The Board of Appeal has upheld an Agency decision rejecting the read-across approach proposed by the Appellant and, consequently, requesting information on pre-natal developmental toxicity.
In appeal case A-001-2012, the Board of Appeal has dismissed the Appellant's request to annul an ECHA decision taken after a compliance check under the dossier evaluation procedure. In the contested decision, the Appellant was required to submit information on pre-natal developmental toxicity for the substance dipropylene glycol methyl ether acetate (commonly known as DPMA).
The Board of Appeal considered that ECHA possesses a margin of discretion when it assesses proposed adaptations of the standard testing requirements using a grouping or read-across approach, as referred to in Annex XI, Section 1.5 of the REACH Regulation.
This margin of discretion applies when ECHA decides whether the information available for the reference or source substance(s) can be used to adequately predict any of the human health or environmental properties of the target substance.
The Board of Appeal concluded that ECHA had acted within its margin of discretion in rejecting the read-across approach proposed by the Appellant as it did not satisfy the requirements set-out in Annex XI, section 1.5 of the REACH Regulation and, consequently, in requesting information on pre-natal developmental toxicity.
