Non-animal methods now a default for skin sensitisation – submit correct information
The new REACH requirements for skin sensitisation entered into force on 11 October 2016 making non-animal testing the default requirement. Remember to take this change into account when submitting information to ECHA, otherwise your dossier will not pass the completeness check.
Helsinki, 23 November 2016 – The information you need to fulfil the REACH information requirement for skin sensitisation, and to be used for the classification and risk assessment of your 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.
Keep this in mind when you submit information to ECHA. To pass the completeness check of registration dossiers, you now need to give information according to the new legal requirements.
If you have already submitted studies conducted in line with the previous requirements, you do not need to modify your registration dossier immediately. However, when updating the registration, you will need to follow the new requirements. This means that if you had met the previous requirements with an in vivo study, you do not need to carry out additional in vitro studies. But, you 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.
Before you submit your dossier to ECHA, we strongly advise you to check it with the IUCLID 6 Validation Assistant. To check your dossier according to the latest requirements, make sure that you use the latest version of IUCLID 6 (v.1.1.0.). If you are still working with an older version of IUCLID 6, the Validation Assistant will not reflect the current completeness check.
When preparing your dossier, also remember that from 21 June 2016, the completeness check includes additional manual verifications by ECHA staff that cannot be replicated by the Validation Assistant.
Registrants to use alternative test methods for skin sensitisation, News alert 5 July
Manuals on preparing REACH and CLP dossiers (for an example of waiving an in vitro study on the basis of an existing in vivo study, consult manual How to prepare registration and PPORD dossiers, Table 9)