Corte di giustizia UE/2013

[OSCURATO:PERSONA] ([OSCURATO:PERSONA]) 24 January 2013 ( * ) (Appeal – Directives 67/548/EEC and 2004/73/EC – Classification, packaging and labelling of dangerous substances – Classification of n‑propyl-bromide) [OSCURATO:PERSONA] C‑118/12 P, APPEAL under [OSCURATO:PERSONA] 56 of the Statute of the [OSCURATO:PERSONA] of Justice of the [OSCURATO:PERSONA], brought on 24 February 2012, [OSCURATO:PERSONA], established in Kingston upon Thames ([OSCURATO:PERSONA]), represented by C. Mereu and K. [OSCURATO:PERSONA], avocats, applicant, the other parties to the proceedings being: [OSCURATO:PERSONA]., established in [OSCURATO:PERSONA] ([OSCURATO:PERSONA]), applicant at first instance, [OSCURATO:PERSONA], represented by P. Oliver and E. Manhaeve, acting as Agents, defendant at first instance, [OSCURATO:PERSONA] ([OSCURATO:PERSONA]), composed of E. Jarašiūnas, President of the [OSCURATO:PERSONA], C. Toader (Rapporteur) and C.G. Fernlund, Judges, [OSCURATO:PERSONA]: N. Jääskinen, Registrar: A. [OSCURATO:PERSONA], having decided, after hearing the [OSCURATO:PERSONA], to give a decision by reasoned order, makes the following [OSCURATO:PERSONA] 1 By its appeal, [OSCURATO:PERSONA] (‘[OSCURATO:PERSONA]’) seeks to have set aside the judgment of the [OSCURATO:PERSONA] of the [OSCURATO:PERSONA] of 16 December 2011 in [OSCURATO:PERSONA]291/04 [OSCURATO:PERSONA] and [OSCURATO:PERSONA] v [OSCURATO:PERSONA] [2011] ECR I‑0000 (‘the judgment under appeal’), by which the [OSCURATO:PERSONA] dismissed its action for (i) annulment in part of [OSCURATO:PERSONA] 2004/73/EC of 29 April 2004 adapting to technical progress for the 29th time [OSCURATO:PERSONA] 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, and corrigendum OJ 2004 L 216, p. 3), in so far as that directive classifies n‑propyl‑bromide (‘nPB’) as a substance having certain dangerous properties, and for (ii) the award of damages. Legal context 2 [OSCURATO:PERSONA] 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, [OSCURATO:PERSONA] 1967(I), p. 234), as amended by [OSCURATO:PERSONA] 2001/59/EC of 6 August 2001 (OJ 2001 L 225, p. 1, ‘[OSCURATO:PERSONA] 67/548’), lays down rules concerning the marketing of ‘substances’, defined as ‘chemical elements and their compounds in the natural state or obtained by any production process, including any additive necessary to preserve the stability of the products and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition’. 3 For that purpose, [OSCURATO:PERSONA] 67/548 proceeds, in accordance with [OSCURATO:PERSONA] 4(1) thereof, to classify the substances on the basis of their intrinsic properties according to the categories laid down in [OSCURATO:PERSONA] 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 [OSCURATO:PERSONA] 4(2) of [OSCURATO:PERSONA] 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’. 5 Section 1.1 of Annex VI to [OSCURATO:PERSONA] 67/548, which forms part of the general introduction in that annex, 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.’ 6 Section 2.2.4 of Annex VI to [OSCURATO:PERSONA] 67/548, regarding highly flammable substances and preparations, provides: ‘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: R11 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. …’ 7 Section 4.2.3.1 of Annex VI to [OSCURATO:PERSONA] 67/548 divides substances toxic for reproduction in Category 2 as follows: ‘… 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. …’ 8 Section 4.2.3.3 of Annex VI to [OSCURATO:PERSONA] 67/548, headed ‘Comments regarding the categorisation of substances toxic to reproduction’, states inter alia: ‘... Placing in 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. …’ Background to the dispute 9 The background to the dispute, as described in paragraphs 43 to 63 of the judgment under appeal, may be summarised as follows. 10 nPB is a volatile organic solvent used inter alia for industrial cleaning and degreasing, especially of metallic parts. 11 The sole activity of [OSCURATO:PERSONA] and [OSCURATO:PERSONA]. (‘[OSCURATO:PERSONA]’) is the production and distribution of a product called ‘EnSolv’ which is made from a patented preparation and is composed essentially of nPB. [OSCURATO:PERSONA] is a company incorporated in accordance with [OSCURATO:PERSONA] law and is wholly owned by [OSCURATO:PERSONA], a company incorporated in accordance with [OSCURATO:PERSONA] law. It holds an exclusive licence for the marketing in [OSCURATO:PERSONA] 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 [OSCURATO:PERSONA] EP 0 781 842 B1 of 29 September 1999, for the exploitation of an invention entitled ‘Cleaning of parts using an environmentally safe solvent’. 12 Pursuant to [OSCURATO:PERSONA] 91/325/EEC of 1 March 1991 adapting to technical progress for the 12th time [OSCURATO:PERSONA] 67/548 (OJ 1991 L 180, p. 1), nPB was classified in Annex I to [OSCURATO:PERSONA] 67/548 as an ‘irritant Xn’ and accompanied inter alia by the risk phrases R 10 ‘Flammable’ and R 20 ‘Harmful by inhalation’. 13 Subsequently, by [OSCURATO:PERSONA] 2004/73, nPB was classified as a highly flammable substance (R11) and as a category 2 substance which is toxic for reproduction (R60). The procedure before the [OSCURATO:PERSONA] and the judgment under appeal 14 On 22 July 2004, [OSCURATO:PERSONA] and [OSCURATO:PERSONA] brought an action for annulment of [OSCURATO:PERSONA] 2004/73, in so far as it classified nPB as a highly flammable substance (R11) and as a category 2 substance which is toxic for reproduction (R60). By the same action, they also sought an order that the [OSCURATO:PERSONA] of the [OSCURATO:PERSONA] pay compensation for the damage they had suffered as a result of its unlawful conduct. 15 By the judgment under appeal, the [OSCURATO:PERSONA] dismissed their action for annulment as inadmissible and their action for damages as unfounded. [OSCURATO:PERSONA] also ordered the applicants to pay the costs, including those relating to the interlocutory proceedings which gave rise to the order of the President of the [OSCURATO:PERSONA] of 10 February 2005 in [OSCURATO:PERSONA] T‑291/04 R [OSCURATO:PERSONA] and [OSCURATO:PERSONA] v [OSCURATO:PERSONA] [2005] [OSCURATO:PERSONA]‑475. 16 In relation to the action for annulment, having held, at paragraph 98 of the judgment under appeal, that, despite the entry into force during the present proceedings, that is to say on 1 December 2009, of [OSCURATO:PERSONA] 263 TFEU, the question of the admissibility of the appeal must be decided on the sole basis of the fourth subparagraph of [OSCURATO:PERSONA] 230 EC, the [OSCURATO:PERSONA] ruled, at paragraph 120 of that judgment, that [OSCURATO:PERSONA] and [OSCURATO:PERSONA] had not established that they were individually concerned, within the meaning of that provision, by the contested classification in [OSCURATO:PERSONA] 2004/73. 17 As regards the application for damages for the harm allegedly suffered by those companies, the [OSCURATO:PERSONA] held that they had not established the existence of unlawful action such as to give rise to non‑contractual liability on the part of the [OSCURATO:PERSONA]. 18 In reaching that conclusion, the [OSCURATO:PERSONA] rejected all the pleas put forward by [OSCURATO:PERSONA] and [OSCURATO:PERSONA] in support of their action for damages, with the exception of the fourth plea alleging misapplication of the precautionary principle, the sixth plea alleging misuse of powers and the fourth and fifth limbs of the fifth plea, all of which were withdrawn. The pleas examined by the [OSCURATO:PERSONA] alleged, first, manifest errors of assessment by the [OSCURATO:PERSONA] and errors of law in the application of [OSCURATO:PERSONA] 67/548, second, infringement of the principles of protection of legitimate expectations, third, infringement of [OSCURATO:PERSONA] 95(3) EC and of the principle of sound administration, fifth, lack of competence and infringement of certain general fundamental principles of EU law and, seventh, infringement of the principle of good administration and the obligation to examine, diligently and impartially, the information and requests submitted by [OSCURATO:PERSONA] and [OSCURATO:PERSONA]. 19 As regards the third limb of the first plea, alleging manifest errors of assessment by the [OSCURATO:PERSONA] and errors of law in the application of [OSCURATO:PERSONA] 67/548 concerning the criterion of ‘normal handling or use’ referred to in Section 1.1 of Annex VI to that directive, the [OSCURATO:PERSONA], at paragraphs 145 and 146 of the judgment under appeal, held as follows: ‘145      With regard to the third branch, it must be held that it is true that the [OSCURATO:PERSONA] of Justice did not rule expressly on compliance by the [OSCURATO:PERSONA] with the criterion of “normal handling or use” within the meaning of section 1.1 of Annex VI to [OSCURATO:PERSONA] 67/548. In that regard, it must however be noted that … [OSCURATO:PERSONA] … had submitted that argument to the [OSCURATO:PERSONA] of Justice which then took it into account [[OSCURATO:PERSONA] C‑425/08 [OSCURATO:PERSONA] ([OSCURATO:PERSONA]) [2009] ECR I‑10035, paragraphs 31 and 34]. In addition, while the [OSCURATO:PERSONA] 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 [[OSCURATO:PERSONA] and [OSCURATO:PERSONA]] 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 [OSCURATO:PERSONA] 67/548), meaning that the [OSCURATO:PERSONA] 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 sections 4.2.3.1 and 4.2.3.3 of Annex VI to [OSCURATO:PERSONA] 67/548, the [OSCURATO:PERSONA] 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 [OSCURATO:PERSONA] of Justice also rejected, in essence, the third limb of the present plea in so far as the “normal handling or use” criterion is concerned.’ Forms of order sought by the parties before the [OSCURATO:PERSONA] of Justice 20 [OSCURATO:PERSONA] claims that the [OSCURATO:PERSONA] should: –        set aside the judgment under appeal in so far as it rejected its claim for damages and declare the [OSCURATO:PERSONA] liable for the damage sustained; –        in the alternative, set aside that judgment under appeal and refer the case back to the [OSCURATO:PERSONA]; and –        order the [OSCURATO:PERSONA] to pay the costs. 21 [OSCURATO:PERSONA] contends that the [OSCURATO:PERSONA] should dismiss the appeal and order [OSCURATO:PERSONA] to pay the costs. The appeal 22 [OSCURATO:PERSONA] 181 of its Rules of Procedure, where an appeal is, in whole or in part, clearly inadmissible or clearly unfounded, the [OSCURATO:PERSONA] may at any time, acting on a report from the Judge-Rapporteur and after hearing the [OSCURATO:PERSONA], dismiss the appeal in whole or in part by reasoned order. 23 That provision should be applied in the present case. Arguments of the parties 24 [OSCURATO:PERSONA] expressly pointed out that its appeal does not concern the judgment under appeal in so far as it declared its action for the annulment of [OSCURATO:PERSONA] 2004/73 inadmissible and that it only contests the [OSCURATO:PERSONA] findings, at paragraphs 145 and 146 of that judgment, in rejecting the third limb of the first plea in relation to ‘normal handling or use’. 25 In support of its appeal, [OSCURATO:PERSONA] puts forward a single ground of appeal alleging that the [OSCURATO:PERSONA] misinterpreted [OSCURATO:PERSONA] ([OSCURATO:PERSONA]) , which resulted in the rejection of the third limb of the first plea of illegality, invoked in support of its claims for damages, without an assessment of the merits. 26 More specifically, [OSCURATO:PERSONA] asserts that the [OSCURATO:PERSONA] erred in law in holding, at paragraphs 145 and 146 of the judgment under appeal, that in [OSCURATO:PERSONA] ([OSCURATO:PERSONA]) , the [OSCURATO:PERSONA] of Justice ‘implicitly’ took into account the criterion of ‘normal handling or use’ within the meaning of section 1.1 of Annex VI to [OSCURATO:PERSONA] 67/548, in its assessment of the flammability and toxicity of nPB. 27 According to [OSCURATO:PERSONA], the [OSCURATO:PERSONA] wrongly rejected its argument that the [OSCURATO:PERSONA] made a manifest error of assessment and an error of law in the application of the criterion of ‘normal handling or use’ laid down in that section, in particular as regards the classification of nPB as a product toxic to reproduction, given that neither the question referred by the national court in the case giving rise to [OSCURATO:PERSONA] ([OSCURATO:PERSONA]) nor the answer handed down by the [OSCURATO:PERSONA] of Justice in that judgment related to that criterion within the meaning of section 1.1 of Annex VI to [OSCURATO:PERSONA] 67/548. 28 In that regard, [OSCURATO:PERSONA] claims that, in [OSCURATO:PERSONA] ([OSCURATO:PERSONA]) , where the question of toxicity for reproduction was examined in paragraphs 66 to 71, the [OSCURATO:PERSONA] of Justice specifically referred to section 4.2.3 of Annex VI to [OSCURATO:PERSONA] 67/548 as containing the criteria for classification of a substance as toxic for reproduction. In that judgment, the [OSCURATO:PERSONA] of Justice did not therefore refer to section 1.1 of Annex VI to [OSCURATO:PERSONA] 67/548. 29 [OSCURATO:PERSONA] submits that [OSCURATO:PERSONA] assertion that its argument regarding the criterion of ‘normal handling or use’ was not raised before the [OSCURATO:PERSONA] of Justice in the case which gave rise to [OSCURATO:PERSONA] ([OSCURATO:PERSONA]) is ineffective. 30 According to the [OSCURATO:PERSONA], first, the second sub-question of the first question referred for a preliminary ruling in that case clearly alluded to the criterion of ‘normal handling or use’ and, second, at paragraph 31 of that judgment, the [OSCURATO:PERSONA] of Justice showed that it was fully aware of this allusion. 31 [OSCURATO:PERSONA] also submits that, given that the criterion of ‘normal handling or use’ is one of the principles underlying the various assessment criteria for effecting the relevant classifications under [OSCURATO:PERSONA] 67/548, the [OSCURATO:PERSONA] of Justice was obliged, by necessary implication, in the context of its assessment of the flammability and toxicity of nPB, to have taken it into account when upholding the validity of the contested classifications. 32 [OSCURATO:PERSONA] contends that the appeal should be dismissed as unfounded and that, in reality, by its appeal, [OSCURATO:PERSONA] is seeking to contest the [OSCURATO:PERSONA] ruling in [OSCURATO:PERSONA] ([OSCURATO:PERSONA]) . Findings of the [OSCURATO:PERSONA] 33 [OSCURATO:PERSONA] seeks, in essence, to show that the [OSCURATO:PERSONA] made an error of law in finding that, in [OSCURATO:PERSONA] ([OSCURATO:PERSONA]) , the [OSCURATO:PERSONA] of Justice implicitly ruled on the [OSCURATO:PERSONA]’s compliance with the criterion of ‘normal handling or use’ within the meaning of section 1.1 of Annex VI to [OSCURATO:PERSONA] 67/548 in the context of its assessment of the flammability and toxicity of nPB. 34 In that regard, it must be noted that, contrary to the appellant’s claim, the [OSCURATO:PERSONA] correctly held that it is apparent in particular from paragraph 31 of [OSCURATO:PERSONA] ([OSCURATO:PERSONA]) that that company, as party to the main proceedings giving rise to that judgment, had raised before the [OSCURATO:PERSONA] of Justice the argument concerning an alleged manifest error of assessment on the part of the [OSCURATO:PERSONA] in the application of the criterion of ‘normal handling or use’. 35 It is true that, in [OSCURATO:PERSONA] ([OSCURATO:PERSONA]) , the [OSCURATO:PERSONA] of Justice did not rule expressly on compliance by the [OSCURATO:PERSONA] with the criterion of ‘normal handling or use’ within the meaning of section 1.1 of Annex VI to [OSCURATO:PERSONA] 67/548. Nevertheless, it is apparent from the [OSCURATO:PERSONA] reasoning in that judgment that the [OSCURATO:PERSONA] took it into account. At paragraph 69 of that judgment, the [OSCURATO:PERSONA] pointed out that, according to the studies in question, ‘the toxic effects are not produced solely on administration of high doses’. [OSCURATO:PERSONA], at paragraph 145 of the judgment under appeal, referred to that passage in order to illustrate its assessment that the criterion of normal handling or use is ‘the expression of a general principle underlying the various assessment criteria governing the inflammability and toxicity of substances’. 36 However, as is apparent from the actual wording of section 1.1, located in Annex VI of [OSCURATO:PERSONA] 67/548 under the section headed ‘[OSCURATO:PERSONA]’, that criterion is the expression of a general principle which must be taken into consideration along with each of the specific assessment criteria laid down in that annex in order to classify a substance under one of the categories contained in that directive. 37 In those circumstances, the [OSCURATO:PERSONA] correctly held, at paragraph 145 of the judgment under appeal, that the criterion of ‘normal handling or use’ underlies the assessment criteria governing the flammability and toxicity of the substances provided for in the respective sections of Annex VI to [OSCURATO:PERSONA] 67/548 and that, consequently, the [OSCURATO:PERSONA] of Justice necessarily took it into consideration, implicitly but indubitably, in [OSCURATO:PERSONA] ([OSCURATO:PERSONA]) during its assessment of the flammability and reproductive toxicity of nPB. 38 Therefore, the [OSCURATO:PERSONA] also correctly rejected the third limb of the first plea concerning the criterion of ‘normal handling or use’ within the meaning of section 1.1 of Annex VI to [OSCURATO:PERSONA] 67/548, advanced by [OSCURATO:PERSONA] in support of its action, without having examined the merits of the arguments raised in support of that plea. 39 It follows from the foregoing that the appeal must be dismissed as clearly unfounded. Costs 40 [OSCURATO:PERSONA] 138(1) of the Rules of Procedure, which applies to appeal proceedings pursuant to [OSCURATO:PERSONA] 184(1) thereof, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings. Since the [OSCURATO:PERSONA] has applied for costs and [OSCURATO:PERSONA] has been unsuccessful, [OSCURATO:PERSONA] must be ordered to pay the costs. On those grounds, the [OSCURATO:PERSONA] ([OSCURATO:PERSONA]) hereby orders: 1. The appeal is dismissed. 2. [OSCURATO:PERSONA] is ordered to pay the costs. [Signatures] * Language of the case: [OSCURATO:PERSONA].