March 28, 2023 by Lucy Kennelly


plan-1725510_1280

The European Commission has revised some of the information requirements for registering chemicals under REACH. New rules have been implemented under this revision which change the automatic and manual completeness checks performed by ECHA on chemical registration dossiers.

The changes were explained in an ECHA webinar held on 8th February. The updates will come into force in May 2023, after the next IUCLID update.

The main changes include:

  • New rules for boundary compositions in IUCLID section 1.2 including for the state/form field, consistency of compositional information, molecular and structural information, and additives. These rules apply to lead registrant dossiers only.
  • Revisions of Annex VII-XI information requirements including updated phrases for data waiving justifications, renaming of some information requirements, sequential information requirements for mutagenicity, and justification requirements for weight of evidence approaches. These rules apply to all registration dossiers.
  • Outcome of chemical safety assessment is no longer a valid data waiving justification for long term aquatic toxicity and degradation. This rule applies to all registration dossiers.
  • The field ‘Product category used’ will become mandatory for uses 3.5.3 “Uses at industrial sites” and 3.5.4 “Widespread uses by professional workers, and article service life required for Environmental Release Categories 8c “Widespread use leading to inclusion into/onto article (indoor)”, 8f “Widespread use leading to inclusion into/onto article (outdoor)” and 5 “Use at industrial site leading to inclusion into/onto article”. These rules apply to all registration dossiers.

The amended completeness checks will apply to dossiers submitted from May 2023.

If you need any help to comply with these changes or with general dossier submission under REACH, please contact us and we can discuss how to meet your needs.