C-6/99

GREENPEACE FRANCE AND OTHERS

OPINION OF ADVOCATE GENERAL MISCHO delivered on 25 November 1999 *

1. The phenomenal advances in scientific legislative framework, that is to say to lay knowledge and applied research in recent down rules governing the use and market- decades have led to the creation of geneti- ing of GMOs. cally modified organisms (hereinafter 'GMOs'). Aware of the potential value of such organisms in the agricultural sector, various industrial groups have acquired the means of producing them on a large scale, so as to create what they see as new and promising markets for themselves. 3. When the administrative authorities charged by the legislature with issuing authorisations to place GMOs on the market as and when the need arises take a favourable decision on an application sub- mitted to them, those not completely reassured by the adoption of those rules may still apply to the courts for a remedy on the ground that the conditions and procedure laid down by the legislature have 2. But this transition, from laboratory to not been duly observed. market, of a product of operations per- formed on living organisms has raised many legitimate questions which have been the subject of debate, not to say confronta- tion, between those who are primarily concerned with the advantages, notably increased productivity, that large-scale use of GMOs may be expected to bring and 4. The questions which the Conseil d'État those who fear that their use may lead to (France) has referred to the Court for a the kind of disaster that befell the sorcerer's preliminary ruling arise from a case of that apprentice and who emphasise the risks kind. No fewer than five applications, involved in the release and general use of including applications from Association GMOs. The scientists were divided and, as Greenpeace France (hereinafter 'Green- the dispute could not be settled, the poli- peace'), the Confédération Paysanne and tical authorities at both national and Com- Association Ecoropa France (hereinafter munity level stepped in to provide a 'Ecoropa'), were submitted to that court, seeking the annulment of an order of 5 February 1998 of the Minister for Agri- * — Original language: French. culture and Fisheries amending the official

6. That order itself followed Commission Decision 97/98/EC of 23 January 1997 concerning the placing on the market of genetically modified maize (Zea mays L.) with the combined modification for insec- ticidal properties conferred by the Bt- endotoxin gene and increased tolerance to the herbicide glufosinate ammonium. 1 The Commission Decision was taken pursuant 8. When it came to consider the substance to Council Directive 90/220/EEC of of the applications, the Conseil d'État 23 April 1990 on the deliberate release encountered a difficulty arising from the into the environment of genetically mod- fact that the ministerial order of 4 February ified organisms. 2 1997, the alleged illegality of which formed the basis of much of the applicants' case, was issued after a highly complex proce- 1 — OJ 1997 L 31, p. 69. dure comprising successive national and 2 — OJ 1990 L 117, p. 15. Community phases.

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The relevant Community provisions 2. At the latest 90 days after receipt of the notification, the competent authority shall either:

9. Directive 90/220 contains the following provisions:

(a) forward the dossier to the Commission with a favourable opinion, or

any other information it has collected 5. Once a product has received a written pursuant to this Directive and advise the consent, it may be used without further competent authority responsible for for- notification throughout the Community in warding the document of the distribution so far as the specific conditions of use and date. the environments and/or geographical areas stipulated in these conditions are strictly adhered to.

2. The competent authority, in the absence of any indication to the contrary from another Member State within 60 days 6. Member States shall take all necessary following the distribution date referred to measures to ensure that users comply with in paragraph 1, shall give its consent in the conditions of use specified in the writing to the notification so that the written consent.' product can be placed on the market and shall inform the other Member States and the Commission thereof.

10. It is therefore clear that, between the examination of the notification by the Member State that has received it, an 3. In cases where the competent authority examination allegedly not carried out cor- of another Member State raises an objec- rectly in the present case, and the granting tion — for which the reasons must be of consent, by ministerial order of 4 Feb- stated — and should it not be possible for ruary 1997 in the present case, there is a the competent authorities concerned to Community phase during which the other reach an agreement within the period Member States, the Commission, and pos- specified in paragraph 2, the Commission sibly the Council, may intervene and shall take a decision in accordance with the which, in the present case, closed with procedure laid down in Article 21. Decision 97/98, which states in the first paragraph of Article 1(1) that:

' 1 . Must the provisions of Council Direc- tive 90/220/EEC of 23 April 1990 be interpreted as meaning that if, after an application to place a genetically mod- 13. However, I for my part consider that ified organism on the market has been the Conseil d'État is indeed putting two forwarded to the Commission of the distinct questions to the Court: European Communities, no Member State has raised an objection as provi- ded for in Article 13(2) of Directive 90/220, or if the Commission of the European Communities has taken a — the first is concerned with whether the "favourable decision" pursuant to national authorities have a measure of Article 13(4), the competent authority discretion once 'the Commission has which forwarded the application to the taken a favourable decision' within the Commission with a favourable opinion meaning of Article 13(4) of Directive is obliged to give the "consent in 90/220; writing" allowing the product to be placed on the market, or does that authority retain a discretion not to give such consent? — the second seeks to ascertain whether, in view of its wording — 'the French authorities shall give consent to ["auto- risent"] the placing on the market of 2. Must the decision of the Commission the product' — and notwithstanding of the European Communities of any irregularities that may be detected 23 January 1997 under which "the in the national authorities' examina- French authorities are to authorise the tion of the notification, Decision 97/98 placing on the market of the product ... required the French authorities to give notified by Ciba-Geigy Limited" be their consent in writing. In other interpreted as requiring the French words, the Conseil d'État wants to

18. Similarly, there is in my view no need 15. There can, in my view, be no question for the Court to consider the Community of the Court ruling on the validity of the legislation on the marketing of seed. It is Commission Decision, still less on that of true that the ministerial order contested Article 13(4) of Directive 90/220 as Ecor- before the Conseil d'État concerns the opa suggests. It is true that there have been inclusion of Novartis genetically modified occasions on which the Court was only maize in the official list of plant species and asked to rule on a question of interpreta- tion but considered that in order to give a useful reply to the national court that had 3 — See, in particular, the judgments in Case 311/84 CBEM referred the question it must also enter into [1985] ECR 3261, paragraphs 9 and 10, and Joined Cases C-297/88 and C-197/89 Dzodzi [1990] ECR I-3763, an assessment of validity. paragraphs 31 to 34.

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20. The national court has sole jurisdiction 23. These are matters of fact and some to determine whether that procedure was might be tempted to think it inadmissible regular and, in examining the second for the Court to leave them out of account. question, the Court must consider the possibility that it was irregular simply as a hypothesis for the purposes of argument, since although the Conseil d'État held that to be a plausible possibility when it pro­ nounced the stay of execution, it certainly did not consider that it was established. 24. However, in my view, that is precisely what it must do, since in this case it is not for the Court, because that is not its role, to settle a social or at the very least a political debate. It is simply required to answer questions of interpretation of certain acts of 21. Before considering the first question, I Community law in force at the time when should like to make one final observation. the dispute arose which the court referring

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the questions has to resolve. That, at any 27. The use of the present indicative and rate, is the strict line to which I propose to the construction of the sentence in the adhere in considering the two questions put French version of Directive 90/220 indicate to the Court by the Conseil d'État. without any shadow of a doubt that the provision imposes an obligation on the Member State in question.

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dream of seriously maintaining that, should 35. Having reached this point in the argu- the Commission take an unfavourable ment, it might be tempting to think that, as decision, it would merely be giving an the wording itself is perfectly unambiguous, opinion that would leave the Member State there is no need to pursue the matter any free to authorise the marketing of the further because, even if factors extraneous GMO in question notwithstanding. to the provision in question were to suggest some other interpretation, there would still be no getting past the fact that those were the terms that were actually used.

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38. There are, of course, some Community risks involved in releasing the product in authorisation procedures which cannot be question. said to end in a decision that is binding in the sense of absolutely requiring a Member State to act in a particular way. Thus, if a Member State intends to grant aid to certain undertakings it must, under Arti- cle 93(3) of the EC Treaty (now Arti- 42. In such cases, the Member State is not cle 88(3) EC), go through the procedure seeking authorisation for itself alone and laid down in paragraph 2 of that article. the outcome of the procedure will have a direct effect on all the Member States, in that they will no longer have the right to refuse to market the product in question.

39. However, even if it has obtained a positive response from the Commission or the Council, it remains at liberty to decide 43. Several Member States may have sup- in the end not to grant the aid in question ported the application of the State that if, for example, it finds it no longer has the initiated the procedure and they will have necessary resources. an interest in seeing it end with a definite decision to go ahead.

40. Similarly, an undertaking which has 44. Another Member State may also have sought permission to market a GMO and received a notification from the same has obtained the Member State's consent in undertaking and may have refrained from writing after the Community procedure has forwarding it to the Commission with a run its course is not thereby obliged favourable opinion merely because it knew actually to place the substance in question that the first Member State had already on the market (though it would be surpris- done so. ing if it did not do so).

47. Establishing a Community procedure necessarily involves more than merely har- 50. But, once it has chosen to follow the monising national procedures. Moreover, it first course, the decision is no longer in its is worth dwelling for a moment on the hands alone, since the other Member States characteristics of this Community proce- and the Commission, and possibly the dure. Directive 90/220 draws a fundamen- Council too, may intervene under the tal distinction between the deliberate conditions set out in Article 13 of Directive release of GMOs into the environment for 90/220. research and development purposes or for any other purpose than for placing on the market, covered in part B, and the placing on the market of products containing GMOs, which is the subject of part C. 51. Once it has the dossier submitted by the Member State that has given a favour- able opinion, the Commission forwards it to the other Member States together with any other information it may have col- lected.

48. In the first case, which constitutes the lesser risk, being by definition confined to experiment within a limited framework, Directive 90/220 leaves it to the Member State that has received a request for author- 52. It is then for them to form an opinion isation to take whatever decision it deems as to the advisability of granting authorisa- appropriate, although it lays down a num- tion to place on the market and, if they ber of procedural and substantive rules think it should not be granted, to present which the Member State must follow and their reasoned objections to the competent sets up a system for informing the Com- authority of the Member State that received mission and the other Member States. the notification.

57. If the agreement of all the Member States cannot be obtained, the situation is 55. A Member State which has given a not irremediable. The refusal of one or favourable opinion on a notification must more Member States to withdraw objec- be supposed to have decided to give its tions they have raised does not preclude a consent unless the joint examination of the Member State which has given a favourable dossier by all the Member States, which opinion on the notification submitted to it also have the benefit of information sup- from simply giving its consent. plied by the Commission, produces justifi- able reasons for refusing it. The other Member States are not going to marshal the substantial resources required to exam- ine a dossier on placing a GMO on the 58. Here too, a Member State cannot by market merely in order to produce an raising an objection arrogate to itself the opinion for a Member State to treat as it power to ban a GMO throughout the thinks fit. Community market. All it can do is cause

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the Commission to intervene, as provided mittee, or if no opinion is delivered, the in Article 13(3) of Directive 90/220. The Commission shall, without delay, submit to Commission will then follow the procedure the Council a proposal relating to the laid down in Article 21 of the Directive, measures to be taken. The Council acts by that is to say the procedure known as 'IIIa' a qualified majority. in committee jargon.

62. If, on the expiry of a period of three months from the date of referral to the Council, the Council has not acted, the proposed measures are adopted by the The role assigned to the Commission Commission.

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consent given by that State under Arti- amended, Article 175 EC). Article 130t of cle 13(5) of Directive 90/220, on all the the EC Treaty (now Article 176 EC) pro- other Member States. vides that: 'The protective measures adopted pursuant to Article 175 shall not prevent any Member State from maintain- ing or introducing more stringent protec- tive measures. Such measures must be compatible with this Treaty. They shall be notified to the Commission'.

The legal basis of the Directive

66. In the second place, it must be borne in mind that Directive 90/220 was adopted on 68. Now, if it were to be admitted that a the basis of Article 100a of the EC Treaty Member State could refuse to give its (now, as amended, Article 95 EC), which consent to the placing on the market of a empowers the Council to adopt measures GMO, despite a favourable decision on the for the approximation of the provisions subject at Community level, it would in fact laid down by law, regulation or adminis- be tantamount to recognising that that trative action in Member States which have Member State had a right to adopt more as their object the establishment and func- protective measures, contrary to the type of tioning of the internal market. harmonisation undertaken by acting within the framework of Article 100a of the Treaty.

73. The plaintiffs in the main proceedings 70. One more, highly important, question who have given their views during the remains to be considered. If Article 13(4) of procedure before the Court have made Directive 90/220 is interpreted as requiring much of the fact that the principle of a Member State to give its consent once the precaution would be flouted if the Member Commission has taken a favourable deci- State that initiated the procedure were to be sion or the Member States have been able denied the right unilaterally to refuse to to reach a consensus, is there not a risk that give its consent. the principle of precaution may be disre- garded? No one has dared to suggest that that principle applies only in cases where the Community legislature adopts rules on the environment under Article 130s of the 74. I see two reasons for not sharing their Treaty and that it may be disregarded in fears on that score. cases where Article 100a provides the legal basis.

78. Where the dossier is forwarded to the Commission 'with a favourable opinion', it must meet certain requirements, as provi- ded in paragraph 3 of that article. 83. Before taking its decision, the Commis- sion obtains opinions from various scien- tific committees. In the present case, it consulted the Scientific Committee on Ani- mal Nutrition, the Scientific Committee for Food and the Scientific Committee for Pesticides. 79. As I have already mentioned, when the Commission forwards the dossier to the other Member States, it must also append any information it may have collected.

84. Lastly, it should be noted that Arti- cle 11(6) of Directive 90/220 provides that:

80. At the next stage, that is to say when the other Member States have received the dossier, any of them may raise objections. However, the reasons for the objections must be given, so that there can be a 'If new information has become available genuine discussion of the risks that may be with regard to the risks of the product to associated with the GMO in question. human health or the environment, either before or after the written consent, the notifier shall immediately:

81. No one can force a Member State to withdraw an objection if it considers that it has not received a satisfactory answer on — revise the information and conditions the subject. specified in paragraph 1,

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85. Under these conditions, it seems to me scarcely credible to maintain that obser- vance of the principle of precaution may be at risk, unless it is to be supposed that all 87. This provision, allowing any Member the authorities invited to participate in the State to prohibit the marketing of a GMO decision-making procedure are deliberately provisionally but, as we shall see in a disregarding the injunctions of Article 4(1) moment, at any time, provided that it has of Directive 90/220, which provides that: justifiable reasons to think that the pro- 'Member States shall ensure that all appro- duct, despite having received consent, con- priate measures are taken to avoid adverse stitutes risks that were not, or could not be, effects on human health and the environ- taken into account during the procedure ment which might arise from the deliberate ending in a favourable decision and that it release or placing on the market of GMOs'. informs the Commission accordingly so that a further decision may be taken following the procedure laid down in Article 21 of Directive 90/220, seems to me to be such as to reassure those who are most demanding about scrupulous compli- 86. My second reason for asserting that the ance with the principle of precaution. principle of precaution is not in danger of being flouted is that there is a safeguard clause, set out in Article 16 of Directive 90/220 in the following terms:

88. It is true that, on a purely literal reading of the provision, it would appear that Member States may avail themselves of the opportunity afforded by Article 16 '1. Where a Member State has justifiable of Directive 90/220 only if consent has reasons to consider that a product which already been given.

90. It would be placing too narrow an interpretation on Article 16 and disregard- 93. Does the conclusion I have reached on ing the fundamental rule laid down in the first question apply unreservedly to Article 4 of Directive 90/220 to hold that, Decision 97/98, irrespective of the factors once the Commission had taken a favour- which caused the Conseil d'État to doubt able decision, consent must absolutely and whether that was in fact the case and which automatically be given, even if its effects I have recapitulated above? are to be suspended a moment later. It will be a purely provisional suspension, how- ever, as the matter will have to be settled within three months in accordance with the procedure laid down in Article 21 of Directive 90/220. 94. In my view, the answer to that question must be that it does. That Decision which, be it noted in passing, is addressed in accordance with Article 2 thereof to the Member States and not just to the French Republic, is perfectly clear and unambig- 91. The principle of precaution may there- uous in its wording even if it does not fore come into play at all stages of the employ exactly the same terms as Directive procedure. 90/220. It does not purport to be a

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'favourable decision' or refer to giving 97. It is true that, as the Commission consent but states, in the first paragraph observed, referring in this connection to of Article 1(1), that: the judgment in Oleificio Borelli v Com- mission, 4 since any irregularity that might affect a national procedure which must precede the adoption of a Community decision, in accordance with the Commu- 'Without prejudice to other Community nity rules themselves, and on the outcome legislation and subject to paragraphs 2 and of which the Community institutions will 3, the French authorities shall give consent rely in making their own decision, it cannot to ["autorisent"] the placing on the market in any way affect the validity of that of the following product, notified by Ciba- decision. Geigy Limited (Ref. C/F/94/11-03), in accordance with Article 13 of Directive 90/220/EEC.'

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100. However, the fact that an irregularity 103. However, that does not mean that in the national procedure does not affect such irregularities ought not to be penalised the validity of the subsequent Community by the national court if they are referred to act must not be misunderstood, particularly it. On the contrary, it follows from the in a case such as the present one where, judgment in Oleificio Borelli v Commis- unlike the situation that obtained in Olei- sion, cited above, that where a national ficio Borelli v Commission cited above, we procedure must, by virtue of Community do not have an unfavourable national law itself, precede the Community decision, decision, which would necessarily have the national legal order must, as the Italian led to an unfavourable decision by the and Austrian Governments pointed out, Community, but on the contrary a favour- ensure that those concerned have an oppor- able one, which, it is true, did not auto- tunity to have the regularity of that proce- matically entail a favourable decision by dure reviewed by the national courts even the Community but did make it possible. if, as a preparatory procedure, it could be held by the national legal order not to be open to appeal.

101. It should be noted that, in the system of Directive 90/220, if a Member State rejects a notification addressed to it, the procedure for the authorisation of the 104. It is true that in the case in which the GMO in question is definitively closed judgment was delivered in Oleificio Borelli and the Commission does not even have v Commission, cited above, the national to be informed of the rejection, whereas the decision at issue was unfavourable but I do act of forwarding the dossier with a not see how it could be claimed that favourable opinion is entirely without pre- judicial review in domestic law should be judice to the eventual outcome. available only in such cases.

Consequences arising from the detection of 109. But if the irregularity led the compe- irregularities in the national procedure tent authority to give a favourable opinion when the notification would otherwise have been rejected and if, to be more precise, it was such as to conceal a genuine risk constituted by the GMO in question, then clearly it cannot be treated in the same way since, in that case, the principle of 106. What will be the effect and utility of a precaution will apply. finding by the national court, having the status of res judicata, that the national procedure was vitiated by irregularities justifying the annulment of the ensuing national decision, in this case the decision to forward the dossier to the Commission with a 'favourable opinion', if there is no 110. What consequence must be attached possibility of calling into question the to it in that event? Here again, it seems to judgment in Oleificio Borelli v Commis- me that there are two possibilities. sion, cited above?

111. Either the examination of the dossier after it was forwarded to the Commission 107. That, as the Commission has afforded an opportunity to detect the risk explained, will depend on the nature of in question and thus to assess whether or the irregularity revealed by the judicial not it justified preventing the GMO in review. question from being placed on the market. In that case, it must be considered that there is no reason to call into question the obligation to give consent, or the consent itself if it has already been given.

117. As I explained in reply to the first 114. Should it fail to do so, it would be in question, a national authority which gives breach of the obligations imposed on it its consent after it has been notified of the under Article 4(1) of Directive 90/220 and Commission's favourable decision, or after could be held responsible. Once alerted, the agreement has been reached among the Commission will draw all the necessary Member States, is exercising a mandatory conclusions from the failure to take duty and that must obviously be taken into account of a genuine risk to health or account by the national court. Clearly, it is environmental protection since, as it stated not for me to set limits here to the review in its observations, a 'favourable' decision which that court may conduct but it should in a situation where the facts call for an nevertheless be borne in mind that, what- 'unfavourable' decision, and vice versa, is ever its own convictions on the subject may unlawful and must be corrected. be, it cannot assume that the Commission's favourable decision is unlawful unless it has obtained confirmation from the Court that it is unlawful through the preliminary ruling procedure or can rely on a declara- tion of annulment by the Court in the context of an action based on Article 173 of the Treaty. 115. The utility of review of the national procedure by the national court is thus patently clear. It will provide an opportu- nity, and there can never be too many opportunities, to verify that the require- ments of the principle of precaution have not been disregarded. In any event, it may, if it leads to an annulment and if the 118. To return to the subject of the second grounds of that annulment are among those question, I consider that Decision 97/98 is I have just mentioned, enable the Commis- to be interpreted as requiring the French sion to detect an irregularity and remedy it Government to give its consent in writing without delay and possibly allow the Com- unless it avails itself of the opportunity munity Court, if the matter is referred to it, afforded by Article 16 of Directive 90/220, to annul a favourable decision taken in should it consider that the conditions are error. fulfilled for that provision to apply.

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