REACH is based on the principle that industry should manufacture, import, use substances or place them on the market in a way that human health and the environment are not adversely affected. Thus, manufacturers and importers need to collect or generate data on the substances, and assess how risks to human health and the environment can be controlled by applying suitable risk management measures. For all substances that are manufactured or imported in volumes equal to or greater than 10 tonnes per year, a Chemical Safety Assessment (CSA) needs to be carried out and documented in a Chemical Safety Report (CSR). The Chemical Safety Assessment shall address the manufacture of a substance and all the identified uses. The CSR contains a detailed summary of information on the human health and environmental hazard properties of the substance, together with an assessment of exposure and risk where such an assessment is required.

Other actors may have to prepare a CSR:

• Downstream users who need or want to make their own CSA /CSR;
• Producers or importers of articles containing substances that are intended to be released from the article, if the substance is not already registered for that use. CSR is required if the substance is present in those articles in volumes above 10 tonnes per year;
• Manufacturers, importers or downstream users prepraring a CSA / CSR as a part of an authorisation application.

Under certain circomstances, the chemical safety assessment does not need to be performed:

• for a substance present in a preparation in a concentration below certain concentration limits;
• for on-site or transported isolated intermediates;
• for Product and Process Oriented Research and Development (PPORD);
• when the use of the substance is already regulated under specific legislation and the substance is therefore exempted from registration (e.g. biocides, pesticides, pharmaceuticals).

The chemical safety assessment need not address human health risks from end uses in food contact materials and in cosmetic products, as these are addressed under other legislation.

Assessment steps

The diagram "Principles of Chemical Safety Assessment under REACH" summarises the CSA steps.

The chemical safety assessment of a substance shall include the following steps:

• hazard, PBT (persistent, bioaccumulative and toxic) and vPvB (very persistent and very bioaccumulative) assessment;
• exposure assessment including exposure scenario(s);
• risk characterisation.
  
  

Any registrant shall identify and apply the appropriate measures to adequately control the risks identified in the chemical safety assessment, and where suitable, recommends them in the safety data sheets which he supplies. Any registrant, required to conduct a chemical safety assessment, shall keep his chemical safety report available and up to date.