The European Chemicals Agency (ECHA) has issued an updated series of guidelines for the Classification, Labelling, and Packaging (CLP) Regulation (EC) No 1272/2008. This revision includes new hazard criteria, specifically addressing endocrine disruptors, persistent and bioaccumulative chemicals, and substances with enhanced environmental mobility. The guidance, developed in partnership with the European Food Safety Authority (EFSA) for endocrine disruptors, assists manufacturers, importers, and downstream users in meeting regulatory requirements to ensure chemical safety for human health and the environment.
Key Updates to CLP Hazard Criteria
The updated guidance document, published in November 2024, expands on hazard classification criteria under the CLP Regulation. The revised criteria include:
- Endocrine Disruptors (EDs): New classification criteria have been introduced for endocrine-disrupting substances, covering potential impacts on human health and the environment. This addition was developed in collaboration with EFSA and integrates methodologies that evaluate hormonal interference and population-level effects in ecosystems.
- Persistent, Bioaccumulative, and Toxic (PBT) and Very Persistent and Very Bioaccumulative (vPvB) Substances: These substances are classified based on their resistance to degradation and their tendency to accumulate in living organisms, leading to long-term environmental and health risks.
- Persistent, Mobile, and Toxic (PMT) and Very Persistent and Very Mobile (vPvM) Substances: Addressing substances that are both difficult to break down and likely to spread across ecosystems, the new guidance includes specific criteria to assess toxicity, persistence, and environmental mobility.
Document Structure and Accessibility
To improve usability, the CLP guidance is now divided into five separate parts, covering general principles, physical hazards, health hazards, and environmental and additional hazards. Each section offers practical examples, decision-making flowcharts, and classification scenarios for both substances and mixtures. The parts are designed to help stakeholders quickly identify relevant criteria, enhancing compliance with the EU’s CLP requirements.
Highlights by Section
- Part 1: General Principles for Classification and Labelling – This section provides foundational guidance, focusing on classification methodology, data evaluation, and the responsibilities of manufacturers and suppliers in ensuring compliance.
- Part 2: Physical Hazards – This part details classification standards for physical hazards, including updates on explosives, flammable gases, and pyrophoric materials. The document highlights new testing protocols and safety measures.
- Part 3: Health Hazards – Revised criteria in Part 3 cover acute toxicity, skin sensitisation, respiratory hazards, and more. This section also provides specific concentration limits (SCLs) for categorising reproductive toxicity hazards.
- Parts 4 and 5: Environmental and Additional Hazards – Environmental classification for aquatic toxicity, degradation, bioaccumulation, and the ozone layer have been reorganised. A major focus is given to the introduction of endocrine disruptors and PBT/vPvB classifications, which include decision trees for regulatory compliance.
Implications for Industry and Compliance
With the introduction of these new classifications, companies handling chemicals within the EU are urged to consult this latest guidance thoroughly to update safety data sheets (SDS), labels, and other hazard communication materials. Non-compliance may lead to regulatory actions, including recalls and sanctions. ECHA recommends that companies review the updated guidance before the regulation’s application deadlines to ensure full alignment with the revised standards.
