The recent amendments introduce new hazard classes to enhance the classification of substances and mixtures under the CLP Regulation. These hazard classes primarily focus on endocrine disruptors, persistent and mobile chemicals, and substances of concern for bioaccumulation.
To ensure compliance, the regulation has established specific deadlines:
For Substances:
- By 1 May 2025: Substances placed on the market for the first time must be classified and labeled according to the new hazard classes.
- By 1 November 2026: Substances already on the market before 1 May 2025 must be reclassified and relabeled to align with the new hazard classes.
For Mixtures:
- By 1 May 2026: Mixtures introduced to the market for the first time must comply with the new classification and labeling requirements.
- By 1 May 2028: Mixtures already on the market before 1 May 2026 must be updated to meet the new hazard classification and labeling standards.
Endocrine Disruptors (ED) – Human Health and Environment
Category 1 – Confirmed Endocrine Disruptors
- A substance is classified in Category 1 if it is demonstrated to have an adverse effect related to endocrine disruption through strong and consistent evidence from human or animal studies.
- The effect must be biologically plausible and not due to secondary mechanisms unrelated to endocrine activity.
Category 2 – Suspected Endocrine Disruptors
- A substance is classified in Category 2 if limited evidence suggests potential endocrine-disrupting properties but does not meet the full criteria of Category 1.
- In vitro data, mechanistic evidence, or epidemiological correlations may support classification in this category.
2. Persistent, Bioaccumulative, and Toxic (PBT) / Very Persistent and Very Bioaccumulative (vPvB)
PBT Classification Criteria
A substance is classified as PBT if it meets all three of the following criteria:
- Persistence (P): Half-life in water, soil, or sediment exceeds regulatory thresholds.
- Bioaccumulation (B): Bioconcentration factor (BCF) ≥ 2000 in aquatic organisms.
- Toxicity (T): The substance is hazardous to aquatic life (e.g., acute aquatic toxicity, chronic effects, or endocrine disruption).
A substance is classified as PBT if it meets all three criteria:
| Criterion | Threshold Value |
| Persistence (P) | Half-life in freshwater > 40 days, seawater > 60 days |
| Bioaccumulation (B) | Bioconcentration Factor (BCF) ≥ 2000 |
| Toxicity (T) | Long-term NOEC (No Observed Effect Concentration) for aquatic species < 0.01 mg/L |
vPvB Classification Criteria
A substance is classified as vPvB if it meets both of the following criteria:
- Very Persistent (vP): Higher threshold than PBT for half-life in environmental media.
- Very Bioaccumulative (vB): Bioconcentration factor (BCF) ≥ 5000.
A substance is classified as vPvB if it meets both criteria:
| Criterion | Threshold Value |
| Very Persistent (vP) | Half-life in freshwater > 60 days, seawater > 120 days |
| Very Bioaccumulative (vB) | Bioconcentration Factor (BCF) ≥ 5000 |
3. Persistent, Mobile, and Toxic (PMT) / Very Persistent and Very Mobile (vPvM)
PMT Classification Criteria
A substance is classified as PMT if it meets all three of the following criteria:
- Persistence (P): Similar to PBT criteria, based on environmental degradation data.
- Mobility (M): High water solubility and low sorption potential, indicating potential for groundwater contamination.
- Toxicity (T): Demonstrates harmful effects on aquatic organisms or potential endocrine disruption.
A substance is classified as PMT if it meets all three criteria:
| Criterion | Threshold Value |
| Persistence (P) | Half-life in freshwater > 40 days, seawater > 60 days |
| Mobility (M) | Log Koc ≤ 4.0 (low sorption potential, high water solubility) |
| Toxicity (T) | Long-term NOEC for aquatic species < 0.01 mg/L |
vPvM Classification Criteria
A substance is classified as vPvM if it meets both of the following criteria:
- Very Persistent (vP): High environmental persistence, exceeding PMT thresholds.
- Very Mobile (vM): Extremely high water solubility, with a very low adsorption coefficient (log Koc < 1.0), indicating rapid movement through water systems.
- A substance is classified as vPvM if it meets both criteria:
| Criterion | Threshold Value |
| Very Persistent (vP) | Half-life in freshwater > 60 days, seawater > 120 days |
| Very Mobile (vM) | Log Koc ≤ 2.0 (very high mobility in water) |
4. Regulatory Implications
- Labeling and Safety Data Sheets (SDS) must reflect the new classifications.
- Restrictions and authorizations under REACH may apply to substances classified under these hazard classes.
- Testing strategies for endocrine disruptors now incorporate mechanistic and in vitro approaches, reducing reliance on animal testing.
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