16

The background to the dispute was set out in paragraphs 16 to 23 of the judgments under appeal as follows: ‘16 CTPHT is, according to its description in Tables 3.1 and 3.2 of Annex VI to Regulation No 1272/2008, the residue from the distillation of high-temperature coal tar, a black solid with an approximate softening point from 30 °C to 180 °C, composed primarily of a complex mixture of three or more membered condensed ring aromatic hydrocarbons. … CTPHT is used mainly to produce electrode binders for the aluminium and steel industry. 17 In September 2010, the Kingdom of the Netherlands submitted a dossier to the ECHA, pursuant to Article 37 of Regulation No 1272/2008, proposing that CTPHT should be classified as Carcinogenic 1A (H350), Mutagenic 1B (H340), Toxic for reproduction 1B (H360FD), Aquatic Acute 1 (H400), and Aquatic Chronic 1 (H410). 18 After having received observations on the dossier in question during a public consultation, the ECHA referred that dossier to the RAC. 19 On 21 November 2011, the RAC adopted its opinion on CTPHT, confirming by consensus the proposal submitted by the Kingdom of the Netherlands. That opinion was accompanied by a background document containing the RAC’s detailed analysis … and a document containing the answers of the Kingdom of the Netherlands to the observations made on the dossier drawn up by that Member State. 20 With regard to the classification of CTPHT as a substance having aquatic toxicity, the RAC considered in its opinion, as the Kingdom of the Netherlands had proposed in its dossier submitted to the ECHA, that this could not be based on data obtained in studies using the Water-Accommodated Fraction approach. The reasons stated by the RAC for that finding were, first, that those data had been obtained in the absence of ultraviolet (UV) irradiation, even though certain polycyclic aromatic hydrocarbon (“PAH”) constituents of CTPHT are phototoxic and, secondly, that the studies concerned had been carried out with only a single loading. The RAC therefore took the view, as the Kingdom of the Netherlands had proposed in its dossier submitted to the ECHA, that the classification of that substance was to be based on an alternative approach, namely to regard CTPHT as a mixture. According to that approach, the 16 PAH constituents of CTPHT, which have been defined as priority substances by the United States Environmental Protection Agency (EPA), and for which sufficient effect and exposure data were available, were analysed separately in accordance with their aquatic toxicity effects. By applying the method referred to in point 4.1.3.5.5 of Annex I to Regulation No 1272/2008, consisting in finding the sum of the results obtained by the attribution of [“M-factors”] to the different PAHs in order to attach more weight to the highly toxic constituents of CTPHT (“the summation method”), that analysis showed, according to the RAC’s opinion, that CTPHT had to be classified as Aquatic Acute 1 (H400) and Aquatic Chronic 1 (H410). 21 On 2 October 2013, on the basis of the RAC’s opinion, the European Commission adopted the regulation [at issue]. In accordance with Article 1(2)(a)(i) and (b)(i) of [the regulation at issue], read together with Annexes II and IV thereto, CTPHT was classified as Carcinogenic 1A (H350), Mutagenic 1B (H340), Toxic for reproduction 1B (H360FD), Aquatic Acute 1 (H400), and Aquatic Chronic 1 (H410). Pursuant to Article 3(3) of [the regulation at issue], that classification was applicable from 1 April 2016. According to recital 5 of [the regulation at issue], a longer transition time before the harmonised classification had to be applied was foreseen as regards CTPHT, in order to allow operators to comply with the obligations resulting from the new harmonised classification for substances classified as very toxic to aquatic organisms which may cause long-term effects in the aquatic environment, in particular with those set out in Article 3 of Directive 2008/68/EC of the European Parliament and of the Council of 24 September 2008 on the inland transport of dangerous goods (OJ 2008 L 260, p. 13) and Annex III thereto. 22 By application lodged at the Court Registry on 20 December 2013 and registered as Case T‑689/13, the [appellants and several other companies] brought an action for the partial annulment of [the regulation at issue] in so far as it classified CTPHT as an Aquatic Acute 1 (H400) and Aquatic Chronic 1 (H410) substance. 23 By judgment of 7 October 2015, Bilbaína de Alquitranes and Others v Commission (T‑689/13, not published, EU:T:2015:767), the [General] Court annulled [the regulation at issue] in so far as it classified CTPHT as an Aquatic Acute 1 (H400) and Aquatic Chronic 1 (H410) substance.’