HAVET & VANHUFFEL – Association d’avocats
Court of Justice of the European Union, (Case T‑174/24), 21 January 2026, Djchem Chemicals Poland SA and The Goodyear Tire & Rubber Company v. European Commission : Dismissal of the action against Commission Delegated Regulation (EU) 2024/197 on the classification of DAPD (Category 1B, reproductive toxicant)
Djchem Chemicals Poland SA and The Goodyear Tire & Rubber Company brought an action for annulment against Commission Delegated Regulation (EU) 2024/197. They challenge the harmonized classification and labeling of the substance 1,4-benzenediamine, a mixture of phenyl and tolyl derivatives (DAPD), as a reproductive toxicant in category 1B, a classification they consider legally and scientifically unjustified.
DAPD is a multi-constituent substance used as an antioxidant in polymers and industrial rubber. The applicants market and use it within the European Union and had previously self-classified it as a reproductive toxicant in category 2. In 2021, the competent German authority submitted a proposal for harmonized classification in category 1B to the ECHA, which was reviewed under the procedure provided for by the CLP Regulation.
Following a public consultation and a review of the dossier, the ECHA Risk Assessment Committee (RAC) adopted, unanimously, an opinion supporting the classification of DAPD as a reproductive toxicant in category 1B, with hazard statement H360FD. On this basis, the Commission adopted the contested regulation, incorporating this classification into Annex VI of the CLP Regulation, with deferred application until 1 September 2025.
Arguments raised by the applicants and the Court’s response
The applicants raised three main pleas: breach of the CLP Regulation rules concerning classification criteria, the existence of manifest errors of assessment in the scientific evaluation, and breach of the principle of proportionality as well as of the rights of defense and the principle of sound administration. They specifically argued that the effects observed in animals were not clearly relevant to humans.
The Court recalls that the CLP Regulation aims to ensure a high level of human health protection through harmonized classification of hazards. In this complex scientific and technical area, the Commission has broad discretion. Judicial review is therefore limited to verifying compliance with procedural rules, the factual accuracy, and the absence of manifest error of assessment or misuse of powers.
Regarding the first plea, the Court considers that the criteria applicable to category 1B do not require direct proof of relevance to humans, but rather the absence of serious evidence casting doubt on such relevance. In this case, the RAC found, based on animal studies, clear and non-secondary effects on fertility and development, and identified no scientific evidence undermining their relevance to humans.
The Court notes that both the Commission and the RAC effectively examined the studies and documents submitted by the applicants. The self-classification document was necessarily part of the dossier, while the relevant scientific studies are explicitly referenced and discussed in the classification proposal and the RAC opinion. The RAC acknowledged differences in parturition between rats and humans, while considering that prostaglandin PGF2α also plays an important role in humans, and that no mechanistic data allowed the exclusion of the relevance of the effects observed in animals. The applicants’ disagreement with this assessment is not sufficient to establish an omission or manifest error.
Regarding the second plea, the applicants also argued that the Commission had committed several manifest errors of assessment in classifying DAPD as a category 1B reproductive toxicant, including wrongly presuming the relevance to humans of the effects observed in rats, neglecting certain mechanistic studies, and failing to consider the reversibility of certain renal effects. The Court rejects all of these arguments, noting that they largely replicate grievances already examined and dismissed under the first plea. The Court finds that the RAC duly considered the available data, examined the reversibility of renal polycystosis, and concluded that persistent, dose-related post-implantation losses constituted a serious effect justifying the classification. The Court also dismisses the claim of violation of the principle of equal treatment, recalling that the harmonization procedure concerns only the substance in question and cannot be based on comparisons with other substances that have not undergone the same procedure.
Regarding the third plea, the Court recalls that the Commission has broad discretion when adopting acts based on complex scientific and technical evaluations, with judicial review limited to manifest error. The Court considers that the harmonized classification of DAPD legitimately pursues the CLP Regulation’s objective of ensuring a high level of human health protection without hindering the free movement of substances on the internal market. The fact that DAPD was previously self-classified as category 2 does not render the measure disproportionate, since self-classification cannot substitute for the harmonization procedure and categories 1B and 2 correspond to distinct hazard levels. Finally, the Court emphasizes that no cost-benefit economic analysis is required within the harmonized classification framework, which is based solely on the hazard criteria defined by the CLP Regulation.
The Court also rejects arguments based on a breach of the rights of defense and the principle of sound administration. It recalls that a harmonized classification constitutes an act of general application, so the right to be heard applies only within the limits set by the CLP Regulation. The applicants were able to participate in the public consultation and submit observations on the classification proposal, which the RAC took into account, without any right to an individual response or consultation on the RAC’s final opinion. The Court further notes that it is not established that the applicants were prevented from conducting additional tests or that such tests were necessary. Arguments regarding the lack of a weight-of-evidence approach are also unsupported. The third plea is therefore rejected, leading to the dismissal of the action in its entirety.
Conclusions of the Court
The Court considers that the applicants have not provided sufficient evidence to demonstrate a manifest error of assessment by the Commission or a breach of applicable rules. The Commission could therefore legitimately rely on the RAC opinion to adopt the contested classification. Consequently, the action is dismissed, and the applicants are ordered to bear the costs.