Case T‑135/13

Hitachi Chemical Europe GmbH and Others

v

European Chemicals Agency (ECHA)

‛REACH — Identification of certain respiratory sensitisers as substances of very high concern — Equivalent level of concern — Action for annulment — Whether directly concerned — Admissibility — Rights of the defence — Proportionality’

Summary — Judgment of the General Court (Fifth Chamber), 30 April 2015

Approximation of laws — Registration, evaluation, authorisation and restriction of chemicals — REACH Regulation — Substances of very high concern — Identification procedure — Determination of the level of concern of a substance — Examination on a case-by-case basis where no objective criteria laid down by the regulation — No infringement of the rights of the defence

Approximation of laws — Registration, evaluation, authorisation and restriction of chemicals — REACH Regulation — Substances of very high concern — Identification procedure — Substances having persistent, bioaccumulable and toxic or very persistent and very bioaccumulable properties — Obligations on information to be supplied as to replacement substances — Scope — Possible relevance of such information to a decision identifying a substance as being of very high concern — Limits

Approximation of laws — Registration, evaluation, authorisation and restriction of chemicals — REACH Regulation — Substances of very high concern — Identification procedure — Possibility of controlling the negative effects of a substance by using management methods — Fact not precluding identification of the substance as being of very high concern — No obligation on ECHA to take account of a risk assessment for a substance falling within category 1 of Directive 67/548

Actions for annulment — Natural or legal persons — Meaning of ‘regulatory act’ in Article 263, fourth paragraph, TFEU — Any act of general scope except for legislative measures — Decision of the European Chemicals Agency (ECHA) identifying a substance as being of very high concern — Included — Act not containing implementing measures within the meaning of that provision of the Treaty

In the context of an action under the fourth paragraph of Article 263 TFEU, the condition that a legal or natural person be ‘directly concerned’ requires, first, that the measure in question directly affect the legal situation of the individual and, secondly, that it leave no discretion to the addressees of that measure, who are entrusted with the task of implementing it, such implementation being purely automatic and resulting only from EU rules, without the application of other intermediate rules. In the case of a decision of the European Chemicals Agency (ECHA), identifying a substance as being of very high concern as a result of the procedure laid down in Article 59 of Regulation No 1907/2006, concerning the registration, evaluation, authorisation and restriction of chemicals, and the restrictions applicable to those substances, the decision produces direct effects on the legal position of suppliers of the substance by reason of the obligation to update the safety data sheet concerned, in accordance with Article 31(9) of that regulation. Consequently, the said suppliers are directly affected by the ECHA decision. (see paras 27, 36-38)

For reasons of procedural economy, if the same decision is challenged by several applicants in an annulment action under Article 263 TFEU and it is established that one of them has locus standi, the EU judicature no longer needs to examine the other applicants’ standing to bring proceedings. (see para. 39)

See the text of the decision. (see para. 40)

The wording of Article 57(f) of Regulation No 1907/2006, which concerns substances that do not fulfil the criteria of Article 57(d) or (e) and which are identified on a case-by-case basis in accordance with the procedure set out in Article 59 of that regulation, does not rule out the inclusion of respiratory sensitisers within scope of that provision. Although Article 57(f) does not make any reference to that category of substances, the fact remains that the substances expressly mentioned in that provision are mentioned solely by way of example, as is apparent from the legislature’s use of the words ‘such as those’. Moreover, a restrictive interpretation of that provision would go against the purpose of Regulation No 1907/2006 which is to ensure a high level of protection of human health and the environment, in that a large number of dangerous substances having serious effects on human health and the environment would be removed from the ambit of the authorisation procedure laid down in Title VII of that regulation. (see paras 44-46)

See the text of the decision. (see paras 52, 53, 111)

With regard to ECHA’s assessment as to whether a substance raises a level of concern equivalent to that of the substances listed in Article 57(a) to (e) of Regulation No 1907/2006, failure by ECHA to take account of the fact that users of the substance concerned implement effective risk management measures does not permit the inference that the ECHA’s assessment is vitiated by a manifest error. It is apparent from Article 60(2) of Regulation No 1907/2006 that the fact that the negative effects associated with the use of a substance can be controlled adequately does not preclude its identification as a substance of very high concern. Otherwise, the possibility, pursuant to the provision in question, of authorising a substance the risks of which can be adequately controlled, would be rendered meaningless. That is confirmed by Article 58(2) of the said regulation. In that regard, a distinction must be made between hazards and risks. Hazard assessment constitutes the first stage of the process of risk assessment, which is a more specific concept. Thus, an assessment of the hazards linked to the intrinsic properties of a substance must not be limited in light of specific circumstances of use, as in the case of a risk assessment, and may be properly carried out regardless of the place where the substance is used, the route by which contact with the substance might arise and the possible levels of exposure to the substance. Moreover, the classification and labelling of substances established by 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 are based on the transmission of information on the hazards linked to the substances’ intrinsic properties. In that regard, since classification amongst carcinogenic substances, mutagenic substances and substances toxic for reproduction in category 1 of Directive 67/548 is sufficient for a substance to be identified as being of very high concern pursuant to Article 57(a) to (c) of Regulation No 1907/2006, it cannot be concluded that, in order for a substance to be identified in accordance with Article 57(f) of Regulation No 1907/2006, the ECHA must take a risk assessment into consideration. (see paras 61, 68-71, 81)

It is not apparent from the identification procedure set out in Article 59 of Regulation No 1907/2006 that information on alternative substances is relevant as regards the outcome of that procedure. (see para. 88)

Lack of objective criteria for determining whether a substance gives rise to a level of concern equivalent to those of other substances listed in Article 57(a) to (e) of Regulation No 1907/2006 for the purposes of Article 57(f) of Regulation No 1907/2006 does not constitute an infringement of the defence rights of a supplier of a substance identified by ECHA as being of very high concern. The objective of Article 57(f) is precisely to make it possible to identify a substance as being of very high concern, on a case-by-case basis, where the objective criteria laid down in Article 57(a) to (e) of Regulation No 1907/2006 are absent. In that context, there must be scientific evidence of a substance’s probable serious effects on human health or the environment which give rise to a level of concern equivalent to those of other substances listed in Article 57(a) to (e) of Regulation No 1907/2006. Moreover, as regards the criteria laid down in section 3.3.3.2 of the guidance for the identification of substances of very high concern, which include, inter alia, the seriousness of the effects, the irreversibility of health effects, the consequences for society and the difficulties in carrying out a risk assessment based on the concentration of the substance in question, whilst those criteria are general in nature, the fact remains that they are sufficiently precise to enable interested parties, properly and effectively, to make known their views as to the assessment as to whether a substance gives rise to a level of concern equivalent to those of other substances listed in Article 57(a) to (e) of Regulation No 1907/2006. In that regard, the fact that those criteria were neither approved by the competent authorities nor debated with the interested parties cannot give rise to an infringement of those parties’ defence rights, since the latter had full knowledge of the criteria and their application from dossiers prepared in the context of the procedure for identifying a substance. (see paras 101-104)

It is not in any way apparent from Regulation No 1907/2006 that the legislature intended to make the identification procedure carried out pursuant to Article 59 of that regulation, which forms part of the authorisation procedure for a substance set out in Title VII of that regulation, subject to the registration procedure laid down in Title II of the regulation and of which the obligations set out in Article 14 of that regulation form part, or to the evaluation procedure set out in Articles 44 to 48 of the regulation. It is true that the registration procedure and the evaluation procedure, which is intended as a follow-up to registration according to recital 20 in the preamble to Regulation No 1907/2006, also serve to improve information for the public and professionals as to the hazards and risks of a substance, as is apparent from recitals 19 and 21 of that regulation. However, whereas the substances registered should be allowed to circulate on the internal market, as is apparent from recital 19 in the preamble to Regulation No 1907/2006, the objective of the authorisation procedure, of which the identification procedure set out in Article 59 of that regulation forms part, is, inter alia, progressively to replace substances of very high concern by suitable alternative substances or technologies, where these are economically and technically viable. Furthermore, as is apparent from recital 69 in the preamble to Regulation No 1907/2006, the legislature wanted particular attention to be paid to substances of very high concern. (see paras 107, 120)

An ECHA decision identifying hexahydromethylphthalic anhydride, hexahydro-4-methylphthalic anhydride, hexahydro-1-methylphthalic anhydride and hexahydro-3-methylphthalic anhydride (MHHP) as substances of very high concern as a result of the procedure set out in Article 59 of Regulation No 1907/2006 is in accordance with the principle of proportionality. Where a substance is identified as being of very high concern, the economic operators concerned are subject to information obligations. The said decision is appropriate to the realisation of the objectives pursued by Regulation No 1907/2006, in that such identification serves to improve information for the public and professionals as to the risks and hazards incurred and, consequently, such identification must be regarded as a means of enhancing the protection of human health, which is the main objective of the said regulation. Similarly, such a decision does not exceed the limits of what is necessary to achieving the objectives pursued by Regulation No 1907/2006. In the first place, neither the evaluation of a substance provided for in Articles 44 to 48 of Regulation No 1907/2006, nor the risk management measures proposed under Article 14(6) of that regulation constitute appropriate measures for the achievement of the objectives pursued by that regulation as regards the treatment of substances of very high concern and they are thus not less onerous measures. Secondly, the mere fact that a substance appears in the list referred to in Article 59(1) of Regulation No 1907/2006 does not prevent that substance from being subject to restrictions rather than to an authorisation where it is contained in an article. As is apparent from Article 58(5) and Article 69 of Regulation No 1907/2006, the Commission or a Member State may still propose that the manufacture, the placing on the market or the use of a substance on its own, in a mixture or in an article be managed by restrictions rather than by an authorisation. Furthermore, as is apparent from Annex XVII to Regulation No 1907/2006, restrictions applicable to the manufacture, the placing on the market and the use of certain dangerous substances and certain preparations and dangerous articles, adopted in accordance with the procedure set out in Title VIII of that regulation, may range from specific conditions imposed on the manufacture or the placing on the market of a substance to a total ban on the use of a substance. Even if restriction measures are also appropriate for the achievement of the objectives pursued by that regulation, they thus do not constitute, as such, less onerous measures compared with the identification of a substance which solely entails information obligations. Moreover, legislation which provides for risk management measures for workers, cannot constitute an appropriate and less onerous measure for the achievement of the objectives pursued by Regulation No 1907/2006 as regards the treatment of substances of very high concern and, in particular, of the objective of progressively replacing substances of very high concern by suitable alternative substances or technologies where these are economically and technically viable. (see paras 113, 114, 122, 124-126)