For all substances subject to registration, a chemical safety assessment must be performed and a chemical safety report produced in cases where the substance is manufactured or imported in quantities of 10 t or above per year and registrant.
The principal element of the chemical safety report is the description of exposure scenarios which are recommended for an identified use. These scenarios contain risk management measures which the manufacturer or importer has taken and which he recommends to downstream users. Should the substance be placed on the market, these exposure scenarios are compiled in an annex to the safety data sheet, together with the risk management measures.
The chemical safety assessment must be performed either for each substance individually, or for a substance group. Compilation of a safety data sheet for a mixture consisting of numerous registered substances would be extremely complicated. Rather than listing the individual chemical safety assessments for all registered ingredients of a mixture during creation of a safety sheet for the mixture, a chemical safety assessment may therefore instead be performed for the mixture as a whole.
The chemical safety assessment of a substance comprises the following steps:
If the manufacturer or importer concludes that the substance meets the criteria for classification as dangerous or is assessed to be a PBT or vPvB substance, the chemical safety assessment must include the following additional steps:
Should a downstream user use a substance in a manner which is not covered by a manufacturer's or importer's chemical safety assessment (identified use, including use as part of an article), he must submit a corresponding notification to the Agency for use quantities exceeding 1 t per year and if applicable prepare his own chemical safety report. Alternatively, he may report back to the supplier and have registration performed by the latter. The supplier is not obliged to do this, however, for example if he is unable to approve this particular use.
(REACH Regulation, Article 14 and Annex I)