A Chemical Safety Assessment (CSA) is a procedure that is implemented to identify and subsequently describe the conditions under which the manufacturing and use of a substance is considered to be safe. This requires an assessment of the substance properties and the uses of the substance which could potentially lead to human and environmental exposure. Chemical Safety Assessments are usually required as part of registration dossiers for a substance that is manufactured or imported in quantities of >10 tonnes per annum.
A Chemical Safety Assessment (CSA) of a substance is conducted in the following sequence:
1. Hazard assessment for Human Health and the Environment
2. Persistent, bioaccumulative. and toxic (PBT) and very persistent and very bioaccumulative (vPvB) assessment.
If a substance meets the criteria as dangerous according to the criteria of Directive 67/548/EEC (Dangerous Substances Directive) or Directive 1999/45/EC (Dangerous Preparations Directive), or is a PBT or vPvB substance then the following is required:
3. Exposure assessment (including appropriate exposure scenarios)
4. Risk characterisation and appropriate risk management measures (RMM) if required
The results of the CSA are documented in the Chemical Safety Report (CSR) and are communicated to downstream users via the Safety Data Sheet (SDS), and if appropriate through Exposure Scenario (ES). Annex I of the REACH Regulation contains details on compilation of the Chemical Safety Report.
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Chemical Safety Assessment
What is a Chemical Safety Assessment (CSA)? Is it required for your REACH registration?
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A. GHS compliance activities in China
B. Risk control on product quality before entering Chinese market
C. Compliance requirements for China new chemical substance notification
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