62004TJ0291_EN
Parties
Grounds
Operative part
Parties
In Case T‑291/04,
Enviro Tech Europe Ltd,
established in Kingston upon Thames (United Kingdom),
Enviro Tech International, Inc.,
established in Melrose Park, Illinois (United States),
represented by C. Mereu and K. Van Maldegem, lawyers,
applicants,
v
European Commission,
represented initially by X. Lewis, and subsequently by P. Oliver and G. Wilms, acting as Agents,
defendant,
APPLICATION, first, for annulment of Commission Directive 2004/73/EC of 29 April 2004 adapting to technical progress for the twenty-ninth time Council Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (OJ 2004 L 152, p. 1), in so far as Directive 2004/73 classified n-propyl bromide as a substance having certain dangerous properties and, second, for damages,
THE GENERAL COURT (First Chamber),
composed of J. Azizi (Rapporteur), President, S. Frimodt Nielsen and D. Gratsias, Judges,
Registrar: N. Rosner, Administrator,
having regard to the written procedure and further to the hearing on 5 May 2011,
gives the following
Judgment
Grounds
Legal context
Treaty provisions
1. Article 95 EC provides:
‘1. By way of derogation from Article 94 [EC] and save where otherwise provided in this Treaty, the following provisions shall apply for the achievement of the objectives set out in Article 14 [EC]. The Council shall, acting in accordance with the procedure referred to in Article 251 [EC] and after consulting the Economic and Social Committee, 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.
…
3. The Commission, in its proposals envisaged in paragraph 1 concerning health, safety, environmental protection and consumer protection, will take as a base a high level of protection, taking account in particular of any new development based on scientific facts. Within their respective powers, the European Parliament and the Council will also seek to achieve this objective.’
Classification as a dangerous substance
2. 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 (I), p. 234), as amended inter alia by Council Directive 92/32/EEC of 30 April 1992 (OJ 1992 L 154, p. 1) and by Directive 2006/121/EC of the European Parliament and of the Council of 18 December 2006 (OJ 2006 L 396, p. 850), lays down rules concerning the marketing of certain ‘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’.
3. For that purpose, Directive 67/548 proceeds, in accordance with Article 4(1), to classify the substances on the basis of their intrinsic properties according to the categories laid down in Article 2(2). Classification of a substance as ‘dangerous’ in Annex I to that directive means that, before it can be placed on the market, its packaging must be provided with mandatory labelling including in particular danger symbols and standard phrases indicating, first, the special risks arising from the dangers involved in the use of the substance and, second, advice on safety precautions relating to its use.
4. According to Article 2(2) of Directive 67/548:
‘The following substances and preparations 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;
...
(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. With regard to the tests which may be carried out in order to classify substances, Article 3(1) of Directive 67/548 states:
‘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. Title A.9 of Annex V to Directive 67/548 lays down the methods for determination of flash points. To that end, it identifies two methods, the equilibrium method and the non-equilibrium method, on the basis of which the apparatus and measuring instruments and the corresponding ISO standards are chosen. Thus, the equilibrium method is based on ISO standards 1516, 3680, 1523 and 3679. The non-equilibrium method uses certain flash point measuring instruments, of which one is known as the Pensky-Martens apparatus, use of which is based on the following standards: ISO 2719, EN 11, DIN 51758, ASTM D 93, BS 2000-34 and NF M07-019.
7. Article 4(2) of Directive 67/548 provides that ‘[t]he general principles of the classification and labelling of substances and preparations shall be applied according to the criteria in Annex VI, save where contrary requirements for dangerous preparations are specified in separate Directives’.
8. Section 1.1 of Annex VI to Directive 67/548 provides:
‘The object of classification is to identify all the physico-chemical, toxicological and ecotoxicological properties of substances and preparations which may constitute a risk during normal handling or use. Having identified any hazardous properties, the substance or preparation must then be labelled to indicate the hazard(s) in order to protect the user, the general public and the environment.’
9. Section 1.2 of Annex VI to Directive 67/548 states:
‘This Annex sets out the general principles governing the classification and labelling of substances and preparations referred to in Article 4 of this Directive, Article 4 of Directive 1999/45/EC and in other directives concerning dangerous preparations.
It is addressed to all those concerned (manufacturers, importers, national authorities) with methods of classifying and labelling dangerous substances and preparations.’
10. Point 1.3 of Annex VI to Directive 67/548 provides:
‘The requirements of this Directive and of Directive 1999/45/EC are intended to provide a primary means by which the general public and persons at work are given essential information about dangerous substances and preparations. The label draws the attention of persons handling or using substances and preparations to the inherent danger of certain such materials.
The label may also serve to draw attention to more comprehensive product information on safety and use available in other forms.’
11. Section 1.4 of Annex VI to Directive 67/548 lays down inter alia:
‘The label takes account of all potential hazards which are likely to be faced in the normal handling and use of dangerous substances and preparations when in the form in which they are placed on the market, but not necessarily in any different form in which they may finally be used, e.g. diluted. The most severe hazards are highlighted by symbols, such hazards and those arising from other dangerous properties are specified in standard risk phrases, and safety phrases give advice on necessary precautions.
…’
12. Section 1.6 of Annex VI to Directive 67/548 refers to the ‘Data required for classification and labelling’. Point 1.6.1(b) states that the data required for classification and labelling may be obtained, inter alia, from the results of previous tests, information taken from reference works, or information derived from practical experience. It also states that, more generally, ‘expert judgment may also be taken into account …’.
13. Section 1.7.2 of Annex VI to Directive 67/548, headed ‘Application of the guide criteria for substances’, provides:
‘The guidance criteria set out in this Annex are directly applicable when the data in question have been obtained from test methods comparable with those described in Annex V. In other cases, the available data must be evaluated by comparing the test methods employed with those indicated in Annex V and the rules specified in this Annex for determining the appropriate classification and labelling.
In some cases there may be doubt over the application of the relevant criteria, especially where these require the use of expert judgment. In such cases the manufacturer, distributor or importer should provisionally classify and label the substance on the basis of an assessment of the evidence by a competent person.
Without prejudice to Article 6, where the above procedure has been followed and there is concern over possible inconsistencies then a proposal may be submitted for the entry of the provisional classification into Annex I. The proposal should be made to one of the Member States and should be accompanied by appropriate scientific data (see also section 4.1).
A similar procedure may be followed when information is identified which gives cause for concern over the accuracy of an existing entry in Annex I.’
14. Section 2.2.4 of Annex VI to Directive 67/548, headed ‘Highly flammable substances and preparations’, states:
‘Substances and preparations shall be classified as highly flammable and assigned the symbol “F” and the indication of danger “highly flammable” in accordance with the results of the tests given in Annex V. Risk phrases shall be assigned in accordance with the following criteria:
R 11 Highly flammable
– 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.
– Liquid substances and preparations having a flash point below 21°C but which are not extremely flammable.
– …’
15. Section 2.2.5 of Annex VI to Directive 67/548, headed ‘Inflammable substances and preparations’, states:
‘Substances and preparations shall be classified as flammable in accordance with the results of the tests given in Annex V. The risk phrase shall be assigned in accordance with the criteria mentioned below:
R 10 Inflammable
– Liquid substances and preparations having a flash point equal to or greater than 21°C, and less than or equal to 55°C.
However, in practice it has been shown that a preparation having a flash point equal to or greater than 21°C and less than or equal to 55°C need not be classified as flammable if the preparation could not in any way support combustion and only so long as there is no reason to fear risks to those handling these preparations or to other persons.’
16. Section 2.2.6 of Annex VI to Directive 67/548, headed ‘Other physico-chemical properties’ states, inter alia:
‘Additional risk phrases shall be assigned to substances and preparations which have been classified by virtue of sections 2.2.1 to 2.2.5 above or by Chapter 3, 4 and 5 below, in accordance with the following criteria (based on experience obtained during compilation of Annex I):
…
R 18 In use, may form flammable/explosive vapour-air mixture
For preparations not in themselves classified as flammable, which contain volatile components which are flammable in air.
…’
17. Section 4.1.2 of Annex VI to Directive 67/548 provides:
‘If a manufacturer, distributor or importer has information available which indicates that a substance should be classified and labelled in accordance with the criteria given in section 4.2.1, 4.2.2 or 4.2.3, he shall provisionally label the substance in accordance with these criteria, on the basis of the assessment of the evidence by a competent person.’
18. Under section 4.1.3 of Annex VI to Directive 67/548, ‘[t]he manufacturer, distributor or importer shall submit as soon as possible a document summarising all relevant information to one Member State in which the substance is placed on the market …’.
19. Section 4.1.4 of Annex VI to Directive 67/548 provides:
‘Furthermore, a manufacturer, distributor or importer who has new data which are relevant to the classification and labelling of a substance in accordance with the criteria given in section 4.2.1, 4.2.2 or 4.2.3, shall submit this data as soon as possible to one Member State in which the substance is placed on the market.’
20. Section 4.1.5 of Annex VI to Directive 67/548 reads:
‘To obtain as quickly as possible a harmonised classification for the Community by the procedure defined in Article 28 of this Directive, Member States which have relevant information available justifying the classification of a substance in one of these categories, whether submitted by the manufacturer or not, should forward such information, together with suggestions for classification and labelling, to the Commission as soon as possible.
The Commission will forward to the other Member States the classification and labelling proposal that it receives. Any Member State may ask the Commission for the information it has received.
…’
21. Sections 4.2.1, ‘Carcinogenic substances’, 4.2.2, ‘Mutagenic substances’ and 4.2.3, ‘Substances toxic to reproduction’, of Annex VI to Directive 67/548 set out the harmful characteristics of the dangerous substances referred to in Article 2(2)(l) to (n) of that directive, and divide them into three categories on the basis of their actual or suspected dangerousness.
22. Thus, point 4.2.3.1 of Annex VI to Directive 67/548, concerning ‘substances toxic to reproduction’, divides the substances having such effects as follows:
‘Category 1
Substances known to impair fertility in humans
There is sufficient evidence to establish a causal relationship between human exposure to the substance and impaired fertility.
Substances known to cause developmental toxicity in humans
There is sufficient evidence to establish a causal relationship between human exposure to the substance and subsequent developmental toxic effects in the progeny.
Category 2
Substances which should be regarded as if they impair fertility in humans
There is sufficient evidence to provide a strong presumption that human exposure to the substance may result in impaired fertility on the basis of:
– clear evidence in animal studies of impaired fertility in the absence of toxic effects, or, evidence of impaired fertility occurring at around the same dose levels as other toxic effects but which is not a secondary non-specific consequence of the other toxic effects;
– other relevant information.
Substances which should be regarded as if they cause developmental toxicity to humans
There is sufficient evidence to provide a strong presumption that human exposure to the substance may result in developmental toxicity, generally on the basis of:
– clear results in appropriate animal studies where effects have been observed in the absence of signs of marked maternal toxicity, or at around the same dose levels as other toxic effects but which are not a secondary non-specific consequence of the other toxic effects,
– other relevant information.
Category 3
Substances which cause concern for human fertility
Generally on the basis of:
– results in appropriate animal studies which provide sufficient evidence to cause a strong suspicion of impaired fertility in the absence of toxic effects, or evidence of impaired fertility occurring at around the same dose levels as other toxic effects, but which is not a secondary non-specific consequence of the other toxic effects, but where the evidence is insufficient to place the substance in Category 2;
– other relevant information.
Substances which cause concern for humans owing to possible developmental toxic effects
Generally on the basis of:
– results in appropriate animal studies which provide sufficient evidence to cause a strong suspicion of developmental toxicity in the absence of signs of marked maternal toxicity, or at around the same dose levels as other toxic effects but which are not a secondary non-specific consequence of the other toxic effects, but where the evidence is insufficient to place the substance in Category 2;
– other relevant information.’
23. Point 4.2.3.3 of Annex VI to Directive 67/548, headed ‘Comments regarding the categorisation of substances toxic to reproduction’, states inter alia:
‘… Placing into Categories 2 or 3 is done primarily on the basis of animal data. Data from in vitro studies, or studies on avian eggs, are regarded as “supportive evidence” and would only exceptionally lead to classification in the absence of in vivo data.
In common with most other types of toxic effect, substances demonstrating reproductive toxicity will be expected to have a threshold below which adverse effects would not be demonstrated. Even when clear effects have been demonstrated in animal studies, the relevance for humans may be doubtful because of the doses administered, for example, where effects have been demonstrated only at high doses, or where marked toxicokinetic differences exist, or the route of administration is inappropriate. For these or similar reasons it may be that classification in Category 3, or even no classification, will be warranted.
…
For the classification of a substance into Category 2 for impaired fertility, there should normally be clear evidence in one animal species, with supporting evidence on mechanism of action or site of action, or chemical relationship to other known anti-fertility agents or other information from humans which would lead to the conclusion that effects would be likely to be seen in humans. Where there are studies in only one species without other relevant supporting evidence, then classification in Category 3 may be appropriate.’
24. According to Article 4(3) of Directive 67/548, ‘[a]nnex I … contains the list of substances classified in accordance with the principles outlined in paragraphs 1 and 2, together with their harmonised classification and labelling. The decision to place a substance in Annex I together with the harmonised classification and labelling shall be taken in accordance with the procedure laid down in Article 29’ of that directive.
25. Classification of a substance as ‘dangerous’ requires, as a precondition for sale, in accordance with Article 23(2)(d) and (e) respectively of Directive 67/548, labelling to be placed on the package, including danger symbols and standard phrases indicating the special risks arising from the dangers involved in using the substance (‘R-phrases’) and standard phrases indicating the advice on safety precautions relating to its use (‘S-phrases’). As regards R-phrases in particular, Article 23(2) of Directive 67/548 provides that:
‘Every package shall show clearly and indelibly the following:
…
(d) standard phrases (R-phrases) indicating the special risks arising from the dangers involved in using the substance. The wording of those R-phrases shall comply with that laid down in Annex III. The R-phrases to be used for each substance shall be as indicated in Annex I ...’
Procedure for the adaptation of Directive 67/548 to technical progress
26. Under Article 28 of Directive 67/548, the amendments necessary for adapting the annexes to technical progress are to be adopted in accordance with the procedure laid down in Article 29 of that directive. In the context of that procedure, under Article 5(1) 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), read in conjunction with paragraph 1 of Annex III to Council Regulation (EC) No 807/2003 of 14 April 2003 adapting to Decision 1999/468 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), the European Commission is to be assisted by a committee composed of representatives of the Member States and chaired by a representative of the Commission. Under Article 5(3) of that decision, the Commission is to adopt the measures envisaged if they are in accordance with the opinion of the committee. Article 5(4) of the decision provides, on the other hand, that if the measures envisaged are not in accordance with the opinion of the committee, or if no opinion is delivered, the matter is to be submitted to the Council of the European Union and the European Parliament informed.
27. In practice, the procedure followed by the Commission for the purpose of adopting measures for the adaptation of Directive 67/548 is structured as follows.
28. A Member State or an industry representative may propose to the European Chemicals Bureau (‘ECB’), a Commission body with its seat in Ispra (Italy), that discussions on the classification of a substance or preparation be initiated. Those discussions first take place within the Technical Committee on Classification and Labelling (‘TCCL’), which is chaired by a member of the ECB and is composed of experts appointed by the competent authorities of the Member States. That committee meets twice a year and draws up a report which proposes, where appropriate, the classification of a substance or a preparation.
29. On a report by the TCCL, the Commission will initiate the drafting of measures to be submitted to the regulatory committee referred to in Article 29 of Directive 67/548, read in conjunction with Article 5 of Decision 1999/468 (see paragraph 26 above), and to be adopted subsequently in accordance with the procedure provided for in Article 28 of that directive. Should the Commission consider that the TCCL’s report creates a suspicion that the substance or preparation examined possesses carcinogenic, mutagenic or toxic for reproduction properties or that that report requires to be reconsidered or supplemented because it does not reach a conclusion on the appropriate classification, it may convene the CMR (acronym for ‘carcinogenic, mutagenic or toxic for reproduction’) working group, which is now the Specialist Expert Committee (SEC). The SEC is an ad hoc non-permanent committee composed of experts in toxicology and classification appointed by the Member States and chaired by a member of the ECB. The SEC also welcomes representatives of the industry concerned by the products at issue who may make observations at the beginning of the meeting, followed by a question and answer session. The experts then deliberate in the absence of the industry representatives.
30. Neither the TCCL nor the CMR/SEC is provided for in any legally binding text. They are bodies intended to assist the Commission before it submits draft measures to the regulatory committee referred to in Article 29 of Directive 67/548, read in conjunction with Article 5 of Decision 1999/468.
31. However, in that regard, a ‘Commission statement’ annexed to Annex VI to Directive 67/548 states:
‘With regard to section 4.1.5., and in particular to the last paragraph of section 4.1.5., the Commission states that, should it envisage making use of the procedure of Article 28, it is prepared to consult in advance appropriate experts designated by Member States and having special qualifications with respect to either carcinogenicity, mutagenicity or reproductive toxicity.
This consultation will take place in the framework of the normal consultation procedure with national experts and/or in the framework of existing committees. The same will be the case when substances already included in Annex I must be reclassified in respect of their carcinogenic, mutagenic effects, or effects toxic to reproduction.’
Partial repeal, amendment and replacement of Directive 67/548 by Regulation (EC) No 1272/2008
32. With effect from 20 January 2009, Directive 67/548 was partially repealed, amended and replaced by Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures (OJ 2008 L 353, p. 1). That regulation is intended, inter alia, to implement the Globally Harmonised System of Classification and Labelling of Chemicals developed within the United Nations (recitals 5 to 8 in the preamble to Regulation No 1272/2008).
33. In that regard, recital 53 in the preamble to Regulation No 1272/2008 states as follows:
‘In order to take full account of the work and experience accumulated under Directive 67/548/EEC, including the classification and labelling of specific substances listed in Annex I to Directive 67/548/EEC, all existing harmonised classifications should be converted into new harmonised classifications using the new criteria. Moreover, as the applicability of this Regulation is deferred and the harmonised classifications in accordance with the criteria of Directive 67/548/EEC are relevant for the classification of substances and mixtures during the ensuing transition period, all existing harmonised classifications should also be placed unchanged in an annex to this Regulation. By subjecting all future harmonisations of classifications to this Regulation, inconsistencies in harmonised classifications of the same substance under the existing and the new criteria should be avoided.’
34. Article 1 of Regulation No 1272/2008 headed ‘Purpose and scope’, provides in particular:
‘1. The purpose of this Regulation is to ensure a high level of protection of human health and the environment as well as the free movement of substances, mixtures and articles as referred to in Article 4(8) by:
(a) harmonising the criteria for classification of substances and mixtures, and the rules on labelling and packaging for hazardous substances and mixtures;
(b) providing an obligation for:
(i) manufacturers, importers and downstream users to classify substances and mixtures placed on the market;
(ii) suppliers to label and package substances and mixtures placed on the market;
(iii) manufacturers, producers of articles and importers to classify those substances not placed on the market that are subject to registration or notification under Regulation (EC) No 1907/2006 [of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Permission and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ 2006 L 396, p. 1; corrigendum in OJ 2007 L 136, p. 3)];
(c) providing an obligation for manufacturers and importers of substances to notify the [European Chemicals Agency (ECHA)] of such classifications and label elements if these have not been submitted to the Agency as part of a registration under Regulation (EC) No 1907/2006;
(d) establishing a list of substances with their harmonised classifications and labelling elements at Community level in Part 3 of Annex VI;
(e) establishing a classification and labelling inventory of substances, which is made up of all notifications, submissions and harmonised classifications and labelling elements referred to in points (c) and (d).
…’
35. Under Article 3 of Regulation No 1272/2008, headed ‘Hazardous substances and mixtures and specification of hazard classes’:
‘A substance or a mixture fulfilling the criteria relating to physical hazards, health hazards or environmental hazards, laid down in Parts 2 to 5 of Annex I is hazardous and shall be classified in relation to the respective hazard classes provided for in that Annex.
Where, in Annex I, hazard classes are differentiated on the basis of the route of exposure or the nature of the effects, the substance or mixture shall be classified in accordance with such differentiation.’
36. Article 36 of Regulation 1272/2008 headed ‘Harmonisation of classification and labelling of substances’ provides inter alia:
‘1. A substance that fulfils the criteria set out in Annex I for the following shall normally be subject to harmonised classification and labelling in accordance with Article 37:
(a) respiratory sensitisation, category 1 (Annex I, section 3.4);
(b) germ cell mutagenicity, category 1A, 1B or 2 (Annex I, section 3.5);
(c) carcinogenicity, category 1A, 1B or 2 (Annex I, section 3.6);
(d) reproductive toxicity, category 1A, 1B or 2 (Annex I, section 3.7).
…
3. Where a substance fulfils the criteria for other hazard classes or differentiations than those referred to in paragraph 1 and does not fall under paragraph 2, a harmonised clas sification and labelling in accordance with Article 37 may also be added to Annex VI on a case-by-case basis, if justification is provided demonstrating the need for such action at Community level.’
37. According to Article 37 of Regulation No 1272/2008, headed ‘Procedure for harmonisation of classification and labelling of substances’:
‘1. A competent authority may submit to the [ECHA] a proposal for harmonised classification and labelling of substances and, where appropriate, specific concentration limits or M-factors, or a proposal for a revision thereof.
The proposal shall follow the format set out in Part 2 of Annex VI and contain the relevant information provided for in Part 1 of Annex VI.
2. A manufacturer, importer or downstream user of a substance may submit to the [ECHA] a proposal for harmonised classification and labelling of that substance and, where appropriate, specific concentration limits or M-factors, provided that there is no entry in Part 3 of Annex VI for such a substance in relation to the hazard class or differentiation covered by that proposal.
The proposal shall be drawn up in accordance with the relevant Parts of sections 1, 2 and 3 of Annex I to Regulation (EC) No 1907/2006 and it shall follow the format set out in Part B of the Chemical Safety Report of section 7 of that Annex. It shall contain the relevant information provided for in Part 1 of Annex VI to this Regulation. Article 111 of Regulation (EC) No 1907/2006 shall apply.
3. Where the proposal of the manufacturer, importer or downstream user concerns the harmonised classification and labelling of a substance in accordance with Article 36(3), it shall be accompanied by the fee determined by the Commission in accordance with the regulatory procedure referred to in Article 54(2).
4. The Committee for Risk Assessment of the [ECHA], set up pursuant to Article 76(1)(c) of Regulation (EC) No 1907/2006, shall adopt an opinion on any proposal submitted pursuant to paragraphs 1 or 2 within 18 months of receipt of the proposal, giving the parties concerned the opportunity to comment. The [ECHA] shall forward this opinion and any comments to the Commission.
5. Where the Commission finds that the harmonisation of the classification and labelling of the substance concerned is appropriate, it shall, without undue delay, submit a draft decision concerning the inclusion of that substance together with the relevant classification and labelling elements in Table 3.1 of Part 3 of Annex VI and, where appropriate, the specific concentration limits or M-factors.
A corresponding entry shall be included in Table 3.2 of Part 3 of Annex VI subject to the same conditions, until 31 May 2015.
That measure, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 54(3). On imperative grounds of urgency, the Commission may have recourse to the urgency procedure referred to in Article 54(4).
6. Manufacturers, importers and downstream users who have new information which may lead to a change of the harmonised classification and labelling elements of a substance in Part 3 of Annex VI shall submit a proposal in accordance with the second subparagraph of paragraph 2 to the competent authority in one of the Member States in which the substance is placed on the market.’
38. Under Article 53(1) of Regulation No 1272/2008, headed ‘Adaptations to technical and scientific progress’:
‘The Commission may adjust and adapt Articles 6(5), 11(3), 12, 14, 18(3)(b), 23, 25 to 29 and 35(2), second and third subparagraphs, and Annexes I to VII to technical and scientific progress, including taking due account of the further development of the [Globally Harmonised System of Classification and Labelling of Chemicals], in particular any UN amendments relating to the use of information on similar mixtures, and considering the developments in internationally recognised chemical programmes and of the data from accident databases. Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 54(3). On imperative grounds of urgency, the Commission may have recourse to the urgency procedure referred to in Article 54(4).’
39. According to Article 54 of Regulation No 1272/2008, headed ‘Committee procedure’:
‘1. The Commission shall be assisted by the Committee instituted by Article 133 of Regulation (EC) No 1907/2006.
2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.
3. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
4. Where reference is made to this paragraph, Article 5a(1), (2), (4) and (6) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.’
40. Under Article 55(11) of Regulation No 1272/2008, headed ‘Amendments to Directive 67/548/EEC’, ‘[a]nnex I [of that directive] is repealed’.
41. According to Article 61 of Regulation No 1272/2008, headed ‘Transitional provisions’:
‘1. Until 1 December 2010, substances shall be classified, labelled and packaged in accordance with Directive 67/548/EEC. Until 1 June 2015, mixtures shall be classified, labelled and packaged in accordance with Directive 1999/45/EC.
2. By way of derogation from the second subparagraph of Article 62 of this Regulation and in addition to the requirements of paragraph 1 of this Article, substances and mixtures may, before 1 December 2010 and 1 June 2015 respectively, be classified, labelled and packaged in accordance with this Regulation. In that case, the provisions on labelling and packaging in Directives 67/548/EEC and 1999/45/EC shall not apply.
3. From 1 December 2010 until 1 June 2015, substances shall be classified in accordance with both Directive 67/548/EEC and this Regulation. They shall be labelled and packaged in accordance with this Regulation.
4. By way of derogation from the second subparagraph of Article 62 of this Regulation, substances classified, labelled and packaged in accordance with Directive 67/548/EEC and already placed on the market before 1 December 2010, are not required to be relabelled and repackaged in accordance with this Regulation until 1 December 2012.
By way of derogation from the second subparagraph of Article 62 of this Regulation, mixtures classified, labelled and packaged in accordance with Directive 1999/45/EC and already placed on the market before 1 June 2015 are not required to be relabelled and repackaged in accordance with this Regulation until 1 June 2017.
5. Where a substance or mixture has been classified in accordance with Directive 67/548/EEC or 1999/45/EC before 1 December 2010 or 1 June 2015 respectively, manufacturers, importers and downstream users may amend the classification of the substance or mixture using the conversion table in Annex VII to this Regulation.’
42. Article 62 of Regulation No 1272/2008, headed ‘Entry into force’, provides:
‘This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union .
Titles II, III and IV shall apply in respect of substances from 1 December 2010 and in respect of mixtures from 1 June 2015.’
Facts
43. N-propyl bromide (‘nPB’) is a volatile organic solvent used inter alia for industrial cleaning and degreasing, in particular of metallic parts.
44. The sole activity of the applicants, Enviro Tech Europe Ltd and Enviro Tech International, is the production and distribution of a product called ‘EnSolv’ which is made from a patented preparation and is composed essentially of nPB. The first applicant is a company incorporated in accordance with United Kingdom law which is wholly owned by the second applicant, a company incorporated in accordance with American law. It holds an exclusive licence for the marketing in Europe of the product EnSolv, including the vapour precision cleaning technology related to it. That licence was granted to it on the basis of a transfer agreement dated 16 October 2001, by the holder of European Patent No EP 0 781 842 B1, of 29 September 1999, for the exploitation of an invention entitled ‘Cleaning of parts using an environmentally safe solvent’. Point 0001 of that European Patent states:
‘The present invention relates generally to molecular level cleaning of parts by vapour degreasing. In particular, the present invention relates to a solvent mixture comprising [nPB], a mixture of terpenes and a mixture of low boiling solvents, and to a method for cleaning an article in a vapour degreaser using this solvent mixture. The solvent mixture of the present invention is non-flammable, non-corrosive and non-hazardous and has an Ozone Depletion Potential (ODP) between 0.001 and 0.046.’
45. Pursuant to Commission Directive 91/325/EEC of 1 March 1991 adapting to technical progress for the 12th time Council Directive 67/548 (OJ 1991 L 180, p. 1), nPB was classified in Annex I to Directive 67/548 as an ‘irritant Xn’ and accompanied inter alia by the risk phrases R 10 ‘Inflammable’ and R 20 ‘Harmful by inhalation’.
46. With regard to the phrase R 10 ‘Inflammable’ the applicants point out, without being contradicted in that regard by the Commission, that, to date, Article 5(1) of Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations (OJ 1999 L 200, p. 1), read in conjunction with point 2.2.5 of Annex VI of Directive 67/548, enabled them, following tests carried out in accordance with Annex V to that directive, to avoid the labelling of the product EnSolv as flammable. First, pursuant to Article 5(1) of Directive 1999/45, ‘[t]he hazards of a preparation deriving from its physico-chemical properties shall be assessed by determining, by means of the methods specified in Part A of Annex V to Directive 67/548/EEC, the physico-chemical properties of the preparation necessary for appropriate classification and labelling in accordance with the criteria laid down in Annex VI to that Directive’. Second, in point 2.2.5 of Annex VI to Directive 67/548, it is stated that ‘[h]owever, in practice it has been shown that a preparation having a flash point equal to or greater than 21°C and less than or equal to 55°C need not be classified as flammable if the preparation could not in any way support combustion and only so long as there is no reason to fear risks to those handling these preparations or to other persons’.
47. At the meeting of the CMR (now SEC) working group of 16 to 18 January 2002, the director of the United Kingdom’s Health & Safety Executive (‘HSE’), as United Kingdom representative and CMR working group rapporteur for the nPB classification file, proposed that nPB be classified also as a substance toxic for reproduction within the meaning of categories 2 (R 60) and 3 (R 63). The CMR working group provisionally accepted that proposal and, in addition, retained the R 10 classification pending production by the HSE of additional information on the question of nPB flammability.
48. In March and April 2002, the HSE proposed that nPB be classified as a highly flammable substance (R 11), on the basis of the results of a new scientific test, named ‘test [B.] 1996 and 2002’, determining -10°C as the flash point of nPB.
49. The International Brominated Solvent Association (‘IBSA’), which represents the majority of nPB producers and distributors, including the patent holders of nPB-based materials, such as the applicants, contested that classification proposal repeatedly before the HSE, ECB and CMR working group and submitted supporting scientific data and arguments. The IBSA also claimed that scientific studies were ongoing that would provide additional relevant information on nPB’s properties, including its mechanism of action.
50. At the meeting of the CMR working group on 15 to 17 May 2002, in the light of doubts expressed by certain experts, including the United Kingdom expert, regarding the difficulties of testing the flammability of nPB and of classifying it either as R 10, R 11 or R 18, it was concluded that the classification R 10 should be provisionally maintained and a group of specialist experts convened in order to discuss questions concerning nPB’s flammability. Also, the CMR working group decided to continue to classify nPB, inter alia, as a substance toxic for reproduction within the meaning of categories 2 (R 60) and 3 (R 63).
51. On 4 December 2002, the group of specialist experts met. Paragraph 4 of the minutes of that meeting reads as follows:
‘The experts agreed that flammability is the capacity of a substance to form a mixture in air under ambient conditions, which in the presence of an ignition source can undergo a self-propagating reaction. Ambient conditions are those likely to prevail under normal environmental climate conditions, for instance -20 [to] 40°C.’
52. With regard more specifically to the flammability of nPB, it is stated, in paragraphs 23 to 30 of those minutes, that:
‘23. The experts were provided with a table listing all the available data on the flammability of nPB (see Annex 1). This had been prepared in advance of the meeting by the … HSE.
24. There was a consensus among the experts that nBP has a flash point and an explosion range and therefore does have an intrinsic flammable hazard.
25. The experts noted that the flash point had been demonstrated in only one type of test and that the test had used a temperature range outside that specified in the test guideline. However, they still regarded these results as valid, because:
– There was no fundamental reason to disregard the findings from the test method at the temperature used;
– The result was confirmed by two independent laboratories with different samples of nPB;
– The experimental flash point value obtained was similar to one calculated (see Annex 2).
26. No flash point for nPB had been identified using other types of test.
27. On the basis of this evidence, the majority position of the experts was that nPB should be classified with F; R 11.
28. One expert considered that this classification may not be appropriate, as the group considered that the risks of nPB are lower than some other liquids classified with F; R 11; nPB may not sustain combustion after removal of the source of ignition.
29. Regarding classification of other substances, the experts agreed that substances with the same flammability characteristics should be classified against the same classification criteria as applied above for nPB. However, classification decisions should always be based upon consideration of the data for each individual chemical; there is no reliable basis on which to assign the same classification to all chemicals in a group, eg to classify all [halogenated hydrocarbons] with F; R 11 by default.
30. The group recommends that for [halogenated hydrocarbons] with explosion limits but no experimentally-derived flash point then the calculation method used for nPB (Annex 2) should be used to estimate a flash point and enable a classification decision.’
53. At its meeting on 15 to 17 January 2003, the CMR working group noted, first, the conclusions of the group of specialist experts with regard to the flammability of nPB and, second, the fact that there was an industry memorandum on the ongoing studies concerning the toxicity of nPB for reproduction. By a majority of votes, the CMR working group decided to classify nPB as a substance toxic for reproduction within the meaning of category 3 (R 63). Finally, that group decided to recommend classification of nPB, at the time of the 29th adaptation to technical progress, inter alia, as a highly flammable substance (R 11) and toxic for reproduction within the meaning of categories 2 (R 60) and 3 (R 63).
54. After adoption of that recommendation, the IBSA attempted repeatedly to convince the CMR working group to reopen its discussions on nPB.
55. At its meeting of 14 to 16 May 2003, the CMR working group decided not to reopen debate on nPB and confirmed, contrary to a request for withdrawal by the representative of the Italian Republic, its recommendation for classification of nPB at the time of the 29th adaptation to technical progress.
56. On 29 August and 29 September 2003 respectively, the IBSA requested the Commission to take such measures as necessary to correct the errors which they regarded as at the root of the CMR working group’s recommendations on nPB.
57. In two letters of 3 November 2003, the Commission informed the legal representatives of the IBSA, who are the applicants’ counsel in the present proceedings, that the arguments presented in their letters of 29 August and 29 September 2003 did not justify any modification of the CMR working group’s classification recommendation in respect of nPB.
58. By application lodged at the Registry of the General Court on 23 December 2003, the applicants brought an action seeking the annulment of the abovementioned letters, which was registered under the reference T‑422/03.
59. By Commission Directive 2004/73/EC of 29 April 2004 adapting to technical progress for the twenty-ninth time Directive 67/548 (OJ 2004 L 152, p. 1; corrigendum OJ 2004 L 216, p. 3; ‘the contested directive’), published in the Official Journal of the European Union
on 30 April 2004, nPB was classified, under Index No 602-019-00-5, as follows in Annex 1 B, p. 32 (boxes where there was no entry or an irrelevant entry not reproduced):
>lt>1
60. According to recital 1 in the preamble to the contested directive:
‘Annex I to Directive 67/548/EEC contains a list of dangerous substances … . That list needs to be updated to include further notified new substances and further existing substances as well as adapting the existing entries to technical progress …’
61. Pursuant to Article 1(1) of the contested directive, Annex I to Directive 67/548 is amended, inter alia, as follows:
‘…
(b) the entries [in Annex I to Directi ve 67/548] corresponding to the entries set out in Annex 1 B to this directive are replaced in the text set out in that [last-mentioned] Annex;
…’
62. Under Article 2(1) of the contested directive, the Member States are to bring into force the laws, regulations and administrative provisions necessary to comply with that directive by 31 October 2005 at the latest.
63. In accordance with Article 3 of the contested directive, it entered into force on the 20th day following its publication in the Official Journal, that is to say 20 May 2004.
Procedure and forms of order sought by the parties
64. By application lodged at the Registry of the Court on 22 July 2004, the applicants brought the present action.
65. The applicants claim that the Court should:
– annul the contested directive to the extent that it classifies nPB as a highly flammable (R 11) and a Category 2 substance for reproductive toxicity (R 60) (‘the contested classification’);
– declare the Commission liable for damages suffered by the applicants as a result of the Commission’s unlawful conduct and award the applicants the provisional sum of EUR 350 000;
– declare the Commission liable for imminent losses and damages foreseeable with sufficient certainty, even if such losses and damages cannot yet be precisely assessed;
– order the Commission to pay the costs.
66. By separate document lodged at the Court Registry on 13 September 2004, the Commission raised an objection of inadmissibility pursuant to Article 114 of the Rules of Procedure of the General Court against the actions for annulment and damages. The applicants lodged their observations on that objection on 25 October 2004.
67. By separate document lodged at the Court Registry on 4 November 2004, the applicants brought an application for interim measures pursuant to Articles 242 EC and 243 EC, seeking suspension by the President of the Court of ‘the inclusion of nPB in the [contested] directive pending the full resolution of the dispute in the main proceedings’. By order of 10 February 2005 in Case T‑291/04 R Enviro Tech Europe and Enviro Tech International
v Commission
[2005] ECR II-475, the President of the Court dismissed that application and reserved the costs.
68. By order of the Court of 30 June 2005, the decision on the objection as to admissibility and on costs was reserved for the final judgment.
69. In its defence, the Commission contends that the Court should:
– dismiss the application;
– order the applicants to pay the costs.
70. By order of the President of the Third Chamber of the Court of 15 July 2005, after the parties had been heard, the present case was joined with Case T‑422/03 for the purposes of the written and oral procedures and of the judgment, pursuant to Article 50 of the Rules of Procedure.
71. By order of the President of the Third Chamber of the Court of 1 March 2007, the proceedings were suspended and then reopened following delivery of the judgment in Case C‑125/06 P Commission
v Infront WM
[2008] ECR I‑1451.
72. By order of the President of the Third Chamber of the Court of 18 December 2008, the proceedings were suspended and then reopened following delivery of the judgment in Case C‑425/08 Enviro Tech (Europe)
[2009] ECR I‑0035.
73. By separate document lodged at the Court Registry on 27 November 2009, the applicants discontinued proceedings in Case T‑422/03.
74. By order of the President of the Third Chamber of 18 December 2009, Case T‑422/03 was removed from the register.
75. In the context of a measure of organisation of procedure under Article 64 of the Rules of Procedure, the Court informed the parties of the adoption and entry into force of Regulation No 1272/2008 and requested them to submit their written observations on the possible inferences to be drawn for the present proceedings. Replying to that request, by separate document lodged at the Court Registry on 15 January 2010, the Commission requested the Court to declare, pursuant to Articles 113 and 114 of the Rules of Procedure, that the present action has become devoid of purpose and that there is no longer any need to adjudicate on the ground that Annex I to Directive 67/548, including the disputed classification, was repealed by Regulation No 1272/2008 with effect from 20 January 2009.
76. The applicants lodged their observations on that application on 11 March 2010. In those observations, they claimed that the Court should accept the amendment to their claims and to their pleas seeking annulment so that they henceforth cover the contested classification as stated in Annex VI, Part 3, table 3.2, of Regulation No 1272/2008.
77. By separate document lodged at the Court Registry on 9 April 2010, the Commission contended that the Court should reject that request.
78. As a member of the Chamber was unable to sit, the President of the Court designated another Judge to complete the Chamber, pursuant to Article 32(3) of the Rules of Procedure.
79. Upon hearing the report of the Judge-Rapporteur, the Court (First Chamber) decided to open the oral procedure.
80. At the hearing held on 5 May 2011, the parties presented their oral arguments and answered the oral questions asked by the Court.
Law
The application for annulment
Application for a declaration that there is no need to adjudicate
81. As a preliminary point, it must be held that, as the Commission accepted at the hearing – that fact being recorded in the minutes of the hearing – the application for a declaration that that there is no need to adjudicate refers only to the application for annulment of the contested directive and not to the application for damages.
82. According to the Commission, following the repeal of the contested classification by Regulation No 1272/2008, the application for annulment must be dismissed, in accordance with Articles 113 and 114 of the Rules of Procedure, on the ground that its has become devoid of purpose. Article 55(11) of Regulation No 1272/2008 provides that Annex I to Directive 67/548, including the contested classification which appears therein, is to be ‘deleted’ – which is synonymous with the term ‘repealed’ – with effect from the date of entry into force of that regulation, that is to say 20 January 2009. In addition, recital 53 in the preamble to that regulation confirms that the classifications referred to in Annex I to that directive were transposed as such to Annex VI to that regulation. The applicants also can no longer claim that that they have retained an interest in bringing proceedings in respect of the contested directive in accordance with the exceptional criteria acknowledged by the case-law.
83. The applicants claim that they have retained an interest in pursuing the present proceedings.
84. According to established case-law, an applicant’s interest in bringing proceedings must, in the light of the purpose of the action, exist at the time at which the action is brought, failing which the action will be inadmissible. That purpose must continue to exist, like the interest in bringing proceedings, until the final decision, otherwise there will be no need to adjudicate; this presupposes that the action must be liable, if successful, to procure an advantage to the party bringing it (Case C‑362/05 P Wunenburger
v Commission
[2007] ECR I‑4333, paragraph 42; Case T‑45/06 Reliance Industries
v Council and Commission
[2008] ECR II‑2399, paragraph 35; and Case T‑299/05 Shanghai Excell M & E Enterprise and Shanghai Adeptech Precision
v Council
[2009] ECR II‑565, paragraph 43 and case-law cited).
85. In the present case, it is not disputed that the applicants had an interest in bringing proceedings against the contested classification when the present action was brought.
86. In addition, without it being necessary to rule on the question whether, following the deletion, pursuant to Article 55(11) of Regulation No 1272/2008, of Annex I to Directive 67/548, the contested classification ceased to produce binding legal effects, it must be recalled that the possible expiry of a measure in the course of proceedings seeking its annulment does not in itself mean that the European Union judicature must declare that there is no need to adjudicate for lack of purpose or for lack of interest in bringing proceedings at the date of the delivery of the judgment (see, to that effect, Wunenburger, cited in paragraph 84 above, paragraph 47, and Shanghai Excell M & E Enterprise and Shanghai Adeptech Precision
v Council, cited in paragraph 84 above, paragraph 46).
87. In that regard, as accepted by the Commission at the hearing, that being noted in the minutes of the hearing, it must be concluded that the applicants have been the subject of criminal proceedings and sanctions, at national level, for infringement, when placing the product EnSolv on the market, of the requirements resulting form the contested classification, as implemented by the relevant national rules. Those proceedings and sanctions were the reason for a legal action brought on 12 July 2007 before the High Court of Justice of England and Wales, Queen’s Bench Division (Administrative Court) (Case CO/5860/2007), which are currently stayed pending the final judgment in the present proceedings (see, also Enviro Tech (Europe), cited in paragraph 72 above, paragraph 25). In that context, it should be noted that the contested directive constitutes the legal basis of the national rules enacted by the Member States in order to comply with the transposition obligations provided for in Article 2(1) of that directive, read in conjunction with the third paragraph of Article 249 EC, and that the contested classification as introduced by that directive continues to be the ground on which every national administrative enforcement measure or sanction adopted in that context, in particular where those rules are infringed, is based.
88. As the applicants have claimed, first, it follows that the contested directive has already produced binding legal effects for them at national level, in so far as they have been subject to legal proceedings and sanctions in the United Kingdom for failing to comply with the requirements imposed by the contested classification, providing the reason for the legal action brought before the High Court of Justice and, second, only an annulment judgment has the effect of eliminating the contested classification retroactively from the legal order as if it never existed (see, to that effect, Case T‑228/02 Organisation des Modjahedines du peuple d’Iran
v Council [2006] ECR II‑4665, paragraph 35).
89. By contrast, the mere finding that the contested classification is repealed or has lapsed, or even a finding that it is unlawful in the context of an application for damages (see Case T‑178/98 Fresh Marine
v Commission
[2000] ECR II‑3331, paragraph 45), are not sufficient to protect the applicants from national enforcement measures taken in respect of them because, in contrast to a judgment annulling a measure, such findings, in principle, only have a prospective effect limited to the action for damages in question and do not retroactively eliminate the legal basis for those measures.
90. In those circumstances, taking into account the enforcement measures adopted in respect of the applicants on the basis of the contested classification introduced, first, by the contested directive and, second, by the national rules intended to implement it, the applicants are justified in arguing that they derive a benefit from the annulment of that contested classification and, therefore, that they retain an interest in bringing proceedings in that regard.
91. Consequently, the Commission’s application for a declaration that there is no need to adjudicate must be dismissed.
Request to adapt claims and pleas in law seeking annulment
92. In support of their request to adapt their claims and pleas in law seeking annulment of the contested classification as stated in Part 3 of Annex VI to Regulation No 1272/2008, the applicants argue that, because the present proceedings were stayed pending delivery by the Court of Justice of its judgment in Case C‑425/08 and publication of Regulation No 1272/2008, on 31 December 2008, they were unable to request permission from the Court to adapt their claims and pleas in law seeking annulment following the entry into force of that regulation. The main reason why they did not bring a separate action against that new classification was because Case C‑425/08 was then pending. If the outcome of those proceedings had been favourable to the applicants, separate legal proceedings contesting Regulation No 1272/2008 would have been unnecessary. In any case, in the present proceedings, the request to adapt the claims and pleas in law seeking annulment would be admissible in the light of the criteria acknowledged by the Court in its judgment in Case T‑348/07 Al-Aqsa
v Council
[2010] ECR I‑0000, paragraphs 30 to 36.
93. The Commission contends that the request to adapt the claims and pleas in law seeking annulment is late and therefore inadmissible.
94. It has been held in settled case-law that, where a decision is, during the proceedings, replaced by another decision with the same subject-matter, this is to be considered a new factor allowing the applicant to adapt its claims and pleas in law. In such a case it would not be in the interests of the due administration of justice and the requirements of procedural economy to oblige the applicant to make a fresh application to the Court. Moreover, it would be inequitable if the institution in question were able, in order to counter criticisms of a decision contained in an application to the European Union judicature, to amend the contested decision or to substitute another for it and to rely in the proceedings on such an amendment or substitution in order to deprive the other party of the opportunity of extending his original pleadings to the later decision or of submitting supplementary pleadings directed against that decision (see, to that effect, Organisation des Modjahedines du peuple d’Iran, cited in paragraph 88 above, paragraph 28 and the case-law cited there; see also Case T‑420/05 Vischim
v Commission
[2009] ECR II‑3841, paragraph 53).
95. However, in the present case, even if the contested classification laid down in the contested directive has been replaced, during the proceedings, by a similar classification contained in Table 3.2 of Part 3 of Annex VI to Regulation No 1272/2008, it must be noted that the applicants, by their own admission, have neither brought a separate action for annulment against that regulation or requested, in the present proceedings, permission to adapt their claims for annulment within the time allowed under the fifth paragraph of Article 230 EC for bringing an action. For reasons analogous to those adopted by the case-law when authorising the rectification of a failure to meet the conditions of admissibility for an action for annulment only where it occurred before expiry of the period allowed for bringing an action (Case 50/84 Bensider and Others
v Commission
[1984] ECR 3991, paragraph 8), an adaptation of the claims for annulment after the expiry of that period would be incompatible with the fifth paragraph of Article 230 EC. In accordance with the principles of legal certainty and equality of persons before the law (see, to that effect, Case C‑229/05 P PKK and KNK
v Council [2007] ECR I‑439, paragraph 101), that provision enshrines a mandatory time-limit which is permanent, absolute and may not be extended. Any derogation from or extension of that period granted by the European Union judicature, albeit unanimously agreed by the parties, would therefore be contrary to the unequivocal wording and scheme of that provision and to the intention of the framers of the Treaty. In addition, the mandatory criteria, as laid down in Articles 111 and 113 of the Rules of Procedure, under which the Court is to declare inadmissible either an action for annulment or an action to amend the claims seeking annulment, may not be interpreted restrictively, so as to avoid the possibility that – contrary to the principle of legal certainty and the equality of persons before the law – the mandatory requirements of the Treaty governing, inter alia, the period of time within which actions must be brought, could be evaded.
96. In that context, the applicants cannot rely on the exceptional approach adopted by the Court in Al-Aqsa, cited in paragraph 92 above, which concerned, moreover, a very specific factual and legal situation which cannot be compared to that of the present case. In the present case, the applicants, either deliberately or negligently, failed to bring an action for annulment against the similar contested classification in Table 3.2 of Part 3 of Annex VI to Regulation No 1272/2008 or to request the corresponding adaptation of their claims seeking annulment within the period laid down for bringing an action in that regard, in the present proceedings, even though they were clearly in a position to do so and could reasonably have been expected to undertake such a step. In that regard, the mere argument based on the fact that these proceedings were stayed, pursuant to Article 77(a) and the first paragraph of Article 79(1) of the Rules of Procedure, when Regulation No 1272/2008 was published in the Official Journal on 31 December 2008, is irrelevant, since that staying of proceedings could not affect the expiry of the period for bringing an action referred to in the fifth paragraph of Article 230 EC.
97. Thus, the applicants’ request to adapt its claims, which was made on 11 March 2010 – that is almost a year after the expiry of the period within which an action could be brought against Regulation No 1272/2008 and almost five months after resumption of the present proceedings following delivery of the judgment in Enviro Tech (Europe), cited in paragraph 72 above – is manifestly late and must be rejected as inadmissible.
Admissibility of the action for annulment in the light of the fourth paragraph of Article 230 EC
98. As a preliminary point, it must be stated that, despite the entry into force during the present proceedings, that is to say on 1 December 2009, of Article 263 TFEU, the question of the admissibility of the action for annulment must be decided on the basis of the fourth paragraph of Article 230 EC alone (orders of the Court in Case T‑532/08 Norilsk Nickel Harjavalta and Umicore
v Commission [2010] ECR I‑0000, paragraphs 68 to 75, and in Case T‑539/08 Etimine and Etiproducts
v Commission
[2010] ECR I‑0000, paragraphs 74 to 81), which is not contested by the parties.
99. According to the Commission, the action for annulment must be declared inadmissible because the applicants are not individually concerned by the contested classification within the meaning of the fourth paragraph of Article 230 EC. First, the applicants do not enjoy procedural rights in the context of the procedure for adaptation of Directive 67/548 to technical progress; second, they could not rely on pre-existing rights distinguishing them individually in the same way as an addressee. Thus, the exclusive licence to use European patent EP 0 781 842 B1, of which the applicants are not the proprietors, does not concern nPB as such, but a mixture of solvents and a cleaning method. Equally, that patent as such is not invalidated by the contested classification. Furthermore, the applicants are not part of the category of operators of which there was an identifiable and limited number when the contested directive was adopted.
100. The applicants consider that they are individually concerned by the contested classification, within the meaning of the fourth paragraph of Article 230 EC, with the result that their action for annulment is admissible. In that regard the applicants claim in essence that, first, they actively participated in the ‘administrative’ procedure which led to the adoption of the contested classification – a procedure in which the Commission addressed ‘individual decisions’ to them – and enjoyed procedural rights. Second, the contested classification rendered invalid their pre-existing right of intellectual property, that is to say the exclusive licence derived from European patent EP 0 781 842 B1 relating to the product EnSolv, 95% of which is composed of nPB, and to a vapour precision cleaning technology, the qualities of which depend on the effective, non-flammable and harmless nature of nPB, with the final result that their position on the market disappeared. Third, the applicants argue that, in the light of their specific position on the market and as holders of such a pre-existing right, they form part of a ‘closed category’ of affected operators. Fourth, the Court should declare the action for annulment admissible in order to comply with their right to effective judicial protection.
101. With regard to whether the applicants are individually concerned by the contested classification, it should be recalled that the contested directive containing that classification is a measure of general application inasmuch as it applies to situations which have been determined objectively and have legal effects as regards a category of persons viewed in a general and abstract manner, that is to say with regard to every natural or legal person producing and/or marketing nPB or products based on nPB. However, the fact that a measure is, by its nature and scope, a provision of general application inasmuch as it applies to the economic operators concerned in general, does not prevent that provision from being of individual concern to some (Case C‑362/06 P Sahlstedt and Others
v Commission [2009] ECR I‑2903, paragraph 29; orders in Case T‑223/01 Japan Tobacco and JT International
v Parliament and Council
[2002] ECR II‑3259, paragraph 29, and in Case T‑154/02 Villiger Söhne
v Council
[2003] ECR II‑1921, paragraph 40).
102. In that regard, it should be recalled that persons other than those to whom an act is addressed can claim to be individually concerned within the meaning of the fourth paragraph of Article 230 EC only if the act affects them by reason of certain attributes peculiar to them or by reason of a factual situation which differentiates them from all other persons and thereby distinguishes them individually in the same way as the addressee (Case 25/62 Plaumann v Commission
[1963] ECR 95, 107, and order of 26 November 2006 in Case C‑444/08 P Região autónoma dos Açores v Council, not published in the ECR, paragraph 36).
103. In addition, where a decision affects a group of persons who were identified or identifiable when that measure was adopted by reason of criteria specific to the members of that group, those persons may be individually concerned by that measure inasmuch as they form part of a limited class of economic operators (Joined Cases C‑182/03 and C‑217/03 Belgium and Forum 187 v Commission
[2006] ECR I‑5479, paragraph 60; Infront WM, cited in paragraph 71 above, paragraph 71; and Sahlstedt and Others, cited in paragraph 101 above, paragraph 30).
104. However, the fact that it is possible to determine more or less precisely the number, or even the identity, of the persons to whom a measure applies, by no means implies that that measure must be regarded as being of individual concern to those persons where it is established that that application takes effect by virtue of an objective legal or factual situation defined by the measure in question (order in Case C‑503/07 P Saint-Gobain Glass Deutschland v Commission
[2008] ECR I‑2217, paragraph 70, and Sahlstedt and Others, cited in paragraph 101 above, paragraph 31).
105. It is in the light of those principles that it must be assessed whether the applicants are individually concerned by the contested classification.
106. In the first place, with regard to the applicants’ participation in the procedure leading to adoption of the contested classification and the existence of possible procedural rights on their behalf, it must be concluded that the relevant legislation does not provide procedural rights which would protect the applicants and on which they could rely in order to prove their capacity to bring legal proceedings against the contested decision (see, to that effect, order in Case T‑369/03 Arizona Chemical and Others
v Commission
[2005] ECR II‑5839, paragraphs 58 to 90). In the absence of procedural rights which would protect them, the applicants cannot claim to be distinguished individually by that fact in relation to the contested classification (see, to that effect, the orders in Norilsk Nickel Harjavalta and Umicore, cited in paragraph 98 above, paragraphs 103 to 106, and Etimine and Etiproducts, cited in paragraph 98 above, paragraphs 109 to 112; see also, to that effect and by analogy, order in Case C‑483/07 P Galileo Lebensmittel
v Commission
[2009] ECR I‑959, paragraph 53). In addition, it is agreed that the applicants intervened in the procedure for adaptation of Directive 67/548 to technical progress leading to the contested classification only after that procedure had been initiated within the CMR working group, by approaching in 2003, inter alia, the HSE, as rapporteur for the file, and by sending it new information in order to reopen the discussions in that regard, and that they were therefore not responsible for the initial classification of nPB, as amended by the contested directive, nor for that made in the latter directive.
107. In the second place, with regard to the allegedly special position of the applicants on the relevant market as a ‘one-product company’ and holders of a specific pre-existing right, and to their possible membership of a closed category of operators, it should be pointed out that it follows from the information relating to the production and marketing of goods based on nPB, as supplied by the parties in reply to the Court’s written questions, first, that nPB is a component of a large number of goods – distinct from solvents used for cleaning – falling within various markets such as aerosols, textiles, adhesives, inks and coatings, and that it is used as an intermediate for the synthesis of pharmaceuticals and other organic compounds, such as insecticides, quarternary ammonium compounds, flavours and fragrances. Second, with regard to the structure of the relevant market of production and sale of solvents based on nPB used for high-precision vapour cleaning, on which the applicants are active, it follows from that information that the applicants are not the only operators to use nPB as an essential ingredient of such a cleaning product but that a number of direct competitors are active on that market. Thus, whereas, in that regard, the Commission has identified three companies (all established in the United States), the applicants, in the first instance, listed four competing producers of solvents based on nPB, which are ‘theoretically affected’ by the contested classification and, in the second instance, at the hearing, stated that some of them have probably left the European market. Moreover, according to a letter of 13 November 2002, addressed by the applicants’ counsel to the Commission on behalf of the IBSA, ‘the members of IBSA represent 90% of the nPE solvent industry and include [five] manufacturers …’ and ‘IBSA’s members hold six U.S. patents for nPB products as well as European and other foreign patents’.
108. Accordingly, even supposing that the contested classification affects nPB only to the extent that it is marketed on the market for the production and sale of solvents based on nPB for high-precision vapour cleaning, which is not the case, it must be concluded that, in the light of the factors referred to in paragraph 107 above, the applicants have not succeeded in establishing their allegedly special situation as a ‘one-product company’ and holder of pre-existing specific rights, nor their possible membership of a closed category of operators.
109. Even following the Commission’s detailed arguments, the applicants have still not specified, to the required legal standard, the particular characteristics and the composition of the allegedly closed category of operators marketing an nPB-based product similar to the product EnSolv; yet the applicants concede that those operators are also affected by the contested classification. Thus, it is not apparent from the applicants’ written pleadings whether that category of operators is deemed to include those producing and/or marketing cleaning solvents based on nPB and/or those holding intellectual property rights similar to that of the applicants, which could be inferred from the IBSA’s letter. In addition, the applicants have not succeeded in establishing that that category of operators could not be altered after entry into force of the contested classification. Considering the lack of reliable details concerning the identity, number and situation of the operators concerned, in particular whether they enjoy a position on the market or similar pre-existing rights and whether they suffer similar negative effects as a result of the contested classification, the conditions which allow it to be concluded that a limited class of operators ( Infront WM, cited in paragraph 71 above, paragraphs 73 to 76) is affected by that classification, are clearly not fulfilled.
110. It should also be noted that the possibility of determining, at the time of adoption of the contested measure, more or less precisely the number, or even the identity, of the persons to whom a measure applies, by no means implies that it must be regarded as being of individual concern to those persons as long as it is established that that application takes effect by virtue of an objective legal or factual situation defined by the measure in question (see the case-law cited in paragraph 104 above). Furthermore, the fact that certain operators are more affected economically by a measure of general application than others is not sufficient to distinguish them individually from all other operators, since the application of that measure takes effect by virtue of an objectively determined situation (see Case T‑16/04 Arcelor
v Parliament and Council
[2010] ECR I‑0000, paragraph 106 and the case-law cited there). In addition, the case-law has acknowledged that the mere fact that the applicant may lose a major source of revenue as a result of new legislation does not prove that he is in a specific situation and is not sufficient to establish that that legislation applies to them individually, the applicant having to adduce proof of circumstances which make it possible to consider that the harm allegedly suffered is such as to distinguish him individually from all other economic operators concerned by that legislation in the same way as he is (order of 29 June 2006 in Case T-311/03 Nürburgring
v Parliament and Council, not published in the ECR, paragraphs 65 and 66 and the case-law cited there).
111. Consequently, the fact that the applicants may suffer, as a result of the entry into force and application of the contested classification, major economic loss, cannot justify, in itself, a finding that they are individually concerned.
112. Equally, if it were proved that the applicants were the only operators to have focused their economic activity on the marketing of an nPB-based cleaning solvent, which is particularly affected by the contested classification on the ground that it is 95% composed of that substance, that fact would also not be sufficient to distinguish them individually as long as there are other operators producing and/or marketing similar solvents or other nPB-based products and the number and identity of those operators are not defined, that group may even change after the entry into force of that classification (see, to that effect, Case C‑152/88 Sofrimport v Commission
[1990] ECR I‑2477, paragraph 11, and order in Case T‑213/02 SNF
v Commission
[2004] ECR II‑3047, paragraphs 62 and 63) and that classification affects their products in the same way as it affects the applicants’ products.
113. In those circumstances, it must be held that the applicants have not proved, to the requisite legal standard, even following the Commission’s detailed arguments and a number of measures of organisation of procedure adopted by the Court that, when the contested directive was adopted, they were either members of a closed category of operators distinguished individually by the contested classification, or their special position on the market for the production and marketing of nPB-based solvents for high-precision vapour cleaning distinguished them individually from all other operators. To the extent that the contested classification applies only to nPB as such and not to any product based on that substance, such as EnSolv, that classification gives rise to binding legal effects, of an abstract and general nature, in relation to all operators using nPB for various purposes and active on various markets. Thus, the contested classification applies to objectively determined situations and has legal effects with regard to categories of persons envisaged generally and in the abstract, that is, all producers and users of nPB.
114. In the third place, with regard to the foregoing considerations, the applicants’ pre-existing right based on the exclusive right to use a patented invention based on nPB, called EnSolv, is also not capable of distinguishing them in the same way as the addressee.
115. Without it being necessary to rule whether the existence, at the time of the adoption of a measure of general application, of a specific or exclusive intellectual property right can, under certain conditions, confer on an applicant holding such a right the capacity to bring legal proceedings under the fourth paragraph of Article 230 EC (Case C‑309/89 Codorníu
v Council
[1994] ECR I‑1853, paragraphs 21 and 22, and Case T‑33/01 Infront WM
v Commission
[2005] ECR II‑5897, paragraphs 160 and 165 to 167), it is apparent from the case-file that, when the contested directive entered into force, a number of the applicants’ competitors, active on the market for nPB-based cleaning solvents, also held intellectual property rights, including patents, linked to the production and marketing of those solvents (see paragraph 107 above), the use of which risked being affected by the contested classification. However, even following a precise written question in that regard, the applicants failed to make any detailed statement on the point whether, and if so to what extent, those other operators were in a similar position to their own, but confined themselves to repeating that their exclusive licence was particularly affected on account of the description of the patented product as neither flammable nor dangerous.
116. However, first, as has been acknowledged in the case-law, the existence of an actual or individual right, including a right of ownership, whose scope or exercise is potentially affected by the contested measure, is not as such capable of distinguishing the rightholder individually, in particular where other operators may enjoy similar rights and hence be in the same situation as that rightholder (see, to that effect, Sahlstedt and Others, cited in paragraph 101 above, paragraph 32, and order in Etimine and Etiproducts, cited in paragraph 98 above, paragraph 104 and the case-law cited there), which is clearly the case here. Second, even following the Court’s written and oral questions, the applicants were unable to explain whether, and if so to what extent, the contested classification was such as to prevent them from continuing to use their exclusive licence, to deprive them of the corresponding right, or even to invalidate European patent EP 0 781 842 B1 (see, in that regard, Codorníu, cited in paragraph 115 above, paragraph 21; orders of 21 November 2005 in Case C‑482/04 P SNF
v Commission, not published in the ECR, paragraph 41, and Galileo Lebensmittel, cited in paragraph 106 above, paragraph 45). Whereas the applicants have submitted that the contested classification affected the marketing of the product EnSolv and their competitive position, they have not however alleged that, following the entry into force of that classification, at the latest at national level, they would have had to stop the commercial use of their exclusive licence.
117. In the fourth place, concerning the right to effective judicial protection, it suffices to note that, while individuals must be able to enjoy such judicial protection of the rights they derive from the European Union legal order, reliance on such a right cannot call into question the conditions laid down in Article 230 EC. The judicial protection of natural or legal persons who are unable, by reason of the conditions for admissibility laid down in the fourth paragraph of Article 230 EC, directly to challenge European Union measures, in particular those of general application, must be effectively guaranteed by a right of action before national courts. The latter are required, in accordance with the principle of cooperation in good faith laid down by Article 10 EC, so far as possible to interpret and apply national procedural rules governing the exercise of rights of action in a way that enables those persons to challenge before the courts the legality of any decision or other national measure relating to the application to them of a European Union act, by pleading the invalidity of such an act and by asking them to make a reference to the Court of Justice for a preliminary ruling on validity (see Case C‑50/00 P Unión de Pequeños Agricultores v Council [2002] ECR I‑6677, paragraphs 43 and 44, and Joined Cases C‑445/07 P and C‑455/07 P Commission
v Ente per le Ville vesuviane and Ente per le Ville Vesuviane
v Commission
[2009] ECR I‑7993, paragraphs 65 and 66).
118. In those circumstances, the applicants’ argument that, were the action for annulment to be deemed inadmissible, their only option would be to infringe the national legislation on the classification and marketing of substances and suffer the imposition of sanctions, including criminal penalties, in order to bring the matter before the national courts, cannot succeed. In any case, it should be pointed out that the applicants were clearly in a position to bring proceedings before the national courts challenging such national measures applying the contested classification. In addition, one such legal challenge led, on a reference for a preliminary ruling, to the judgment in Enviro Tech (Europe), cited in paragraph 72 above, and a second to the proceedings before the High Court of Justice of England and Wales, Queen’s Bench Division (Administrative Court) (Case CO/5860/2007), which are currently stayed pending judgment ending the present proceedings.
119. Thus, the applicants’ argument founded on the right to effective judicial protection must be rejected.
120. In the light of all of the foregoing considerations, it must be held that the applicants have not established that they are individually concerned by the contested classification, within the meaning of the fourth paragraph of Article 230 EC and, therefore, their action for annulment must be declared inadmissible.
The action for damages
Preliminary observation
121. Since the Commission withdrew, at the hearing, the plea of inadmissibility with regard to the action for damages – that being noted in the minutes of the hearing – and no other factor capable of casting doubt on the admissibility of that action having arisen, it is necessary to consider the substance of that action.
Conditions to be satisfied in order to give rise to the non-contractual liability of the European Union
122. The non-contractual liability of the European Union for unlawful conduct on the part of its organs, within the meaning of the second paragraph of Article 288 EC, depends on fulfilment of a set of conditions, namely the unlawfulness of the conduct alleged against the institutions, the fact of damage and the existence of a causal link between that conduct and the damage complained of (see Case C‑243/05 P Agraz and Others
v Commission
[2006] ECR I‑10833, paragraph 26 and the case-law cited there, and Arcelor, cited in paragraph 110 above, paragraph 139 and the case-law cited there).
123. Given the cumulative nature of those conditions, the action must be dismissed in its entirety where one of those conditions is not satisfied (see Arcelor, cited in paragraph 110 above, paragraph 140 and the case-law cited there).
124. As regards the first of those conditions, there must be a sufficiently serious breach of a rule of law which is intended to confer rights on individuals (Case C‑352/98 P Bergaderm and Goupil
v Commission
[2000] ECR I‑5291, paragraph 42). In relation to the requirement that there must be a sufficiently serious breach, the decisive criterion for establishing that a breach is sufficiently serious is whether the European Union institution concerned manifestly and gravely disregarded the limits on its discretion. It is solely where that institution has only considerably reduced, or even no, discretion, that the mere infringement of European Union law may suffice to establish the existence of a sufficiently serious breach (Case C‑312/00 P Commission v Camar and Tico
[2002] ECR I‑11355, paragraph 54; see Arcelor, cited in paragraph 110 above, paragraph 141 and the case-law cited there).
125. It is necessary to assess the soundness of the pleas of illegality raised by the applicants in the light of the above criteria. In that regard, it must be pointed out that the contested classification, which the applicants consider to be unlawful, was adopted by the Commission in the form of a directive relating to the protection of consumer health and in the exercise of the broad discretion which is conferred upon it in this complex technical and legal context, which is essentially in a state of flux (see, to that effect, Enviro Tech (Europe), cited in paragraph 72 above, paragraphs 46 and 47). Thus, for there to be a sufficiently serious breach of the rules of law at issue, the bounds of the broad discretion enjoyed by the Commission when exercising its powers on issues concerning the protection of health and of consumers must have been clearly and seriously exceeded (see, to that effect and by analogy Case T‑13/99 Pfizer Animal Health
v Council
[2002] ECR II‑3305, paragraph 166, and Joined Cases T‑74/00, T‑76/00, T‑83/00 to T‑85/00, T‑132/00, T‑137/00 and T‑141/00 Artegodan and Others
v Commission
[2002] ECR II‑4945, paragraph 201).
126. Consequently, it is necessary to assess whether the alleged infringement of the rules of law invoked by the applicant involves a manifest and grave disregard of the limits of the broad discretion which the Commission enjoyed when adopting the contested directive (see paragraph 59 above).
Illegality pleas
127. In support of their action for damages, the applicants rely, in essence, on seven pleas in law seeking to claim that the contested classification is unlawful.
128. The first plea is divided into three branches, which allege manifest errors of assessment and of law in the application of the provisions of Directive 67/548, that is, first, the test methods provided for in Annex V thereto, second, the classification criteria provided for in Annex VI thereto and, third, the criterion of normal handling or use referred to in Annex VI.
129. The second plea concerns infringement of legitimate expectations in the correct application of the relevant classification criteria provided for under Directive 67/548.
130. The third plea alleges infringement of Article 95(3) EC and of the principle of ‘sound administration’ in so far as the Commission failed to examine all the available scientific evidence concerning nPB.
131. The fourth plea alleges the erroneous application (de facto) of the precautionary principle, which is not applicable to measures based on a risk evaluation.
132. The fifth plea alleges lack of competence and the infringement of certain general principles of European Union law.
133. That plea is subdivided into five branches, that is to say, first, lack of competence of the Commission in that it ignored and went beyond the relevant classification criteria provided for by Directive 67/548; second, infringement of the principle of legal certainty and of legitimate expectations; third, infringement of the principle of the independence and excellence of scientific advice for having endorsed a recommendation of the CMR working group which did not meet the requirements of independence, excellence, transparency, impartiality and integrity; fourth, infringement of the principle of proportionality in so far as the irreversible commercial and regulatory effects go beyond what is necessary to achieve the aims pursued; fifth, infringement of the principle of equal treatment for using a test method that has not been used to classify any other similar solvent, such as brominated or chlorinated solvents.
134. The sixth plea (presented as a branch of the fifth plea) alleges misuse of powers in so far as the contested classification is based on a single test which does not comply with the temperature ranges specified in Annex V to Directive 67/548 or with the methods laid down by that directive.
135. The seventh plea (presented as a branch of the fifth plea) alleges infringement of the principle of ‘sound administration’, and of the obligation to examine, diligently and impartially, the information and requests submitted by the applicants.
136. At the hearing, in the light of Enviro Tech (Europe), cited in paragraph 72 above, the applicants withdrew the fourth plea, alleging disregard of the precautionary principle, the fourth and fifth branches of the fifth plea, alleging the infringement of the principle of proportionality and the principle of equal treatment respectively, and the sixth plea, alleging misuse of power, as noted in the minutes of the hearing.
Consequences of Enviro Tech (Europe)
137. As a preliminary point, it should be noted that the subject-matter of the present proceedings largely overlaps with that of the challenge to the validity of the contested classification, which was brought before the Court of Justice in the context of the questions referred for a preliminary ruling which led to the judgment in Enviro Tech (Europe), cited in paragraph 72 above: the first applicant and the Commission participated in both procedures; the measure, the validity of which was called into question – that is the contested classification introduced by the contested directive (see paragraph 59 above) – was identical; and the complaints seeking its annulment or lack of validity were essentially the same.
138. Thus, to the extent that, in Enviro Tech (Europe), cited in paragraph 72 above, the Court of Justice rejected, in the light of the questions referred to it for a preliminary ruling, the pleas seeking to call into question the validity of the contested classification which are renewed in essence by the applicants in the present action, and therefore confirmed, to that extent, the lawfulness of the contested classification, the Court may no longer call that assessment into question (see, to that effect, order of 13 December 1999 in Case T‑268/94 Tyco Toys and Others
v Commission and Council
[1999] ECR II‑3569, paragraph 24).
The first plea, alleging manifest errors of assessment and disregard of the relevant provisions of Directive 67/548
139. According to the applicants, by endorsing the contested classification, first, the Commission made manifest errors of assessment and disregarded the provisions regarding the test methods provided for in Annex V to Directive 67/548. The classification ‘highly flammable’ (R 11) was based on one single test result identifying a flashpoint at -10°C, obtained by Ms B by applying the equilibrium method in accordance with ISO standard 1523 using a Pensky-Martens apparatus, whereas the application of other methods, according to ISO standards 3689, DIN 51755, ISO 13736 and ASTM 1310, did not lead to ignition. Whereas even the ISO standard 1523 applied expressly provides that tests performed under such standards are valid only within the range between 10°C and 110°C, the test carried out by Ms B did not reveal any flash point for nPB within that range and its result was invalid having regard to paragraph 1.1 of Title A.9 to Annex V to Directive 67/548. Second, the Commission made a manifest error of assessment and disregarded the criteria governing the classification of a substance as toxic for reproduction laid down in section 4.2.3 of Annex VI to Directive 67/548. In that regard, it wrongly assessed the required evidence and drew erroneous conclusions from the tests carried out on rats by applying the results of those tests to humans. Third, the Commission committed a manifest error of assessment and incorrectly applied the normal handling or use criterion referred to in section 1.1 of Annex VI to Directive 67/548 in relation to the classification of nPB as both highly flammable and toxic for reproduction. In that regard, the applicants point out that, in Enviro Tech (Europe), cited in paragraph 72 above, the Court of Justice did not rule on the branch alleging a manifest error of assessment in the application of the normal handling or use criterion, since the Conseil d’État (Council of State) (Belgium) did not refer an express question for a preliminary ruling in that regard.
140. The Commission contends that the present plea should be rejected as manifestly unfounded in law, because the Court of Justice has decided with the force of res judicata all the legal questions raised by the applicants.
141. With regard to the first two branches of the present plea, it should be recalled that the Court of Justice has ruled as follows ( Enviro Tech (Europe), cited in paragraph 72 above, paragraphs 46 to 71):
‘– Preliminary observations
46 First of all, it must be pointed out that, in this complex technical and legal context, essentially in a state of flux, Directive 67/548 basically gives the Commission wide powers of assessment as to the scope of the measures to be taken to adapt the Annexes to that directive to technical progress.
47 As the Court has already held, where the [European Union] authorities have a broad discretion, in particular as to the assessment of highly complex scientific and technical facts in order to determine the nature and scope of the measures which they adopt, review by the [European Union] judicature is limited to verifying whether there has been a manifest error of appraisal or a misuse of powers, or whether those authorities have manifestly exceeded the limits of their discretion. In such a context, the [European Union] judicature cannot substitute its assessment of scientific and technical facts for that of the institutions on which alone the Treaty has placed that task (see Case C‑326/05 P Industrias Químicas del Vallés
v Commission
[2007] ECR I‑6557, paragraphs 75 to 77).
– The question of flammability
48 In accordance with section 1.2 of Title A.9 of Annex V to Directive 67/548, a liquid’s flammability is determined, initially, by measuring its flash point. The flash-point is the lowest temperature at which, under the conditions defined in the test method, a liquid’s vapours form a flammable mixture with air.
49 According to the applicant in the main proceedings, by classifying [nPB] as a highly flammable substance, [the contested directive] did not follow the methods laid down in Title A.9 of Annex V to Directive 67/548 for determination of the flash point.
50 In that regard, it must be noted that, … to determine the flash point of liquids a choice must be made between an equilibrium method in accordance with ISO standards 1516, 3680, 1523 or 3679, and a non-equilibrium method. [T]he choice of the most appropriate method depends on the properties of the substance to be analysed.
51 Those methods set criteria for the choice of equipment according to the temperature gradient at which the measurements must be made. There are a number of categories of measuring instruments appropriate to different temperature gradients.
52 It is apparent from the documents before the Court that the Commission, basing its findings on the view of experts contained in the report of the [specialist] expert group of 4 December 2002 … took the view that [nPB] was a highly flammable substance on the basis of the results obtained from experiments conducted, inter alia, in accordance with the equilibrium method and ISO standard 1523, with a Pensky-Martens apparatus, which found a flash point at -10ºC.
53 Firstly, with regard to the complaint of the applicant … that the classification of [nPB] as a highly flammable substance rests on the result of a single test carried out in accordance with the specifications referred to above, the [specialist] experts’ report enables that allegation to be rejected.
54 Thus, it is apparent from that document that a number of tests were carried out in accordance with the most widely accepted standards for measuring the flash point and that the majority of those tests did not give a flash point for the substance in question.
55 Nevertheless, … account must be taken of the fact that it is as a general rule difficult to determine the flash point of halogenated hydrocarbons, such as [nPB], the properties of which may mean that results of calculations are inexact or imprecise. As set out in ISO standard 1523 itself, the interpretation of results obtained from solvent mixtures containing halogenated hydrocarbons should be considered with caution, as these mixtures can give anomalous results.
56 That being so, the result obtained by the equilibrium method and by ISO standard 1523 with Pensky-Martens apparatus is not the only one to have shown the existence, for [nPB], of a flash point lower than 21°C.
57 In addition to the measurement referred to, the [specialist] experts’ report contains the results of another test carried out using the same apparatus, but by the non-equilibrium method, ASTM D 93-94, which exactly meets the requirements of point 1.6.3.2 of Title A.9 in Annex V to Directive 67/548 and which found a flash point for [nPB] of -4.5ºC. To supplement those tests, a theoretical calculation of the flash point was carried out, which showed that [nPB] may become flammable from -7ºC. On the basis of that information and after discussions, the majority opinion of the expert group was that [nPB] is a highly flammable substance which must be classified as R 11.
58 It follows from the foregoing that neither the [specialist] expert group nor the Commission based their findings on a single test but on a number of scientific factors which enabled a flash point lower than 21ºC to be found for [nPB], which permitted them to classify that substance in the category of “highly flammable” liquids, in accordance with points 2.2.3 to 2.2.5 of Annex VI to Directive 67/548.
59 Secondly, the applicant in the main proceedings alleges that, on its technical specifications, the Pensky-Martens apparatus is more suitable for the determination of a flash point in accordance with ISO standard 1523 in a temperature gradient between 10ºC and 110ºC.
60 In that regard, it must be held that the fact that the measurements were made in a temperature gradient other than that recommended for the measuring instrument is liable to affect the reliability of the classification.
61 Nevertheless, it must be pointed out that, taking account of the safety margin which has to be applied to a result obtained relative to the temperature which determines the classification, that fact is not sufficient of itself to call into question the conclusions of the [specialist] expert group and of the Commission that [nBP] must be classified as a highly flammable substance.
62 Thus, it is settled case-law that, where a [European Union] authority is called upon, in the performance of its duties, to make complex assessments, its discretion applies also, to a certain extent, to the finding of facts underlying its action (see, to that effect, Case 138/79 Roquette Frères
v Council
[1980] ECR 3333, paragraph 25, and Case C‑120/97 Upjohn
[1999] ECR I‑223, paragraph 34). Furthermore, in such circumstances, it is the duty of the competent institution to examine carefully and impartially all the relevant aspects of the individual case (Case C‑269/90 Technische Universität München
[1991] ECR I‑5469, paragraph 14).
63 It is apparent from the [specialist] experts’ report that, even if the expert group was not unanimous on the question of whether or not [nPB] should be classified as R 11, a majority opinion that it should be so classified emerged within the group. It must also be observed that the experts reached a consensus on the fact that [nPB] did indeed have a flash point and an explosive range enabling the view to be taken that, accordingly, it carried an intrinsic risk of flammability.
64 It follows from the foregoing that, in the assessment of the flammability of [nPB], the Commission followed the opinion of the flammability [specialist] expert group, which is based on the results of a number of tests carried out using different methods, confirmed by information taken from specialist publications.
65 Accordingly, it is apparent that the exercise of the Commission’s discretion as to the classification of [nPB] as a “highly flammable” substance is not vitiated by manifest error or abuse of power and that the Commission has not manifestly exceeded the limits of its discretion.
– The question of toxicity for human reproduction
66 Since the classification of [nPB] as a substance toxic for human reproduction is based solely on results of tests carried out on animals, which showed marked toxic effects on their reproduction, the applicant … has disputed, before the national court, the fact that it is possible to interpret those results widely in order to deduce from them that the substance in question is harmful to human reproduction.
67 The criteria for classification of a substance as toxic for reproduction are set out in point 4.2.3 of Annex VI to Directive 67/548. In particular, to classify a substance as being of category 2 toxicity on the basis of impaired fertility, there must be clear evidence of impairment of fertility in an animal species, together with either additional evidence as to the mechanism or seat of the effect or as to the existence of a chemical analogy with other known ‘anti-fertility’ agents, or other information leading to the conclusion that comparable effects are likely to be found in humans.
68 As is apparent from the summary reports of the CMR … working group of 14 to 16 May 2003 and of 15 to 17 January 2003 …, the grounds for the classification of [nPB] as category 2 toxic are based on the harmful effects on fertility, found during standard studies on a species of rat, and on the structural similarity between that substance and its isomer, 2-bromopropane, also called iso-bromopropane, classified as category 1 toxic due to both known impairment of human fertility and developmental toxicity to humans.
69 Thus, the fact that [nPB] causes marked harm to the reproductive organs in rats of both sexes on administration of doses which have not given rise to other systematic effects constitutes the most obvious effect resulting from the studies referred to in the CMR working group reports. Furthermore, those studies conclude that the toxic effects are not produced solely on administration of high doses.
70 It is therefore apparent that the experts’ opinion was based on the criteria set out in point 4.2.3 of Annex VI to Directive 67/548 and, in particular, in point 4.2.3.3 of that annex and that the Commission, on the basis of that opinion, was thus able reasonably to classify [nPB] as a substance “toxic for reproduction in category 2”.
71 Accordingly, it must be held that the Commission’s exercise of its discretion in classifying [nPB] as a substance “toxic for reproduction in category 2” is not vitiated by manifest error or by an abuse of power and that the Commission has not manifestly exceeded the limits of its discretion.’
142. That reasoning of the Court of Justice expressly responds to claims which are similar, if not identical, to those raised in the context of the first and second branches of the present plea in law, which the applicants did not call into question.
143. With regard to the first branch, it suffices to note that the Court of Justice rejected all the claims submitted to it which were repeated in essence by the applicants in the present action concerning, in particular, first, the alleged manifest error in the carrying out of the test establishing the flash point of nPB and in the assessment of its results and, second, the alleged error linked to the fact that that flash point lies outside the temperature range foreseen by ISO standard 1523.
144. With regard to the second branch, it must be noted that the Court of Justice also gave a final response to all the claims submitted by the applicants. Thus, it endorsed the Commission’s argument, which is sufficient to reject the second branch, that the classification of nPB as a substance which is toxic for reproduction under category 2 relies, inter alia, on the evidence obtained and assessed in accordance with point 4.2.3.3 of Annex VI to Directive 67/548 (see the minutes of the meetings of the CMR working group of 15 to 17 January and 14 to 16 May 2003). In that regard, the applicants cannot reasonably claim that the Commission disregarded the standard of proof required in the light of point 4.2.3.1 of Annex VI to Directive 67/548. It is not apparent from that provision, the criteria of which largely overlap, that the phrases ‘clear evidence in animal studies’ and ‘results in … studies’, on the one hand, and the phrases ‘strong suspicion’ and ‘strong presumption’, on the other hand, express different standards of proof. In addition, in the cases mentioned in that provision where classification is made in category 2 or 3, the Commission may rely on its conclusions in relation to ‘other relevant information’, or ‘appropriate’ information, which indicates the wide discretion it enjoys when assessing scientific evidence. Finally, the applicants cannot call into question the Court of Justice’s final assessment with regard to the merits of the analysis of the test results and of the other evidence underlying the classification of nPB as a substance which is toxic for reproduction under category 2.
145. With regard to the third branch, it must be held that it is true that the Court of Justice did not rule expressly on compliance by the Commission with the criterion of ‘normal handling or use’ within the meaning of section 1.1 of Annex VI to Directive 67/548. In that regard, it must however be noted that the first applicant, Enviro Tech (Europe), had submitted that argument to the Court of Justice which then took it into account ( Enviro Tech (Europe), cited in paragraph 72 above, paragraphs 31 and 34). In addition, while the Court of Justice did not refer expressly to the criterion of normal handling or use in its assessment of the inflammability and toxicity of nPB, the fact remains that, as the applicants themselves stated at the hearing, that criterion is the expression of a general principle underlying the various assessment criteria governing the inflammability and toxicity of substances (see sections 2.2.5 and 4.2.3 of Annex VI to Directive 67/548), meaning that the Court could not avoid taking it into account implicitly. Thus, in paragraph 69 of its judgment, concerning the toxicity of nPB for reproduction and with reference to the requirements laid down in points 4.2.3.1 and 4.2.3.3 of Annex VI to Directive 67/548, the Court of Justice considered that the studies in question conclude ‘that the toxic effects are not produced solely on administration of high doses’.
146. It follows that the Court of Justice also rejected, in essence, the third branch of the present plea in so far as the ‘normal handling or use’ criterion is concerned.
147. With regard in particular to the flammability of nPB, it must also be pointed out in addition that the applicants’ arguments refer in essence to the normal handling and use of their product EnSolv, which, in contrast to its essential ingredient, nPB, is not, as such, the subject of the contested classification. By contrast, the applicants do not take into account the broad range of uses of nPB in other products (see paragraph 107 above), the conditions of normal handling and use of which may differ considerably from those applicable to the product EnSolv or other nPB‑based vapour degreasing products. Accordingly, the applicants have not succeeded in calling into question the merits of the finding in paragraphs 56 and 58 of the judgment of the Court of Justice that, in the light of the range of temperatures provided for by ISO standard 1523, it is sufficient for the Commission to prove the existence of a flash point lower than 21°C.
148. Finally, to the extent that the applicants claim that the Court of Justice did not have at its disposal all the scientific facts and evidence which the Court currently has at its disposal and which would justify conclusions other than those arrived at by the Commission and the Court of Justice, it suffices to hold that it would have been open to the applicants to rely on them and to produce them in the proceedings before the Court of Justice. Given that, according to their own admission at the hearing, the applicants manifestly failed to act in that way, they can no longer call into question the merits of those conclusions contained in the judgment of the Court of Justice.
149. In the light of all the foregoing considerations, the first plea in law must be rejected in its entirety as lacking legal foundation.
The second plea in law, alleging infringement of legitimate expectations in the correct application of the relevant classification criteria laid down in Directive 67/548
150. According to the applicants, the contested classification damages their legitimate expectations of a careful and impartial examination by the Commission, for the purposes of the correct classification of nPB, of the relevant scientific data submitted by the applicants. The Commission contends that the present plea should be rejected as manifestly unfounded.
151. Whereas, in its judgment in Enviro Tech (Europe), cited in paragraph 72 above, the Court of Justice did not rule expressly on such a plea, the fact nevertheless remains that that plea only reformulates the first plea by which the applicants complain that the Commission made manifest errors of assessment in the application of the classification criteria laid down by Directive 67/548 and disregarded those criteria.
152. Furthermore, as is clear from settled case-law, any person whom an institution has caused to entertain well-founded expectations on the basis of clear assurances given to him may rely on the principle of the protection of legitimate expectations to the extent that those assurances are not contrary to the applicable legislation. However, where a prudent and circumspect economic operator could have foreseen that the adoption of a measure is likely to affect his interests, he cannot plead that principle if the measure is adopted (see, to that effect, Case C‑201/08 Plantanol
[2009] ECR I‑8343, paragraphs 46 and 53 and the case-law cited there, and Case C‑519/07 P Commission
v Koninklijke FrieslandCampina
[2009] ECR I‑8495, paragraph 84).
153. In the present case, it must be held that none of the conditions giving rise to the application of the principle of protection of legitimate expectations is fulfilled. First, in the absence of clear assurances by the Commission or another institution having powers in that regard, the applicants cannot rely on a legitimate expectation that nPB would not be classified as stipulated by the contested classification or otherwise. Second, it is not disputed that the legal criteria to be applied when making that classification are sufficiently clear and precise as to render their application to the present case foreseeable for the applicants, which is the reason why they intervened in the procedure used for the adoption of the contested classification in order to influence its outcome. Equally, the applicants cannot claim to have legitimate expectations regarding the choice by the competent authority of the test methods in conformity with those legal criteria (see paragraph 6 above), nor, all the more so, regarding the scientific result to which that authority may come when applying such a test.
154. Consequently, the present plea in law must be rejected as unfounded.
The third and seventh pleas in law, alleging infringement of Article 95(3) EC and the principle of ‘sound administration’
155. In support of the third and seventh pleas, the applicants rely in essence on the arguments submitted in the context of the first and second pleas. According to the applicants, by not examining the large amount of relevant scientific data provided by them, the Commission infringed, first, Article 95(3) EC and, second, the principle of ‘sound administration’, by virtue of which, inter alia, it must comply with the rights of defence of the operators and assess each case individually, impartially and diligently. The Commission contends that the present pleas should be rejected as manifestly unfounded.
156. In so far as the applicants claim, in the present case, that certain procedural rights protecting them have been infringed, it should be recalled that the procedure for adaptation of Directive 67/548 to technical progress does not provide such rights for the economic operators concerned (see the case-law cited in paragraph 106 above). Therefore, the claims that the Commission infringed the procedural rights, or even the rights of the defence, of the applicants cannot succeed.
157. In so far as the applicants claim that the Commission did not comply with its duty to act with care or the requirements of Article 95 EC, it suffices to hold that it follows from paragraphs 62 to 65 of Enviro Tech (Europe), cited in paragraph 72 above, that the Court of Justice rejected the applicants’ arguments that the Commission infringed its duty to act with care. In any case, the applicants did not succeed in proving that the Commission failed to take due account of the data and documents they submitted during the pre-litigation phase, or even that such taking into account could have affected the outcome of the procedure which led to the adoption of the contested classification (see the reasoning contained in paragraphs 139 to 154 above in relation to the first and second pleas in law). Furthermore, in the light of the reasoning of the Court of Justice in Enviro Tech (Europe), cited in paragraph 72 supra, which is referred to in paragraph 141 above, the applicants cannot reasonably claim that, in that regard, the Commission disregarded, in a manifest and serious manner, the limits of its broad discretion when adopting the contested directive (see paragraph 59 above).
158. Finally, to the extent that the applicants complain that the Commission failed to postpone the adoption of the contested classification even after it had been informed that studies were underway to reexamine the toxicity of nPB for reproduction, that vague argument cannot act as a basis for establishing an infringement of the duty to act with care or of Article 95(3) EC, because the still uncertain results of those studies were not yet available when the properties of nPB were being assessed and the Commission was in possession – in conformity with the reasoning of the Court of Justice referred to in paragraph 141 above – of scientific proof sufficient in order to proceed, at that stage, to the adoption of the contested classification.
159. Accordingly, the present pleas in law must be rejected as unfounded, without it being necessary to rule on the question whether Article 95 EC is applicable to the present case.
The fifth plea in law, alleging lack of competence and infringement of certain general principles of European Union law
160. In support of the first branch of the present plea, the applicants essentially reiterate the arguments submitted in the context of the first and second pleas in order to claim, in essence, that, by ‘amending’ the scope of the rules laid down by Directive 67/548, the Commission exceeded the mandate conferred upon it by that directive. In the context of the second branch, they recall, in essence, their arguments put forward in support of the second plea, alleging infringement of the principle of protection of legitimate expectations. In the context of the third branch, the applicants maintain that the contested classification endorses a recommendation of the CMR working group which does not meet ‘the requirements of independence, excellence, transparency, impartiality and integrity which are required for proper scientific advice’ on which decisions of the European Union must be founded. The Commission contends that the present plea should be rejected as manifestly unfounded.
161. It must be concluded that the applicants’ arguments in support of the first branch, alleging lack of competence, are only a nuanced version of those relied on in the context of the first plea. Given that, in that regard, the Court of Justice held that the Commission did not manifestly exceed the limits of its discretion and complied with the relevant nPB classification criteria, that institution cannot be regarded as lacking competence to adopt the contested classification. That branch cannot therefore succeed.
162. With regard to the second branch, it is sufficient to refer to the reasoning in paragraphs 151 to 154 above, in order to reject it as unfounded.
163. With regard to the third branch, alleging infringement of the principle of independence and excellence of scientific advice, it must be held that that branch largely overlaps with the first plea and with that alleging infringement of the principle of ‘sound administration’ (see paragraph 157 above). It should be noted in that regard that, as confirmed by the Court of Justice, the applicants cannot reasonably claim that the Commission failed to take into account the information and evidence submitted, or even that it manifestly and seriously exceeded the bounds of its broad discretion (see the case-law cited in paragraph 125 above) by relying, in the context of the required complex technical and scientific evaluations, on unconvincing evidence.
164. Consequently, the present plea must be rejected in its entirety as unfounded.
165. Since the applicants have not established the existence of unlawful action such as to give rise to non-contractual liability on the part of the European Union, the damages claim must therefore be dismissed.
166. Accordingly, the action must be dismissed in its entirety.
Costs
167. Under Article 87(2) of the Rules of Procedure, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings.
168. Since the applicants have been unsuccessful, they must be ordered to pay the costs, including those relating to the interlocutory proceedings, in accordance with the form of order sought by the Commission.
Operative part
On those grounds,
THE GENERAL COURT (First Chamber)
hereby:
1. Dismisses the action;
2. Orders Enviro Tech Europe Ltd and Enviro Tech International, Inc. to pay the costs, including those relating to the interlocutory proceedings.