The new REACH requirements for skin sensitisation entered into force on 11 October 2016 making non-animal testing the default requirement.
The information needed to fulfil the REACH information requirement for skin sensitisation, and to be used for the classification and risk assessment of a substance, should now be obtained through non-animal methods as a first step. In vivo methods can only be used if the in vitro/in chemico test methods are not adequate for the substance or cannot be used for classification and risk assessment.
To pass the completeness check of registration dossiers, the registrant now needs to give information according to the new legal requirements.
If already submitted studies conducted in line with the previous requirements, registrants do not need to bemodify registration dossier immediately. However, when updating the registration, registrants will need to follow the new requirements. This means that if registrants had met the previous requirements with an in vivo study, they do not need to carry out additional in vitro studies. But, registrants need to add a data waiving record addressing the endpoint skin sensitisation in vitro or in chemico, and include a justification for not submitting the in vitro study due to the availability of existing in vivo data.