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Board of Appeal's press release: Board of Appeal Decision on Additional Testing Requirements

BoA/PR/13/5

In its latest decision the Board of Appeal has upheld an ECHA decision requiring information on sub-chronic toxicity, and developmental toxicity in a second species.

Helsinki, 11 October 2013 – In appeal case A-004-2012, the Appellant requested the Board of Appeal to extend the deadline set for it to provide information on sub-chronic toxicity (90-day) in the rat via the oral route. The Appellant requested an extension of this deadline to allow it to take into consideration the results of a 13-week (Dosed-Feed) sub-chronic toxicity study on mice which was planned under the United States National Toxicology Programme (the ‘USNTP'). In its decision, the Board of Appeal considered, however, that the timing of the USNTP study was uncertain and outside the control of the Appellant. The Board of Appeal found therefore that the performance of a study at some unspecified time in the future cannot justify the revision of the Contested Decision with respect to the requested information.

The Appellant also contested ECHA's decision to require information on developmental toxicity in a second species. The Appellant, which had already provided information on a pre-natal developmental toxicity study in one species, claimed that in requiring information on developmental toxicity in a second species as a standard information requirement ECHA had incorrectly interpreted the REACH Regulation. The Board of Appeal concluded in its decision that the provisions of the REACH Regulation, when read as a whole, mean that registrants manufacturing or importing substances at 1000 or more tonnes per year are required to perform a developmental toxicity study also on a second species, unless, as a result of the adaptations set out in the legislation, such a study is not necessary.

Whilst the Appellant's appeal was rejected in its entirety, the Board of Appeal highlighted that as a result of the principle of the suspensive effect of appeals, the Appellant should be permitted 24 months from the date of its decision to provide the requested information. This time limit is the same as that which had been set in the Contested Decision.