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Board of Appeal's press release: Board of Appeal's latest decision emphasises the importance of fully justifying read-across proposals

 

BoA/PR/14/01

Case A-006-2012 concerned the Agency's interpretation of the conditions that have to be met when a registrant adapts the standard information requirements through the use of a read-across approach.

Helsinki, 13 February 2014 - The Board of Appeal decided that for a read-across adaptation to be assessed and potentially accepted by the Agency, registrants have to show with clear reasoning and supporting data that the substances involved are structurally similar and are likely to have similar properties (or follow a regular pattern); registrants should also explain how and why the similarity of properties is as a result of the structural similarity. The decision also clarifies the role of the Agency in verifying whether read-across adaptations are in compliance with the rules set out in the REACH Regulation, and in particular Section 1.5 of Annex XI.

The Board of Appeal found that the Appellant had not demonstrated that the Agency, in rejecting the Appellant's read-across approach, had incorrectly interpreted the REACH Regulation requirements on read-across. The Board of Appeal also found that the other pleas made by the Appellant were unfounded and the appeal was therefore rejected.