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HomeResourcesEU REACHEU REACH Revision: Evaluation and Compliance

EU REACH Revision: Evaluation and Compliance

3 min read

Evaluation and improved dossier compliance have been a focus for the authorities especially since the last REACH registration deadline seven years ago. The revision of REACH puts forward several proposals streamline dossier and substance evaluations (Title VI of REACH) and strengthen the impact of compliance checks. 

Process for Revoking Registration Numbers:

The most prominent proposed change is introducing the process of revoking registration numbers in cases of persistent non-compliance with evaluation decisions, both under dossier and substance evaluations. Such process, if introduced, would need to be transparent and offer procedural guarantees.

Increase Efficiency and Impact of Compliance Checks:

The European Commission is also proposing measures to increase efficiency and impact of compliance checks by: 

  • Clarifying the process to increase predictability, particularly concerning available information not currently in the dossier  
  • Clarifying ECHA’s powers to address non-compliance in its decisions, such as options to request specific adaptations or instruct specific derivation of DNEL/PNAL based on the data in the dossier 
  • Considering ways to address self-classification issues in evaluation decisions 

Substance Evaluation:

The proposal looks at ways of simplifying, increasing efficiency and strengthening the impact of substance evaluation, including the following actions: 

  • Consider options to explicitly refer to potential hazard (alongside potential risk) for justifying substance evaluation and potentially requesting additional data to clarify it 
  • Clarify that justification to select substance for substance evaluation can be based on structurally similar substances, constituents, degradation products or groups of substances 
  • Include ECHA as an evaluating authority, on request of the Commission 
  • Replace the formally adopted annual Community Rolling Action Plan for evaluations with a registry maintained between authorities (part of ‘One Substance One Assessment’ initiative and ECHA’s Public Activities Coordination Tool, PACT). 

The Commission also suggested expanding the Generic Risk Management (GRA) approach and shared plans for digitalisation, supply chain communication simplification and enforcement.

Evaluation Decision-Making:

Finally, the proposal aims to add clarity and increase efficiency in evaluation decision-making by:  

  • Clarifying the process and expectation in specific situations (e.g. cease manufacture during decision making) and optimising the workflow timelines to facilitate efficient organisation  
  • Allowing simplified scrutiny of test proposal (TP) draft decisions for subsets of data requirements where TP is needed  
  • Formalise the process for enabling prolonged evaluation decision deadlines to take account justified circumstances 
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Published May 27, 2025 

This article was generated with the assistance of Artificial Intelligence.