The latest draft REACH Revision proposal, circulated last month, touches on all aspects of the REACH Regulation – we will review them in a series of posts, starting from the proposed changes to Registration followed by Data Requirements, Evaluation, Risk Management, Hazard Communication and Enforcement in the coming days – please follow our channels to stay tuned.
The key proposed changes to Registration (Title II of REACH) include:
- Setting a 10-year validity period for the REACH Registrations (currently, no ‘expiration date’)
- European Chemical Agency’s ability to carry out ad-hoc completeness checks (currently, done only upon dossier submission)
- Implement full tonnage-based information requirements for substances notified under the previous regulation (currently, lighter data requirements for 1-10 tpa legacy registrations)
- Introduce notification and registration provisions for polymers (currently exempted, only the monomers are subject to registration)
Provisions on the option and mechanisms for revoking REACH Registrations has, perhaps, caused the most news waves. The Draft proposal outlines the following mechanisms and triggers for revocation:
- Expiry of the proposed 10-year validity period
- Negative decision following (proposed) ad-hoc completeness check
- Failure to update a previous simplified registration with full dataset by the deadline
- Failure to update a dossier following evaluation decision
The proposal would introduce mandatory dossier updates:
- If a substance is identified as substance of very high concern (SVHC)
- For legacy dossiers with only physicochemical data to meet full Annex VII requirements
- Updates concerning data requirements are reviewed in the following post.
Introducing notification and registration requirements for polymers has been long contemplated by the authorities and is part of the latest REACH Review proposal. The proposal aims to:
- Introduce notification of all polymers exceeding 1 tonne per year production/import volume
- Map polymer universe and identify Polymers requiring registration (PRR) based on the hazard criteria
- Define PRR grouping criteria and introduce registration requirement. Hazards and risk assessment data for certain polymers will be required in the joint submission for groups of polymers
Within the registration context, the European Commission is proposing measures to encourage data sharing and minimize animal testing (Title III of REACH), in particular:
- Allow potential registrants to obtain access to studies also on structurally similar substances during the 12 years data exclusivity period
- Allow the use of robust study summaries and study summaries for adaptations by registrants of other substances after the 12 years data exclusivity period ends
A final legislative proposal expected by the end of this year, following consultations and adoption procedures.
Published May 20, 2025
This article was generated with the assistance of Artificial Intelligence.