THE BOTTOM LINE
- Costly Testing Can Be Challenged: Companies can successfully overturn demands for expensive new chemical studies if the regulator’s scientific justification is based on factual errors. This ruling saved the applicants the significant cost of additional neurotoxicity testing.
- Scrutinise the Data: While the Court upheld the need for a basic study, the case proves that a detailed, evidence-based challenge to a regulator’s data interpretation is a viable strategy. A flaw in the agency’s analysis can invalidate its decision.
- Judicial Review Has Teeth: This decision is a stark reminder that regulatory agencies like the European Chemicals Agency (ECHA) are not infallible. Their scientific assessments are subject to strict judicial review, and a material error of fact can be enough to unravel a costly compliance obligation.
THE DETAILS
A group of chemical companies, including Nouryon and Arkema, recently challenged a decision by the European Chemicals Agency (ECHA) at the EU’s General Court. At the heart of the dispute was ECHA’s demand that the companies conduct a comprehensive and expensive “extended one-generation reproductive toxicity study” (EOGRTS) for one of their registered substances. ECHA’s own Board of Appeal had largely upheld the decision, prompting the companies to seek judicial review, questioning whether the existing data truly justified such extensive new testing requirements under the REACH Regulation.
The Court delivered a split verdict, offering important clarity for businesses navigating REACH compliance. It upheld the requirement for a basic toxicity study, finding that evidence from an existing study indicating potential adverse effects on reproductive tissues was a sufficient trigger. The judges clarified that once this legal trigger is met, ECHA is obligated to require the standard test, leaving no room for arguments about proportionality or avoiding animal testing as a “last resort.” This confirms that standard information requirements under REACH are mandatory when the preconditions are met.
However, the companies scored a major victory when the Court annulled the most extensive part of ECHA’s demand—the requirement for additional studies on developmental neurotoxicity. The ruling hinged on a critical “material error of fact” made by ECHA’s Board of Appeal. The agency had justified the extra tests by claiming a higher incidence of thyroid effects in treated animals compared to the control group. But its decision mistakenly stated that only one control animal showed these effects, when the study data showed that eight of them did. This factual error was so significant it rendered the agency’s entire scientific assessment on this point implausible, leading the Court to strike down that part of the decision. The key takeaway is clear: while ECHA’s scientific discretion is broad, it must be exercised on a foundation of accurate facts.
SOURCE
General Court of the European Union
