EU REACH Revision: Proposed Changes to Chemical Information

The European Commission’s latest draft proposal on the revision of REACH outlines modification of REACH information requirements (Annexes I, VI, VII – X and XI), subject to further detailed discussion among the authorities’ expert groups.

Table of Contents

Overview:

In its current version, REACH specifies data requirement based on quantity with increasing information requirements based on increased quantity placed on the market.

The Commission is proposing to require more information, including testing data, to register substances across all tonnage bands and those considered most hazardous. This means enforcing stricter data requirements for low tonnage Annex VII substances as well as for the most harmful substances with the focus on issues of endocrine disruptors, chemicals with widespread uses and significant environmental persistence (e.g. PFAS).

The details of this proposal are described below:

Substance notified under previous legislation would need to meet the full requirement for REACH legislation with updates based on substance volume.

Deletion of Annex III & XIII and updating Annexes I, VI-X & XI, meaning that physiochemical-only dossier will need be upgraded to a full Annex VII dossier.

Extended information requirement under Annex VII including in vitro testing for identification of endocrine disruptors which could also trigger testing proposal for higher tier studies.

Mandatory dossier updates for chemicals identified as substance of very high concern (SVHC) or received harmonized classification.

Reduction in animal testing: testing proposal is required for all in vivo testing regardless of the tonnage band.

Polymers manufactured or imported > 1 t/y will now require notification and registration of polymer within the criteria for ‘Polymers requiring registration (PRR).

Chemical safety assessment will include evaluation of persistence, mobile and toxic (PMT), very persistence, very mobile (vPvM) and endocrine disruptors.

Risk thresholds such as derived no / minimal effect levels (DNELs & DMEL) would be considered more systemically, taking into account methods for combined exposure such as the mixture allocation factor (MAF) for substance produced >1000 t/y.

Conclusion:

The ongoing REACH revision represents a paradigm shift in the legislation that will affect how companies manage both the existing and future registrations. The information requirements have increased significantly, and chemical risk assessments have expanded. It is important that companies are up to date with regards to these proposed changes and be prepared to make the necessary changes.