The General Court of the European Union has delivered a significant ruling, upholding the European Chemicals Agency’s (ECHA) compliance decision regarding Polynt SpA’s registration dossier for the chemical 1,3-dioxo-2-benzofuran-5-carboxylic acid and nonan-1-ol under the REACH Regulation. The ruling (Case T-29/22) reaffirms ECHA’s right to request additional safety data, even after a company has ceased production of a substance.
Background: ECHA Compliance Check Under REACH
Polynt SpA, an Italian chemical company, registered the substance in 2014, intending to manufacture it in quantities exceeding 1,000 tonnes annually. In 2017, following a compliance check under the Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) Regulation, ECHA issued a decision requiring Polynt to conduct a 90-day toxicity study and submit further studies on the substance.
Despite the company’s initial registration approval, ECHA found gaps in the dossier and requested additional information to ensure compliance with the EU’s stringent chemical safety standards.
Force Majeure Argument Rejected
In 2019, Polynt ceased production of the substance due to a fire at one of its supplier’s plants, which it claimed was a force majeure event, making it impossible to complete the requested studies. The company argued that under REACH rules, it should be relieved of its compliance obligations after ceasing production and submitted a read-across justification instead of the required toxicity study.
The General Court, however, dismissed Polynt’s argument, stating that the cessation of production did not exempt the company from providing the required safety data. According to the Court, compliance obligations under the REACH Regulation remain in force, even after production halts, unless explicitly stated otherwise in the legislation.
ECHA's Follow-Up Decision Confirmed
In 2020, ECHA issued a follow-up decision, notifying Italian authorities of Polynt’s non-compliance. Polynt appealed this decision, arguing that the request for further information was disproportionate and that ECHA failed to properly consider the company’s cessation of production. However, the General Court ruled in favour of ECHA, confirming that the agency acted within its powers and that the compliance decision was valid and enforceable.
The Court found that ECHA’s decision did not violate the principles of good administration or proportionality. Polynt remains obligated to conduct the requested studies and provide the necessary data, regardless of the production status of the substance.
Impact of the Ruling on REACH Compliance
This ruling serves as a reminder to chemical companies operating under REACH that compliance requirements remain binding, even in cases where production has ceased. The General Court’s decision reinforces the strict obligations imposed on companies to ensure the safety and environmental impact of chemicals produced or imported into the EU, in line with REACH’s overarching goal of protecting human health and the environment.
Conclusion
The General Court’s ruling in the case of Polynt SpA vs ECHA is a landmark decision, underlining the importance of compliance with the REACH Regulation. Companies are reminded of their ongoing responsibilities under EU chemical safety laws, with the Court making it clear that force majeure does not absolve registrants of their legal obligations to provide essential safety data.
