Contents
Judgment of the Court (Third Chamber)5 November 2026note(Appeal — Environment and protection of human health — Regulation (EC) No 1272/2008 — Classification, labelling and packaging of substances and mixtures — Delegated Regulation (EU) 2022/692 — Amendment for the purposes of its adaptation to technical and scientific progress — Classification of the substance silanamine, 1,1,1-trimethyl-N-(trimethylsilyl)-, hydrolysis products with silica; pyrogenic, synthetic amorphous, nano, surface treated silicon dioxide — Action for annulment)In Case C‑121/25 P,APPEAL under Article 56 of the Statute of the Court of Justice of the European Union, brought on 5 February 2025,Evonik Operations GmbH, established in Essen (Germany), represented by T. Delille and M. Escorneboueu, avocats,the other parties to the proceedings being:European Commission, represented by M. Farley, J. Jokubauskaitė and R. Lindenthal, acting as Agents,European Chemicals Agency (ECHA), represented by W. Broere, M. Heikkilä and J.-P. Trnka, acting as Agents,THE COURT (Third Chamber),composed of C. Lycourgos, President of the Chamber, N. Fenger, S. Rodin (Rapporteur), O. Spineanu-Matei, and N. Piçarra, Judges,Advocate General: M. Szpunar,Registrar: V. Di Bucci,having regard to the written procedure,after hearing the Opinion of the Advocate General at the sitting on 30 April 2026,gives the following
Judgment
1By its appeal, Evonik Operations GmbH seeks to have set aside the judgment of the General Court of the European Union of 27 November 2024, Evonik Operations v Commission (T‑449/22, EU:T:2024:866; ‘the judgment under appeal’), by which the General Court dismissed Evonik Operations GmbH’s application for annulment of Commission Delegated Regulation (EU) 2022/692 of 16 February 2022 amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures (OJ 2022 L 129, p. 1; ‘the regulation at issue’), in so far as it concerns the harmonised classification and labelling of the substance silanamine, 1,1,1-trimethyl-N-(trimethylsilyl)-, hydrolysis products with silica; pyrogenic, synthetic amorphous, nano, surface treated silicon dioxide (‘the contested classification’).
I.Legal context
A.The REACH Regulation
2Article 59 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ 2006 L 396, p. 1, and corrigendum OJ 2007 L 136, p. 3; ‘the REACH Regulation’), provides, in paragraph 4 thereof:‘The [European Chemicals Agency (ECHA)] shall publish on its website a notice that an Annex XV dossier has been prepared for a substance. [ECHA] shall invite all interested parties to submit comments within a specified deadline to [ECHA].’
3Article 64(1) to (5) of the REACH Regulation provides:1 [ECHA] shall acknowledge the date of receipt of the application. [ECHA’s] Committees for Risk Assessment [(“the RAC”)] and Socio-economic Analysis shall give their draft opinions within ten months of the date of receipt of the application.2. [ECHA] shall make available on its web-site broad information on uses, taking into account Articles 118 and 119 on access to information, for which applications have been received and for reviews of authorisations, with a deadline by which information on alternative substances or technologies may be submitted by interested third parties.3. In preparing its opinion, each Committee referred to in paragraph 1 shall first check that the application includes all the information specified in Article 62 that is relevant to its remit. If necessary, the Committees shall, in consultation with each other, make a joint request to the applicant for additional information to bring the application into conformity with the requirements of Article 62. The Committee for Socio-economic Analysis may, if it deems it necessary, require the applicant or request third parties to submit, within a specified time period, additional information on possible alternative substances or technologies. Each Committee shall also take into account any information submitted by third parties.4.The draft opinions shall include the following elements:(a) [RAC]: an assessment of the risk to human health and/or the environment arising from the use(s) of the substance, including the appropriateness and effectiveness of the risk management measures as described in the application and, if relevant, an assessment of the risks arising from possible alternatives;(b) Committee for Socio-economic Analysis: an assessment of the socio-economic factors and the availability, suitability and technical feasibility of alternatives associated with the use(s) of the substance as described in the application, when an application is made in accordance with Article 62 and of any third party contributions submitted under paragraph 2 of this Article.5. [ECHA] shall send these draft opinions to the applicant by the end of the deadline set out in paragraph 1. Within one month of receipt of the draft opinion, the applicant may provide written notice that he wishes to comment. The draft opinion shall be deemed to have been received seven days after [ECHA] has sent it.If the applicant does not wish to comment, [ECHA] shall send these opinions to the [European] Commission, the Member States and the applicant, within 15 days of the end of the period within which the applicant may comment or within 15 days of receipt of notice from the applicant that he does not intend to comment.If the applicant wishes to comment, he shall send his written argumentation to [ECHA] within two months of the receipt of the draft opinion. The Committees shall consider the comments and adopt their final opinions within two months of receipt of the written argumentation, taking this argumentation into account where appropriate. Within a further 15 days [ECHA] shall send the opinions, with the written argumentation attached, to the Commission, the Member States and the applicant.’
B.The CLP Regulation
4Recital 52 of 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), as amended by Commission Regulation (EU) 2019/521 of 27 March 2019 (OJ 2019 L 86, p. 1) (‘the CLP Regulation’), states:‘The resources of the authorities should be focused on substances of the highest concern with regard to health and to the environment. Provision should therefore be made to enable competent authorities and manufacturers, importers and downstream users to submit proposals to [ECHA] for a harmonised classification and labelling of substances classified for carcinogenicity, germ cell mutagenicity or reproductive toxicity categories 1A, 1B or 2, for respiratory sensitisation, or in respect of other effects on a case-by-case basis. The competent authorities of Member States should also be able to propose harmonised classification and labelling for active substances used in plant protection products and biocidal products. [ECHA] should give its opinion on the proposal while interested parties should have an opportunity to comment. The Commission should submit a draft decision on the final classification and labelling elements.’
5Article 1(1)(d) of the CLP Regulation provides:‘The purpose of this 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) by:…(d) establishing a list of substances with their harmonised classifications and labelling elements at Community level in Part 3 of Annex VI’.
6The first paragraph of Article 3 of that regulation provides:‘A substance or a mixture fulfilling the criteria relating to physical hazards, health hazards or environmental hazards, laid down in Parts 2 to 5 of Annex I is hazardous and shall be classified in relation to the respective hazard classes provided for in that Annex.’
7Article 37(1), (2), (4) and (5) of that regulation provides:1. A competent authority may submit to [ECHA] a proposal for harmonised classification and labelling of substances and, where appropriate, specific concentration limits or [multiplying factors; “M-factors”], or a proposal for a revision thereof.The proposal shall follow the format set out in Part 2 of Annex VI and contain the relevant information provided for in Part 1 of Annex VI.2. A manufacturer, importer or downstream user of a substance may submit to [ECHA] a proposal for harmonised classification and labelling of that substance and, where appropriate, specific concentration limits or M-factors, provided that there is no entry in Part 3 of Annex VI for such a substance in relation to the hazard class or differentiation covered by that proposal.The proposal shall be drawn up in accordance with the relevant Parts of sections 1, 2 and 3 of Annex I to [the REACH Regulation] and it shall follow the format set out in Part B of the Chemical Safety Report of section 7 of that Annex. It shall contain the relevant information provided for in Part 1 of Annex VI to this Regulation. Article 111 of [the REACH Regulation] shall apply.…4. The [RAC] set up pursuant to Article 76(1)(c) of [the REACH Regulation] shall adopt an opinion on any proposal submitted pursuant to paragraphs 1 or 2 within 18 months of receipt of the proposal, giving the parties concerned the opportunity to comment. [ECHA] shall forward this opinion and any comments to the Commission.5. The Commission shall without undue delay adopt delegated acts in accordance with Article 53a, where it finds that the harmonisation of the classification and labelling of the substance concerned is appropriate, to amend Annex VI by inclusion of that substance together with the relevant classification and labelling elements in Table 3.1 of Part 3 of Annex VI and, where appropriate, the specific concentration limits or M-factors.…’
8Article 50(1) of that regulation provides:‘[ECHA] shall provide the Member States and the institutions of the [European] Community with the best possible scientific and technical advice on questions relating to chemicals which fall within its remit and which are referred to it in accordance with this Regulation.’
9Section 1.1.1.3 of Annex I to the CLP Regulation provides:‘A weight of evidence determination means that all available information bearing on the determination of hazard is considered together, such as … relevant … data [from] information from the application of the category approach (grouping, read-across), (Q)SAR results …’
10Section 3.6.2.2.1 of that annex provides as follows:‘Classification as a carcinogen is made on the basis of evidence from reliable and acceptable studies and is intended to be used for substances which have an intrinsic property to cause cancer. The evaluations shall be based on all existing data, peer-reviewed published studies and additional acceptable data.’
11Section 3.9.1.1 of that annex provides:‘Specific target organ toxicity-repeated exposure means specific toxic effects on target organs occurring after repeated exposure to a [substance] or mixture. All significant health effects that can impair function, reversible and irreversible, immediate and/or delayed are included. However, other specific toxic effects that are specifically addressed in sections 3.1 to 3.8 and 3.10 are not included here.’
12Section 3.9.2.1 of that annex provides:‘Substances are classified as specific target organ toxicants following repeated exposure by the use of expert judgement (see 1.1.1) on the basis of the weight of all evidence available, including the use of recommended guidance values which take into account the duration of exposure and the dose/concentration which produced the effect(s), (see 3.9.2.9), and are placed in one of two categories, depending upon the nature and severity of the effect(s) observed (Table 3.9.1).’
13Section 3.9.2.3 of Annex I to the CLP Regulation provides:‘Classification is determined by expert judgement (see section 1.1.1), on the basis of the weight of all evidence available including the guidance presented below.’
14Section 3.9.2.4 of that annex provides:‘Weight of evidence of all data (see section 1.1.1), including human incidents, epidemiology, and studies conducted in experimental animals, is used to substantiate specific target organ toxic effects that merit classification. This taps the considerable body of industrial toxicology data collected over the years. Evaluation shall be based on all existing data, including peer-reviewed published studies and additional acceptable data.’
15Under Section 3.9.2.10.3 of that annex:‘A substance that has not been tested for specific target organ toxicity may, where appropriate, be classified on the basis of data from a validated structure activity relationship and expert judgement-based extrapolation from a structural analogue that has previously been classified together with substantial support from consideration of other important factors such as formation of common significant metabolites.’
II.Background to the proceedings and the regulation at issue
16The background to the dispute, as set out in paragraphs 2 to 10 of the judgment under appeal, may be summarised as follows.
17The appellant is a company incorporated under German law which manufactures silanamine, 1,1,1-trimethyl-N-(trimethylsilyl)-, hydrolysis products with silica; pyrogenic, synthetic amorphous, nano, surface treated silicon dioxide (SAS-HMDS) (‘silanamine’).
18It is a type of synthetic amorphous silica (‘SAS’), with a molecular formula of ‘[SiO2]n-[OSi(CH3)3]m’ and which has been treated with hexamethyldisilazane (HMDS) to become hydrophobic. SAS, including surface treated forms, are used in various products, such as medicinal and pharmaceutical products, food and cosmetics, and also in a variety of industrial applications, as reinforcement and thickening agents in various systems such as elastomers, resins and inks.
19Silanamine is also an active substance within the meaning of Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ 2012 L 167, p. 1).
20On 17 December 2018, the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail (National Agency for Food, Environmental and Occupational Health and Safety (ANSES) (France) submitted to ECHA, in accordance with Article 37(1) of the CLP Regulation, a proposal for the harmonised classification and labelling of silanamine (‘the classification and labelling proposal’) in the hazard class ‘Specific target organ toxicity – repeated exposure’ (‘the hazard class STOT RE’) of Category 2 (‘the hazard class STOT RE 2’).
21Between 4 March 2019 and 3 May 2019, several of the parties concerned submitted their comments on the classification and labelling proposal, in accordance with Article 37(4) of the CLP Regulation.
22On the basis of that provision, the RAC adopted an opinion dated 5 December 2019 (‘the RAC Opinion’), in which it proposed the classification of silanamine in the hazard class STOT RE 2, with hazard statement code ‘H373’ (lungs, inhalation), as well as in the Category 2 acute-toxicity hazard class via the inhalation route (H330) with an acute toxicity estimate of 0.45 milligram per litre (mg/L).
23During the period from 3 February to 17 February 2020, a targeted public consultation was organised on the classification of silanamine in the Category 2 acute-toxicity hazard class via the inhalation route (H330).
24On 16 February 2022, on the basis of the RAC Opinion, the Commission adopted the regulation at issue. By that regulation, the Commission added silanamine to Part 3 of Table 3 of Annex VI to the CLP Regulation, with harmonised classification and labelling in the hazard class STOT RE 2, hazard statement code ‘H373’ (lungs, inhalation) and pictogram hazard code ‘GHS 08Wng’.
25By contrast, the Commission considered that the classification of silanamine in the Category 2 acute-toxicity hazard class, recommended in the RAC Opinion, should not be included in that part 3, since that institution took the view, after assessing the new scientific information received, that that information required further assessment by the RAC.
III.The action before the General Court and the judgment under appeal
26By application lodged at the Registry of the General Court on 20 July 2022, the appellant brought an action for annulment of the regulation at issue.
27In support of that action, the appellant raised four pleas in law. The first plea alleged manifest errors of assessment and breach of the criteria for classification of a substance in the hazard class STOT RE Category 2. By the second plea, the appellant alleged a breach of the harmonised classification and labelling procedure (‘the CLH procedure’). The third plea alleged breach of the Commission’s obligation to examine the appropriateness of the contested classification. By the fourth plea, the appellant alleged an absence of any impact assessment.
28By the judgment under appeal, the General Court dismissed that action and ordered the appellant to pay the costs.
IV.Forms of order sought by the parties
29By its appeal, the appellant claims that the Court should:– declare the appeal admissible and well-founded;– set aside the judgment under appeal;– alternatively, refer the case back to the General Court to rule on the action for annulment, and– order the Commission to pay the costs of the appeal proceedings and the costs incurred in the proceedings at first instance.
30The Commission contends that the Court should:– dismiss the appeal and– order the appellant to pay the costs.
31ECHA contends that the Court should:– dismiss the appeal and– order the appellant to pay the costs.
V.The appeal
32In support of its appeal, the appellant puts forward two grounds of appeal. The first ground of appeal alleges that the General Court erred in its examination of the lawfulness of the regulation at issue in the light of the harmonised classification and labelling criteria laid down in the CLP Regulation. The second ground of appeal alleges errors made by the General Court in its interpretation of Article 37(4) of that regulation.
A.The first ground of appeal
33The first ground of appeal is divided into four parts. The first part of that ground of appeal alleges breach of the general principle, to which the General Court referred in the judgment of 23 November 2022, CWS Powder Coatings and Others v Commission (T‑279/20, T‑283/20 and T‑288/20, ‘the judgment in CWS Powder Coatings and Others v Commission’, EU:T:2022:725, paragraph 136), according to which any hazard supporting a classification, within the meaning of the CLP Regulation, must be the consequence of the intrinsic properties of the substance under review. The second part of that ground of appeal alleges misrepresentation of the argument put forward at first instance by the appellant that the RAC had failed to consider the conditions of testing when drawing conclusions on the STOT RE properties of silanamine and, therefore, a lack of judicial review in that regard. The third part of that ground of appeal alleges that the General Court failed to examine whether the contested classification was based on significant health effects. The fourth part of that ground of appeal alleges errors made by the General Court in its examination of the merits of the reliance, in the RAC Opinion, on a read-across with an SAS that is sufficiently similar to silanamine (‘the read-across’).
1.The first part of the first ground of appeal
34The first part of the first ground of appeal, alleging breach of the general principle that any hazard supporting classification, within the meaning of the CLP Regulation, must be the consequence of the intrinsic properties of the substance under review, is divided into three subsections. The first and second subsections of that part, which it is appropriate to examine together, allege errors made by the General Court in the application of the requirements arising from that general principle. The third subsection of that part alleges that the General Court failed to review whether the intrinsic properties of silanamine supported the contested classification.
(a)The first and second subsections of the first part of the first ground of appeal
(1)Arguments of the parties
35In the context of the first and second subsections of the first part of the first ground of appeal, alleging errors made by the General Court in the application of the requirements arising from the general principle that any hazard supporting classification, within the meaning of the CLP Regulation, must be the consequence of the intrinsic properties of the substance under review, the appellant raises, in essence, three complaints.
36By the first complaint of those first and second subsections, the appellant complains that, in paragraphs 105, 106 and 113 of the judgment under appeal, the General Court incorrectly distinguished the concepts of ‘specific toxic effects’ and ‘intrinsic properties’, within the meaning of the CLP Regulation, which led it wrongly and contrary to paragraphs 119 and 146 of that judgment to reach a conclusion opposite to that which it had reached in the judgment in CWS Powder Coatings and Others v Commission. It submits that, in order to support a classification under that regulation, including in the hazard class STOT RE 2, the observed toxic effects produced by a substance must, as the General Court found in paragraph 139 of that latter judgment, be specific to that substance in that they should be the result of a hazardous, intrinsic property of that substance, and not, as the General Court wrongly understood from its arguments at first instance, in that they must be specific to the same substance.
37By the second complaint of the first and second subsections, the appellant complains, in essence, that the General Court referred only partially to the judgment in CWS Powder Coatings and Others v Commission and thus failed to find, despite other contradictory passages of the judgment under appeal, that the aim of harmonised classification and labelling is, inter alia, to determine the intrinsic properties of substances.
38By the third complaint of the first and second subsections of the first part of the first ground of appeal, the appellant complains, in essence, that the General Court wrongly distinguished, in paragraphs 146 to 150 of the judgment under appeal, the case before it from that which gave rise to the judgment in CWS Powder Coatings and Others v Commission. First, the fact that the classification criteria and the substances concerned, the reasoning set out in the RAC opinions issued and the scientific studies taken into consideration by the RAC were different in those two cases is irrelevant since, according to that latter judgment, all harmonised classifications under the CLP Regulation are based on the concepts of ‘intrinsic properties’ and ‘specific effects’, which are causally linked. Second, contrary to what it did in paragraph 147 of the judgment under appeal, the General Court should not rely on RAC opinions to determine whether effects observed result from the intrinsic properties of the substance concerned and, in any event, the RAC expressed doubts that that was not the case here. Third, the General Court failed to take account of the fact that the toxicity observed in the judgment in CWS Powder Coatings and Others v Commission was not specific to the substance at issue, but was common to other poorly soluble low-toxicity substances, and that both that substance and, by analogy, silanamine had unspecific particle-related inhalation toxicity.
39The Commission and ECHA submit that the first and second subsections of the first part of the first ground of appeal must be rejected as unfounded.
(2)Findings of the Court
40As a preliminary point, it should be noted that the judgment in CWS Powder Coatings and Others v Commission was the subject of an appeal before the Court of Justice. In the judgment of 1 August 2025, France and Commission v CWS Powder Coatings and Others (C‑71/23 P and C‑82/23 P, EU:C:2025:601), the Court of Justice did not endorse the General Court’s interpretation in that first judgment as regards the concept of ‘intrinsic properties’ and that of ‘[substance] which [has] an intrinsic property to cause cancer’, within the meaning of Section 3.6.2.2.1 of Annex I to the CLP Regulation.
41In paragraphs 96 to 173 of the judgment under appeal, the General Court examined and rejected the first part of the first plea raised at first instance, by which the appellant claimed that, for the purposes of classifying a substance in the hazard class STOT RE, that substance must produce specific toxic effects, namely effects which result from its intrinsic properties, and that silanamine did not produce such effects, the effects observed having resulted from the deposition of large numbers of inhaled particles in the context of the relevant studies and from the high dose or concentration administered in those studies.
42It is apparent from paragraph 121 of the judgment under appeal that it was in the light of the considerations set out in paragraphs 96 to 120 of that judgment that the General Court examined the arguments put forward by the appellant in support of the first part of the first plea raised at first instance.
43The General Court found, inter alia, in paragraphs 104 to 106 of the judgment under appeal, that the term ‘specific’ in the concept of ‘specific toxic effects’, provided for in Section 3.9.1.1 of Annex I to the CLP Regulation, refers to the target organ, without it being required that those toxic effects be specific to the substance concerned. In paragraph 113 of that judgment, the General Court pointed out that, in the judgment in CWS Powder Coatings and Others v Commission, it had interpreted the concept of ‘intrinsic properties’, which relates to the cause of the hazard, without ruling on the concept of ‘specific toxic effects’, which refers to the result of the hazard.
44In addition, in paragraphs 117 to 120 of the judgment under appeal, the General Court pointed out, referring to paragraphs 136 and 138 to 141 of the judgment in CWS Powder Coatings and Others v Commission, that it followed therefrom that, first, the CLP Regulation concerns the transmission of information on the hazards linked to the substances’ intrinsic properties, second, the concept of ‘intrinsic properties’ must be interpreted as referring to the properties which a substance ‘has in and of itself’ and, third, such an interpretation was consistent, inter alia, with the fact that classification and labelling, within the meaning of that regulation, relate to hazard assessment, and not risk assessment, since hazard assessment must not be limited to taking into consideration specific circumstances of use and may be properly carried out regardless of the place of use of the substance concerned or the possible levels of exposure to it.
45The General Court then examined, in paragraphs 122 to 151 of the judgment under appeal, the appellant’s arguments alleging that the effects observed resulted from the deposition of a large number of inhaled particles in the context of the relevant studies before assessing, in paragraphs 152 to 173 of that judgment, its arguments alleging that the effects observed resulted from the high dose or concentration administered in the relevant studies.
46In the context of the assessment of that first group of arguments, the General Court noted, in the first place, in paragraph 128 of the judgment under appeal, that the appellant had merely reiterated the argument of the industry put forward during the procedure for the adoption of the regulation at issue that the effects observed in the studies taken into consideration in the RAC Opinion resulted from the deposition of particles inhaled into the lungs which caused an inflammatory response, without showing that that the morphological tissue reaction, consisting of several effects observed, could not form the basis of the contested classification in that those effects were also inflammatory effects resulting from the deposition of a large number of inhaled particles in the studies taken into account. In paragraph 129 of the judgment under appeal, the General Court recalled that, as regards complex facts, it was not its role to substitute its assessment for that made by the RAC, as accepted by the Commission.
47In the second place, in paragraphs 130 to 144 of the judgment under appeal, the General Court found that the RAC and the Commission had taken into account the industry’s arguments relied on in the course of the procedure for the adoption of the RAC Opinion, but had ultimately rejected them.
48In the third place, the General Court found, in paragraph 145 of the judgment under appeal, that the analogy drawn by the appellant between the case before it and that which gave rise to the judgment in CWS Powder Coatings and Others v Commission was unfounded.
49In that regard, it is apparent from paragraphs 146 to 148 of the judgment under appeal that the General Court considered that the classification criteria, the substance concerned, the reasoning set out in the RAC Opinion and the scientific studies taken into consideration by that committee in the case which gave rise to the judgment in CWS Powder Coatings and Others v Commission were different from those at issue in the present case.
50In addition, the General Court noted, in paragraph 149 of the judgment under appeal, that it had indeed found, in the judgment in CWS Powder Coatings and Others v Commission, that an accumulation of particles in the lungs in sufficient quantities to bring about a significant impairment of particle clearance mechanisms, which occurred only when certain quantities of particles had been inhaled, could not be regarded as forming part of the intrinsic properties of the particles at issue. In paragraph 150 of the judgment under appeal, the General Court pointed out that the specific circumstances referred to in paragraph 158 of the judgment in CWS Powder Coatings and Others v Commission did not, however, exist in the present case.
51In paragraph 150 of the judgment under appeal, the General Court pointed out that, in the regulation at issue, the classification at issue was not linked to a specific size of the particles at issue, unlike that of titanium dioxide in the case which gave rise to the judgment in CWS Powder Coatings and Others v Commission. It added, in paragraph 150, that there was no assessment or quantified data in the file to suggest that the effects identified had been observed in target organ overload conditions, as had been the situation in that case.
52In that regard, it should be noted, as a preliminary point, that a substance or mixture fulfilling the criteria relating to physical hazards, health hazards or environmental hazards, laid down in Parts 2 to 5 of Annex I to the CLP Regulation is, under the first paragraph of Article 3 thereof, considered to be hazardous and is to be classified in relation to the respective hazard classes provided for in that annex.
53Section 3.9 of Annex I to the CLP Regulation, entitled ‘Specific target organ toxicity – repeated exposure’, which appears in Part 3 thereof, entitled ‘Health hazards’, lays down (i) criteria for classification in the hazard class STOT RE and (ii) requirements relating to the communication of that hazard.
54Section 3.9.1.1 of that annex defines ‘Specific target organ toxicity-repeated exposure’ as ‘specific toxic effects on target organs occurring after repeated exposure to a [substance] or mixture. All significant health effects that can impair function, reversible and irreversible, immediate and/or delayed are included. However, other specific toxic effects that are specifically addressed in sections 3.1 to 3.8 and 3.10 are not included here’.
55As regards the first complaint raised in the first and second subsections of the first part of the first ground of appeal, alleging that the distinction between the concepts of ‘specific toxic effects’ and ‘intrinsic properties’ is incorrect, it must admittedly be noted that, in paragraphs 104 to 106 of the judgment under appeal, the General Court drew a distinction between the concepts of ‘specific toxic effects’ and ‘intrinsic properties’ referred to in the CLP Regulation in order to explain that the term ‘specific’ included in the concept of ‘specific toxic effects’, which appears in Section 3.9.1.1 of Annex I to that regulation, refers to the target organ rather than the substance concerned.
56However, in paragraphs 128 to 150 of the judgment under appeal, the General Court did not rely on the finding that it is not required that the effects observed in the context of the relevant studies in the present case be specific to the substance concerned in order to reject as unfounded the appellant’s argument that those effects resulted not from the intrinsic properties of silanamine, but from the deposition of a large number of inhaled particles in the context of the relevant studies.
57It is apparent from paragraph 128 of the judgment under appeal that the General Court rejected that argument in so far as, inter alia, it was based on an unsubstantiated claim and, as is apparent from paragraph 150 of that judgment, it refused to reach a conclusion comparable to that which it had reached in the judgment in CWS Powder Coatings and Others v Commission, since, in particular, the regulation at issue did not state that the contested classification was linked to a specific size of the particles at issue and since no assessment or numerical data in the file supports the conclusion that the effects identified were observed in lung overload conditions.
58Similarly, in paragraphs 152 to 172 of the judgment under appeal, the General Court rejected the appellant’s argument that the effects observed result from the high dose or concentration administered in the relevant studies without relying on the finding referred to in paragraph 56 of the present judgment.
59Accordingly, even assuming that, in paragraphs 104 to 106 of the judgment under appeal, the General Court erred in distinguishing between the concepts of ‘specific toxic effects’ and ‘intrinsic properties’, within the meaning of the CLP Regulation, that error did not affect the merits of its decision to reject the argument alleging that silanamine produces no specific toxic effects on the lungs.
60Furthermore, since the General Court examined the merits of the appellant’s argument that the toxic effects observed in the context of the relevant studies did not result from the intrinsic properties of silanamine, the alleged misrepresentation of that argument in paragraph 105 of the judgment under appeal, as summarised in paragraph 36 of the present judgment, must be rejected as ineffective.
61Accordingly, the first complaint raised in the first and second subsections of the first part of the first ground of appeal must be rejected as ineffective.
62As regards the second complaint of those subsections, by which the appellant submits that the General Court should have held, as the appellant claims that it did in paragraphs 135 and 138 to 140 of the judgment in CWS Powder Coatings and Others v Commission, that a substance may be classified, within the meaning of the CLP Regulation, only in the light of its intrinsic properties, it should be noted that (i) in paragraphs 117 to 120 of the judgment under appeal, the General Court specifically adopted such an interpretation of that regulation and that (ii) it examined the merits of the appellant’s argument that the effects observed in the context of the relevant studies did not result from the intrinsic qualities of silanamine.
63That second complaint is therefore based on a misreading of the judgment under appeal and must accordingly be rejected as unfounded.
64As regards the third complaint of those subsections, by which the appellant complains, in essence, that the General Court incorrectly drew a distinction, in paragraphs 146 to 150 of the judgment under appeal, between the case before it from the case which gave rise to the judgment in CWS Powder Coatings and Others v Commission, it must be stated that, even if the facts at issue in those two cases are similar, that would not, as such, be capable of establishing that the Commission’s assessment of silanamine was adopted in breach of the requirements of the CLP Regulation.
65In support of that third complaint, the appellant merely submits that those facts have common features, without demonstrating how those factors necessarily imply that the General Court erred in finding that it had not been established that the Commission’s assessment was contrary to those requirements. Such a line of argument is therefore not, in any event, capable of demonstrating that the conclusion reached by the General Court in paragraph 151 of the judgment under appeal is vitiated by an error of law.
66Accordingly, that third complaint must be rejected as ineffective.
67It follows that the first and second subsections of the first part of the first ground of appeal must be rejected.
(b)The third subsection of the first part of the first ground of appeal
(1)Arguments of the parties
68In the third subsection of the first part of the first ground of appeal, alleging that the General Court did not verify, in disregard of its judicial review, whether the RAC and the Commission had demonstrated that the intrinsic properties of silanamine supported the contested classification, the appellant submits that, first, in paragraphs 125 and 126 of the judgment under appeal, the General Court merely cited the RAC’s assessments to that effect and, second, in paragraph 127 of the judgment under appeal, the General Court placed the burden of proof on it by requiring it to demonstrate (i) that the RAC and the Commission had not proved that the effects observed in relevant studies were the consequence of an intrinsic property of silanamine and (ii) that that absence of evidence constituted a manifest error of assessment.
69The Commission and ECHA contend that the third subsection of the first part of the first ground of appeal must be rejected as unfounded.
(2)Findings of the Court
70It should be noted that, in paragraphs 125 and 126 of the judgment under appeal, the General Court referred to the effects on which the RAC had based the contested classification.
71In paragraphs 127 and 128 of the judgment under appeal, the General Court observed that the appellant had not demonstrated that the RAC and, therefore, the Commission, had made a manifest error of assessment in taking those effects into consideration since the appellant had merely claimed that those effects had resulted from the deposition of a large number of inhaled particles in the context of the relevant studies.
72Accordingly, in paragraph 129 of the judgment under appeal, the General Court held that, in the absence of sufficient evidence to render implausible the assessments set out in the RAC Opinion and reproduced by the Commission in the regulation at issue, it was not for the General Court, as regards complex facts, to substitute its own assessment for that made by the RAC and accepted by the Commission.
73In that regard, it should be noted that it is apparent from the case-law of the Court of Justice that the party which is claiming an inadequate investigation of the relevant factors or manifest errors of assessment must first adduce factors justifying the doubts, which are relevant to the decision, regarding the plausibility of the assessment made by the EU authority in question, with it being for the latter, if necessary, to rebut that plausibility; this does not constitute a reversal of the burden of proof (judgment of 9 November 2023, Global Silicones Council and Others v ECHA, C‑559/21 P, EU:C:2023:842, paragraph 47).
74In the present case, it was therefore for the appellant to produce, before the General Court, evidence capable of demonstrating the plausibility of the inadequacy of the analysis or of the errors which it attributed to the competent authority.
75Accordingly, the General Court was entitled, after recalling in paragraphs 124 to 126 of the judgment under appeal the reasoning which led to the classification of silanamine as falling within the hazard class STOT RE 2, to confine itself to assessing whether the material adduced by the appellant was sufficient to demonstrate the plausibility of its claims.
76The General Court carried out that assessment by finding, in paragraphs 127 and 128 of that judgment, that the appellant had merely claimed that the effects on which the RAC had based the contested classification resulted from the deposition of a large number of inhaled silanamine particles in the context of the relevant studies and had therefore not demonstrated a manifest error of assessment on the part of the RAC or the Commission when taking those effects into consideration.
77Accordingly, it cannot be alleged that the General Court failed to verify whether the RAC and the Commission had demonstrated that the intrinsic properties of silanamine supported that classification or that it placed an excessive burden of proof on the appellant, with the result that the third subsection of the first part of the first ground of appeal must be rejected as unfounded.
78In the light of all the foregoing, the first part of the first ground of appeal must be rejected in its entirety.
2.The second part of the first ground of appeal
(a)Arguments of the parties
79In the second part of the first ground of appeal, the appellant submits that, in paragraph 99 of the application initiating proceedings, and in paragraphs 43 and 44 of the reply, it had argued that, when assessing the properties of silanamine in the light of the requirements laid down for the hazard class STOT RE in the CLP Regulation, the RAC had failed to consider the conditions of testing. The General Court misrepresented that argument and therefore refrained from responding to it by stating, in paragraph 171 of the judgment under appeal, that it had relied on the potential risks associated with silanamine or on the specific circumstances in which it is used, in order to find that those risks and circumstances were irrelevant in the context of the CLP Regulation.
80The Commission and ECHA contend that the second part of the first ground of appeal must be rejected as unfounded.
(b)Findings of the Court
81In paragraph 153 of the judgment under appeal, the General Court held that the appellant claimed that the effects observed did not result from silanamine in the form or physical state in which it was placed on the market or in which it was reasonably possible to expect that it would be used. That claim was set out again and examined by the General Court in paragraph 171 of the judgment under appeal.
82It follows that, according to the General Court, the appellant took issue at first instance with the RAC’s not having taken into account the fact that the studies referred to in the information used in support of the contested classification had been carried out with silanamine, the form and physical state of which did not correspond to the manner in which it was placed on the market or its use under normal conditions.
83Paragraph 99 of the application initiating proceedings was worded as follows:‘This is particularly true since the form of the Substance used for the conduct of the repeated exposure studies (such as in the Reuzel Studies) is modified and does not reflect the form of the Substance to which humans would be exposed in normal and foreseeable conditions of intended uses. Those modifications aim at making the material respirable for the purpose of conducting the repeated dose inhalation studies, which are designed to produce effects at the highest dose used. However, workers and consumers will not be exposed to either such high doses or in such a respirable form in normal and foreseeable conditions of intended uses. The relevance for human health of effects observed at such high doses/concentration of particulate substances in the relevant studies, is therefore at best a matter of conjecture.’
84Moreover, in paragraphs 43 and 44 of the reply lodged with the General Court, the appellant argued that:43. It follows that the form in which the Substance is placed on the market or is reasonably expected to be used and the particle size distribution used for testing purposes should have been given due consideration to verify i) if the effects observed in studies could be considered of human relevance and ii) if it could still be considered specific to the Substance. This was not done by [the] RAC nor, in turn, by the [Commission].44. However, ensuring that the effects seen could be attributed to the Substance in the form it is placed on the market and in which it can reasonably be expected to be used is of the utmost importance considering that “different surface modifications of synthetic amorphous silicas, such as [the Substance], can affect the hazardous properties of the substance, which can lead to different classifications” as the [Commission] itself recognises.’
85It cannot therefore be considered that it is manifestly apparent from paragraph 99 of the application initiating proceedings or from paragraphs 43 and 44 of the reply lodged before the General Court that the appellant put forward an argument other than that which the General Court examined in paragraph 171 of the judgment under appeal. In the absence of distortion, it cannot be held that the General Court failed to respond to that argument either.
86Accordingly, the second part of the first ground of appeal must be rejected as unfounded.
3.The third part of the first ground of appeal
(a)Arguments of the parties
87In the third part of the first ground of appeal, alleging that the General Court did not examine whether the contested classification was based on significant adverse health effects, the appellant puts forward, in essence, three arguments.
88First, it is apparent from paragraph 65 of the judgment under appeal that the General Court merely verified that the RAC had identified, in support of that classification, effects other than fibrosis alone, without verifying whether, and to what extent, the RAC had demonstrated the significance of one of those other effects even though fibrosis was not sufficient, in itself, to support the classification of silanamine.
89Second, in paragraph 74 of the judgment under appeal, the General Court wrongly criticised the appellant for not having adduced evidence to render the assessments used in the RAC Opinion implausible and, thus, reversed the burden of proof.
90Third, in paragraph 147 of the application initiating proceedings, the appellant did, in any event, demonstrate that those other effects were not significant.
91The Commission and ECHA contend that the third part of the first ground of appeal is inadmissible in so far as it relates to the latter argument and, in any event, unfounded in its entirety.
(b)Findings of the Court
92It should be noted that, in paragraphs 60 to 93 of the judgment under appeal, the General Court examined the arguments relied on by the appellant in support of its claim that the RAC relied on conclusions which did not meet the criteria set out in Section 3.9 of Annex I to the CLP Regulation.
93In that regard, it should be noted that, after listing in paragraph 65 of the judgment under appeal the effects other than fibrosis relied on in the RAC Opinion, the General Court examined, from paragraph 67 of that judgment onwards, the appellant’s arguments seeking to demonstrate that those effects were not capable of supporting the contested classification.
94In that context, the General Court noted, inter alia, in paragraph 69 of that judgment, that the hazard class STOT RE covers all significant health effects that can impair function. In addition, in paragraph 90 of that judgment, it found that a reading of the RAC Opinion and of the analysis of the studies as a whole which it took into account makes it possible to understand the reasons why the RAC considered that the effects observed constituted effects capable of justifying the contested classification, in accordance with the criteria laid down in Section 3.9 of Annex I to the CLP Regulation.
95Accordingly, it cannot be held that the General Court merely relied, in that judgment, on the effects identified by the RAC, without examining whether the RAC had verified that those effects could be regarded as constituting significant adverse health effects.
96In that context, in accordance with the case-law referred to in paragraph 73 of the present judgment, it was for the appellant to produce, before the General Court, evidence capable of demonstrating the plausibility of its claim that the effects identified by the RAC cannot be classified as significant adverse health effects.
97Therefore, it cannot be held that the General Court reversed the burden of proof by finding that, in the absence of evidence adduced by the appellant to render the assessments used in the RAC Opinion implausible, the RAC cannot be criticised for considering that the contested classification was justified at the very least on the basis of the morphological tissue reaction (hypertrophy, lung injury, partial hyperplasia of the bronchiolar epithelium, collagen remodelling).
98Furthermore, as regards the appellant’s claim that it demonstrated that the effects identified by the RAC are not significant, it must be stated that upholding that claim would require an assessment of the evidence submitted by the appellant.
99However, in accordance with settled case-law, where the General Court has established or assessed the facts, the Court of Justice has jurisdiction, under Article 256 TFEU, solely to review their legal characterisation and the legal conclusions which were drawn from them. The appraisal of the facts by the General Court does not therefore constitute, save where the clear sense of the evidence produced before it is distorted, a question of law which is subject, as such, to review by the Court of Justice (judgment of 28 January 2021, Qualcomm and Qualcomm Europe v Commission, C‑466/19 P, EU:C:2021:76, paragraph 42 and the case-law cited).
100Moreover, where an appellant alleges distortion of the evidence by the General Court, that person must, under Article 256 TFEU, the first paragraph of Article 58 of the Statute of the Court of Justice of the European Union and Article 168(1)(d) of the Rules of Procedure of the Court of Justice, indicate precisely the evidence alleged to have been distorted by the General Court and show the errors of appraisal which, in that person’s view, led to such distortion. However, a distortion of the application initiating proceedings must be obvious from the documents on the Court’s file, without there being any need to carry out a new appraisal of the facts and the evidence (see, to that effect, judgment of 28 January 2021, Qualcomm and Qualcomm Europe v Commission, C‑466/19 P, EU:C:2021:76, paragraph 43 and the case-law cited).
101In the present case, the appellant does not rely on any distortion of evidence, so that the claim referred to in paragraph 98 of the present judgment must be rejected as inadmissible.
102Accordingly, the third part of the first ground of appeal must be rejected as in part inadmissible and in part unfounded.
4.The fourth part of the first ground of appeal
103The fourth part of the first ground of appeal, alleging errors made by the General Court in its examination of the merits of the reliance on the read-across in the RAC Opinion, is divided into two subsections. By the first subsection of that fourth part, the appellant complains that the General Court distorted the second part of the first plea raised at first instance, which led it to conclude that one of the arguments was inadmissible. The second subsection of that fourth part alleges errors made by the General Court in its assessment of the compliance of the use of the read-across in the RAC Opinion with the requirements laid down in Section 3.9.2.10.3 of Annex I to the CLP Regulation.
(a)The first subsection of the fourth part of the first ground of appeal
(1)Arguments of the parties
104By the first subsection of the fourth part of the first ground of appeal, the appellant complains that the General Court distorted the second part of the first plea raised at first instance by suggesting that it had only relied, in that part, on the failure to demonstrate in the RAC Opinion that SAS-DDS, used as the source substance in that opinion, constituted a ‘structural analogue that has previously been classified’ within the meaning of Section 3.9.2.10.3 of Annex I to the CLP Regulation.
105Thus, in paragraph 201 of the judgment under appeal, the General Court wrongly declared as new and, therefore, inadmissible, the appellant’s argument relied on in the reply at first instance, according to which the RAC had not demonstrated either that the data relating to SAS-DDS concerned a validated ‘structure activity’ relationship between SAS-DDS and silanamine, or that an expert judgment-based extrapolation existed for that purpose. In paragraphs 112 and 113 of the application initiating proceedings, the appellant stated, quoting Section 3.9.2.10.3 of Annex I to the CLP Regulation in its entirety, that it considered that all the conditions set out in that section had not been satisfied by the RAC. That complaint was supported by the lack of identification of the existence of an existing harmonised classification for the substances relied upon by the RAC for the read-across, while the development of that complaint is set out in paragraph 66 of the reply to the defence.
106The Commission and ECHA contend that the first subsection of the fourth part of the first ground of appeal is ineffective and, in any event, unfounded.
(2)Findings of the Court
107The General Court found, in paragraph 200 of the judgment under appeal, that it was not at all apparent from the application initiating proceedings that it contained an argument relating to data from a validated structure activity relationship and to the existence of an expert judgment-based extrapolation, since the second part of the first plea put forward in that application related, in essence, to the requirement of a structural analogue that has previously been classified. It concluded, in paragraph 201 of that judgment, that that argument was new and therefore had to be declared inadmissible.
108In that regard, it should indeed be noted that, in paragraph 112 of that application, the appellant had claimed that ‘the conditions for using a read-across from SAS-DDS (the source substance) to the Substance (the target substance), as provided in Section 3.9 of Annex I to the CLP [Regulation], [were] not met in the present case’ and, in paragraph 113 of that application, had cited the entirety of Section 3.9.2.10.3 of Annex I to the CLP Regulation, according to which, ‘a substance that has not been tested for specific target organ toxicity may, where appropriate, be classified on the basis of data from a validated structure activity relationship and expert judgement-based extrapolation from a structural analogue that has previously been classified together with substantial support from consideration of other important factors such as formation of common significant metabolites’.
109However, by citing Section 3.9.2.10.3 of that annex, the appellant had emphasised the words ‘structural analogue that has previously been classified’ and not the other criteria set out in that section. Moreover, in the remainder of the second part of the first plea raised at first instance, the appellant had not put forward any argument other than that relating to the criterion resulting from that wording.
110In those circumstances, it cannot be held that the General Court manifestly misinterpreted the application initiating proceedings, with the result that it cannot be complained that the General Court distorted that application by finding that the appellant’s argument, put forward in the reply at first instance, that the RAC had not demonstrated either a ‘validated structure/activity’ relationship between SAS-DDS and silanamine, or the existence of an expert judgment-based extrapolation for that purpose, constituted a new argument.
111It follows that the first subsection of the fourth part of the first ground of appeal must be rejected as unfounded.
(b)The second subsection of the fourth part of the first ground of appeal
(1)Arguments of the parties
112The second subsection of the fourth part of the first ground of appeal, alleging errors made by the General Court in its assessment of the compliance of the use of read-across in the RAC Opinion with the requirements laid down in Section 3.9.2.10.3 of Annex I to the CLP Regulation, comprises two complaints.
113By the first complaint of that subsection, the appellant complains that the General Court did not carry out the required judicial review of the use of the read-across in the RAC Opinion. It submits that the General Court wrongly considered that the general justification of that read-across was sufficient when it should have verified whether the RAC had examined the specific conditions referred to in Section 3.9.2.10.3 of Annex I to the CLP Regulation. More specifically, the appellant complains that the General Court failed to examine several relevant aspects, namely, first, that those specific conditions are not cited in the RAC Opinion, second, that the classification of the substances used for the read-across is not included in that opinion and, third, that the RAC did not justify its choice to rely on a read-across with two substances that have not been subject to harmonised classification.
114By the second complaint of that subsection, the appellant complains that the General Court substituted its reasoning for that of the RAC as regards the use of the read-across in the RAC Opinion.
115It submits, first, that, although the CER had not mentioned this, the General Court found, in paragraph 192 of the judgment under appeal, that SAS-DDS ‘[had] been notified by eight notifiers, three of which [had] explicitly referred to the lungs as the target organ’, which, in its view, enabled the General Court to infer, in paragraph 193 of the judgment under appeal, that SAS-DDS could be considered to be a structural analogue that has previously been classified, within the meaning of Section 3.9.2.10.3 of Annex I to the CLP Regulation.
116Second, in paragraph 180 of the judgment under appeal, the General Court found that the RAC had assessed that ‘several characteristics, such as chemical composition, particle size and shape, surface chemistry, surface area, solubility and rate of dissolution, hydrophobicity, zeta potential, dispersibility and dustiness, support the use of SAS-DDS as a source substance’, whereas, on page 6 of the RAC Opinion, the RAC did not take those characteristics into account for the classification in the hazard class STOT RE.
117Third, in that paragraph 180, the General Court found that ‘a similar grouping approach had been widely accepted and used in the open literature for both human health and environmental hazards’, although that circumstance was not relevant, in the light of the specific criteria laid down in Section 3.9.2.10.3 of Annex I to the CLP Regulation, for classification in the hazard class STOT RE and the RAC did not refer to that circumstance in its opinion.
118The Commission and ECHA submit that that subsection is ineffective and, in any event, unfounded.
(2)Findings of the Court
119It should be noted that, in paragraphs 52, 178, 180 and 182 of the judgment under appeal, the General Court found that, in the RAC Opinion, studies relating to both silanamine and the substance SAS-DDS had been taken into account in relation to the lungs as the target organ, since SAS-DDS had been used as a source substance because it was structurally similar to silanamine and had the same physical, chemical and toxicological properties as silanamine. In addition, in paragraph 181 of that judgment, the General Court held that it was on the basis of the weight of the evidence of all of the available data that the RAC had considered that it was appropriate to classify silanamine in the hazard class STOT RE.
120Accordingly, the General Court concluded, in paragraphs 183 and 184 of that judgment, that, in accordance with Section 1.1.1.3 of Annex I to the CLP Regulation, the results of the studies using SAS-DDS had been taken into account in the RAC Opinion, as part of the determination of the weight of the evidence of all of the available data. and, more specifically, of the substance category approach (grouping, read-across).
121In paragraphs 186 to 194 of the judgment under appeal, the General Court subsequently examined the appellant’s argument that SAS-DDS could not be considered to be a ‘structural analogue that has previously been classified’, within the meaning of Section 3.9.2.10.3 of Annex I to the CLP Regulation, since it had not been subject to harmonised classification.
122In that regard, it should be noted that, according to Sections 3.9.2.1, 3.9.2.3 and 3.9.2.4 of Annex I to the CLP Regulation, the classification of substances in the hazard class STOT RE and the assessment of specific target organ toxicity effects are determined by expert judgement on the basis of the weight of evidence of all of the available data, within the meaning of Section 1.1.1 of that annex, and taking into account the guidance values referred to in Section 3.9.2.9 of that annex.
123Section 1.1.1 of that annex includes, inter alia, Section 1.1.1.3 thereof, according to which ‘a weight of evidence determination means that all available information bearing on the determination of hazard is considered together, such as … relevant … data … [from] … information from the application of the category approach (grouping, read-across) [as well as (quantitative) structure-activity relationships] [(Q)SARs]’.
124By contrast, Section 3.9.2.10.3 of Annex I to the CLP provides that ‘a substance that has not been tested for specific target organ toxicity may, where appropriate, be classified on the basis of data from a validated structure activity relationship and expert judgement-based extrapolation from a structural analogue that has previously been classified together with substantial support from consideration of other important factors such as formation of common significant metabolites’.
125It follows that, as the Advocate General observed, in essence, in point 63 of his Opinion, and as the General Court essentially found in paragraph 177 of the judgment under appeal, Sections 3.9.2.1, 3.9.2.3 and 3.9.2.4 of Annex I to the CLP Regulation, read in conjunction with Section 1.1.1.3 thereof, lay down the general rules for the classification of substances in the hazard class STOT RE, on the one hand, and that Section 3.9.2.10.3 of that annex lays down a special rule for the same purpose in the event that the specific target organ toxicity of the substance concerned has not been tested, on the other.
126Thus, the conditions laid down in Section 3.9.2.10.3 are subject to the requirement that the specific toxicity of the substance to be classified has not been tested for the target organ, with the result that, where such tests exist, the classification of the substance must be carried out in accordance with Sections 3.9.2.1, 3.9.2.3 and 3.9.2.4 of Annex I to the CLP Regulation, read in conjunction with Section 1.1.1.3 of that annex.
127In the present case, as is apparent from paragraph 119 of the present judgment, the results of the studies using silanamine as regards specific toxicity on the target organ, namely the lungs, had been taken into consideration in the RAC Opinion as part of the determination of the weight of the evidence of all of the available data, within the meaning of Sections 3.9.2.1, 3.9.2.3 and 3.9.2.4 of Annex I to the CLP Regulation, read in conjunction with Section 1.1.1.3 thereof.
128The appellant does not dispute the existence of the data relating to silanamine which are apparent from the studies using that substance.
129Therefore, for the purposes of the contested classification, the RAC was not required to satisfy any condition applicable to the consideration of structural analogues, laid down in Section 3.9.2.10.3 of Annex I to the CLP Regulation, in order to be able to take into consideration studies using SAS-DDS.
130In that context, the grounds set out in paragraphs 186 to 194 of the judgment under appeal, to which the first complaint and part of the second complaint of the second subsection of the fourth part of the first ground of appeal relate, must be regarded as being included for the sake of completeness.
131According to settled case-law, grounds of appeal, parts, subsections or complaints directed against the grounds included in a decision of the General Court purely for the sake of completeness cannot lead to that decision being annulled and are therefore ineffective (see, to that effect, judgment of 25 February 2021, Dalli v Commission, C‑615/19 P, EU:C:2021:133, paragraph 103 and the case-law cited).
132Accordingly, the second subsection of the fourth part of the first ground of appeal must be rejected as ineffective in so far as it relates to paragraphs 186 to 194 of the judgment under appeal.
133Furthermore, as regards paragraph 180 of the judgment under appeal, since the purpose of that paragraph is not to refer to assessments made by the General Court, but to set out the content of the RAC Opinion, that paragraph cannot, in any event, be regarded as having substituted grounds.
134It follows that the fourth part of the first ground of appeal must be rejected in its entirety.
135In the light of the foregoing, the first ground of appeal must be rejected in its entirety.
B.The second ground of appeal
136The second ground of appeal, which is divided into two parts, alleges that the General Court erred in its interpretation of Article 37(4) of the CLP Regulation. The first part of the second ground of appeal alleges errors made by the General Court as regards compliance with the deadline, laid down in that provision, within which the RAC Opinion was to be adopted. The second part of the second ground of appeal alleges errors made by the General Court in the context of the assessment of the second part of the second plea raised at first instance, according to which the RAC failed to fulfil its obligation to organise, in accordance with that provision, public consultations on its opinion.
1.The first part of the second ground of appeal
137The first part of the second ground of appeal, alleging errors made by the General Court as regards compliance with the deadline, laid down in Article 37(4) of the CLP Regulation, within which the RAC Opinion was to be adopted, is divided into four subsections. The first subsection of that part alleges errors made by the General Court as regards the point at which, in the present case, time began to run in respect of that deadline. By the second subsection of that first part, the appellant complains that the General Court (i) refrained from annulling the regulation at issue on account of the absence of an ascertainable adoption date for the RAC Opinion and (ii) distorted the evidence in that regard. By the third subsection of that first part, the appellant complains that the General Court did not classify the failure to meet the deadline for the adoption of the opinion laid down in Article 37(4) of the CLP Regulation as an infringement of an essential procedural requirement entailing the annulment of the regulation at issue. By the fourth subsection of that first part, raised in the event that the Court were to decide that failure to meet that deadline does not constitute such an infringement, the appellant submits that the failure to meet that deadline should, in any event, have led to the annulment of the regulation at issue, given that the procedure at issue could have led to a different result.
138It is appropriate to examine, first of all, the third subsection of the first part of the second ground of appeal and then, in turn, the fourth, first and second subsections of that part.
(a)Third subsection of the first part of the second ground of appeal
(1)Arguments of the parties
139In the context of the third subsection of the first part of the second ground of appeal, by which the appellant complains that the General Court did not classify the failure to meet the deadline for the adoption of the opinion laid down in Article 37(4) of the CLP Regulation as an infringement of an essential procedural requirement leading to the annulment of the regulation at issue, it submits that failure to meet that deadline is, in itself, capable of leading to the annulment of that regulation, without it being necessary to provide evidence of the impact of such an infringement on the outcome of the decision-making process. In paragraphs 218 and 219 of the judgment under appeal, the General Court observed however that failure to meet that deadline could lead to the annulment of such an act only if, were it not for that irregularity, the procedure could have led to a different result.
140According to the appellant, the wording ‘shall adopt’, used in Article 37(4) of the CLP Regulation, indicates that that deadline is mandatory, its substantive nature also following from the context of that provision. The appellant argues that the approach advocated by the Ombudsman in its Recommendation on the risk management of dangerous chemical substances by the Commission of 8 June 2023 (case OI/2/2023/MIK), according to which an application for authorisation of chemical substances should be rejected where the deadline laid down in the REACH Regulation cannot be met, should be followed as regards the deadline laid down in Article 37(4) of the CLP Regulation.
141The Commission and ECHA contend that the third subsection of the first part of the second ground of appeal must be rejected as unfounded.
(2)Findings of the Court
142It should be noted that, in paragraphs 205 to 226 of the judgment under appeal, the General Court examined the first part of the second plea raised at first instance, by which the appellant claimed that the RAC Opinion had not been adopted within the 18-month deadline provided for in Article 37(4) of the CLP Regulation, which in its view constituted an infringement of an essential procedural requirement.
143In paragraphs 218 to 225 of the judgment under appeal, the General Court analysed whether, even if the RAC Opinion had not been adopted within that deadline, failure to meet that deadline could lead to the annulment of the regulation at issue.
144In paragraph 219 of that judgment, it held in that regard that, in accordance with the case-law of the Court of Justice, a procedural irregularity could entail annulment of the act ultimately adopted only if, were it not for that irregularity, the procedure could have led to a different result.
145In that regard, it should be noted that Article 37(4) of the CLP Regulation 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’.
146Thus, it is in no way apparent from that provision that the EU legislature intended to ensure that a failure to meet that 18-month deadline should lead to the annulment of the decision adopted at the end of the CLH procedure.
147It must also be pointed out that it is not alleged or, a fortiori, demonstrated that, in general, any failure to meet that deadline would be such as to have an effect on the outcome of that procedure.
148Furthermore, while that deadline was introduced in order to ensure that a swift decision is taken on proposals submitted in accordance with Article 37(1) and (2) of the CLP Regulation, a solution consisting of annulling any regulation adopted on the basis of an opinion issued in breach of that deadline would risk, in practice, preventing the Commission from exercising its powers within a reasonable period of time by requiring it to recommence in its entirety the CLH procedure when the RAC Opinion is adopted belatedly.
149It is also important to note that, as the Advocate General stated in point 116 of his Opinion, such a solution would ultimately risk hindering the attainment of the objectives of the CLP Regulation, by delaying the possibility for the Commission to take the measures necessary to ensure an adequate level of protection of human health and the environment.
150Therefore, the General Court cannot be criticised for having held, with reference to the judgment of 25 October 2005, Germany and Denmark v Commission (C‑465/02 and C‑466/02, EU:C:2005:636), that a failure to meet the deadline set out in Article 37(4) of the CLP Regulation can lead to the annulment of the regulation at issue only if, as a result of the failure to meet that deadline, the procedure could have led to a different result.
151It follows that the third subsection of the first part of the second ground of appeal must be rejected as unfounded.
(b)The fourth subsection of the first part of the second ground of appeal
(1)Arguments of the parties
152In the fourth subsection of the first part of the second ground of appeal, by which the appellant claims that, should the Court of Justice decide that the failure to meet the 18-month deadline provided for in Article 37(4) of the CLP Regulation does not constitute an infringement of an essential procedural requirement, the failure to meet that deadline should, in any event, have led to the annulment of the regulation at issue, it raises, in essence, two complaints.
153By the first complaint of that fourth subsection, the appellant complains that the General Court wrongly required it to demonstrate that compliance with the 18-month deadline laid down in that provision would have led to a different result in the present case, whereas it was merely required to prove that such a possibility was not entirely ruled out.
154By the second complaint in that fourth subsection, the appellant submits that it demonstrated, before the General Court, the possibility of a different outcome of the CLH procedure if that deadline had been complied with by the RAC. According to the appellant, it cannot be ruled out that, had the time limit not been infringed, the information in the RAC’s possession would have been insufficient since the RAC would not have had at its disposal the additional information which it obtained as a result of the failure to comply with that time limit.
155The Commission and ECHA contend that the fourth subsection of the first part of the second ground of appeal must be rejected as unfounded.
(2)Findings of the Court
156In paragraph 220 of the judgment under appeal, the General Court held that compliance with the 18-month deadline for the adoption of the RAC Opinion could not have led to a different result.
157In order to justify that assessment, in paragraphs 221 to 224 of the judgment under appeal, the General Court took account of the fact that, first, the RAC Opinion had proposed, in its version of 5 December 2019, the contested classification, a proposal which was not the subject of the targeted public consultation which took place in February 2020, second, that proposal had been based on the information contained in the classification and labelling proposal and on studies from the open literature and, third, the appellant did not establish that that targeted public consultation could also have had an impact on the contested classification.
158It must be held that, contrary to what the appellant claims by the first complaint of the fourth subsection of the first part of the second ground of appeal, by examining those circumstances, the General Court did not require the appellant to demonstrate that compliance with the 18-month period laid down in Article 37(4) of the CLP Regulation would have led to a different result in the present case.
159Taking account of the fact that the RAC’s proposal in the initial version of its opinion corresponds to the final version of that opinion as regards the contested classification, on the one hand, and of the origin of the information on which the final proposal for that classification was based, on the other, the General Court was fully entitled to find that the information then in the RAC’s possession in that initial version was sufficient to support the contested classification and that the information obtained by the RAC after the expiry of the 18-month deadline laid down in Article 37(4) of the CLP Regulation could not have had an impact on the result of the CLH procedure. The General Court moreover examined not whether the appellant had established that the targeted public consultation had had an impact on the contested classification, but whether that consultation could have had such an impact.
160Accordingly, that first complaint must be rejected as unfounded.
161As regards the second complaint raised in the fourth subsection of the first part of the second ground of appeal, by which the appellant claims to have demonstrated, before the General Court, the possibility of a different outcome of the CEH procedure if the deadline laid down in Article 37(4) of the CLP Regulation had been met by the RAC, it must be stated that, by that second complaint, the appellant seeks, in essence, to challenge the General Court’s assessment of the facts in paragraphs 220 to 223 of the judgment under appeal, which, as is apparent from the case-law cited in paragraphs 99 and 100 of the present judgment, falls solely within the jurisdiction of the General Court, save where the clear sense of the evidence produced before it has been distorted, which the appellant does not claim in the present case.
162Accordingly, that second complaint must be rejected as inadmissible.
163It follows that the fourth subsection of the first part of the second ground of appeal must be rejected as in part unfounded and in part inadmissible.
(c)The first and second subsections of the first part of the second ground of appeal
(1)Arguments of the parties
164By the first subsection of the first part of the second ground of appeal, the appellant submits that the General Court’s reasoning in paragraph 212 of the judgment under appeal as regards the starting date of the deadline laid down in Article 37(4) of the CLP Regulation, within which the RAC Opinion was to be adopted, is vitiated by errors.
165By the second subsection of the first part of the second ground of appeal, the appellant complains that the General Court (i) refrained from annulling the regulation at issue on account of the ‘absence of an ascertainable adoption date’ for the RAC Opinion and (ii) distorted the evidence in that regard.
166The Commission and ECHA contend that the first and second subsections of the first part of the second ground of appeal must be rejected.
(2)Findings of the Court
167It should be noted that, by the first and second subsections of the first part of the second ground of appeal, the appellant seeks to demonstrate that the General Court should have found that the deadline laid down in Article 37(4) of the CLP Regulation had not been met during the procedure leading to the adoption of the regulation at issue.
168It follows from the fact that the third and fourth subsections of that first part have been rejected that the General Court was fully entitled to hold, in paragraph 225 of the judgment under appeal, that, even assuming that the RAC failed to meet that deadline, this could not have had an effect on the inclusion of silanamine in the hazard class STOT RE by that regulation, so that such an irregularity could not have led to the annulment of that regulation.
169It follows that the first and second subsections of the first part of the second ground of appeal must be rejected as ineffective.
2.The second part of the second ground of appeal
170The second part of the second ground of appeal, alleging errors made by the General Court in the context of the assessment of the second part of the second plea raised at first instance, according to which the RAC failed to comply with its obligation to organise, in accordance with Article 37(4) of the CLP Regulation, public consultations on its opinions, is divided into two subsections.
171It is appropriate to examine, first of all, the second subsection of the second part of the second ground of appeal.
(a)The second subsection of the second part of the second ground of appeal
(1)Arguments of the parties
172The second subsection of the second part of the second ground of appeal, alleging errors made by the General Court in interpreting Article 37(4) of the CLP Regulation, in so far as that provision guarantees the right to submit comments by the parties concerned, may be divided into two complaints.
173By the first complaint of that second subsection, the appellant complains that the General Court erred, in paragraph 236 of the judgment under appeal, in interpreting that provision as meaning that the comments of the parties concerned could be submitted only on a proposal for harmonised classification and labelling of substances, and not on the RAC Opinion. According to the appellant, the RAC should adopt its opinion after granting those parties the opportunity to comment on that opinion or on the draft of that opinion.
174The appellant submits, first, that the General Court disregarded the wording of that provision, which is unambiguous and, in paragraph 234 of the judgment under appeal, contrary to the judgments of 19 June 1980, Roudolff (803/79, EU:C:1980:166, paragraph 7), and of 6 September 2018, Czech Republic v Commission (C‑4/17 P, EU:C:2018:678, paragraph 45), based its interpretation of that provision on the conduct of the CLH procedure, as that procedure is set out in Article 37 of the CLP Regulation. According to a combined reading of Article 37 of that regulation with recital 52 thereof, Article 37 concerns only the conditions relating to the drafting of the RAC Opinion and does not refer to the proposal for harmonised classification and labelling.
175Second, according to the appellant, a teleological interpretation of Article 37(4) of the CLP Regulation should have led the General Court to conclude that it was obligatory to organise a consultation on the RAC Opinion, which is the main scientific basis for harmonised classification and labelling and must contain an assessment of all the available information.
176Third, the General Court could not reason by analogy with the judgment of 9 June 2021, Exxonmobil Petroleum & Chemical v ECHA (T‑177/19, EU:T:2021:336), which concerns the interpretation of Article 59(4) of the REACH Regulation, the structure of which is different from that of Article 37(4) of the CLP Regulation. The latter provision neither relates to the adoption of an opinion by ECHA nor to providing the parties concerned an opportunity to comment.
177By the second complaint of that second subsection, the appellant complains that the General Court infringed its obligation to state reasons in so far as it did not provide a sufficient justification for understanding its interpretation and enabling judicial review. The General Court merely described the different steps of the CLH procedure in paragraph 234 of the judgment under appeal, without substantiating however how those steps would support the consultation being conducted on the CLH Dossier rather than the RAC Opinion.
178The Commission and ECHA contend that the second subsection of the second part of the second ground of appeal is unfounded.
(2)Findings of the Court
179It should be noted that the General Court examined, in paragraphs 227 to 243 of the judgment under appeal, the arguments relied on by the appellant in the context of the second part of the second plea raised at first instance, by which the appellant claimed that it had, under Article 37(4) of the CLP Regulation, a right to submit its comments on the RAC Opinion, or even on the draft version of the RAC Opinion.
180In the first place, in paragraphs 229 to 232 of the judgment under appeal, the General Court examined whether the appellant had the right to be heard on the RAC Opinion under Article 41(2)(a) of the Charter of Fundamental Rights of the European Union and held that it not did not have such a right in the present case since the regulation at issue laid down measures of general application, such as the contested classification.
181In the second place, in paragraphs 233 to 242 of the judgment under appeal, the General Court examined whether the appellant had a right to be consulted on the RAC Opinion under Article 37(4) of the CLP Regulation and held that it did not have such a right.
182First, the General Court held, in paragraph 234 of the judgment under appeal, that that provision had to be interpreted in the light of the CLH procedure, which involves, first of all, the submission of a proposal for harmonised classification and labelling of substances in accordance with paragraphs 1 and 2 of that Article 37; next, the adoption of an opinion by the RAC ‘giving the parties concerned the opportunity to comment’; followed by the forwarding by ECHA of that opinion and all comments to the Commission, in accordance with paragraph 4 of that article; 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, in accordance with paragraph 5 of that article.
183Second, in paragraphs 235 and 236 of the judgment under appeal, the General Court concluded that (i) the public consultation provided for in Article 37(4) of the CLP Regulation was intended to allow interested parties to submit the comments and elements presented by those parties during that phase and (ii) that regulation did not, however, provide for the possibility for those parties to submit observations on the RAC Opinion. In paragraph 237 of the judgment under appeal, the General Court subsequently found that, in the present case, the appellant had had the right to comment on the classification and labelling proposal and to be heard in that regard before the RAC.
184Third, in paragraphs 240 and 241 of the judgment under appeal, the General Court examined (i) the appellant’s argument that the right to be heard on the RAC Opinion is more justified where the classification proposed by the RAC is different from that referred to in the classification and labelling proposal and (ii) the appellant’s argument that consultation of the parties concerned on the draft opinion is particularly necessary where that opinion takes into account studies which had not been taken into account in the classification proposal. As regards the first of those arguments, the General Court noted that the RAC was not bound by a proposal for harmonised classification and labelling of substances and that the public consultation provided for in Article 37(4) of the CLP Regulation was not concerned with the RAC Opinion. As regards the second of those arguments, the General Court considered that the reference to ‘all evidence available’, provided for in Section 3.9.2.1 of Annex I to that regulation, without any limitation, was a sufficient basis for considering that the RAC could take into account studies which do not form part of a proposal for harmonised classification and labelling of substances.
185As regards the first complaint of the second subsection of the second part of the second ground of appeal, alleging misinterpretation of Article 37(4) of the CLP Regulation, it should be recalled that that provision states 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’. Recital 52 of the CLP Regulation states in that regard that ‘[ECHA] should give its opinion on the proposal while interested parties should have an opportunity to comment.’
186Contrary to what the appellant claims, it cannot be inferred either from the wording of Article 37(4) or from the wording of recital 52 that the RAC is required to adopt a document other than the opinion on the proposal submitted in accordance with paragraphs 1 and 2 of that article, such as a draft opinion which is the subject of the comments of the parties concerned and, subsequently, a final opinion which takes those comments into account.
187The CLH procedure thus differs from that laid down in Article 64 of the REACH Regulation, which expressly provides that ECHA is to send its draft opinions to the applicant, whose comments must be taken into consideration by ECHA, before subsequently adopting a final opinion.
188As the Advocate General observed in point 135 of his Opinion, if the EU legislature had intended to give the parties concerned, as part of the CLH procedure, the opportunity to submit their comments on the RAC Opinion, it would have expressly provided for this, as evidenced by Article 64 of the REACH Regulation.
189In addition, Article 37(4) of the CLP Regulation cannot be interpreted as meaning that the comments of the parties concerned may be submitted after RAC adopts its opinion so that the Commission has those comments at its disposal.
190Under Article 50(1) of the CLP Regulation, the task of ECHA, of which RAC is one of its committees, is to provide, inter alia, the Commission with the best possible scientific and technical advice on questions relating to chemicals which fall within its remit and which are referred to it in accordance with that regulation.
191Therefore, in order to be able to fulfil that task, the RAC must have at its disposal any comments from the parties concerned before it adopts its opinion.
192It follows that the General Court did not err in law when it held, in paragraphs 235 and 236 of the judgment under appeal, that the public consultation provided for in Article 37(4) of the CLP Regulation is intended to allow interested parties to comment only on a proposal for harmonised classification and labelling of substances.
193Accordingly, the first complaint of the second subsection of the second part of the second ground of appeal must be rejected as unfounded.
194As regards the second complaint of that subsection, by which the appellant complains that the General Court failed to state adequate reasons in its examination of the second part of the second plea raised at first instance, it should be borne in mind that the statement of the reasons on which a judgment or order is based must disclose in a clear and unequivocal fashion the General Court’s reasoning in such a way as to enable the persons concerned to ascertain the reasons for the decision taken and the Court of Justice to exercise its power of review. The obligation to state reasons does not require the General Court to provide an account which responds exhaustively and one by one to all the arguments put forward by the parties to the case. The statement of reasons may therefore be implicit, on condition that it enables the persons concerned to know why the General Court has not upheld their arguments and provides the Court of Justice with sufficient material for it to exercise its power of review (judgment of 16 April 2026, HG v Commission, C‑899/24 P, EU:C:2026:306, paragraph 33 and the case-law cited).
195The clear and unequivocal reasoning of the General Court, which enabled the appellant to challenge that reasoning and the Court of Justice to exercise its power of review in paragraphs 185 to 192 of the present judgment, is apparent from paragraphs 227 to 243 of the judgment under appeal.
196Accordingly, the second complaint of that subsection must be rejected as unfounded.
197It follows that the second subsection of the second part of the second ground of appeal must be rejected as unfounded.
(b)The first subsection of the second part of the second ground of appeal
(1)Arguments of the parties
198In the context of the first subsection of the second part of the second ground of appeal, by which the appellant complains that the General Court distorted the second part of the second plea raised at first instance, it submits that, in paragraphs 229 to 232, 238 and 240 of the judgment under appeal, the General Court examined that second part of the second plea raised at first instance as referring to the right to be heard before the RAC concerning the opinion adopted by the latter. However, the appellant relied on Article 37(4) of the CLP Regulation in order to invoke the right to comment. The General Court therefore erred, in paragraphs 232 and 236 of the judgment under appeal, in drawing an analogy with the judgment of 5 July 2023, TIB Chemicals v Commission (T‑639/20, EU:T:2023:374).
199The Commission and ECHA contend that the first subsection of the second part of the second ground of appeal is ineffective and, in any event, unfounded.
(2)Findings of the Court
200It follows from paragraphs 233 to 242 of the judgment under appeal that the General Court examined whether the appellant had a right to be consulted on the RAC Opinion under Article 37(4) of the CLP Regulation and, as is apparent from paragraph 192 of the present judgment, correctly held that it did not have such a right.
201Thus, even assuming that the General Court distorted the second part of the second plea raised at first instance by finding that that part referred to the right to be heard before the RAC concerning the opinion adopted by the RAC, that distortion would have had no effect on the examination of that part.
202Therefore, the first subsection of the second part of the second ground of appeal must be rejected as ineffective.
203Accordingly, the second part of the second ground of appeal must be rejected in its entirety.
204In the light of all the foregoing, the second ground of appeal must be rejected in its entirety and, accordingly, the appeal must be dismissed.
VI.Costs
205In accordance with the Article 184(2) of the Rules of Procedure, where the appeal is unfounded, the Court is to make a decision as to costs.
206Under Article 138(1) of the Rules of Procedure, which applies to appeal proceedings by virtue of Article 184(1) thereof, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings.
207In the present case, since the Commission and ECHA have applied for costs against the appellant and the latter has been unsuccessful in its appeal, the appellant must be ordered to bear its own costs and to pay those incurred by the Commission and ECHA, in accordance with the forms of order sought by them.
Operative part
On those grounds, the Court (Third Chamber) hereby:
1.Dismisses the appeal;
2.Orders Evonik Operations GmbH to bear its own costs and to pay those incurred by the European Commission and the European Chemicals Agency (ECHA).
Delivered in open court in Luxembourg on 5 November 2026.
Source: EUR-Lex, © European Union, 1998-2026. Reuse authorised under Decision 2011/833/EU.