Case C‑324/15 P

Hitachi Chemical Europe GmbH

and

Polynt SpA

v

European Chemicals Agency (ECHA)

(Appeal — Regulation (EC) No 1907/2006 (REACH Regulation) — Article 57(f) — Authorisation — Substances of very high concern — Identification — Equivalent level of concern — Hexahydromethylphthalic anhydride, hexahydro-4-methylphthalic anhydride, hexahydro-1-methylphthalic anhydride and hexahydro-3-methylphthalic anhydride)

Summary — Judgment of the Court (First Chamber), 15 March 2017

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 — Consideration of data relating to human exposure reflecting the risk management measures in force — Whether permissible

(European Parliament and Council Regulations No 1907/2006, Art. 57(f) and Annexes I and XV, and No 1272/2008, Annexe I)

Article 57(f) of Regulation No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) requires, as regards the identification of substances other than those meeting the criteria for classification in the hazard class carcinogenicity, mutagenicity or reproductive toxicity (CMR), substances which are persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB), that it be established, on a case-by-case basis, on the basis of scientific evidence, first, that it is probable that the substances concerned have serious effects on human health or the environment, and, second, that those effects give rise to an equivalent level of concern to those of CMR, PBT or vPvB substances. Those conditions are cumulative, so that the identification of a substance as being of very high concern must be rejected if either of those conditions is not met.

The examination of the first condition is based on an assessment of the hazards to human health or to the environment, on the basis of the information in the relevant parts of sections 1 to 4 of Annex I to Regulation No 1907/2006, as stated in section 2 of Annex XV to that regulation. It is therefore clear that that first condition laid down in Article 57(f) of that regulation requires an analysis of the hazards arising from the intrinsic properties of the substance under consideration. In this connection, the classification of a substance under Annex I to Regulation No 1272/2008 on classification, labelling and packaging of substances and mixtures, constitutes a relevant, but not decisive, element. Where a substance falls within one of the hazard classes in respect of human health or the environment provided for in that regulation, that circumstance may be sufficient to show the probability of serious effects to human health or the environment. Inclusion in a hazard class is nevertheless neither a necessary condition, nor a sufficient condition in this regard.

The second condition laid down in Article 57(f) of Regulation No 1907/2006 does not lay down any criterion and does not provide any clarification as regards the nature of the concerns that may be taken into consideration for the purposes of identifying a substance other than CMR, PBT or vPvB. In that regard, by providing that substances may be identified, on a case-by-case basis, if their serious effects on human health give rise to an equivalent level of concern to those of CMR substances, Article 57(f) of Regulation No 1907/2006 does not prohibit the taking into consideration of data other than those relating to the hazards arising from the intrinsic properties of the substances concerned. Thus, in the context of the examination of the second condition laid down in Article 57(f) of Regulation No 1907/2006, taking data relating to human exposure reflecting the risk management measures in force into consideration, where they exist, makes it possible to refine, for substances other than CMR, PBT or vPvB, the material on the basis of which recourse to the authorisation procedure appears, in the light of all the data available, to be the most appropriate course, having regard to the concerns to which their serious effects on health or on the environment give rise.

(see paras 26-28, 31, 32, 40, 41)