European Court of Justice upholds STOT RE 2 classification for silanamine in Evonik case
- The ECJ upheld the harmonized classification of silanamine as STOT RE 2.
- The Court confirmed read‑across is a permissible method for hazard assessment in CLH procedures.
- The case followed Evonik's appeal after the General Court dismissed its action against the classification.
- The judgment permits basing hazard assessments on data from structurally or physicochemically comparable particulate substances and addresses particle size as an intrinsic property.
ECJ decision
The European Court of Justice upheld the harmonized classification of silanamine as STOT RE 2 (specific target organ toxicity following repeated inhalation exposure, affecting the lungs). The ruling followed Evonik's appeal after the General Court had dismissed the company's action against that classification.
Read‑across and particle characteristics
The ECJ confirmed that read‑across is a permissible method in CLH (harmonized classification and labeling) procedures, allowing hazard assessments to rely on test data from structurally or physicochemically comparable particulate substances. The Court also confirmed that a hazard assessment may be based on such comparable substances and addressed the treatment of particle size characteristics as intrinsic properties of a substance.
Implications
The judgment provides legal clarity on the application of read‑across in CLH proceedings and is expected to make future regulatory assessments more predictable for modified synthetic amorphous silicas and other particulate substances. Frank Menzel, Vice President Regulatory Marketing Silica at Evonik Smart Effects, said the ruling offers legal certainty and greater clarity regarding read‑across in CLH proceedings.
Source: Evonik