or to use it himself for his own needs.
40. If, in the context of a parallel import, marketing authorisation were linked only to the imported product and not to the person of the importer, he would have to carry out the necessary checks. If operators were permitted, without any prior monitoring, to make available to third parties or use a plant protection product which had already been subjected to a simplified marketing authorisation procedure, the risk of improper or irregular use of that product might increase. Firstly, it could not be guaranteed that importers would carry out dependable checks as to whether and on what conditions a plant protection product introduced as a parallel import has the benefit of a marketing authorisation issued in favour of another product. Secondly, compliance with the strict rules concerning the labelling and packaging of plant protection products, the objective of which is, inter alia, to ensure that the products are correctly used, could equally not be efficiently monitored by the competent authorities of the Member State concerned.
41. Further, marketing authorisations may be re-examined and may be cancelled. In such cases, as stated by the Advocate General in point 50 of her Opinion and by the French Government, Member States must, depending on the reasons for cancellation of the authorisation, be able to ensure the withdrawal as soon as practicable of all the products concerned on their territory, which would not be possible if marketing authorisation was not personal and if only the first parallel import of a product was subject to a simplified marketing authorisation procedure.
42. It follows from the foregoing that the fact that the marketing authorisation issued under a simplified procedure is personal is justified.
50. Against that background, the answer to be given to the first question is that a Member State may subject to a simplified marketing authorisation procedure the parallel import of a plant protection product from another Member State in which it already has the benefit of such an authorisation, where the importation is made by a farmer solely for the needs of his own farm, and the marketing authorisation thus granted is personal to each operator. It cannot be made a condition of that authorisation that the imported product be named with the brand name belonging to the operator concerned where he is a farmer who is making the parallel importation solely for the needs of his own farm. That authorisation cannot be subject to payment of a charge which bears no relation to the costs incurred by the control or the administrative steps needed for examination of the application. An appraisal of such costs as a fixed sum is however permissible provide that the principle of proportionality is observed.
The second question