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: http://bit.ly/1I8Xls7
Draft guidance on reproductive toxicity (pdf): http://bit.ly/1EkbULi
Adapted from ECHA e-News
February 25, 2015
back to overview