Case T‑449/22

Evonik Operations GmbH

European Commission

Judgment of the General Court (Sixth Chamber) of 27 November 2024

(Environment and protection of human health – Regulation (EC) No 1272/2008 – Classification, labelling and packaging of certain substances and mixtures – Delegated Regulation (EU) 2022/692 – 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 – Criteria for classification of a substance in the hazard class ‘Specific target organ toxicity – repeated exposure’ – Appropriateness of the classification – Absence of public consultation on the opinion of ECHA’s Committee for Risk Assessment – Interinstitutional Agreement on Better Law-Making – Absence of impact assessment)

Approximation of laws – Classification, packaging and labelling of substances and mixtures – Regulation No 1272/2008 – Adaption to scientific and technical progress – Harmonised classification and labelling of the substance silanamine in the hazard class ‘Specific target organ toxicity – repeated exposure’ – Discretion of the Commission – Judicial review – Scope – Limits

(European Parliament and Council Regulation No 1272/2008, as amended by Regulation 2022/692)

(see paragraphs 20-29)
Approximation of laws – Classification, packaging and labelling of substances and mixtures – Regulation No 1272/2008 – Adaption to scientific and technical progress – Harmonised classification and labelling of the substance silanamine in the hazard class ‘Specific target organ toxicity – repeated exposure’ – Criteria – Manifest errors of assessment and infringement of those criteria – Absence

(European Parliament and Council Regulation No 1272/2008, as amended by Regulation 2022/692, Annex I, Sections 3.9.1.1 and 3.9.1.2)

(see paragraphs 62-93, 96-120, 124-129, 145-150, 154-172, 178-194, 202, 203)
Approximation of laws – Classification, packaging and labelling of substances and mixtures – Regulation No 1272/2008 – Adaption to scientific and technical progress – Harmonised classification and labelling of the substance silanamine in the hazard class ‘Specific target organ toxicity – repeated exposure’ – Obligation of public consultation on the opinion of the Committee for Risk Assessment of the European Chemicals Agency (ECHA) – Absence

(European Parliament and Council Regulation No 1272/2008, as amended by Regulation 2022/692, Art. 37(4))

(see paragraphs 229-238, 243)
Approximation of laws – Classification, packaging and labelling of substances and mixtures – Regulation No 1272/2008 – Adaption to scientific and technical progress – Harmonised classification and labelling of the substance silanamine in the hazard class ‘Specific target organ toxicity – repeated exposure’ – Obligation for the Commission to examine the appropriateness of that classification – Absence – Broad discretion conferred on the Commission

(European Parliament and Council Regulation No 1272/2008, as amended by Regulation 2022/692, Art. 37(5))

(see paragraphs 246-251)
Approximation of laws – Classification, packaging and labelling of substances and mixtures – Regulation No 1272/2008 – Adaption to scientific and technical progress – Harmonised classification and labelling of the substance silanamine in the hazard class ‘Specific target organ toxicity – repeated exposure’ – Obligation for the Commission to carry out an impact assessment – Absence – Breach of the principle of sound administration – Absence

(European Parliament and Council Regulation No 1272/2008, as amended by Regulation 2022/692, Art. 37(4))

(see paragraphs 266-277)

Résumé

By its judgment, the General Court first of all clarifies the application of the criteria for classification of a substance in the hazard class ‘Specific target organ toxicity – repeated exposure – (STOT RE)’ which are laid down in Regulation No 1272/2008. ( 1 ) It then clarifies the scope of public consultations during the harmonised classification and labelling procedure under that regulation. Lastly, it clarifies the scope of the European Commission’s obligations under the Interinstitutional Agreement on Better Law-Making ( 2 ) when adopting delegated regulations under that regulation.

The applicant, Evonik Operations, is a company incorporated under German law which manufactures silanamine. That substance is used in various products, such as medicinal and pharmaceutical products, food and cosmetics, and also in a variety of industrial applications.

In December 2018, the French competent authority ( 3 ) submitted to the European Chemicals Agency (ECHA) a proposal for the classification of silanamine in the hazard class ‘Specific target organ toxicity – repeated exposure’ (‘the hazard class STOT RE’) of Category 2. ( 4 ) Between March and May 2019, several of the parties concerned submitted their comments on the classification proposal. ( 5 )

In December 2019, ECHA’s Committee for Risk Assessment (‘the RAC’) adopted an opinion, by which 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).

In February 2022, on the basis of the RAC Opinion, the Commission adopted Delegated Regulation 2022/692, ( 6 ) 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’).

The applicant then brought an action before the General Court seeking annulment of Delegated Regulation 2022/692, as regards the harmonised classification and labelling of silanamine.

Findings of the Court

As a preliminary point, as regards the intensity of its review relating to the classification of a substance under Regulation No 1272/2008, the Court recalls that, if the Commission is to be able to carry out that classification, account being taken of the complex scientific and technical assessments which it must undertake, it must be recognised as enjoying a broad discretion. However, the exercise of that discretion is not excluded from review by the Court. In the context of such a review the Courts of the European Union must verify whether the relevant procedural rules have been complied with, whether the facts accepted by the Commission have been accurately stated and whether there has been a manifest error in the appraisal of those facts or a misuse of powers. In addition, the limits to review by the Courts of the European Union do not affect their duty to establish whether the evidence relied on is factually accurate, reliable and consistent and also whether that evidence contains all the information which must be taken into account in order to assess a complex situation and whether it is capable of substantiating the conclusions drawn from it.

Furthermore, as regards the evaluation of scientific studies, the Court holds that the Commission must be allowed a broad discretion with regard to that assessment, as well as the choice of studies which must take precedence over others, irrespective of their chronology. Thus, it is not sufficient for the applicant to rely on the age of a scientific study to call into question its reliability, but it is also necessary for the applicant to provide sufficiently precise and objective evidence to argue that any recent scientific developments would call into question the soundness of the conclusions of such a study. The Court adds that, in order to establish that the administration committed a manifest error in assessing complex facts such as to justify the annulment of the contested act, the evidence adduced by the applicant must be sufficient to make the factual assessments used in the act implausible. Subject to that review of plausibility, it is not the Court’s role to substitute its assessment of complex facts for that made by the institution which adopted the act.

In the first place, the Court rejects as unfounded the applicant’s pleas alleging (i) manifest errors of assessment and breach of the criteria for classification of a substance in the hazard class STOT RE Category 2 and (ii) breach of the Commission’s obligation to examine the appropriateness of the contested classification.

As regards the hazard class STOT RE, the Court notes that it is provided for in Section 3.9 of Part 3 of Annex I to Regulation No 1272/2008. In particular, under Section 3.9.1.1 of Annex I to that regulation, that hazard class means specific toxic effects on target organs occurring after repeated exposure to a substance or mixture; in addition, all significant health effects that can impair function, reversible and irreversible, immediate and/or delayed are included. With regard to the hazard categories, it follows from Section 3.9.2.1 and Table 3.9.1 of Annex I to Regulation No 1272/2008 that the classification for the hazard class STOT RE is divided into two categories, depending upon the nature and severity of the effect(s) observed, namely Category 1 and Category 2. More specifically, Category 2 covers substances that on the basis of evidence from studies in experimental animals can be presumed to have the potential to be harmful to human health following repeated exposure. Substances are classified in that category on the basis of observations from appropriate studies in experimental animals in which significant toxic effects, of relevance to human health, were produced at generally moderate exposure concentrations.

In the present case, the Court finds that none of the arguments put forward by the applicant is such as to establish that the RAC Opinion is based on conclusions which do not meet the criteria set out in Section 3.9 of Annex I to Regulation No 1272/2008. The applicant has not demonstrated that the effects identified in the RAC Opinion could not justify the contested classification in that they were not provided for in that section or that they resulted from the deposition of a large number of inhaled particles in the context of the relevant studies and not from the intrinsic qualities of the substance. In addition, the RAC took into account, for the purposes of the contested classification, the dose/concentration and duration of exposure in relation to which the effects were observed and, without committing any error, took into account the guidance values provided for by Regulation No 1272/2008 when making the contested classification. Thus, the Court finds that the applicant does not establish that the RAC and, consequently, the Commission committed a manifest error of assessment in that regard. In the absence of evidence to render implausible the factual assessments used in the RAC Opinion and accepted by the Commission in the contested regulation in that regard, it is not the Court’s role to substitute its assessment of complex facts for that made by the RAC and accepted by the Commission.

As regards the Commission’s alleged obligation to examine the appropriateness of the contested classification, the Court observes that, as is clear from the wording of Article 37(5) of Regulation No 1272/2008, the Commission is to adopt delegated acts for the purposes of the inclusion of a substance in Annex VI to Regulation No 1272/2008 if ‘it finds that the harmonisation of the classification and labelling of the substance concerned is appropriate’. However, neither that article nor any other provision of Regulation No 1272/2008 sets out the criteria which must be taken into account by the Commission in order to find that the harmonisation of the classification and labelling of a substance is ‘appropriate’. The Commission must be recognised as enjoying a broad discretion, in the light of the complex scientific and technical assessments which it must undertake if it is to be able to classify a substance. It follows that the Commission has a broad discretion in determining the appropriateness of a proposal for harmonised classification and labelling pursuant to Article 37(5) of that regulation.

In the second place, the Court rejects as unfounded the plea alleging breach of the harmonised classification and labelling procedure and, in particular, the absence of public consultation on the RAC Opinion.

In that regard, the Court observes that, in the case of acts of general application, neither the process of drafting them nor those acts themselves require, in accordance with the general principles of EU law, such as the right to be heard, consulted or informed, the participation of the persons affected. That is not the case if an express provision of the legal context governing the adoption of that act confers such a procedural right on a person affected.

In the present case, the Court states that the contested regulation lays down measures of general application, including the contested classification. Against that background, the procedural rights which the applicant enjoys in the procedure for harmonised classification and labelling are those expressly provided for in Regulation No 1272/2008.

In that regard, the Court recalls that Article 37(4) of Regulation No 1272/2008 must be interpreted in the light of the procedure for harmonisation of classification and labelling of substances, referred to in Article 37 of that regulation. That procedure takes place in several stages, namely, first of all, the submission of a classification proposal; next, the adoption of an opinion by the RAC ‘giving the parties concerned the opportunity to comment’; subsequently, the forwarding by ECHA of that opinion and all comments to the Commission; and, lastly, the adoption by the Commission of a delegated act, where it considers that harmonisation of the classification and labelling of the substance concerned is appropriate. It follows that the public consultation provided for in Article 37(4) of Regulation No 1272/2008 is intended to allow interested parties to comment on the classification proposal and thus possibly to contribute elements not mentioned in that proposal, so as to allow the RAC to take account, in its opinion, of the comments and elements presented by the interested parties during that phase.

Accordingly, the Court notes that, although Article 37(4) of Regulation No 1272/2008 provides for the possibility of submitting comments on the proposal for harmonised classification and labelling, that regulation does not, however, provide for the possibility for the parties concerned to submit observations on the RAC Opinion. Accordingly, in the present case, the applicant had the right to comment on the proposal for harmonised classification and labelling and to be heard in that regard before the RAC, and availed itself of that right. Between March and May 2019, a public consultation on the proposal for harmonised classification and labelling of silanamine was organised. Moreover, as is apparent from the content of the RAC Opinion itself, the RAC took into consideration the comments submitted by the parties concerned. In those circumstances, the Court concludes that the applicant did not have a right to be heard or consulted on the RAC Opinion.

In the third and last place, the Court rejects as unfounded the plea alleging the absence of an impact assessment by the Commission in the context of the procedure for the harmonisation of classification and labelling of substances governed by Regulation No 1272/2008.

To that end, the Court notes that the Interinstitutional Agreement on Better Law-Making, which establishes a series of initiatives and procedures with a view to improving the way in which the European Union legislates, makes provision for impact assessments, in points 12 to 18 thereof, as one of the ‘tools for better law-making’.

As regards the legislative process, the General Court observes that the Court of Justice has already held that an obligation to carry out an impact assessment in every circumstance does not follow from the wording of points 12 to 15 of the Interinstitutional Agreement on Better Law-Making. It follows on the other hand that the preparation of impact assessments is a step in the legislative process that, as a rule, must take place if a legislative initiative is liable to have such implication.

In the present case, the General Court notes that it does not follow from point 13 of the Interinstitutional Agreement on Better Law-Making ( 7 ) that the Commission is required, in all circumstances, to carry out an impact assessment of its delegated acts. Moreover, such an obligation does not follow from Article 37 of Regulation No 1272/2008 either, governing the procedure for harmonised classification and labelling, which does not provide for such an assessment at any of the stages of that procedure. By contrast, it follows from the provisions of Article 76(1)(c) and (d) of Regulation No 1907/2006 that, in the context of the procedure for the harmonisation of classification and labelling of substances governed by Regulation No 1272/2008, it is the RAC which is to be responsible for preparing the opinions of ECHA and that the Committee for Socio-economic Analysis is not involved. In the absence of any express provision for the involvement of the latter, it can be deduced that the legislature did not wish to include the socioeconomic impact in that procedure.

The Court concludes that, in the context of the procedure for harmonisation of classification and labelling which led to the adoption of the contested regulation, the Commission was under no obligation to carry out an impact assessment of that regulation under point 13 of the Interinstitutional Agreement on Better Law-Making.

( 1 ) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ 2008 L 353, p. 1).

( 2 ) Interinstitutional Agreement of 13 April 2016 between the European Parliament, the Council of the European Union and the Commission on Better Law-Making (OJ 2016 L 123, p. 1; ‘the Interinstitutional Agreement on Better Law-Making’).

( 3 ) Namely, 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).

( 4 ) Proposal for harmonised classification and labelling in accordance with Article 37(1) of Regulation No 1272/2008.

( 5 ) In accordance with Article 37(4) of Regulation No 1272/2008.

( 6 ) Commission Delegated Regulation (EU) 2022/692 of 16 February 2022 amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures (OJ 2022 L 129, p. 1; ‘the contested regulation’).

( 7 ) Point 13 of that interinstitutional agreement provides as follows: ‘The Commission will carry out impact assessments of its legislative and non-legislative initiatives, delegated acts and implementing measures which are expected to have significant economic, environmental or social impacts. The initiatives included in the Commission Work Programme or in the joint declaration will, as a general rule, be accompanied by an impact assessment. In its own impact assessment process, the Commission will consult as widely as possible. The Commission’s Regulatory Scrutiny Board will carry out an objective quality check of its impact assessments. The final results of the impact assessments will be made available to the European Parliament, the Council and national Parliaments, and will be made public along with the opinion(s) of the Regulatory Scrutiny Board at the time of adoption of the Commission initiative.’