Review of extended one-generation reproductive toxicity studies
In 2021, ECHA will start to review extended one-generation reproductive toxicity (EOGRT) studies that registrants have submitted following a dossier or substance evaluation decision. The EOGRT study has been the new information requirement for reproductive toxicity under REACH since March 2015.
The aim is to:
- analyse the extent to which studies meet the regulatory expectations;
- inform on potential concerns, such as for endocrine-disrupting properties; and
- analyse the study expansions (production of the second filial generation, developmental neurotoxicity and immunotoxicity) and the relationship with regulatory triggers under REACH.
ECHA runs the project with support from Member States. Other stakeholders may also be consulted. The final report is expected in 2023.