1. Human health hazard assessment: determination of the classification and labelling of the substance, derivation of no effect levels (DNELs)
2. Physicochemical hazard assessment: determination of the classification and labelling of the substance
3. Environmental hazard assessment: determination of the classification and labelling of the substance, derivation of predicted no effect concentrations (PNECs)
4. Persistent, Bioaccumulative and Toxic (PBT) and very Persistent and very Bioaccumulative (vPvB) assessment (or substances of similar concern): comparison of the data on degradation, bioaccumulation and toxicity with the criteria as given in the legislation If, the substance meets the criteria for classification as dangerous, or meets the PBT/vPvB criteria
5. An exposure assessment for all identified and relevant uses of the substance and resulting life cycle steps, including the generation of exposure scenario(s). An exposure estimation of humans and the environmental compartments to the substance is performed from the conditions defined in the exposure scenarios.
6. A risk characterization which is the final step in the chemical safety assessment. The risk characterization identifies if the risks arising from manufacture/export and uses of a substance are adequately controlled.

The company performing the CSA (exporter, or downstream user performing his own CSA) has to assess all the identified uses, e.g., own uses which include use in a production or formulation process, or storage uses which are made known to it by downstream users. In addition, the assessment shall cover all life-cycle stages resulting from these uses, for example, the “use” of an article containing the substance (sometimes referred to as “service life”) as well as the waste stage. The information generated from CSA shall be recorded under the relevant section of the Chemical Safety Report and, where required, summarized in the Safety Data Sheet under relevant headings that will be passed down the supply chain. In particular, the exposure scenarios developed shall be annexed to it.

If while carrying out the CSA, with respect to the identified uses of the substance, it is assessed that further information is needed and that the information can only be obtained by a test - a proposal for testing has to be developed. The proposal is submitted in the technical dossier as part of the registration of the substance and the reasons are given in the CSR. This proposal will be evaluated as part of the dossier evaluation. No testing shall be conducted before a decision is taken under evaluation. Until then the risk management measures put in place, taking into account the need for further information, should be recorded in the CSR.

Chemical Safety Report (CSR)

The chemical safety report will document the chemical safety assessment for either each substance on its own or in a preparation or in an article or a group of substances. Chemical safety report can be prepared by one or more competent person with appropriate experience and will have to include identified uses of manufactured substance, the environmental fate properties of the substance, its physicochemical, toxicological and eco-toxicological properties, human health hazard, exposure assessment and the main element responsible for exposure.