Judgment of the General Court (Fifth Chamber) of 30 April 2015 — Polynt and Sitre v ECHA

(Case T‑134/13)

‛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’

1. 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 a substance as being of very high concern — Action brought by suppliers of the substance — Admissibility (Art. 263, fourth para., TFEU; European Parliament and Council Regulation No 1907/2006, Arts 31(9), and 59) (see paras 27, 36-38)

2. Actions for annulment — Admissibility criteria — Natural or legal persons — Action brought by several applicants against the same decision — Capacity to act of one of them — Admissibility of the action as a whole (Art. 263, fourth para., TFEU) (see para. 39)

3. 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 (Art. 263, fourth para., TFEU; European Parliament and Council Regulation No 1907/2006, Arts 57(f), and 59) (see para. 40)

4. Approximation of laws — Registration, evaluation, authorisation and restriction of chemicals — REACH Regulation — Substances of very high concern — List of substances in Article 57(f) of the regulation — Not exhaustive (European Parliament and Council Regulation No 1907/2006, recital 16 and Arts 57(f), and 59) (see paras 44-46)

5. 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 — Manifest error, misuse of powers or manifest exceeding of the limits of the discretion (European Parliament and Council Regulation No 1907/2006, Arts 57 and 59) (see paras 52, 53, 105)

6. Approximation of laws — Registration, evaluation, authorisation and restriction of chemicals — REACH Regulation — Substances of very high concern — Procedure for identification — 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 the European Chemicals Agency (ECHA) to take account of a risk assessment for a substance falling within category 1 of Directive 67/548 (European Parliament and Council Regulation No 1907/2006, Arts 57(a) to (f), 58(2), 59(4), and 60(2), and Annex XI ; Council Directive 67/548) (see paras 61, 68-71, 81)

7. Approximation of laws — Registration, evaluation, authorisation and restriction of chemicals — REACH Regulation — Substances of very high concern — Procedure for identification — 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 (European Parliament and Council Regulation No 1907/2006, Art. 59) (see para. 88)

8. Approximation of laws — Registration, evaluation, authorisation and restriction of chemicals — REACH Regulation — Substances of very high concern — Procedure for identification — 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 (European Parliament and Council Regulation No1907/2006, recital 16 and Arts 57(a) to (f), and 59; Guidance for the identification of substances of very high concern, point 3.3.3.2) (see paras 95-98)

9. Approximation of laws — Registration, evaluation, authorisation and restriction of chemicals — REACH Regulation — Substances of very high concern — Procedure for identification — Distinct from and independent of the evaluation procedure (European Parliament and Council Regulation No 1907/2006, recitals 19 to 21 and 69 and Arts 14, 44 to 48 and 59) (see paras 101, 114)

10. 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 hexahydromethylphthalic anhydride as a substance of very high concern — No breach of principle of proportionality (European Parliament and Council Regulation No 1907/2006, recital 16 and Arts 14(6), 44 to 48, 55, 58(5), 59 and 69 and Annex XVII) (see paras 107, 108, 116, 118-120)

11. Approximation of laws — Registration, evaluation, authorisation and restriction of chemicals — REACH Regulation — Substances of very high concern — Procedure for identification — Unanimous agreement of the Member State Committee — Abstention of a Member State — Irrelevant to a decision voted unanimously by the Member States present (Art. 238(4) TFEU; European Parliament and Council Regulation No 1907/2006, Art. 59(8); Rules of Procedure for the Member State Committee of the European Chemicals Agency (ECHA), Art. 19(1)) (see para. 126)

Re:

APPLICATION for annulment in part of Decision ED/169/2012 of the ECHA of 18 December 2012 concerning the inclusion of substances of very high concern in the list of candidate substances, in accordance with Article 59 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation 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), in so far as it concerns cyclohexane-1,2-dicarboxylic anhydride (EC No 201-604-9), cis-cyclohexane-1,2-dicarboxylic anhydride (EC No 236-086-3) and trans-cyclohexane-1,2-dicarboxylic anhydride (EC No 238-009-9).

Operative part

The Court:

1. Dismisses the action;

2. Orders Polynt SpA and Sitre Srl to bear their own costs and to pay those incurred by the European Chemicals Agency (ECHA);