Background
Evonik Operations GmbH manufactures silanamine, 1,1,1-trimethyl-N-(trimethylsilyl)-, hydrolysis products with silica; pyrogenic, synthetic amorphous, nano, surface treated silicon dioxide (SAS-HMDS), referred to in the judgment as silanamine. It is a synthetic amorphous silica treated with hexamethyldisilazane to become hydrophobic. Such substances are used in medicinal and pharmaceutical products, food, cosmetics and industrial applications, and silanamine is also an active substance under the Biocidal Products Regulation.
On 17 December 2018, France’s ANSES submitted a proposal to ECHA for harmonised classification and labelling in the hazard class specific target organ toxicity following repeated exposure, Category 2 (STOT RE 2). Interested parties commented between 4 March and 3 May 2019. ECHA’s Committee for Risk Assessment (RAC) adopted an opinion dated 5 December 2019 proposing STOT RE 2 classification, with hazard statement H373 for the lungs by inhalation, and Category 2 acute toxicity by inhalation. A targeted consultation in February 2020 concerned only the acute-toxicity classification.
Commission Delegated Regulation (EU) 2022/692 of 16 February 2022 added silanamine to Annex VI to Regulation (EC) No 1272/2008 (the CLP Regulation) with the STOT RE 2 classification and H373 labelling. The Commission did not include the acute-toxicity classification because new scientific information required further RAC assessment. Evonik sought annulment, but the General Court dismissed its action on 27 November 2024 in Case T‑449/22, EU:T:2024:866. Evonik appealed on two grounds: the legal review of the classification criteria and the interpretation of Article 37(4) of the CLP Regulation.
The Court’s Holding
The Third Chamber dismissed the appeal in its entirety. It rejected challenges concerning the distinction between intrinsic properties and specific toxic effects, the alleged failure to review testing conditions and significant health effects, and the use of studies involving the structurally similar substance SAS-DDS. Some complaints were unfounded, others ineffective because they could not affect the operative decision, and challenges requiring a fresh appraisal of evidence were inadmissible on appeal. The Court reiterated that an appellant alleging inadequate investigation or manifest assessment error must first adduce relevant factors casting doubt on the plausibility of the authority’s assessment; this does not reverse the burden of proof.
The Court distinguished the general weight-of-evidence rules for STOT RE classification from the special rule in Section 3.9.2.10.3 of Annex I. That special rule applies where the substance’s specific target-organ toxicity has not been tested. Here, studies using silanamine itself concerning lung toxicity had been considered, and Evonik did not dispute their existence. The RAC therefore did not have to satisfy Section 3.9.2.10.3’s conditions for structural analogues before also considering SAS-DDS studies. Challenges to supplementary General Court reasoning were ineffective, and the paragraph said to substitute new reasoning merely set out the RAC Opinion’s content.
On procedure, the Court held that missing Article 37(4)’s 18-month deadline for a RAC opinion does not automatically invalidate the resulting regulation. Annulment requires that, without the irregularity, the procedure could have produced a different result. Automatic annulment could require the entire classification procedure to restart, delay Commission action and hinder health and environmental protection. The General Court had properly considered whether the later targeted consultation could have affected the STOT RE classification; Evonik’s remaining factual challenge was inadmissible, while its other deadline arguments were ineffective.
The Court further held that Article 37(4) provides consultation on the harmonised classification and labelling proposal, not on the RAC opinion or a draft opinion. Unlike Article 64 of REACH, the CLP procedure contains no express draft-opinion comment stage, and comments cannot simply be submitted after adoption because the RAC must have them before adopting its opinion. The General Court’s reasoning was sufficiently stated. The Court ordered Evonik to bear its own costs and pay those of the Commission and ECHA.
Key Takeaways
- The appeal was dismissed, leaving the General Court’s judgment and the contested STOT RE 2 classification undisturbed.
- Where target-organ toxicity studies on the substance itself exist, STOT RE classification follows the general weight-of-evidence provisions rather than the special untested-substance rule.
- Breach of the RAC’s 18-month opinion deadline warrants annulment only if the procedure could otherwise have produced a different result.
- Article 37(4) consultation concerns the classification proposal, not a draft or adopted RAC opinion.
Why It Matters
The judgment clarifies both the scientific-evidence framework for repeated-exposure classifications and the procedural consequences of delay and consultation challenges. It confirms that read-across information may contribute to an overall weight-of-evidence assessment without automatically triggering the special conditions applicable to untested substances.
For companies challenging harmonised classifications, the decision also underscores the limited scope of appellate review: factual reappraisal is generally excluded absent a properly substantiated distortion of the clear sense of the evidence, and attacks on ineffective or supplementary reasoning cannot secure annulment.