Appeal against a compliance check decision dismissed
In case A-010-2019, the appellant contested the requirement of an ECHA compliance check decision to provide information on a fish early-life stage (FELS) test on propane-1,2,3-triyl 3,5,5-trimethylhexanote.
The Board of Appeal confirmed its interpretation of the information requirements for long-term toxicity testing on fish under Column 2 of Section 9.1. of Annex IX to REACH. This provision allows registrants to adapt the standard information requirement on long-term toxicity testing on fish only by providing, instead, an even longer-term or more extensive study (see previous decisions of the Board of Appeal in cases A-010-2018 and A-011-2018).
The Agency was therefore correct in finding that the appellant’s registration dossier has a data-gap in regard to long-term toxicity testing on fish.
Decision
Court dismisses an action against a Board of Appeal decision
In its decision, the Board of Appeal had upheld an ECHA substance evaluation decision requesting a simulation biodegradation study on a substance used as a UV filter in cosmetic products. A registrant of the substance challenged the Board of Appeal decision before the General Court.
The Court confirmed that, rather than using ‘real life’ or ‘realistic’ conditions, the assessment of a substance must be based on data obtained under ‘relevant’ conditions that enable an objective assessment of the properties of that substance. It was therefore appropriate to conduct the requested study at 20 ̊C as the aim was to clarify the degradation pathways of the substance.
Judgment | Board of Appeal decision
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