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The European Commission prepares a draft authorisation decision within three months after receiving the opinions from ECHA. Following the draft decision, a minimum of three months is needed for the vote in the REACH Committee and the subsequent adoption procedure, including translations, in the Commission. The whole decision-making process therefore takes normally more than six months.
Obligations after an authorisation has been granted
If the authorisation is granted by the European Commission, it is subject to the conditions described in the Chemical Safety Report submitted in the application. The Commission’s authorisation decision may stipulate additional conditions. The authorisation holder should continue its efforts to find safer alternatives after receiving the Commission's decision.
Authorisation holders must comply with the conditions of the decision. Upstream authorisation holders, that is manufacturers, importers or only representatives, must include the authorisation number on the label before they place the substance or the mixture containing the substance on the market. Upstream authorisation holders must also update the safety data sheet (SDS).
Downstream users covered by the authorisation of an upstream actor
Downstream users of an Annex XIV substance covered by the authorisation of an upstream actor must comply with the conditions of the decision and notify to ECHA their use of the substance within three months of the first supply of the substance. ECHA keeps a register of these notifications, provides them to the Member State competent authorities and publicises summaries of the notifications on its website. Downstream users should also be in contact with the authorisation holders and suppliers and provide them with information for a possible review report. If the downstream users sell the substance further down in the supply chain, either on its own (following re-packaging) or in a mixture, they also have to pass on the information about the authorisation (in the SDS and the label) to their customers.