62003TO0422_EN
Parties
Grounds
Operative part
Parties
In Case T-422/03 R,
Enviro Tech Europe Ltd,
established in Surrey (United Kingdom),
Enviro Tech International Inc.,
established in Chicago (United States of America),
represented by C. Mereu and K. Van Maldegem, lawyers,
applicants,
v
Commission of the European Communities,
represented by X. Lewis and F. Simonetti, acting as Agents, with an address for service in Luxembourg,
defendant,
APPLICATION for suspension of two acts of the Commission of 3 November 2003 and an order requiring the Commission not to propose the reclassification of nPB under the 29th adaptation to technical progress of Council Directive 67/548/EEC on the approximation of laws, regulations and administrative provisions relating to the classification, packaging, and labelling of dangerous substances (OJ, English Special Edition 1967, p. 234),
THE PRESIDENT OF THE COURT OF FIRST INSTANCE OF THE EUROPEAN COMMUNITIES
makes the following
Order
Grounds
Relevant legislation
General framework
1. Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging, and labelling of dangerous substances (OJ, English Special Edition 1967, p. 234), as amended by Council Directive 92/32/EEC of 30 April 1992 (OJ 1992 L 154, p. 1), lays down rules concerning the marketing of
" substances", defined as
" chemical elements and their compounds in the natural state or obtained by any production process, including any additive necessary to preserve the stability of the products and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition" .
2. Directive 67/548 has been amended several times since its adoption and, most recently, by Council Regulation (EC) No 807/2003 of 14 April 2003 adapting to Decision 1999/468/EC the provisions relating to committees which assist the Commission in the exercise of its implementing powers laid down in Council instruments adopted in accordance with the consultation procedure (unanimity) (OJ 2003 L 122, p. 36).
3. Article 4 of Directive 67/548, as amended, provides that substances are to be classified on the basis of their intrinsic properties according to the categories of danger laid down in Article 2(2). Classification of a chemical as
" dangerous"
requires appropriate labelling on the package, including a danger symbol, standard phrases indicating the special risks arising from the dangers involved in using the substance ( " R-phrases" ) and standard phrases relating to the safe use of the substance ( " S-phrases" ).
4. Article 2(2) of Directive 67/548, as amended, provides:
" The following are
" dangerous"
within the meaning of this directive:
...
(c) extremely flammable substances and preparations: liquid substances and preparations having an extremely low flash-point and a low boiling-point and gaseous substances and preparations which are flammable in contact with air at ambient temperature and pressure;
(d) highly flammable substances and preparations:
─ substances and preparations which may become hot and finally catch fire in contact with air at ambient temperature without any application of energy, or
─ solid substances and preparations which may readily catch fire after brief contact with a source of ignition and which continue to burn or to be consumed after removal of the source of ignition, or
─ liquid substances and preparations having a very low flash-point, or
─ substances and preparations which, in contact with water or damp air, evolve highly flammable gases in dangerous quantities;
(e) flammable substances and preparations: liquid substances and preparations having a low flash-point;
...
(j) irritant substances and preparations: non-corrosive substances and preparations which, through immediate, prolonged or repeated contact with the skin or mucous membrane, may cause inflammation;
...
(n) substances and preparations which are toxic for reproduction: substances and preparations which, if they are inhaled or ingested or if they penetrate the skin, may produce, or increase the incidence of, non-heritable adverse effects in the progeny and/or an impairment of male or female reproductive functions or capacity ...
" .
5. As regards the tests that may be used to classify substances, Article 3 of directive 67/548, as amended, provides that:
" 1. Tests on chemicals carried out within the framework of this directive shall as a general principle be conducted according to the methods laid down in Annex V. The physico-chemical properties of substances shall be determined according to the methods specified in Annex V.A ...."
6. Annex V, Point A.9, to Directive 67/548, as amended, establishes the applicable testing methods for the determination of a flash point.
7. Article 4(2) of Directive 67/548, as amended, provides that the general principles of the classification and labelling of substances and preparations are to be applied according to the criteria set out in Annex VI, save where contrary requirements for dangerous preparations are specified in separate directives.
8. Annex VI, Point 4.2.3, to Directive 67/548, as amended, contains the criteria applicable for reproductive toxicity and divides reproductive toxicant substances into three categories:
─ Category 1:
" substances known to impair fertility in humans"
and
" substances known to cause developmental toxicity in humans" ;
─ Category 2:
" substances which should be regarded as if they impair fertility in humans"
and
" substances which should be regarded as if they cause developmental toxicity in humans" ;
─ Category 3:
" substances which cause concern for human fertility"
and
" substances which cause concern for humans owing to possible developmental toxic effects" .
Adaptation of Directive 67/548 to technical progress
9. Pursuant to Article 28 of Directive 67/548, as amended:
" The amendments necessary for adapting the Annexes to technical progress shall be adopted in accordance with the procedure laid down in Article 29."
10. In its observations, the Commission explained that, as a matter of practice, when it works on an initial draft of measures adapting Directive 67/548 to technical progress, it consults the Commission Working Group on Classification and Labelling ( " the CMR Working Group" ), a group comprised of experts sent by the Member States, such as toxicologists and classification experts, representatives of the chemical industry and representatives of the particular segment of the industry concerned by the products under discussion. After consulting with the CMR Working Group, the Commission submits the draft measures to the committee established by Article 29 of Directive 67/548 ( " the Regulatory Committee" ).
11. Article 29 of Directive 67/548, as amended by Regulation No 807/2003, provides:
" 1. The Commission shall be assisted by a committee.
2. Where reference is made to this article, Articles 5 and 7 of Decision 1999/468/EC shall apply.
The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.
"
12. Article 5 of Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (OJ 1999 L 184, p. 23) reads as follows:
" 1. The Commission shall be assisted by a regulatory committee composed of the representatives of the Member States and chaired by the representative of the Commission.
2. The representative of the Commission shall submit to the committee a draft of the measures to be taken. The committee shall deliver its opinion on the draft within a time-limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 205(2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the committee shall be weighted in the manner set out in that article. The chairman shall not vote.
3. The Commission shall, without prejudice to Article 8, adopt the measures envisaged if they are in accordance with the opinion of the committee.
4. If the measures envisaged are not in accordance with the opinion of the committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken and shall inform the European Parliament.
5. If the European Parliament considers that a proposal submitted by the Commission pursuant to a basic instrument adopted in accordance with the procedure laid down in Article 251 of the Treaty exceeds the implementing powers provided for in that basic instrument, it shall inform the Council of its position.
6. The Council may, where appropriate in view of any such position, act by qualified majority on the proposal, within a period to be laid down in each basic instrument but which shall in no case exceed three months from the date of referral to the Council.
If within that period the Council has indicated by qualified majority that it opposes the proposal, the Commission shall re-examine it. It may submit an amended proposal to the Council, re-submit its proposal or present a legislative proposal on the basis of the Treaty.
If on the expiry of that period the Council has neither adopted the proposed implementing act nor indicated its opposition to the proposal for implementing measures, the proposed implementing act shall be adopted by the Commission.
"
Facts and procedure
13. N-propyl-bromide ( " nPB" ) is a volatile organic solvent used inter alia for industrial cleaning.
14. Enviro Tech Europe Ltd and Enviro Tech International Inc. ( " the applicants" ) are companies engaged solely in the production and sale of the nPB-based product
" Ensolv" . Enviro Tech Europe is the European subsidiary of Enviro Tech International, and its exclusive licensee in Europe for
" Ensolv" .
15. Pursuant to Commission Directive 91/325/EEC of 1 March 1991 adapting to technical progress for the twelfth time Council Directive 67/548 (OJ 1991 L 180, p. 1), nPB was included in Annex I to Directive 67/548 and was classified as an irritant and flammable substance.
16. At the meeting of the CMR Working Group of 16 to 18 January 2002, the United Kingdom ' s Health & Safety Executive ( " the HSE" ) proposed classifying nPB as a category 2 reproductive toxicant.
17. Subsequently, in April 2002, the HSE proposed the classification of nPB as a highly flammable substance, based on a new test result.
18. Since that date, the applicants have made submissions to the HSE, the European Chemical Bureau and the CMR Working Group objecting to the proposed classifications and providing scientific data and arguments in support of their position.
19. At its January 2003 meeting, the CMR Working Group decided to recommend the classification of nPB as highly flammable and as a category 2 reproductive toxicant. After that decision was made, the applicants unsuccessfully tried to convince the CMR Working Group to re-open its discussions on nPB.
20. On 29 August and 29 September 2003 respectively, the applicants sent two letters to the Commission requesting inter alia that it take such measures as necessary to correct the errors underlying the CMR Working Group recommendations on nPB.
21. In two letters of 3 November 2003, the Commission informed the applicants that the arguments presented in their letters of 29 August and 29 September 2003 did not provide appropriate reasons to modify the classification of nPB recommended by the CMR Working Group ( " the contested acts" ).
22. By application lodged at the Registry of the Court of First Instance on 23 December 2003, the applicants brought an action seeking inter alia:
─ the annulment of the contested acts;
─ a declaration that the Commission is liable for damages suffered by the applicants as a result of the Commission ' s unlawful conduct;
─ a declaration that the Commission is liable for imminent losses and damages foreseeable with sufficient certainty, even if such losses and damages cannot be precisely assessed.
23. Shortly after their application was filed, the applicants were informed that the Regulatory Committee was scheduled to meet on 15 January 2004 to formally adopt the 29th adaptation of Directive 67/548 to technical progress.
24. By separate application lodged at the Court Registry on 30 December 2003, the applicants, in accordance with Articles 242 EC and 243 EC, brought an application for interim measures, by which they requested the President of the Court of First Instance:
─ to declare their application admissible and well founded;
─ to suspend the operation of the contested acts;
─ to order the Commission not to propose the reclassification of nPB under the 29th adaptation to technical progress of Directive 67/548/EEC at the next Regulatory Committee meeting scheduled for 15 January 2004, and thereafter, until such time as the Court of First Instance has given judgment in the main action;
─ to adopt any other interim relief measures the President deems appropriate to preserve the applicants ' position pending the full resolution of the dispute in the main proceedings; and
─ to order the Commission to pay the costs.
25. The applicants also requested, pursuant to Article 105(2) of the Rules of Procedure of the Court of First Instance, that the President grant the orders sought as a matter of extreme urgency before the Commission submitted its observations.
26. On 12 January 2004, the Commission filed its observations on the application for interim measures. In these observations, the Commission contends that the President should:
─ reject the request for interim measures;
─ order the applicants to pay the costs.
27. In its observations, the Commission specified that the Regulatory Committee meeting was never fixed to take place on 15 January 2004 and that the consultation of its different services on the measures contemplated for the purpose of the 29th adaptation of Directive 67/548 to technical progress had taken longer than expected. Accordingly, the aforesaid meeting, which was initially scheduled to take place on 23 January 2004, was postponed sine die.
Law
28. Pursuant to Article 104(2) of the Rules of Procedure an application for interim measures must state the circumstances giving rise to urgency and the pleas of fact and law establishing a prima facie case (fumus boni juris) for the interim measures applied for. Those conditions are cumulative, so that an application for interim measures must be dismissed if any one of them is absent (order of the President of the Court of Justice of 14 October 1996 in Case C-268/96 P(R)
SCK and FNK
v
Commission
[1996] ECR I-4971, paragraph 30). Where appropriate, the judge hearing such an application must also weigh up the interests involved (order of the President of the Court of Justice of 23 February 2001 in Case C-445/00 R
Austria
v
Council
[2001] ECR I-1461, paragraph 73).
29. Furthermore, in the context of that overall examination, the judge hearing the application enjoys a broad discretion and is free to determine, having regard to the specific circumstances of the case, the manner and order in which those various conditions are to be examined, there being no rule of Community law imposing a pre-established scheme of analysis within which the need to order interim measures must be analysed and assessed (order of the President of the Court of Justice of 19 July 1995 in Case C-149/95 P(R)
Commission
v
Atlantic Container Line and Others
[1995] ECR I-2165, paragraph 23).
30. It is in the light of the foregoing principles that the application for interim measures must be examined.
Arguments of the parties
Arguments presented by the applicants
─ Admissibility
31. The applicants submit that they have standing to bring proceedings under Article 230(4) EC because the contested acts are Commission acts, signed by a director, addressed directly to them, as a result of which they do not have to show that they are directly and individually concerned, such test relating only to measures addressed to a third party.
32. The applicants also submit that the contested acts produce definitive legal effects that adversely affect their legal position in that they lay down the final position of the Commission on the classification of nPB.
33. The applicants also point out first, that the Regulatory Committee, when voting on the proposal presented by the Commission, would not review the underlying scientific or legal factors that lead to the reclassification of nPB, as this was already done by their representatives in the CMR Working Group and ultimately by the Commission and, second, that some of the representatives of the Regulatory Committee are usually the same persons as those participating in the CMR Working Group meetings. Therefore, according to the applicants, the contested acts not only constitute the final position of the Commission bringing to an end the administrative review of nPB, but are also virtually dispositive on the classification of nPB.
34. The applicants further contend that even if the contested acts were to be regarded as preparatory acts, they would still be subject to challenge under the reasoning followed by the Court of Justice in Case C-3l2/90 ( Spain
v
Commission
[1992] ECR I-4117) and Case C-47/91 ( Italy
v
Commission
[1992] ECR I-4145), in which actions brought against preparatory measures, namely letters initiating the procedure provided for in Article 88(2) EC, were declared admissible.
─ A prima facie case
35. The applicants maintain that their action against the contested acts, which is based on five pleas in law, is not unfounded.
36. First, the applicants submit that the contested acts endorse the recommendation of the CMR Working Group to classify nPB as a highly flammable substance based on one single test result which objectively, manifestly and irrefutably violates the relevant testing method set out in Annex V, Point A.9, to Directive 67/548.
37. Second, the applicants contend that the contested acts endorse the recommendation of the CMR Working Group to reclassify nPB as a category 2 reproductive toxicant, based essentially on one test result presented by the HSE. However, the conclusions reached by the HSE are, according to the applicants, scientifically unsound and inconsistent with the classification criteria set out in Annex VI, Point 4.2.3, to Directive 67/548.
38. Third, the applicants submit that the contested acts are based on a narrow and incomplete assessment of nPB, as data contradicting the conclusions of the CMR Working Group, and in turn those of the Commission, were ignored or overlooked by the Commission, thereby violating Article 95(3) EC and the principle of sound administration.
39. Fourth, the applicants submit that the classification of nPB as a category 2 reproductive toxicant is based on an improper application of the precautionary principle. The applicants contend that the precautionary principle cannot be applied to the classification of nPB under Directive 67/548. They add that even if the precautionary principle were to apply it would be incompatible with a classification under category 2, for which Directive 67/548 requires
" clear evidence"
in the absence of other toxic effects.
40. Finally, according to the applicants, the Commission lacked competence to adopt the contested acts, and the contested acts violate the principle of legal certainty and the protection of legitimate expectations, the principle of independence and excellence of scientific advice, the principle of proportionality, the principle of equal treatment, the prohibition of misuse of powers and the principle of sound administration.
─ Urgency
41. The applicants submit that the suspension of the operation of the contested acts and of the related Commission proposal to the Regulatory Committee is necessary because there is an urgent need to prevent the adoption of the 29th adaptation of Directive 67/548 to technical progress, scheduled on 15 January 2004. This measure is necessary to prevent irreparable commercial and regulatory consequences to the applicants, including the risk of endangering their very existence.
42. In particular, the applicants submit that the adoption and implementation of the Commission decision to reclassify nPB, which ensures that nPB will be reclassified under the forthcoming 29th adaptation of Directive 67/548 to technical progress, produces three adverse consequences resulting in damages for the applicants which are severe, irreversible and can be established with a sufficient degree of certainty.
43. First, the applicants submit that the new classification of nPB as highly flammable and as a category 2 reproductive toxicant nullifies their patent on
" Ensolv", because the latter is based on the non-flammable and nonhazardous properties of nPB.
44. Second, according to the applicants, the new classification of nPB as highly flammable creates irreversible financial and administrative consequences which endanger the very existence of the applicants ' business due to the fact that the current standard vapour degreasing equipment of the applicants would be made inadequate from a regulatory standpoint for handling substances classified as highly flammable, which would oblige nPB users, including all of the applicants ' customers, to replace it. Specifically, the classification as highly flammable requires that all equipment be flameproof and used in exclusion zones. As a result, storage and handling of substances classified as highly flammable will require specialised equipment and precautions, which will not be available to users without very significant and in most cases prohibitive costs.
45. Third, the applicants stress that the new classification of nPB as a reproductive toxicant of category 2 requires them to immediately propose and within the shortest possible time implement the replacement of nPB with
" safer"
alternatives under Council Directive 1999/13/EC of 11 March 1999 on the limitation of emissions of volatile organic compounds due to the use of organic solvents in certain activities and installations (OJ 1999 L 85, p. 1). The new classification of nPB thus places the applicants ' survival at risk because they are engaged solely in the production and sale of
" Ensolv", which is based on nPB. If nPB is phased out or is no longer purchased by customers due to regulatory and financial constraints, the applicants will cease to operate. The amount of future losses and damages is neither quantifiable nor reparable, as it relates to the applicants ' very existence.
─ Balance of interests
46. As regards the balance of interests, the applicants note that the orders requested would do no more than maintain the current situation until the final resolution of the matter in the main proceedings.
47. While rejecting the premiss that nPB may be classified as flammable without this being supported by adequate test results, the applicants believe that the current classification is sufficient to warn those handling and using nPB about its alleged flammable properties. By contrast, applying a
" highly flammable"
classification would achieve no more than the same purpose, but would drive the applicants out of business before the full resolution of the matter in the main proceedings. The applicants further note that since the introduction of nPB in Europe and in the rest of the world there has never been any reported incident due to the alleged flammable properties of this substance.
48. According to the applicants, the same reasoning could be applied to the proposed reclassification of nPB as a reproductive toxicant of category 2, as in the absence of interim relief the applicants would have to immediately present and within the shortest possible time implement a phase-out plan for nPB under Directive 1999/13. The cessation of the applicants ' business activities is not justified by the need to protect users since nPB is neither included in any of the European priority lists for substances
" of concern"
nor marketed in high volumes.
49. Based on the foregoing, the applicants consider that the balance of interests at stake favours the suspension of the operation of the contested act and the related reclassification proposal for reproductive toxicity. In the alternative, while rejecting the premiss that test results unlawfully interpreted by the Commission could constitute the basis for the reclassification of nPB as a category 2 reproductive toxicant, the applicants would be prepared to temporarily classify their nPB product as a category 3 reproductive toxicant pending the final resolution of the matter in the main proceedings. Such voluntary classification would, on the one hand, avoid the irreparable consequence of driving the applicants out of business while, on the other hand, sufficiently warning those handling and using nPB about its alleged reproductive toxicity properties, thus alleviating any remaining concerns with respect to such properties.
50. Finally, the applicants note that the granting of a suspension order is all the more important in the present case as there is also a need to clarify, first, that the Commission cannot classify substances without using the testing methods and classification criteria specifically provided for in Directive 67/548, second, that the precautionary principle cannot be applied in hazard-based classification decisions and, third, the role and powers of the CMR Working Group to adopt policy decisions.
Arguments presented by the Commission
51. First, the Commission submits as a preliminary matter that the applicants ' request to the effect that the President order the Commission not to propose the reclassification of nPB would result in granting what the applicants seek in the main action, rendering the latter nugatory.
52. Second, as regards admissibility, the Commission contends that the main action is manifestly inadmissible because the applicants purport to impugn acts which do not affect their legal position.
53. Third, as regards urgency, the Commission submits that the applicants have exaggerated the harm which they are likely to suffer as a result of the reclassification of nPB, in particular in respect of the inevitability of such harm. The Commission raises doubts as to the applicants ' claims regarding the potential effects of the classification of nPB on the patent for Ensolv. The Commission also submits that the applicants ' allegation that nPB users will have to replace their current standard degreasing equipment is imprecise, and that the wording of Article 5(6) of Directive 1999/13 does not lead inevitably to the withdrawal or the cessation of use of nPB. In addition, the fact that the applicants have lodged a claim for damages under Article 288 EC in the main action indicates that they themselves consider that an award of damages could compensate them. Furthermore, the applicants have not shown that recovering a significant proportion of their respective market shares would be difficult because of obstacles of a structural or legal nature.
54. Finally, the Commission notes that the meeting of the Regulatory Committee for the 29th adaptation of Directive 67/548 to technical progress, which was fixed initially to take place on 23 January 2004, has been postponed sine die.
Findings of the President
55. Since the written observations of the parties contain all the information needed to give judgment on the application for interim measures, there is no need to hear oral argument from them.
56. In the present case, without there being any need to decide whether the contested acts prima facie produce legal effects which affect the applicants ' interests, it must first be considered whether the first measure sought, the suspension of the contested acts, can be ordered by the judge hearing the application for interim measures and then, regarding the other two measures sought, whether urgency has been established by the applicants.
57. Assuming that the contested acts constitute formal decisions, it is not disputed that they constitute negative decisions.
58. In that light it should be noted that, in principle, there can be no application to suspend the operation of a negative administrative decision, since the granting thereof cannot have the effect of changing the position of the applicant (orders of the Court of Justice of 31 July 1989 in Case 206/89 R
S.
v
Commission
[1989] ECR 2841, paragraph 14, and of the President of the Court of Justice of 30 April 1997 in Case C-89/97 P(R)
Moccia Irme
v
Commission
[1997] ECR I-2327, paragraph 45).
59. In the present case, an order suspending the operation of the contested acts could not have any consequences of use to the applicants as it could not amount to a positive decision ordering the Commission not to propose the reclassification of nPB under Directive 67/548.
60. Accordingly, this request must be rejected.
61. As regards the applicants ' requests that, first, the President order the Commission not to propose the classification of nPB recommended by the CMR Working Group and, second, the President adopt
" any other interim relief measures he deems appropriate to preserve the applicants ' position pending the full resolution of the dispute in the main proceedings", it must be considered whether the applicants have demonstrated that it is urgent to order such interim measures.
62. It is common ground that the urgency of an application for interim measures must be assessed in relation to the necessity for an order granting relief in order to prevent serious and irreparable harm to the party requesting the interim measure (order of the President of the Court of Justice in Case C-213/91 R
Abertal and Others
v
Commission
[1991] ECR I-5109, paragraph 18; order of the President of the Court of First Instance of 8 December 2000 in Case T-237/99 R
BP Nederland and Others
v
Commission
[2000] ECR II-3849, paragraph 48).
63. It is for the party who pleads serious and irreparable harm to prove its existence (order of the President of the Court of Justice of 12 October 2000 in Case C-278/00 R
Greece
v
Commission
[2000] ECR I-8787, paragraph 14).
64. It does not have to be established with absolute certainty that the harm is imminent. It is sufficient that the harm in question, particularly where it depends on the occurrence of a number of factors, should be foreseeable with a sufficient degree of probability (order in
Commission
v
Atlantic Container Line and Others
cited above, paragraph 38).
65. However, it is also settled case-law that damage which is purely hypothetical in so far as it is based on the occurrence of future and uncertain events cannot justify granting the interim measures requested (orders of the President of the Court of First Instance of 15 July 1998 in Case T-73/98 R
Prayon-Rupel
v
Commission
[1998] ECR II-2769, paragraphs 22, 26 and 38, and in
BP Nederland and Others
v
Commission, cited above, paragraphs 57 and 66; and of 15 January 2001 in Case T-241/00 R
Le Canne
v
Commission
[2001] ECR II-37, paragraph 37).
66. In the present case, it is necessary to consider whether the damage on which the applicants rely is foreseeable with a sufficient degree of probability.
67. The three types of harm invoked by the applicants and described at paragraphs 43 to 45 above allegedly result from the adoption of the reclassification of nPB recommended by the CMR Working Group. Therefore, the urgency invoked by the applicants presupposes that this measure will be adopted without any modification at the end of the legislative procedure set out in Article 29 of Directive 67/548. Thus, the applicants ' arguments rely entirely on the premisses that, first, the next meeting scheduled for the 29th adaptation of Directive 67/548 to technical progress will take place shortly, second, the Commission will propose the classification of nPB recommended by the CMR Working Group at this meeting and, third, this proposal will be approved by the Regulatory Committee without any modification.
68. Each of these three premisses must be examined separately.
69. First, as regards the date of the next Regulatory Committee meeting scheduled for the adaptation of Directive 67/548 to technical progress, it must be recalled that in its observations the Commission specified that the aforesaid meeting, which was originally set down to take place on 23 January 2004, has been postponed, and that a new date for this meeting has not been fixed yet. Accordingly, at this stage, the date of this meeting remains highly uncertain. Indeed, the judge hearing the application for interim measures is even not in a position to foresee with a sufficient degree of probability that it will take place before the Court has given judgment in the main action.
70. Second, the applicants ' arguments rely on the premiss that at this meeting the Commission will propose the reclassification of nPB recommended by the CMR Working Group.
71. The contested acts indeed tend to indicate that the Commission considers making such a proposal. In addition, the examination of a presentation made by the HSE and submitted by the applicants in their application reinforces this probability to a certain degree, as in this document the HSE expresses the view that the proposals made by the CMR Working Group are
" normally accepted"
by the Commission.
72. However, the fact remains that the Commission is not bound to approve this recommendation, and nothing in the record indicates that the Commission is precluded from changing the position it expressed in the contested acts before the meeting scheduled for the 29th adaptation of Directive 67/548 to technical progress.
73. Furthermore, the scope of the contested acts remains substantially limited in that, first, they merely reflect the Commission ' s position on the evidence submitted by the applicants in their two requests and, second, they merely reflect this position at the time when they were drafted. Accordingly the contested acts do not prejudge the Commission ' s position at the next Regulatory Committee meeting scheduled for the 29th adaptation of Directive 67/548 to technical progress, as before this meeting the Commission may well change its position.
74. Indeed, the Commission ' s position seems all the more susceptible to change before this meeting as, first, the consultation of its different services is still pending, second, the date of the meeting may be remote and third, the applicants themselves submitted evidence indicating that recently the Commission has been critical of several recommendations made by the CMR Working Group. Notably, the applicants provided a letter of the Commission of 25 June 2003 in which the latter expressed serious reservations about some of the scientific work performed recently by the CMR Working Group. Accordingly, contrary to what the applicants assume, at this stage it cannot be foreseen with a sufficient degree of probability that the Commission will propose the measures recommended by the CMR Working Group to the Regulatory Committee.
75. Third, the applicants ' arguments also rely on the premiss that, once the Commission has proposed to the Regulatory Committee the measures recommended by the CMR Working Group, the Regulatory Committee will approve the proposal without any modification.
76. In that regard, the applicants stressed that a proposal made by the Commission on nPB was virtually dispositive of the classification of this substance. They explained that the Regulatory Committee would not review the underlying scientific or legal factors that lead to the reclassification of nPB, as this was already done by their representatives in the CMR Working Group and by the Commission.
77. However, as a matter of law, pursuant to Article 29 of Directive 67/548, as amended, the Regulatory Committee is not bound to approve the Commission ' s proposal. Moreover, the applicants ' arguments are not supported by precise evidence that would allow the judge hearing the application for interim measures to consider that, as a matter of fact, it is sufficiently probable that the Regulatory Committee will approve the measures proposed. In particular, even assuming that the applicants had proved that some of the representatives of the Regulatory Committee are usually the same persons as those participating in the CMR Working Group, that would still not prove to the requisite legal standard that the Regulatory Committee will approve the proposal, as nothing apparently precludes those representatives from changing the position they expressed previously as members of the CMR Working Group, possibly on the basis of data that was not reviewed by the CMR Working Group.
78. It follows that there is no need to examine the three types of harm invoked by the applicants, as the premisses on which they are based are too hypothetical to justify granting interim measures.
79. Accordingly, without its being necessary to consider whether the applicants have demonstrated the existence of a prima facie case, the application for interim measures must be dismissed.
Operative part
On those grounds,
THE PRESIDENT OF THE COURT OF FIRST INSTANCE
hereby orders:
1. The application for interim measures is dismissed.
2. Costs are reserved.