How to address the information requirement on pre-natal developmental toxicity

ECHA/NA/15/15

Registrants of the highest volume chemicals are invited to check that the information on pre-natal developmental toxicity (PNDT) is adequately addressed while avoiding unnecessary animal testing.

Helsinki, 20 May 2015 – From 1 September 2015, ECHA will, where relevant, request in one go in its dossier evaluation decisions information on two species to be provided in the dossier, instead of the current stepwise approach by addressing only the first species.

The information requirement on two species may be fulfilled totally or partly by applying valid adaptations depending on case specific situations. The registrants should avoid unnecessary animal testing by considering if adaptation approaches in REACH apply for their substances and update their dossiers as needed.

For the highest volume chemicals (over 1 000 tonnes a year), refined information on pre-natal developmental toxicity is needed in particular to estimate their impact on the developing foetus. Chemically-induced developmental defects are a serious concern for human health and this is why REACH requires testing for PNDT on two species for the highest-tonnage substances.

More information on PNDT studies can be found in REACH annexes IX and X and in the relevant guidance. ECHA has published information on the adaptation rules in Chapter R7a of the Guidance on Information Requirements and Chemical Safety Assessment. Endpoint specific guidance is being updated and is expected to be published in July 2015.