The European Chemicals Agency (ECHA) has outlined key timelines for integrating hazard identifications from other EU regulations into the revised Classification, Labelling, and Packaging (CLP) Regulation. The process ensures a harmonized approach to chemical safety by aligning classifications across different regulatory frameworks while avoiding duplication of work by using existing hazard assessments from other legislation.
Integration of Hazard Classifications into CLP
The revised CLP Regulation introduces a mechanism to integrate hazard identifications from the REACH Regulation, Plant Protection Products Regulation (PPPR), and Biocidal Products Regulation (BPR) directly into Annex VI to CLP, as defined in CLP Article 37(7). If a substance has already been identified under these regulations as having endocrine-disrupting (ED) and/or PBT (persistent, bioaccumulative, toxic) / vPvB (very persistent, very bioaccumulative) properties, it can be directly included in Annex VI without requiring a separate assessment.
Types of Substances and Their Regulatory Pathways
The regulatory timelines set by ECHA apply to two broad categories of substances:
Substances with decisions adopted by 11 June 2025: These substances have already been assessed and determined to have hazardous properties under REACH, PPPR, or BPR.
Substances with assessments ongoing but no decision adopted yet: These substances are still undergoing evaluation, and their classification will be finalized as regulatory decisions are made.
Timeline for Substances with Decisions Adopted by 11 June 2025 These substances have already undergone assessment by the European Food Safety Authority (EFSA) or ECHA and have been identified by ECHA as substances of very high concern (SVHCs) or classified by the European Commission under the BPR or the PPPR as having hazardous properties.
By 11 June 2025:
The substance has been included in the REACH Candidate List, or
A decision on approval or renewal has been adopted under the PPPR or the BPR.
By 11 June 2026:
The substance will be included in Annex VI of the CLP Regulation.
Timeline for SVHC Substances with Ongoing Assessments
By 11 June 2025:
An Annex XV dossier must be submitted to ECHA for the substance.
By 11 June 2026:
The substance will be included in the REACH Candidate List for one or more SVHC properties.
Timeline for Substances under PPPR with Ongoing Assessments
An application for approval or renewal must be submitted to EFSA.
By 11 June 2032:
A decision on approval or renewal concluding that the substance has one or more hazardous properties is adopted under PPPR.
Timeline for Substances under BPR with Ongoing Assessments
By 1 September 2013:
An application was submitted under the Biocidal Products Directive (before BPR) and evaluated, but no decision was adopted.
By 11 June 2025:
A draft assessment report for approval or renewal is submitted to ECHA.
ECHA submits an opinion to the Commission concluding that the substance meets endocrine-disrupting (ED) and/or PBT/vPvB criteria.
By 11 June 2030:
A decision on approval or renewal concluding that the substance has hazardous properties is adopted under BPR.
These deadlines are crucial for industry stakeholders to track regulatory changes and ensure compliance with the updated classification framework. Companies handling affected substances should take proactive steps to align with ECHA’s evolving regulatory landscape.