Are you ready for ECHA’s inspections on CSRs?
Are you ready for ECHA’s inspections on CSRs?
mercredi 10 février 2021
Initially expected in April 2020, the inspections of ECHA on the completeness of the chemical safety report has been postponed due to the Covid-19 pandemic. First postponed to 2 November 2020, the date was finally set to the 1st of March 2021.
These inspections will be done on parts of the registration dossier that cannot be checked automatically. The verifications are quantitave, to check that the required information is present, and not qualitative.
Are you concerned by these inspections?
You are concerned if:
- You registered a substance at more than 10 tonnes / year,
- The registered substance is classified as hazardous or fulfils the PBT criteria or vPvB criteria.
Caution: If the attached Chemical Safety Report (CSR) cannot be opened or is not written in an EU language, it will be considered incomplete.
ECHA staff will check the following items:
- The CSR contains an exposure assessment and risk characterisation,
- Each use has a corresponding exposure scenario,
- Each contributing activity has a corresponding contributing scenario,
- Each contributing scenario contains the following information:
□ Conditions of use describe the operational conditions and the risk management measures,
□ Exposure estimates for all relevant routes/compartment,
□ RCR for all routes of exposure (individually) (If derived DNEL/PNEC),
□ RCR for combined routes (If derived DNEL/PNEC),
□ Environmental contributing scenarios contains local releases for water, air and soil.
- The part «Humans exposed via environment» has been assessed in the following case:
□ Tonnage band > 1000 T/year or
□ Tonnage band > 100 T/year and the substance is classified:
▪ STOT RE 1, and/or
▪ Carcinogenic, Mutagenic (any categories) and/or
▪ Reprotoxic Cat.1A or 1B.
Caution: missing information must always be justified. If not, the CSR will be considered incomplete (no checks on the quality or adequacy of the given justification).
For even more information, you can find on ECHA a document about these inspections Information on manual verification at completeness check – 23 November 2020 as well as a webinar Revised completeness check: what changes and how you can prepare – 29 January 2020