Opinion of the Advocate General — ECLI:EU:C:2003:305
Date: 2003-05-22
Based on: Treaty establishing the European Economic Community (1957)
Subject matter: Environment;Approximation of laws
Procedure: Action for failure to fulfil obligations - successful;Action for failure to fulfil obligations - unfounded
Origin: France

summary of each notification received. The format of this summary will be established by the Commission in accordance with the procedure laid down in Article 21. 2. The Commission shall immediately forward these summaries to the other Member States, which may, within 30 days, ask for further information or present observations through the Commission or directly. 3. The competent authorities shall inform the other Member States and the Commission of the final decisions taken in compliance with Article 6(2). 52. The French Government considers that Article 9(3) of the Directive need not be the subject of transposing measures, since it organises the relations between Member State authorities and between those authorities and the Commission. The French Government points out that, with regard to other directives (namely Council Directive 92/59/EEC of 29 June 1992 on general product safety, (4) Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations, (5) and Directive 98/48/EC of the European Parliament and of the Council of 20 July 1998 amending Directive 98/34), (6) the Commission has been satisfied with mere administrative practices, in some circumstances set out in interministerial circulars, as is the case in France. 53. The Commission considers that this argument is irrelevant. No conclusion can be drawn from any lack of Commission action concerning the transposition of directives other than the directive in question in the present case. For example, the provisions of Directive 92/59, namely those in Article 8 of that directive, are not comparable to those laid down in Article 9(3) of Directive 90/220. According to the Commission, the former involves obligations on Member States in emergencies which derogate from the generally applicable law and which must, a priori, be exceptional, whereas Article 9(3) of Directive 90/220 concerns an obligation on an authority of the Member State in question, an authority which must be required to carry out a certain kind of action in the course of a procedure which is to be applied regularly. 54. I suggest that the Court accept the Commission's argument. Article 9(3) of the Directive imposes a clear and precise obligation on the competent authority of each Member State, namely the obligation to inform the Commission and the other Member States - and here this must mean the corresponding authorities designated by the other Member States - of the final decision taken following the exchange of information. This final decision is of the greatest interest to the other participants in the system as it concerns the very question whether, ultimately, the release of a particular GMO has been authorised or refused (Article 6(2)). 55. It is necessary therefore that the competent authorities of each Member State be fully informed of this important obligation by domestic law and that they do not have to consult the Directive in parallel to check whether they have satisfied all their obligations. H - Article 11(1) of the Directive and Annexes II and III thereto 56. Article 11(1) of the Directive specifies the content of the notification which a manufacturer or an importer to the Community must submit to the competent authority of the Member State where the product is to be placed on the market for the first time. Annexes II and III list the information and the requirements which the notification must include. 57. The Commission considers that these provisions of the Directive have been transposed only in part by the French authorities. It claims that the various sector-based decrees describe the content of the technical dossier only in relation to information concerning the assessment of the impact of tests on health and on the environment, the standard-form dossier to be transmitted to the Commission for information and the public information sheet. According to these decrees, the remaining information is to be specified by order. However, only three ministerial orders have been adopted (the Order of 21 September 1994 on the plant, seed and seedling sector, the Order of 18 July 1995 on other human foodstuff sectors and cleaning products for materials and articles intended to come into contact with foodstuffs, products or beverages for human or animal consumption, and the Order of 18 October 2000 on biomedical research). According to the Commission, these three orders do not transpose the requirements under the second indent of the first subparagraph of Article 11(1), or even the minimum information listed in the annexes to the Directive which, moreover, have not been the subject of any transposing measures at all. 58. The French Government takes the view that Article 15 of Law No 92-654, under which prior authorisation is required for the placing on the market of products consisting wholly or partly of GMOs, has transposed the obligations under Article 11(1) of the Directive and Annexes II and III thereto. 59. It adds that, as regards the categories of products subject to specific authorisation procedures prior to being placed on the market, Article 17 of the Law states that a single authorisation is issued pursuant to these specific procedures and the procedure established by Law No 92-654, in accordance with detailed rules laid down by secondary legislation. 60. So far as concerns medicinal products for human or veterinary use consisting of GMOs, the French Government states that the placing on the market of these products is dependent on authorisations issued at Community level. Finally, as high-technology medicinal products require a European marketing authorisation, the French Government considers that no transposing measures are necessary. 61. For medicinal products for human use, generators, kits and precursors consisting of GMOs which are not subject to Community marketing authorisation, Article 18 of Decree No 95-1172 states that the national marketing authorisation or the pre-market approval is equivalent to authorisation under Article 15 of the Law. In that case, Article 20-I of Decree No 95-1172 states that the application for authorisation is to be accompanied by a technical dossier including all the information necessary for evaluating the impact of the medicinal or other product on public health and on the environment, the content of which is to be laid down by an order of the Minister of Health. 62. The order envisaged by Article 20-I has not been adopted by the French authorities, as these medicinal and other products are still at the stage of clinical research, but the situation will be reviewed by the French authorities in the context of transposition of Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Directive 90/220. (7) 63. Finally, for the other health products caught by Decree No 96-850 of 20 September 1996 which are not covered by sector-based provisions, the draft order which is being prepared will lay down the content of the technical dossier. 64. The Commission acknowledges that Article 11 of the Directive does not apply - and therefore need not be transposed - in respect of medicinal products for human or veterinary use which consist of GMOs and are subject to a Community marketing authorisation. 65. On the other hand, the Commission contends that: - the various sector-based decrees do not set out all the information which the technical dossier must include, and the implementation of these dossiers by order is still incomplete; - the three orders invoked by the French Government do not transpose the conditions for placing the product on the market, including specific conditions for use and handling and a proposal for labelling which should comprise at least the requirements laid down in Annex III. 66. I share the Commission's view: the measures implementing Article 11(1) of the Directive and Annexes II and III are incomplete; the only general provision put forward by the French Republic, namely Article 15 of Law No 92-654, merely lays down the requirement to obtain prior authorisation, issued after an examination of the risks for public health or the environment posed by the placing on the market and therefore far from mentions all the information required by the relevant provisions of the Directive. I conclude that, in this regard also, the infringement is established. I - Article 11(2) and (3) of the Directive 67. Article 11(2) of the Directive specifies information which the notifier must include in the prior notification, concerning the data or results from releases of the same GMOs or the same combination of GMOs previously or currently notified and/or carried out by the notifier either inside or outside the Community. Article 11(3) provides that the notification may also refer to data or results from notifications previously submitted by other notifiers, provided that the latter have given their agreement in writing. 68. The Commission points out that the content of these provisions is not reproduced in any legislation, with the exception of the Order of 18 July 1995 on other human foodstuff sectors and cleaning products for materials and articles intended to come into contact with foodstuffs, products or beverages for human or animal consumption, and the Order of 18 October 2000 on biomedical research. 69. The French Government notes that, as regards veterinary medicinal products, no transposing measure is necessary because authorisation is issued at Community level, a point which the Commission accepts. 70. As to the remainder, in the French Government's submission the implementation of these provisions falls within the scope of the orders envisaged by Articles 20-I of Decree No 95-1172 (human medicinal products) and 21-II of Decree No 96-850 (other products). 71. However, the Commission observes that all the decrees implementing Law No 92-654 refer to the obligation on the notifier to provide, in connection with his application, the information enabling the impact of the tests on public health and the environment to be assessed. The provisions referred to by the French authorities do not thereby set out with the necessary precision the matters which the notifier must include in his notification dossier. 72. The Commission considers that it is pointless for the French Government to invoke Article 8 of the Directive (on notifications after a release), since Article 11(2) and (3) lays down a clear and unconditional obligation which must be carried out at the time of the notification. 73. I agree with the Commission that the French provisions do not implement Article 11(2) and (3) of the Directive with the necessary completeness and precision and I therefore conclude that the infringement is also established in this regard. J - Article 11(6) of the Directive 74. Article 11(6) of the Directive states that if new information has become available with regard to the risks of the product to human health or the environment, either before or after the written consent, the notifier shall immediately: - revise (revoir in the French version of the provision) the information and conditions specified in Article 11(1), - inform the competent authority, and - take the measures necessary to protect human health and the environment. 75. The French Government considers that the wording of Article 19 of Law No 92-654 transposes Article 11(6) of the Directive since it provides that all persons must inform the authority of any new information and take all necessary measures to protect public health or the environment. 76. The French Government contends that the obligation laid down in the first indent of Article 11(6) of the Directive is necessarily observed when the person concerned informs the competent authority and takes the necessary measures to protect health and the environment. 77. This submission appears, at first sight, to be based on common sense. On the other hand, however, the fact remains that the Commission may rely on the legislative wording when pointing out that the three obligations under Article 11(6) of the Directive are complementary and separate from each other and must be transposed separately. As, furthermore, the Commission maintains that the first of the three obligations on the notifier (namely the obligation to revise immediately the information and conditions) has not been set out in any of the sector-based decrees, I must conclude that the infringement is also established in this respect. K - Article 12(3) and (4) of the Directive 78. Article 12(3) of the Directive provides that, where the competent authority forwards the notification dossier to the Commission with a favourable opinion, the dossier is to include a summary of the notification together with a statement of the conditions under which the competent authority proposes to consent to the placing on the market of the product. 79. Article 12(4) of the Directive imposes the obligation on the competent authority to inform the Commission and the other Member States of additional information disclosed by the notifier as regards the risks of the product, if the competent authority receives additional information pursuant to Article 11(6) of the Directive. 80. The Commission states that Article 12(3) of the Directive has not been fully transposed because only two orders mention a summary of the dossier requesting marketing authorisation. Nor does any of the legislation intended to transpose the Directive mention the obligation on the competent authority to draw up a statement of the conditions under which it proposes to consent to the placing on the market of the product, with a view to transmitting it to the Commission. The Commission adds that Article 12(4) has been transposed only in Decree No 94-359, Decree No 95-1172 and Decree No 96-850. Furthermore, Article 12(4) has not been transposed for the sectors which are not covered by transposing measures. 81. The Commission takes the view that Article 12(3) and (4) of the Directive sets out the details of a procedure under which national administrative bodies are required to communicate certain information to the Commission and to the other Member States. It is thus necessary for national law to set out for those authorities the legal framework within which they operate. 82. The French Government repeats that provisions which prescribe the communication of information to other Member States and to the Commission do not require to be covered by transposing measures. 83. In that regard, I can only confirm that I have already explained the necessity, for each Member State, to specify in the transposing measures the obligations imposed on the competent authorities. 84. As regards transmission of the statement of the conditions to which marketing authorisation is to be subject, the French Government invokes Article 20-VI of Decree No 95-1172 and Article 22 of Decree No 96-850, which provide that the competent authority is to forward the dossier to the Commission accompanied where relevant by specific conditions. Moreover, Article 12(4) of the Directive is transposed by Article 21 of Decree No 95-1172 and Article 25 of Decree No 96-850. 85. The Commission replies that in Article 20-VI of Decree No 95-1172 the specific conditions are listed exhaustively, which is not envisaged by Article 12(3) of the Directive. As for Decree No 96-850, the Commission points out that it has a limited field of application. 86. It is clear from the foregoing that, in this respect also, the Commission's complaints are valid and that the infringement is established. L - Article 13(2) and (4) of the Directive 87. In the grounds of its application, the Commission pleads failure to implement Article 13(2) and (4) of the Directive. However, as the Commission does not mention these provisions in the form of order sought in its application, I consider that the Court need not examine this point. M - Article 19(2) and (3) of the Directive 88. Article 19(2) of the Directive provides that the notifier may indicate the information in the notification submitted under the Directive, the disclosure of which might harm his competitive position and should be treated as confidential. Verifiable justification must be given in such cases. Article 19(3) provides that the competent authority is to decide, after consultation with the notifier, which information will be kept confidential and is to inform the notifier of its decision. 89. The Commission observes that, as set out in Article 21(1) of Law No 92-654, an applicant for authorisation to release GMOs or to place a product on the market may indicate to the authorities the information provided in support of his application the disclosure of which might prejudice his interests or which concerns confidential matters protected by legislation. However, according to the Commission, the Law does not require the notifier to give verifiable justification. With the exception of Decree No 94-359, no sector-based decree imposes an obligation on the notifier to give verifiable justification. 90. As for Article 19(3) of the Directive, according to the Commission neither Law No 92-654 nor the sector-based decrees transposing the Directive (with the exception of Decree No 94-359 relating to plant-protection products) lay down obligations to consult the notifier and to inform him once a decision has been taken. 91. The French Government claims that the substance of Article 19(2) and (3) of the Directive is transposed by virtue of Article 21 of Law No 92-654 and the sector-based secondary legislation. 92. In the view of the French Government, the Commission appears not to know that, under French administrative law, it is generally for the person pleading confidentiality to prove it. 93. In relation to Article 19(3) of the Directive, the French Government considers that administrative law is sufficient to transpose the Directive precisely, because it provides that: - decisions, including refusals, must be reasoned (Article 1 of Law No 79-587); - individual administrative decisions are to be taken following an inter partes procedure during which the person concerned has the opportunity to put forward his comments (Article 24 of Law No 2000-321). 94. So far as concerns the transposition of Article 19(2) of the Directive, I suggest that the Court uphold the Commission's view. In the light of the interests which the Directive aims to protect, the request for confidentiality must be based on a verifiable justification the detailed rules for which must be set out in specific transposing measures. 95. On the other hand, as regards the transposition of Article 19(3) of the Directive, it is uncertain whether the general principles of French administrative law provide the necessary procedural guarantees. I suggest that the Court give the French Republic the benefit of the doubt on this point. N - Article 19(4) of the Directive 96. Article 19(4) provides as follows: In no case may the following information when submitted according to Articles 5 or 11 be kept confidential: - description of the GMO or GMOs, name and address of the notifier, purpose of the release and location of release; - methods and plans for monitoring of the GMO or GMOs and for emergency response; - the evaluation of foreseeable effects, in particular any pathogenic and/or ecologically disruptive effects. 97. According to the Commission, all the sector-based decrees implementing Law No 92-654 include a standard provision requiring an applicant for authorisation to release GMOs to attach a public information sheet to the application dossier. The list of data to be included on the sheet does not mention information as regards the location of release or the name and address of the notifier. Since the French authorities have intended to implement the requirements flowing from Article 19(4) of the Directive by means of a public information sheet, it is imperative for the sheet to include all the matters mentioned in that provision as not allowed to be kept confidential. The Commission points out, furthermore, that the Order of 21 September 1994, which specifies the content of the public information sheet in the Annex thereto, does not mention information regarding emergency response plans, contrary to Decree No 93-1177 which the order is nevertheless supposed to implement. 98. The French Government contends that Article 19(4) of the Directive is transposed by Article L.513.3-II of the Environment Code (previously Article 21 of Law No 92-654) which is directly applicable, as, moreover, is Article 19(4) of the Directive. French legislation distinguishes between cases where non-confidential information is submitted in connection with applications for the deliberate release of GMOs for the purpose of research and cases concerning applications for marketing authorisation. Annex II to the Directive provides that certain information which must be included in notifications under Article 5 of the Directive for releases for the purpose of research is not required in notifications under Article 11 of the Directive for placing a product on the market. The Commission is therefore wrong to look for provisions transposing Article 19(4) of the Directive in the sector-based decrees. 99. The French Government also points out that the absence from the public information sheet envisaged by the standard provision under Law No 92-654 of certain information which is not categorised as confidential by the Directive, namely the location of the release and the name and address of the notifier, does not in any way affect its non-confidential nature. The French Government contends that this information is, on request, to be communicated to the public as of right, pursuant to Articles 1 and 6 of Law No 78-753 of 17 July 1978 laying down various measures to improve relations between administrative authorities and the public. (8) 100. The French Government adds, finally, as regards biomedical research, that it had considered that it was inappropriate to give excessive publicity to the name and address of the research location, in order to protect those operations. 101. I do not share the Commission's view according to which, since the French authorities have intended to implement the requirements flowing from Article 19(4) of the Directive by means of a public information sheet, it is imperative for the sheet to include all the matters mentioned in that provision as not allowed to be kept confidential. 102. Article 19(4) relates to the information submitted according to Articles 5 or 11. These provisions concern the notifications to be made to the competent authority. 103. It does not in any way follow from the Directive that a Member State which chooses to publish a public information sheet must include in that sheet all the non-confidential information which the notifier is bound to communicate to the competent authority. 104. The lack of confidentiality of certain information under the Directive must be distinguished from an obligation to publicise this information. Therefore, in my view, the French Republic is entitled to consider that the obligation to respond to a request for information under administrative law suffices in order to comply with the provisions in question of the Directive. This would not be the case only if, in practice, the French authorities refused to reply to requests for information, which the Commission has not claimed. 105. I conclude that, in this respect, the infringement is not established. III - Conclusion 106. I therefore suggest that the Court: - declare that, by failing to transpose correctly and fully Articles 5(1), (2), (3) and (4), 6(2) and (5), 9(3), 11(1), (2), (3) and (6), 12(3) and (4) and 19(2) and (3) of Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms, the French Republic has failed to fulfil its obligations under the Directive and Article 249 EC; - dismiss the remainder of the action; - order the French Republic to pay the costs. 1: - Original language: French. 2: - OJ 1990 L 117, p. 15. 3: - Case C-230/00 [2001] ECR I-4591. 4: - OJ 1992 L 228, p. 24. 5: - OJ 1998 L 204, p. 37. 6: - OJ 1998 L 217, p. 18. 7: - OJ 2001 L 106, p. 1. 8: - Journal Officiel de la République Française of 18 July 1978, p. 2851.