Chemical safety report

For all substances subject to registration in quantities of 10 tonnes or more per year per registrant, a chemical safety assessment must be performed and a chemical safety report completed. Specific rules apply to mixtures.

A chemical safety assessment of a substance shall include a human health hazard assessment; a physicochemical hazard assessment; an environmental hazard assessment; and a persistent, bioaccumulative, and toxic (PBT) and very persistent and very bioaccumulative (vPvB) assessment. If the substance is assessed to be a PBT or vPvB, or if it fulfils the criteria for certain hazard classes or categories, the chemical safety assessment shall also include exposure assessment, including the generation of exposure scenarios/¹ exposure estimation, and risk characterisation. The assessment is to address not only the manufacturers’ or importers’ own uses and the uses for which they place their substances on the market, but also uses which their customers ask them to address.

The chemical safety report must be kept available and up to date by the registrant.

An important general requirement is that all registrants must identify and apply the appropriate measures to adequately control the risks identified in the chemical safety assessment. (Art 14.)

Also, downstream users—that is, natural or legal persons established within the EU, other than the manufacturer or the importer, who use a substance, either on its own or in a mixture, in the course of their industrial or professional activities—are required, with certain exceptions, to prepare a chemical safety report for any use outside the conditions described in an exposure scenario or for any use the supplier advises against (Arts 3 and 37).