CJEU Dismisses Evonik’s Appeal Over Silanamine Classification

The Court of Justice of the European Union dismissed Evonik Operations’ appeal against the harmonised classification of silanamine on 5 November 2026. The judgment in C-121/25 P rejects the challenge to the classification introduced by Regulation (EU) 2022/692.

The case concerns a specified surface-treated synthetic amorphous silica, CAS 68909-20-6, described in the regulation as silanamine, 1,1,1-trimethyl-N-(trimethylsilyl)-, hydrolysis products with silica; pyrogenic, synthetic amorphous, nano, surface treated silicon dioxide. It does not decide the classification of all silica forms.

Classification And Earlier Proceedings

The 2022 regulation added classification for specific target organ toxicity following repeated exposure, category 2 (STOT RE 2), with H373 identifying the lungs and inhalation route. That regulation applied from 1 December 2023.

Evonik challenged the measure before the General Court, which dismissed its action on 27 November 2024. The new judgment dismisses the subsequent appeal; it does not create a new classification or compliance deadline.

Scientific Evidence And Consultation

The Court distinguished the general weight-of-evidence assessment from a special rule for substances not tested for specific target organ toxicity. Because relevant tests on silanamine existed, the Risk Assessment Committee could consider studies on a structurally similar substance within the overall evidence assessment without meeting that special rule’s conditions.

The Court also confirmed that public consultation under Article 37(4) of the Classification, Labelling and Packaging Regulation concerns the classification proposal. It does not give interested parties a separate right to comment on the Risk Assessment Committee’s opinion. The Court explains these findings in paragraphs 119–132 and 185–192.