Registrants to use alternative test methods for skin sensitisation
The REACH requirements for skin sensitisation are changing, making non-animal testing the default requirement. Registrants are encouraged to consider their testing strategies now for the 2018 registration deadline.
Helsinki, 5 July 2016 - The amended REACH annexes concerning skin sensitisation are expected to enter into force in autumn 2016. The information needed for the classification or risk assessment of a substance will then be obtained through non-animal methods as a first step. In vivo methods can only be used if the in chemico or in vitro test methods are not adequate for the substance or cannot be used for classification and risk assessment.
With the amended requirements, if a substance is predicted to be a skin sensitiser based on the available data, skin sensitisation potency should also be assessed. There is currently no standardised way to assess potency with the in vitro methods and therefore the in vivo test may still be necessary.
However, estimating potency is not necessary if an existing in vivo study does not allow potency estimation and the study has been performed according to internationally-adopted test methods and good laboratory practice.
The amended requirements will be implemented in the completeness check of IUCLID and REACH-IT in the autumn.
ECHA's draft guidance takes the amended information requirements into account and gives advice to registrants. Some minor changes might still occur in the final consultation process. The final guidance will be published in the autumn after the Annex amendment has been published in the Official Journal.