This news update regarding changes to reproductive toxicity tests is brought to you by ECHA.
Are you affected by changes to reproductive toxicity tests?
The extended one-generation reproductive toxicity study (EOGRTS) is now the information requirement for reproductive toxicity in REACH. The amended REACH annexes VIII, IX and X entered into force on 13 March 2015. ECHA will examine registrants’ testing proposals and compliance of dossiers according to the amended requirement.
Those registrants with a testing proposal in their dossier for this endpoint will be contacted by ECHA through REACH-IT about the amended information requirements and timelines for the next steps. Registrants are encouraged to familiarise themselves with the amended annexes and the respective guidance. There is a need to consider the implications on the registered substances, because of the new aspects in the information requirements. In particular, attention should be paid to the various study designs based on specific conditions or triggers. These are explained in more detail in the guidance.
The guidance on reproductive toxicity is currently being updated to reflect the regulatory changes. It should be finalised by July 2015. The draft is already available on ECHA’s website.
For more information regarding changes to reproductive toxicity tests please visit the ECHA link above. Please contact Nexreg for regulatory services.