OPINION OF ADVOCATE GENERAL

Sharpston

delivered on 15 May 2007 ( )

Joined Cases C‑439/05 P and C‑454/05 P

Land Oberösterreich and Republic of Austria

v

Commission of the European Communities





(Appeal – Approximation of legislation – Protection of human health and the environment – Request for approval of national provisions derogating from a harmonising measure – Ban on the use of genetically modified organisms in Upper Austria – Rejection by the Commission)

1. This appeal concerns an attempt by one of the Austrian Länder to introduce, with a view to creating a farming area free of genetically modified organisms (GMOs), a law imposing a general ban on the cultivation of genetically modified plants or seed, and on the breeding and release of transgenic animals.

2. However, under Directive 2001/18, ( ) the release or placing on the market of a GMO is subject to an authorisation regime which requires a health and environmental risk assessment on a case-by-case basis.

3. The draft law was notified to the Commission with a view to obtaining a derogation from the directive’s requirements, pursuant to Article 95(5) and (6) EC, on the basis of ‘new scientific evidence relating to the protection of the environment or the working environment on grounds of a problem specific to that Member State arising after the adoption of the harmonisation measure’. The Commission considered that no such evidence had been produced, and rejected the request for approval of the draft law.

4. That decision was challenged before the Court of First Instance by both the Land in question, Land Oberösterreich (Upper Austria), and the Republic of Austria. The Court of First Instance dismissed the actions in a joint judgment, and both applicants have appealed.

5. They submit essentially that the Court of First Instance disregarded the fact that Austria had not been able to respond to an opinion of the European Food Safety Authority (‘EFSA’), in breach of its right to be heard; did not give proper consideration to the specific nature of the problem in Upper Austria, thereby failing to give adequate reasons for its decision; and failed to give proper weight to the precautionary principle.





Community legislation

Treaty provisions

6. Article 95(4), (5) and (6) EC provides:

‘4. If, after the adoption by the Council or by the Commission of a harmonisation measure, a Member State deems it necessary to maintain national provisions on grounds of major needs referred to in Article 30, or relating to the protection of the environment or the working environment, it shall notify the Commission of these provisions as well as the grounds for maintaining them.

5. Moreover, without prejudice to paragraph 4, if, after the adoption by the Council or by the Commission of a harmonisation measure, a Member State deems it necessary to introduce national provisions based on new scientific evidence relating to the protection of the environment or the working environment on grounds of a problem specific to that Member State arising after the adoption of the harmonisation measure, it shall notify the Commission of the envisaged provisions as well as the grounds for introducing them.

6. The Commission shall, within six months of the notifications as referred to in paragraphs 4 and 5, approve or reject the national provisions involved after having verified whether or not they are a means of arbitrary discrimination or a disguised restriction on trade between Member States and whether or not they shall [sic] constitute an obstacle to the functioning of the internal market.

In the absence of a decision by the Commission within this period the national provisions referred to in paragraphs 4 and 5 shall be deemed to have been approved.

When justified by the complexity of the matter and in the absence of danger for human health, the Commission may notify the Member State concerned that the period referred to in this paragraph may be extended for a further period of up to six months.’

7. Community policy on the environment is dealt with in Articles 174 to 176 EC. In particular, Article 174(2) provides:

‘Community policy on the environment shall aim at a high level of protection taking into account the diversity of situations in the various regions of the Community. It shall be based on the precautionary principle and on the principles that preventive action should be taken, that environmental damage should as a priority be rectified at source and that the polluter should pay.

In this context, harmonisation measures answering environmental protection requirements shall include, where appropriate, a safeguard clause allowing Member States to take provisional measures, for non-economic environmental reasons, subject to a Community inspection procedure.’





Directive 2001/18

8. The deliberate release of GMOs into the environment has been governed since 17 October 2002 by Directive 2001/18, the aim of which is to approximate national legislation and procedures in that field.

9. The deliberate release or placing on the market of a GMO is subject to an authorisation regime. There is a procedure for releases of GMOs for any purpose other than placing on the market (essentially for the purpose of experimentation – part B of the directive, Articles 5 to 11), which involves authorisation at national level, and a procedure for placing GMOs on the market as or in products (part C, Articles 12 to 24), which lays down a Community procedure, the final decision being valid throughout the European Union. The Community procedure under part C is initiated before the competent authority of the Member State in which the GMO is to be first placed on the market and includes extensive involvement of the competent authorities of all the Member States. ( )

10. Among the general provisions in part A, Article 4 provides, inter alia, that,

– in accordance with the precautionary principle, Member States must ensure that all appropriate measures are taken to avoid adverse effects on human health and the environment which might arise from the deliberate release or the placing on the market of GMOs;

– any person wishing to submit a notification under part B or part C must carry out an environmental risk assessment;

– Member States and the Commission must ensure that GMOs which contain genes expressing resistance to antibiotics in use for medical or veterinary treatment are taken into particular consideration, with a view to identifying and phasing out antibiotic resistance markers in GMOs which may have adverse effects on human health and the environment;

– Member States and where appropriate the Commission must ensure that potential adverse effects on human health and the environment are accurately assessed on a case-by-case basis;

– Member States must designate a competent authority to examine notifications and decide whether the environmental risk assessment carried out is appropriate;

– Member States must ensure that the competent authority organises inspections and other control measures and that necessary measures are taken to terminate the release or placing on the market, to initiate remedial action if necessary, and to inform its public, the Commission and other Member States.

11. In part C, Article 20, headed ‘Monitoring and handling of new information’, reads:

‘1. Following the placing on the market of a GMO as or in a product, the notifier shall ensure that monitoring and reporting on it are carried out according to the conditions specified in the consent. The reports of this monitoring shall be submitted to the Commission and the competent authorities of the Member States. On the basis of these reports, in accordance with the consent and within the framework for the monitoring plan specified in the consent, the competent authority which received the original notification may adapt the monitoring plan after the first monitoring period.

2. If new information has become available, from the users or other sources, with regard to the risks of the GMO(s) to human health or the environment after the written consent has been given, the notifier shall immediately take the measures necessary to protect human health and the environment, and inform the competent authority thereof.

In addition, the notifier shall revise the information and conditions specified in the notification.

3. If information becomes available to the competent authority which could have consequences for the risks of the GMO(s) to human health or the environment, or under the circumstances described in paragraph 2, it shall immediately forward the information to the Commission and the competent authorities of the other Member States ...

When the information has become available after the consent has been given, the competent authority shall within 60 days after receipt of the new information, forward its assessment report indicating whether and how the conditions of the consent should be amended or the consent should be terminated to the Commission which shall, within 30 days of its receipt, forward it to the competent authorities of the other Member States.

Comments or reasoned objections to further placing on the market of the GMO or on the proposal for amending the conditions of the consent shall, within 60 days following the circulation of the assessment report, be forwarded to the Commission which shall immediately forward them to all competent authorities.

The competent authorities and the Commission may discuss any outstanding issues with the aim of arriving at an agreement within 75 days from the date of circulation of the assessment report.

In the absence of any reasoned objection from a Member State or the Commission within 60 days following the date of circulation of the new information or if outstanding issues are resolved within 75 days, the competent authority which prepared the report shall amend the consent as proposed, shall transmit the amended consent to the notifier and shall inform the other Member States and the Commission thereof within 30 days.

4. So as to ensure its transparency, the results of the monitoring carried out under part C of the Directive shall be made publicly available.’

12. Also in part C, Article 23, headed ‘Safeguard clause’, reads as follows:

‘1. Where a Member State, as a result of new or additional information made available since the date of the consent and affecting the environmental risk assessment or reassessment of existing information on the basis of new or additional scientific knowledge, has detailed grounds for considering that a GMO as or in a product which has been properly notified and has received written consent under this Directive constitutes a risk to human health or the environment, that Member State may provisionally restrict or prohibit the use and/or sale of that GMO as or in a product on its territory.

The Member State shall ensure that in the event of a severe risk, emergency measures, such as suspension or termination of the placing on the market, shall be applied, including information to the public.

The Member State shall immediately inform the Commission and the other Member States of actions taken under this Article and give reasons for its decision, supplying its review of the environmental risk assessment, indicating whether and how the conditions of the consent should be amended or the consent should be terminated, and, where appropriate, the new or additional information on which its decision is based.

2. A decision shall be taken on the matter within 60 days …’

13. After the material time in the present case, Regulation No 1826/2003 ( ) introduced Article 26a, which provides:

‘1. Member States may take appropriate measures to avoid the unintended presence of GMOs in other products.

2. The Commission shall gather and coordinate information based on studies at Community and national level, observe the developments regarding coexistence in the Member States and, on the basis of the information and observations, develop guidelines on the coexistence of genetically modified, conventional and organic crops.’

14. At the time of the contested decision in the present case, no GMOs had been authorised (at Community level, for placing on the market) under Directive 2001/18. Since then, five applications concerning plant material have been granted, ( ) none of them for cultivation, and eight more are pending, ( ) of which five include cultivation as a requested use. Eighteen authorisations for the placing on the market of GMOs had been granted under the previous Directive 90/220, ( ) of which nine included authorisation for cultivation.

15. Directive 2001/18 also provides for the placing on the market and experimental release into the environment of transgenic animals, although no applications have yet been submitted for approval.

16. As regards release for purposes other than placing on the market (with authorisation at national level), it would appear that there have been more than 2000 notifications throughout the Community since Directive 90/220 came into force, of which three were in Austria (two in 1996 and one in 1997). ( )

17. It may be noted that, in the light of concerns as to the safeness of GMOs, no Community authorisations for placing on the market were in fact granted between October 1998 and July 2004, although a number of experimental releases were authorised at national level in certain Member States. The effects of that informal ‘moratorium’ agreed upon between the Member States ( ) were challenged in the World Trade Organisation, ( ) and it has now been abandoned.





Coexistence guidelines

18. On 23 July 2003, while the request in issue in the present case was pending, the Commission adopted recommended guidelines for ensuring coexistence between GM crops and other types of farming. ( )

19. Those guidelines address the economic aspects of coexistence, which may entail loss of income and/or increased expense for farmers who wish to avoid admixture of GMOs, and seek to help Member States develop national strategies and approaches to minimise the risks. They draw a clear distinction between those issues and the environmental and health aspects dealt with in Directive 2001/18.





The draft law and the contested decision

20. A draft law prohibiting the cultivation of genetically modified seed and plant material and the use of transgenic animals for breeding or release, in particular for the purposes of hunting and fishing, ( ) was introduced in the Upper Austrian legislature in 2002. Its aim was stated to be ‘to safeguard organic farming as well as traditional agricultural crop and animal products from GMO contamination (hybridisation). In addition, natural biodiversity, particularly in sensitive ecological areas, as well as genetic resources in nature, including those of hunting and fishing, are to be protected from GMO contamination.’ It was based on a report (‘the Müller report’ ( )) commissioned by the Upper Austrian authorities.

21. The draft law was notified to the Commission by Austria on 13 March 2003, with a view to its approval pursuant to Article 95(5) and (6) EC, by way of derogation from Directive 2001/18. The Austrian Government put forward justifications based essentially on the Müller report. That report, it asserted, had brought to light new scientific evidence showing a danger for the local environment, and had demonstrated that Upper Austria had a specific farming structure, with small-scale farms and a substantial proportion of organic farming. It also stated that the issue of coexistence between GM and non-GM crops, not tackled by Directive 2001/18, was still regarded as unsolved.

22. To assist in its assessment, the Commission requested EFSA ( ) to provide a scientific opinion in particular as to whether the Müller report provided any new scientific evidence, in terms of risk to human health and the environment, that would justify banning cultivation of GMOs authorised under Directive 90/220 or Directive 2001/18, and as to whether the scientific information presented provided new data that would invalidate the provisions for the environmental risk assessment under those directives.

23. The EFSA panel stated in its opinion of 4 July 2003, ( ) inter alia:

‘The evidence presented was mostly a review of current knowledge on crop to crop gene flow and crop to wild relative gene flow of a few crop types with limited references to gene flow studies in Austria. The evidence also examined issues of co-existence of GM and non-GM varieties of three main crop types and this was the main argument presented for establishing the GMO exclusion area in Upper Austria. The report concluded that gene flow per se was a hazard without reference to any environmental or human health impacts or consequences of gene flow. Gene flow is a basic biological function that is fundamental to the evolution and survival of all living species. No scientific evidence was presented which showed that gene flow from transgenic organisms is per se different to gene flow from conventional or organically grown organisms. Furthermore no reports of GM crop or animal studies in Austria were presented which indicated any adverse consequences of gene flow. The report cited only a limited number of peer reviewed references on which evidence is based. A rather high number of references were not directly related to GMOs, but reported on biological invasions, pesticide persistence and ozone depletion. Furthermore, many references were dedicated to legislation or economic affairs and therefore did not provide further scientific evidence to justify the exclusion of GMOs in Upper Austria. No references were made to GM animals.

No evidence was presented in the report to show that co-existence is an environmental or human health risk issue. EFSA was not asked by the Commission to comment on the management of co-existence of GM and non-GM crops, but the Panel recognised that it is an important agricultural issue.

The scientific evidence presented contained no new or uniquely local scientific information on the environmental or human health impacts of existing or future GM crops or animals.

No scientific evidence was presented which showed that this area of Austria had unusual or unique ecosystems that required separate risk assessments from those conducted for Austria as a whole or for other similar areas of Europe. No specific cases were presented of impacts of GMOs on biodiversity, either directly or through changes in agricultural practices.’

24. It concluded that:

‘– the scientific information presented in the report provided no new data that would invalidate the provisions for the environmental risk assessment established under Directive 90/220/EEC or Directive 2001/18/EC.

– the scientific information presented in the report provided no new scientific evidence, in terms of risk to human health and the environment, that would justify a general prohibition of cultivation of genetically modified seeds and propagating material, the use of transgenic animals for breeding purposes and the release of transgenic animals, authorised for these purposes under Directive 90/220/EEC or Directive 2001/18/EC in this region of Austria.’

25. The Commission reached its decision on 2 September 2003. ( )

26. In the course of its assessment it noted that it was clear from the report of the Austrian Committee on National Economic Affairs (‘the committee report’) that Austria was fully aware of the possibility offered by the safeguard clause in Directive 2001/18, ( ) but considered it an inappropriate means to meet the objectives of a total ban of GMOs in the province of Upper Austria. ( )

27. The Commission then considered, at point 65, that:

‘[T]he Müller Report contains data, which were for a large part available prior to the adoption of Directive 2001/18/EC on 12 March 2001. This assessment is confirmed by the EFSA. In addition to this, Austria relies on the fact that the Müller Study was released on 28 April 2002, about a year after the date of adoption of Directive 2001/18/EC (12 March 2001). However, the vast majority of the sources referred to in the bibliography were published prior to the adoption of Directive 2001/18/EC. Therefore, the core of the study appears more as a validation of previous works than like new material identifying specific problems arising after the adoption of Directive 2001/18/EC.’

28. At point 70, it stated that:

‘in light of the documentation provided by Austria, particularly the excerpts from the Müller study included with the notification, it is clear that small-structured farming systems are certainly not specific to this region and exist in all Member States. The acceptance of the Act with regard to Article 95(5) of the Treaty cannot, therefore, be founded on such justification’, ( )

going on, at point 71, to quote, from the EFSA opinion, the last two paragraphs set out above at point 23 of this Opinion.

29. The Commission concluded:

‘(74) Article 95(5) of the EC Treaty requires that, if a Member State deems it necessary to introduce national provisions in derogation from Community harmonisation measures, the national provisions must be justified by new scientific evidence relating to the protection of the environment or the working environment, there must be a problem specific to the State making the request, and the problem must have arisen after the adoption of the harmonisation measure.

(75) In this case, after having examined the Austrian request, the Commission considers that Austria has not provided new scientific evidence relating to the protection of the environment or the working environment, and has not demonstrated that there is a specific problem within the territory of Upper Austria, which arose following the adoption of Directive 2001/18/EC on the deliberate release into the environment of GMOs, and which makes it necessary to introduce the notified national measures.

(76) Consequently, the request from Austria for introducing national measures aimed at prohibiting the use of GMOs in Upper Austria does not fulfil the conditions set out in Article 95(5).’

30. The Commission therefore rejected the notified provisions.





The judgment under appeal

31. Both Austria and Land Oberösterreich brought actions seeking annulment of the contested decision. The Court of First Instance joined the cases, and gave judgment on 5 October 2005 dismissing both actions. ( ) Both parties now seek to have that judgment set aside.

32. The applicants raised four pleas in law: (i) infringement of the right to be heard, (ii) breach of the obligation to state reasons, (iii) infringement of Article 95(5) EC and (iv) breach of the precautionary principle. Of those, only the first and third are expressly in issue on appeal, although the precautionary principle is also relied on in argument.





Infringement of the right to be heard

33. The applicants argued that the Commission had not given them an opportunity to state their views before adopting the contested decision. Although the Court of Justice had ruled in Denmark v Commission ( ) that the right to be heard did not apply to the Article 95 EC procedure, the circumstances of this case called for a different answer. First, Denmark v Commission concerned a request under Article 95(4) for derogation relating to a national measure already in force whereas, here, since the notified measure was still in draft form, the Commission could have continued the procedure in accordance with the third subparagraph of Article 95(6) EC, in order to give the Member State the opportunity to state its views. Second, in the present case, the Commission had sought an expert report from EFSA, on which its decision was based. It should therefore have given Austria the opportunity to state its views on the EFSA opinion. ( )

34. The Court of First Instance noted that, in Denmark v Commission, the Court of Justice relied on the fact that the procedure in Article 95(4) EC was initiated by a Member State, the Commission adopting its decision merely in response to that initiative. Thus the Member State could comment in its request on the decision sought, and was indeed required to indicate the grounds for maintaining the national provisions in question. The Commission in turn must be able, within the prescribed period, to obtain the necessary information without having to hear the Member State again. Moreover, the second and third subparagraphs of Article 95(6) EC provide, respectively, that the derogating national provisions are deemed to have been approved if the Commission does not take a decision within a certain period and that no extension of that period is allowed where there is a danger for human health. The intention was thus that the procedure should be speedily concluded. That objective would be difficult to reconcile with a requirement for prolonged exchanges of information and observations. ( )

35. The Court of First Instance considered that the same reasoning could be applied to the procedure in Article 95(5) EC. It too is initiated by the notifying Member State, which may comment on the decision sought, and must be concluded rapidly. The fact that the national measures are still in draft form does not mean that the right to be heard must apply, and the requirement for speed is no less when the national measure has not yet entered into force. Article 95(6) EC applies without distinction whether the measures are in force or in draft form. Also, the Commission may extend the deadline for taking a decision only if the complexity of the matter makes it necessary and in the absence of danger for human health, not so that the Member State can be given the opportunity to state its views. ( )

36. The procedures in Article 95(4) and (5) EC are both intended to ensure that no Member State applies rules derogating from the harmonised legislation without obtaining prior approval from the Commission. Under both procedures, the measures in question are inapplicable as long as the Commission has not adopted its decision. Under Article 95(5) EC, that follows from the very nature of the measures, still in draft form. Under Article 95(4) EC, it follows from the subject-matter of the procedure: harmonising measures which concern the establishment and functioning of the internal market would be rendered ineffective if Member States retained the right unilaterally to apply national rules derogating from those measures. ( )

37. Since the right to be heard did not apply, it was irrelevant that the Commission did not rule on the basis only of information submitted by Austria, but asked EFSA to produce a report, on which the contested decision was based. Moreover, the fact that the right to be heard was not applicable did not mean that the Commission was obliged to come to a decision solely on the basis of the information provided in support of the request for derogation. On the contrary, it was clear from Denmark v Commission that the Commission must be able, within the prescribed period, to obtain the information which proves to be necessary without having to hear the Member State again. ( )

38. The Court of First Instance therefore dismissed the plea.





Infringement of Article 95(5) EC

39. The applicants submitted that the requirements of Article 95(5) EC were satisfied. The notified measure was intended to protect the environment, was based on new scientific evidence, was justified by a problem specific to Austria and complied with the principle of proportionality. ( )

40. The Court of First Instance noted that under Article 95(4) EC, the maintenance of existing provisions must be justified on grounds of major needs referred to in Article 30 EC or relating to the protection of the environment or the working environment. Under Article 95(5) EC, the introduction of new provisions must be based on new scientific evidence relating to the protection of the environment or the working environment on grounds of a problem specific to that Member State arising after the adoption of the harmonisation measure. ( )

41. The difference is that national provisions predating a harmonisation measure are known to the Community legislature, which cannot or does not seek to be guided by them for the purpose of harmonisation. It is therefore considered acceptable for the Member State to request that its own rules remain in force, if they are justified on grounds of major needs referred to in Article 30 EC or relating to the protection of the environment or the working environment. The adoption of new national legislation is more likely to jeopardise harmonisation. By definition, the Community legislature could not have taken account of such legislation when drawing up the harmonisation measure. In that case, the needs referred to in Article 30 EC are not taken into account, and only grounds relating to protection of the environment or the working environment are accepted, on condition that the Member State provides new scientific evidence and that the need to introduce new national provisions results from a problem which is specific to the Member State and subsequent to the adoption of the harmonisation measure. ( )

42. It is for the Member State to prove that the conditions for application of Article 95(5) EC are met. ( ) Here, it was for Austria to demonstrate, on the basis of new scientific evidence, that the level of environmental protection afforded by Directive 2001/18 was not acceptable having regard to a problem specific to Austria which arose after the adoption of that directive. ( )

43. In its decision, the Commission had rejected the argument that there was a specific problem within the meaning of Article 95(5) EC, on the ground that it was clear from the notification that the small size of farms was not specific to Upper Austria but a common characteristic to be found in all the Member States. The Commission also adopted the conclusions of EFSA, in particular that ‘the scientific evidence presented contained no new or uniquely local scientific information on the environmental or human health impacts of existing or future GM crops or animals’ and that ‘no scientific evidence was presented which showed that this area of Austria had unusual or unique ecosystems that required separate risk assessments from those conducted for Austria as a whole or for other similar areas of Europe’. ( )

44. The applicants had failed to refute those assessments convincingly, merely drawing attention to the small size of farms and the importance of organic production in Upper Austria. There was no evidence to rebut EFSA’s conclusion that Upper Austria had not been shown to contain unusual or unique ecosystems requiring separate risk assessments from those for Austria as a whole or other similar areas of Europe. At the hearing, the applicants were unable to state whether the presence of GMOs had been recorded in Upper Austria. Land Oberösterreich stated that the draft measure was prompted by the imminent expiry of an agreement between Member States temporarily not to issue consents for GMOs. ( ) Such considerations could not invalidate the findings in the contested decision. ( )

45. The Court of First Instance therefore rejected the arguments disputing the Commission’s findings as to the existence of a problem specific to the notifying Member State. The conditions required by Article 95(5) EC being cumulative, it was sufficient that only one of them was not satisfied for the request for derogation to be rejected. ( ) The whole plea was therefore dismissed.

46. As a consequence, the fourth plea alleging breach of the precautionary principle was dismissed as irrelevant; since the conditions for granting the request under Article 95(5) EC were not met, the Commission had no option but to reject the application. ( )





Arguments on appeal

47. The two appeals are very similar, even to a considerable extent identically worded, although that of the Republic of Austria is rather more complete. It does not seem helpful to present them separately.

48. The judgment under appeal is challenged on two grounds: (i) ‘procedural irregularity’, under which heading the appellants take issue with the reasoning dealing with their third plea at first instance, namely, ‘infringement of Article 95(5) EC’; and (ii) ‘breach of Community law’, under which they challenge the conclusion on their right to be heard in response to the EFSA opinion.

49. On those grounds, the appellants ask the Court to set aside the judgment under appeal and, principally, to annul the contested decision or, in the alternative, to refer the case back to the Court of First Instance for fuller consideration.





Procedural irregularity

50. The appellants assert that they had demonstrated in their applications at first instance that all the conditions stipulated in Article 95(5) EC were fulfilled. In particular, they had shown that there was a problem ‘specific’ (which does not mean ‘unique’) to Upper Austria. Even if similar configurations exist in other areas of the Community, the fact remains that farming in Upper Austria is characterised by particularly small areas and by a particularly high rate of organic farming, which means that usual methods are insufficient to prevent the spread of GMOs. Since the Court of First Instance dismissed the plea on the ground that that single condition was not fulfilled, it should have given the submissions more thorough consideration, instead of which it merely followed the Commission and the EFSA opinion. Nor should it have simply omitted to consider whether the other conditions in Article 95(5) EC were fulfilled.

51. Austria considers that new scientific evidence is a crucial element in Article 95(5) EC, and that the precautionary principle cannot be ignored. The Commission however did not carry out a thorough scientific risk analysis. Nor did it ask EFSA to address the central issue in Austria’s argument, namely the coexistence of GMOs and natural crops, yet it based its decision entirely on the EFSA opinion. That central issue, which is highly controversial, as is clear from debates within the Council, was thus not examined by either the Commission or the Court of First Instance. Since the scientific evidence was never examined in the light of the precautionary principle, the Court of First Instance failed in its duty to give adequate reasoning.

52. The appellants criticise also the Court of First Instance’s reliance on the fact that there was no evidence of the presence of GMOs in Upper Austria. Given the Community legislature’s duty to ‘take as a base a high level of protection’ in harmonising legislation concerning health, safety, environmental protection and consumer protection, ( ) it cannot be the case that a Member State may have recourse to Article 95(4) and (5) EC only once damage has actually occurred.

53. The failure to examine the scientific evidence thoroughly constitutes, in the appellants’ view, a breach of both the right to be heard and the duty to provide adequate reasons.

54. The Commission submits that those arguments are entirely unfounded in so far as they allege a procedural irregularity in the form of an inadequate statement of reasons. It deals with the criticisms of the substance of the reasoning in response to the plea of ‘breach of Community law’.

55. The Commission first summarises paragraphs 63 to 67 of the judgment under appeal as follows. ( ) Since, according to settled case-law, it is for a Member State invoking Article 95(5) EC to prove that the conditions for its application are met, it was necessary to examine whether the contested decision had wrongly considered that such proof had not been adduced. The decision was based on the findings that small agricultural holdings are a feature of all Member States and that, according to EFSA, there was no scientific evidence demonstrating that Upper Austria had an exceptional or particular ecosystem requiring a separate risk assessment from that for Austria as a whole or other similar regions in Europe. The applicants had not adduced any evidence casting doubt on that assessment, merely stressing the small size of holdings and the importance of organic farming in Upper Austria. Consequently, the applicants’ general considerations were not such as to invalidate the concrete assessments in the contested decision. That, in the Commission’s submission, is a perfectly adequately reasoned assessment.

56. Second, the Commission stresses that ‘new scientific evidence’ and ‘protection of the environment’ are not elements of a ‘specific problem’ but that all three are cumulative conditions for the application of Article 95(5) EC; if any one of them is absent, the request must be rejected.

57. Third, paragraph 71 of the judgment under appeal explains why the precautionary principle is irrelevant, and is not challenged, at least in any explicit or circumstantiated manner.

58. Fourth, considerations relating to alleged failures by the Commission or debates within the Council are irrelevant to the question whether the judgment under appeal is vitiated by an error of law.

59. Finally, the question of the right to a fair hearing is irrelevant in this context, since that right is not alleged to have been infringed in the procedure before the Court of First Instance.





Breach of Community law

60. The appellants submit that the Court of First Instance was wrong to consider that the reasoning in Denmark v Commission, to the effect that the right to be heard did not apply in the context of Article 95(4) EC, was also valid in the context of Article 95(5).

61. The two cases cited by the Court of First Instance to support its reasoning in that regard ( ) both referred to the old Article 100a(4) of the EC Treaty, which did not distinguish between measures already in force and new measures to be adopted.

62. Under the present Article 95(4) and (5) EC, the two situations are distinguished. A national measure in force does not cease to exist when Community harmonisation with which it is incompatible is introduced. Unless and until it is approved by the Commission, it becomes inapplicable to the extent of the incompatibility, but may apply in other cases. That coexistence with the harmonising measure gives rise to uncertainty and thus to the urgency referred to in Denmark v Commission. Where proposed measures are concerned, there is no particular Community need for a speedy resolution.

63. The appellants take issue also with the statement, at paragraph 67 of the judgment under appeal, that ‘the applicants have not put forward evidence to rebut EFSA’s conclusions’. What was at issue before the Court of First Instance was the Commission’s findings of fact. There has never been an opportunity to challenge EFSA’s conclusions, which should be treated not as emanating from the Commission but as an independent expert report on which Austria should have been able to present comments. A mere blanket adoption of those conclusions by the Commission is not compatible with its responsibility to take a decision under Article 95(5) EC.

64. Consequently, the ruling in Denmark v Commission is not relevant, and the Court of First Instance’s decision was in breach of the Community law right to be heard (and the right to a fair hearing under Article 6 of the European Convention on Human Rights).

65. Finally, by basing its reasoning on a misinterpretation of the term ‘specific’ in Article 95(5) EC and thus failing to examine the other conditions in that provision, the Court of First Instance also infringed Community law.

66. The Commission deals first with the alleged breach of the right to be heard or the right to a fair hearing. The Court of First Instance relied on Denmark v Commission solely in order to state that the requirements of the internal market mean that a Member State may not apply rules derogating from a harmonising measure without Commission approval. There is no difference in that regard between Article 95(4) and (5). A drawn-out debate is equally undesirable, and the need for clarification and certainty is equally great, in both cases. In other regards, the appellants appear to confuse the right to be heard in the administrative procedure and the right to a hearing before the Court of First Instance, their arguments being to that extent irrelevant or inadmissible.

67. Second, the Commission stresses that there was no need in the judgment under appeal to examine in detail what might constitute a ‘specific problem’, since the criterion of ‘new scientific evidence’ was not met.

68. It states moreover that the absence of such evidence is unsurprising, since on 7 November 2005 Austria notified the Commission of a fundamentally different draft law for Upper Austria ( ) which, like those previously notified by other Member States and other Austrian Länder, seeks not to impose a blanket ban on GMOs but rather to introduce specific measures to prevent contamination of non-GMO crops. The Commission did not object in principle to such measures. ( )





Assessment

Preliminary remarks

69. At the hearing, the agent for the Commission began his submissions with a reminder that this is an appeal before the Court of Justice, and that its scope is circumscribed by its nature. It is indeed salutary to bear that fact in mind and to consider its context.

70. The role of this Court is to determine whether the appellants have identified any breach of procedure or error of law in the judgment under appeal such as to vitiate that judgment.

71. The role of the Court of First Instance was to determine whether the applicants had identified any essential procedural defect, error of law or manifest error of assessment in the Commission’s decision such as to justify its annulment.

72. The role of the Commission was to determine whether Austria had justified its request under Article 95(5) EC by producing new scientific evidence relating to the protection of the environment or the working environment on grounds of a problem specific to that Member State arising after the adoption of Directive 2001/18.

73. None of those roles properly involves any decision as to what is, or is not, appropriate environmental policy. As regards Community policy, such decisions are to be taken jointly by the Parliament and the Council, on a proposal by the Commission (acting here in a different capacity) and after consulting the Economic and Social Committee and the Committee of the Regions. ( ) Member States for their part retain freedom to determine national environmental policy within their sphere of competence.

74. A second preliminary remark concerns the Commission’s contention that in presenting their grounds of appeal the appellants confuse to some extent the grounds of ‘breach of procedure’ and ‘infringement of Community law’. I agree, but do not consider that anything turns on the point. Provided that a ground of appeal falls within a permissible category, it is of no consequence whether the appellant has categorised it correctly. All the arguments raised by the appellants appear to me to fall within a category provided for in Article 58 of the Statute of the Court of Justice. I note too that, as the Commission points out, the appellants do not expressly challenge the Court of First Instance’s finding that their plea of breach of the precautionary principle was irrelevant. That does not however, in my view, preclude them from invoking that principle in the context of their challenges to other aspects of the judgment.

75. In essence, the appellants allege that the Court of First Instance

– wrongly dismissed their claim that their right to be heard was infringed because the Commission relied on the EFSA opinion but did not give them an opportunity to comment on it;

– misinterpreted the concept of a problem ‘specific to’ a Member State or region as a result of failing to examine properly the submissions in that regard, and consequently gave inadequate reasons for its conclusion;

– failed to examine the submissions in the light of the precautionary principle.

76. I shall deal with the first two allegations in that order, considering where appropriate the possible relevance of the precautionary principle.





Right to be heard

77. ‘[T]he right to be heard does not apply to the procedure in question’, stated the Court of First Instance at paragraph 45 of its judgment, echoing the words of this Court at paragraph 50 of Denmark v Commission. It may be helpful to reflect on what is meant by the ‘right to be heard’ in that context. Where the English version of both judgments speaks of the ‘right to be heard’, the French uses ‘principe du contradictoire’, an expression (closely reflected in other language versions) which may have somewhat different connotations. The appellants refer to Article 6 of the European Convention on Human Rights, which guarantees a fair and public hearing in the determination of civil rights and obligations or of any criminal charge.

78. The notion of the ‘principe du contradictoire’ – often expressed in Latin as audi alteram partem or audiatur et altera pars – is clearly applicable primarily to adversarial proceedings, in which opposing parties must be able to respond to each others’ allegations before a decision is reached by the adjudicating body. Typical examples include civil litigation, arbitration and accusatorial criminal proceedings – and, of course, direct actions before this Court or the Court of First Instance. ( )

79. More broadly it applies also to, inter alia, cases where a person’s rights or interests may be affected by a procedure initiated against him by an authority, in which he must be allowed to respond to the elements which the authority proposes to take into account. Such cases include inquisitorial criminal proceedings and many administrative proceedings – in the Community sphere, for example, investigations by the Commission in the field of competition or dumping, or Treaty-infringement proceedings under Article 226 EC.

80. The situation in the present case differs in that the procedure is initiated by a Member State, which is required to state its grounds for wishing to derogate from harmonising legislation, and which may present as complete a statement and as much supporting evidence as it sees fit. The request is made to the Commission, which assesses the grounds and evidence, and takes a decision. In principle, therefore, the Member State is heard at its own initiative and there is no adversary party.

81. What the appellants seek to have recognised is essentially that they had a right to comment on EFSA’s assessment of the request before the final decision was taken. It is perhaps less important to decide whether that is accurately described by the expressions ‘right to be heard’ or ‘principe du contradictoire’ than to be clear as to what is at issue.

82. The principal obstacle to recognising that right is the Court’s judgment in Denmark v Commission and the reasoning which it contains. The appellants do not suggest that the case-law should be reversed but rather that it should be confined to the context in which it was formulated, namely Article 95(4) EC and not Article 95(5). I do not find their argument persuasive.

83. The relevant paragraphs of Denmark v Commission read as follows:

‘42 … [N]o provision provides for the application of the principle of the right to be heard to the decision procedure laid down in Article 95(4) and (6) EC relating to the approval of national provisions derogating from a harmonisation measure adopted at Community level.

43 Similarly, no provision requires the Commission, under that procedure, to gather opinions from the other Member States, as it has done in the present case.

44 It is therefore important to establish whether the principle of the right to be heard is applicable even in the absence of specific legislation, in particular in the situation where such opinions have been requested.

45 The principle of the right to be heard, whose observance is ensured by the Court of Justice, requires the public authority to hear interested parties before adopting a decision which concerns them (Case C-315/99 P Ismeri Europea v Court of Auditors [2001] ECR I-5281, paragraph 28).

46 The Court has consistently held that the principle of the right to a fair hearing, to which the principle of the right to be heard is closely linked, applies not only to citizens but also to the Member States. As regards the latter, that principle has been recognised in the context of proceedings brought by a Community institution against Member States, such as those concerning the review of State aid or the monitoring of Member State conduct as regards public enterprises (see, for example, Joined Cases C-48/90 and C-66/90 Netherlands and PTT Nederland v Commission [1992] ECR I-565, paragraph 44, and Case C-288/96 Germany v Commission [2000] ECR I-8237, paragraph 99).

47 However, the procedure provided for under Article 95(4) and (6) EC is initiated not by a Community institution but by a Member State, with the decision of the Community institution being adopted merely in response to that initiative.

48 That procedure is initiated at the request of a Member State seeking the approval of national provisions derogating from a harmonisation measure adopted at Community level. In its request, that Member State is at liberty to comment on the decision it asks to have adopted, as is quite clear from Article 95(4) EC, which requires that Member State to state the grounds for maintaining the national provisions in question. The Commission in turn must be able, within the prescribed period, to obtain the information which proves to be necessary without being required once more to hear the applicant Member State.

49 That conclusion is confirmed by the second subparagraph of Article 95(6) EC, according to which the derogating national provisions are deemed to have been approved if the Commission does not take a decision within a certain period. In addition, under the third subparagraph of Article 95(6) EC, no extension of that period is allowed where there is a danger for human health. It is therefore clear that the authors of the Treaty intended, in the interest of both the applicant Member State and the proper functioning of the internal market, that the procedure laid down in that article should be speedily concluded. That objective would be difficult to reconcile with a requirement for prolonged exchanges of information and observations.

50 It follows that the principle of the right to be heard does not apply to the procedure provided under Article 95(4) and (6) EC.’

84. Reading those paragraphs in conjunction with the whole of Article 95(4) to (6) EC, I cannot see any reason why what is said in relation to Article 95(4) should not apply to Article 95(5). The Court’s reasoning was not primarily based on a Community interest in a speedy resolution, which might not apply if the measures were not yet in force and the Member State were not in a hurry. Rather, it derives from the fact that (i) the Member State initiates the procedure and may be expected to present all relevant evidence and argument with its request, in contrast to a situation in which proceedings leading to a sanction are initiated against a party, and (ii) Article 95(6) offers no alternative to compulsory deemed approval if the Commission has not rejected the proposed provisions within the time-limit. That time-limit makes no provision for protracted debate, only for a single extension (at the Commission’s discretion) if justified by the complexity of the matter and if there is no danger for human health.

85. Nor is the appellants’ case assisted by the fact that the Court of First Instance also cited authority ( ) concerning the former Article 100a(4) of the EC Treaty, which did not distinguish between measures already in place before the adoption of a harmonising directive and measures to be introduced subsequently. If anything, that circumstance would tend to confirm that the same principles apply to both.

86. I am therefore of the view that the appellants have not established any legal error in the Court of First Instance’s application of the existing case-law on the right to be heard. ( )

87. Since Denmark v Commission was a judgment of the Full Court, it would not seem appropriate for the Chamber hearing the present case to reconsider that case-law – a referral to the Grand Chamber would be preferable. Indeed, as I have noted, the appellants do not suggest that it should be reconsidered. However, I do not think that such a course of action would be called for in any event.

88. The Commission’s decision is open to challenge before the Court of First Instance, with the possibility of two rounds of written submissions and full oral argument. There is thus full opportunity for a fair and public hearing by an independent and impartial tribunal established by law, in the words of Article 6(1) of the European Convention on Human Rights.

89. It is however necessary to mention another Full Court judgment which might at first sight appear to conflict with Denmark v Commission, namely Technische Universität München. ( ) In that case, a university sought to import scientific apparatus duty-free on the ground that no equivalent was manufactured in the Community. Its application had to include detailed reasons establishing why equipment available in the Community would not be suitable for the particular scientific work to be undertaken. The application was referred to the Commission, which consulted a group of experts, by whose conclusion it was bound. The group reached a negative conclusion, after considering a letter from a Community manufacturer of similar equipment, to which the university was not given an opportunity to respond.

90. The Court found the Commission’s decision invalid. At paragraph 25 of its judgment, it stated:

‘The right to be heard ( ) in such an administrative procedure requires that the person concerned should be able, during the actual procedure before the Commission, to put his own case and properly make his views known on the relevant circumstances and, where necessary, on the documents taken into account by the Community institution. This requirement was not met when the disputed decision was adopted.’

91. Although the circumstances seem comparable to those of the present case and the statement of the law appears to support the appellants’ contention, I believe that the two cases can be distinguished. In Technische Universität München, the point was not that the applicant was not allowed to respond to the conclusion of the group of experts but that it was not allowed to respond to evidence accepted by that group and submitted by a party whose interests were opposed to its own. That was not the case here.

92. I also note that, in Technische Universität München, the Court identified no fewer than three grounds on which it decided that the decision was invalid. ( ) Neither of the other grounds is advanced on appeal in the present case. ( ) It therefore seems to me better to treat Technische Universität München as a case that is unquestionably relevant in terms of the administrative procedure applicable in the field of customs duties and to distinguish it, rather than seek to transpose its dictum on the right to be heard to the different administrative procedure applicable under Article 95 EC.

93. As for the appellants’ assertions that in the present case their right to be heard was not respected before the Court of First Instance itself, on the ground that it did not examine their arguments in sufficient depth, it seems to me that those assertions do not properly concern the right to be heard. It is not alleged that they were in any way denied the right to present argument or evidence at first instance.

94. To the extent that the appellants in fact complain that the Court of First Instance reached the wrong conclusion from the argument and evidence presented, their submission is admissible only in so far as it relates to a possible error in law. I shall consider any aspects which may come under that heading below, when examining the concept of a problem specific to a Member State.

95. To the extent however that they allege that the Court of First Instance simply failed to examine the evidence they submitted, some remarks are called for. Such failure must be a matter for scrutiny on appeal and, if established, may be a ground for quashing the judgment at first instance, though I am unaware of any case in which the issue has arisen in quite such a form. ( ) In this case, it appears from paragraphs 66 and 67 of the judgment under appeal that the Court of First Instance did consider the evidence presented. That evidence (the Müller report and the committee report ( )) had been available to EFSA and the Commission. As I shall explain in greater detail below, the applicants did not indicate to the Court of First Instance in what way it contradicted the conclusions reached by those bodies. In those circumstances, that Court cannot in my view be criticised for not having examined the evidence in that specific light.

96. Finally, as regards the precautionary principle, I would merely point out that the right to be heard, the right to a fair hearing and the obligation to respect the adversarial principle are determined by the nature of the proceedings and do not vary according to any greater or lesser need for precaution.





‘Specific’ problem

97. The appellants argue in essence that the Court of First Instance failed to examine correctly the evidence which they had put forward to rebut the Commission’s conclusion that no problem specific to Upper Austria had been shown to exist.

98. However, those arguments encounter difficulty in so far as they seek to challenge the Court of First Instance’s assessment of the evidence before it. Pursuant to Article 58 of the Statute of the Court of Justice, that assessment is not open to appeal unless it is alleged that the evidence was distorted. ( )

99. None the less, the appellants have raised (though perhaps not pursued as far as might have been expected) a pertinent point in submitting that the word ‘specific’ does not mean the same as ‘unique’. If the Court of First Instance were to have used the wrong legal criterion in assessing the evidence, its judgment would be flawed in that regard, and the evidence would have to be assessed anew in the light of the correct criterion.

100. On closer inspection, the situation seems rather complex but leads me to doubt whether the reasoning of the Court of First Instance can safely be upheld on this point. The difficulty is linguistic and requires some explanation.

101. EFSA’s opinion was drafted in English. Its website states: ‘English is the authentic language of EFSA scientific opinions. In case of doubt, please refer to the English language version of the opinion and its summary.’ As far as the opinion in issue is concerned, no full version other than the English appears to exist, although there is a summary in English, French, German and Italian.

102. The opinion stated, inter alia: ( )

‘The scientific evidence presented contained no new or uniquely local scientific information on the environmental or human health impacts of existing or future GM crops or animals.

No scientific evidence was presented which showed that this area of Austria had unusual or unique ecosystems that required separate risk assessments from those conducted for Austria as a whole or for other similar areas of Europe. No specific cases were presented of impacts of GMOs on biodiversity, either directly or through changes in agricultural practices.’

103. The use of the words ‘uniquely’ and ‘unique’ seems significant to me. Whilst not unequivocal, it appears to suggest that EFSA’s conclusion may have been based on an understanding that, in order to justify a derogation from Directive 2001/18, it is necessary to establish that there is a problem in the Member State or region in question which is found nowhere else.

104. In EFSA’s summary of the opinion, the phrase ‘no new or uniquely local scientific information’ does not appear, but the phrase ‘unusual or unique ecosystems’ does. It is translated into French and German respectively as ‘écosystèmes atypiques ou uniques’ and ‘ungewöhnliche oder einzigartige Ökosysteme’, both of which seem to reflect the English accurately.

105. The two paragraphs of the opinion are quoted ‘verbatim’ in point 71 of the Commission’s contested decision, where they appear clearly as having some importance in its reasoning. I put the word ‘verbatim’ in inverted commas because the two paragraphs are laid out as one and the French and German versions diverge somewhat from the authentic English of the original. ‘No new or uniquely local scientific information’ becomes, in French, ‘aucune information nouvelle ou spécifiquement locale’ – thus camouflaging any possible discrepancy between the wording of Article 95(5) EC and EFSA’s interpretation of it – and, in German, ‘keine oder nur lokal begrenzte wissenschaftliche Daten’, which has a quite different meaning and may derive from a misreading of the English. ‘Unusual or unique ecosystems’ is translated into French as ‘écosystèmes particuliers ou exceptionnels’ and into German as ‘ein ungewöhnliches oder einzigartiges Ökosystem’. Again, the French removes the notion of uniqueness (and differs from EFSA’s summary in French), but here the German reflects both the English of the opinion and the German of the summary.

106. The Commission’s decision is addressed to Austria, and specifies that only the German text is authentic. It is not clear whether that necessarily implies that the Commission’s analysis was carried out only in German and the decision drafted originally in that language. In any event, the German version of the EFSA opinion, on which the decision was based (at least in part), does not seem to have been entirely an accurate translation.

107. The language of the case before the Court of First Instance was of course German. It is however no secret that the working language of that Court, like that of the Court of Justice, is French. Consequently, its analysis may have been based on French versions of the documents in the case – including in particular the French text of the contested decision, which effaces any reference to uniqueness in the quotation from the EFSA opinion at point 71. In any event the judgment under appeal will have been drafted in French. ( )

108. Those considerations take on some relevance when one looks at the French version of paragraphs 65 to 67 of the judgment. Paragraph 65 reproduces most of the quotation in point 71 of the contested decision, referring to ‘aucune information nouvelle ou spécifiquement locale’ and ‘des écosystèmes particuliers ou exceptionnels’. Paragraph 66 goes on to state that the applicants had failed to provide convincing evidence such as to cast doubt on the merits of the assessments as to the existence of a specific problem, and paragraph 67 that they had not put forward evidence to rebut EFSA’s conclusions that it was not established that Upper Austria contained ‘des écosystèmes particuliers ou exceptionnels’ that required separate risk assessments from those conducted for Austria as a whole or other similar areas of Europe.

109. Consequently, from the French in which the judgment under appeal was drafted, there is no indication that the Court of First Instance was aware of the possibility that EFSA in its opinion might have been proceeding on the assumption that, in order to justify a derogation on the basis of Article 95(5) EC, Austria had to establish the existence of a problem unique to the region in question, rather than one which was specific, particular or in some other way exceptional.

110. It seems to me clear that, as the appellants submit, the word ‘specific’ in Article 95(5) EC cannot be equated with ‘unique’. A problem may be specific to more than one region or Member State, but can be unique only to one. It is perhaps unnecessary to draw a precise line for present purposes, but a specific problem clearly lies somewhere between one which is unique and one which is common, generalised or widespread. The criterion in Article 95(5) EC is that the problem must be specific, and to require uniqueness would be to misinterpret or misapply that provision.

111. That is not to say that the Court of First Instance did misinterpret or misapply the criterion. Its use of the adjectives ‘spécifique’, ‘particulier’ and ‘exceptionnel’ seems entirely consistent with my understanding of the provision.

112. However, after examining the evidence put to it by the applicants, ( ) the Court of First Instance concluded that they had not rebutted or cast doubt on EFSA’s conclusions or the Commission’s assessments. However, that finding concerned the conclusions and assessments as expressed in French, without any reference to a criterion of uniqueness. It does not seem to me safe to conclude that the Court of First Instance would have reached the same view if it had been evaluating the evidence against EFSA’s references to uniqueness or had considered the Commission’s assessment to be based on such references.

113. On that basis, the Court of First Instance’s dismissal of the applicants’ plea of infringement of Article 95(5) EC cannot stand. Having found that the conclusion that there was no problem specific to Upper Austria had not been rebutted, the Court did not consider any of the other cumulative conditions laid down in that provision. No sure ground for dismissing the plea thus remains in the judgment.

114. It is therefore necessary to examine the remaining conditions for the application of Article 95(5) EC. Pursuant to the first paragraph of Article 61 of its Statute, the Court of Justice may do so itself or refer the case back to the Court of First Instance, depending on the circumstances. Here, it seems to me that the Court of Justice is in a position to effect the examination.





The cumulative conditions in Article 95(5) EC

115. As I have noted, in order to obtain a derogation pursuant to Article 95(5) EC, a Member State must provide new scientific evidence relating to the protection of the environment or the working environment on grounds of a problem specific to that Member State arising after the adoption of the harmonisation measure. Those various conditions are cumulative, as the Court of First Instance stated and as was expressly accepted by the Austrian Government at the hearing on appeal. In other words, if any one condition is not fulfilled, the derogation cannot be accorded.

116. It does not appear to be contested, either in EFSA’s opinion or in the Commission’s decision, that at least some of the evidence on which Austria relied related to the protection of the environment, although the Commission found, at point 68 of its decision, that Austria’s concerns could not be regarded as relating specifically to protection of the environment. The condition of ‘evidence relating to the protection of the environment’ may therefore be deemed to be fulfilled. A brief remark is however called for.

117. The appellants have argued, on the basis of EFSA’s statement that it ‘was not asked by the Commission to comment on the management of co-existence of GM and non-GM crops’, that EFSA and the Commission ignored the central issue raised by Austria in its request.

118. It seems to me, however, that the Commission correctly sought to distinguish between the environmental issues with which Article 95(5) EC and Directive 2001/18 are concerned and the socio-economic issues of agricultural management, which fall outside the scope of the legislation. ( ) In setting out its terms of reference, EFSA stated that it was ‘not requested to comment on information that does not impact on risk to human health and the environment, in particular that relating to the management of co-existence.’ ( ) Its opinion clearly did – properly – consider the environmental issues, in particular concerning gene flow, but – equally properly – did not comment on those other issues.

119. Returning to the conditions set out in Article 95(5) EC, it seems to be agreed that the Müller report presented at least some evidence which was scientific, although the EFSA opinion pointed out that many references concerned legislation or economic affairs.

120. The remaining conditions are that the evidence must be new, and that the problem to which it relates must have arisen after the adoption of Directive 2001/18.

121. As regards the question whether the scientific evidence presented in the Müller report was new, EFSA stated that it was mostly a review of current knowledge on crop to crop gene flow and crop to wild relative gene flow of a few crop types. At point 65 of its decision, the Commission considered that the Müller report contained data which were for a large part available prior to the adoption of Directive 2001/18.

122. In their applications at first instance, Land Oberösterreich and Austria accepted that the Müller report was based largely on data already available. They argued, however, that it reached new conclusions from the existing data and that those conclusions should be regarded as ‘new scientific evidence’. They submitted also that it was confirmed by more recent scientific literature. ( )

123. It is easily verifiable that of the 115 references cited in the Müller report completed in April 2002, only 22 date from that year or from 2001, the year in which Directive 2001/18 was adopted, and that fewer than half of those appear to be of a scientific nature. The appellants have made no claim that the 2001 or 2002 scientific references were decisive or even significant as regards the conclusions presented. And, since the issue is whether the evidence Austria presented to justify its request was new, the fact that other new evidence may subsequently have come to light cannot affect the validity in law of the Commission’s decision, having regard to the evidence on the basis of which it was taken and the time at which it was taken.

124. There remains the question whether a new conclusion drawn from existing data can constitute ‘new scientific evidence’. In English, that would not normally be the case. ‘Evidence’ normally designates the raw material from which conclusions may be drawn. The picture is less clear however when one looks at a broader range of language versions of Article 95(5) EC. The Dutch (‘nieuwe wetenschappelijke gegevens’) appears to agree with the English. Several of the Latin languages use terms (‘preuves scientifiques nouvelles’ in French, ‘nuove prove scientifiche’ in Italian and ‘novas provas cientificas’ in Portuguese) which may have a broader meaning. And the Spanish (‘novedades cientificas’) and German (‘neue wissenschaftliche Erkenntnisse’) versions certainly appear more capable than the English of bearing the meaning for which the appellants argued at first instance. I do not think it necessary to look further in order to reach the view that new conclusions drawn from existing data may constitute new scientific evidence within the meaning of Article 95(5) EC.

125. However, I find nothing in the pleadings which goes beyond a simple assertion that the Müller report drew such new conclusions from the existing data. No new conclusion is even identified. Still less is there any explanation of how such a conclusion might differ from conclusions previously drawn from the same data. Since one of the grounds on which the request for a derogation had been rejected was that the scientific evidence was not new, it was incumbent upon the applicants at first instance to rebut that ground if their action was to succeed. It is not sufficient to show that evidence could in theory have been new without identifying and explaining what was in fact new about it.

126. I therefore take the view that the appellants have failed to rebut the Commission’s findings as to the inexistence of new scientific evidence. That is itself a sufficient ground for dismissing their third plea at first instance, but I shall also examine the condition that the problem alleged must have arisen after the adoption of Directive 2001/18.

127. The problem which the appellants have argued is specific to Upper Austria derives, in their submission, from the (relatively) high proportions of organic farming and of small holdings.

128. As regards the size of holdings, they have not submitted that the situation changed in any way after the adoption of Directive 2001/18.

129. As regards the proportion of organic farming, they have given figures for the increase between 31 December 2001 and 31 December 2002: from 2 792 to 3 040 farms, and from 45 950 to 50 077 hectares, making an increase of just under 9% over the year in each regard; organic farming thus accounted (apparently at the end of 2002) for 7.5% of the number of holdings and 8.85% of the farmed area in the region. ( )

130. They have given no figures for the whole of the relevant period from March 2001, when Directive 2001/18 was adopted, to March 2003, when the request for a derogation from the directive was made. If the trend was linear both before (from March to December 2001) and after (from January to March 2003) – as to which there is no evidence one way or the other – extrapolation from the 2002 calendar year figures would lead to the conclusions that there may have been an increase of roughly 18%. Depending on whether area or number of holdings is taken as the basis, that would take the proportion of organic farming within total agriculture in Upper Austria from between 6% and 8% to around 8% or 9%.

131. As a matter of degree, such an increase does not seem sufficient to demonstrate the existence of a newly-arisen problem. The appellants have however argued that Article 95(5) EC does not require that the problem should have arisen in its entirety since the adoption of the harmonising measure. It may in their submission have been previously latent and only subsequently have been revealed to its full extent. In the present case, they allege, it was the publication of the Müller report in April 2002 which revealed that true extent. ( )

132. I would agree that, in principle, a problem which was latent at the time of the adoption of a harmonising measure may, depending on all the circumstances, be regarded as having arisen after that adoption for the purposes of Article 95(5) EC if it is only subsequently revealed. It does not, however, seem particularly likely that a progressive increase in the proportion of organic farming should give rise to such a revelation unless some threshold is crossed which triggers a significant change in the situation. I find nothing in the appellants’ pleadings which goes beyond the simple assertion that the scale of the problem became apparent only with the publication of the Müller report. That, taken together with the fact that they have not identified any specific new conclusion in that report, drawn from new or existing data, leads me to the view that they have not established the existence of a problem which arose after the adoption of Directive 2001/18.

133. Consequently, the appellants have not rebutted the conclusions in point 75 of the contested decision, to the effect that Austria had provided no new scientific evidence and had not demonstrated that there was a specific problem which arose after the adoption of Directive 2001/18.

134. Having regard to the stress laid by the appellants on the precautionary principle, I would add that, relevant though the principle may undoubtedly be when assessing new evidence concerning a new situation, no amount of precaution can actually render that evidence or that situation new. The novelty of both situation and evidence is a dual criterion which must be satisfied before the precautionary principle comes into play.

135. The third plea at first instance may therefore be dismissed in any event, regardless of whether the ground on which the Court of First Instance dismissed it can safely be upheld.





Summary and final considerations

136. My analysis may be summarised as follows.

137. In the procedure under Article 95(4) or (5) EC, it is for the Member State to submit with its request all the evidence and argument necessary to support that request. The Commission then takes a decision on that basis. It may before taking its decision obtain the opinion of other Member States (as in Denmark v Commission) or of an expert body set up to assist it in such matters (as in the present case). Because of the nature of the procedure (initiated by the Member State, which has full opportunity to make all relevant submissions) and the time constraints (six months, with the possibility of a single extension in exceptional circumstances of complexity), the Member State does not necessarily enjoy any general right to respond to any opinion obtained by the Commission. However, if an expert body were to give an opinion after hearing evidence or argument contradicting that put forward by the Member State but to which the Member State had not been given an opportunity to respond, it might be necessary to consider whether that was not an essential procedural defect in the formulation of the opinion (Technische Universität München). In the absence of any such difficulty, the Member State’s right to respond to any opinion on which the Commission bases its decision is satisfied by its right to challenge that decision before the Court of First Instance. At that stage, it may put forward any evidence or argument liable to refute any element on which the Commission’s decision is based.

138. If, in such circumstances, the only evidence which the Member State asks the Court of First Instance to consider is that which was already put to the Commission, and which it therefore alleges was incorrectly assessed by the Commission, the Member State must indicate precisely how the evidence should have led to a different conclusion. It is not enough to demonstrate in the abstract that evidence of the kind presented may be capable of interpretation in a different way, and to ask the Court of First Instance to carry out a reassessment of the evidence actually presented. The Member State must at the very least identify specific parts of that evidence which it alleges called for a different interpretation and explain in detail why that interpretation is justified and the interpretation on which the Commission’s decision is based is not.

139. In the present case, Austria had to demonstrate in its application under Article 95(5) EC that all the conditions enumerated in that provision were satisfied: (i) new evidence must be presented, (ii) the evidence must be scientific, (iii) it must relate to protection of the environment or the working environment, (iv) there must be a problem specific to the Member State, and (v) the problem must have arisen after the adoption of the harmonising measure.

140. EFSA in its opinion and the Commission in its decision considered that (i), (iii) and (iv) were not fulfilled. They cannot be said to have found that (ii) was not satisfied at all. They did not explicitly examine (v), but may (justifiably) have considered that the absence of new evidence implied the absence of a newly-arisen problem, or that in the absence of a problem specific to Upper Austria there was no need to examine the timing more closely.

141. Before the Court of First Instance, Land Oberösterreich and Austria submitted that all the conditions in Article 95(5) EC were satisfied. That Court found that they had not established (iv) to be satisfied and concluded that the failure was sufficient for it to dismiss their claim that the contested decision infringed Article 95(5) EC. On the basis of that finding, its conclusion was correct, but the finding is open to doubt in that it may not have realised that EFSA possibly applied a more demanding standard than ‘specific’, namely ‘unique’.

142. The claim of infringement of Article 95(5) EC could succeed only if is it shown that all the conditions in that provision were satisfied. Land Oberösterreich and Austria have not shown that to be the case, either before the Court of First Instance or before the Court of Justice, because they have not shown that (i) and (v), taken together, were satisfied – that there is new evidence of a problem which arose after the adoption of Directive 2001/18. They have merely resubmitted evidence considered by EFSA and the Commission, and have pointed out (correctly) that a new analysis of existing data leading to a new conclusion may qualify as ‘new evidence’ for the purposes of Article 95(5) EC and that a problem which was latent at the time of adoption of a harmonising measure may be regarded for the same purposes as having arisen after that adoption if it became apparent only after that date. They have not explained how the evidence is alleged to meet those criteria or identified which aspects of it are alleged to be relevant.

143. I am well aware that the conclusion which I reach – or perhaps rather its implications – will disappoint not only the appellants but also many individuals and organisations deeply and genuinely concerned about the as yet not wholly determined risks involved in the propagation of GMOs.

144. I would recall, however, two considerations.

145. On the one hand, as I outlined above, ( ) the concerns in question are policy concerns which must be dealt with in political fora. It is not for this or any other court to determine proper national or Community environmental policy. And the concerns in question are not in themselves directly relevant to the legal issues raised in this case, whether at first instance or on appeal.

146. On the other hand, it is clear that national and regional authorities within the Member States have considerable powers and duties to take those concerns into account in the formulation of their own policies and in the application of Community policies. They may pass legislation such as that finally adopted in Upper Austria, which imposes stringent safeguards on the cultivation of GMOs. They may intervene in the Community approval process under part C of Directive 2001/18. They must monitor and report new information under Article 20 of that directive, they may invoke the safeguard clause in Article 23 and they may take measures under Article 26a. ( ) Moreover, in accordance with the 2003 guidelines, ( ) they may and should take steps to ensure that any cultivation of GMOs within their territory can coexist, without admixture, with neighbouring conventional or organic farming.

147. What they may not do is to adopt legislation imposing a blanket ban on GMOs within their territory, unless they can provide evidence which complies with all the criteria in Article 95(5) EC.





Costs

148. Under Article 69(2) of the Rules of Procedure, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings. The Commission has applied for costs, and the appellants’ arguments should in my view be unsuccessful overall, even though they have identified a possible flaw in the judgment under appeal.

Conclusion

149. In the light of all the above considerations, I am of the opinion that the Court should

– set aside the judgment of the Court of First Instance in Joined Cases T-366/03 and T-235/04 in so far as it dismisses the plea of infringement of Article 95(5) EC,

– dismiss the applications in those cases and

– order the appellants to pay the costs.