On 5 July 2023, the General Court rendered its judgment in case T-639/20 TIB Chemicals AG. The action was dismissed but the judgment contains highly relevant rulings for economic actors confronted with a Harmonized Classification process under the CLP Regulation.
In particular, the General Court implies that when RAC relies on read-across, it should follow the rules of Annex XI to REACH and ECHA’s applicable guidance. The General Court would review if RAC committed Manifest errors of assessment in that regard. This is a very important clarification for on-going harmonized classification processes.
In that case, the applicant was challenging the harmonized classification of the substances dioctyltin dilaurate (EC: 222-883-3; CAS: 3648-18-8) and stannane, dioctyl-, bis(coco acyloxy) derivs. (EC: 293-901-5; CAS: 91648-39-4) as Repr. 1B and STOT RE 1 (DOTL). The seven pleas in law raised by the applicant were rejected and the action was ultimately dismissed.
Some key takeaways can be highlighted from that case:
- The General Court implies that the conditions of Annex XI to REACH to conduct a valid read-across may not only apply to registrants under REACH but also to EU authorities, including the RAC. In the case at hand, the Court links the justification of a read across in the CLH report With requirements of Annex XI to REACH, which notably specifies the conditions to be met for a read-across. The Court even refers to the relevant guidance of ECHA i.e., Chapter R.6 of the Guidance on information requirements and CSA, and the Read-Across Assessment Framework (RAAF). Interestingly, the Court makes a relatively advanced analysis as to how the RAC justified its read-across to verify that it did not commit manifest errors of assessment. It is implied that Annex XI to REACH serves as a benchmark for such assessment/ Although the applicant was not successful in that case, authorities including ECHA may have to follow Annex XI and their own guidance when relying on read-across and, possibly, more broadly on grouping.
- The Commission has no obligation to await the completion of ongoing studies as regard to substances undergoing a CLH process. The Court makes a strict reading of the CLP, and considers that such obligation would "make it impossible to classify a substance" and would thus be contrary to the objective of the CLP to ensure a high level of protection of human health and the environment. The Court also draws on Article 37(5) of the CLP that provides that the Commission is to adopt CLH "without undue delay" where it finds that a CLH is appropriate, to reject the obligation to generate additional information in the course of the CLH process. It could still be argued that this should not be the case in situations where authorities would be responsible for the delay.
- The industry has no procedural right to comment on the RAC opinion itself. The General Court considers that Article 37(4) seeks to ensure that comments can be submitted on the proposal of CLH. However, the Court fails to see any right to comment on the RAC opinion itself. The reasoning followed by the judges to came to this conclusion is not evident in the judgement.
- The Commission is not required to conduct an impact assessment before adopting a CLH. For the Court the decision of the Commission to adopt a CLH is essentially based on scientific data. Moreover, there is no indication in the CLH procedure, as foreseen in article 37 of the CLP, that the Commission is to conduct such impact assessment but rather that it should follow a given process including the submission of a CLH dossier by specific actors and the involvement of the RAC of ECHA.