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Registrants encouraged to re-assess information on reproductive toxicity


ECHA to start addressing EOGRTS in dossier evaluation decisions

Helsinki, 17 June 2015 - From 1 October, ECHA will start the decision making on testing proposals on the reproductive toxicity endpoint, i.e. extended one-generation reproductive toxicity study (EOGRTS). The Agency will soon contact registrants with pending testing proposals under examination in ECHA through REACH-IT and encourage them to update their testing proposal on reproductive toxicity to correspond with the REACH annexes. The information requirement for this endpoint in REACH was amended in March 2015.

ECHA will also start addressing the EOGRTS information requirement in its compliance check decisions. Registrants are invited to re-assess whether the information they provided on reproductive toxicity fulfils the current requirement and adequate justifications are in place when omitting studies.

Registrants need to follow certain criteria to decide on the study design of EOGRTS. The draft updated guidance on reproductive toxicity provides useful information in this regard. It also guides registrants in a stepwise manner on how to meet information requirements and avoid unnecessary animal testing. The guidance is to be finalised by end of July 2015 and the draft is already published on ECHA's website.

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