JUDGMENT OF THE GENERAL COURT (Sixth Chamber)
8 October 2025 (*)
( Environment and protection of human health – Regulation (EC) No 1272/2008 – Classification, labelling and packaging of certain substances and mixtures – Delegated Regulation (EU) 2024/197 – Classification and labelling of dibutyltin oxide – Criteria for classification of a substance in the hazard class reproductive toxicity, Category 1B – Absence of public consultation on the opinion of ECHA’s Committee for Risk Assessment – No obligation to review – Regulation (EC) No 1907/2006 – Read-across – Maternal toxicity – Manifest error of assessment )
In Case T‑169/24,
PMC Vlissingen Netherlands BV, established in Leiden (Netherlands), represented by J.-P. Montfort, P. Chopova-Leprêtre and N. Kyriazopoulou, lawyers,
applicant,
v
European Commission, represented by J. Jokubauskaitė and B. Cullen, acting as Agents,
defendant,
supported by
Kingdom of the Netherlands, represented by M. Bulterman and J. Langer, acting as Agents,
and by
Republic of Austria, represented by J. Schmoll, acting as Agent,
and by
Kingdom of Sweden, represented by J. Olsson, F.-L. Göransson, C. Meyer-Seitz and H. Eklinder, acting as Agents,
and by
European Chemicals Agency (ECHA), represented by A. Hautamäki, A. Deloff‑Bialek, W. Broere and M. Heikkilä, acting as Agents,
interveners,
THE GENERAL COURT (Sixth Chamber),
composed, at the time of the deliberations, of M.J. Costeira (Rapporteur), President, M. Kancheva and P. Zilgalvis, Judges,
Registrar: S. Spyropoulos, Administrator,
having regard to the written part of the procedure,
further to the hearing on 4 June 2025,
gives the following
Judgment
1        By its action under Article 263 TFEU, the applicant, PMC Vlissingen Netherlands BV, seeks the annulment of Commission Delegated Regulation (EU) 2024/197 of 19 October 2023 amending Regulation (EC) No 1272/2008 as regards the harmonised classification and labelling of certain substances (OJ L, 2024/197; ‘the contested regulation’), in so far as it introduces the harmonised classification and labelling of the substance dibutyltin oxide in the hazard class reproductive toxicity, Category 1B.
Background to the dispute
2        The applicant is a company established under Netherlands law which is a manufacturer, supplier and the lead registrant of the substance dibutyltin oxide (‘DBTO’).
3        DBTO is used essentially in industrial applications, such as paints and electrodeposition coatings, in particular in the manufacturing of vehicles in order to protect them against corrosion.
4        On 2 September 2020, the Umweltbundesamt (Environment Agency, Republic of Austria) submitted to the European Chemicals Agency (ECHA) a proposal for the harmonised classification and labelling of DBTO (‘the classification proposal’) under Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC and amending Regulation (EC) No 1907/2006 (OJ 2008 L 353, p. 1; ‘the CLP Regulation’). That Environment Agency proposed, in particular, the harmonised classification and labelling of DBTO in the hazard class reproductive toxicity, Category 1B.
5        The parties concerned were invited to submit observations on the classification proposal until 29 January 2021. Several Member States and concerned parties have submitted their observations.
6        On 16 September 2021, on the basis of Article 37(4) of the CLP Regulation, ECHA’s Committee for Risk Assessment (‘RAC’) adopted an opinion in which it proposed the harmonised classification and labelling of DBTO, inter alia, in the hazard class reproductive toxicity, Category 1B (‘the RAC opinion’).
7        The European Commission received additional information and, as stated in recital 3 of the contested regulation, did not find that information sufficient to call into question the scientific analysis contained in the RAC opinion.
8        On 19 October 2023, on the basis of the RAC opinion, the Commission adopted the contested regulation. By Article 1 of that regulation, DBTO was added to Table 3 of Part 3 of Annex VI to the CLP Regulation, with harmonised classification and labelling in the hazard class reproductive toxicity, Category 1B (presumed human reproductive toxicant), with the hazard statement code ‘H360FD’ (May damage fertility. May damage the unborn child) (‘the classification in dispute’). Furthermore, the contested regulation introduced the harmonised classification and labelling of that substance in the hazard classes germ cell mutagenicity, Category 2, acute toxicity, Category 3, STOT RE, Category 1, skin irritation, Category 2, and serious eye damage, Category 1.
9        Under Article 2 of the contested regulation, the amendments to Annex VI to the CLP Regulation, as regards the classification in dispute, apply as from 1 September 2025.
10      Furthermore, the applicant, as the registrant of DBTO, adopted self-classification decisions for DBTO as a substance toxic for reproduction, for the adverse effects on development, initially in Category 1B and, from March 2023, in Category 2.
Forms of order sought
11      The applicant claims that the Court should:
–        annul the contested regulation in so far as it concerns the classification in dispute;
–        order the Commission to pay the costs.
12      The Commission, supported by the Kingdom of the Netherlands, the Republic of Austria, the Kingdom of Sweden and ECHA, contends that the Court should:
–        dismiss the action;
–        order the applicant to pay the costs.
Law
13      In support of its action, the applicant puts forward four pleas in law, alleging:
–        first, failure to take into consideration all the available information on DBTO;
–        second, a flawed and unlawful application of the read-across approach;
–        third, a lack of clear evidence that DBTO has adverse effects on the development of the offspring; and
–        fourth, absence of public consultation on the RAC opinion.
Preliminary considerations on the harmonised classification and labelling of substances in the hazard class reproductive toxicity
14      As a preliminary point, it must be stated that, in accordance with recital 1 and Article 1(1) of the CLP Regulation, the purpose of that regulation is to ensure a high level of protection of human health and the environment as well as the free movement of chemical substances, mixtures and certain specific articles in the internal market of the European Union. As is apparent from, in particular, recitals 5 to 8, 10 and 27 thereof, the objective of that regulation is to determine the intrinsic properties of the substances which must lead to their classification as hazardous products, so that the hazards posed by those substances (and by mixtures containing such substances) can be correctly identified and notified. To that end, in accordance with Article 1(1)(a) thereof, the purpose of that regulation is, inter alia, to ‘[harmonise] the criteria for classification of substances and mixtures, and the rules on labelling and packaging for hazardous substances and mixtures’.
15      Furthermore, it is apparent from recitals 4 to 8 of the CLP Regulation that the EU legislature intended to contribute to the global harmonisation of criteria for classification and labelling, not only at the level of the United Nations (UN) but also through the incorporation of the internationally agreed Globally Harmonised System of Classification and Labelling of Chemicals into EU law. To that effect, Annex I to that regulation reproduces verbatim almost all of the provisions of that system (judgment of 22 November 2017, Commission v Bilbaína de Alquitranes and Others, C‑691/15 P, EU:C:2017:882, paragraph 42).
16      As regards the classification of hazardous substances and mixtures, it should be recalled that, according to Article 3 of the CLP Regulation, a substance or a mixture fulfilling the criteria relating to physical hazards, health hazards or environmental hazards, such as laid down in Annex I of that regulation, presents a hazard and is to be classified in relation to the respective hazard classes provided for in that annex.
17      In that regard, the CLP Regulation provides, in Title V thereof, a procedure for the harmonisation of classification and labelling of substances throughout the European Union, which concerns substances meeting the criteria set out in Annex I for the hazards listed in Article 36(1) of that regulation, including for the hazard of reproductive toxicity. That regulation also lays down, in particular in Articles 5, 9 and 13 thereof, a self-classification obligation imposed on manufacturers, importers and downstream users, which relates to substances and mixtures.
18      The procedure for the harmonisation of classification and labelling of substances is triggered by the competent authority of a Member State or by manufacturers, importers or downstream users of a substance and by the submission of a proposal for harmonised classification and labelling of that substance to ECHA, in accordance with Article 37(1) and (2) of the CLP Regulation. Next, RAC is to ‘adopt an opinion on any proposal submitted … giving the parties concerned the opportunity to comment’, and ECHA is to ‘forward this opinion and any comments to the Commission’, in accordance with Article 37(4) of that regulation. Lastly, where the Commission finds that the harmonisation of the classification and labelling of the substance concerned is appropriate, it must adopt a delegated act, in accordance with Article 37(5) and Article 53a of that regulation, in order to amend Annex VI to that regulation by including in Table 3 of Part 3 of that annex the substance in question together with the relevant classification and labelling elements.
19      As regards the hazard of reproductive toxicity, Article 36(1)(d) of the CLP Regulation provides that, if a substance meets the criteria set out in Annex I to that regulation for the hazard of reproductive toxicity, it will normally be subject to harmonised classification and labelling. Those criteria are defined in Part 3, Section 3.7 of Annex I to that regulation.
20      In particular, the first paragraph of Section 3.7.1.1 of Annex I to the CLP Regulation and points (a) and (b) of the second paragraph of that section thereof, provides that reproductive toxicity is subdivided into two ‘headings’ of adverse effects, the first relating to adverse effects on sexual function and fertility in adult males and females and the second to the adverse effects on development of their offspring.
21      Section 3.7.1.3 of Annex I to the CLP Regulation defines adverse effects on sexual function and fertility as corresponding to ‘any effect of substances that has the potential to interfere with sexual function and fertility’. This includes, but is not limited to, ‘alterations to the female and male reproductive system, adverse effects on onset of puberty, gamete production and transport, reproductive cycle normality, sexual behaviour, fertility, parturition, pregnancy outcomes, premature reproductive senescence, or modifications in other functions that are dependent on the integrity of the reproductive systems’.
22      Section 3.7.1.4 of Annex I to the CLP Regulation defines the adverse effects on development of the offspring as ‘any effect which interferes with normal development of the conceptus, either before or after birth, and resulting from exposure of either parent prior to conception, or exposure of the developing offspring during prenatal development, or postnatally, to the time of sexual maturation’. It is considered that ‘classification under the heading of developmental toxicity is primarily intended to provide a hazard warning for pregnant women, and for men and women of reproductive capacity.’ Therefore, ‘for pragmatic purposes of classification, developmental toxicity essentially means adverse effects induced during pregnancy, or as a result of parental exposure [; t]hese effects can be manifested at any point in the life span of the organism [; t]he major manifestations of developmental toxicity include (1) death of the developing organism, (2) structural abnormality, (3) altered growth, and (4) functional deficiency’.
23      As regards hazard categories, it follows from Section 3.7.2.1.1 and Table 3.7.1(a) of Annex I to the CLP Regulation that classification for reproductive toxicity is divided into two categories, namely Category 1, which is subdivided into Categories 1A and 1B, and Category 2. In particular, Category 1B corresponds to presumed human reproductive toxicants and Category 2 corresponds to suspected human reproductive toxicants.
24      As regards the weight of evidence of the data, Section 3.7.2.3.1 of Annex I to the CLP Regulation provides that ‘classification as a reproductive toxicant is made on the basis of an assessment of the total weight of evidence’ and that ‘all available information that bears on the determination of reproductive toxicity is considered together, such as epidemiological studies and case reports in humans and specific reproduction studies along with sub-chronic, chronic and special study results in animals that provide relevant information regarding toxicity to reproductive and related endocrine organs.’ Moreover, ‘evaluation of substances chemically related to the substance under study may also be included, particularly when information on the substance is scarce[; t]he weight given to the available evidence will be influenced by factors such as the quality of the studies, consistency of results, nature and severity of effects, the presence of maternal toxicity in experimental animal studies, level of statistical significance for inter-group differences, number of endpoints affected, relevance of route of administration to humans and freedom from bias[; b]oth positive and negative results are assembled together into a weight of evidence determination[; a] single, positive study performed according to good scientific principles and with statistically or biologically significant positive results may justify classification’.
25      Furthermore, it should be recalled that the CLP Regulation concerns the assessment of hazards of substances and that that assessment must be distinguished from the risk assessment provided for in 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’). The assessment of hazards constitutes the first stage of the process of risk assessment, which is a more specific concept. Thus, an assessment of the hazards linked to the substances’ intrinsic properties must not be limited in light of specific circumstances of use, as in the case of a risk assessment, and may be properly carried out regardless of the place where the substance is used (in a laboratory or elsewhere), or the possible levels of exposure to the substance (see to that effect, judgment of 21 July 2011, Nickel Institute, C‑14/10, EU:C:2011:503, paragraphs 81 and 82).
Preliminary observations on the intensity of the Court’s review
26      As regards the intensity of the Court’s review, it should be observed that, in accordance with settled case-law, if the Commission is to be able to classify a substance pursuant to the CLP Regulation, account being taken of the complex scientific and technical assessments which it must undertake, it must be recognised as enjoying a broad discretion (see judgment of 22 November 2017, Commission v Bilbaína de Alquitranes and Others, C‑691/15 P, EU:C:2017:882, paragraph 34 and the case-law cited).
27      However, the exercise of that discretion is not excluded from review by the Court. The Court has consistently held that in the context of such a review, the EU judicature must verify whether the relevant procedural rules have been complied with, whether the facts admitted by the Commission have been accurately stated and whether there has been a manifest error of assessment or a misuse of powers (see judgment of 18 July 2007, Industrias Químicas del Vallés v Commission, C‑326/05 P, EU:C:2007:443, paragraph 76 and the case-law cited).
28      In particular, where a party claims that the institution competent in the matter has committed a manifest error of assessment, the EU judicature must verify whether that institution has examined, carefully and impartially, all the relevant facts of the individual case on which that assessment was based. That duty to act diligently is inherent in the principle of good administration and applies generally to the actions of the EU administration (see judgment of 22 November 2017, Commission v Bilbaína de Alquitranes and Others, C‑691/15 P, EU:C:2017:882, paragraph 35 and the case-law cited).
29      Moreover, the limits of the review by the EU judicature do not affect their duty to establish whether the evidence relied on is factually accurate, reliable and consistent, and whether that evidence contains all the information which must be taken into account in order to assess a complex situation, and whether it is capable of substantiating the conclusions drawn from it (see, to that effect, judgment of 6 November 2008, Netherlands v Commission, C‑405/07 P, EU:C:2008:613, paragraph 55 and the case-law cited).
30      It must be added that, in order to establish that the administration made a manifest error in assessing complex facts such as to justify the annulment of the contested measure, the evidence adduced by the applicant must be sufficient to make the factual assessments used in that measure implausible. Without prejudice to that examination of plausibility, it is not for the General Court to substitute its assessment of complex facts for that of the institution which adopted the measure (see judgment of 17 May 2018, BASF Agro and Others v Commission, T‑584/13, EU:T:2018:279, paragraph 94 and the case-law cited; see also, to that effect and by analogy, judgment of 14 June 2018, Lubrizol France v Council, C‑223/17 P, not published, EU:C:2018:442, paragraph 39).
31      Furthermore, as regards the evaluation of scientific studies, the Court has already held that the Commission must be recognised as enjoying a broad discretion with regard to that assessment, as well as the choice of studies which must take precedence over others, irrespective of their chronology. Thus, it is not sufficient for the applicant to rely on the age of a scientific study to call into question its reliability, but it is also necessary for the applicant to provide sufficiently precise and objective evidence to argue that any recent scientific developments would challenge the soundness of the conclusions of such a study (see, to that effect, judgment of 24 October 2018, Deza v Commission, T‑400/17, not published, EU:T:2018:712, paragraph 95).
32      It is in the light of those considerations that the applicant’s pleas in law must be examined.
The first plea in law, alleging failure to take into consideration all the available information on DBTO
33      The applicant claims that the Commission adopted the contested regulation in infringement of Articles 36(1)(d) and 37(5) of the CLP Regulation, of Section 3.7.2.3.1 of Annex I to that regulation, and of Article 77(3)(c) of the REACH Regulation, as well as in breach of the principle of good administration and the duty of care, because it did not duly take into account the combined repeated dose toxicity study of DBTO for reproduction and development in rats, according to the test method Guideline 422 of the Organisation for Economic Co-operation and Development (OECD) (‘the TG 422 study’).
34      In the first place, it follows from Sections 1.1.1.3 and 3.7.2.3.1 of Annex I to the CLP Regulation that, in order to determine the reproductive toxicity of a substance, the Commission is obliged to take into account all available data and to examine it together, with a view to assessing its relevance, reliability and importance in the context of the weight of evidence assessment. ECHA and the Commission examined the TG 422 study merely to a limited extent. First, they rejected it by maintaining, incorrectly, that it was only a screening study. Second, in the context of the weight of evidence determination, they did not examine the TG 422 study together with all the other data, in particular the June 2017 prenatal developmental toxicity study of DBTO in rats, according to test method guideline 414 of the OECD (‘the 2017 TG 414 study’).
35      In the second place, the applicant claims that the TG 422 study is decisive evidence for the assessment of the reproductive toxicity of DBTO, which could have led to different conclusions for the classification of DBTO. Only the TG 422 and the 2017 TG 414 studies have DBTO itself as their subject matter and comply with OECD guidelines and the principles of good laboratory practice. In addition, the TG 422 study casts serious doubts on the reliability of the study by Noda et al. (1993) (‘the 1993 Noda study’) on the teratogenic effects of various di-n-butyltin compounds in rats, as well as on the appropriateness of the classification of DBTO based on read-across. In addition, the TG 422 study, which is the only study analysing fertility and sexual function, shows that DBTO should not have been classified for its effect on the impairment of fertility.
36      In the third place, in so far as the TG 422 study was subsequent to the RAC opinion, the Commission should have mandated ECHA to request RAC to review its opinion to take account of that study, pursuant to Article 77(3)(c) of the REACH Regulation. The RAC is the scientific body responsible for determining the weight of evidence of the data and, consequently, ECHA’s comments on the TG 422 study could therefore not replace RAC’s assessment of that study.
37      In the fourth place, the Commission breached the principle of good administration and the duty of care in that it failed to examine, fully and appropriately, all the available information and did not request RAC to review its opinion having regard to the TG 422 study.
38      The Commission, supported by the Kingdom of the Netherlands, the Republic of Austria, the Kingdom of Sweden and ECHA, disputes those arguments.
39      The applicant submits, in essence, that the Commission committed a manifest error of assessment in that it did not take due account of the TG 422 study, even though that study constitutes a decisive piece of evidence for the assessment of the toxicity of DBTO, which had led to different conclusions on the classification of that substance. More specifically, the applicant claims that the Commission reviewed that study in a limited manner, without taking it into account together with the other pieces of evidence, in particular the 2017 TG 414 study. In addition, according to the applicant, as the TG 422 study was subsequent to the RAC opinion, the Commission should have requested RAC to review its opinion in the light of that study.
40      It follows from Article 37(5) of the CLP Regulation that the Commission must adopt delegated acts only where it finds that the harmonisation of the classification and labelling of the substance concerned is appropriate (see paragraph 18 above). Furthermore, it follows from Section 3.7.2.3.1 of Annex I to the CLP Regulation, read in conjunction with Article 36(1)(d) and Article 37(5) of that regulation, that classification as a reproductive toxicant is to be made on the basis of an assessment of the total weight of evidence. To that end, the Commission must take into account all available information contributing to the determination of reproductive toxicity. Moreover, the weight given to the available evidence is to be influenced by factors such as the quality of the studies, consistency of the results, nature and severity of the effects. In addition, both positive and negative results are assembled together into a weight of evidence determination (see paragraph 24 above).
41      In the present case, first of all, it is apparent from the file that the TG 422 study consisted of the preliminary results of 6 July 2022 and the draft report of 9 March 2023. It follows that that study was subsequent to the RAC opinion (see paragraph 6 above), but prior to the contested regulation (see paragraph 8 above).
42      Next, it is apparent from the file, and in particular from an annex to the application, that, in response to a request to review the RAC opinion, following the disclosure of the TG 422 study, ECHA produced a document containing its comments on that study. It concluded that that study did not provide evidence capable of overturning the conclusion in the RAC opinion that the classification of DBTO as toxic for reproduction in Category 1B was justified.
43      In that regard, ECHA observed that the TG 422 study was a screening study which was not intended to provide evidence of the absence of adverse effects on sexual function and fertility or development. Due, inter alia, to the choice of the effects and to the short duration of the study, the method followed did not provide evidence such as to substantiate a definitive conclusion as to the absence of toxic effects on reproduction and development. In addition, it took the view that the TG 422 study did not make it possible to disregard the conclusions of the 2017 TG 414 study. Moreover, it considered that the TG 422 study had not examined, inter alia, skeletal malformations, which had been found in other studies, including the 1993 Noda study. In addition, ECHA did not share the view that the TG 422 study had not observed any effect on the development of the offspring. In contrast, ECHA considered that that study had noted a reduction in the weight of descendants and a lower survival rate.
44      Lastly, it is apparent from the file that ECHA’s comments referred to in paragraph 43 above were communicated at the ad hoc meeting of the expert group ‘Competent Authorities for REACH and CLP’ (‘CARACAL’) of 25 May 2023, at which, inter alia, industry associations representing the applicant were present. At that meeting, the Commission stated that it shared ECHA’s comments on the TG 422 study and those of certain Member States and that it considered that the classification of DBTO as toxic for reproduction, Category 1B, was still appropriate. The Commission also concurred with the view that a possibly negative screening study did not guarantee the absence of any hazardous property for reproductive toxicity, with the result that a different outcome could not be expected upon a review of all the available data.
45      In that regard, it should be observed that CARACAL is an expert group composed of representatives of the competent national authorities for REACH and CLP, representatives of the competent authorities of the European Economic Area (EEA) and the European Free Trade Association (EFTA), as well as observers from non-EU Member States, industry stakeholders, professional associations, non-governmental organisations (NGOs), trade unions and international organisations. CARACAL assists the Commission and ECHA in the implementation of the REACH and CLP Regulations, in accordance with Article 121 of the REACH Regulation and Article 43 and Article 53a(4) of the CLP Regulation.
46      In the first place, it should be noted that, contrary to what the applicant claims, the Commission and ECHA did take into account the TG 422 study in the weight of evidence assessment, referred to in Section 3.7.2.3.1 of Annex I to the CLP Regulation. Furthermore, the applicant’s assertion that the ad hoc CARACAL meeting cannot constitute an appropriate examination of the TG 422 study is speculative and, in any event, unsubstantiated.
47      It is apparent from paragraphs 41 to 44 above that ECHA submitted comments on the TG 422 study which were communicated at the ad hoc CARACAL meeting of 25 May 2023, at which, inter alia, industry associations representing the applicant were present. The Commission, following ECHA’s comments, concluded that the classification of DBTO as toxic for reproduction, Category 1B, was still appropriate, within the meaning of Article 37(5) of the CLP Regulation. As a result of that, the Commission and ECHA took the TG 422 study into account together with, inter alia, the 2017 TG 414 and the 1993 Noda studies.
48      In the second place, it should be noted that it has not been demonstrated in the present case that the Commission’s assessment of the TG 422 study and its probative value in the total weight of evidence is vitiated by a manifest error of assessment, that is to say, that it lacks plausibility, within the meaning of the case-law referred to in paragraph 30 above.
49      In that regard, the applicant submits, in essence, that the TG 422 study constitutes a decisive piece of evidence for the assessment of the toxicity of DBTO. By contrast, ECHA considered that the TG 422 study was a screening study which did not provide the proof enabling the conclusion that there were no reproductive toxic effects and that it did not rule out the adverse effects of DBTO observed in the 2017 TG 414 study. In addition, the applicant submits that the TG 422 study casts doubt on the reliability of the 1993 Noda study, whereas ECHA considered that the skeletal malformations observed during that study had not been examined by the TG 422 study. Moreover, the applicant submits that the TG 422 study demonstrates that DBTO should not have been classified for its effect on the impairment of fertility, whereas ECHA considered that the TG 422 study was not intended to provide evidence of the absence of effects on, inter alia, fertility.
50      It follows that the Commission, like ECHA, took the view that the TG 422 study, which consisted solely of preliminary results and a draft report (see paragraph 41 above), was only a screening study which did not provide the necessary evidence to support the conclusion that there were no reproductive toxic effects and that it did not rule out the adverse effects of DBTO observed in the 2017 TG 414 study. The applicant’s arguments, which are limited to presenting an assessment of the TG 422 study which differs from that followed by the Commission, are not such as to call into question the plausibility of that assessment by the Commission.
51      In that regard, it should be borne in mind that, in accordance with the case-law cited in paragraph 31 above, the Commission must be recognised as enjoying a broad discretion as regards the assessment of scientific studies and the choice of those which should take precedence over others. Therefore, in the absence of any challenge to the plausibility of the Commission’s assessment, it follows from the case-law cited in paragraph 30 above that the General Court cannot substitute itself for the Commission and ECHA in the assessment of the results of the 2017 TG 414 and TG 422 studies and their probative value in the assessment of the total weight of evidence.
52      In the third place, the applicant’s argument that the Commission is legally obliged to request RAC to review the toxicity of DBTO by issuing a new opinion in the light of the LD 422 study must be rejected.
53      RAC is, admittedly, responsible for preparing an opinion on any proposal for harmonised classification and labelling, in accordance with Article 76(1)(c) of the REACH Regulation and Article 37(4) of the CLP Regulation. Furthermore, at the request of the Executive Director of ECHA, RAC may be responsible for drawing up an opinion on any other aspects concerning the safety of substances, in accordance with Article 77(3)(c) of the REACH Regulation.
54      However, it does not follow from those provisions that, in the circumstances of the present case, the Commission was required to request RAC to review its opinion that it had already issued on the toxicity of DBTO.
55      In that regard, it should be noted that, as regards the classification in dispute, the Commission followed the procedure for harmonisation of classification and labelling referred to in Article 37 of the CLP Regulation, as regards, inter alia, the participation of RAC. Thus, following the classification proposal and the observations of the Member States and stakeholders on that proposal, RAC issued its opinion on the toxicity of DBTO (see paragraphs 4 to 6 above). Next, the contested regulation was adopted on the basis of the RAC opinion (see paragraph 8 above).
56      It therefore follows from the circumstances of the present case that, first, on the date on which the TG 422 study was communicated to the Commission, RAC had already issued the opinion referred to in Article 37(4) of the CLP Regulation.
57      Second, as is apparent from paragraphs 7 and 50 above, the Commission considered that the additional information which it had received, including the TG 422 study, was insufficient to call into question the scientific analysis set out in the RAC opinion.
58      The Commission followed ECHA’s comments on the TG 422 study, the preliminary results and the draft report of which are subsequent to the RAC opinion (see paragraph 41 above). In essence, ECHA considered that that study was a screening study which was not intended to provide evidence of the absence of adverse effects on reproduction (see paragraphs 43, 49 and 50 above). The Commission concluded from that that the harmonised classification and labelling of DBTO remained appropriate (see paragraph 44 above).
59      As noted in paragraphs 48 and 50 above, it has not been demonstrated in the present case that the Commission committed a manifest error of assessment in following ECHA’s comments on the TG 422 study.
60      In those circumstances, in view of the Commission’s assessment of the TG 422 study, the plausibility of which is not called into question by the applicant’s arguments, the Commission cannot be criticised for not having requested RAC to review its opinion in the light of that study.
61      In the fourth place, and consequently, the applicant is incorrect to claim that the Commission did not examine all the available information. A breach of the principle of good administration and of the duty of care has therefore not been demonstrated in the present case.
62      In addition, in so far as, by the argument alleging breach of the duty of care, the applicant submits that the Commission did not carry out its own scientific assessment, suffice it to observe that, for the purposes of the contested regulation, the Commission relied on the RAC opinion (see paragraphs 6 and 8 above) and, in particular, on scientific assessments carried out within ECHA and CARACAL (see paragraphs 43 and 44 above), in accordance with the procedure for harmonisation of classification and labelling under the CLP Regulation (see paragraphs 18 and 55 above).
63      It follows from the foregoing that an infringement of Article 36(1)(d), of Article 37(5), of Section 3.7.2.3.1 of Annex I to the CLP Regulation and of Article 77(3)(c) of the REACH Regulation has not been demonstrated in the present case.
64      Consequently, the applicant’s argument alleging breach of the principle of good administration and of the duty of care must also be rejected, as it has not been demonstrated that the Commission had failed to examine, carefully and impartially, all the relevant information for the purposes of the classification in dispute.
65      Furthermore, as regards the applicant’s line of argument relating to read-across, it is appropriate to examine that in the context of the second plea in law.
66      Consequently, the first plea in law must be rejected as being unfounded.
The second plea, alleging a flawed and unlawful application of the read-across approach
67      The applicant submits that, to the extent that the Commission based the classification in dispute on the read-across approach, it committed manifest errors of assessment and infringed Articles 36(1)(d) and 37(5) of the CLP Regulation and Sections 1.1.1.3 and 3.7.2.3.1 of Annex I to that regulation, as well as the relevant requirements of Annex XI to the REACH Regulation, ECHA’s 2013 guidance on Grouping of substances and read-across approach and ECHA’s 2017 ‘Read-Across Assessment Framework’ guidance (‘RAAF’).
68      In the first place, the applicant claims that the read-across approach can be adopted only in situations in which the information on the classified substance itself is scarce and that, as a result, the Commission committed a manifest error of assessment by adopting the classification in dispute on the basis of that approach, to the detriment of the available data from studies specifically on DBTO, namely the 2017 TG 414 study and the TG 422 study. The read-across approach may be used only in the absence of information on the substance covered by the classification. In the present case, although studies on DBTO exist, the classification in dispute is based exclusively on data extrapolated from studies on other substances, namely dibutyltin dichloride (‘DBTC’), and dibutyltin maleate (‘DBTM’), dibutyltin (di)acetate (‘DBTA’), dibutyltin dilaurate (‘DBTL’) and dibutylbis (pentane-2,4-dionato-O_O’) tin (‘DBTP’).
69      In the second place, the applicant submits that the Commission committed a manifest error of assessment inasmuch as the read-across between DBTO and DBTC was not substantiated by scientific evidence or justified in accordance with the provisions of Section 1.5 of Annex XI to the REACH Regulation, the ECHA guidelines and the RAAF.
70      The applicant submits, first, that the read-across approach could be used only for substances that were demonstrated to be structurally similar and to have similar physiochemical, toxicological and ecotoxicological properties. However, RAC did not substantiate its conclusion that DBTO and DBTC have similar toxicological properties. In that regard, according to the applicant, RAC incorrectly relied on the 1993 Noda study. Moreover, the difference between the effects produced by DBTO and DBTC became even more obvious when the TG 422 study was considered together with the 2017 TG 414 study. In addition, the applicant states that RAC, on the basis of the 2017 TG 414 study, only found that the properties of DBTC regarding immunotoxicity could not be relevant for the purpose of classifying DBTO in the hazard class reproductive toxicity.
71      The applicant submits, second, that the read-across approach could be adopted only if the formation of a common substance was demonstrated. In the present case, RAC based the read-across on the common hydrolytic behaviour of DBTO and DBTC, without however demonstrating that those substances hydrolyse to form a toxicologically relevant, common substance. In other words, RAC was not in a position to demonstrate that DBTO belonged to a category of substances, which was a prerequisite for the application of the read-across approach. In that regard, firstly, RAC failed to take into account that the original assumption, according to which DBTO would form DBTC, had been replaced by the understanding that DBTO formed distannoxane dimer. Secondly, according to the applicant, RAC failed to examine whether the differences between the half-life of DBTO and that of DBTC might explain the different effects observed in the animal studies on those substances. Thirdly, it failed to assess the possible formation of non-common substances in the context of read-across based on bio-transformation.
72      Furthermore, in the context of the first plea in law, the applicant submitted that the TG 422 study cast serious doubts on the appropriateness of the classification of DBTO based on read-across.
73      The Commission, supported by the Kingdom of the Netherlands, the Republic of Austria, the Kingdom of Sweden and ECHA, disputes those arguments.
74      As a preliminary point, it should be noted that, in the procedure for harmonisation of classification and labelling of substances, it follows from Article 9(3) of the CLP Regulation that where the criteria for classification for each hazard class cannot be applied directly to available identified information a weight of evidence approach must be used, in accordance with Section 1.1.1 of Annex I to that regulation. More specifically, it follows from Section 1.1.1.3 of that annex that the weight of evidence determination means that all available information bearing on the determination of hazard is to be considered together, including information from the application of the category approach, which includes read-across.
75      As regards weight of evidence of the hazard class reproductive toxicity, Section 3.7.2.3.1 of Annex I to the CLP Regulation provides that all available information that bears on the determination of reproductive toxicity is to be considered together. Evaluation of substances chemically related to the substance under study may also be included, ‘particularly when information on the substance is scarce’ (see paragraph 24 above).
76      Section 1.5 of Annex XI to the REACH Regulation provides inter alia that ‘substances whose physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or “category” of substances’ and that ‘[the a]pplication of the group concept requires that physicochemical properties, human health effects and environmental effects or environmental fate may be predicted from data for reference substance(s) within the group by interpolation to other substances in the group (read-across approach)’. That section adds that ‘this avoids the need to test every substance for every endpoint.’
77      The provisions of Section 1.5 of Annex XI to the REACH Regulation are relevant to the procedure for harmonisation of classification and labelling at issue in the present case, in accordance with Article 5(1)(c), Article 6(1)(c) and Article 8(1) of the CLP Regulation.
78      In the present case, it is apparent from the file that the classification proposal was based on studies on DBTO and on read-across from studies on DBTC, DBTM, DBTA, DBTL and DBTP (together, ‘the substances in the category’). According to that proposal, the substances in the category had been regrouped on the basis of their common hydrolytic behaviour, the result of hydrolysis being a common tin compound that was responsible for the toxic effects observed.
79      It is apparent from the RAC opinion that RAC agreed with the read-across approach proposed in the classification proposal, taking into account, inter alia, the metabolism studies and similar toxicological profiles of the substances in the category. According to RAC, the classification proposal for DBTO in the hazard class reproductive toxicity was based, in particular, on studies on DBTC, and supported by studies dealing with other substances in the category, which is consistent with RAC opinions on those other substances.
80      In particular, as regards adverse effects on sexual function and fertility, RAC considered that there were no data available on DBTO and that the assessment had to be based on studies with DBTC, in the same way as the assessment already carried out for several substances in the category, namely DBTA, DBTP and DBTL. As regards the adverse effects on development, RAC referred to two studies on DBTO, namely the 2017 TG 414 study and the 1993 Noda study, the latter being a comparative study of several substances in the category, including DBTO, as well as other studies with DBTC and DBTA.
81      RAC concluded that the read-across was robust and valid and that the data from substances in the same category as DBTO, in particular DBTC, could be used to assess the reproductive toxicity of DBTO.
82      Furthermore, Annex 1 to the RAC opinion contains a compilation of information considered relevant by the author of the classification proposal or by RAC for the purposes of the proposed classification, including, in Section 9 thereof, detailed information on the scientific reasons why the read-across approach was justified, the common properties of the substances in the category and the application of that approach in the present case.
83      In the first place, the applicant maintains that the classification in dispute was based on read-across to the detriment of studies specifically on DBTO, in particular the TG 422 study.
84      First, that claim is contradicted by the RAC opinion, under which the classification in dispute was also based on two studies on DBTO, namely the 2017 TG 414 and 1993 Noda studies. In addition, it is also apparent from the RAC opinion that there were no studies on DBTO concerning adverse effects on sexual function and fertility (see paragraph 80 above).
85      Second, as regards the TG 422 study, it should be recalled that, as is apparent from paragraphs 41 to 44 above, even though that study was subsequent to the RAC opinion, it was taken into account by ECHA and the Commission, together with the 2017 TG 414 and the 1993 Noda studies. However, the Commission concluded, as did ECHA, that that study was not capable of calling into question the classification of DBTO as toxic for reproduction, Category 1B, and that, therefore, that classification was still appropriate.
86      The applicant is therefore incorrect to claim that the classification in dispute is based on read-across to the detriment of studies on DBTO.
87      In the second place, the applicant submits that Section 3.7.2.3.1 of Annex I to the CLP Regulation must be interpreted as requiring that the read-across approach be used only in the absence of information on the substance covered by the classification.
88      In that regard, it should be noted that, in the weight of evidence approach, the Commission enjoys a broad discretion in choosing to use the read-across approach, in accordance with Section 3.7.2.3.1 of Annex I to the CLP Regulation, the content of which is set out in paragraph 75 above. In addition, it should be noted that it follows from the RAC opinion that, as regards adverse effects on development, the studies on DBTO were scarce and that, as regards adverse effects on sexual function and fertility, there were no studies on DBTO (see paragraph 80 above).
89      It follows from the foregoing that, contrary to what the applicant claims, the use of the read-across approach did not disregard Section 3.7.2.3.1 of Annex I to the CLP Regulation.
90      In the third place, the applicant claims that the Commission committed a manifest error of assessment in finding that the read-across between DBTO and DBTC was not supported by scientific evidence or justified.
91      However, contrary to what the applicant claims, RAC substantiated its conclusion that DBTO and DBTC had similar toxicological properties. It is apparent from the RAC opinion that RAC considered, like the author of the classification proposal, that those substances, together with others, had to be grouped into a category on the basis of their common hydrolytic behaviour and that the result of hydrolysis was a common tin compound which was responsible for the toxic effects observed (see paragraph 78 above). In addition, a detailed assessment in that regard is set out in Section 9 of Annex 1 to the RAC opinion, from which it is apparent, inter alia, that RAC took the view that, first, the substances in the category are structurally similar, that, second, they have similar hydrolytic behaviour and that they are likely to form common breakdown products, that is to say, a common hydrolysis product and that, third, they have similar toxicological profiles.
92      Furthermore, it should be noted that, by its line of argument, the applicant merely puts forward its own opinion on the question of what would be the conditions under which DBTO and DBTC could be regarded as similar, namely when their common hydrolytic behaviour would form a common substance. In that regard, the Commission must be recognised as enjoying broad discretion in determining the conditions under which two or more substances are similar, in accordance with the case-law cited in paragraph 26 above. Thus, the applicant’s line of argument is not capable of calling into question the plausibility of RAC’s assessments of the similarities between DBTO and DBTC, referred to in paragraph 91 above.
93      It follows that an infringement of Article 36(1)(d) and Article 37(5) of the CLP Regulation, as well as of Sections 1.1.1.3 and 3.7.2.3.1 of Annex I to that regulation and the applicable requirements of Annex XI to the REACH Regulation has not been demonstrated in the present case.
94      Furthermore, a breach of the ECHA guidance on the Grouping of substances and read-across approach from 2013 or the RAAF has also not been demonstrated in the present case. The applicant’s arguments in that regard overlap with those alleging infringement of the CLP and REACH Regulations, which have been rejected in paragraph 93 above. As to the remainder, even if the Commission were bound by those guidelines of which, however, it is not the author, the applicant does not explain how the Commission infringed the provisions of those documents.
95      Consequently, the second plea in law must be rejected as being unfounded.
The third plea in law, alleging a lack of clear evidence that DBTO has adverse effects on development of the offspring
96      The applicant submits that the classification in dispute was adopted in infringement of Article 36(1)(d) and of Article 37(5) of the CLP Regulation, as well as of Section 3.7.2.1.1 and Table 3.7.1(a) of Annex I to that regulation, inasmuch as it was not based on clear evidence establishing that the adverse effects of DBTO on development of the offspring occurred in the absence of other toxic effects, or, if other toxic effects were observed, that those developmental effects were not considered as a secondary non-specific consequence of those other toxic effects. In that regard, the applicant states that the Commission committed two manifest errors of assessment. In the first place, the Commission did not identify clear evidence that DBTO produced effects on development in the absence of severe maternal toxicity. In the second place, the Commission did not include the TG 422 study with all the studies on DBTO and, in particular, did not take that study into account to assess the influence of maternal toxicity.
97      The Commission, supported by the Kingdom of the Netherlands, the Republic of Austria, the Kingdom of Sweden and ECHA, disputes those arguments, contending that the present plea in law is ineffective and, in any event, unfounded.
98      The applicant submits, in essence and in the first place, that it did not identify clear evidence that DBTO produced effects on development of the offspring in the absence of severe maternal toxicity.
99      As a preliminary point, it should be recalled that the first paragraph of Section 3.7.1.1 of Annex I to the CLP Regulation and points (a) and (b) of the second paragraph thereof, provide that reproductive toxicity is subdivided into two ‘headings’ of adverse effects, the first relating to adverse effects on sexual function and fertility in adult males and females and the second to adverse effects on development of the offspring (see paragraph 20 above).
100    Section 3.7.1.4 of Annex I to the CLP Regulation defines adverse effects on development of the offspring as corresponding to any effect which interferes with normal development of the conceptus, either before or after birth, the major manifestations of developmental toxicity including death of the developing organism, structural abnormality, altered growth, and functional deficiency (see paragraph 22 above).
101    Section 3.7.2.2.1 of Annex I to the CLP Regulation requires that the effect of specifically harming reproduction, or even of specifically harming development of the offspring, is not to be considered as a ‘non-specific secondary consequence of other toxic effects’.
102    As regards the influence of maternal toxicity on the adverse effects on development, Section 3.7.2.2.2 of Annex I to CLP Regulation provides that, in the evaluation of toxic effects on the developing offspring, it is important to consider the possible influence of maternal toxicity.
103    In the present case, as regards the adverse effects of DBTO on development and the possible influence of maternal toxicity, it is apparent from the RAC opinion that, in the context of a study which was conducted on DBTO, namely the 2017 TG 414 study, the effects of developmental toxicity had been observed due to an increased number of post-implantation losses and foetal malformations. In addition, maternal toxicity was shown by a reduction in body weight, lower body weight gain, reduced food consumption and clinical signs. Two mothers in the high-dose group were sacrificed as a last resort, while three mothers showed no clear signs of maternal toxicity.
104    Moreover, the RAC opinion states that the 1993 Noda study, which was a comparative study of several substances, including DBTO (see paragraph 80 above), had not shown maternal mortality or signs of maternal toxicity.
105    In addition, the RAC opinion states that in several studies with DBTC and DBTA, which consistently showed a dose-dependent increase in foetal effects, maternal effects were minimal or absent at the lowest doses that induced foetal effects.
106    It follows from the foregoing that the RAC opinion identified adverse effects of DBTO on development, within the meaning of Section 3.7.1.4 of Annex I to the CLP Regulation (see paragraph 100 above), consisting of post-implantation losses and foetal malformations. As regards the possible influence of maternal toxicity, RAC concluded, inter alia, that there was clear evidence that DBTO caused adverse effects on development, even at low levels of maternal toxicity or in the absence thereof.
107    Furthermore, it should be noted that Section 3.7.2.3.5 of Annex I to the CLP Regulation provides that ‘generally, the presence of maternal toxicity shall not be used to negate findings of embryo/foetal effects, unless it can be clearly demonstrated that the effects are secondary non-specific effects.’ Similarly, Section 3.7.2.4.3 of the same annex provides that ‘classification shall not automatically be discounted for substances that produce developmental toxicity only in association with maternal toxicity, even if a specific maternally mediated mechanism has been demonstrated.’
108    In the present case, for the reasons set out in paragraphs 104 to 107 above, RAC found that adverse effects on development of DBTO were not a secondary consequence of maternal toxicity. The applicant’s line of argument does not call that assessment into question.
109    Therefore, the applicant’s argument that the classification in dispute is not based on clear evidence that DBTO produces effects on the development of the offspring in the absence of severe maternal toxicity must be rejected.
110    The applicant submits, in the second place, that, as regards the influence of maternal toxicity, the Commission did not take into account the TG 422 study together with all the studies on DBTO.
111    However, as is apparent from paragraphs 46 and 58 above, although the TG 422 study was subsequent to the RAC opinion, it is apparent from the CARACAL ad hoc meeting of 25 May 2023 that the Commission and ECHA took that study into account in the total weight of evidence assessment, referred to in Section 3.7.2.3.1 of Annex I to the CLP Regulation, and that they took it into account together with, inter alia, the 2017 TG 414 and 1993 Noda studies. By contrast, the Commission concluded, like ECHA, that that study was a screening study which was not intended to provide evidence of the absence of adverse effects on reproduction and, consequently, concluded that the harmonised classification and labelling of DBTO as toxic for reproduction, Category 1B, remains appropriate.
112    In the absence of a manifest error of assessment, which the applicant’s arguments do not demonstrate, the General Court cannot substitute itself for the Commission in its assessments of a scientific and complex nature.
113    Accordingly, the third plea in law must be rejected as being unfounded, without it being necessary to examine the Commission’s arguments alleging its ineffectiveness.
The fourth plea in law, alleging absence of public consultation on the RAC opinion
114    The applicant submits that the contested regulation was adopted in infringement of Article 37(4) of the CLP Regulation, inasmuch as the Commission should have organised a public consultation on the RAC opinion and not only on the classification proposal. It is apparent from the literal, teleological and contextual interpretations of that provision that it gives the parties concerned the right to comment on the RAC opinion. First, in so far as it is RAC, and not the Commission, which is required to give the parties concerned the opportunity to comment, those comments must necessarily be on its opinion. Second, the intention of the legislature is to give the parties concerned the opportunity to comment on the main scientific document on the basis of which the harmonised classification is adopted. Furthermore, the case-law arising from the judgment of 5 July 2023, TIB Chemicals v Commission (T‑639/20, not published, EU:T:2023:374, paragraph 184) concerned developments particular to that judgment, regarding the right to be heard, and should not be applied in the present case. In the present case, if the parties concerned had had the opportunity to comment on the RAC opinion, the outcome might have been different. Although the classification proposal and the RAC opinion refer to the same studies, the RAC opinion followed a different, even erroneous, approach to justify the read-across, on which the applicant did not have the opportunity to comment.
115    The Commission, supported by the Kingdom of the Netherlands, the Republic of Austria, the Kingdom of Sweden and ECHA, disputes those arguments.
116    As a preliminary point, it should be recalled that, according to Article 41(2)(a) of the Charter of Fundamental Rights of the European Union, the right to good administration includes the right of every person to be heard, before any individual measure which would affect him or her adversely is taken. Respect for the right to be heard is, in all proceedings initiated against a person which are liable to culminate in a measure adversely affecting that person, a fundamental principle of EU law which must be guaranteed even in the absence of rules governing the proceedings in question. That principle requires that the addressees of decisions which significantly affect their interests should be placed in a position in which they can effectively make known their views on the accusation made against them forming the basis of the contested measure (see, to that effect, judgment of 19 December 2019, Probelte v Commission, T‑67/18, EU:T:2019:873, paragraph 86 and the case-law cited).
117    By contrast, in the case of acts of general application, neither the process of drafting them nor those acts themselves require, in accordance with the general principles of EU law, such as the right to be heard, consulted or informed, the participation of the persons affected. That is not the case if an express provision of the legal context governing the adoption of that act confers a procedural right on a person affected (see, to that effect, judgment of 19 December 2019, Probelte v Commission, T‑67/18, EU:T:2019:873, paragraph 87 and the case-law cited).
118    In the present case, the contested regulation lays down measures of general application, including the classification in dispute. As is apparent from paragraph 8 above, Article 1 of that regulation lays down a measure of general application concerning the inclusion of the substances constituting DBTO on the ‘list of harmonised classification and labelling of hazardous substances’, which is set out in Table 3 of Part 3 of Annex VI to the CLP Regulation.
119    Against that background, the procedural rights which the applicant enjoys in the procedure for harmonisation of classification and labelling of substances are those provided for in the CLP Regulation (see, to that effect, judgment of 5 July 2023, TIB Chemicals v Commission, T‑639/20, not published, EU:T:2023:374, paragraph 180 and the case-law cited).
120    In that regard, Article 37(4) of the CLP Regulation provides that RAC ‘shall adopt an opinion on any proposal submitted pursuant to paragraphs 1 or 2 [of that article] within 18 months of receipt of the proposal, giving the parties concerned the opportunity to comment’ and that ECHA ‘shall forward this opinion and any comments to the Commission’.
121    Article 37(4) of the CLP Regulation must be interpreted in the light of the procedure for harmonisation of classification and labelling of substances, referred to in that article. As stated in paragraph 18 above, that procedure takes place in several stages, consisting in, first of all, the submission of a classification proposal, next, the adoption of an opinion by RAC ‘giving the parties concerned the opportunity to comment’, then, the forwarding by ECHA of that opinion and any comments to the Commission, and, lastly, the adoption by the Commission of a delegated act, where it considers that harmonisation of the classification and labelling of the substance concerned is appropriate.
122    It follows that the public consultation provided for in Article 37(4) of the CLP Regulation is intended to allow interested parties to comment on the classification proposal and thus possibly to communicate elements not mentioned in that proposal, in order to allow RAC to take into account, in its opinion, the comments and elements presented by the interested parties during that phase (see, to that effect and by analogy, judgment of 9 June 2021, Exxonmobil Petroleum & Chemical v ECHA, T‑177/19, not published, EU:T:2021:336, paragraph 236 and the case-law cited).
123    Accordingly, it should be noted that, although Article 37(4) of the CLP Regulation provides for the possibility to submit comments on the proposal for harmonised classification and labelling, that regulation does not, however, provide for the possibility for the parties concerned to submit observations on the RAC opinion (see, to that effect, judgment of 5 July 2023, TIB Chemicals v Commission, T‑639/20, not published, EU:T:2023:374, paragraph 184).
124    It follows from the foregoing that, in the present case, the applicant had the right to comment on the proposals for harmonised classification and labelling and to be heard in that regard before RAC. The parties concerned were invited to comment on the classification proposal by 29 January 2021, which several of them did (see paragraph 5 above). In addition, as is apparent from the file, RAC drew up a document with the comments received and its responses to those comments. In addition, RAC expressly states that it took those comments into account in its opinion.
125    It also follows from the foregoing that, in accordance with the case-law cited in paragraphs 119 and 123 above, Article 37(4) of the CLP Regulation does not provide for the opportunity for the parties concerned, including the applicant, to submit observations on the RAC opinion.
126    Contrary to what the applicant appears to claim, the fact that it is for ECHA and not the Commission to organise the public consultation referred to in Article 37(4) of the CLP Regulation does not alter that conclusion. As recalled in paragraph 123 above, the public consultation provided for in that article seeks, inter alia, to ensure that the parties concerned may provide information not stated in the classification proposal in order to enable RAC to take them into account in its opinion.
127    Furthermore, the applicant is wrong to maintain that the case-law referred to in paragraph 123 above cannot be applied in the present case. Indeed, the case referred to in paragraph 123 and the present case are similar, in so far as they both concern the question whether Article 37(4) of the CLP Regulation confers on the parties concerned the right to comment on the RAC opinions.
128    Moreover, the applicant’s argument that the outcome of the procedure for harmonisation of the classification and labelling of DBTO would have been different if the parties concerned had had the opportunity to submit comments on the RAC opinion must be rejected at the outset since it is hypothetical and cannot, in any event, affect the interpretation of Article 37(4) of the CLP Regulation, which is at issue in the present case. Moreover, it is apparent from the file that, as the applicant itself acknowledges, industry associations representing, inter alia, the applicant, were able, during the CARACAL meetings, to make their views known after the adoption of the RAC opinion.
129    It follows that an infringement of Article 37(4) of the CLP Regulation has not been demonstrated in the present case.
130    In the light of all of the foregoing, the fourth plea must be rejected as unfounded and, consequently, the action must be dismissed in its entirety.
Costs
131    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.
132    Since the applicant has been unsuccessful, it must be ordered to bear its own costs and to pay those incurred by the Commission, in accordance with the form of order sought by the latter.
133    Under Article 138(1) of the Rules of Procedure, the Member States and institutions which have intervened in the proceedings are to bear their own costs. Under Article 1(2)(g) of the Rules of Procedure, the term ‘institutions’ means the institutions of the European Union referred to in Article 13(1) TEU and the bodies, offices or agencies established by the Treaties, or by an act adopted in implementation thereof, which may be parties before the General Court. According to Article 100 of the REACH Regulation, ECHA is a body of the European Union. It follows that the Kingdom of the Netherlands, the Republic of Austria, the Kingdom of Sweden and ECHA are each to bear their own costs.
On those grounds,
THE GENERAL COURT (Sixth Chamber)
hereby:
1.      Dismisses the action;
2.      Orders PMC Vlissingen Netherlands BV to bear its own costs and to pay the costs incurred by the European Commission;
3.      Orders the Kingdom of the Netherlands, the Republic of Austria, the Kingdom of Sweden and the European Chemicals Agency (ECHA) each to bear their own costs.
Costeira
Kancheva
Zilgalvis
Delivered in open court in Luxembourg on 8 October 2025.
V. Di Bucci
S. Papasavvas
Registrar
President
*      Language of the case: English.