Information;Judgment — ECLI:EU:T:2022:86
Date: 2022-02-23
Language of the case: English
Court formation: Eighth Chamber
Subject matter: Approximation of laws;Research and technological development;REACH
Procedure: Action for annulment - unfounded
Origin: Netherlands

Summary and discussion of carcinogenicity’. However, it has already been established that the contested decision was not based on a carcinogenicity potential of HFPO-DA (see paragraphs 71 to 76 above). Consequently, and in the absence of any indication as to how the applicant’s arguments could nevertheless call into question the conclusions on which the contested decision is based, those arguments are, in any event, ineffective. 245 Lastly, in so far as the applicant adapted in the reply the arguments raised in the context of this part of the plea so that it now claims that all the information on PFOA and APFO should have been rejected as irrelevant to the conclusions relating to HFPO-DA and that the information’s mere presence and the fact that it was taken into consideration, either in the weight of evidence or as a means of interpretation of the information on HFPO-DA, constitutes a manifest error of assessment, it is sufficient to state the following. Those arguments are too vague and the applicant still does not explain what specific conclusion or what specific interpretation of ECHA is vitiated by a manifest error of assessment. Moreover, the mere fact that, in the support document, information relating to other substances, such as PFOA, was mentioned, for example in order to make comparisons between bioconcentration factors or the persistence of those two substances, does not in itself mean that conclusions concerning HFPO-DA were drawn on the basis of the data relating to PFOA, let alone demonstrates the existence of a manifest error of assessment. 246 The fourth part of the first plea must therefore be rejected on the ground that the arguments are in part unfounded, and in particular have no factual basis, and are in part irrelevant. 247 The first plea must therefore be rejected in its entirety. B. The second plea, alleging breach of the principle of proportionality 248 The applicant submits that the contested decision breaches the principle of proportionality because that decision is neither necessary nor appropriate to attaining the objective legitimately pursued by the authorisation procedure set out in Title VII of Regulation No 1907/2006, for two main reasons. 249 First, since HFPO-DA is used only by one declarant for a single registered use, authorisation is not appropriate, in particular since there are already stringent risk-management measures in place for that registered use and emissions are minimised. 250 Second, the absence of any commercially viable alternatives to HFPO-DA hinders the authorisation process aimed at replacing substances subject to authorisation with ‘less dangerous substances or technologies’. 251 ECHA, supported by the Kingdom of the Netherlands and ClientEarth and CHEM Trust Europe, disputes that line of argument. 252 According to settled case-law, the principle of proportionality, which is part of the general principles of EU law, requires that EU measures do not exceed the limits of what is appropriate and necessary in order to attain the objectives legitimately pursued by the legislation in question; when there is a choice between several appropriate measures recourse must be had to the least onerous, and the disadvantages caused must not be disproportionate to the aims pursued (judgments of 8 July 2010, Afton Chemical, C‑343/09, EU:C:2010:419, paragraph 45; of 21 July 2011, Etimine, C‑15/10, EU:C:2011:504, paragraph 124; and of 1 February 2013, Polyelectrolyte Producers Group and Others v Commission, T‑368/11, not published, EU:T:2013:53, paragraph 75). 253 As regards judicial review of the conditions referred to in paragraph 252 above, 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 area can be affected only if the measure is manifestly inappropriate having regard to the objective which the legislature is seeking to pursue (judgments of 21 July 2011, Etimine, C‑15/10, EU:C:2011:504, paragraph 125, and of 30 April 2015, Polynt and Sitre v ECHA, T‑134/13, not published, EU:T:2015:254, paragraph 105). 254 It is apparent from Article 1(1) of Regulation No 1907/2006 that the purpose of that regulation is to ensure a high level of protection of human health and the environment, including the promotion of alternative methods for assessment of hazards of substances, as well as the free circulation of substances on the internal market while enhancing competitiveness and innovation. Having regard to recital 16 of that regulation, the legislature established the first of those three objectives as the main objective, namely to ensure a high level of protection of human health and the environment (see judgments of 7 March 2013, Rütgers Germany and Others v ECHA, T‑94/10, EU:T:2013:107, paragraph 134 and the case-law cited, and of 30 April 2015, Polynt and Sitre v ECHA, T‑134/13, not published, EU:T:2015:254, paragraph 106 and the case-law cited). 255 As regards, more specifically, the aim of the authorisation procedure, of which the identification procedure referred to in Article 59 of Regulation No 1907/2006 forms part, Article 55 of that regulation provides that it seeks essentially to ensure the good functioning of the internal market while ensuring that the risks from substances of very high concern are properly controlled and that those substances are progressively replaced by suitable alternative substances or technologies where these are economically and technically viable (see judgments of 7 March 2013, Rütgers Germany and Others v ECHA, T‑94/10, EU:T:2013:107, paragraph 134 and the case-law cited, and of 30 April 2015, Polynt and Sitre v ECHA, T‑134/13, not published, EU:T:2015:254, paragraph 106 and the case-law cited). Furthermore, as is apparent from recital 69 of Regulation No 1907/2006, the legislature wanted particular attention to be paid to substances of very high concern (judgments of 7 March 2013, Bilbaína de Alquitranes and Others v ECHA, T‑93/10, EU:T:2013:106, paragraph 124; of 30 April 2015, Hitachi Chemical Europe and Others v ECHA, T‑135/13, EU:T:2015:253, paragraph 120; and of 30 April 2015, Polynt and Sitre v ECHA, T‑134/13, not published, EU:T:2015:254, paragraph 114). 256 As regards the objective of protecting human health and the environment, it must be stated that the 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 that, consequently, such identification must be regarded as a means of enhancing that protection (judgments of 7 March 2013, Rütgers Germany and Others v ECHA, T‑94/10, EU:T:2013:107, paragraph 136, and of 30 April 2015, Polynt and Sitre v ECHA, T‑134/13, not published, EU:T:2015:254, paragraph 108 and the case-law cited; see also, by analogy, judgment of 7 July 2009, S.P.C.M. and Others, C‑558/07, EU:C:2009:430, paragraph 49). 257 In that regard, it should be noted, as a preliminary point, that the applicant’s line of argument in the context of the second plea appears to be based on an incorrect premiss, since, contrary to what the applicant presupposes, the contested decision does not pursue the objective of ‘address[ing] the perceived ubiquitous nature of [HFPO-DA] in the environment’. The contested decision has no immediate bearing on the use of HFPO-DA and its presence in the environment. 258 In any event, the arguments put forward by the applicant in the context of this plea cannot succeed. 259 First, as regards the applicant’s argument that the contested decision is inappropriate because there are at present no commercially viable alternatives to HFPO-DA, with the exception of other fluorinated substances, it must be observed that the contested decision does not entail a prohibition on placing HFPO-DA on the market, thereby obliging the operators concerned to use alternative substances. Such a consequence only follows, under Article 56 of Regulation No 1907/2006, for substances included in Annex XIV to that regulation, that is to say, the list of substances subject to authorisation. It is apparent from the procedure set out in Article 58 of Regulation No 1907/2006 that the inclusion of a substance in the candidate list does not automatically entail its inclusion in Annex XIV to that regulation. The question whether or not alternative substances exist is therefore irrelevant as regards whether or not the identification of a substance as a substance of very high concern is appropriate (see, to that effect, judgment of 7 March 2013, Bilbaína de Alquitranes and Others v ECHA, T‑93/10, EU:T:2013:106, paragraph 119). 260 Second, as regards the applicant’s line of argument relating to the single registered use of HFPO-DA, it must be pointed out that a substance is identified as a substance of very high concern solely on account of the hazards arising from the intrinsic properties of the substance and not because of its uses (see, to that effect, judgments of 11 July 2019, PlasticsEurope v ECHA, T‑185/17, not published, EU:T:2019:492, paragraph 75, and of 20 September 2019, PlasticsEurope v ECHA, T‑636/17, EU:T:2019:639, paragraph 67). Uses may be taken into account at the stage of the inclusion in Annex XIV to Regulation No 1907/2006, or at the stage of the granting of an authorisation pursuant to Article 60(2) or (4) of that regulation (judgment of 20 September 2019, PlasticsEurope v ECHA, T‑636/17, EU:T:2019:639, paragraph 207). 261 Consequently, contrary to what is claimed by the applicant, even if it were established that HFPO-DA is used only by one declarant for a single registered use, this would not make the inclusion of that substance in the candidate list inappropriate. 262 That finding is supported by the fact that, according to the Court of Justice’s case-law, a substance may be identified as a substance of very high concern even if none of the known uses of the substance falls within the scope of the authorisation procedure laid down in Chapters 2 and 3 of Title VII of Regulation No 1907/2006 (see, to that effect, judgment of 25 October 2017, PPG and SNF v ECHA, C‑650/15 P, EU:C:2017:802, paragraphs 62, 63 and 71). It is therefore necessary to reject a fortiori the applicant’s line of argument that the contested decision is inappropriate because the substance in question is registered only for a single use which, following potential inclusion in Annex XIV to Regulation No 1907/2006, would be subject to an authorisation requirement. 263 Third, it must be stated that even if the applicant’s assertion that there were already stringent risk-management measures in place and that emissions were minimised were established, this would also not permit the inference that the contested decision is inappropriate. It is apparent from Article 60(2) of Regulation No 1907/2006 that the fact that the negative effects associated with the use of a substance can be controlled adequately by risk-management measures does not preclude its identification as a substance of very high concern (judgment of 30 April 2015, Hitachi Chemical Europe and Others v ECHA, T‑135/13, EU:T:2015:253, paragraph 61). This is also confirmed by Article 58(2) of Regulation No 1907/2006, under which uses or categories of uses may be exempted from the authorisation requirement provided that, on the basis of the existing specific EU legislation imposing minimum requirements relating to the protection of human health or the environment for the use of the substance, the risk is properly controlled (judgment of 30 April 2015, Hitachi Chemical Europe and Others v ECHA, T‑135/13, EU:T:2015:253, paragraph 68). 264 In any event, even if the existence of risk-management measures put in place by the applicant were established, this would not imply either that those measures are sufficient to manage the risks, which the applicant has not established, or that other undertakings would adopt the same solutions. 265 Moreover, according to the case-law, risk-management measures proposed under Article 14(6) of Regulation No 1907/2006 are not less onerous measures than the identification of a substance as being of very high concern. Such measures do not constitute appropriate measures for the achievement of the objective of progressively replacing substances of very high concern by suitable alternative substances or technologies where these are economically and technically viable, or of the objective that particular attention be paid to substances of very high concern (see paragraph 255 above) (see, to that effect, judgments of 7 March 2013, Bilbaína de Alquitranes and Others v ECHA, T‑93/10, EU:T:2013:106, paragraphs 124 and 125; of 30 April 2015, Hitachi Chemical Europe and Others v ECHA, T‑135/13, EU:T:2015:253, paragraphs 120 and 122; and of 30 April 2015, Polynt and Sitre v ECHA, T‑134/13, not published, EU:T:2015:254, paragraphs 114 and 116). 266 Similarly, the risk-management measures to which the applicant refers do not constitute such less onerous measures. 267 Consequently, the applicant’s arguments relating to the existence of risk-management measures must be rejected. 268 Fourth, as regards the applicant’s line of argument raised at the stage of the reply, according to which ECHA’s weighing up of interests is flawed because it failed to acknowledge all the consequences of the contested decision, namely inter alia the information obligations under Article 33 of Regulation No 1907/2006, it must be stated that, according to the case-law, the objective of the candidate list of substances concerning the sharing of information on substances of very high concern within the supply chain and with consumers prevails over the difficulties resulting, inter alia, from an application of Article 31(9) and Article 34 of Regulation No 1907/2006 (judgment of 11 July 2019, PlasticsEurope v ECHA, T‑185/17, not published, EU:T:2019:492, paragraph 64). That objective also prevails over the difficulties resulting from an application of Article 33 of that regulation. The mere fact that, in its defence, ECHA mentioned only the information obligations under Article 31(9) of Regulation No 1907/2006 and not those under Article 33 of that regulation has no bearing on that finding. 269 Consequently, the applicant’s arguments relating to the weighing up of interests must also be rejected. 270 The second plea in law, alleging breach of the principle of proportionality, must therefore be rejected and, accordingly, the action must be dismissed in its entirety. V. Costs 271 Under Article 134(1) of the Rules of Procedure of the General Court, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings. Since the applicant has been unsuccessful, it must be ordered to bear its own costs and to pay those incurred by ECHA and ClientEarth and CHEM Trust Europe, in accordance with the forms of order sought by them. 272 In accordance with Article 138(1) of the Rules of Procedure, Member States which have intervened in the proceedings are to bear their own costs. The Kingdom of the Netherlands must therefore bear its own costs. On those grounds, THE GENERAL COURT (Eighth Chamber) hereby: 1. Dismisses the action; 2. Orders Chemours Netherlands BV to bear its own costs and to pay the costs incurred by the European Chemicals Agency (ECHA) and ClientEarth AISBL, ClientEarth and CHEM Trust Europe Ev; 3. Orders the Kingdom of the Netherlands to bear its own costs. Svenningsen Barents Laitenberger Delivered in open court in Luxembourg on 23 February 2022. E. Coulon S. Papasavvas Registrar President Table of contents I. Legal framework II. Background to the dispute III. Procedure and forms of order sought IV. Law A. The first plea in law, alleging that ECHA breached Article 57(f) of Regulation No 1907/2006, exceeded its competence and manifestly erred in its assessment 1. The first part of the first plea, alleging that ECHA breached Article 57(f) of Regulation No 1907/2006 and manifestly erred in its assessment inasmuch as it failed to establish to the requisite legal standard that HFPO-DA causes probable serious effects on human health and the environment of an equivalent level of concern to those of other substances listed in Article 57(a) to (e) of that regulation (a) The first complaint of the first part of the first plea in law concerning serious effects on human health of an equivalent level of concern to those of CMR, PBT and vPvB substances (1) Assessment of the scientific evidence (i) Developmental toxicity (ii) Repeated dose toxicity (iii) Toxicokinetics and bioaccumulation (iv) Carcinogenicity (v) Reproductive toxicity (2) Whether serious effects on human health have been established (3) Equivalent level of concern of the serious effects (b) The second complaint of the first part of the first plea in law concerning serious effects on the environment of an equivalent level of concern to those of PBT and vPvB substances (1) Whether serious effects on the environment have been established (2) The finding that persistent, bioaccumulative and toxic properties or very persistent and very bioaccumulative properties were relevant under Article 57(f) of Regulation No 1907/2006 (3) Assessment of certain scientific evidence (i) Bioaccumulation potential (ii) Occurrence of HFPO-DA in the environment (iii) Control of HFPO-DA emissions into the environment (iv) Whether HFPO-DA can be removed from drinking water 2. The second part of the first plea in law, alleging that ECHA breached Article 57(f) of Regulation No 1907/2006, exceeded its competence and manifestly erred in its assessment inasmuch as it considered exposure to HFPO-DA to be a relevant factor for establishing probable serious effects and inasmuch as it failed to take into account the potential control of exposure to the substance, and concluded in consequence that HFPO-DA was of an equivalent level of concern 3. The third part of the first plea, alleging breach of Article 57(f) of Regulation No 1907/2006 and a manifest error of assessment committed by ECHA inasmuch as it did not examine the available scientific evidence in accordance with the principles of scientific excellence 4. Fourth part of the first plea in law, alleging that ECHA breached Article 57(f) of Regulation No 1907/2006 and manifestly erred in its assessment inasmuch as it concluded that HFPO-DA was a substance of very high concern on the basis of information related to a different substance B. The second plea, alleging breach of the principle of proportionality V. Costs * Language of the case: English.