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Information requirements for reproductive toxicity changed


The REACH annexes VIII, IX and X have been amended with the inclusion of the extended one-generation reproductive toxicity study (EOGRTS, EU B.56, OECD TG 443).

EOGRTS will now be the information requirement for reproductive toxicity in REACH instead of the two-generation reproductive toxicity study (EU B.35, OECD TG 416). The updated annexes will enter into force 13 March 2015. ECHA is updating its guidance on reproductive toxicity to reflect the regulatory changes and aims to finalise it by July 2015. A draft is already available on ECHA's website.