European Chemicals Agency Board of Appeal Dismisses Evonik Operations GmbH's Appeal

Background of the Case

The appeal (Case A-004-2023) revolved around a follow-up compliance check concerning the substance 2,4,6-tris(dimethylaminomethyl)phenol. Initially registered by Air Product Chemicals PLC, the registration responsibility was later transferred to Evonik Operations GmbH. The substance was registered under Annex X of the REACH Regulation, indicating a high volume of use exceeding 1,000 tonnes per year.

The dispute began in November 2016 when the ECHA required the original registrant to submit additional toxicity data, including a 90-day sub-chronic toxicity study and an extended one-generation reproductive toxicity study (EOGRTS). The latter was to be conducted according to the OECD Test Guideline 443, focusing on potential endocrine-disrupting properties.

Key Points of the Contested Decision

The contested decision, adopted by the ECHA on 9 December 2022, concluded that Evonik's EOGRTS was insufficient. Specifically, the ECHA found that histopathological investigations were missing for:

• Selected reproductive organs in Cohort 1B animals at all dose levels.
• Identified target organs (liver and spleen) in Cohort 1B animals at all dose levels.
• Organs demonstrating treatment-related changes in male and female animals of the parental (P0) generation and Cohort 1A at low and mid doses.

The ECHA asserted that the absence of these histopathological examinations prevented a reliable determination of the No Observed Adverse Effect Level (NOAEL) for organ toxicity, a critical measure in assessing the safety of chemical substances.

Arguments and Findings

Evonik Operations GmbH contested the decision on two primary grounds:

1. Histopathological Investigations in Cohort 1B: Evonik argued that these investigations were unnecessary as the substance was not definitively identified as an endocrine toxicant and that the results from Cohort 1A were not equivocal. However, the Board of Appeal upheld the ECHA's position, citing that previous studies indicated potential endocrine-disrupting effects, necessitating further investigation.
2. Investigations of Organs in the P0 Generation: The company also claimed that repeating the histopathological examinations of male animals in the P0 generation at low and mid doses would not provide additional valuable information, given the data from a prior 90-day study. The Board disagreed, noting that the REACH Regulation requires these studies to be comprehensive and consistent with test guidelines. The prior study's data did not fully substitute for the missing information, particularly due to differences in statistical power and study design.

Outcome

The Board of Appeal found no merit in Evonik's arguments and dismissed the appeal in its entirety. As a result, the original ECHA decision stands, and Evonik must fulfil the outstanding data requirements or face potential enforcement actions from Member State authorities.

Moreover, the appeal fee will not be refunded as the appeal was not decided in favour of the appellant. The Board also rejected Evonik's request to reset any deadlines related to the contested decision, emphasising that compliance obligations remain in effect from the date of the Board's ruling.