Overview
The European Parliament and the Council have adopted Directive (EU) 2025/2456, formally amending Directive 2011/65/EU (RoHS)—the EU framework restricting hazardous substances in electrical and electronic equipment.
Adopted on 26 November 2025, the Directive strengthens EU chemical safety governance by transferring and expanding scientific and technical responsibilities from the European Commission to the European Chemicals Agency (ECHA). The reform aims to improve the quality, consistency, and efficiency of scientific assessments under EU chemicals legislation.
Importance:
The Directive supports the EU’s “One Substance – One Assessment” strategy by streamlining how substances are evaluated across regulatory frameworks. By leveraging ECHA’s scientific expertise, the reform delivers:
- Greater harmonisation of chemical safety assessments across EU legislation
- Reduced duplication of work between EU institutions and Member States
- Stronger scientific rigour and transparency in regulatory decisions
- Improved coherence for substance restrictions and RoHS exemptions
Changes Highlight
1. Expanded Role for ECHA
The Directive formally assigns ECHA responsibility for key scientific and technical evaluations, including:
- Assessment of RoHS exemption applications
- Scientific reviews supporting updates to restricted substance lists
ECHA’s scientific committees—such as those for Risk Assessment and Socio-Economic Analysis—will play a central role in these evaluations.
2. Enhanced RoHS Exemption Procedure
The updated exemption process introduces clearer and more transparent steps:
- Applications must be submitted directly to ECHA
- Acknowledgement of receipt within 15 days
- Publication of non-confidential summaries
- Structured stakeholder consultation
- Scientific committee opinions prior to Commission decisions
3. Structured Reviews of Restricted Substances
The Directive establishes a periodic review cycle, requiring substances restricted under RoHS to be reviewed at least every four years.
ECHA will prepare restriction dossiers when requested by the European Commission or EU Member States.
4. Greater Transparency and Public Engagement
- Non-confidential assessment documents will be made publicly available on ECHA’s website
- Stakeholders will be able to participate in open consultations on exemption applications
Expected Impact
a. For Regulators and Authorities
- More efficient allocation of scientific resources
- Stronger alignment with REACH and the wider EU chemicals framework
- More consistent and evidence-based outcomes
b. For Industry
- Clearer and more predictable exemption procedures
- Improved transparency on timelines and stakeholder involvement
- Reduced regulatory uncertainty through harmonised assessments
c. For Public Health and the Environment
- Stronger protection of human health and ecosystems
- Improved access to regulatory decision-making information
Next Steps
- Implementation Period: A 20-month transition phase will allow Member States and stakeholders to adapt to the new procedures
- Guidance Development: ECHA and the European Commission will publish harmonised application formats and guidance documents to support implementation
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