REACH Guidance on information requirements updated

ECHA/NI/15/27

Helsinki, 22 July 2015 - ECHA has updated two sections in Chapter R7a of the Guidance on Information Requirements and Chemical Safety Assessment: Section R.7.2 on Skin corrosion/irritation, serious eye damage/eye irritation and respiratory tract corrosion/irritation and Section R.7.6 on Reproductive Toxicity.

The update to Section R.7.2 specifically addresses the recently adopted and revised OECD test guidelines for the testing of skin corrosion/irritation and serious eye damage/eye irritation. The revised text also reflects the OECD Integrated Approach on Testing and Assessment (IATA) for skin corrosion and irritation. This update involved a revision and re-organisation of Section R.7.2, expanding in particular the information on alternative (i.e. in vitro and non-testing) methods for each endpoint and clarifying when and how to use them for REACH purposes. The recommended testing and assessment strategies for these endpoints have been refined accordingly.

The update to Section R.7.6 specifically addresses the new test method, the extended one-generation reproductive toxicity study (EOGRTS), which is to be used for the purposes of the REACH Regulation. In addition, it updates the text on prenatal developmental toxicity (PNDT) (second species) to better reflect the correct interpretation of the legislative information requirements on PNDT, following a decision of ECHA's Board of Appeal and a subsequent recommendation from ECHA's Legal Affairs Unit. At the same time, the entire section has been updated and re-organised to make the structure more user-friendly.