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EU: REACH 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 two-generation reproduc­tive toxicity study uses a minimum of 2,200 animals while the EOGRTS uses a minimum of 960 animals per test, a 40% re­duction. The updated annexes will enter into force March 13, 2015. ECHA is updating its guidance on reproductive toxicity to reflect the regulatory changes and aims to finalize it by July 2015. A draft is already available on ECHA's website.

Updated annexes:

Draft guidance on reproductive toxicity (pdf):



Adapted from ECHA e-News

February 25, 2015

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