For long, the Chemical Safety Report (CSR) has not been an integral part of the ECHA dossier completeness checks when submitting a lead or member registration. This is about to change! As of 1st of March 2021, ECHA will start doing manual completeness checks of CSRs submitted as part of a new registrations or an update of an existing dossier. Will your CSR stand the test? Unfortunately, our experience unfortunately learns us that the answer is often no…
Already since 2016, completeness checks include a manual verification of certain elements of the registration dossier that cannot be checked automatically using the IUCLID validation assistant. So far, the CSRs have not been in the centre of attention for those manual checks. On 23 November 2020, ECHA published a list of items that will be checked during the manual CSR completeness check.
A CSR must contain an exposure assessment and risk characterisation when a substance is classified as hazardous according to CLP, or when a substance is indicated as fulfilling the PBT/vPvB criteria. Identification of one hazard category ticks the box of ‘classified as hazardous according to CLP’ and is hence sufficient to trigger an exposure and risk assessment. The scope of that exposure and risk assessment however still depends on multiple factors e.g. availability of PNECs or DNELs. For example, a substance classified as a flammable liquid for which PNECs are available, require a quantitative environmental exposure assessment and risk characterisation. Often this is ‘forgotten’. Another pitfall is not assessing the risks for humans exposed via environment while the registration tonnage is > 1000 tpa (or > 100 tpa in case the substance is classified STOT RE 1 or CMR).
Furthermore, note that unless the CSR is submitted by the Lead Registrant on behalf of the co-registrants, every co-registrant is responsible for its own CSR and can hence be subject to a manual completeness check. Ensure your CSR indeed includes a quantitative risk assessment when required, covers all uses reported in the registration dossier (full consistency is important!) and ensure that each contributing scenario contains: conditions of use, exposure estimates and risk characterisation ratios for all relevant routes or environmental compartments (water, air, soil).
More information on the manual verification by ECHA is available via this link:
Echa Europa manual completeness check PDF document
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