Opinion of Advocate General Szpunar delivered on 30 April 2026.###

OPINION OF ADVOCATE GENERAL

SZPUNAR

delivered on 30 April 2026 (1)

Case C‑121/25 P

Evonik Operation GmbH

v

European Commission

( Appeal – Environment and protection of human health – Regulation (EC) No 1272/2008 – Classification, labelling and packaging of substances and mixtures – Hazard class ‘Specific target organ toxicity – repeated exposure’ – Delegated Regulation (EU) 2022/692 – Harmonised classification and labelling of silanamine, 1,1,1-trimethyl-N-(trimethylsilyl)-, hydrolysis products with silica; pyrogenic, synthetic amorphous, nano, surface treated silicon dioxide – Procedure for the harmonisation of the classification and labelling of that substance )

I.      Introduction

1.        By its appeal, the appellant, 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 its action for annulment of Delegated Regulation (EU) 2022/692, (2) 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 (‘silanamine’) in the hazard class ‘Specific target organ toxicity – repeated exposure’ (‘the hazard class STOT RE’) of Category 2.

2.        In support of its claims, the appellant relies on two grounds of appeal, divided into several parts and subsections. In accordance with the Court’s wishes, in this Opinion I shall focus on the following complaints: in respect of the first ground of appeal, I shall examine the complaint alleging non-compliance of the use by the Committee for Risk Assessment of the European Chemicals Agency (ECHA) (‘the RAC’) of the read-across approach for the purposes of the classification of silanamine (first complaint of the second subsection of the fourth part); in respect of the second ground of appeal, I shall analyse the complaints alleging infringement of the provisions governing the procedure for harmonisation of classification and labelling of substances relating, first, to the deadline for adoption of the RAC opinion on the proposal for harmonised classification and labelling (‘the CLH proposal’) (first complaint of the first subsection of the first part and the second and third subsections of that part) and, secondly, to the public consultation (first complaint of the second subsection of the second part).

II.    European Union law

A.      Regulation (EC) No 1272/2008

3.        Recitals 5, 6, 8, 10, 12 and 52 of Regulation (EC) No 1272/2008, (3) in the version applicable on the date of adoption of the regulation at issue, state:

‘(5)      With a view to facilitating worldwide trade while protecting human health and the environment, harmonised criteria for classification and labelling have been carefully developed over a period of 12 years within the United Nations (UN) structure, resulting in the Globally Harmonised System of Classification and Labelling of Chemicals (hereinafter referred to as “the GHS”).

(6)      This Regulation follows various declarations whereby the Community confirmed its intention to contribute to the global harmonisation of criteria for classification and labelling, not only at UN level, but also through the incorporation of the internationally agreed GHS criteria into Community law.

…

(8)      Therefore it is essential to harmonise the provisions and criteria for the classification and labelling of substances, mixtures and certain specific articles within the Community, taking into account the classification criteria and labelling rules of the GHS …

…

(10)      The objective of this Regulation should be to determine which properties of substances and mixtures should lead to a classification as hazardous, in order for the hazards of substances and mixtures to be properly identified and communicated. …

…

(12)      The terms and definitions used in this Regulation should be consistent with those set out in Regulation (EC) No 1907/2006 …, [(4)] with those set out in the rules governing transport and with the definitions specified at UN level in the GHS, in order to ensure maximum consistency in the application of chemicals legislation within the Community in the context of global trade. The hazard classes specified in the GHS should be set out in this Regulation for the same reason.

…

(52)      … [ECHA] should give its opinion on the [CLH proposals for substances] while interested parties should have an opportunity to comment. The Commission should submit a draft decision on the final classification and labelling elements.’

4.        Article 1(1) of that 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:

(a)      harmonising the criteria for classification of substances and mixtures, and the rules on labelling and packaging for hazardous substances and mixtures;

…

(d)      establishing a list of substances with their harmonised classifications and labelling elements at Community level in Part 3 of Annex VI;

…’

5.        The first paragraph of Article 3 of that regulation, entitled ‘Hazardous substances and mixtures and specification of hazard classes’, 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.’

6.        Article 4 of that regulation, entitled ‘General obligations to classify, label and package’, provides, in paragraphs 1 and 3:

‘1.      Manufacturers, importers and downstream users shall classify substances or mixtures in accordance with Title II before placing them on the market.

…

3.      If a substance is subject to harmonised classification and labelling in accordance with Title V through an entry in Part 3 of Annex VI, that substance shall be classified in accordance with that entry, and a classification of that substance in accordance with Title II shall not be performed for the hazard classes or differentiations covered by that entry.

However, where the substance also falls within one or more hazard classes or differentiations not covered by an entry in Part 3 of Annex VI, classification under Title II shall be carried out for those hazard classes or differentiations.’

7.        Article 9 of Regulation No 1272/2008, entitled ‘Evaluation of hazard information for substances and mixtures’, provides, in paragraphs 1 and 3:

‘1.      Manufacturers, importers and downstream users of a substance or a mixture shall evaluate the information identified in accordance with Chapter 1 of this Title by applying to it the criteria for classification for each hazard class … in Parts 2 to 5 of Annex I, so as to ascertain the hazards associated with the substance or mixture.

…

3.      Where the criteria cannot be applied directly to available identified information, manufacturers, importers and downstream users shall carry out an evaluation by applying a weight of evidence determination using expert judgement in accordance with section 1.1.1 of Annex I to this Regulation, weighing all available information having a bearing on the determination of the hazards of the substance or the mixture, and in accordance with section 1.2 of Annex XI to [Regulation No 1907/2006].’

8.        Article 37 of that regulation, entitled ‘Procedure for harmonisation of classification and labelling of substances’, is worded as follows:

‘1.      A competent authority may submit to [ECHA] a [CLH proposal for] substances and, where appropriate, specific concentration limits or 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.

…

4.      The [RAC] … 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 … 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.

…

6.      Manufacturers, importers and downstream users who have new information which may lead to a change of the harmonised classification and labelling elements of a substance in Part 3 of Annex VI shall submit a proposal … to the competent authority in one of the Member States in which the substance is placed on the market.’

9.        Annex I to that regulation (‘Annex I’), entitled ‘Classification and labelling requirements for hazardous substances and mixtures’, includes, in Part 1 thereof on the general principles for classification and labelling, section 1.1.1, entitled ‘The role and application of expert judgement and weight of evidence determination’, which is worded as follows:

‘1.1.1.1.      Where the criteria cannot be applied directly to available identified information, … the weight of evidence determination using expert judgment shall be applied in accordance with Article 9(3) …

…

1.1.1.3.      A weight of evidence determination means that all available information bearing on the determination of hazard is considered together, such as the results of suitable in vitro tests, relevant animal data, information from the application of the category approach (grouping, read-across), (Q)SAR results, human experience such as occupational data and data from accident databases, epidemiological and clinical studies and well-documented case reports and observations. The quality and consistency of the data shall be given appropriate weight. Information on substances or mixtures related to the substance or mixture being classified shall be considered as appropriate, as well as site of action and mechanism or mode of action study results. Both positive and negative results shall be assembled together in a single weight of evidence determination.

…’

10.      That annex also contains Part 3, entitled ‘Health hazards’, which includes section 3.9, entitled ‘ Specific target organ toxicity – repeated exposure’, worded as follows:

‘3.9.1.      Definitions and general considerations

3.9.1.1.      Specific target organ toxicity-repeated exposure means specific toxic effects on target organs occurring after repeated exposure to a substances 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.

…

3.9.2.            Classification criteria for substances

3.9.2.1.      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).

…

3.9.2.3.      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.

3.9.2.4.      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.

…

3.9.2.10.      Other considerations

…

3.9.2.10.3.      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.

…’

B.      Regulation No 1907/2006

11.      Article 13 of Regulation No 1907/2006, in the version applicable on the date of adoption of the regulation at issue (‘Regulation No 1907/2006’), entitled ‘General requirements for generation of information on intrinsic properties of substances’, provides, in paragraph 1:

‘Information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI are met. In particular for human toxicity, information shall be generated whenever possible by means other than vertebrate animal tests, through the use of alternative methods, for example, in vitro methods or qualitative or quantitative structure-activity relationship models or from information from structurally related substances (grouping or read-across). …’

12.      Annex XI to that regulation, entitled ‘General rules for adaptation of the standard testing regime set out in Annexes VII to X’, contains, inter alia, section 1, entitled ‘Testing does not appear scientifically necessary’, divided into five subsections. (5)

13.      Subsection 1.3 of that annex, entitled ‘Qualitative or Quantitative structure-activity relationship ((Q)SAR)’, (6) is worded as follows:

‘Results obtained from valid qualitative or quantitative structure-activity relationship models ((Q)SARs) may indicate the presence or absence of a certain dangerous property. Results of (Q)SARs may be used instead of testing when the following conditions are met:

–      results are derived from a (Q)SAR model whose scientific validity has been established,

–      the substance falls within the applicability domain of the (Q)SAR model,

–      results are adequate for the purpose of classification and labelling and/or risk assessment, and

–      adequate and reliable documentation of the applied method is provided.

[ECHA] in collaboration with the Commission, Member States and interested parties shall develop and provide guidance in assessing which (Q)SARs will meet these conditions and provide examples.

…’

14.      Subsection 1.5 of that annex, entitled ‘Grouping of substances and read-across approach’, states, in its first paragraph:

‘Substances whose physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity, may be considered as a group, or category, of substances. Application of the group concept requires that physicochemical properties, human health effects and environmental effects or environmental fate may be predicted from data for reference substance(s) within the group by interpolation to other substances in the group (read-across approach). This avoids the need to test every substance for every endpoint.’

III. Background to the dispute, the action before the General Court, the procedure before the Court of Justice and the forms of order sought

A.      Background to the dispute

15.      The background to the dispute is set out in paragraphs 2 to 10 of the judgment under appeal. It may be summarised as follows.

16.      The applicant and appellant (‘the appellant’), a company incorporated under German law, manufactures silanamine, a type of synthetic amorphous silica (‘SAS’), which has been processed to become hydrophobic. (7) 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. Silanamine is also an active substance within the meaning of Regulation (EU) No 528/2012. (8)

17.      On 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); ‘the French competent authority’) submitted to ECHA, in accordance with Article 37(1) of Regulation No 1272/2008, a CLH proposal for silanamine in the hazard class STOT RE Category 2. The classification proposal was marked ‘version 2’.

18.      Between 4 March and 3 May 2019, several of the parties concerned submitted their comments on the abovementioned CLH proposal, in accordance with Article 37(4) of Regulation No 1272/2008.

19.      On 5 December 2019, on the basis of Article 37(4) of Regulation No 1272/2008, the RAC adopted an opinion (‘the RAC Opinion’). In that opinion, it proposed the classification of silanamine in the hazard class STOT RE Category 2, with hazard statement code ‘H373’ (lungs, inhalation), as well as in the hazard class acute toxicity of Category 2 via the inhalation route (H330) with an acute toxicity estimate of 0.45 milligram per litre (mg/L).

20.      Between 3 and 17 February 2020, a targeted public consultation was organised on the classification of silanamine in the hazard class acute toxicity.

21.      On 16 February 2022, on the basis of the RAC Opinion, the European Commission adopted the regulation at issue, by which silanamine was added to Table 3 of Part 3 of Annex VI to Regulation No 1272/2008, with harmonised classification and labelling in the hazard class STOT RE Category 2, hazard statement code ‘H373’ (lungs, inhalation) and pictogram hazard code ‘GHS 08Wng’ (‘the contested classification’).

B.      The action before the General Court

22.      On 20 July 2022, the appellant brought an action before the General Court for annulment of the regulation at issue in so far as it concerns the harmonised classification and labelling of silanamine.

23.      In support of its action, it put forward four pleas in law. (9) In the context of the first plea for annulment, the appellant submitted, in essence, that the contested classification was vitiated by manifest errors of assessment and did not meet the criteria for classification in the hazard class STOT RE Category 2. It claimed, inter alia, in the second part of that plea, that the RAC had based its opinion on animal studies relating to a substance analogous to silanamine even though the conditions for using those studies were not met. In the context of the second plea for annulment, it submitted that the regulation at issue had been adopted in breach of Article 37(4) of Regulation No 1272/2008 on the ground, first, that the RAC had not adopted its opinion within the mandatory 18-month deadline and, secondly, that that opinion had not been the subject of a public consultation.

24.      By the judgment under appeal, the General Court dismissed the action in its entirety.

C.      The procedure before the Court of Justice and the forms of order sought

25.      On 5 February 2025, the appellant lodged an appeal against the judgment under appeal. The Commission and ECHA, which was granted leave to intervene in support of the form of order sought by the Commission in the case before the General Court, submitted responses. By decision of the President of the Court, the parties were authorised to submit a reply and a rejoinder.

26.      By its appeal, the appellant claims that the Court should:

–        declare the appeal admissible and well-founded;

–        annul 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.

27.      The Commission and ECHA contend that the Court should:

–        dismiss the appeal, and

–        order the appellant to pay the costs.

28.      The Court has decided to give judgment without holding a hearing.

IV.    Analysis

29.      In support of its appeal, the appellant relies on two grounds of appeal. As I have stated and in accordance with the Court’s wishes, I shall focus my Opinion, first, on the first complaint of the second subsection of the fourth part of the first ground of appeal and, secondly, on the first complaint of the first subsection of the first part, and the second and third subsections of the first part of the second ground of appeal, and, lastly, on the first complaint of the second subsection of the second part of the second ground of appeal.

A.      Compliance of the RAC’s use of the read-across approach (first complaint of the second subsection of the fourth part of the first ground of appeal)

30.      The complaints raised by the appellant in the first ground of appeal allege the incorrect and incomplete application of the classification criteria laid down by Regulation No 1272/2008. By the first complaint of the second subsection of the fourth part of that ground of appeal, the appellant alleges that the General Court erred in law in its assessment of the compliance of the RAC’s use, in its opinion, of read-across with section 3.9.2.10.3 of Annex I.

31.      Before presenting the parties’ arguments on that complaint and analysing it, I consider it appropriate to begin by making some general remarks on the criteria for the classification of substances (10) in the hazard class STOT RE in order to provide the context for section 3.9.2.10.3, on which the appellant relies.

1.      General remarks

32.      Under Article 3 of Regulation No 1272/2008, a substance fulfilling the criteria laid down in Parts 2 to 5 of Annex I is hazardous and must be classified in relation to the respective hazard classes provided for in that annex. Its classification is determined, in accordance with Chapter 1 of Title II of that regulation, on the basis of information evaluated in accordance with Chapter 2 of that title. Under Article 9 of that regulation, contained in the latter chapter, the evaluation is to be carried out by applying the criteria for classification for each hazard class.

33.      The criteria for classification of substances in the hazard class STOT RE, at issue in the present case, are set out in section 3.9.2 of Annex I. It follows from sections 3.9.2.1, 3.9.2.3 and 3.9.2.4 of section 3.9.2 that the classification of substances in that hazard class and the evaluation of specific target organ toxic effects are to be determined by expert judgement, within the meaning of section 1.1.1 of that annex, on the basis of the weight of all evidence available including the guidance presented in section 3.9.2.

34.      Section 1.1.1 of Annex I, to which the sections mentioned in the preceding point refer, contains, inter alia, section 1.1.1.3, in accordance with which ‘a weight of evidence determination means that all available information bearing on the determination of hazard is considered together’. As regards such information, that section expressly mentions, inter alia, information from the application of the category approach (grouping, read-across) and (quantitative) structure-activity relationships ((Q)SARs).

35.      The category approach (grouping, read-across) consists of using data from substances with a similar structure (analogous) (source substances) to predict the behaviour of an evaluated substance (the target substance) belonging to the same category. (11)

36.      As regards structure-activity relationship (SAR) and quantitative structure-activity relationship (QSAR) models, together referred to as (Q)SAR, these are models used to predict the properties or behaviour of substances based on knowledge of their chemical structure. (12)

37.      Scientifically, the concepts of chemical category and (Q)SAR are intrinsically linked, since they are based on the same assumption that the properties of the substances depend on their structure. (13) The method of forming a chemical category and then using empirical data on a few substances in that category to estimate the missing values for the untested substances is, in essence, an internal (Q)SAR. (14) Similarly, the term ‘read-across’, used in section 1.1.1.3 of Annex I, is generic and widely used in science and can also be applied in the context of the use of (Q)SAR models. (15)

38.      However, regardless of the similarities between those two methods and the scientific meaning of the terms used to describe them, it must be noted that, from a legal point of view, they are two different methods. First, they are presented as such in Regulation No 1272/2008. (16) Secondly, they are also presented separately in Regulation No 1907/2006, which is intrinsically linked to Regulation No 1272/2008, as stated in recital 12 and numerous provisions of the latter regulation. In particular, Article 9(3) of Regulation No 1272/2008 refers, in the context of assessing the strength of evidence, directly to section 1.2 of Annex XI to Regulation No 1907/2006. That annex, entitled ‘General rules for adaptation of the standard testing regime set out in Annexes VII to X’, presents each of those methods in a separate section. (17)

39.      Moreover, the GHS – which Regulation No 1272/2008 seeks to incorporate into EU law, as is apparent from recital 6 thereof – also draws that distinction between the two methods. (18)

40.      In any event, the analysis of the use of the term ‘read-across’ in Regulations No 1272/2008 and No 1907/2006 does not support the conclusion that that term is intended to describe the use of data from qualitative or quantitative structure-activity relationship ((Q)SAR) models.

41.      In that context, I recall that the present complaint is based on section 3.9.2.10.3 of subsection 3.9.2.10, entitled ‘Other considerations’, contained in section 3.9.2 of Annex I, according to which a substance that has not been tested for specific target organ toxicity may 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.

42.      Thus, while sections 3.9.2.1, 3.9.2.3 and 3.9.2.4 of Annex I provide that the classification of substances in the hazard class STOT RE is to be determined by expert judgement, within the meaning of section 1.1.1 of that annex, on the basis of the weight of all evidence available, section 3.9.2.10.3 of that annex states that that classification may be determined by extrapolation from a structural analogue that has been previously classified, if all the conditions set out in that section are met.

2.      Arguments of the parties

43.      The appellant complains that the General Court did not derive appropriate consequences from the non-compliance of the RAC’s use of the read-across approach with section 3.9.2.10.3 of Annex I. It notes that, in its opinion, the RAC proposed that silanamine (SAS-HMDS) be classified in the hazard class STOT RE by relying on the read-across with two other substances, namely SAS-DDS and SAS-PDMS, (19) whereas the conditions for using the read-across approach, laid down in section 3.9.2.10.3 of Annex I, were not satisfied. In particular, the latter two substances were not subject to harmonised classification in the hazard class STOT RE. The appellant submits that the RAC has in no way demonstrated that it took into account the conditions of section 3.9.2.10.3 of Annex I, which the General Court failed to verify and sanction.

44.      The Commission, supported by ECHA, contends that that complaint should be rejected as ineffective. It submits, first, that the RAC was not required to justify the compliance of the use of the read-across approach with section 3.9.2.10.3 of Annex I, since that section does not apply in the present case. Silanamine was classified in the hazard class STOT RE not only on the basis of the read-across from another substance but also on the basis of the results of tests carried out on it.

45.      Secondly, the Commission notes, in its rejoinder, that, had section 3.9.2.10.3 of Annex I been relevant and applicable to the use of the read-across approach with SAS-DDS in the context of the determination of the weight of the evidence of all of the available data, the conditions set out in that section were fulfilled in any case. In that regard, the Commission agrees with the General Court’s findings that SAS-DDS could be considered to be a structural analogue ‘that has previously been classified’, in view of the fact that those terms should be understood as relating not only to substances which have been subject to harmonised classification, but also to those which have been subject to self-classification, that is to say classification carried out by manufacturers, importers or downstream users.

3.      Assessment

46.      First of all, the General Court notes, in paragraph 182 of the judgment under appeal, that, in its opinion, the RAC took into account both the results of studies using SAS-DDS and the results of studies using SAS-HDMS and that the contested classification is based on the weight of the evidence of all of the available data. In that context, it recalls, in paragraph 183 of that judgment, that, in accordance with section 1.1.1.3 of Annex I, a weight of evidence determination means that all available information bearing on the determination of hazard is considered together, in particular information from the application of the category approach (grouping, read-across). Next, it states, in paragraph 184 of that judgment, that the results of the studies using SAS-DDS were taken into account in the RAC Opinion, as part of the determination of the weight of the evidence of all of the available data. In addition, it observes, in paragraphs 185 and 186 of the judgment, that the RAC took into account studies using SAS-DDS in finding that that substance was sufficiently similar to silanamine and that that fact is not disputed by the appellant.

47.      As regards the argument that SAS-DDS was not subject to harmonised classification, the General Court observes, in paragraph 190 of the judgment under appeal, that, with regard to the hazard class STOT RE, substances are normally subject to self-classification. It then finds, in paragraph 191 of that judgment, that the expression ‘structural analogue that has previously been classified’, within the meaning of section 3.9.2.10.3 of Annex I, must be interpreted as covering not only substances which have been subject to harmonised classification, but also those which have been subject to self-classification. According to the information available on the ECHA website, reproduced in paragraph 192 of that judgment, SAS-DDS has been subject to self-classification on several occasions.

48.      It follows from the two preceding points of this Opinion that, according to the General Court, in connection with the classification of silanamine in the hazard class STOT RE, both section 1.1.1.3 and section 3.9.2.10.3 of Annex I were applicable. As is apparent from point 43 of this Opinion, in the context of the present complaint, the appellant alleges that the General Court erred in law only in its interpretation of the latter section. In those circumstances, it is necessary to determine, first of all, whether section 3.9.2.10.3 of that annex was applicable in the present case. Only if that question is answered in the affirmative is it necessary to determine whether the General Court made that error.

(a)    The (in)applicability of section 3.9.2.10.3 of Annex I

49.      The appellant submits, in essence, that, given its wording and the fact that it appears in a subsection of section 3.9.2, section 3.9.2.10.3 of Annex I has the character of lex specialis in relation to the general rules for the classification of substances in the hazard class STOT RE, in that it imposes additional conditions for the use of the read-across approach in the context of that classification. In so far as those conditions were not satisfied in the present case, the RAC’s use of that approach is not consistent with Regulation No 1272/2008.

50.      I do not share that view.

51.      As is clear from my presentation of the criteria for classification of substances in the hazard class STOT RE, (20) section 3.9.2.10.3 of Annex I does not lay down any additional conditions for using the read-across approach: nothing in its wording suggests that it would modify the general rules for classification set out in sections 3.9.2.1, 3.9.2.3 and 3.9.2.4 of that annex, read in conjunction with section 1.1.1.3 thereof. However, in my view, it sets out a separate classification rule that can be applied independently of the general rules.

52.      In the first place, section 3.9.2.10.3 of Annex I contains no express reference to sections 3.9.2.1, 3.9.2.3 and 3.9.2.4, or to section 1.1.1 or section 1.1.1.3 thereof. By contrast, an express reference to section 1.1.1 of that annex can be found in sections 3.9.2.1, 3.9.2.3 and 3.9.2.4 thereof, which specify the criteria for classification in the hazard class STOT RE. Given the legislative technique adopted in that annex, it seems to me that, if the EU legislature had intended to amend the general classification rules, it would have indicated this explicitly by also referring to section 1.1.1 of that annex. In addition, it would probably have specified this in sections 3.9.2.1, 3.9.2.3 and 3.9.2.4 of that annex, which already contain certain additional criteria to be applied in connection with the classification of substances in that hazard class, such as the obligation to take account of the guidance values referred to in section 3.9.2.9 of that annex. (21)

53.      In the second place, although it refers to structure-activity relationships, section 3.9.2.10.3 of Annex I does not use the terms set out in section 1.1.1.3 of that annex and, in particular, does not refer to the determination of the weight of the evidence of all of the available data, or the category approach, grouping or read-across. If the EU legislature had intended to restrict the use of those approaches, in particular the use of read-across, there is no doubt that it would have used the terms used to designate them in Regulations No 1272/2008 and No 1907/2006.

54.      In the third place, I consider that the implicit argument underlying the appellant’s present complaint, according to which the concept of ‘data from a … structure activity relationship’ encompasses the results of the application of the read-across approach, must be rejected as incorrect.

55.      First, although section 3.9.2.10.3 of Annex I does not use the acronym (Q)SAR, there is, in my view, no doubt that the reference, in that section, to structure-activity relationships must be interpreted as referring to the use of qualitative or quantitative structure-activity relationship models within the meaning of Article 13(1) and section 1.3 of Annex XI to Regulation No 1907/2006. (22) As I have explained, (23) that method is defined in detail in that regulation. In any event, I see no reason why the concept of ‘structure activity relationship’, used in section 3.9.2.10.3, should be given a different meaning from that specified in Regulation No 1907/2006.

56.      Secondly, that interpretation is supported by the reference to the validation of the structure-activity relationship (‘validated structure activity relationship’). The validation of a structure-activity relationship is the essential condition for the use of (Q)SAR models to determine the properties of substances. (24)

57.      Thirdly, apart from the wording of Regulation No 1272/2008, there is nothing to suggest that the concept of ‘structure-activity relationship’, as a generic term, should be interpreted as also encompassing the read-across approach.

58.      In that regard, I note that the Court has already had occasion to rule on the relationship between structure-activity relationship methods and the read-across approach in the judgment in Nickel Institute, (25) in which it interpreted the provisions of Directive 67/548/EEC. (26) After observing that, unlike Regulation No 1272/2008, (27) that directive did not mention the read-across approach even though it provided, in an annex, for the possibility of taking into account, as sources of data for the classification and labelling of substances, the results of validated structure-activity relationships and expert judgement, the Court considered that, although they were founded on the same principles, they were two different methods. (28)

59.      Fourthly, as I have already pointed out, (29) having regard to the current legal framework, the use of data from structure-activity relationships and the read-across approach must be considered as two separate methods, which are defined in two different sections of Regulation No 1272/2008.

60.      In the light of the foregoing, it seems to me impossible to consider that, by referring to data relating to a structure-activity relationship, the EU legislature also intended to refer to the use of the read-across approach.

61.      In the fourth place, it cannot in any event be inferred from the words ‘where appropriate’, used at the beginning of section 3.9.2.10.3 of Annex I, that the use of those words at the beginning of the phrase alters the criteria for classification in the hazard class STOT RE, set out in the preceding sections of section 3.9.2 of that annex, in particular by introducing an additional condition to those laid down in those sections. By contrast, those words clearly indicate that section 3.9.2.10.3 is an additional rule, which may be applied under certain specific conditions.

62.      In that regard, I note that the French version of the 2021 GHS (ninth version) contains a paragraph 3.9.2.10.3, the wording of which was reproduced in section 3.9.2.10.3 of Annex I. That version of the GHS uses the expression ‘in certain instances’ and not ‘where appropriate’. That expression seems to emphasise more that it is not a change to the general rules for classification in the hazard class STOT RE, but a separate classification rule.

63.      It follows from the foregoing considerations that section 3.9.2.10.3 of Annex I does not amend the criteria for the classification of substances in the hazard class STOT RE, as set out in sections 3.9.2.1, 3.9.2.3 and 3.9.2.4 of that annex, read in conjunction with section 1.1.1.3 thereof, but establishes a separate rule for the classification of a substance in that hazard class, which may apply where the target substance has not been tested. The application of that rule requires four conditions to be met, relating to the existence of (i) a structural analogue that has been previously classified, (ii) data from a validated structure-activity relationship, (iii) expert judgement-based extrapolation from a structural analogue that has previously been classified, and (iv) important factors which support that extrapolation substantially, such as the formation of common significant metabolites.

64.      In the present case, it is not apparent from the RAC Opinion that it made use of the option provided for in section 3.9.2.10.3 of Annex I. That is, moreover, why that opinion does not contain any reference to any classification of SAS-DDS or SAS-PDMS in the hazard class STOT RE or to the other conditions laid down in that section. By contrast, it is apparent from the RAC Opinion that it carried out the weight of evidence determination of all of the available data, in accordance with section 1.1.1.3 of that annex, and that it used the data concerning SAS-DDS and SAS-PDMS in the context of the use of grouping and the read-across approach between substances belonging to the same category, given the similarities between those substances. The merits of taking into account, under section 1.1.1.3 of that annex, data concerning SAS-DDS and SAS-PDMS is, moreover, not disputed by the appellant.

65.      The RAC was therefore not required to base its classification on section 3.9.2.10.3 of Annex I since it had data enabling it to carry out a classification in accordance with the general rules.

66.      Moreover, recourse to section 3.9.2.10.3 of Annex I was not necessary in so far as the RAC had access to the tests concerning SAS-HMDS. In its opinion, the RAC took into account three studies relating directly to SAS-HMDS, which present the results of tests on rats and cynomolgus monkeys. (30) As regards the effects on the lungs of exposure to silanamine via inhalation, which is relevant from the point of view of the contested classification, those studies constitute half of all the studies taken into account, the other three relating to SAS-DDS. It cannot therefore be argued that, due to the lack of tests on that substance, the classification of silanamine could be carried out only in accordance with the rule set out in section 3.9.2.10.3 of Annex I.

67.      Since section 3.9.2.10.3 of Annex I was not applied and was not applicable in the present case, the appellant’s complaint alleging infringement of that section is, in my view, ineffective.

68.      In view of the above, I consider that the first complaint of the second subsection of the fourth part of the first ground of appeal must be rejected.

(b)    The interpretation of the concept of ‘structural analogue that has previously been classified’, used in section 3.9.2.10.3 of Annex I

69.      Since section 3.9.2.10.3 of Annex I was not applicable in the present case, it is irrelevant whether or not the conditions laid down therein are satisfied. However, for the sake of completeness, in the event that the Court does not share my view and considers that section to be applicable in the present case, I shall briefly examine the Commission’s argument that the expression ‘that has previously been classified’ should be understood as referring not only to substances which have been subject to harmonised classification, but also to those which have been subject to self-classification.

70.      I would state at the outset that I do not share that interpretation.

71.      It is true that section 3.9.2.10.3 of Annex I uses the words ‘structural analogue that has previously been classified’, without specifying whether it is the structure of a substance which has been the subject of harmonised classification or a classification carried out by the manufacturers, importers or downstream users of substances. However, in my view, in the light of the principles of the system established by Regulation No 1272/2008, where harmonised classification is based on that section, the structural analogue referred to must have been the subject of harmonised classification.

72.      I would point out that, as is apparent from recitals 16 and 17 and Article 4(1) and (3) of Regulation No 1272/2008, it is primarily the responsibility of manufacturers, importers and downstream users of substances to identify their hazards and classify them. It is only in the case of harmonised classification that they are required not to classify them themselves.

73.      Harmonised classification, although carried out according to the same criteria as self-classification, is an independent classification determined by the Commission, supported by ECHA and the RAC, in accordance with the procedure laid down in Article 37 of Regulation No 1272/2008. Harmonised classification is therefore not limited to a registration or validation of classifications determined by manufacturers, importers and downstream users of substances.

74.      Therefore, in so far as a harmonised classification of a substance is determined on the basis of section 3.9.2.10.3 of Annex I, that is to say by extrapolation from a structural analogue that has been previously classified, the latter structural analogue must have been subject to harmonised classification. Otherwise, the harmonised classification would be limited to a mere validation of the classification determined by the manufacturers, importers and downstream users of substances, the regularity and validity of which have not been checked by the Commission.

75.      In the present case, the RAC Opinion does not contain any information capable of establishing that the conditions set out in section 3.9.2.10.3 of Annex I were satisfied in the present case. Moreover, if SAS-DDS was subject not to harmonised classification, but to self-classification, it cannot be classified as a ‘structural analogue that has previously been classified’ for the purposes of the harmonised classification. In the event that the Court does not share my view set out in point 67 of this Opinion, the present complaint should be upheld and, consequently, the judgment under appeal should be set aside.

B.      Compliance with the time limit for the adoption of the RAC Opinion (first complaint of the first subsection and second and third subsections of the first part of the second ground of appeal)

76.      By the first part of the second ground of appeal, the appellant complains that the General Court erred in law by failing to find and to sanction the breach of the mandatory 18-month deadline for the adoption of the RAC Opinion. In particular, by the third subsection of the first part of the second ground of appeal, the appellant complains, in essence, that the General Court erred in law by not classifying the failure to comply with that time limit as a breach of an essential procedural requirement.

77.      In so far as the actual date of adoption of the RAC Opinion is uncertain, by the first two subsections of the first part of the second ground of appeal, the appellant seeks, as a preliminary point, to call into question the General Court’s findings regarding the starting point and end date of the period at issue, which could indicate that that time limit was complied with. The third subsection of the first part of the second ground of appeal would be ineffective if it were considered that the RAC adopted its opinion within the prescribed period of 18 months.

78.      I shall analyse the complaints which form the subject matter of this part of the Opinion in the order in which they are raised in the appeal. I shall first make some preliminary remarks with regard to the time limit for the adoption of the RAC Opinion.

1.      General remarks

79.      As a reminder, Article 37 of Regulation No 1272/2008 governs the procedure for harmonisation of classification and labelling of substances (‘the CLH procedure’) and provides, first, that any CLH proposal is to be submitted to ECHA (paragraphs 1 and 2); secondly, that the proposal submitted by the competent authority must follow the format set out in Part 2 of Annex VI to Regulation No 1272/2008 and contain the relevant information provided for in Part 1 of Annex VI to that regulation (second subparagraph of paragraph 1); thirdly, that the RAC is to adopt an opinion on any CLH proposal within 18 months of receipt of the proposal, giving the parties concerned the opportunity to comment (paragraph 4), and, fourthly, that the Commission (after receiving the opinion) is to adopt, without undue delay, delegated acts where it finds that the harmonisation of the classification and labelling of the substance concerned is appropriate (paragraph 5).

80.      The RAC is a constituent body of ECHA, established in accordance with Article 76(1)(c) of Regulation No 1907/2006. It follows from recital 102 of that regulation that it was through the RAC, inter alia, that ECHA was to take over the role of the scientific committees attached to the Commission in issuing scientific opinions in its field of competence. The role of the RAC is therefore to establish and provide scientific expertise within ECHA’s field of competence.

81.      I note that both Regulation No 1907/2006 and Regulation No 1272/2008 lay down precise time limits for the adoption of RAC opinions. By contrast, those regulations do not provide for any specific consequences in the event of failure to comply with those time limits.

2.      The starting date of the 18-month deadline (first complaint of the first subsection of the first part)

82.      By that complaint, the appellant challenges the General Court’s finding that the CLH proposal concerning silanamine was received by ECHA on 17 December 2018.

(a)    Arguments of the parties

83.      The appellant complains that the General Court erred in law in determining the starting date of the 18-month deadline for the adoption of the RAC Opinion. In its view, that period began to run not on 17 December 2018, the date on which the French competent authority submitted (for the second time) the dossier relating to the CLH proposal concerning silanamine, but on 6 December 2017, that is to say the date on which it submitted the CLH proposal (for the first time). Moreover, it criticises the interpretation given by the General Court, based on a combined reading of Article 37(1) and (4) of Regulation No 1272/2008, according to which the RAC must adopt its opinion on any proposal submitted which complies with the format set out in Part 2 of Annex VI to that regulation and contains the relevant information provided for in Part 1 of that annex. According to the appellant, if the legislature had considered that only the receipt of a complete dossier could trigger the start of the 18-month period, it would have expressly stated so in Regulation No 1272/2008. Acceptance of ECHA’s administrative practice of having RAC rapporteurs check the compliance of dossiers with a CLH proposal (31) leads to a potentially unlimited extension to that time limit, thus depriving it of any practical effect. Furthermore, according to the appellant, the General Court’s interpretation runs counter to the broader objectives of the CLH procedure.

84.      The Commission, supported by ECHA, contends that that complaint should be rejected. In its view, the General Court was correct, from a literal and contextual point of view, in interpreting Article 37(4) of Regulation No 1272/2008 as meaning that the time limit laid down in that provision begins to run only upon receipt of a proposal that complies with the format set out in Part 2 of Annex VI to that regulation and contains the relevant information provided for in Part 1 of Annex VI thereto. Moreover, it submits that the General Court’s interpretation does not run counter to the objectives of the CLH procedure. By contrast, to consider that the 18-month time limit starts to run from the submission of a non-compliant CLH proposal, without the RAC having sufficient time to adopt a well-informed opinion, would not serve the objective of the CLH procedure to establish an appropriate harmonised classification and labelling of a substance. The Commission recalls that the RAC can adopt an informed opinion only based on a CLH proposal that contains all the relevant information required. The effectiveness of Article 37(4) of Regulation No 1272/2008 therefore requires the start of the 18-month period to be linked to the submission of a CLH proposal that complies with the necessary requirements. The Commission notes that the check that that proposal complies with the necessary requirements constitutes good administrative practice, provided for in the ECHA Guidance, and that it is part of ECHA’s tasks set out in Article 50(1) of that regulation.

(b)    Assessment

85.      The General Court finds, first of all, in paragraph 211 of the judgment under appeal, that the 18-month period for the adoption of the RAC Opinion, provided for in Article 37(4) of Regulation No 1272/2008, starts to run from the date of receipt of a CLH proposal which complies with the requirements laid down in Parts 1 and 2 of Annex VI to that regulation. It then notes, in paragraph 212 of that judgment, that it can be seen from the Registry of CLH intentions until outcome that the French competent authority submitted a classification proposal for ‘accordance check’ on 6 December 2017 and the ‘final submission date’ was 17 December 2018. According to the General Court, that second date is the date on which the version of the CLH proposal was deemed to comply with the necessary requirements and, consequently, should be taken into account as the starting point of the 18-month period.

86.      I am of the opinion that the General Court did not err in its interpretation of Article 37(4) of Regulation No 1272/2008.

87.      In the first place, I would point out that, in accordance with Article 37(1) and (2) of Regulation No 1272/2008, the CLH procedure is initiated not by ECHA of its own motion, but following the submission of a CLH proposal by its author, in particular by a competent national authority. (32) Moreover, that regulation lays down specific requirements as regards the form and content of that CLH proposal and provides, in Article 37(1), second subparagraph, that CLH proposals submitted by the competent national authorities must follow the format set out in Part 2 of Annex VI and contain the relevant information provided for in Part 1 of Annex VI.

88.      The EU legislature has assumed that the procedure before ECHA is initiated on the basis of the results of the evaluation of the available data, carried out by the initiator of the CLH procedure, which are reproduced in its CLH proposal. It is that proposal which is then the subject of public consultation. (33)

89.      If the EU legislature has provided for a strict period of 18 months for the adoption of the RAC Opinion and if that period must also allow for a public consultation to be organised and the results of that consultation to be analysed, it seems logical to me that that period should not begin to run until the CLH proposal complies with the requirements laid down by Regulation No 1272/2008. Only a complete CLH proposal will enable, first, ECHA and the RAC to examine its substance and, secondly, the parties concerned to submit their comments. The completeness of the dossier on which the CLH proposal is based is therefore a prerequisite for initiating the procedure for the preparation of the RAC Opinion. It that period was considered to start running even though the dossier does not comply with the requirements laid down by that regulation, this would reduce the time available to the RAC for the adoption of the opinion, in so far as it would first have to regularise the CLH proposals. By contrast, the practice of checking that the documents initiating the procedure do indeed comply with the formal requirements makes it possible to ensure the proper conduct of the procedure in question by, inter alia, giving the parties concerned the opportunity to comment on all of the relevant information that was available to the author of the CLH proposal.

90.      In the second place, Regulation No 1272/2008 does not provide for a time limit for submitting CLH proposals to ECHA, after which certain substances could no longer be classified as hazardous. By contrast, that regulation expressly provides, in Article 37(1) and (6), for the possibility of revising the harmonised classification and labelling. Moreover, it cannot be ruled out that the competent national authority may withdraw a CLH proposal and then submit a new proposal. It follows that the CLH proposal concerning silanamine could have been validly submitted both in December 2017 and in December 2018.

91.      In the third place, although the verification of compliance of the CLH proposal with the necessary requirements is not expressly provided for in Regulation No 1272/2008, the parties are aware of such administrative practice by ECHA since it is described in ECHA’s Guidance on the preparation of dossiers for harmonised classification and labelling.

92.      In the fourth place, that practice forms part of ECHA’s tasks, described in Article 50(2)(b) of Regulation No 1272/2008. That provision expressly provides that the Secretariat of ECHA is to provide competent authorities with technical and scientific guidance on the implementation of that regulation and provide support to the helpdesks established by Member States. (34) I see no reason why the accordance check of a CLH proposal should not be considered to fall within the scope of that activity.

93.      In the fifth place, the CLH procedure is regulatory and not administrative in nature. Although its outcome has an impact on the situation of undertakings active in the chemical sector, the direct purpose of that procedure is, however, not to determine the rights and obligations of specific undertakings, but to identify the hazards associated with certain substances. The check of a CLH proposal in order to ensure the proper conduct of the CLH procedure and to allow the parties concerned to comment on that proposal does not conflict with individual interests. On the contrary, that procedure offers all parties the opportunity to participate in the public consultation on a CLH proposal which complies with the strict requirements laid down by Regulation No 1272/2008.

94.      In the light of the foregoing considerations, I consider that the first complaint of the first subsection of the first part of the second ground of appeal should be rejected.

3.      The date of adoption of the RAC Opinion (second subsection of the first part of the second ground of appeal)

(a)    Arguments of the parties

95.      The appellant complains that the General Court erred in law by not penalising the absence of a verifiable date of adoption of the RAC Opinion. It observes that the General Court acknowledged that the date of adoption of that opinion is uncertain and repeatedly highlighted factual inconsistencies, yet it ignored those inconsistencies and took 5 December 2019 as that date. The appellant submits that, in doing so, the General Court distorted the available evidence and manifestly exceeded the limits of a reasonable assessment. The General Court therefore erred in law by (i) ignoring the lack of clarity on the date of adoption of the RAC Opinion, (ii) approving a date that was not supported by evidence, and (iii) not penalising the absence of a verifiable date of adoption when that affected its ability to exercise its judicial review. According to the appellant, that had a direct impact on the judgment under appeal, since the RAC Opinion was adopted, at the earliest, on 4 May 2020, thus 28.6 months after receipt of the initial CLH dossier (in December 2017). Moreover, the appellant complains that the General Court ignored evidence it had adduced showing that the opinion had not been finalised on 4 May 2020.

96.      The Commission, supported by ECHA, contends that that part should be rejected on the ground that the appellant has not provided all the evidence necessary to establish that the General Court distorted the evidence. Moreover, it submits that the General Court did not ignore the evidence adduced by the appellant and that it also examined the scenario of a potential adoption of the RAC Opinion after 4 May 2020.

(b)    Assessment

97.      In paragraphs 213 to 216 of the judgment under appeal, the General Court notes that, although the RAC Opinion was dated 5 December 2019, the RAC had nevertheless organised a targeted public consultation after that date, which took place between 3 and 17 February 2020 and which related to the hazard class acute toxicity Category 2. In its view, it is apparent from the minutes of the 52nd meeting of the RAC of 4 May 2020 that the RAC ‘took note of the outcome of the ad hoc consultation’, ‘reviewed the data on the studies and addressed industries[’] comments in detail but did not change its earlier classification conclusion as a result’. The RAC also asked the ‘Rapporteurs to finalise the opinion with the outcome of the ad hoc consultation and provide it to [the ECHA Secretariat]’, so that the latter could ‘make an editorial check of the opinion documents in consultation with the Rapporteurs’, ‘forward the adopted opinion and its annexes to [the Commission] and publish it on the ECHA website’. The General Court also observes that, although Annex 3 to the RAC Opinion contains the comments of the parties concerned submitted in February 2020, the published version of the opinion is dated 5 December 2019. In the light of those factors, the General Court accepts that the actual date of adoption of the RAC Opinion is not self-evident. Nevertheless, it considers, in paragraph 217 of the judgment under appeal, that, although the date of adoption of the RAC Opinion is 4 May 2020, the date of the minutes of the 52nd meeting of the RAC, that means that the 18-month period provided for in Article 37(4) of Regulation No 1272/2008 was observed.

98.      Thus, the General Court explicitly acknowledged that, in the light of the available evidence, the actual date of adoption of the RAC Opinion was not self-evident.

99.      In the light of that finding, I consider that two of the three specific complaints raised by the appellant should be rejected, whereas the third should be examined in the context of the analysis of the third subsection of the first part of the second ground of appeal.

100. As regards, in the first place, the complaint alleging that the General Court wrongly took 5 December 2019 as the date of adoption of the RAC Opinion, I consider, in the light of the General Court’s findings in that regard, (35) that that complaint is unfounded in so far as it is based on a misreading of the judgment under appeal. The General Court expressly stated that the actual date of adoption of the RAC Opinion was not self-evident and presented the facts indicating that the public consultations had taken place after 5 December 2019. It went on to consider the possibility that the opinion had been adopted on 4 May 2020.

101. As regards, in the second place, the complaint alleging distortion of the evidence, I would point out that, according to settled case-law, a distortion of the evidence exists where, without recourse to new evidence, the assessment of the existing evidence is clearly incorrect. However, such distortion must be obvious from the documents on the Court’s file, without there being any need to carry out a new assessment of the facts and the evidence. Moreover, where an appellant alleges distortion of the evidence by the General Court, he or she must indicate precisely the evidence alleged to have been distorted by that court and show the errors of appraisal which, in his or her view, led to that distortion. (36) In the absence of such evidence, I am of the opinion that the appellant’s complaint alleging distortion of evidence should be rejected.

102. As regards, in the third place, the complaint alleging that the General Court failed to draw the legal consequences from the absence of a verifiable date of adoption of the RAC Opinion, I am of the opinion that it overlaps with the third subsection of the first part of the second ground of appeal and should be examined in the context of the analysis of the latter. The appellant has not specified what consequences the General Court should have drawn. The only consequence capable of affecting the judgment of the General Court was the finding that the procedural irregularity at issue was in the nature of an infringement of an essential procedural requirement within the meaning of the second paragraph of Article 263 TFEU. The question whether that irregularity was of such a nature is the subject of the third subsection of the first part of the second ground of appeal.

4.      The consequences of the possible failure to comply with the time limit for the adoption of the RAC Opinion (third subsection of the first part of the second ground of appeal)

103. In the light of the conclusions drawn from my analysis of the first two subsections of the first part of the second ground of appeal, it must be considered that the evidence available to the General Court does not make it possible to refute the appellant’s argument alleging failure to comply with the 18-month period and the third subsection of that part must be examined.

(a)    Arguments of the parties

104. The appellant complains that the General Court erred by classifying the failure to comply with the 18-month period for the adoption of the RAC Opinion ‘merely as a procedural irregularity’, despite indicators that it constitutes, in the context of Regulation No 1272/2008, an infringement of essential procedural requirements. In support of its argument, it refers, first, to the case-law of the Court relating to the overrunning of the time limit set for the Commission in Article 100(5) of Regulation (EC) No 1083/2006 (37) to adopt financial corrections (38) being classified as ‘an infringement of essential procedural requirements’ and, secondly, to a recommendation by the European Ombudsman concerning the application by the Commission of Article 64(8) of Regulation No 1907/2006. (39) The appellant submits that the failure to comply with the time limit for the adoption of the RAC Opinion was, in itself, capable of triggering the annulment of the regulation at issue, without the need to provide evidence of the impact of such a breach on the outcome of the decision-making process. Any other interpretation would amount to considering that the institutions may freely disregard binding time limits set by the legislature, without such a breach having any legal consequences.

105. The Commission, supported by ECHA, contends that that part should be rejected as unfounded. It its view, the evidence put forward by the appellant does not demonstrate that the 18-month period constitutes an essential procedural requirement, non-compliance with which should preclude the continuation of the classification procedure. The annulment of a regulation in such a situation would merely cause the administrative procedure to be reopened. The Commission submits that the use of the words ‘shall adopt’ in Article 37(4) of Regulation No 1272/2008 is of relevance only for assessing whether the time limit at issue is indicative or mandatory. It adds, however, that, even the mandatory nature of that time limit is not sufficient to conclude that failure to comply with it is in the nature of an infringement of an essential procedural requirement; the consequences of that irregularity must be determined having regard to the objective and structure of the relevant act. According to the Commission, the General Court was right to consider that the assumed non-adoption of the RAC Opinion within the 18-month deadline was a mere procedural irregularity and could entail annulment of the act adopted only if, were it not for that irregularity, the procedure could have led to a different result.

(b)    Assessment

106. The General Court, starting from the premiss that the 18-month period provided for in Article 37(4) of Regulation No 1272/2008 had started to run on 17 December 2018, (40) concludes, first of all, in paragraphs 213 to 217 of the judgment under appeal, that that period had not been exceeded in the present case. Both the date of adoption of the RAC Opinion indicated on that opinion, namely 5 December 2019, and the date of the minutes of the 52nd meeting of the RAC, namely 4 May 2020, fall within that period. Next, the General Court finds, in paragraphs 218 to 225 of that judgment, that, even assuming that the RAC Opinion did not comply with the time limit at issue, such an irregularity cannot lead to the annulment of the regulation at issue given that, were it not for that irregularity, the procedure could not have led to a different result.

107. In my opinion, the General Court’s reasoning is not vitiated by error.

108. As a preliminary point, I note that the Court, in its case-law, has not defined in an abstract manner the concept of ‘essential procedural requirement’ within the meaning of the second paragraph of Article 263 TFEU. In this regard, reference is often made to the definition proposed by Advocate General Fennelly in his Opinion in Commission v ICI, (41) who considers that the concept of ‘essential procedural requirement’ is ‘reserved for procedural requirements which are intrinsically linked to the formation and expression of the intention of the adopting authority, and that … any breach of such a requirement necessarily justifies the annulment of the measure as a whole. As the breach concerns the measure in its entirety, it is neither necessary, nor in most cases possible, for the party relying on it to show a particular adverse effect on its subjective rights or interests; the breach constitutes a failure to respect so fundamental a rule affecting the adoption or form of the measure that it cannot be considered to be the valid and authentic act of the institution’. (42)

109. The Court, while also referring to certain elements of the definition proposed by Advocate General Fennelly, (43) does not always appear to interpret the concept of ‘essential procedural requirement’ so restrictively, in that it considers that, in principle, a procedural irregularity will entail the annulment of a decision in whole or in part only if it is shown that in the absence of such irregularity the decision being challenged might have been substantively different. (44)

110. Academic writers have identified three types of situation in which an infringement of essential procedural requirements could arise, namely, first, that where the adopted act could have been substantially different if that procedure had been followed; (45) second, that where the rule infringed constitutes an essential institutional rule (46) and, third, that where the infringement of the procedural rule makes judicial review impossible. (47)

111. Academic writers also interpret the Court’s case-law as meaning that procedural defects are ‘substantive’ and can therefore justify an action if they are likely to influence the outcome of the contested measure. It is therefore not a question, strictly speaking, of whether a provision is substantive, but whether the infringement of the procedural requirement was substantive in the specific case. If there was no legal alternative to the measure adopted, it is not substantive in nature. (48) The institutional rights to be heard and to participate are essential formalities the infringement of which always renders the measure null and void, since, in such cases, it can never be ruled out that those infringements have had an impact on that measure. (49)

112. Regardless of how the Court’s case-law on the second paragraph of Article 263 TFEU is interpreted, I consider that, in the present case, the irregularity at issue is not in the nature of an infringement of an essential procedural requirement.

113. In the first place, although the Commission’s obligation to consult the RAC before taking its decision on the harmonised classification and labelling of a substance does indeed appear to me to be intrinsically linked to the formation and expression of the intention of that institution, I am of the opinion that the requirement that the RAC Opinion must be adopted within the 18-month period cannot be characterised in the same way. While there is no doubt that that requirement is important from the point of view of the proper conduct of the CLH procedure, in my view it does not, in itself, affect the Commission’s assessment of the harmonised classification and labelling of the substance concerned.

114. In the second place, I note that neither Article 37 nor any other provision of Regulation No 1272/2008 lays down any specific consequences in the event of failure to comply with the time limit for the adoption of the RAC Opinion. Nor does it follow from that regulation that, if the opinion is not adopted within the prescribed period, the CLH procedure should be terminated or that the CLH proposal should be rejected or considered unfounded. There is therefore nothing to suggest that that time limit is preclusive.

115. In the third place, such consequences cannot be inferred from the objective and structure of Regulation No 1272/2008 either. In that regard, first, in accordance with Article 1(1) thereof, the purpose of that regulation is to ensure a high level of protection of human health and the environment. Secondly, it is apparent from recital 10 thereof that the objective of that regulation should be to determine which properties of substances should lead to a classification as hazardous, in order for the hazards of those substances to be properly identified and communicated.

116. In that context, to consider that failure to comply with the time limit at issue in the present case constitutes, in itself, an obstacle to the identification of a substance as a hazardous product would risk undermining the attainment of the objectives of Regulation No 1272/2008. In that case, the identification of a substance as hazardous and the adoption of delegated acts by the Commission would not be possible, or could take place only after a new CLH proposal is submitted. There would then be a risk that the adequate level of protection of human health and the environment would not be ensured because of the lack of information on the hazards associated with the use of a substance.

117. In the fourth place, I do not see any particular interests which would outweigh the general interest in identifying the hazards associated with substances, with the result that failure to comply with the time limit for the adoption of the RAC Opinion would, in itself, preclude the possibility for the Commission to adopt delegated acts on the basis of the opinion adopted after that deadline. The CLH procedure is not a judicial or administrative procedure, but a procedure leading to the adoption of a regulatory act. The undertakings affected by its outcome do not have the status of parties to proceedings providing for the creation and forfeiture of certain procedural rights depending on whether or not procedural time limits have been complied with. The case-law of the Court on the consequences of exceeding the time limits for the adoption of decisions on financial corrections, to which the appellant refers, cannot therefore be transposed to the present case. The same applies to the applicability of the recommendation by the European Ombudsman concerning the application by the Commission of Article 64(8) of Regulation No 1907/2006.

118. In the fifth place, to accept that failure to comply with the time limit for the adoption of the RAC Opinion constitutes an infringement of an essential procedural requirement justifying the annulment of the delegated act adopted by the Commission on the basis of that opinion, irrespective of the impact of that irregularity on the content of the act, would mean that the CLH procedure would have to be reopened. It cannot be accepted that failure to comply with that time limit could lead to the possibility of identifying the substance concerned as hazardous being excluded. Thus, in order to ensure the attainment of the objectives of Regulations No 1907/2006 and No 1272/2008, it would be necessary to initiate a new CLH procedure during which the same acts as those undertaken during the first procedure would have to be repeated, taking into account, in principle, the same data. The reopening of the procedure would therefore, save in exceptional cases, have no effect on the content of the RAC Opinion.

119. In the sixth and last place, if it is considered that it should be established that, in the absence of the procedural irregularity, the content of the contested decision might have been different, I must confess that I see no argument in favour of the thesis that that could actually be the consequence of merely exceeding the time limit at issue in the present case. In any event, the appellant does not claim that there is a link between the duration of the procedure and its outcome.

120. In the light of the foregoing, should the Court find that the 18-month period has not been complied with, I am of the opinion that that irregularity should not be regarded as constituting an infringement of an essential procedural requirement within the meaning of the second paragraph of Article 263 TFEU.

121. In those circumstances, I consider that the third subsection of the first part of the second ground of appeal should also be rejected.

C.      The public consultation as part of the CLH procedure (first complaint of the second subsection of the second part of the second ground of appeal)

122. The appellant complains that the General Court erred in law by misinterpreting Article 37(4) of Regulation No 1272/2008, in respect of the public consultation as part of the CLH procedure.

1.      Arguments of the parties

123. The appellant complains that the General Court wrongly ignored its arguments that Article 37(4) of Regulation No 1272/2008 should be read as meaning that the parties concerned have the opportunity to comment not on the CLH proposal, but on the RAC Opinion. According to the appellant, that is apparent from the literal interpretation of that provision which, contrary to what the Commission maintains, is not ambiguous.

124. The Commission, supported by ECHA, contends that that part should be rejected. In its view, the General Court correctly relied on the contextual and teleological interpretation of Article 37(4) of Regulation No 1272/2008, given the potential ambiguity of that provision. The Commission submits that the possibility of submitting comments on the CLH proposal – and not on the RAC Opinion – is apparent from recital 52 of that regulation.

2.      Assessment

125. The General Court observes, in paragraphs 234 and 236 of the judgment under appeal, that Article 37(4) of Regulation No 1272/2008 must be interpreted in the light of the CLH procedure, referred to in Article 37 of that regulation, which takes place in several stages: (i) the submission of a CLH proposal, (ii) the adoption of an opinion by the RAC ‘giving the parties concerned the opportunity to comment’, (iii) the forwarding by ECHA of that opinion and all comments to the Commission and, lastly, (iv) 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. The General Court also notes that, although Article 37(4) of that regulation provides for the possibility of submitting comments on the CLH proposal, it does not, however, provide for the possibility for the parties concerned to submit observations on the RAC Opinion.

126. I consider that that interpretation is not vitiated by error.

127. First of all, I must confess that I am not convinced by the arguments of the parties based on the analysis of the wording of Article 37(4) and recital 10 of Regulation No 1272/2008. In respect of that provision, I take the view, contrary to what the appellant claims, that it is not unambiguous, as regards whether the parties concerned have the opportunity to comment on the RAC Opinion or on the CLH proposal; both interpretations seem to me to be tenable. Moreover, contrary to what the Commission maintains, there is nothing in the wording of recital 52 of that regulation to indicate that the comments of the parties concerned should relate not to the RAC Opinion, but to the CLH proposal. By contrast, according to my reading, that recital contains no indication as to the subject matter of the public consultation.

128. In the light of the foregoing, the General Court cannot be criticised for having erred in carrying out a contextual and teleological interpretation of Article 37(4) of Regulation No 1272/2008, since a literal interpretation of that provision alone does not make it possible to determine whether it is the RAC Opinion or the CLH proposal that should be the subject of the public consultation.

129. As regards the contextual and teleological interpretation given by the General Court, I am of the view that it is not vitiated by error.

130. In the first place, the CLH procedure takes place in several stages, and the stage relating to the RAC Opinion is specific since it in fact consists of a scientific analysis carried out by a specialised committee established on the basis of Regulation No 1907/2006. Although the final decision on the classification and labelling of a substance rests with the Commission, it must be noted that it is not for the Commission to carry out a new scientific assessment. In so far as the EU legislature entrusted that analysis to a specialised body, it seems clear to me that its intention was that all arguments of a scientific nature should be assessed not by the Commission but by that body. It would therefore be illogical for the scientific debate to take place before the Commission and, in the event of divergent opinions, for the Commission to decide on technical and scientific issues. That would go against the role of the RAC. (50)

131. In the second place, it is not apparent from Article 37(4) of Regulation No 1272/2008 that the parties concerned may intervene more than once during the procedure preceding the forwarding of the RAC Opinion to the Commission. Since, given their scientific nature, the observations of the parties should be able to influence the RAC Opinion, they must clearly be submitted before that opinion is drawn up and not after.

132. In the third and last place, that interpretation is supported by the results of a comparative analysis of Regulations No 1272/2008 and No 1907/2006 which are intrinsically linked in that they (i) use the same terms and definitions in order, inter alia, to ensure consistency in the application of chemicals legislation within the European Union in the context of global trade, (51) (ii) share certain basic principles (52) and use (iii) the same instruments and bodies (53) and (iv) the same methods. (54)

133. In that context, I note that Article 64 of Regulation No 1907/2006 provides for a procedure for authorisation decisions involving, inter alia, the RAC, which is called upon to give its opinion on the risk associated with the use of a substance covered by the applications for authorisation. Thus, first of all, the RAC prepares a draft opinion (paragraphs 1 and 4); the draft is then forwarded to the applicant (paragraph 5), which has the opportunity to submit comments, and finally, those comments will be taken into account by the RAC in the final opinion.

134. Admittedly, there are significant differences between that procedure and the CLH procedure, provided for by Regulation No 1272/2008, in particular as regards their subject matter, their nature and the status of the interested parties. (55) However, those two procedures are part of the same regime encompassing Regulations No 1272/2008 and No 1907/2006, and provide for consultation with the same body in order to obtain its scientific opinion. Therefore, it seems to me to be entirely justified to draw conclusions about the differences between the provisions governing those two procedures.

135. In that regard, it seems to me that 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 it did in Article 64 of Regulation No 1907/2006. There was nothing to prevent the introduction of the same procedural stages: first of all, the adoption by the RAC of a draft opinion, next, the submission of that draft for public consultation, and, finally, the adoption of a final opinion. In so far as, within the same regime and in relation to a similar activity of the same body, the EU legislature decided not to follow the existing procedural model, it must be concluded that, in the context of the CLH procedure, it chose not to give the parties concerned the opportunity to submit their comments on the RAC Opinion.

136. In the light of the foregoing, I am of the opinion that the General Court did not err in finding that the public consultation provided for in Article 37(4) of Regulation No 1272/2008 relates not to the RAC Opinion, but to the CLH proposal.

137. In view of the above, I consider that the first complaint of the second subsection of the second part of the second ground of appeal should be rejected.

V.      Costs

138. Since this Opinion is limited to the analysis of certain complaints in the appeal, I shall not make any proposal as to costs, since the response in that regard depends on the outcome of the other complaints, in accordance with Article 138 of the Rules of Procedure of the Court.

VI.    Conclusion

139. In light of all the foregoing considerations, I propose that the Court should:

reject

–        in the context of the first ground of appeal:

–        the first complaint of the second subsection of the fourth part;

–        in the context of the second ground of appeal:

–        the first complaint of the first subsection of the first part,

–        the second and third subsections of the first part, and

–        the first complaint of the second subsection of the second part.

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1      Original language: French.

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2      Commission Delegated Regulation 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’).

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3      Regulation 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 Delegated Regulation (EU) 2021/1962 of 12 August 2021 (OJ 2021 L 400, p. 16) (‘Regulation No 1272/2008’).

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4      Regulation 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).

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5      Those five subsections are entitled ‘Use of existing data’, ‘Weight of evidence’, ‘Qualitative or Quantitative structure-activity relationship ((Q)SAR)’, ‘In vitro methods’ and ‘Grouping of substances and read-across approach’.

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6      As regards the qualitative or quantitative structure-activity relationship, in the French version, Regulation No 1907/2006 uses the French acronym R(Q)SA in Annex I, whereas in other provisions it uses the English acronym (Q)SAR. It is, however, the same concept. Other language versions use only the English acronym (Q)SAR (see, inter alia, the German, Spanish, Dutch and Polish versions).

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7      As stated in the RAC Opinion (p. 4), SAS are generally hydrophilic but can become hydrophobic through surface treatment following a physical or chemical reaction with a Si-organic compound such as hexamethyldisilazane (HMDS; CAS No 999-97-3), dimethyldichlorosilane (DDS; CAS No 75-78-5) and polydimethylsiloxanes (PDMS; CAS No 9016-00-6). Depending on the compound used in that reaction, different types of SAS hydrophobes are distinguished: SAS-HMDS (CAS No 68909-20-6), SAS-DDS (CAS No. 68611-44-9) and SAS-PDMS (CAS No 67762-90-7). When treated with HMDS, silanamine is an SAS-HMDS.

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8      Regulation 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).

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9      Only the first two are relevant in the context of this Opinion.

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10      Although, in principle, those rules also apply to mixtures, in the light of the circumstances of the present case, I shall refer only to substances.

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11      See Patlewicz, G., Ball, N., Becker, R.A., Booth, E.D., Cronin, M.T.D., Kroese, D., Steup, D., van Ravenzwaay, B., Hartung, T., ‘Read-across approaches – misconceptions, promises and challenges ahead’, Altex 2014, Vol. 31, No 4, DOI: https://doi.org/10.14573/altex.1410071, pp. 387 and 388.

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12      See OECD (2025), ‘Guidance on Grouping of Chemicals, Third Edition’, OECD Series on Testing and Assessment, No 418, OECD Publishing, Paris, https://doi.org/10.1787/b254a158-en, p. 22.

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13      See ‘Guidance on Grouping of Chemicals, Third Edition’, op. cit., p. 38.

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14      See ‘Guidance on Grouping of Chemicals, Third Edition’, op. cit., p. 38.

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15      See ‘Guidance on Grouping of Chemicals, Third Edition’, op. cit., p. 54. See also Patlewicz, G., et al., ‘Read-across approaches – misconceptions, promises and challenges ahead’, p. 388. See, also, the Opinion of Advocate General Bot in Nickel Institute (C‑14/10, EU:C:2011:178, points 62 to 65).

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16      The distinction between them is even clearer in the version of Regulation No 1272/2008, as amended by Commission Delegated Regulation (EU) 2023/707 of 19 December 2022 (OJ 2023 L 93, p. 7), in force from 20 April 2023. See, in particular, sections 3.11.2.3.1 and 4.2.2.3.1 of Annex I to that version of the regulation, in which, on the one hand, data from analogue substances using structural activity relationships (SAR) and, on the other hand, the evaluation of substances chemically similar to the substance under study, which may also be included (grouping, read-across), are presented in separate sections.

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17      Namely sections 1.3 and 1.5 of Annex XI.

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18      See, for example, section 3.2.2.6, entitled ‘Classification based on non-test methods’ of the 2021 GHS (ninth version), concerning the hazard class ‘Skin corrosion/irritation’, in which a very clear distinction is made between read-across using analogue or category approaches and (Q)SAR methods, the former having, under certain conditions, greater weight than (Q)SAR methods.

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19      See footnote 7 of this Opinion.

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20      See points 33 to 42 of this Opinion.

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21      Moreover, section 3.9.2.5 of Annex I contains further clarification in respect of the information required to evaluate specific target organ toxicity.

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22      I note that, although the acronym (Q)SAR is not used in Article 13(1) of Regulation No 1907/2006, it is found, however, in the wording of section 1.3 of Annex XI to that regulation.

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23      See points 36 and 38 of this Opinion.

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24      See section 1.3 of Annex XI to Regulation No 1907/2006. See, with regard to the validation of (Q)SAR models, OECD (2014), ‘Guidance Document on the Validation of (Quantitative) Structure-Activity Relationship [(Q)SAR] Models’, OECD Series on Testing and Assessment, No 69, OECD Publishing, Paris, https://doi.org/10.1787/9789264085442-en.

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25      Judgment of 21 July 2011 (C‑14/10, EU:C:2011:503).

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26      Council Directive of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (OJ, English Special Edition: Series I Volume 1967, p. 234).

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27      That regulation repealed Directive 67/548.

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28      Judgment of 21 July 2011, Nickel Institute (C‑14/10, EU:C:2011:503, paragraph 70).

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29      See point 38 of this Opinion.

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30      See the RAC Opinion, p. 20.

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31      Provided for on p. 34 of ECHA’s Guidance on the preparation of dossiers for harmonised classification and labelling.

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32      However, in the case of an active substance within the meaning of Regulation (EU) No 528/2012, such as silanamine, the CLH proposal can come from a national competent authority only (Article 36(2), read in conjunction with Article 37(1), (4), (5) and (6) of Regulation No 1272/2008).

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33      See, in that regard, points 122 to 137 of this Opinion.

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34      In addition, Article 50(2)(a) of Regulation No 1272/2008 provides that the Secretariat must also provide industry with technical and scientific guidance and tools where appropriate on how to comply with the obligations laid down by that regulation.

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35      See point 97 of this Opinion.

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36      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, paragraph 67 and the case-law cited).

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37      Council Regulation of 11 July 2006 laying down general provisions on the European Regional Development Fund, the European Social Fund and the Cohesion Fund and repealing Regulation (EC) No 1260/1999 (OJ 2006 L 210, p. 25).

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38      The appellant refers to the judgments of 4 September 2014, Spain v Commission (C‑192/13 P, EU:C:2014:2156, paragraphs 103 and 104), and of 21 September 2016, Commission v Spain (C‑140/15 P, EU:C:2016:708, paragraphs 114 and 118), cited by the General Court in its judgment of 1 March 2018, Poland v Commission (T‑402/15, EU:T:2018:107, paragraph 81).

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39      Recommendation on the risk management of dangerous chemical substances by the European Commission (case OI/2/2023/MIK), 8 June 2023. Article 64(8) of Regulation No 1907/2006 provides for a period of three months for the Commission to prepare a draft decision on applications for the authorisation of specific uses of particularly hazardous chemicals submitted by undertakings.

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40      See point 85 of this Opinion.

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41      C‑286/95 P and C‑287/95 P, EU:C:1999:578.

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42      Opinion of Advocate General Fennelly in Commission v ICI (C‑286/95 P and C‑287/95 P, EU:C:1999:578, points 22 to 26), cited, by way of example, in the Opinion of Advocate General Sharpston in Spain v Commission (C‑114/17 P, EU:C:2018:309, point 95) and in the Opinion of Advocate General Medina in D & A Pharma v Commission and EMA (C‑291/22 P, EU:C:2023:651, point 79).

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43      See judgments of 10 March 2022, Commission v Freistaat Bayern and Others (C‑167/19 P and C‑171/19 P, EU:C:2022:176, paragraph 89), and of 29 July 2024, Koiviston Auto Helsinki v Commission (C‑697/22 P, EU:C:2024:641, paragraph 45).

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44      Judgment of 11 March 2020, Commission v Gmina Miasto Gdynia and Port Lotniczy Gdynia Kosakowo (C‑56/18 P, EU:C:2020:192, paragraph 80 and the case-law cited).

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45      See Wathelet, M., ‘§ 3. – Quelles violations?’, Contentieux européen, 2nd edition, Brussels, Larcier, 2014, p. 216. The author refers, in particular, to the judgment of 25 October 2011, Solvay v Commission (C‑109/10 P, EU:C:2011:686, paragraphs 66 to 71), in which the Court held that the failure to hear the undertaking concerned before the adoption of the decision at issue constituted a breach of essential procedural requirements, and the judgment of 29 October 1980, van Landewyck and Others v Commission (209/78 to 215/78 and 218/78, EU:C:1980:248, paragraph 47), in which the Court held that a procedural irregularity has no influence on the content of the contested decision.

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46      Wathelet, M., ‘§ 3. – Quelles violations?’, Contentieux européen, op. cit., p. 217. The author gives the example of the judgment of 29 October 1980, Roquette Frères v Council (138/79, EU:C:1980:249, paragraphs 32 to 37), concerning the obligation on the Council to consult the European Parliament in advance under the second paragraph of Article 43 EEC.

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47      Wathelet, M., ‘§ 3. – Quelles violations?’, Contentieux européen, op. cit., p. 217. The author cites by way of example the judgment of 15 June 1994, Commission v BASF and Others (C‑137/92 P, EU:C:1994:247, paragraphs 74 to 78), concerning the procedural defect consisting of the failure to authenticate the measures referred to in an article of the Commission’s Rules of Procedure.

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48      Wendenburg, A., in von der Groeben, H., Schwarze, J., Hatje, A., Terhechte, J.P. (ed.), ‘Artikel 263 AEUV’, Europäisches Unionsrecht (Kommentar), Band 4, 8th edition, Nomos, Baden-Baden, 2025, paragraph 270.

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49      Wendenburg, A., in von der Groeben, H., Schwarze, J., Hatje, A., Terhechte, J.P. (ed.), ‘Artikel 263 AEUV’, Europäisches Unionsrecht (Kommentar), op. cit., paragraph 277.

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50      See point 80 of this Opinion.

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51      See recital 12 of Regulation No 1272/2008.

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52      See recital 27 of Regulation No 1272/2008.

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53      See recitals 40, 60, 65 and 79 of Regulation No 1272/2008.

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54      See Article 8 of Regulation No 1272/2008 on test methods.

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55      That is why I took the view above (see point 117 of this Opinion) that the appellant’s arguments based on the recommendation by the European Ombudsman concerning the application by the Commission of Article 64(8) of Regulation No 1907/2006 were irrelevant in the context of assessing whether exceeding the 18-month period imposed on the RAC was substantive in nature.