REGULATORY NEWS
Manual Completeness Check of CSRs by ECHA
Date: 15 December 2020
ECHA announced to extend the Manual Completeness Check to chemical safety reports. The technical completeness of the dossier can be checked by registrants using the validation assistant available in IUCLID. In addition, however, there are further issues not covered by the validation assistant but checked manually by ECHA. The manual verification will contain the following items:
- In case a substance is classified as hazardous or includes PBT properties an exposure assessment and risk characterisation must be included in the CSR
- Exposure scenarios (ES) in the CSR must correspond to all uses reported in the IUCLID dossier
- ES must contain contributing scenarios that correspond to contributing activities reported in the use description (described by the assigned process categories and environmental release categories)
- Required elements of the contributing scenarios are conditions of use, exposure estimates for all relevant routes /compartments and RCRs
If one of the above points is not included in the CSR, a relevant justification needs to be provided. If a relevant justification is not found, the CSR will be regarded as incomplete. As per Article 20(2), quality or adequacy of justifications will not be checked by ECHA.
Further information is available on the ECHA homepage. Although the completeness check of the CSRs has been postponed by ECHA for an indefinite period, it is strongly recommended to thoroughly check the IUCLID dossier for technical completeness by the validation assistant as well as the IUCLID dossier and CSR for compliance before submission to ECHA.
