ECHA Board of Appeal Dismisses Jungbunzlauer Ladenburg GmbH's Appeal

Case Overview

The case, numbered A-003-2023, revolves around the ECHA's decision dated 9 December 2022, which required Jungbunzlauer Ladenburg GmbH, the lead registrant for tributyl O-acetylcitrate, to submit additional information on prenatal developmental toxicity (PNDT) studies. The company contested the decision, arguing that it should be addressed to all registrants of the substance rather than just the lead registrant.

Background

• Initial Compliance Check Decision: On 24 July 2017, ECHA adopted a compliance check decision under Article 41(3) of the REACH Regulation, requiring Jungbunzlauer Ladenburg GmbH to provide information on human health and environmental endpoints, including PNDT studies in rats or rabbits.
• Policy Change: From 1 January 2019, ECHA's policy required compliance check decisions to be addressed to all registrants of a substance. However, this change did not apply retroactively to follow-up decisions on earlier compliance checks.

Appeal and Arguments

Jungbunzlauer Ladenburg GmbH appealed, citing:

1. Right to Good Administration: Argued that ECHA's decision should have been addressed to all registrants, ensuring compliance from all parties involved.
2. Equal Treatment and Non-Discrimination: Claimed that addressing the decision only to the lead registrant placed an undue burden on Jungbunzlauer Ladenburg GmbH, giving other registrants a competitive advantage.
3. Article 25 of the REACH Regulation: Alleged ECHA failed to ensure that animal testing is undertaken only as a last resort by not verifying if other registrants had the necessary information.

Board of Appeal Findings

• Scope of Follow-Up Decisions: The Board found that follow-up decisions are a continuation of the initial compliance check. Since the initial decision was addressed solely to Jungbunzlauer Ladenburg GmbH, the follow-up decision legally could not include other registrants.
• Procedural Rights: It was determined that including other registrants in the follow-up decision would breach their procedural rights, as they were not part of the initial compliance check decision process.
• Principles of Equal Treatment and Non-Discrimination: The Board ruled that at the time of the contested decision, Jungbunzlauer Ladenburg GmbH was not in a comparable situation to other registrants, as it was the sole addressee of the initial decision.
• Article 25 Compliance: ECHA had examined the dossiers of other registrants, and the Board found no relevant information that would negate the need for the PNDT studies requested from Jungbunzlauer Ladenburg GmbH.

Decision

The appeal was dismissed, and the Board concluded that:

1. No Infringement: ECHA did not breach Articles 42 or 41 of the Charter of Fundamental Rights, nor did it violate the principles of equal treatment and non-discrimination.
2. Non-Compliance: Jungbunzlauer Ladenburg GmbH's registration dossier remained non-compliant with the necessary information requirements.
3. Appeal Fee: As the appeal was not decided in favour of the appellant, the appeal fee would not be refunded.

Antoine Buchet, Chairman of the Board of Appeal, emphasised that the decision ensures consistent application of the REACH Regulation, maintaining regulatory compliance and protecting human health and the environment.

This decision underscores the importance of thorough compliance with ECHA's regulatory requirements and clarifies the scope and procedural aspects of compliance check follow-ups. Companies must ensure that their registration dossiers are comprehensive and adhere to all stipulated guidelines to avoid similar outcomes.