C-296/01

1 — Original language: French. — declare that, by failing to transpose 2 — OJ1990 L 117, p. 15. correctly and fully Articles 5(1), (2), (3) I-13912

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and (4), 6(2) and (5), 9(3), 11(1), (2), — the taking of preventive action with a (3) and (6), 12(3) and (4) and 19(2), (3) view to attaining a high level of and (4) of the Directive, the French protection of human health and the Republic has failed to fulfil its obli- environment, on account of the risks gations under the Directive and likely to arise from the deliberate Article 249 EC; release of genetically modified organ- isms (GMOs) (first, third and fifth recitals);

— order the French Republic to pay the costs. — the approximation of the laws of the Member States concerning the deliber- ate release into the environment of GMOs, in the light of existing dispar- ities, which may create unequal con- 5. The French Republic claims that the ditions of competition or barriers to Court should: trade in products containing such organisms (fourth recital);

— dismiss the entire action as unfounded;

— the setting up of harmonised pro- cedures and criteria for the case-by- case evaluation of the potential risks arising from the deliberate release of — order the Commission to pay the costs. GMOs into the environment (eighth recital);

12. The Commission alleges that the French Republic has not fully transposed Article 5(1) and (2) of the Directive. It A — The field of application of the Direc- considers that the various sector-based tive decrees lay down only in part the content of the technical dossier. According to these decrees, the remaining information is to be specified by order. However, only three ministerial orders, dated 21 September 1994, 18 July 1995 and 18 October 2000, have been adopted. 9. The Commission alleges that the French Republic has not transposed the Directive so far as concerns GMO-based reagents. According to the Commission, the imple- mentation of the Directive by sector is thus incomplete. 13. The French Government refers to the Order of 23 December 1999 laying down the content of the technical dossier accom- panying applications for authorisation for the deliberate release of GMOs in the course of experiments relating to veterinary medicinal products, to the Order of 10. It is apparent, however, that this com- 18 October 2000 laying down the content plaint was not set out in the form of order of the technical dossier accompanying sought in the application. I therefore sug- applications for authorisation for the delib- gest not examining it. erate release of GMOs in the course of

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biomedical research relating to medicinal 16. The Commission submits that the rule products for human use and to the Order of provided for in Article 5(3) of the Directive 30 November 2001 laying down the con- has not been transposed in Decrees tent of the technical dossier accompanying No 93-1177 (plants, seeds and seedlings), applications for authorisation for the delib- No 94-359 (plant-protection products erate release of GMOs in the course of composed wholly or in part of GMOs), biomedical research relating to elements and No 95-487 (genetically modified ani- and products of the human body geneti- mal organisms). cally modified after having been removed or collected. The French Government adds that other orders are being prepared.

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20. It is not possible, I believe, to accept 23. The parties agree that all the decrees that Article 11 of Law No 92-654 fully implementing Law No 92-654 refer to the implements Article 5(3) of the Directive. obligation on the notifier to supply 'all' The field of application of the single information enabling the impact of the tests notification provided for by French law on public health or on the environment to and the field of application of the single be assessed. notification authorised by the Directive do not coincide: under the Directive, a pro- gramme of release spread over time cannot be the subject of a single notification, and a single authorisation if it is not carried out for only one purpose and within a limited 24. The Commission considers, however, period. that the word 'all' used in these decrees does not set out the information required by Article 5(4) of the Directive with the requisite accuracy.

21. The implementation of this provision 25. In its opinion, with the exception of the of the Directive is therefore not complete Order of 18 July 1995 and the Order of and the infringement is established. 18 October 2000, the French provisions do not transpose Article 5(4) of the Directive. It adds that, in referring to orders which are being prepared, the French authorities themselves admit the failure to transpose the Directive fully.

D — Article 5(4) of the Directive 26. The French Government submits that the provision set out in Article 5(4) of the Directive also appears in the Order of 23 December 1999.

E — Article 6(2) of the Directive 29. As to these submissions, the provisions implementing Article 5(3) of the Directive are certainly not as precise as the provision of the Directive. It is clear that in the case of a directive, the structure of Community 32. Article 6(2) of the Directive provides law requires that national implementing that the written response of the competent provisions be as precise as the provisions of authority, whether positive (indicating that the directive, or at the very least that it be the release may proceed) or negative (indi- clearly established that their effect at least cating that the notification does not fulfil corresponds to that of the provisions of the the conditions of the Directive and is directive. rejected) must be sent to the notifier within 90 days of receipt of the notification.

30. The implementation of a directive must 33. The Commission accepts that the sec- be consistent with its aims in the light of the tor-based decrees transposing the Directive specific field which it is intended to govern. lay down an obligation on the competent

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34. Thus, according to the Commission, Article 6(2) of the Directive has not been correctly transposed. By providing expressly that silence is tantamount to 38. The French Government points out refusal, a refusal for which the notifier that the insertion, in the decrees transpos- does not know the reason, the French ing the Directive, of an obligation to give provisions risk creating a doubt in the reasons for a refusal is not necessary from a mind of the notifier as to the exact scope of legal point of view since, pursuant to his rights under the Directive in this regard. Article 1 of Law No 79-587, adverse individual administrative decisions must, as a matter of principle and unless expressly provided otherwise, be reasoned. In the words of Article 3 of the Law, the required statement of reasons 'must be in writing and set out the considerations of law and of fact on which the decision is based'. According to Article 5 of the Law, an implied decision arising in cases where an express decision would have had to be reasoned is not unlawful merely because 35. Furthermore, the fact that a written reasons are not stated for it. Article 5 of the response is 'in practice' always sent to Law requires however that the grounds for notifiers within the prescribed period and any implied refusal be disclosed to the their ability to assert their rights by way of litigation cannot replace transposition of the provisions of the Directive. 3 — Case C-230/00 [2001] ECR I-4591.

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40. The French Government maintains that the establishment of a system of implied authorisation would have been contrary to the spirit of the Directive, which sought to wrap the deliberate release of GMOs in guarantees, having regard, in particular, to 42. Article 6(5) of the Directive provides: existing uncertainties as to their effects on health and on the environment. This is the reason why, according to the French Gov- ernment, the decrees provide that, if the competent authority has not been able to determine the application for authorisation within the prescribed time-limit, authori- sation is deemed to have been refused. In the light of the requirements linked to the 'If the competent authority considers that protection of health and the environment, it sufficient experience has been obtained of not possible to maintain a state of uncer- releases of certain GMOs, it may submit to tainty as to the consequences of a failure by the Commission a request for the appli- the competent authority to respond within cation of simplified procedures for releases the prescribed time-limit. of such types of GMOs. The Commission shall, in accordance with the procedures laid down in Article 21, establish appropri- ate criteria and take a decision accordingly on each application. The criteria shall be 41. I fully share the Commission's view on based on safety to human health and the this point. The Directive requires a environment and on the evidence available Member State to take an express and on such safety.'

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49. In this respect, I also agree with the 45. The French Government draws atten- Commission's view: it is essential not only tion to the fact that the Directive refers to a that formal provisions of national law possibility and not to an obligation. It designate the competent authorities for submits that this possibility is subject to a the purpose of the measures envisaged by condition and to an analysis, namely that the Directive, but also that these authorities the competent authority considers that are given, in the national provisions, a clear sufficient experience has been obtained of definition of their rights and obligations in releases of certain GMOs. that regard.

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52. The French Government considers that Article 9(3) of the Directive need not be the subject of transposing measures, since it G — Article 9(3) of the Directive organises the relations between Member State authorities and between those auth- orities 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 51. Article 9 of the Directive provides: product safety, 4Directive 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, 5and Directive 98/48/EC of the European Parlia- ment and of the Council of 20 July 1998 amending Directive 98/34), 6the Commis- ' 1 . The Commission shall set up a system sion has been satisfied with mere adminis- of exchange of the information contained trative practices, in some circumstances set in the notifications. The competent auth- out in interministerial circulars, as is the orities shall send to the Commission, within case in France. 30 days of its receipt, a summary of each notification received. The format of this summary will be established by the Com- 4 — OJ 1992 L 228, p. 24. mission in accordance with the procedure 5 —OJ1998 L 204, p. 37. laid down in Article 21. 6 —OJ 1998 L 217, p. 18.

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54. I suggest that the Court accept the 57. The Commission considers that these Commission's argument. Article 9(3) of the provisions of the Directive have been trans- Directive imposes a clear and precise obli- posed only in part by the French auth- gation on the competent authority of each orities. It claims that the various sector- Member State, namely the obligation to based decrees describe the content of the inform the Commission and the other technical dossier only in relation to infor- Member States — and here this must mean mation concerning the assessment of the the corresponding authorities designated by impact of tests on health and on the the other Member States — of the final environment, the standard-form dossier to decision taken following the exchange of be transmitted to the Commission for information. This final decision is of the information and the public information greatest interest to the other participants in sheet. According to these decrees, the the system as it concerns the very question remaining information is to be specified whether, ultimately, the release of a by order. However, only three ministerial particular GMO has been authorised or orders have been adopted (the Order of refused (Article 6(2)). 21 September 1994 on the plant, seed and

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61. For medicinal products for human use, generators, kits and precursors consisting of GMOs which are not subject to Com- munity marketing authorisation, Article 18 of Decree No 95-1172 states that the national marketing authorisation or the pre-market approval is equivalent to auth- 58. The French Government takes the view orisation under Article 15 of the Law. In that Article 15 of Law No 92-654, under that case, Article 20-1 of Decree which prior authorisation is required for No 95-1172 states that the application for the placing on the market of products authorisation is to be accompanied by a consisting wholly or partly of GMOs, has technical dossier including all the infor- t r a n s p o s e d the o b l i g a t i o n s under mation necessary for evaluating the impact Article 11(1) of the Directive and of the medicinal or other product on public Annexes II and III thereto. health and on the environment, the content of which is to be laid down by an order of the Minister of Health.

59. It adds that, as regards the categories of products subject to specific authorisation 62. The order envisaged by Article 20-1 has procedures prior to being placed on the not been adopted by the French authorities, market, Article 17 of the Law states that a as these medicinal and other products are single authorisation is issued pursuant to still at the stage of clinical research, but the these specific procedures and the procedure situation will be reviewed by the French established by Law No 92-654, in accord- authorities in the context of transposition ance with detailed rules laid down by of Directive 2001/18/EC of the European secondary legislation. Parliament and of the Council of 12 March

— the various sector-based decrees do not 67. Article 11(2) of the Directive specifies set out all the information which the information which the notifier must include technical dossier must include, and the in the prior notification, concerning the implementation of these dossiers by data or results from releases of the same order is still incomplete; GMOs or the same combination of GMOs previously or currently notified and/or carried out by the notifier either inside or 7 — OJ 2001 L 106, p. 1. outside the Community. Article 11(3) pro-

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vides that the notification may also refer to 71. However, the Commission observes data or results from notifications pre- that all the decrees implementing Law viously submitted by other notifiers, pro- No 92-654 refer to the obligation on the vided that the latter have given their agree- notifier to provide, in connection with his ment in writing. 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.

68. The Commission points out that the content of these provisions is not repro- duced in any legislation, with the exception of the Order of 18 July 1995 on other human foodstuff sectors and cleaning prod- 72. The Commission considers that it is ucts for materials and articles intended to pointless for the French Government to come into contact with foodstuffs, products invoke Article 8 of the Directive (on or beverages for human or animal con- notifications after a release), since sumption, and the Order of 18 October Article 11(2) and (3) lays down a clear 2000 on biomedical research. and unconditional obligation which must be carried out at the time of the notifi- cation.

— take the measures necessary to protect human health and the environment.

K — Article 12(3) and (4) of the Directive

75. The French Government considers that the wording of Article 19 of Law No 92-654 transposes Article 11(6) of the 78. Article 12(3) of the Directive provides Directive since it provides that all persons that, where the competent authority for- 'must inform the authority of any new wards the notification dossier to the Com- information' and take 'all necessary meas- mission with a favourable opinion, the ures to protect public health or the environ- dossier is to include a summary of the ment'. notification together with a statement of

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the conditions under which the competent 81. The Commission takes the view that authority proposes to consent to the plac- Article 12(3) and (4) of the Directive sets ing on the market of the product. 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.

83. In that regard, I can only confirm that I have already explained the necessity, for each Member State, to specify in the trans- posing measures the obligations imposed on the competent authorities. 8 0 . The C o m m i s s i o n s t a t e s t h a t Article 12(3) of the Directive has not been fully transposed because only two orders mention a summary of the dossier reques- ting marketing authorisation. Nor does any of the legislation intended to transpose the 84. As regards transmission of the state- Directive mention the obligation on the ment of the conditions to which marketing competent authority to draw up a state- authorisation is to be subject, the French ment of the conditions under which it Government invokes Article 20-VI of proposes to consent to the placing on the Decree No 95-1172 and Article 22 of market of the product, with a view to Decree No 96-850, which provide that the transmitting it to the Commission. The competent authority is to forward the Commission adds that Article 12(4) has dossier to the Commission accompanied been transposed only in Decree No 94-359, where relevant by specific conditions. Decree No 95-1172 and Decree No 96-850. Moreover, Article 12(4) of the Directive is Furthermore, Article 12(4) has not been transposed by Article 21 of Decree transposed for the sectors which are not No 95-1172 and Article 25 of Decree covered by transposing measures. No 96-850.

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85. The Commission replies that in mation in the notification submitted under Article 20-VI of Decree No 95-1172 the the Directive, the disclosure of which might specific conditions are listed exhaustively, harm his competitive position and should which is not envisaged by Article 12(3) of be treated as confidential. Verifiable jus- the Directive. As for Decree No 96-850, the tification must be given in such cases. Commission points out that it has a limited Article 19(3) provides that the competent field of application. authority is to decide, after consultation with the notifier, which information will be kept confidential and is to inform the notifier of its decision.

91. The French Government claims that the 94. So far as concerns the transposition of substance of Article 19(2) and (3) of the Article 19(2) of the Directive, I suggest that Directive is transposed by virtue of the Court uphold the Commission's view. Article 21 of Law No 92-654 and the In the light of the interests which the sector-based secondary legislation. Directive aims to protect, the request for confidentiality must be based on a verifi- able justification the detailed rules for which must be set out in specific transpos- ing measures.

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 confiden- tiality to prove it. 95. On the other hand, as regards the transposition of Article 19(3) of the Direc- tive, it is uncertain whether the general principles of French administrative law provide the necessary procedural guaran- tees. I suggest that the Court give the French Republic the benefit of the doubt 93. In relation to Article 19(3) of the on this point. Directive, the French Government con- siders that administrative law is sufficient to transpose the Directive precisely, because it provides that:

N — Article 19(4) of the Directive

— decisions, including refusals, must be reasoned (Article 1 of Law No 79-587);

96. Article 19(4) provides as follows:

— individual administrative decisions are to be taken following an inter partes procedure during which the person concerned has the opportunity to put 'In no case may the following information forward his comments (Article 24 of when submitted according to Articles 5 or Law No 2000-321). 11 be kept confidential:

— methods and plans for monitoring of 98. The French Government contends that the GMO or GMOs and for emergency Article 19(4) of the Directive is transposed response; 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 Direc- tive. French legislation distinguishes between cases where non-confidential information is submitted in connection with applications for the deliberate release — the evaluation of foreseeable effects, in of GMOs for the purpose of research and particular any pathogenic and/or eco- cases concerning applications for market- logically disruptive effects.' ing 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 Direc- tive for placing a product on the market. 97. According to the Commission, all the The Commission is therefore wrong to look sector-based decrees implementing Law for provisions transposing Article 19(4) of No 92-654 include a standard provision the Directive in the sector-based decrees. requiring an applicant for authorisation to release GMOs to attach a public infor- mation 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 99. The French Government also points of the notifier. Since the French authorities out that the absence from the public have intended to implement the require- information sheet envisaged by the stan- ments flowing from Article 19(4) of the dard provision under Law No 92-654 of Directive by means of a 'public information certain information which is not catego- sheet', it is imperative for the sheet to rised as confidential by the Directive, include all the matters mentioned in that namely the location of the release and the provision as not allowed to be kept con- name and address of the notifier, does not fidential. The Commission points out, fur- in any way affect its non-confidential thermore, that the Order of 21 September nature. The French Government contends 1994, which specifies the content of the that this information is, on request, to be public information sheet in the Annex communicated to the public as of right,

102. Article 19(4) relates to the infor- mation 'submitted according to Articles 5

105. I conclude that, in this respect, the 8 — Journal Officiel de la République Française of 18 July 1978, p. 2851. infringement is not established.

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I I I— Conclusion

106. I therefore suggest that the Court: