Keywords

Summary



Keywords

1. Actions for annulment — Natural or legal persons — Measures of direct and individual concern to them — Action brought by a European economic interest grouping — Admissibility — Conditions

(Art. 263, fourth para., TFEU)

2. Actions for annulment — Natural or legal persons — Measures of direct and individual concern to them — Whether directly concerned — Criteria — Decision of the European Chemicals Agency (ECHA) identifying acrylamide as a substance of very high concern — Action brought by companies manufacturing or importing that substance — Identification giving rise to the obligation to communicate to users of the substance an updated safety data sheet — Admissibility

(Art. 263, fourth para., TFEU; European Parliament and Council Regulation No 1907/2006, Arts 31(9)(a), 57(a) and (b), and 59 and Annex II; Commission Regulation No 453/2010, Art. 1)

3. Approximation of laws — Registration, evaluation, authorisation and restriction of chemicals — REACH Regulation — Substances of very high concern — Procedure for identification — Applicability to substances used as intermediates

(European Parliament and Council Regulation No 1907/2006, Art. 3, points 15, 57 and 59)

4. Approximation of laws — Registration, evaluation, authorisation and restriction of chemicals — REACH Regulation — Substances of very high concern — Procedure for identification — Discretion of the EU authorities — Scope — Judicial review — Limits

(European Parliament and Council Regulation No 1907/2006, Arts 57 and 59)

5. Approximation of laws — Registration, evaluation, authorisation and restriction of chemicals — REACH Regulation — Substances of very high concern — Procedure for identification — Decision of the European Chemicals Agency (ECHA) identifying acrylamide as a substance of very high concern — No breach of principle of proportionality

(Article 296 TFEU; European Parliament and Council Regulation No 1907/2006, sixteenth recital, Arts 1(1), 2(1)(c), 8(b), 55 and 59 and Annex XVII)

6. Approximation of laws — Registration, evaluation, authorisation and restriction of chemicals — REACH Regulation — Substances of very high concern — Procedure for identification — No obligation on ECHA to state reasons for the choice of the substance to be identified

(European Parliament and Council Regulation No 1907/2006, Arts 57 and 59)

Summary

1. An association responsible for defending the collective interests of its members, was, as a rule, entitled to bring an action for annulment only if the undertakings that it represented or some of these undertakings themselves had locus standi or if it could prove an interest of its own. That rule also applies to a European economic interest grouping which, like the first applicant, was created in order to defend the interests of a category of undertakings.

(see para. 32)

2. The condition for admissibility of an annulment action that the natural or legal person concerned be directly affected requires, first, that the measure complained of directly affect the legal situation of the individual and, second, 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 from EU rules without the application of other intermediate rules.

In that regard, in the context of the identification of a substance as being of very high concern in accordance with the procedure referred to in Article 59 of Regulation No 1907/2006, concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), a decision of the European Chemicals Agency identifying acrylamide as such a substance, on the ground that it fulfils the criteria set out in Article 57(a) and (b) of that regulation may directly affect the legal situation of suppliers of that substance, in so far as, where identification of the latter constitutes new information which may affect risk management measures or relates to hazards within the meaning of Article 31(9)(a) of that regulation, suppliers must update that safety data sheet, in accordance with Annex II to that regulation.

That conclusion is not called into question by the fact that Annex II to Regulation No 1907/2006 was amended, in accordance with Article 1 of Regulation No 453/10, only after the lodging of the application, since the fact that the effects of an act do not materialise until a subsequent date determined in the same act does not preclude an individual from being directly affected by it as a result of an obligation entailed by that act.

(see paras 34, 42, 43, 47)

3. The fact that a substance may have intermediate status within the meaning of Article 3(15) of Regulation No 1907/2006 does not mean that it is exempt from identification as being of very high concern in accordance with the procedure referred to in Article 59 of that regulation. Whereas a substance within the meaning of Regulation No 1907/2006 is defined by its intrinsic properties, the concept of an intermediate laid down in that regulation does not relate to the properties of a substance and does not change those properties in any way, but defines an intermediate according to the intended purpose of the manufacture and use of a substance.

Consequently, in so far as any substance may, in principle, be manufactured for chemical processing and consumed in or used in that processing in order to be synthesised and, therefore, have the status of an intermediate, the fact that a substance has, in a specific case, the status of an intermediate cannot exempt it from the identification procedure provided for by Article 59 of Regulation No 1907/2006.

(see paras 66, 67)

4. See the text of the decision.

(see paras 73, 74)

5. As regards judicial review of the conditions referred to in the previous paragraph, ECHA must be allowed a broad discretion in a field which entails political, economic and social choices on its part, and in which it is called upon to undertake complex assessments. The legality of a measure adopted in that field can be affected only if the measure is manifestly inappropriate having regard to the objective which the legislature is seeking to pursue. Having regard to recital 16 of Regulation No 1907/2006, the legislature established as the main objective the first of the three objectives referred to in Article 1(1) of that regulation, namely to ensure a high level of protection of human health and the environment.

A decision of the ECHA identifying anthracene oil as a substance of very high concern resulting from the procedure under Article 59 of Regulation No 1907/2006 does not infringe the principle of proportionality. In the first place, such a decision is appropriate for achieving the objectives pursued by Regulation No 1907/2006, since identification of a substance as being of very high concern 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 that protection. Moreover, since there is no reason to conclude that uses of acrylamide other than as intermediates are precluded, that substance would not be exempt from Title VII of Regulation No 1907/2006 by virtue of Article 2(8)(b) of that regulation.

In the second place, the said decision does not exceed the limits of what is necessary to achieve the objectives pursued by Regulation No 1907/2006, since the option of not acting does not constitute a measure as appropriate as identification of that substance as being of very high concern. The same applies to restrictive measures concerning the use of acrylamide, since, 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, mixtures and 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. Similarly, existing legislation on the protection of 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. Finally, identification of acrylamide as a substance of very high concern only in so far as it is not used as an intermediate does not constitute an appropriate measure either, in that the legislature introduced specific rules relating to intermediates in Article 2(1)(c) and Article 2(8)(b) of Regulation No 1907/2006.

(see paras 82-86, 88-93)

6. Since the procedure for identifying a substance as being of very high concern under Article 59 of Regulation No 1907/2006 does not confer on ECHA any power as regards the choice of the substance to be identified, that prerogative belonging exclusively to the Commission and the Member States pursuant to Article 59 of Regulation No 1907/2006, ECHA cannot be accused of breaching the principle of equal treatment by identifying acrylamide, and not the allegedly comparable substances, as a substance of very high concern. Similarly, given that, under Article 59(3) of Regulation No 1907/2006, any Member State may prepare a dossier in accordance with Annex XV to that regulation for substances which in its opinion meet the criteria set out in Article 57 of that regulation, ECHA cannot be blamed for giving no reasoning as to why acrylamide was chosen by a Member State and not other substances with identical properties.

(see paras 99-101)