Chemical safety assessment – chemical safety report

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Requirements concerning the chemical safety report
Source: IFA

As soon as you, the registrant, manufacture or import a substance subject to registration in quantities of ten tons or more per year, you must perform a chemical safety assessment (CSA) and document it in a chemical safety report (CSR). The chemical safety report provides information on the substance's effects upon human health and the environment.

An overview of the required scope of a chemical safety report is provided in the above image, "Requirements concerning the chemical safety report".

If you are an importer, the chemical safety assessment covers all identified uses.

If you are a manufacturer, the chemical safety assessment also covers manufacture of the substance, in addition to all identified uses.

By default, the chemical safety assessment includes the hazard assessment. You must take the following steps into account:

  • Human health hazard assessment
  • Human health hazard assessment of physicochemical properties
  • Environmental hazard assessment
  • PBT and vPvB assessment (persistent, bioaccumulative and toxic substances and very persistent and very bioaccumulative substances).

Should you determine that the substance meets the criteria for a hazard classification (physicochemical hazard, health hazard, environmental hazard) in accordance with the CLP Regulation or that it is a PBT or vPvB substance, you must also undertake:

  • an exposure assessment and
  • a risk characterisation.

You must include in the exposure assessment all data relevant to exposure that are gained from the manufacture and use of the substance with respect to its effect on:

  • employees who handle the substance;
  • consumers who use or come into contact with the substance; and
  • the different environmental compartments into which the substance is introduced.

In this process you must fully determine and document the exposure (its duration and frequency) and all exposure routes.

As the manufacturer or importer, you must prepare an exposure scenario for each identified activity that exposes humans to the substance or causes it to enter the environment. The exposure scenario states the operational conditions and risk management measures.

You must attach the exposure scenarios to the relevant safety data sheet (REACH, Article 31). A safety data sheet including the exposure scenarios is termed an extended safety data sheet (eSDS).

The risk characterisation must state the potential risk for humans and the environment which is produced by comparison of the hazard assessment and the exposure assessment.

Finally, the chemical safety report provides a detailed summary of the information gathered during the chemical safety assessment on the properties of the substance that are hazardous to the environment and human health. Where necessary, it also includes the exposure assessment and risk characterisation.

Precise information on the requirements concerning the chemical safety assessment and preparation of a chemical safety report can be found in the ECHA guidance document.