Substances identified as Substances of Very High Concern (SVHC), by ECHA’s Member State Committee (based on a proposal prepared by a Member State or a proposal prepared by ECHA on request of the Commission), will gradually be included in ECHA’s ‘Candidate List’ of substances that could be subject to authorisation. The European Commission decides whether to include a substance in the ‘Authorisation List’ (Annex XIV of the REACH Regulation) via a regulatory committee procedure.
Under REACH, substances on the ‘Authorisation List’ cannot be placed on the market or used after the so called “sunset date” unless specific exceptions apply. These substances may only be placed on the market if an authorisation has been granted for both the substance and its uses.
In line with this, any company wishing to market or use a substance on the authorisation list must submit an application for authorisation to the Agency in which they must demonstrate that the socio-economic benefits of use outweigh the risks posed by that use of the substance. They are also required to analyse whether there are any suitable ‘safer’ alternative substances or technologies available; if there are then they must prepare substitution plans and if not then they should provide information on research and development activities if appropriate. Authorisations must be submitted to the Agency in conjunction with the registration dossier. With help from ECHA’s Committees on Risk Assessment and Socio-economic analysis, the European Commission decides on the granting or refusing of authorisations.
Further information on Authorisation can be found on the ECHA website.