JUDGMENT OF THE GENERAL COURT (Second Chamber)
28 June 2023 (*)
(REACH – Evaluation of substances – Hexahydro-4-methylphthalic anhydride – ECHA decision requesting one or more additional tests – Article 40 of Regulation (EC) No 1907/2006 – Appeal brought before the Board of Appeal – Error of law)
In Case T‑207/21,
Polynt SpA, established in Scanzorosciate (Italy), represented by C. Mereu, P. Sellar and I. Zonca, lawyers,
applicant,
v
European Chemicals Agency (ECHA), represented by N. Herbatschek, T. Basmatzi and M. Goodacre, acting as Agents,
defendant,
THE GENERAL COURT (Second Chamber),
composed of A. Marcoulli, President, S. Frimodt Nielsen (Rapporteur) and W. Valasidis, Judges,
Registrar: I. Kurme, Administrator,
having regard to the written part of the procedure,
having regard to the order of 22 June 2021, Polynt v ECHA (T‑207/21 R, not published, EU:T:2021:382),
further to the hearing on 19 January 2023,
gives the following
Judgment
1 By its action brought under Article 263 TFEU, the applicant, Polynt SpA, seeks annulment of Decision A-015-2019 of the Board of Appeal of the European Chemicals Agency (ECHA) of 9 February 2021, by way of which the latter dismissed the appeal brought by Polynt SpA against the decision relating to a testing proposal submitted in the applicant’s registration dossier for the substance hexahydro-4-methylphthalic anhydride (‘the contested decision’).
Legal background
2 Under Article 6(1) 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) (‘the REACH Regulation’), save where that regulation provides otherwise, any manufacturer or importer of a substance, either on its own or in one or more mixture(s), in quantities of one tonne or more per year is to submit a registration to ECHA.
3 In order to register a substance with ECHA, a manufacturer or importer is required to submit a registration dossier containing the information specified in Article 10 of the REACH Regulation. Under Article 10(a)(ix) of that regulation, that information is to include proposals for testing concerning information on the intrinsic properties of substances, derived from the application of Annexes IX and X to that regulation.
4 Under Article 12(1)(e) of the REACH Regulation, registrants who manufacture or import substances in quantities of 1 000 tonnes or more per year are required to provide the information specified in Annexes VII and VIII to that regulation and testing proposals for the provision of the information specified in Annexes IX and X.
5 Column 1 of Annexes VII to X to the REACH Regulation sets out the studies in respect of which registrants are required to provide summaries, depending on the tonnage band for which they intend to register the substance at issue. Column 2 of Annexes VII to X to the REACH Regulation lists the specific rules on amending or replacing the standard information required by other information provided at a different stage or otherwise adapted (specific adaptations). Where the conditions set out in column 2 of Annexes VII to X to the REACH Regulation allow specific adaptations to be proposed, registrants must clearly indicate this fact and state the reasons for each adaptation under the appropriate heading of the registration dossier. In addition to these specific adaptations, registrants may refrain from conducting studies where they can demonstrate that the conditions set out in Annex XI to the REACH Regulation are met (general adaptations).
6 Article 40(1) of the REACH Regulation provides that ECHA is to examine any testing proposal set out in a registration or a downstream user report for provision of the information specified in Annexes IX and X for a substance.
7 Article 40(2) of the REACH Regulation provides, in essence, that information relating to testing proposals involving tests on vertebrate animals are to be published on ECHA’s website, and that ECHA is to invite third parties to submit scientifically valid information and studies that address the relevant substance and hazard end-point, addressed by the testing proposal, within 45 days of the date of publication. All such scientifically valid information and studies received are to be taken into account by ECHA in preparing its decisions in accordance with Article 40(3) of the REACH Regulation.
8 Article 40(3) of the ECHA Regulation provides that ECHA is to draft one of the following decisions:
‘(a) a decision requiring the registrant(s) or downstream user(s) concerned to carry out the proposed test and setting a deadline for submission of the study summary, or the robust study summary if required by Annex I;
(b) a decision in accordance with point (a), but modifying the conditions under which the test is to be carried out;
(c) a decision in accordance with points (a), (b) or (d) but requiring registrant(s) or downstream user(s) to carry out one or more additional tests in cases of non-compliance of the testing proposal with Annexes IX, X and XI;
(d) a decision rejecting the testing proposal; …’
9 Article 40(4) of the REACH Regulation provides that registrants or downstream users are to submit to ECHA the information required by the deadline set.
10 Decisions under Article 40(3) of the REACH Regulation are to be taken in accordance with the procedure laid down in Articles 50 and 51 of that regulation.
11 Under Article 50(1) of the REACH Regulation, ECHA is to notify any draft decision to the registrant(s) or downstream user(s) concerned, informing them of their right to comment within 30 days of receipt. If the registrant(s) or downstream user(s) concerned wish to present comments, they are to submit them to ECHA. The latter is to take any comments received into account and may amend the draft decision accordingly.
12 Article 51 of the REACH Regulation provides that ECHA is to notify its draft decision together with the comments of the registrant, to the competent authorities of the Member States. Within 30 days of circulation, Member States may propose amendments to the draft decision to ECHA. Article 51(3) of the REACH Regulation provides that if ECHA does not receive any proposals, it is to take the decision in the version notified to the registrants or the downstream user(s) concerned.
13 Article 57 of the REACH Regulation provides the following:
‘The following substances may be included in Annex XIV in accordance with the procedure laid down in Article 58:
(a) substances meeting the criteria for classification in the hazard class carcinogenicity category 1A or 1B in accordance with section 3.6. of Annex I to Regulation (EC) No 1272/2008;
(b) substances meeting the criteria for classification in the hazard class germ cell mutagenicity category 1A or 1B in accordance with section 3.5. of Annex I to Regulation (EC) No 1272/2008;
(c) substances meeting the criteria for classification in the hazard class reproductive toxicity category 1A or 1B, adverse effects on sexual function and fertility or on development in accordance with section 3.7. of Annex I to Regulation (EC) No 1272/2008;
(d) substances which are persistent, bioaccumulative and toxic in accordance with the criteria set out in Annex XIII [to] this Regulation;
(e) substances which are very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII [to] of this Regulation;
(f) substances – such as those having endocrine disrupting properties or those having persistent, bioaccumulative and toxic properties or very persistent and very bioaccumulative properties, which do not fulfil the criteria of points (d) or (e) – for which there is scientific evidence of probable serious effects to human health or the environment which give rise to an equivalent level of concern to those of other substances listed in points (a) to (e) and which are identified on a case-by-case basis in accordance with the procedure set out in Article 59.’
14 Section 8.7. of Annex X to the REACH Regulation (‘Section 8.7. of Annex X’) provides that a reproductive toxicity study is not to be carried out if:
‘– the substance is known to be a genotoxic carcinogen … and appropriate risk management measures are implemented, or
– the substance is known to be a germ cell mutagen … and appropriate risk management measures are implemented, or
– the substance is of low toxicological activity (no evidence of toxicity seen in any of the tests available), it can be proven from toxicokinetic data that no systemic absorption occurs via relevant routes of exposure (e.g. plasma/blood concentrations below detection limit using a sensitive method and absence of the substance and of metabolites of the substance in urine, bile or exhaled air) and there is no or no significant human exposure.’
15 Column 1 of Section 8.7.3. of Annex X to the REACH Regulation provides for the provision of an Extended One-Generation Reproductive Toxicity Study (‘EOGRTS’), basic design test (cohorts 1A and 1B without extension to include a F2 generation), one species, most appropriate route of administration, having regard to the likely route of human exposure.
16 Column 2 of Section 8.7.3. of Annex X to the REACH Regulation (‘column 2 of Section 8.7.3.’) provides that an EOGRTS with the extension of cohort 1B to include the F2 generation is to be proposed by the registrant or may be required by ECHA if:
‘(a) the substance has uses leading to significant exposure of consumers or professionals, taking into account, inter alia, consumer exposure from articles, and
(b) any of the following conditions are met:
– the substance displays genotoxic effects in somatic cell mutagenicity tests in vivo which could lead to classifying it as Mutagen Category 2, or
– there are indications that the internal dose for the substance and/or any of its metabolites will reach a steady state in the test animals only after an extended exposure, or
– there are indications of one or more relevant modes of action related to endocrine disruption from available in vivo studies or non-animal approaches.’
17 Column 2 of Section 8.7.3. also states that an EOGRTS including cohorts 2A/2B (developmental neurotoxicity) and/or cohort 3 (developmental immunotoxicity) is to be proposed by the registrant or may be required by ECHA in accordance with Articles 40 and 41 of the REACH Regulation, in case of particular concerns on developmental neurotoxicity or developmental immunotoxicity which may be justified by any of the following:
‘– existing information on the substance itself derived from relevant available in vivo or non-animal approaches (e.g. abnormalities of the CNS, evidence of adverse effects on the nervous or immune system in studies on adult animals or animals exposed prenatally), or
– specific mechanisms/modes of action of the substance with an association to (developmental) neurotoxicity and/or (developmental) immunotoxicity (e.g. cholinesterase inhibition or relevant changes in thyroidal hormone levels associated to adverse effects), or
– existing information on effects caused by substances structurally analogous to the substance being studied, suggesting such effects or mechanisms/modes of action.’
18 Article 13 TFEU provides that ‘in formulating and implementing the Union’s agriculture, fisheries, transport, internal market, research and technological development and space policies, the Union and the Member States shall, since animals are sentient beings, pay full regard to the welfare requirements of animals, while respecting the legislative or administrative provisions …’.
19 Article 25 of the REACH Regulation states that ‘in order to avoid animal testing, testing on vertebrate animals for the purposes of [that] Regulation shall be undertaken only as a last resort’ and that ‘it is also necessary to take measures limiting duplication of other tests’.
20 Recitals 63 and 64 of the REACH Regulation provide the following:
‘(63) It is also necessary to ensure that generation of information is tailored to real information needs. To this end evaluation should require [ECHA] to decide on the programmes of testing proposed by manufacturers and importers. In cooperation with Member States, [ECHA] should give priority to certain substances, for instance those which may be of very high concern.
(64) In order to prevent unnecessary animal testing, interested parties should have a period of 45 days during which they may provide scientifically valid information and studies that address the relevant substance and hazard end-point, which is addressed by the testing proposal. The scientifically valid information and studies received by [ECHA] should be taken into account for decisions on testing proposals.’
Background to the dispute
21 On 21 October 2010, the applicant submitted a technical dossier to ECHA in the context of an application for registration of the substance hexahydro-4-methylphthalic anhydride (under references EC 243-072-0 and CAS 19438-60-9) (‘4-MHHPA’), in accordance with Article 6(1) of the REACH Regulation. The applicant applied for registration of 4-MHHPA as a substance manufactured or imported in quantities of 1 000 tonnes or more.
22 In the context of the registration procedure, on 27 February 2015, the applicant filed a partial appeal against ECHA Decision CCH-D-2114289309-36-01/F on compliance check, adopted on 28 November 2014, requiring the applicant to submit a 90-day sub-chronic toxicity study, oral route, in rats, in accordance with Section 8.6.2. of Annex IX to the REACH Regulation (test method: EU B.26/OCDE 408), and a pre-natal developmental toxicity study in rats or rabbits, oral route, in accordance with Section 8.7.2. of Annex IX to that regulation (test method: EU B.31/OCDE 414). On 19 October 2016, the Board of Appeal of ECHA dismissed the appeal and confirmed the decision requiring the applicant to submit those studies by 28 October 2018 (Polynt Decision, A-004‑2015 of the Board of Appeal of ECHA).
23 On 4 July 2017 and 20 October 2017, the applicant received messages from ECHA via the ‘REACH-IT’ IT system, requesting that it submit ‘a testing proposal, a justification for adaptation, or a robust study summary of an existing study’, addressing the information requirements of Annex IX and Section 8.7.3. of Annex X to the REACH Regulation. That request was made following the entry into force of Commission Regulation (EU) 2015/282 of 20 February 2015 amending Annexes VIII, IX and X to [the REACH Regulation] as regards [EOGRTS] (OJ 2015 L 50, p. 1), recital 4 of which highlighted the fact that that study was considered to offer a number of advantages in comparison to the two-generation reproductive toxicity study.
24 From 18 February to 16 April 2018, ECHA conducted a public consultation on that testing proposal. It received information on the EOGRTS from a third party, which considered, in essence, that, in the present case, there was no scientific justification for conducting such a study and that this was not in the interests of animal welfare.
25 On 5 December 2018, ECHA notified a draft decision to the applicant requiring it to carry out a study meeting the following conditions:
‘[EOGRTS] (Annex X, Section 8.7.3.; method: OECD TG 443) in rats, oral route with the registered substance specified as follows:
Ten weeks premating exposure duration for the parental (P0) generation;
Dose level setting shall aim to induce systemic toxicity at the highest dose level;
Cohort 1A (Reproductive toxicity);
Cohort 1B (Reproductive toxicity) without extension to make the Cohort 1B animals to produce the F2 generation; and Cohort 3 (Developmental immunotoxicity).’
26 ECHA invited the applicant to submit comments on that draft decision. The applicant responded within the time allowed.
27 On 4 September 2019, ECHA adopted Decision TPE-D-2114483466-38-01/F on a testing proposal for the substance at issue pursuant to Article 40 of the REACH Regulation (‘the initial decision’), inviting the applicant to submit the EOGRTS, as described in paragraph 25 above, by 13 September 2021.
28 On 4 December 2019, the applicant filed an appeal against the initial decision, pursuant to Article 91 of the REACH Regulation, with the Board of Appeal of ECHA.
29 By way of the contested decision, the Board of Appeal dismissed the appeal. In the first place, it found that, first, column 2 of Section 8.7. of Annex X to the REACH Regulation (‘column 2 of Section 8.7.’) did not provide for any exemption for omitting studies on reproductive toxicity on the basis that a substance has been identified as being of very high concern (‘SVHC’) due to its respiratory sensitising properties. Second, according to the Board of Appeal, the applicant’s arguments that the conditions set out in the third indent of column 2 of Section 8.7. had been met were unsubstantiated. In the second place, the Board of Appeal concluded that the applicant had failed to demonstrate that ECHA had made an error of assessment in requiring the inclusion of cohort 3 in the EOGRTS based on the reduction in thymus weight observed in the sub-chronic toxicity study. In the third place, it concluded that the applicant had not demonstrated that ECHA had failed to take into account third-party observations as required by Article 40(2) of the REACH Regulation. In the fourth place, it concluded that the applicant’s arguments relating to ECHA’s infringement of, first, the principle of sound administration and, second, Article 13 TFEU and Article 25 of the REACH Regulation, had to be rejected for the same reasons as those which had led to the rejection of the other arguments.
Forms of order sought
30 The applicant claims that the Court should:
– annul the contested decision;
– in the alternative, annul in part the contested decision in so far as it concerns the obligation to include an analysis of cohort 3 in the EOGRTS;
– order ECHA to pay the costs.
31 ECHA contends that the Court should:
– dismiss the action;
– order the applicant to pay the costs.
Law
32 The applicant raises five pleas in law in support of its action. First, the Board of Appeal erred in law when it reviewed the lawfulness of the initial decision and failed actually to assess the applicant’s arguments. Second, it erred in law when it concluded that the examination of testing proposals was the same as a compliance check. Third, it failed to apply the correct legal test. Fourth, it infringed or misapplied Articles 91 to 93 of the REACH Regulation. Fifth, the Board of Appeal failed to address the applicant’s arguments relating to the infringement of Article 13 TFEU, Article 25 of the REACH Regulation and the principles of protection of animal welfare, proportionality and sound administration.
The first plea, alleging an error of law, in that the Board of Appeal carried out an incorrect legal review and misinterpreted Section 8.7. of Annex X
33 The applicant maintains that ECHA infringed Section 8.7. of Annex X by ordering it to carry out an EOGRTS, even though 4-MHHPA was a known respiratory sensitiser deemed equivalent to substances which are carcinogenic, mutagenic and toxic for reproduction (‘CMR’). According to the applicant, the waiver set out in column 2 of Section 8.7. could be applied to 4-MHHPA.
34 The applicant claims that, in the contested decision, the Board of Appeal expressly confined its examination to determining whether a manifest error of assessment had been committed in the initial decision. It also claims that the Board of Appeal failed to address its core argument that if, in respect of 4-MHHPA, there had been scientific evidence of serious effects on human health, giving rise to an equivalent level of concern to CMR substances, the specific rules in column 2 of Section 8.7. exempting registrants from conducting new studies should also apply. Thus, no other reproductive toxicity study should have been carried out, since there were stringent risk management measures designed to ensure the protection of workers and only industrial uses were recommended.
35 The applicant claims that, had the Board of Appeal started from the correct premiss for its legal assessment of ECHA’s application of column 2 of Section 8.7., it would not have confined itself to a literal interpretation, but would instead have taken into account its context and 4-MHHPA would have benefited from the same data waivers as those applicable to a CMR substance.
36 ECHA disputes the applicant’s claims.
37 In the first place, it should be noted that the applicant does not dispute the findings of the Board of Appeal set out in point 1.2. of the contested decision concerning the application of the third indent of column 2 of Section 8.7., namely that the applicant had failed to demonstrate that the conditions for a specific adaptation, as laid down in that indent, were satisfied in the present case (see paragraph 14 above).
38 In the second place, as regards the applicant’s claim relating to the standard of review applied by the Board of Appeal, it is true that, in paragraphs 36 and 66 of the contested decision, the Board of Appeal referred, by analogy, to the case-law resulting from paragraph 71 of the judgment of 19 January 2012, Xeda International and Pace International v Commission (T‑71/10, not published, EU:T:2012:18) concerning the situation in which a party relied on a manifest error of assessment committed by the competent institution, in respect of which it was held that the Courts of the European Union must examine whether that institution has examined, carefully and impartially, all the relevant facts of the individual case which support the conclusions reached. First, although such a reference appears inappropriate in the circumstances of the present case, it is clear that the first sentence of those paragraphs also refers to paragraph 89 of the judgment of 20 September 2019, BASF Grenzach v ECHA (T‑125/17, EU:T:2019:638), which states that the review, by the Board of Appeal, of the scientific assessments in an ECHA decision is not limited to verifying the existence of manifest errors. It goes on to state that, on the contrary, in that regard, by relying on the legal and scientific competences of its members, that board must examine whether the arguments put forward by the applicant are capable of demonstrating that the considerations on which that ECHA decision is based are vitiated by error.
39 Second, in paragraphs 35, 36 and 66 of the contested decision, the Board of Appeal correctly refers to the applicant’s argument alleging an ‘error of assessment’ and states that it will assess whether ECHA has committed such an ‘error’. Thus, it does not confine its examination of the initial decision to determining whether there was a manifest error of assessment.
40 In those circumstances, it cannot be concluded solely on the basis of the citation of case-law in paragraphs 36 and 66 of the contested decision that the Board of Appeal confined its approach to seeking a ‘manifest’ error of assessment. At the hearing, the parties accepted, moreover, that that question should instead be resolved in the light of the approach actually adopted by the Board of Appeal in the contested decision, when assessing the applicant’s various claims.
41 In that regard, it must be held that it is apparent from a reading of the contested decision as a whole that the Board of Appeal did not confine itself in its legal or scientific analyses to finding a manifest error. On the contrary, a reading, in particular, of paragraphs 47, 56, 58 and 70 to 74 of the contested decision supports the finding that the Board of Appeal specifically assessed whether the criticisms made before it by the applicant were capable of demonstrating that the considerations on which the initial decision was based were vitiated by errors. A similar reading is apparent from paragraph 84 of the contested decision, concerning the assessment, by the Board of Appeal, of the comments submitted by a third party (see also paragraph 24 above).
42 Accordingly, it must be held that the applicant has failed to demonstrate that the Board of Appeal confined itself, expressly or implicitly, to seeking a manifest error of assessment.
43 In the third place, as the Board of Appeal essentially recalls in paragraph 33 of the contested decision, the applicant applied for registration of 4-MHHPA as a substance manufactured or imported in quantities of 1 000 tonnes or more. For such substances, in accordance with column 1 of Section 8.7.3. of Annex X to the REACH Regulation, the EOGRTS is deemed to be a standard information requirement (see paragraph 15 above). Furthermore, the applicant confirmed at the hearing that it had not formally amended that tonnage and that no procedure to that effect had been initiated by ECHA.
44 In those circumstances, as stated in paragraphs 34 and 37 of the contested decision, in order to omit the EOGRTS, in accordance with the first indent of column 2 of Section 8.7., a registrant must be able to demonstrate, first, that the substance is known to be a genotoxic carcinogen and, second, that appropriate risk management measures have been implemented in respect of that substance (see paragraph 14 above). It is apparent from the wording of column 2 of Section 8.7., that those conditions were cumulative.
45 The main issue in the present case is therefore whether the Board of Appeal rightly found, in paragraphs 37 to 53 of the contested decision, that, contrary to the applicant’s claims, the first indent of column 2 of Section 8.7. does not allow the omission of the EOGRTS on the ground that a substance which is not known to be a genotoxic carcinogen nevertheless presents an ‘equivalent level of concern’ to a substance with CMR properties.
46 In paragraphs 41 to 43 of the contested decision, the Board of Appeal states, in essence, that column 2 of Section 8.7. contains a closed list of conditions which must be fulfilled in order for the EOGRTS to be omitted. None of the provisions provide for a waiver that is linked to the fact that a substance has been identified as an SVHC on account of its respiratory sensitising properties. Such a circumstance gives no indication as to its reproductive toxicity and thus does not justify the omission of the requirement to provide standard information as to the potential of that substance to cause reproductive toxicity.
47 It is apparent from paragraphs 41 to 43 of the contested decision that the Board of Appeal carried out, first of all, a grammatical analysis of the first indent of column 2 of Section 8.7. The applicant argues that it was appropriate to carry out a contextual interpretation, in accordance with paragraph 47 of the judgment of 10 December 2018, Wightman and Others (C‑621/18, EU:C:2018:999), by also taking account of the fact that 4-MHHPA gave rise to an equivalent level of concern to CMR substances and that appropriate risk management measures were implemented. 4-MHHPA should therefore be treated in the same way as a CMR substance in so far as concerns waivers as to the information to be supplied in accordance with Annex X to the REACH Regulation.
48 In that connection, the wording of the first indent of column 2 of Section 8.7. is sufficiently clear. It includes an explicit reference to a given substance being ‘known to be a genotoxic carcinogen’. It is common ground that that was not the case for 4-MHHPA. Moreover, in paragraphs 44 to 50 of the contested decision, the Board of Appeal was entitled to state, with reference to recital 19 of the REACH Regulation and the aforementioned provision, that it was for the applicant to provide information on the other inherent risks associated with the substance at issue, in addition to those linked to the fact that it was a known respiratory sensitiser. In particular, it was necessary to assess possible risks associated with reproductive toxicity, by means of standard information presented in that connection, as laid down in Regulation 2015/282.
49 As the Board of Appeal points out in paragraph 46 of the contested decision, and as was also maintained by ECHA at the hearing, in the absence of standard information on all endpoints, there was uncertainty as to whether the respiratory sensitisation properties of the substance at issue posed the greatest risk. The applicant has failed to adduce evidence capable of invalidating the Board of Appeal’s finding, in the same paragraph, that the data derived from an EOGRTS could lead to or affect authorisation and restriction decisions regarding the substance at issue or may lead to different risk management measures being required.
50 On the latter point, the appropriate risk management measures implemented with regard to the respiratory sensitisation properties of the substance could prove to be insufficient or inappropriate in respect of other possible risks. As ECHA explained at the hearing, it could not be ruled out that more stringent measures, linked to the possible risks to reproductive toxicity, might be required, including the minimisation of the use of the substance at issue or preference for risk management measures relating directly to the places of manufacture or use of the substance, rather than to the measures for personal protection of professionals coming in contact with the substance, since there might be shortcomings to such measures. It is also apparent from the items of evidence submitted by the applicant in the context of explanations concerning the practical use of the substance at issue that ‘80% of accidents were related to the human aspect’.
51 Following that logic, the applicant’s claims relating to the fact that it had stringent risk management measures in place and that, therefore, the EOGRTS would not bring about any improvements are not such as to call into question the Board of Appeal’s assessments. First, the evidence adduced by ECHA at the hearing, summarised in paragraph 50 above, clearly indicates that there could even be substantial improvements to made to those measures, if it were to transpire that 4-MHHPA was toxic to reproduction. Second, it cannot be ruled out that, in such a case, one of the main measures to be taken might even be to minimise the use of that substance and to introduce its gradual replacement with another substance which is less harmful, or even harmless, from a toxicological point of view.
52 In those circumstances, as the Board of Appeal found in paragraph 47 of the contested decision, the fact that the substance at issue was identified as a ‘respiratory sensitiser’ with an equivalent level of concern to CMR substances did not mean that the applicant was exempt from its obligation to submit standard information, in particular in respect of reproductive toxicity. The approach taken in paragraphs 44 to 53 of the contested decision – which, moreover, took the context of the provision into consideration – reinforces the literal interpretation of the first indent of column 2 of Section 8.7. It should also be pointed out that equivalence, as to the level of concern, between 4-MHHPA and CMR substances is not, however, identity between those substances. Had that been the intention of the EU legislature, it would have been sufficient for it to provide, in that provision, that a waiver of the studies in question may apply not only in the event that it is found that the substance is a ‘genotoxic carcinogen’ but also when it is an ‘equivalent substance’ (see, by analogy, judgment of 15 March 2017, Polynt v ECHA, C‑323/15 P, EU:C:2017:207, paragraph 33).
53 As ECHA contends, it should also be noted that, contrary to the applicant’s claims, there is no ‘contradiction’ between, on the one hand, the fact that the substance at issue was identified as an SVHC within the meaning of Article 57(f) of the REACH Regulation, on account of its respiratory sensitising properties by equating it to a CMR substance, and, on the other hand, the application of rules other than those applicable to CMR substances as regards column 2 of Section 8.7., on account of the clear wording of that provision, which is limited only to those substances which are found to be ‘a genotoxic carcinogen’.
54 That approach takes account of the different purposes of those two provisions and is consistent with the case-law of the Court of Justice, which states that Article 57(f) of the REACH Regulation establishes an independent mechanism that makes it possible to identify, as being of very high concern, substances which had not already been designated as such under that provision (judgment of 23 January 2019, Deza v ECHA, C‑419/17 P, EU:C:2019:52, paragraph 32).
55 It is clear from that case-law that it cannot be ruled out that the intrinsic properties of a substance may come under several of the grounds set out in Article 57(a) to (f) of the REACH Regulation (judgment of 23 January 2019, Deza v ECHA, C‑419/17 P, EU:C:2019:52, paragraph 35).
56 It is also clear from the wording of Article 57(f) of the REACH Regulation, which states that the identification of substances other than CMR, persistent, bioaccumulative and toxic (‘PBT’) or very persistent and very bioaccumulative (‘vPvB’) substances is possible only in the case of substances the serious effects of which give rise to ‘an equivalent level of concern’ to those of CMR, PBT or vPvB substances, that the scope of that provision encompasses the possibility of taking into consideration, for the purposes of comparison, material going beyond merely the hazards arising from the intrinsic properties of the substances concerned (judgment of 15 March 2017, Polynt v ECHA, C‑323/15 P, EU:C:2017:207, paragraph 34). Those other factors may include, apart from the probability that the serious effects of a substance may occur under the normal conditions of use of that substance, the difficulty of adequately assessing the risks posed by those substances when it is impossible to determine, with the necessary certainty, a derived no-effect level or a predicted no-effect concentration, or indeed the level of concern that those substances engender in the public, the number of persons affected, and the impact of those effects on the lives, and in particular, the professional lives, of the persons affected (judgment of 15 March 2017, Polynt v ECHA, C‑323/15 P, EU:C:2017:207, paragraph 39).
57 Thus Article 57(f) of the REACH Regulation does not allow certain substances, such as 4-MHHPA in the present case, to be completely equated to CMR (or PBT or vPvB) substances, but only to identify those substances as being of very high concern. For such substances, the question may remain open as to precisely which other risks they pose, since they require a specific and adequate scientific assessment. Moreover, it is clear from a reading of the table comparing the levels of concern of CMR substances and 4-MHHPA, reproduced in paragraph 53 of the application as ‘Table 6.1’, that the effects on health may be different, since the possibility of death, or even of irreversible general effects, is indicated in respect of CMR substances only. It is apparent from the initial decision that those reasons, namely the lack of clarity as regards the risks of 4-MHHPA other than those relating to respiratory sensitisation, led ECHA to request the EOGRTS at issue.
58 In those circumstances, the Board of Appeal rightly found, in paragraphs 51 to 53 of the contested decision, that the first indent of column 2 of Section 8.7. did not allow an EOGRTS to be omitted on the sole ground that 4-MHHPA was of an ‘equivalent level of concern’ to a substance with CMR properties. Furthermore, as stated in paragraphs 50 and 51 above, that finding cannot be invalidated by the applicant’s claim that ‘appropriate risk management measures [were] implemented’ concerning the respiratory sensitising properties of 4-MHHPA.
59 Accordingly, the applicant’s first plea must be rejected as unfounded.
The second plea, alleging an error of law consisting in the failure to differentiate between examination of a testing proposal and a compliance check
60 According to the applicant, the examination of testing proposals differs from the compliance check, which is a more formalistic, administrative check of the dossier. In support of that distinction, the applicant refers to recital 63 of the REACH Regulation. The applicant argues, in essence, that, in the examination of testing proposals, as in the present case, it is for ECHA to ensure that testing on vertebrate animals is required only to meet real information needs in order to avoid proposals for unnecessary animal testing. It also refers to the ECHA Guidance of April 2020, entitled ‘How to act in dossier evaluation’, according to which the ‘compliance check of dossiers assesses whether the quality and adequacy of information submitted in the registration dossiers is compliant with the legal requirements of REACH Annexes I and VI to X, including possible adaptations [made] according to Annex XI’ to that regulation, whereas the ‘examination of testing proposals in dossier aims to ensure that adequate and reliable data are generated, and that testing proposal is tailored to real information needs, in particular to prevent unnecessary testing on vertebrate animals’ (pages 5 and 6 of that guidance).
61 The applicant claims that the EOGRTS was not necessary, first, because stringent risk management measures were already in place and, second, because 4-MHHPA is produced and used in the European Union only in industrial settings, and there are no consumer uses in the European Union. The Board of Appeal based its conclusion on a non-critical element, namely the fact that column 2 of Section 8.7. applies to both stages of dossier evaluation, whereas it should have assessed whether ECHA had conducted an examination of the testing proposals, and should have given reasons for rejecting the argument that the EOGRTS would neither clarify a potential risk nor improve risk management measures. By failing to do so and by maintaining that the two stages include the same type of assessment, the Board of Appeal erred in its legal assessment.
62 ECHA disputes the applicant’s claims.
63 As regards the applicant’s claim that the examination of a testing proposal is different from a compliance check, which is a more formalistic administrative check to ensure the completeness of the registration dossier, and its reference to recital 63 of the REACH Regulation, it should be noted, as a preliminary point, that it is clear from the wording of that recital (see paragraph 20 above) that it sets out an objective of that regulation consisting in ECHA receiving the information it needs to assess the dossier in question, which objective applies to all assessment processes and is not confined solely to examinations of testing proposals, contrary to the applicant’s claims. It is an expression of the principle of proportionality, under which the information requested must be necessary to the objective pursued.
64 In so far as the preamble of an EU act may explain the content of the provisions of that act and provide guidance on interpretation which may clarify the intention of the author of that act (see, to that effect, judgment of 19 December 2019, Puppinck and Others v Commission, C‑418/18 P, EU:C:2019:1113, paragraphs 75 and 76 and the case-law cited), recital 63 of the REACH Regulation cannot be relied on in order to go beyond what is laid down by the actual provisions of the articles in that regulation. It must therefore be held that the ‘real information needs’ referred to in recital 63 of that regulation are identified by the legislature as standard information requirements under Annexes VII to X to that regulation, in accordance with the objective of achieving a high level of protection of human health through the generation of relevant information on the substances concerned.
65 In the present case, as has already been found in the context of the first plea, the relevant adaptation is clearly set out in column 2 of Section 8.7. (see paragraphs 5 and 44 above).
66 In so far as concerns Articles 40 and 41 of the REACH Regulation, concerning the examination of testing proposals and the compliance check for registration, respectively, the Board of Appeal states, in paragraph 51 of the contested decision, that those provisions make it possible to ensure that the registration dossier contains standard information, according to that regulation, or ‘acceptable adaptations’. The Board of Appeal states that the specific principles of adaptation laid down in column 2 of Section 8.7., which indeed contain an explicit reference to Articles 40 and 41 of the REACH Regulation, apply in the same way to compliance check and to the examination of testing proposals.
67 In that connection, first, it is apparent from paragraph 63 of the application that the applicant accepts that column 2 of Section 8.7. applies to both stages of the assessment of the dossier, although it takes the view that that fact is not a ‘critical element’.
68 Second, it is not disputed that, in the present case, ECHA did indeed apply Article 40 of the REACH Regulation. It is, however, apparent from the applicant’s claims, as elucidated at the hearing, that it criticises ECHA for having, in fact, applied by analogy the procedure laid down in Article 41 of the REACH Regulation or, in other words, for having taken inspiration from that article. The applicant argues that the legislature has divided the dossier compliance step in two different stages for a reason: the first step serves to conduct an administrative check of completeness of the registration dossier, and the second to conduct a more in-depth assessment of the testing proposal with a view to avoiding testing on vertebrate animals.
69 It is clear that, in the present case, ECHA correctly followed the procedure laid down in Article 40 of the REACH Regulation, first, by examining, in accordance with Article 40(1) of that regulation, the applicant’s testing proposals; next, by publishing, in accordance with Article 40(2) of that regulation, on the ECHA website, information relating to testing proposals involving tests on vertebrate animals or by inviting third parties to submit their observations; and, finally, in accordance with Article 40(3) of that regulation, by taking the initial decision, requiring the EOGRTS (see paragraphs 21 to 27 above).
70 ECHA rightly argued, before the General Court, that, in the context of testing proposals, it is legally required, under Article 40 of the REACH Regulation, to give a decision on a testing proposal requiring the registrant to conduct a test, when the information referred to in Annex X to that regulation is missing from the registration dossier and no valid adaptation has been submitted.
71 As ECHA contends, in the context of the assessment of the need for information additional to that submitted by the applicant, the intrinsic properties of the substance at issue may be analysed separately from exposure to it, prior to the issue of risk management. As was discussed at the hearing, that management is closely dependent on the types of risk identified and may differ depending on whether it is solely respiratory sensitisation properties or other potential risks, in particular reproductive toxicity, which may lead to changes in the harmonised classification, with the result that mandatory, stringent risk management principles are involved.
72 In those circumstances, the applicant’s claims that the Board of Appeal relied on non-critical elements by failing to examine the relevant issues must be rejected (see paragraph 61 above).
73 Accordingly, the second plea must be rejected as unfounded.
The third plea, alleging, in essence, the application of an incorrect legal test and reversal of the burden of proof
74 In the context of this plea, as it stated at the hearing, the applicant claims that the contested decision should be annulled in part, in so far as ECHA unlawfully required the applicant to evaluate the developmental immunotoxicity of the substance at issue through a cohort 3 study, in accordance with column 2 of Section 8.7.3. It claims that ECHA failed to show that the inclusion of cohort 3 was based on a particular concern specific to developmental inmunotoxicity and which reaches a certain level of severity. It is claimed that the Board of Appeal addressed that argument solely from the perspective of a ‘manifest error of assessment’, thus applying an incorrect legal test.
75 The applicant maintains that it was for the Board of Appeal to decide whether ECHA had, in the case in point, identified a particular concern specific to developmental immunotoxicity reaching a certain level of severity. However, the Board of Appeal confined itself to analysing whether ECHA had detected a problem, without examining the seriousness thereof, which is contrary to the mandatory guidance document, namely Chapter R.7a, entitled ‘Endpoint specific guidance’ in the ECHA Guidance on Information Requirements and Chemical Safety Assessment (version 6.0, July 2017, pages 530 and 531) (‘the 2017 ECHA Guidance’). By applying the incorrect legal test, the Board of Appeal failed to engage with the applicant’s arguments and reversed the burden of proof.
76 The applicant argues that, during the administrative procedure, it had proposed that the need to include the developmental immunotoxicity cohort 3 would be determined from the findings of studies on similar cyclic anhydrides and the proposed 90-day repeat dose toxicity study. It produced the results of a prenatal developmental toxicity study in compliance with good laboratory practice and a 90-day sub-chronic study, OECD TG 408 (dated 2018). Those studies did not show a significant concern sufficient to justify the need to add cohort 3 to the extended toxicity study design. Although ECHA had included cohort 3 in the initial decision, the applicant claimed that that decision was based on minor statistical variations in various parameters, misinterpreted by ECHA. Thus, as regards the slightly reduced thymus weight and white blood cell counts, this is an effect occurring as a result of individual variation and clustering leading to statistically significant differences in the data set. Lastly, in paragraph 74 of the contested decision, the Board of Appeal failed to address the argument in relation to the item of evidence entitled ‘Concise International Chemical Assessment document 75 on cyclic acid anhydrides and their human health aspects’ from the World Health Organization (WHO) (‘the 2009 WHO document’). According to the applicant, the conclusion on the absence of toxicity met the requirement laid down in column 2 of Section 8.7. for omitting the EOGRTS with its extended cohort 3.
77 ECHA disputes the applicant’s claims.
78 It is apparent from the initial decision that ECHA concluded, after examining the applicant’s testing proposals, that there was a ‘particular concern’ for developmental immunotoxicity, as defined in the second paragraph of column 2 of Section 8.7.3., with the result that it was appropriate to request that the additional developmental immunotoxicity cohort be included in the EOGRTS.
79 It should also be observed that, in the initial decision, ECHA stated that it had asked the applicant whether alternative adaptation methods could be taken into consideration in order to fulfil the information requirements for reproductive toxicity. It took account of the applicant’s response, according to which there were no such methods.
80 As regards the terms ‘particular concern’, in addition to the reference in the second paragraph of column 2 of Section 8.7.3., these are defined further in the 2017 ECHA Guidance. In accordance therewith, such concerns must relate specifically to the issue of developmental immunotoxicity, but must also present a certain level of severity. In that connection, additional explanations can be drawn from the wording of column 2 of Section 8.6.1. of Annex VIII to the REACH Regulation (see footnote 155 to the 2017 ECHA Guidance) and of column 2 of Section 8.7.3. of Annexes IX and X to the REACH Regulation. In essence, the level of severity is contextualised as requiring that there be sufficient evidence, in view of all available information, reasonably to expect the substance to be immunotoxic for development.
81 In the present case, as ECHA maintains before the Court, its ‘particular concern’ was based primarily on evidence of reduced thymus weight, observed in an in vivo sub-chronic toxicity study carried out on rats and relating to the substance submitted by the applicant (reduction concerning male rats). Although the initial decision also identified other reasons justifying a request for a developmental immunotoxicity cohort, namely the reduction in white blood cell counts (reduction concerning female rats), those reasons were not examined in the contested decision, since the Board of Appeal found that thymus weight reduction was sufficient in that regard.
82 The applicant argues, before the Court, that it is necessary to assess the ‘level of severity’ associated with the ‘particular concern’ at issue, and it relies on certain elements which, in its view, serve to demonstrate that the adverse effects related to minor statistical variations in various parameters. This is a repetition of the claims which the applicant made previously before the Board of Appeal, reproduced in paragraphs 60 to 62 of the contested decision, to which the Board of Appeal responded in paragraphs 66 to 73 of that decision.
83 As regards the applicant’s argument that the Board of Appeal did not carry out its review with the requisite intensity (see paragraphs 74 and 75 above), it has already been recalled in paragraph 38 above that it is clear from the case-law that the review, by the Board of Appeal, of scientific assessments set out in an ECHA decision is not limited to verifying the existence of manifest errors. On the contrary, in that regard, by relying on the legal and scientific competences of its members, that board must examine whether the arguments put forward by the applicant are capable of demonstrating that the considerations on which that decision of ECHA is based are vitiated by error (judgment of 20 September 2019, BASF Grenzach v ECHA, T‑125/17, EU:T:2019:638, paragraph 89).
84 By contrast, in the context of an action for annulment under Article 263 TFEU, the review carried out by the Courts of the European Union is limited where it involves the assessment of highly complex scientific and technical facts. Regarding such assessments, the Courts of the European Union are limited to reviewing whether they are vitiated by a manifest error, a misuse of powers or whether the author of the decision clearly exceeded the limits of its discretion (see, to that effect, judgment of 20 September 2019, BASF Grenzach v ECHA, T‑125/17, EU:T:2019:638, paragraph 87).
85 In the first place, it is apparent from the wording of the part of the contested decision relating to cohort 3 that the Board of Appeal did not limit itself to analysing a ‘manifest error of assessment’, but referred, on several occasions, to ‘errors of assessment’.
86 In the second place, the same conclusion is apparent from the assessment of the specific grounds, based on concrete scientific indicators, on which the Board of Appeal relied in its decision as to cohort 3. In paragraphs 66 to 74 of the contested decision, it refers to the applicant’s studies, on which ECHA based its finding, relating to the requirement that a cohort 3 be included. In particular, in paragraph 67 of the contested decision, the Board of Appeal relies on the concrete factors, highlighted by ECHA, relating to the concerns as to thymus development. In paragraph 68 of the contested decision, it states that that was the main factor of ECHA’s concern, whereas the other factors (such as the decreased white blood cell counts) were only supporting factors. In paragraph 69 of the contested decision, the Board of Appeal assesses what it considers to be statistically significant data concerning thymus reduction in males, both at low doses (less than 19% in terms of weight reduction) and at high doses (less than 21% in terms of weight reduction). Moreover, it points out that even the comparative recovery group presented a significant reduction in thymus weight, namely -22%, suggesting that the animals studied did not recover their initial state of health following exposure to the substance at issue. In paragraph 70 of the contested decision, the Board of Appeal takes account of the fact that there was an absence of body weight changes in the subjects tested, since those data had not, in its view, been rebutted by the applicant.
87 It is in those circumstances, that is to say, following a detailed scientific assessment, that the Board of Appeal finds, first of all, in paragraph 71 of the contested decision, that the fact that identical results (thymus weight reduction) were not observed in females was not decisive, given that the effects on males were sufficient. It highlights the fact that it was common ground there can be sex-specific differences between male and female test subjects.
88 Next, paragraph 72 of the contested decision provides a precise response to the applicant’s claim that the tests in question and the results thereof were linked solely to ‘minor statistical variations in various parameters’. The Board of Appeal points out that that claim is not capable of demonstrating that ECHA made an error of assessment regarding the risks relating to immunotoxicity and that, moreover, the latter had previously responded to a similar argument. The Board of Appeal finds that, rather than demonstrating an error of assessment, the applicant instead showed a ‘difference of … scientific opinion on’ the assessments of the scientific facts and the results of the sub-chronic toxicity study.
89 It is clear that the applicant has failed to adduce evidence before the Court from which it is possible to infer a manifest error of assessment on the part of the Board of Appeal, in accordance with the case-law referred to in paragraph 84 above. In particular, it is not disputed that the reduction in thymus weight did in fact occur, although the applicant regards this as minimal or as having no consequences from a statistical point of view. In the latter connection, it has failed to demonstrate why a comparison with a ‘historical’ group of vertebrates to which it referred should take precedence over the comparison, made by ECHA, with the ‘recovery’ group. In the absence of decisive elements adduced by the applicant on that point, it is reasonable to take the view, as ECHA also maintained at the hearing, that the comparison with a ‘recovery’ group of vertebrates which was examined at the same time and under the same conditions by the same laboratory, takes precedence when weighed up against ‘historical’ data from other, earlier studies.
90 Furthermore, it is common ground that a reduction in the weight of an organ such as the thymus may be regarded as one indication of the reproductive toxicity of a test substance (see page 266 of the 2017 ECHA Guidance).
91 Moreover, where there are scientific opinions which differ from, on the one hand, the position taken by the applicant – namely that, in the present case, thymus reduction was not statistically significant to indicate a particular hazard to reproductive toxicity – and, on the other hand, the opposite position taken by ECHA, and confirmed by the Board of Appeal, it is precisely the study requested in the initial decision the EOGRTS including cohort 3 which would allow decisive information to be obtained on that point. Such an approach – that is to say, the approach that consists in requesting that study – remains in line with the information requirements laid down in the REACH Regulation, in particular Article 40 thereof.
92 Furthermore, a failure to include cohort 3 in the EOGRTS may be contrary to the precautionary principle as set out in Article 1(3) of the REACH Regulation. In accordance with that principle, it is for manufacturers, importers and downstream users to ensure that they manufacture, place on the market or use such substances that do not adversely affect human health or the environment. It is apparent, moreover, from the 2017 ECHA Guidance that cohort 3 is specifically intended to assess the factors concerning reproductive toxicity which are not apparent from other information previously submitted as part of other studies provided for in the REACH Regulation and which may be relevant in the risk assessment.
93 Consequently, the applicant has failed to demonstrate that the Board of Appeal committed a manifest error of assessment in its appraisal of the seriousness of the effects caused by the studies at issue on the thymus (see also paragraphs 80 to 82 above).
94 Inasmuch as this is the main issue which, in the initial decision, led ECHA to require the inclusion of cohort 3 in the EOGRTS, the Board of Appeal also did not commit such a manifest error in finding, in paragraph 74 of the contested decision, that it was not necessary to assess the claims derived from the 2009 WHO document.
95 As ECHA argues, one of the three conditions to which column 2 of Section 8.7.3. refers relates to existing information on the substance itself from relevant, available in vivo studies, including those involving adult animals. Even though the thymus weight reduction results in the sub-chronic toxicity study satisfied that condition, the 2009 WHO document does not concern the same substance, but related substances only. Moreover, the applicant has failed to adduce evidence establishing the relationship between 4-MHHPA and the substances which were the subject of WHO analyses, which it describes as ‘structurally related substances trimellitic anhydride, phthalic anhydride, succinic anhydride, and maleic anhydride’. Moreover, the applicant has also failed to clarify unambiguously whether it sought to draw conclusions, from the WHO 2009 document, on the question of thymus weight reduction or solely on the assessment relating to white blood cells.
96 In the light of the foregoing, the third plea must be rejected as unfounded.
The fourth plea, alleging infringement or misapplication of Articles 91 to 93 of the REACH Regulation
97 The applicant claims that, by failing to conduct a substantive review of ECHA’s decision, the Board of Appeal misapplied the requisite legal standard under Articles 91 to 93 of the REACH Regulation, which is to conduct a full review of ECHA decisions and to ‘exercise any power which lies within the competence of [ECHA]’, as opposed to just a review of ‘manifest errors’.
98 In its reply, the applicant argues that it was not implying that the Board of Appeal should have carried out a ‘de novo’ evaluation, but that it was equipped by law to review the lawfulness of ECHA’s decision and examine any questions related to the misapplication and misinterpretation of the law and/or science.
99 ECHA disputes the applicant’s claims.
100 In so far as it has already been found, in the context of the three preceding pleas, that, in the contested decision, the Board of Appeal acted in accordance with the case-law stating that its review of scientific assessments contained in an ECHA decision is not limited to verifying the existence of manifest errors (as explained in paragraph 83 above), the present plea must also be rejected. It is in fact clear that the plea is based, in essence, on the same criticisms as those made in the context of the three preceding pleas.
The fifth plea, alleging failure to address the arguments raised by the applicant before the Board of Appeal of ECHA in relation to the infringement of Article 13 TFEU, Article 25 of the REACH Regulation and the principles of protection of animal welfare, proportionality and sound administration
101 The applicant submits that, in paragraphs 92, 97 and 98 of the contested decision, the Board of Appeal rejected its arguments relating to the infringement of the principles of protection of animal welfare, proportionality and sound administration, on the ground that its arguments were allegedly the same as those raised in its previous pleadings. However, according to the applicant, it is apparent from the reasons set out under the first four pleas that the conclusion reached in those paragraphs of the contested decision was equally unlawful. In any event, the Board of Appeal should have assessed the applicant’s arguments since they were raised separately in relation to principles enshrined in the Charter of Fundamental Rights of the European Union, the TFEU and the case-law of the Court of Justice, respectively, thereby constituting fundamental principles that deserve a proper, independent assessment.
102 The applicant argues that, in the notice of appeal lodged with the Board of Appeal of ECHA, it had indicated that the basic design for an EOGRTS required the use of 200 animals for the initial parental generation, and experimentation on an additional 320 animals forming cohorts 1A and 1B. The inclusion of cohort 3 required experimentation on a further 80 animals. For reasons already discussed in the context of the previous pleas, the study was neither necessary nor useful in the absence of a significant concern for developmental immunotoxicity. Similarly, on account of the lack of absorption via relevant exposure and the fact that the registered substance had a low toxicological activity, other than its sensitising properties as defined and understood, the study was not justified.
103 The applicant claims that the approach taken by ECHA therefore exceeded the limits of what was appropriate and necessary to achieve the objectives pursued by the initial decision and also infringed the principle of protection of animal welfare. Furthermore, ECHA infringed the principle of sound administration in so far as it failed to examine carefully and impartially all the relevant factors.
104 ECHA disputes the applicant’s claims.
105 In the first place, it should be recalled that, according to settled case-law, the principle of proportionality, which is one of the general principles of EU law, requires that measures adopted by EU institutions 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 (judgment of 21 July 2011, Etimine, C‑15/10, EU:C:2011:504, paragraph 124).
106 In the second place, as regards the applicant’s argument that the death of almost 600 animals, 80 of which on account of the inclusion of cohort 3 in the EOGRTS, is, in the present case, disproportionate, it should be observed, as a preliminary point, that the EU legislature established, as the main objective of the obligation to register laid down in Article 6 of the REACH Regulation, the objective of ensuring a high level of protection of human health and the environment. The means by which to achieve that objective is, as recital 19 of the REACH Regulation states, the registration obligation imposed on manufacturers and importers, which includes the obligation to generate data on the substances which they manufacture or import, to use those data to assess the risks related to those substances and to develop and recommend appropriate risk-management measures (judgment of 7 July 2009, S.P.C.M. and Others, C‑558/07, EU:C:2009:430, paragraphs 45 and 46).
107 It is true that the objective of ensuring animal protection is also pursued by the REACH Regulation, in particular by Article 13(1) and Article 25(1) thereof. According to that latter provision, testing on vertebrate animals for the purposes of that regulation is to be undertaken only as a last resort.
108 However, the information requirements set out in Annexes VII to X to the REACH Regulation confirm that animal testing cannot be avoided in every case. In some cases, only testing on vertebrate animals will provide sufficient scientific information to enable measures to be taken to protect human health and the environment.
109 Furthermore, as regards the applicant’s reference to Article 13 TFEU (see paragraph 18 above), it is essentially stating that in formulating and implementing certain EU policies as listed, the European Union and the Member States are, since animals are sentient beings, to pay full regard to the welfare requirements of animals, while respecting the legislative or administrative provisions and customs of the Member States relating in particular to religious rites, cultural traditions and regional heritage. In the present case, it is appropriate to refer to paragraphs 106 to 108 above, which make reference to the logic of the REACH Regulation, which ECHA and the Board of Appeal, in the contested decision, have observed in the present case.
110 More specifically, as regards the circumstances of the present case, it should be noted that, in so far as, under Article 10(a)(vi) of the REACH Regulation, read in conjunction with Section 8.7.3. of Annexes X and XI to that regulation, a registrant’s dossier must contain information on an EOGRTS or, failing that, an acceptable adaptation, ECHA was neither required, under that regulation, to examine whether it was proportionate for the applicant to be required to provide that information, nor empowered by that regulation to do so. It has already been found, in the context of the applicant’s preceding pleas, that the applicant has failed to establish the unlawfulness of the contested decision, confirming the initial decision in so far as ECHA had required it to carry out an EOGRTS, including cohort 3.
111 In those circumstances, first, the applicant also cannot rely on an infringement of Article 13 TFEU, since ECHA acted in compliance with the legislative provisions which had already laid down the procedures to be followed in order to take full account of animal welfare requirements. Nor can it rely, secondly, on Article 25 of the REACH Regulation, since ECHA submitted evidence supporting the view that the study required in the present case was indispensable. Moreover, from the beginning of the administrative procedure, ECHA concerned itself with the question of possible alternative solutions, by requesting, in addition, information on potential adaptations proposed by the applicant.
112 Lastly, as regards the arguments relating to sound administration, ECHA rightly contends that the Board of Appeal points out, in paragraphs 91 and 92 of the contested decision, the lack of justification for the applicant’s arguments, while continuing to deal with the applicant’s specific arguments relating to different aspects of the initial decision. Thus, in paragraphs 1 and 2 of the contested decision, the Board of Appeal rejects both the arguments relating to the alleged low toxicological activity of 4-MHHPA (in particular in paragraph 55 of the contested decision) and those that that substance posed no risk of developmental immunotoxicity. Accordingly, the Board of Appeal was fully entitled to reject, in point 4.1 of the contested decision, the claim alleging infringement of the principle of sound administration, based on those arguments, by referring to its previous findings. Furthermore, it has already been found that ECHA correctly followed the procedure laid down in Article 40 of the REACH Regulation, read in conjunction with Article 50 thereof, and it has not been demonstrated, contrary to what the applicant claims in support of that argument, that the Board of Appeal was biased and negligent in its examination of the relevant factors.
113 In those circumstances, the fifth plea must also be rejected as unfounded and the action dismissed in its entirety.
Costs
114 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 pay the costs, including those relating to the proceedings for interim measures, in accordance with the form of order sought by ECHA.
On those grounds,
THE GENERAL COURT (Second Chamber)
hereby:
1. Dismisses the action;
2. Orders Polynt SpA to pay the costs, including those relating to the interim proceedings.
Marcoulli | Frimodt Nielsen | Valasidis |
Delivered in open court in Luxembourg on 28 June 2023.
V. Di Bucci | | S. Papasavvas |