Judgment of the General Court (Sixth Chamber) of 21 January 2026

Preliminary considerations on the harmonised classification and labelling of substances in the hazard class reproductive toxicity

15 As a preliminary point, it should be noted that, in accordance with recital 1 and Article 1(1) of Regulation No 1272/2008, 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 within the EU market. As is apparent, in particular, from recitals 5 to 8, 10 and 27 of that regulation, the latter’s objective is to determine the intrinsic properties of substances which should 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 communicated. To that end, in accordance with Article 1(1)(a), that regulation aims, inter alia, to ‘[harmonise] the criteria for classification of substances and mixtures, and the rules on labelling and packaging for hazardous substances and mixtures’.

16 In addition, it is apparent from recitals 4 to 8 of Regulation No 1272/2008 that the EU legislature intended to contribute to the global harmonisation of criteria for classification and labelling, not only at the level of the United Nations Organisation, but also through the incorporation of the internationally agreed Globally Harmonized System of Classification and Labelling of Chemicals criteria 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 ).

17 As regards the classification of hazardous substances and mixtures, it should be noted that, according to Article 3 of Regulation No 1272/2008, a substance or a mixture fulfilling the criteria relating to physical hazards, health hazards or environmental hazards, as laid down in Annex I to that regulation, is hazardous and is to be classified in relation to the respective hazard classes provided for in that annex.

18 In that regard, Regulation No 1272/2008 provides, in Title V, for a procedure for harmonisation, throughout the European Union, of classification and labelling of substances, which concerns substances fulfilling the criteria set out in Annex I for the hazards listed in Article 36(1)(a) to (d) 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.

19 The procedure for 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, to ECHA, of a proposal for harmonised classification and labelling of that substance, in accordance with Article 37(1) and (2) of Regulation No 1272/2008. 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 4(4) of that regulation. Lastly, where the Commission finds that the harmonisation of classification and labelling of the substance concerned is appropriate, it is to 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.

20 As regards the hazard of reproductive toxicity, Article 36(1)(d) of Regulation No 1272/2008 provides that, if a substance fulfils 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 laid down in Section 3.7. of Annex I to the regulation.

21 In particular, in the first paragraph and in points (a) and (b) of the second paragraph of Section 3.7.1.1. of Annex I to Regulation No 1272/2008, it is provided 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 their offspring.

22 As regards hazard categories, it follows from Section 3.7.2.1.1. and from Table 3.7.1(a) of Annex I to Regulation No 1272/2008 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.

23 Furthermore, it should be noted that Regulation No 1272/2008 concerns the assessment of hazards of substances and that that assessment must be distinguished from the risk assessment provided for in Regulation No 1907/2006. 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

24 As regards the intensity of the Court’s review, it should be borne in mind that, according to settled case-law, if the Commission is to be able to classify a substance pursuant to Regulation No 1272/2008, 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).

25 However, the exercise of that discretion is not excluded from review by the Court. The latter 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 appraisal or a misuse of power (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).

26 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 sound 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).

27 Furthermore, the limits on the review by the EU judicature do not affect the latter’s duty to establish whether the evidence relied on is factually accurate, reliable and consistent and to review 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).

28 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 ).

29 Furthermore, as regards the evaluation of scientific studies, the Court has already held that the Commission must be allowed 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 call into question 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 ).

30 It is in the light of those considerations that the applicants’ pleas in law must be examined.

The first plea in law, alleging infringement of Article 36(1)(d) and Article 37(5) of Regulation No 1272/2008 and of Sections 1.1.1.3., 1.1.1.5., 3.7.2.1.1. and 3.7.2.3.1. and Table 3.7.1(a) of Annex I to that regulation

31 The present plea alleges infringement of Article 36(1)(d) and Article 37(5) of Regulation No 1272/2008 and of Sections 1.1.1.3., 1.1.1.5., 3.7.2.1.1. and 3.7.2.3.1. and of Table 3.7.1(a) of Annex I to that regulation. It is divided into five complaints relating to:

• first, the lack of clear evidence demonstrating the relevance of adverse effects of DAPD in humans;

• second and third, failure to take into account all the relevant information;

• fourth, failure to use the read-across approach;

• fifth, infringement of Article 36(1)(d) and Article 37(5) of Regulation No 1272/2008.

32 The Commission, supported by the Federal Republic of Germany, the Kingdom of the Netherlands and ECHA, disputes the applicants’ arguments.

The second plea in law, alleging manifest errors of assessment

86 The applicants submit that the Commission made several manifest errors of assessment in classifying DAPD as a substance that is toxic for reproduction category 1B.

87 The Commission, supported by the Federal Republic of Germany, the Kingdom of the Netherlands and ECHA, disputes the applicants’ arguments.

88 In the first place, the applicants claim that, if the Commission had not wrongly presumed the relevance, for humans, of the adverse effects of DAPD that were observed in rats, or had not ignored the doubts which the applicants had raised in that regard, and if it had taken a view on the possible need for further testing, that would have led it to classify DAPD in category 2.

89 In that regard, it should be noted that the applicants’ arguments relating to the relevance, for humans, of the adverse effects of DAPD that were observed in rats are identical to the arguments put forward in the context of the first and second complaints of the first plea. Those arguments must therefore be rejected for the same reasons as those set out in paragraphs 35 to 45 and 50 to 68 above.

90 Furthermore, as regards the applicants’ argument concerning the lack of additional tests, it is appropriate to examine it in the context of the third plea.

91 In the second place, the applicants submit that, by relying on the RAC opinion, the Commission disregarded the mechanistic studies which, in the applicants’ view, give rise to doubts as to the mode of action of DAPD in humans. In particular, they argue that RAC should have considered that the absence of evidence supporting other explanations allowed, at most, a suspicion, rather than a presumption, that prostaglandin inhibition might be relevant to humans. In addition, the applicants argue that the Commission wrongly rejected the importance of the data relating to the constituent DPPD showing that prostaglandin inhibition is the mechanism that is actually responsible for dystocia in rats.

92 In that regard, it is sufficient to note that the arguments referred to in paragraph 91 above, alleging, in essence, that the Commission ignored mechanistic studies that gave rise to doubts as to the mode of action of DAPD in humans, namely studies on the constituent DPPD, are identical to the arguments put forward in the fourth complaint of the first plea. Those arguments must therefore be rejected for the same reasons as those set out in paragraphs 70 to 82 above.

93 In the third place, the applicants submit that the Commission did not take into account the reversibility of the effects observed on kidneys (polycystic kidneys) following exposure to DAPD, when only the irreversible effects on reproduction justify a classification in category 1B. In addition, the post-implantation losses were not due to those effects on kidneys, which are developmental effects, but rather were due to dystocia, which is an effect on fertility.

94 As regards the reversibility of the effects observed on kidneys, it follows from the opinion of RAC that the latter considered that the fact that polycystic kidneys are also observed in adults indicates that the effect is not fully reversible and that, overall, it is not clearly established whether polycystic kidneys are the result of exposure to DAPD in utero, via lactation or via diet (or a combination thereof).

95 As regards post-implantation losses, it follows from the opinion of RAC that the latter considered that consistent and dose-related post-implantation losses were key to the classification of DAPD under the heading of developmental effects. In addition, it took the view that polycystic kidneys observed in offspring were a factor which supported that conclusion, given that the effects were regarded as permanent and serious, but that it was not certain that they were due solely to in utero exposure.

96 It follows that RAC, first, took into account the reversibility of polycystic kidneys and concluded that the effect was not entirely reversible and, second, considered that polycystic kidneys, the causes of which were unclear, were merely a factor in support of its conclusion that post-implantation losses were in themselves an irreversible and dose-related effect and therefore key to the classification of DAPD under the heading of developmental effects.

97 Accordingly, the applicants’ arguments concerning polycystic kidneys and post-implantation losses are based on a misreading of the RAC opinion and cannot therefore succeed. In any event, those arguments are not sufficient to call into question the plausibility of the RAC’s assessments and therefore to establish that the Commission made a manifest error of assessment.

98 In the fourth place, the applicants submit that the classification of DAPD in category 1B is arbitrary and unjustified, in so far as that substance is similar to salicylic acid and acetylsalicylic acid, which are classified as toxic for reproduction category 2. The applicants therefore rely on breach of the principle of equal treatment.

99 In that regard, it should be recalled that the principle of equal treatment requires that comparable situations must not be treated differently and different situations must not be treated in the same way unless such treatment is objectively justified (see judgment of 16 December 2008, Arcelor Atlantique et Lorraine and Others , C‑127/07, EU:C:2008:728, paragraph 23 and the case-law cited).

100 In addition, it must be borne in mind that the procedure for harmonisation of classification and labelling of substances, pursuant to Title V of Regulation No 1272/2008, relates only to the substance which, first of all, is the subject of the classification proposal submitted to the Commission, the initiative for which belongs to those identified in Article 37 of that regulation, next, is the subject of the RAC opinion on the proposal that was submitted and, lastly, is the subject of a delegated act of the Commission, where the latter considers that harmonisation is appropriate (see paragraph 19 above). In the present case, the procedure for harmonised classification and labelling at issue cannot therefore be based on a comparison between DAPD and other substances which have not been the subject of such a procedure.

101 The contested classification covers only DAPD, in accordance with the classification proposal and the procedure for harmonisation of classification and labelling which gave rise to it (see paragraphs 7 to 10 above). Thus, the fact that DAPD was classified as toxic for reproduction category 1B, whereas salicylic acid and acetylsalicylic acid were classified as toxic for reproduction category 2, cannot result in a breach of the principle of equal treatment, irrespective of any similarities between those acids and DAPD.

102 Consequently, the second plea must be rejected as being unfounded.

The third plea in law, alleging breach of the principle of proportionality, infringement of the rights of the defence and breach of the principle of good administration

103 In the first place, the applicants submit that the contested regulation is in breach of the principle of proportionality, laid down in Article 5(4) TEU, since the Commission should have pursued the objectives of Regulation No 1272/2008 by balancing that regulation’s various objectives, namely, on the one hand, to ensure a high level of protection of human health and the environment and, on the other hand, to ensure the free movement of chemical substances, while enhancing competitiveness and innovation. They assert that DAPD has already been the subject of self-classification decisions as toxic for reproduction category 2, which entails obligations similar to those in category 1B, in particular as regards the safety and protection of workers, and does not cause disproportionate disadvantages to manufacturers and users of DAPD, of which they are part. In addition, they complain that the Commission did not carry out the economic cost-benefit analysis, advocated by Communication COM(2000) 1 final of 2 February 2000 on the precautionary principle.

104 In the second place, the applicants submit that, when adopting the contested regulation, the Commission infringed their rights of defence, in particular the right to be heard, provided for in Article 41(2)(a) of the Charter of Fundamental Rights of the European Union. First of all, they submit that RAC did not respond to the comments which they had submitted, in writing, during the public consultation, and orally, at the meetings. Next, they claim that additional information was added to the RAC opinion, without the applicants having had the opportunity to examine it. Lastly, they state that, although the Commission had a meeting with their representative and authorised it to attend several meetings of the ‘Competent Authorities for REACH and CLP’ expert group, the Commission did not respond to the comments which they had made. In addition, they claim that they were not able to defend their position, since they had not been authorised to carry out additional animal testing and had been placed in the impossible situation of having to demonstrate that DAPD had no adverse effects in humans. Furthermore, they complain that the Commission disregarded the Interinstitutional Agreement of 13 April 2016 between the European Parliament, the Council of the European Union and the European Commission on Better Law-Making (OJ 2016 L 123, p. 1), which requires that a fair hearing be guaranteed and that all available information and evidence be examined before the adoption of a decision imposing constraints on the economic operators concerned.

105 In the third place, the applicants submit that the Commission acted in breach of the principle of good administration, referred to in Article 6(1) TEU and in Article 41 of the Charter of Fundamental Rights, in so far as it did not respect their right to be heard or take account of all the relevant scientific studies, as follows from the second plea. In their view, the Commission relied on the RAC opinion which did not take into account all the relevant scientific studies, thus failing to apply the weight of evidence approach.

106 The Commission, supported by the Federal Republic of Germany, the Kingdom of the Netherlands and ECHA, disputes the applicants’ arguments.

107 In the first place, as regards the applicants’ complaint alleging breach of the principle of proportionality, 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 (see judgment of 21 July 2011, Etimine , C‑15/10, EU:C:2011:504, paragraph 124 and the case-law cited).

108 With regard to judicial review of the conditions referred to in paragraph 107 above, in so far as adoption by the Commission of a directive or a regulation entails political, economic and social choices on its part, in which it is called upon to undertake complex assessments, it must be stated that the Commission has a broad discretion in that respect, so that judicial review of the legality of those acts is necessarily limited. The legality of a measure adopted in that sphere can be affected only if the measure is manifestly inappropriate having regard to the objective which the Commission is seeking to pursue (see judgment of 21 July 2011, Etimine , C‑15/10, EU:C:2011:504, paragraph 125 and the case-law cited).

109 In the present case, it should be noted at the outset that, as follows from the case-law cited in paragraph 24 above, the contested classification was made in a context of complex scientific and technical assessments which the Commission had to carry out and in respect of which it must be recognised as enjoying a broad discretion.

110 First of all, as regards the applicants’ argument alleging a failure to weigh up the objectives of Regulation No 1272/2008, it follows from paragraph 15 above that 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 within the EU market. The objective of that regulation is to determine the intrinsic properties of the substances which are to lead to their classification as hazardous products, so that the hazards posed by those substances (and mixtures containing such substances) can be correctly identified and communicated.

111 In addition, it follows from Article 1(1)(a) of Regulation No 1272/2008 that 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 substances, mixtures and articles as referred to in Article 4(8) of that regulation, by harmonising the criteria for classification of substances and mixtures, and the rules on labelling and packaging for hazardous substances and mixtures.

112 In that regard, first, it follows from Article 3 of Regulation No 1272/2008 that a substance or a mixture fulfilling the criteria relating to physical hazards, health hazards or environmental hazards, as laid down in Parts 2 to 5 of Annex I to that regulation, is hazardous and is to be classified in one of the hazard classes provided for in Annex I to that regulation.

113 In addition, it follows from Article 36 of Regulation No 1272/2008 that a substance that fulfils the criteria set out in Annex I to that regulation for the hazards indicated in paragraph 1(a) to (d) of that article, including for the hazard of reproductive toxicity, is normally subject to harmonised classification and labelling in accordance with Article 37 of that regulation.

114 Second, according to the free movement clause laid down in Article 51 of Regulation No 1272/2008, Member States are not to prohibit, restrict or impede the placing on the market of substances or mixtures which comply with that regulation and, where appropriate, with EU acts adopted in implementation of that regulation, on grounds relating to the classification, labelling and packaging of substances and mixtures within the meaning of that regulation.

115 It follows that, in the context of Regulation No 1272/2008, the objective of the free movement of chemical substances, mixtures and certain specific articles within the EU market cannot be achieved without ensuring a high level of protection of human health and the environment, which is achieved by, inter alia, the harmonised classification and labelling of substances in order to identify and communicate their hazards. Moreover, harmonised classification and labelling do not result in a prohibition on the placing on the market of substances which comply with the provisions of that regulation.

116 Thus, in the present case, the contested classification, in so far as it adopts a harmonised classification and labelling under Article 37 of Regulation No 1272/2008, in order to identify and communicate the reproductive toxicity hazard of DAPD, must be regarded as a means of enhancing protection of health which, however, does not prevent the free movement of the substance within the EU market.

117 It follows from the foregoing that the applicants’ argument alleging that the objectives of Regulation No 1272/2008 were not weighed up cannot succeed.

118 Next, as regards the applicants’ argument that the contested classification is not necessary given that DAPD had already been the subject of self-classification decisions as toxic for reproduction, category 2, suffice it to note that, first, the self-classification of DAPD cannot replace the procedure for harmonisation of classification and labelling of that substance (see paragraphs 15 to 19 above) and, second, categories 1B and 2 of the hazard reproductive toxicity do not identify or communicate the same hazard. Category 1B corresponds to presumed human reproductive toxicants whereas category 2 corresponds to suspected human reproductive toxicants (see paragraph 22 above).

119 Lastly, as regards the applicants’ argument based on the absence of an economic cost-benefit analysis, it should be noted that, even though such an analysis is referred to in the Communication from the Commission of 2 February 2000 on the precautionary principle, it is not however provided for in the context of the procedure for harmonisation of classification and labelling of substances referred to in Title V of Regulation No 1272/2008.

120 In that regard, as noted in paragraph 23 above, Regulation No 1272/2008 concerns the assessment of the hazards of substances and that assessment must be distinguished from the risk assessment provided for in Regulation No 1907/2006. Thus, an assessment of the hazards linked to the intrinsic properties of substances must not be limited in view of specific circumstances of use, as in the case of a risk assessment.

121 In any event, an economic cost-benefit analysis cannot derogate from the criteria for classification of substances for the hazard of reproductive toxicity, set out in Section 3.7. of Annex I to Regulation No 1272/2008 (see paragraph 20 above). As follows from a reading of the first paragraph of Article 3 in conjunction with Article 36(1) of that regulation, harmonised classification and labelling are based on criteria relating to physical hazards, health hazards or environmental hazards, as laid down in Annex I to that regulation (see paragraph 111 above), and not on other factors not provided for in that regulation.

122 The applicants’ complaint alleging breach of the principle of proportionality must therefore be rejected.

123 In the second place, as regards the applicants’ complaint alleging infringement of their rights of defence and, in particular, of the right to be heard, it should be noted that, according to Article 41(2)(a) of the Charter of Fundamental Rights, 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).

124 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).

125 In the present case, the contested regulation lays down measures of general application, including the contested classification. As follows from paragraph 10 above, Article 1 of that regulation lays down a measure of general application concerning the inclusion of DAPD 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 Regulation No 1272/2008.

126 Against that background, the procedural rights which the applicants enjoy in the procedure for harmonisation of classification and labelling of substances are those expressly provided for in Regulation No 1272/2008 (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).

127 In that regard, Article 37(4) of Regulation No 1272/2008 provides that ‘the [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.’

128 Article 37(4) of Regulation No 1272/2008 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 19 above, that procedure takes place in several stages, namely, 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’; subsequently, the forwarding, by ECHA, of that opinion and all comments to the Commission; and, lastly, the adoption, by the Commission, of a delegated act, where it considers that harmonisation of classification and labelling of the substance concerned is appropriate.

129 It follows that the public consultation provided for in Article 37(4) of Regulation No 1272/2008 is intended to allow interested parties to comment on the classification proposal and thus possibly to contribute elements not mentioned in that proposal, so as to allow RAC to take into consideration, 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).

130 Accordingly, it must be noted that, although Article 37(4) of Regulation No 1272/2008 provides for the possibility of submitting 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 RAC’s 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 ).

131 Thus, in the present case, the applicants had the right to comment on the proposal for harmonised classification and labelling of DAPD and to be heard in that regard before RAC, which did happen. Between March and May 2021, a public consultation on the classification proposal was organised and several Member States and interested parties, including the applicants through the DAPD consortium of which they are members, submitted comments (see paragraph 8 above). Moreover, as follows from the content of the opinion of RAC, the latter took into consideration the comments submitted by several Member States and parties concerned; those comments were compiled as an annex to that opinion.

132 In those circumstances and in accordance with the case-law cited in paragraphs 123 and 124 above, it should be noted that, first, the applicants did not have a right to obtain a response from RAC to the comments which they submitted. Second, they did not have a right to be consulted on any additional information added by RAC in its opinion.

133 Furthermore, it has not been demonstrated in the present case that the applicants were prevented from carrying out additional tests or that such tests were necessary for the adoption of the contested classification. As the Commission submits, the applicants could have submitted to ECHA a testing proposal under Articles 40 and 41 of Regulation No 1907/2006. In addition, it follows from recital 3 of the contested regulation that the Commission received additional information from stakeholders challenging the scientific assessment set out in the RAC opinion, and that the Commission examined that information but did not consider it sufficient to cast doubt on the scientific analysis set out in that opinion.

134 It follows that the applicants’ argument alleging infringement of the Interinstitutional Agreement referred to in paragraph 104 above, in that the Commission did not follow a fair hearing and did not examine all the available information and evidence, cannot succeed.

135 Furthermore, the applicants’ argument that they were placed in the impossible situation of having to demonstrate that DAPD had no adverse effects in humans must be rejected for the same reasons previously examined in the context of the first complaint of the first plea (see paragraphs 35 to 45 above).

136 The applicants’ complaint alleging infringement of their rights of defence must therefore be rejected.

137 In the third place, as regards the applicants’ complaint alleging breach of the principle of good administration, it should be noted that the applicants have not put forward any new argument in relation to those which have already been rejected in the context of the examination of the second plea and the present plea.

138 Furthermore, in the reply, the applicants raise an argument alleging that there was no weight of evidence approach, without, however, explaining how the absence of such an approach, which, moreover, has not been demonstrated, is linked to the principle of good administration.

139 The applicants’ complaint alleging breach of the principle of good administration must therefore be rejected.

140 Accordingly, the third plea must be rejected as unfounded and, consequently, the action must be dismissed in its entirety.