The chemical safety assessment
The chemical safety assessment
A chemical safety assessment shall be performed and a chemical safety report completed for all substances subject to registration if the registrant manufactures or imports such a substance in quantities of 10 tonnes or more per year.
The chemical safety assessment shall be conducted for either each substance on its own or in a preparation or a group of substances.
Assessment steps
Under REACH, the chemical safety assessment of a substance shall include the following steps:
(a) human health hazard assessment;
(b) human health hazard assessment of physicochemical properties;
(c) environmental hazard assessment;
(d) PBT and vPvB assessment (persistent, bioaccumulative and toxic substances and very persistent and very bioaccumulative substances).
If, as a result of carrying out these steps, the manufacturer or importer concludes that the substance meets the criteria for classification as dangerous or is assessed to be a PBT or vPvB, the chemical safety assessment shall include the following additional steps:
(a) exposure assessment;
(b) risk characterisation.
Uses covered by the assessment
The assessment shall address all uses identified to the registrant by his downstream users, unless he chooses not to supply the substance for some uses. It shall also address his own uses.
The uses addressed in the registrant’s chemical safety assessment are known as identified uses. Any downstream user shall have the right to make a use known in writing to the manufacturer, importer or downstream user who supplies him with a substance with the aim of making this an identified use. In so doing, he shall provide sufficient information to allow his supplier to prepare an exposure scenario for his use in the supplier’s chemical safety assessment. If a downstream user is using a substance in a way not covered by a manufacturer’s or importer’s chemical safety assessment (including incorporating it into an article) or if he intends to use different risk management measures, then he must send a short report to the Agency (for uses of more than 1 tonne per year).
Any manufacturer or importer shall apply the appropriate measures to adequately control the risks identified in the chemical safety assessment, recommend them in the safety data sheets.
Notes:
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Certain uses do not need to be addressed in the CSA as they are adequately addressed by other EU legislation (see chemicals covered).
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Chemical safety assessments and chemical safety reports are not required for on-site isolated intermediates, or transported isolated intermediates.
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A chemical safety assessment does not need to be conducted if the concentration of the substance in a preparation is below some concentration limits because below these concentration limits the substance is considered not to pose a significant risk to human health and the environment.