The European Chemicals Agency (ECHA) implemented new checks on Chemical Safety Reports (CSR) submitted via European Union (EU) Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) registration dossiers since March 1, 2021, so that it can “better fulfil” its obligation to ensure that registrations meet the information requirements.
ECHA’s CSR manual completeness check includes the following elements:
- The CSR must contain an exposure assessment and risk characterization if the substance is (self)classified as hazardous or indicated as fulfilling the persistent, bioaccumulative, and toxic (PBT) or very persistent and very bioaccumulative (vPvB) criteria;
- Each use reported in IUCLID Section 3.5 must have a corresponding exposure scenario in the CSR. As a general rule, there should be one exposure scenario per use. Deviations from this 1:1 principle should be limited to absolute exceptions and relevant reasoning must be provided;
- Each exposure scenario must contain the contributing scenarios that cover each contributing activity reported for that use in IUCLID Section 3.5., where:
- The worker contributing activities are normally labeled by at least one process category (PROC) and associated with at least one environmental contributing activity labeled by an environmental release category (ERC);
- The consumer contributing activities are normally labeled by product categories (PC) or article categories (AC). These are associated with at least one environmental contributing activity, labeled by an ERC. Again, the general rule is that each contributing activity should be covered by one contributing scenario. Also here, the deviation from this 1:1 principle should be an exception and well justified in the CSR; and
- If any of the required information is missing in the CSR, a substantiated justification must be provided within the relevant exposure scenario (at the place where the information is missing) or in the relevant subsection of Chapter 9.0 of the CSR, if the waiver systematically applies to many (all) exposure scenarios.