OPINION OF ADVOCATE GENERAL

delivered on 30 May 2002 (1)

((Approximation of legislation – Labelling of dangerous substances – Directive 97/69/EC – Derogating national measures – Article 95(5) EC – Conditions of application))

Introduction

I ─ Community legislation

4. By contrast with Article 100 of the EC Treaty, from which by express definition it constituted a derogation, Article 100a in practice gave the Council the possibility of deciding, by a qualified majority and in accordance with the cooperation procedure laid down in Article 189b of the EC Treaty (now, after amendment, Article 251 EC), to adopt the measures for the approximation of the provisions laid down by law, regulation or administrative action in Member States which have as their object the establishment and functioning of the internal market. Within this framework, paragraph 3 of the article set a high level of protection as the objective for such measures if they concerned health, safety, environmental protection and consumer protection. Indeed, it required the Commission to base its proposals for such matters on a high level of protection. However, as these were measures to be adopted by a qualified majority, and hence entailed the risk of sacrificing national needs worthy of protection, the same article gave Member States the possibility of derogating from the measures in question in order to protect such needs.

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.

8. When a Member State raises a specific problem on public health in a field which has been the subject of prior harmonisation measures, it shall bring it to the attention of the Commission which shall immediately examine whether to propose appropriate measures to the Council.

10. The harmonisation measures referred to above shall, in appropriate cases, include a safeguard clause authorising the Member States to take, for one or more of the non-economic reasons referred to in Article 30, provisional measures subject to a Community control procedure.

B ─ The harmonisation directives

8. Annex I to Directive 67/548 contains a list of dangerous substances and specifies the harmonised procedures for their classification and labelling. The list is regularly updated by means of successive amendments in the light of advances in scientific and technical knowledge; the 23rd of these amendments, contained in Directive 97/69, is of relevance here.

10. Directive 97/69 provides inter alia for the introduction of a general entry on mineral wool into the list of dangerous substances in Annex I to Directive 67/548 and for the insertion of a Note Q relating specifically to mineral wool into the Foreword to Annex I.

11. Mineral wool is defined in the general entry as man-made vitreous (silicate) fibres with random orientation and alkaline oxide and alkali earth oxide ... content greater than 18% by weight.

13. According to the definition in Annex VI, in particular at paragraph 4.2.1, the carcinogenic substances of category 3 are substances which cause concern owing to their possible carcinogenic effects. Category 2 is indicative of a higher level of risk: the substances placed in this category are those for which scientific studies and animal tests have established a strong presumption as to their carcinogenic effects on humans. In accordance with these criteria, mineral wool is generally included in the list provided for by Directive 67/548 as category 3 substances with carcinogenic effects, except those classified residually in the category of irritants on account of their lower risk. In particular, the latter classification is made where animal tests have produced negative results with regard to carcinogenic effects, in compliance with Note Q.

14. Under Article 3 of Directive 97/69, the Member States were required to implement the directive by 16 December 1998.

II ─ Facts

15. Germany implemented the directive in good time, amending its national legislation accordingly. However, as it did not consider the provisions introduced in this way to be sufficient to meet some of the major needs referred to in Article 36 of the EC Treaty (now Article 30 EC), (7) the German Government initiated a procedure to obtain authorisation and to adopt derogating measures under Article 100a(4) EC.

16. In particular, it requested authorisation to classify certain types of mineral wool as category 2 carcinogens, as it considered that they presented a higher degree of risk than was attributed to them by Directive 97/69. For other types of mineral wool, however, the German Government concurs with the classification contained in Directive 97/69 and therefore lists them among category 3 carcinogens. According to Notes Q1 and Q2 in the proposed national legislation, however, the new classification would not apply where the results of a particular animal test or the value of a certain carcinogenicity index derived from the chemical structure of the substance (the KI Index) showed that the risk was not excessive. In that case the mineral wool would not be classified as a dangerous substance and hence not even in the category of irritants, as provided for in Directive 97/69.

17. Germany justifies its application not only by criticising some procedures for assessing the carcinogenic potential of mineral wool indicated in Note Q of Directive 97/69, but also by claiming that specific scientific studies prove that the classification of certain types of mineral wool as category 3 carcinogens under Directive 97/69 breaches the parameters laid down in the base directive, that is to say Directive 67/548. Moreover, it maintains that a study for the European Chemical Bureau by the joint research centre in 1997 shows that the assessment criteria set out in that directive lead to inconsistent results. Choosing one or the other could change not only the classification of individual substances but even their relative degree of risk.

18. In view of the alleged inadequacies of Directive 97/69, Germany asserts that the proposed national regulations are an appropriate means of ensuring respect for the needs protected by the Treaty and by the harmonisation directive, amply illustrates their scientific basis and points out that they also make it possible to avoid unnecessary animal testing.

19. As regards the compatibility of the proposed measures with the Treaty, Germany points not only to the necessary and proportional nature of the measures but also to the fact that they have a limited prejudicial effect on trade within the Community. It maintains that the industries producing mineral wool adapted years ago to the information flowing from the scientific and technical debate on which the German proposal is based, indeed that they participated actively in that debate and in the regulatory process and geared production accordingly. In the view of the applicant government, the German measures would therefore not have an adverse effect on the movement of goods, or at most any such effect would be barely significant.

21. As regards the classification of the fibres as category 2 carcinogens, the Commission decision merely states that there is no comparison between the exclusion criteria in the German Note Q1 and those laid down in Note Q of Directive 97/69, in that they relate to a lower level of toxicity. With regard to fibres classified as category 3, the Commission considers the changes proposed by Germany to be unacceptable, in particular the use of the KI Index, in that it has not been extensively tested. Moreover, it rejects the accusation of inadequacy that Germany levels at the harmonised legislation, invoking the report of the labelling experts, which refuted each individual argument presented. This included reference to the year long, in-depth scientific/technical discussions that had taken place during the preparation of Directive 97/69/EC. (10) However, the Commission itself points out that the CSTEE considered the technical report to be of unsatisfactory quality. (11)

22. Finally, assessing the German request from the standpoint of Article 95(5) EC, the Commission finds that the applicant government has not provided new scientific evidence to justify the proposed measures nor has it adduced a problem specific to Germany.

23. Germany has brought the present application against the said decision and seeks its annulment. In the course of the proceedings the Republic of Finland subsequently intervened in support of the Commission on certain specific points, of which I shall say more later.

III ─ Legal analysis

Introduction

24. Germany's application is based on a series of arguments of various kinds that can be summarised as follows. First and foremost, Germany contends that the decision is based on a provision (Article 95(5)) which in reality was not applicable in the present case as it was not in force at the time of the German request. Secondly, it alleges that the decision was the outcome of a procedure in which the Commission infringed both the right to a fair hearing and the duty to cooperate set out in Article 10 EC. In any event, it maintains that the decision should be annulled in that it rests on a false legal basis or, in the alternative, in that it is vitiated by misapplication of Article 95(5) EC and by errors of fact, in particular as regards the appraisal of the scientific evidence put forward by Germany. Lastly, it alleges that the Commission was wrong in that it failed to apply paragraph 6 of Article 95 EC.

25. I shall examine the six grounds of the application in the order I have indicated.

26. As I have already mentioned, the first ground of the application is based on an alleged infringement by the Commission of the rules of transitional law.

Arguments of the parties

27. Germany maintains that the Commission should have assessed the German notification not on the basis of the current Article 95(5) EC but by applying Article 100a(4) of the EC Treaty, in the version in force before 1 May 1999. This was the provision in force when Directive 97/69 was adopted, when that directive was transposed and at the date of the German notification (11 December 1998), which made explicit reference to that provision. According to Germany, therefore, only application of Article 100a(4) was consistent with the system of the Treaty and moreover there would have been no doubt on this point had examination of the notification not lasted all of ten and a half months.

28. The German Government also adds that there is a close link between the first paragraph of Article 100a, which authorises the Council to adopt harmonisation legislation by a qualified majority, and the fourth paragraph of the same article, which permits a Member State placed in a minority to apply diverging national measures. That link cannot be broken because of the slowness of the Commission, which is all the more unjustifiable in a case in which the scientific issues were well known to the experts of that institution.

29. Germany observes that the fact that Article 100a(4) refers explicitly only to Council directives does not mean that the provision cannot be applied when, as in the present case, the legislation at issue is a Commission directive and in particular when, as in the present case, the Commission's regulatory power is based on a clause of a Council directive and relates only to the adaptation of the latter to technical progress and when the Member State requesting the derogation was in a minority in the vote within the regulatory committee assisting the Commission for the purposes of such adaptation. All the more so as in the case under examination the Council directive had been adopted unanimously.

31. The Commission replies that the principle of the attribution of tasks set out in Article 7(1) EC requires the institutions to act on the basis of the powers conferred on them when they adopt the measure. Furthermore, the Treaty of Amsterdam laid down no transitional arrangements for the provisions which it amended, so that the general principles on the temporal application of the legal rules must be applied. On this basis, and recalling the case-law of the Court, (12) the Commission points out that amending legislation applies not only to all situations arising after it comes into effect but also to the present and future consequences of situations which arose under the previous legislation; it cannot, however, be applied to situations that are definitively settled nor used to modify existing legal relationships. In the present case, no settled legal situation had crystallised before the decision, because the notification of an application under Article 100a(4) EC does not in itself give rise to such a situation; only the decision of the Commission can have such an effect, defining the legal relationship. Hence that is the moment to which reference must be made to establish the rules applicable at the time.

32. With regard to the alleged slowness of the procedure, the Commission firmly denies that it intentionally delayed the adoption of the decision requested by the German Government. Moreover, the time it took to complete the complex procedure was broadly the same as that taken by the German Government to prepare its application after approval of the Directive (in December 1997) and to notify it to the Commission (in December 1998). It is true that, as the Court has clarified on another occasion, (13) the Commission should have delivered the decision under Article 100a(4) as soon as possible; according to the defendant, however, that parameter should also be compared with the diligence demonstrated by the Member State in notifying the national provisions. As to the period of six months laid down in Article 95(6), the Commission maintains that it was also complied with, because in the case in point the period began on 1 May 1999, the date on which the Treaty of Amsterdam came into force, and not, as the German Government contends, when the procedure was initiated, that is to say in December 1998.

Assessment

33. I must begin by saying that although the criticism in question was much discussed during the hearing, I believe that in reality within the economy of the present case it is of less importance than the applicant government claims. It is clear that the German Government is insisting on the application of Article 100a(4) of the EC Treaty in order to circumvent the stricter conditions set by Article 95(5) EC for derogations from harmonised legislation, in the belief that there is a substantive difference between the two provisions.

34. For my part, as I have sought to explain more fully elsewhere, (14) I consider that there is substantial continuity between Article 100a(4) of the Treaty and the subsequent paragraphs 4 and 5 of Article 95 EC and that the claimed differences between them are probably only the result of a hasty reconstruction of the legislative process that effected the transition from one to the other, in other words a reconstruction that stems from the notion that Article 100a(4) only provided for the possibility of maintaining national provisions in derogation from a Community harmonisation measure on the basis of an assessment of the need for such measures that was left to the Member State concerned; the subsequent Article 95 EC then reiterated the same hypotheses in paragraph 4 and added another in paragraph 5, regulated in a more analytical and restrictive manner, to cater for the possible introduction of new national provisions in derogation from the aforesaid harmonisation measure.

35. In my opinion, however, such a reconstruction does not represent a correct interpretation of the provisions in question, for a series of reasons that I illustrated in the Opinion to which I have referred and which I shall summarise briefly here in so far as is necessary for the purposes of the present case.

(a) The relationship between Article 100a of the EC Treaty and Article 95 EC

36. I observe first that all the provisions in question patently meet the same concern to cater for two distinct needs that are not always easy to reconcile: first, to give impetus to the establishment of the common market, and secondly to ensure high standards of protection of health, safety, environmental protection and consumer protection. For the latter, in particular, the said provisions openly show the desire to take account of concerns legitimately expressed by the Member States in a legislative process which, from Article 100a onwards, can now be decided by a qualified majority, although on the premiss that in principle such concerns are presumed to have already been satisfied by the harmonisation measure itself, given that it must by definition be based on a high level of protection.

37. The differences between the said provisions relate to the specific methods laid down for pursuing the aims I have just indicated ─ but for good measure they do not always do so ─ and are due in part to a subsequent refinement of the rules and in part to the differences in the cases contemplated. As to the first aspect, I note in particular that Article 100a(4) referred generally to the situation where a Member State intended to apply national provisions in derogation from a harmonisation measure, giving rise to the erroneous belief that it was limited to the hypothesis of maintaining such provisions. In reality this was not the case, as the wording already served to cover both the hypotheses in question, in other words both the maintenance of existing provisions and the introduction of new ones. (15) Indirect confirmation of this is to be found in the subsequent Article 95, which explicitly separated the two hypotheses, replacing the general term apply with the more specific terms maintain and introduce, which in my opinion confirms that in reality Article 100a previously covered them both.

38. Despite this, and moving on to the second aspect, it could be objected that only the fourth paragraph of Article 95 repeats the general wording of Article 100a(4), whereas the fifth explicitly requires certain conditions to be met for the derogation to be authorised (the derogating national provisions must be based on new scientific evidence in the sectors indicated, there must be a problem specific to the requesting State and that problem must have arisen after the adoption of the directive). This could lead one to conclude that the said conditions do not apply to the fourth paragraph of Article 95 EC, just as they did not apply to the corresponding paragraph of Article 100a; hence, at most there would be continuity only between Article 100a(4) and the fourth paragraph of Article 95.

39. There is no doubt that paragraphs 4 and 5 of Article 95 lay down different rules, as they refer to different situations; however, it is necessary to agree where those differences really lie and what consequences they entail. In my opinion, they cannot but relate to the factor which plainly distinguishes the two situations in question from one another, that is to say the fact that the fifth paragraph refers to the introduction of derogating measures after the adoption of the Community measure and justified by new scientific evidence. It follows that within the framework of the more precise and developed derogation regime provided for in Article 95 EC the fifth paragraph of the provision is in turn even more special, so to speak, than the preceding paragraph (as to some extent is confirmed by the paragraph itself when it gives precedence to that paragraph) and hence makes the hypothesis for which it provides subject to even stricter criteria than those laid down by the fourth paragraph, both as regards the major needs considered ─ given that in this case it is possible to introduce a safeguard measure only for protection of the environment or the working environment ─ and above all as regards the conditions for operation of the provision. As I have said, the national measure must be based on new scientific evidence and justified by a problem specific to the Member State concerned arising after the adoption of the directive.

40. But these last two conditions are strictly interdependent, in the sense that the specific nature of the problem is not sufficient to justify the subsequent national measure: new scientific evidence must also have emerged. If reference had been made only to the first condition, it would have been possible to find an argument in favour of the position criticised here, but the provision also demands new evidence; it is precisely for this reason that the fifth paragraph, but not the fourth, makes express reference also to the specific nature of the problem. If this reconstruction failed to convince, it would have to be explained for what mysterious reason a Member State must rely on a problem specific to itself if it wishes to introduce derogating measures after the adoption of the directive but not if it wants to maintain existing ones, particularly if one considers that it has also had an opportunity to defend its reasons for the latter during the preparation of the directive.

41. The fact that the requirement for a specific problem to exist also applies to the situation referred to in Article 95(4), as it did under Article 100a, appears to me to stem above all from systematic considerations. First and foremost, to the extent that it creates an exception to the principles of uniform application of Community law and unity of the market, Article 95(4) EC must, like all provisions which allow derogations, be strictly interpreted, so as to ensure that it is not extended to cases other than those specifically provided for in it. By contrast, the proposition criticised here would effect just such an extension. In any case, to me it seems very difficult to reconcile with that interpretative principle the claim of a Member State to rely in general terms on the inadequacy of the standard of protection guaranteed by the Community legislature as grounds for requesting, on the basis of a unilateral assessment of the need for raising that standard, authorisation to maintain or introduce a derogation from the provision and hence from the principle of unity of the market. On the contrary, it seems to me that to allow such a claim would mean transforming Article 95(4) EC into a veritable permanent opt-out clause from any harmonisation directive, in stark contrast with the principles and purposes of the system and with the logic which, in the protection of the general interest, inspires the division of powers between the Community and the Member States, all the more so if one considers that the provisions under examination already take ample account of the needs of the Member States sacrificed by the transition to majority voting, given that they expressly introduce a substantial derogation from the established principle that where Community harmonisation has taken place in a given matter the Member States may no longer adopt unilateral measures justified by the protection of the needs referred to in Article 30 EC. In the case under examination, provided the conditions are met, such measures can be authorised, and this in my opinion is already in itself a significant reinforcement of the guarantees sought. To go further, and to translate those conditions into a possibility of derogations ad libitum, would not be a compromise but an abuse.

42. In reality, if that paradoxical consequence is to be avoided, it must be conceded that further justifications and conditions are necessary for the derogation to be legitimately requested, and these cannot but consist in a problem specific to the State concerned for which the general measures contained in the directive are not able to cater. If it were a problem common to all or the majority of Member States, it would presumably already have been resolved by the directive, but if that were not so, it would be necessary to verify whether the conditions for challenging the directive directly were met, given that the directive must already ensure not just general protection but a high level of protection; in any case, the problem would be of a general nature and it is not therefore possible to understand why it should be resolved only for the fortunate citizens of a single more meticulous Member State, to the detriment of the uniform application of the harmonised rules and hence of the functioning of the common market. If, on the other hand, the level of protection were considered adequate, it is still not possible to understand why one Member State should be allowed the liberty to raise it unilaterally, even with the laudable intention of ensuring an even higher level of protection for its own citizens, again to the detriment of the unity of the market, unless this State can demonstrate the existence of a situation specific to itself that justifies such consequences.

43. I therefore consider that Article 100a(4) also requires a situation specific to the Member State interested in the derogation. As to the other two conditions set by paragraph 5 of Article 95, as I have already said, they are patently linked to the particular nature of the hypothesis contemplated by that provision. If, however, the notion is accepted that Article 100a(4) also referred to the possibility of introducing national measures after the directive had been adopted, it must also be concluded that it also had to require the existence of factors not known or not considered previously that could justify permitting that state to exempt itself a posteriori from Community harmonisation.

44. Without expatiating further on this point, therefore, I merely reiterate my belief that the underlying reasons that led the German Government to insist on the complaint in question are probably less justified than that government avers.

(b) The applicability of Article 95 EC

45. That having been said, and to return to the question of transitional law, I too must first recall that the Treaty of Amsterdam does not contain transitional provisions for the amendments it made to Article 100a, nor indeed for the other amendments it introduced. It is therefore necessary to refer to the general principles on the succession of rules over time.

46. In this connection I recall that it is a generally accepted principle, endorsed by the consistent case-law of the Court, that legislation amending other legislation applies, unless otherwise provided, to the future consequences of situations which arose under the previous legislation. In this regard one speaks of the immediate applicability of the legislation, in the sense that the temporal scope of a rule also includes the future effects of ongoing situations which were created but were not permanently fixed before the rule entered into force. It therefore becomes essential to establish the moment at which the legal situation became fixed, because this is the decisive moment for determining the applicable legislation; the situation in question will be governed by the legislation in force at the time at which it was fixed.

47. From this point of view I believe I can agree with the observation of the Commission, which points out that the introduction of an application by a Member State under Article 100a(4) of the EC Treaty is not an appropriate means of establishing any definitive legal situation in favour of the applicant, because only the subsequent decision by the Commission can produce such an effect. For the purpose of determining the applicable legislation it is therefore not the moment at which the application is made that is relevant but the moment at which the decision is adopted by the Commission. Furthermore, the fact that it is the latter that fixes the procedure seems to me to be confirmed indirectly by a reading of the Kortas judgment, in which the Court held that the mere notification under Article 100a(4) of the EC Treaty does not influence the direct effects of the directive until the Commission has adopted the authorising decision. That decision therefore takes on the character of an authorising provision of a substantive nature, that is to say a conditio sine qua non for the applicability of national provisions which are more restrictive than the directive.

48. Lastly, nor does it appear to me that the conclusion I have outlined can be called into question by considerations about the principle of the protection of legitimate expectations. As the Court has stated, while the principle of the protection of legitimate expectations is one of the fundamental principles of the Community, it is settled case-law that this principle cannot be extended to the point of generally preventing new rules from applying to the future consequences of situations which arose under the earlier rules.

49. In the light of the foregoing, I therefore consider that the first plea should be dismissed.

50. The second plea adduced by the German Government is based on the alleged infringement by the Commission of the principle of audiatur et altera pars and the obligation of loyal cooperation enshrined in Article 10 EC. Arguments of the parties

52. The Commission denies that it is obliged to notify Member States of the Community provisions applicable from time to time, relying in this regard on the principle that it is for the States themselves to be acquainted with such provisions. In the present case, the legislative facts in question were well known to all, and Germany was certainly well acquainted with the date on which the Treaty of Amsterdam came into force and with the fact that that Treaty contained no transitional provisions regarding the legislation relevant to the present case. According to the Commission, there was therefore nothing to prevent Germany from amending its application accordingly after the Treaty of Amsterdam came into force. The Commission also denies that its different conduct in relation to the German measures on creosote can in any way support the applicant government's claim; indeed, it submits that from that communication itself Germany should have deduced that any application submitted on the basis of Article 100a EC would be assessed from that time onwards on the basis of Article 95 EC. Lastly, with regard to the claim that the Commission exceeded the period of six months laid down in the latter provision, I have already noted that, according to the Commission, that period began on the date on which the new Treaty came into effect.

53. Although it is undeniable that the Commission has a duty to respect scrupulously the right to a fair hearing in procedures such as the one under examination, I find it difficult to criticise it in the present case for not having notified Germany of the new legal basis that it had adopted for its decision following the entry into force of the Treaty of Amsterdam. Frankly, it seems rather improbable that the German Government was not aware of the entry into force of the new Treaty on 1 May 1999 or of the fact that the Treaty contained no transitional provisions for the change-over from Article 100a to Article 95 EC, with the consequent possibility that the abovementioned principles on the temporal succession of rules would be applied. Nor can I go along with the deductions that the German Government draws from the communication sent by the Commission with regard to the change in the law applicable to creosote. Indeed, as the defendant has observed, far from being able to expect that in other cases the Commission would apply the law previously in force, that communication should have constituted, if ever there was need, a further indication of the fact that the system had changed on 1 May 1999.

54. I therefore do not see the Commission's conduct as infringing the interested party's right to a fair hearing and the duty of loyal cooperation that must guide relations between Member States and institutions, particularly since, as the Commission observes, nothing prevented the German Government from submitting, of its own volition, additions to the documentation attached to its application without it being necessary for the Commission to invite it to do so. I recall again in this regard that in the Kortas judgment the Court was at pains to emphasise that the notification scheme provided for in Article 100a(4) EC requires both the Commission and the Member State concerned to demonstrate a particular degree of diligence (paragraph 35).

55. Lastly, with regard to the German complaint about the length of the procedure in question, it seems to me that the Commission is right to rely on the fact that the time-limit could not begin to run until the new legislation came into force, given that the preceding legislation set no such time-limit.

56. I therefore consider that the second ground of the application should also be dismissed. If the Court considers otherwise, however, I must point out that, in view of the argument I outlined previously, the infringements of which Germany accuses the Commission had no effect on the outcome of the procedure. As I consider that there are no significant differences between the conditions for the admissibility of derogating national measures before and after the entry into force of the Treaty of Amsterdam, in my opinion the Commission's conduct considered here cannot have had any prejudicial effect. And it is hardly necessary to remind you that, in accordance with the case-law of the Court, for such an infringement of the right to be heard to result in annulment of a decision it must be established that, had it not been for that irregularity, the outcome of the procedure might have been different.

57. The German Government then objects that, while acknowledging that in the present case Article 95 EC is applicable, the correct legal basis of the Commission decision is not paragraph 5 but paragraph 4 of that provision. It alleges that Article 95(4) EC, despite using the verb to maintain in place of the more general to apply that figured in the old text, also covers the situation in which new measures are adopted at the time of transposition of the harmonised Community legislation. In any case, the German Government claims that the national provisions, for the introduction of which it requested authorisation in the present application, were in reality already in operation in that legislation, recalling in particular certain regulations in force under German labour law and the consensual procedure that had already been carried out with the industries concerned for the adoption of statutory standards.

58. The Commission replies simply that in reality the abovementioned German provisions were not in force when the directive was adopted nor are they in force at present. Indeed, as the notification and Germany's application confirm, these are provisions that the German Government has yet to adopt, if approved. In these circumstances, there is no doubt, according to the Commission, that the appropriate legal basis of the decision could only be Article 95(5) EC.

59. In truth, it seems to me difficult to contest that the verb to maintain refers to existing measures and the verb to introduce to new ones. Moreover, in essence even the German Government does not contest this, given that it is attempting to trace the derogating measures in question back to existing regulations in force in other sectors of its law.

60. It is common ground that the national measures in question did not exist when the directive was adopted. Nor can that conclusion be contradicted by the claimed self-regulatory practices of the industry, precisely because they could not rise to the rank of positive legislation and were in any case not binding on those who did not subscribe to them. Nor is it valid to point to rules for the same purpose in other sectors of national law. What had to exist in order for Article 95(4) to apply was a body of national regulations on classification and labelling that covered mineral wool; but as the Commission observes, such national regulations did not exist and do not exist even today in German law. There is therefore no doubt that, for assessing the legitimacy of the subsequent introduction of such regulations, reference had to be made to paragraph 5 of Article 95.

4. Misapplication of Article 95(5) EC

61. In the alternative, Germany contests the correctness of the assessment made by the Commission on the basis of Article 95(5) because, in its opinion, the notification met all the conditions laid down in that provision: the national provisions are based on new scientific evidence on the protection of the environment and the working environment; the problem it is intended to address is specific to Germany and arose after adoption of the Community legislation. I shall examine the three conditions and the arguments about their alleged or denied existence, but not necessarily in the above order.

Arguments of the parties

62. As to the specific nature of its situation for the purposes of relevance here, Germany claims that it is particularly affected by the problem of mineral wool because of the widespread use of such fibres and the particular social composition of the category of users of mineral wool. With regard to the first aspect, it notes that in 1997 20 million cubic metres of mineral wool was consumed in Germany, out of a total of 60 million in the entire Union, and that the number of exposed workers is approaching 500 000, probably far higher than in the other Member States. This is not a function of the number of inhabitants, because the statistics on sales of mineral wool show that annual per capita consumption in Germany is 0.25 cubic metres, compared with a European average of 0.16 cubic metres.

63. As to the second aspect, the applicant government states that the German market consists largely of private individuals, do-it-yourself users, without any specific training, partly because of the ease of use of these materials and partly because of the German desire to avoid, where possible, the use of paid manpower to carry out work not requiring specialist knowledge, in view of the high hourly cost of labour. This second group of users is not covered by the employment safety regulations, nor are they used to taking special precautions, given that they are carrying out work for their own account.

64. The particular nature of the German situation also stems, on the one hand, from the climatic conditions of the country, which has very hard winters, and on the other from a stricter environmental policy than in other countries to encourage the use of thermal insulation. In recent years, the German Government goes on, regulations on such insulation for new buildings have introduced ever higher standards and a regulation on the insulation of old buildings is also being drafted in order to meet the targets for a reduction in greenhouse gas emissions set by the Kyoto Protocol of 7 December 1997. These targets require the German Government to take measures with particular regard to the energy efficiency of buildings, given the fact that around one quarter of German emissions of carbon monoxide is due to the heating of family dwellings.

65. In such a context, according to the German Government, demand for insulating materials must be expected to increase substantially in the years to come, so that the specific nature of the German situation is likely to be confirmed, particularly as greater sensitivity to ecological issues has shown the need for a more efficient energy policy, so that the country will face a large increase in the use of mineral wool in future. According to the applicant government, it is therefore no surprise that the epidemiological risk is higher in Germany than in countries that are already well equipped from the point of view of thermal insulation, such as Finland and the other Nordic countries.

66. Furthermore, according to the applicant government, the application for derogating measures also meets the requirement that there be a problem justifying the grant of approval. Such a problem allegedly arose only after the adoption of the harmonisation directive because, as has already been asserted, the epidemiological risk increased in Germany owing to the increased severity of the energy-saving policy, especially following the signing of the Kyoto Protocol a few days after the adoption of the directive.

67. Lastly, with regard to the existence of new scientific evidence, the German Government states that scientific studies published in 1998 and 1999, that is to say after the adoption of the directive, confirm suspicions about the possible carcinogenic effects of mineral wool and thus justify both the approach proposed by the German authorities and the criticism of the criteria adopted in Directive 97/69. The German Government notes, on the other hand, that the new evidence must be assessed responsibly, because it is known that scientific and technological progress does not usually advance by means of revolutionary innovations but is a continuous process of evolution. From that point of view, therefore, studies giving grounds for a different assessment of previous knowledge, making it possible to view and resolve a known problem in new terms, are also new scientific evidence. As to the objection that these studies were adduced as evidence late in the day, the German Government replies that the same charge could be levelled at the Commission, as the infringement of the principle of a fair hearing and the duty of loyal cooperation committed by that institution allegedly made it impossible for Germany to use such arguments from the outset.

68. The Commission contests point by point the contention that the conditions required by Article 95(5) EC are met in the present case.

70. With regard to the scientific evidence used by Germany to support its application, the Commission objects to the late submission of the allegation by the applicant, given that the German notification did not refer to the studies that appeared in 1998, even though it was incumbent upon Germany to raise them. In the Commission's view, the Commission can therefore not be reproached for not having taken them into consideration in its decision. In this respect it is also supported by the arguments of the Finnish Government, an intervener in the present case, which denies that the scientific evidence adduced by the German Government contains anything really new, and objects, more fundamentally, that there is no sound scientific basis for distinguishing between carcinogenic and non-carcinogenic fibres; at most, a distinction may be the result of a discretionary assessment, which should be made by the Community legislature, as in reality occurred here, without one Member State being able to call it into question.

71. Lastly, with regard to the requirement that there be a problem raised by the State applying for the derogation, the Commission objects that the application of the German Government made no reference either to the Kyoto Protocol and the changes it would bring about in that government's policy nor to other new factors; on the contrary, it gave it to be understood that the risks from mineral wool had been debated in Germany for years.

Assessment

72. I must first point out that the conditions indicated in Article 95(5) EC are cumulative, which means that a derogation requested under that provision can be authorised only if all the conditions are met. I should also add, if that were ever necessary, that it is for the State requesting the derogation to show that such conditions are satisfied.

73. Moving on to examine the individual conditions, I observe first of all that the application notified in 1998 did not claim any specific feature in the factual situation in Germany that would justify the adoption of measures different from those laid down in Directive 97/69. But even leaving that finding aside and considering the reasons subsequently adduced by the applicant government in this action, the requirement that there be a specific problem is not, in my opinion, met.

74. As the Commission has correctly observed, the argument about the high usage of mineral wool by private individuals does not seem convincing, because a similar trend can also be observed in other Member States. Nor do I feel able to endorse the argument based on the high consumption of energy for heating. It has not been demonstrated, as the defendant has pointed out, that per capita consumption in Germany is higher than elsewhere. Indeed, the objection raised by the intervener Finland, which notes that the Nordic countries have an even harsher climate and hence in all likelihood a higher energy requirement for heating, for which they too use large quantities of materials to insulate buildings, in particular mineral wool, appears to me to be particularly pertinent in this regard. If that is the case, nor can the applicant government claim that the national measures to adapt to the standards of the Kyoto Protocol will lead to a higher consumption of mineral wool in Germany than elsewhere.

75. Hence, if the situation adduced by Germany is not or has not been demonstrated to be specific to that country, this would in itself be sufficient to reject this ground, in the light of what I have said previously. Despite this, I feel bound, for the sake of completeness, also to examine the further conditions mentioned above.

76. With regard first to the condition regarding the occurrence of the problem in relation to the adoption of the directive, I make the general observation that in my opinion this condition may be met even if the Member States' health and safety needs have already been taken into account, in general terms, at the time of adoption of the directive. What matters is the current situation as it appears after the adoption of the directive, if not actually as a consequence of it; the new element should therefore be assessed in the light of, in particular, the facts taken into account in that context, the objectives of protection for that purpose addressed by the directive and the adequacy, in the new situation, of the means it employs for that purpose.

77. That having been said, I must nevertheless note that Germany appears to base the communication of 1998 on an unchanged factual situation, or at the very least not to bother to indicate any new factors, merely introducing in the course of the case certain legislative factors that are not current but only foreseen (associated essentially with the Kyoto Protocol). It therefore does not appear to me that this condition can be said to be met.

78. Lastly, as to the final condition on the existence of new scientific evidence, I agree with the German Government that scientific progress is a continuous process and that the newness of such evidence can therefore not be assessed on the basis of, so to speak, legalistic criteria as to the moment at which it was officially placed in the public domain or at which the evidence acquires a different relevance. However, it remains a fact that the Member State claiming the need for a derogation must prove either that the evidence is really, and in a strict sense, new or that a different factual situation has arisen, in relation to which even existing scientific data can be or needs to be reassessed.

79. Having clarified that point, I observe nevertheless that in the present case it is no easy matter to take sides in the debate between the parties in this regard, because it tends to be confused on the one hand with the question of the late submission of the German allegations and on the other with that of the assessment of whether they are well founded. I have already addressed the first question above in general terms with regard to the necessary conditions for the acceptance of an application under Article 95(5), and from this point of view I am bound to acknowledge that the allegations were submitted late; I shall deal with the second, more complex, issue in the pages that follow.

Arguments of the parties

80. Germany claims that the Commission's assessment of the scientific aspects of the German measures is based on wrong or incomplete factual data and is the result of a procedure that does not comply with principles of impartiality; in the applicant's view, this is further confirmed by the contradictory statement of reasons for the contested decision. In any case, the criteria used by the Commission to assess whether the German measures are really necessary and proportionate are contrary to the precautionary principle, which should be applied in this matter.

81. The applicant government reiterates in particular that the classification of a product as carcinogenic is necessarily linked not to the certainty of a carcinogenic effect in man but to the mere risk that this effect is produced, especially in view of the long period of time which experimental and epidemiological observations show to elapse between exposure to a carcinogenic substance and the development of the disease. In such a situation of uncertainty, consideration of the supreme value of human life and health should militate in favour of national norms which, in the light of the results of scientific research, appear able to protect such fundamental values better than the debatable and tolerant provisions of Directive 97/69. Instead, despite that situation of scientific uncertainty recognised by the Commission itself, the latter allegedly prevented the applicant from applying more stringent legislation.

82. More specifically, Germany then points out that the Commission made its assessment of the German scientific allegations on the basis of two documents: the report of three experts in labelling and classification appointed ad hoc by the Commission to assess the said allegations and the Opinion of the Scientific Committee on Toxicity, Ecotoxicity and the Environment (CSTEE) (see paragraph 19 above). In the opinion of the German Government, these documents are both wrong and incomplete, for different reasons.

83. According to the applicant government, the first report merely states the outcome of the debate between the parties, without carrying out a detailed assessment of the evidence provided by Germany and without taking account, in particular, of the fact that the German protection measures accord with established practice in the producing industry. Serious doubts can then be raised as to the independence of the three experts, given that two of them had already adopted a position on the question in previous committees established to assist the Commission in the procedure for the adoption of the directive and the third was actually a consultant to the Commission in the preparation of the proposal in question.

84. As to the CSTEE Opinion, Germany questions whether it is well founded and, above all, disputes the assessments which the Commission bases on it. With regard to the first aspect, it notes that when the CSTEE drew up its Opinion it did not have the scientific assessments on which Germany had based its application but only the German communication and the report from the three experts. According to Germany, this explains why the Committee concluded that it was not able to assess either the German communication or the report from the experts; that failing was not the fault of the German Government but due to omissions on the part of the Commission. As to the second point, Germany contends that the Commission misinterpreted the CSTEE Opinion by overlooking an aspect of fundamental importance for evaluating the German application, namely the fact that it endorsed the epidemiological concerns expressed in the latter.

85. Lastly, the applicant claims that the statement of reasons for the Commission decision is in obvious contradiction with the positions previously adopted by the Commission. In particular, whereas the original draft directive was based on the KI Index, the decision reproaches Germany for having adopted that index on the grounds that it is backed by insufficient scientific evidence.

86. The Commission replies first, on a general level, that the contested decision cannot be criticised on the basis of a simple error in the assessment of the facts; as it is a decision based on a discretionary appraisal, it can be criticised only on grounds of manifest error or misuse of powers.

87. As to the substance, it then confirms the assessment that the scientific evidence provided by Germany is incomplete, citing the CSTEE Opinion. However, it denies having based such an assessment on the report from the experts, which the Commission itself considered to be incomplete; but a little further on in the same defence document it also denies having based itself on the CSTEE Opinion, contradicting what it had stated a little earlier.

88. Finally, as regards the claimed infringement of the precautionary principle, the Commission begins by stating that that principle must be applied within the system established by Article 95 EC and not take its place. This means that national safeguard measures may be accepted only if all the conditions set out in Article 95(5) EC are met and hence, in the present case, if it is scientifically proven that they are necessary and better able than the directive to protect the needs indicated in the said provision. If, however, that proof has not been provided because the scientific position cannot yet be assessed definitively, it is necessary to hold to the general application of the Community legislation. Hence, while recognising that where there is doubt the precautionary principle can lead to the adoption of higher protective measures, the Commission points out that ─ except in the exceptional instances described in Article 95 EC and only if all the conditions of application are met ─ the measures must be Community measures and not measures adopted unilaterally by one Member State.

89. For my part, albeit within the limits of the review entrusted to the Court on the technical and scientific assessments made by the Commission, I cannot conceal that the German allegations appear more persuasive and even cast serious doubts on whether Commission Directive 97/69 complies with the criteria laid down in Annex VI of Council Directive 67/548, even though the legitimacy of the Commission directive has not been challenged in the present case.

90. Leaving that aside, however, I must agree above all with the applicant government on the shortcomings of the administrative procedure, because it also seems to me that there are disconcerting contradictions in the reasons stated for the alleged lack of scientific basis for the German application. In particular, this stems from the Commission's vague and cavalier reference to the report from the experts, which is of pivotal importance in the decision, contrary to what it asserts with some embarrassment in its own defence. Indeed, the decision is based on that report, despite the Commission's simultaneous recognition that it is deficient; by contrast, no account at all is taken of the Opinion of the CSTEE, particularly where it criticises the report's silence about the scientific evidence produced by the German Government. Nor does it appear to me to be a practice in accordance with the principles of correctness and impartiality to have entrusted the task of comparing the Community legislation with the German measures to experts who had already clearly expressed their view on this issue.

91. I therefore consider the criticism under examination to be well founded.

92. Lastly, the applicant government complains of the failure to assess the German measures in the light of Article 95(6) EC, submitting various arguments to demonstrate that they would not have constituted arbitrary discrimination or a disguised restriction on trade between Member States. The Commission replies that as it had already transpired that authorisation was inadmissible in the light of the examination of the requirements of the fifth paragraph of the provision, it would have been futile to ascertain whether the measures were compatible with the sixth paragraph.

93. It seems clear to me that paragraphs 5 and 6 of Article 95 are not alternatives one for the other, because the conditions they indicate must all be met simultaneously: if even one of them is not satisfied, the national measures cannot be approved. In the present case, as the Commission correctly notes, the denial of approval for the German measures is based on non-compliance with the positive conditions required by Article 95(5) EC, so that there was no need to ascertain whether or not the conditions laid down in the sixth paragraph of the article were also met.

94. This complaint is therefore unfounded.

Final considerations

96. I therefore propose that the present application be dismissed.

Costs

98. Article 69(4) of the Rules of Procedure provides that the Member States which intervene in the proceedings shall bear their own costs. Finland will therefore bear its own costs.

IV ─ Conclusion

In the light of the foregoing considerations, I therefore propose that the Court declare:

(1) The application of the Federal Republic of Germany is dismissed.

(2) The Federal Republic of Germany is ordered to pay the costs.

(3) The Republic of Finland shall bear its own costs.

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1 – Original language: Italian.

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2 – OJ 1999 L 329, p. 100.

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3 – OJ 1997 L 343, p. 19.

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4 – OJ, English Special Edition 1967 (I), p. 234, most recently amended by Directive 1999/33/EC of the European Parliament and the Council (OJ 1999 L 199, p. 57).

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5 – The Committee was established by Article 8b of Directive 67/548, inserted by Council Directive 73/146/EEC of 21 May 1973 amending Directive 67/548 of 27 June 1967 (OJ 1973 L 167, p. 1).

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6 – As amended by Commission Directive 93/21/EEC of 27 April 1993 adapting Directive 67/548 to technical progress (OJ 1993 L 110, p. 20).

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7 – This refers to requirements relating to public morality, public policy or public security, the protection of health and life of humans, animals or plants, the protection of national treasures possessing artistic, historic or archaeological value and the protection of industrial and commercial property.

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8 – Technical report on the reasons put forward by the Federal Republic of Germany for applying national provisions which divert from the requirements of Directive 97/69/EC, the 23rd adaptation to the technical progress of Council Directive 67/548/EEC, Annex 5 produced in the proceedings by Germany in support of its application.

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9 – Opinion on a Request of the Federal Republic of Germany for a Article 100a(4) (Maastricht Treaty) derogation with regard to the classification of man made mineral fibres (MMMF) adopted by written procedure on September 10, 1999 (original English text), in http://europa.eu.int/comm/food/fs/sc/sct/out48_en.html , Annex 4 produced in the proceedings by Germany.

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10 – Decision, paragraph 14, second subparagraph.

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11 – Decision, paragraph 14, final subparagraph.

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12 – In particular the judgment in Case C-60/98 Butterfly Music v C arosello Edizioni Musicali e Discografiche [1999] ECR I-3939.

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13 – Judgment in Case C-319/97 Kortas [1999] ECR I-3143.

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14 – I refer to my Opinion in Case C-3/00 Denmark v Commission [2003] ECR I-2643, paragraph 69 et seq.

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15 – Moreover, some of the literature from the very outset had already taken this view (see in particular C. Gulmann, The Single European Act ─ Some Remarks from a Danish Perspective , CMLR 24 (1987), pp. 31 to 40, especially p. 38).

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16 – Opinion of Advocate General Tesauro in Case C-41/93 France v Commission [1994] ECR I-1831, paragraph 4.

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17 – With regard to that principle, see in the case-law of the Court, among many others, the judgments in Cases 5/77 Tedeschi v Denkavit [1977] ECR 1555, paragraph 35, 148/78 Ratti [1979] ECR 1629, paragraph 36, 251/78 Denkavit [1979] ECR 3369, paragraph 14, 190/87 Moormann [1988] ECR 4689, paragraph 10, and C-323/93 Crespelle [1994] ECR I-5077, paragraph 31.

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18 – See most recently the judgment in Case C-28/00 Liselotte Kauer v Pensionsversicherungsanstalt der Angestellten [2002] ECR I-1343, paragraph 20. Among many earlier cases, see the judgments in Cases 68/69 Bundesknappschaft v Brock [1970] ECR 171, paragraph 6, 1/73 Westzucker v Einfuhr- und Vorratsstelle für Zucker [1973] ECR 723, paragraph 5, 270/84 Licata v ESC [1986] ECR 2305, paragraph 31, and C-60/98 Butterfly Music, paragraph 24.

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19 – Opinion of Advocate General Cosmas in Case C-321/97 Andersson [1999] ECR I-3551, paragraph 57; to the same effect, see the Opinion of Advocate General Cosmas in Case C-60/98 Butterfly Music, paragraph 25, footnote 15.

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20 – Judgment in Case C-319/97 Kortas [1999] ECR I-3143, paragraph 28.

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21 – Opinion of Advocate General Saggio in Case C-127/97 Burstein v Freistaat Bayern [1998] ECR I-6005, paragraph 23.

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22 – Judgment in the Butterfly Music case, paragraph 25. See also the judgments in Cases 278/84 Germany v Commission [1987] ECR 1, paragraph 36, 203/86 Spain v Council [1988] ECR 4563, paragraph 19, and C-221/88 ECSC v Busseni [1990] ECR I-495, paragraph 35.

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23 – That case related to Commission Directive 96/94/EC of 18 December 1996 establishing a second list of indicative limit values in implementation of Council Directive 80/1107/EEC on the protection of workers from the risks related to exposure to chemical, physical and biological agents at work (OJ 1996 L 338, p. 86). The national measures related mainly to wood-protection products containing creosote, a potentially carcinogenic substance.

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24 – See the Commission Decision of 26 October 1999 on the national provisions notified by the Federal Republic of Germany concerning the limitations of the marketing and use of creosote (OJ 1999 L 329, p. 43). The communication to the German Government had been made by letter from the Commission dated 24 August 1999.

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25 – See the judgments in Cases 259/85 France v Commission [1987] ECR 4393, paragraph 13, and C-142/87 Belgium v Commission [1990] ECR I-959, paragraph 48.

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26 – The industries involved agreed to adopt a voluntary quality mark certifying the production of biodegradable mineral fibres.

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27 – The German Government notes in particular that Germany is the member country with the coldest winters after Austria, with an average temperature of -1.4 o C. All the other members of the Union have average winter temperatures above zero.

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28 – CSTEE Opinion of 10 September 1999, cited above, Answer B, third paragraph; the italics are in the original.