Get ready for the new REACH information requirements

Get ready for the new REACH information requirements

The ECHA has announced upcoming changes to certain REACH information requirements that will start applying from 14 October, 2022

The update of the REACH annexes, published in the Commission Regulation (EU) 2022/477 of 24 Mars, 2022, aims to overcome two needs detected by the Reach Evaluation Joint Action Plan back in 2019:

  • 1. To provide more clarity on the obligations of registrants regarding the submission of information in their registration dossiers.
  • 2. To make ECHA´s evaluation practices more transparent and predictable.

According to the information published by the ECHA, the main changes concern:

  • a) Requirements and specific rules for adaptation of:
  • •In vitro and in vivo mutagenicity studies specifying when further studies are needed.
  • •Reproductive toxicity studies specifying the preferred animal species and administration routes.
  • •Aquatic toxicity studies, clarifying when long-term studies must be performed instead of short-term studies.
  • •Toxicity studies on terrestrial and sediment organisms.
  • •Degradation and bioaccumulation studies, specifying when further testing is needed.

  • b) The obligation for only representatives to provide more details on the non-EU manufacturer they represent.

  • c) Substance identification information including:
  • •Requirement to describe the compositions, nanoform or set of similar nanoforms.
  • •New requirements for reporting a crystal structure and for reporting compositions for substances with unknown or variable composition, complex reaction products or of biological materials (UVCBs).
  • •Clarified requirements for reporting constituents, impurities, and additives as well as for analytical information.

To help registrants to understand the upcoming changes, the ECHA is already working on some guidance materials which are expected to be published during the second half of 2022.

However, companies affected by the new regulations are advised to get familiar with the updated annexes.

For our part, we will remain attentive to any additional information that is added to these new ECHA dossiers and that is necessary to show in the SDS, updating our Software, CHEMETER, accordingly.