|A manufacturer or importer of a substance in quantities of 10 tonnes or more per year needs to prepare a chemical safety assessment (CSA) and needs to document this assessment in his chemical safety report (CSR) as part of his registration dossier.
A methodology for assessing whether risks from the use of substances to human health and the environment are adequately controlled as well as the format for the chemical safety report must be devised.
In the chemical safety report the registrant needs to document how he derived his - positive or negative - hazard classification as "dangerous" according to Directive 67/548/EEC (hazard classification of substances) [More] and his PBT and vPvB assessment of the substance. The assessment shall also include the identification of derived no-effect levels (DNELs) and predicted no-effect concentrations (PNECs).
To focus resources and priorities on substances of higher concern, the registrant only needs to document how he developed appropriate risk management measures (RMM) for those substances that are either classified as dangerous or identified as a PBT or vPvB. He does this, by documenting the relevant exposure assessments and the risk characterisations for these substances.
A CSA need not to be performed for a substance which is present in a preparation below any of the concentration limits defined in Art. 14 (2). For substances with similar properties, a group assessment can be performed.
Results of the chemical safety assessment shall also be used when compiling safety data sheets for information that will be passed down the supply chain, in particular the exposure scenarios developed shall be annexed to it.
Where a safety data sheet (SDS) is prepared for a preparation, the supplier may carry out a Chemical Safety Assessment for the preparation, and ensure the SDS is consistent with that assessment, rather than with that for each substance. The methodology for this is set out in Annex IB and includes documenting his hazard classification according to Directive 1999/45/EC (hazard classification of preparations), deriving DNELs and PNECs for the preparation, and carrying out an exposure assessment.