29

More specifically, the Court of Justice, in paragraphs 39, 41 to 47 and 51 to 55, held, inter alia, as follows: ‘39 It is true that point 4.1.3.5.5 of Annex I to Regulation No 1272/2008 does not provide for the use of criteria other than those expressly referred to in that provision. However, it should be noted that no provision expressly prohibits other factors liable to be relevant to the classification of a … substance [which is among the substances of unknown or variable composition, complex reaction products or biological materials] from being taken into consideration. … 41 … the use of the expressions “where appropriate” and “all available data” tends to undermine the interpretation that taking into account information other than that expressly used in the course of the summation method should, in all circumstances, be excluded. 42 Furthermore, it is apparent from recitals 4 to 8 of Regulation No 1272/2008 that the EU legislature intended “to contribute to the global harmonisation of criteria for classification and labelling, not only at UN level, but also through the incorporation of the internationally agreed [GHS] into Community law”. To that effect, Annex I to that regulation reproduces verbatim almost all of the [provisions of the GHS]. 43 … it is apparent from the very wording of the [GSH], in particular Annex 9, entitled “Guidance on hazards to the aquatic environment”, that the indicated methodological approach for determining the classification of substances’ hazards to the aquatic environment is difficult due, inter alia, to the fact that “the term substances covers a wide range of chemicals, many of which pose difficult challenges to a classification system based on rigid criteria”. That document therefore highlights “a complex interpretational problem, even for experts” presented by classification, in particular of so-called “complex or multi-component” substances for which “biodegradation, bioaccumulation, partitioning behaviour and water solubility all present problems of interpretation, where each component of the mixture may behave differently”. 44 The authors of that document thus sought to draw attention to the limits inherent in the methodological criteria laid down in the [GHS] for classification of hazards to the aquatic environment, in respect of certain substances characterised by, inter alia, their complexity, stability or low water solubility. 45 The EU legislature integrated the provisions of the [GHS] in Annex I to Regulation No 1272/2008, without demonstrating any intention to deviate from that approach. In those circumstances, it cannot be held that, by thus integrating the [GHS] in Regulation No 1272/2008, the EU legislature disregarded its methodological limitations. 46 The strict and automatic application of the summation method in all circumstances is liable to result in an undervaluing of the aquatic toxicity of a … substance [which is among the substances of unknown or variable composition, complex reaction products or biological materials] with few known constituents. Such a result cannot be regarded as consistent with the goal of protection of the environment and human health pursued by Regulation No 1272/2008. 47 … when it applies the summation method in order to determine whether a … substance [which is among the substances of unknown or variable composition, complex reaction products or biological materials] comes within the categories of acute or chronic aquatic toxicity, the Commission is not required to limit its assessment solely to the factors expressly referred to in point 4.1.3.5.5 of Annex I to Regulation No 1272/2008, to the exclusion of any other factor. In accordance with its duty to act diligently, the Commission is required to examine carefully and impartially other factors which, although not expressly referred to by those provisions, are nevertheless relevant. … 51 The classification method referred to in point 4.1.3.5.5 of Annex I to Regulation No 1272/2008 is based on the assumption that the constituents taken into consideration are 100% soluble. On the basis of that assumption, that summation method implies that there is a concentration level of constituents below which the threshold of 25% cannot be reached and, thus, consists of calculating the sum of the concentrations of the constituents coming within the categories of acute or chronic toxicity, each weighted by factor M corresponding to their toxicity profile. 52 It is, however, inherent in that method that it loses reliability in situations where the weighted sum of the constituents exceeds the level of concentration corresponding to the threshold of 25% in a proportion less than the ratio between the observed solubility rate at the level of the substance in question as a whole and the hypothetical solubility rate of 100%. In such situations, it thus becomes possible that the summation method may lead, in specific cases, to a result greater than or less than the level corresponding to the regulatory threshold of 25%, according to whether the hypothetical solubility rate of the constituents is taken into consideration or that of the substance as a whole. 53 It is common ground that Table 7.6.2 of Annex I to the report attached to the RAC’s opinion shows that, first, the summation method leads to the result of 14521% and that, secondly, that result is 581 times greater than the minimum level required for the threshold of 25%, after weighting by factor M, to be reached. Nor is it disputed that it is, moreover, apparent from point 1.3 of that document, entitled “Physiochemical properties”, that the maximum rate of water solubility of CTPHT was 0.0014%, a rate approximately 71000 times lower than the hypothetical solubility rate of 100% used for the constituents taken into consideration. 54 The General Court therefore did not distort or err in the legal classification of the facts in holding, in paragraph 34 of the [judgment of 7 October 2015, Bilbaína de Alquitranes and Others v Commission (T‑689/13, not published, EU:T:2015:767)], that, “by assuming that all of those [constituents] dissolve in water, the Commission therefore, in essence, based the classification in question on the assumption that 9.2% of CTPHT could dissolve in water. However, as can be seen from point 1.3 of the background document [annexed to the RAC’s opinion], such a value is not realistic, given that the maximum rate is 0.0014%”. 55 Since it found, in paragraph 32 of [the judgment of 7 October 2015, Bilbaína de Alquitranes and Others v Commission (T‑689/13, not published, EU:T:2015:767)], that “neither the Commission nor [the] ECHA [had been] able to establish that the Commission [had taken] into consideration the fact that, according to point 1.3 of the background document [annexed to the RAC’s opinion], entitled ‘Physiochemical properties’, the constituents of CTPHT were released from CTPHT only to a limited extent and that that substance was very stable”, the General Court held, without erring in law, in paragraph 30 of the judgment that “the Commission [had] committed a manifest error of assessment in that, by classifying CTPHT as an Aquatic Acute 1 (H400) and Aquatic Chronic 1 (H410) substance on the basis of its constituents, it [had] failed to comply with its obligation to take into consideration all the relevant factors and circumstances so as to take due account of the proportion in which the 16 constituents … are present in CTPHT and their chemical effects”.’