REACH annexes amended – registrants to use alternative test methods

ECHA/NA/16/20

The REACH requirements for skin corrosion/irritation, serious eye damage/eye irritation, acute dermal toxicity and skin sensitisation are changing, making non-animal testing the default requirement. ECHA reminds registrants of their obligations to consider and, where possible, use alternative methods.  

Helsinki, 6 June 2016 – The amended REACH annexes concerning skin and eye irritation and acute dermal toxicity have been published in the Official Journal of the European Union and will enter into force on 20 June. In addition, the amendments for skin sensitisation are expected in autumn 2016. In many cases, the information needed under REACH for the classification or risk assessment of a substance will now be obtained through non-animal methods.

Companies need to take the changed requirements into account when submitting information to ECHA. To pass the completeness check of registration dossiers, registrants need to give information according to the new legal requirements as of 21 June 2016. This is the date when the new version of REACH-IT is launched. For skin sensitisation, the new requirements will be implemented in the completeness check in the autumn.

Registrants who have already submitted studies conducted in accordance with the previous requirements do not need to modify their registration dossiers immediately. However, when updating their dossier, they need to follow the new requirements. Those registrants who, for example, met the previous requirements with an in vivo study do not need to carry out additional in vitro studies. However, a justification for not submitting the in vitro study needs to be included at the time the dossier is updated.

To help companies, ECHA is updating its guidance on information requirements in the autumn. The Agency will also shortly update its advice on the use of OECD test guidelines related to skin and eye irritation. Step-by-step instructions for preparing dossiers with IUCLID 6 is available in a user manual. In addition, the IUCLID 6 Validation Assistant allows registrants to check their dossiers for completeness before submitting them to ECHA.