An amendment to Regulation (EC) No. 1272/2008 has ushered in new substance hazard classes. These classes specifically target endocrine disruptors (EDs) and substances categorized as persistent, bioaccumulative, toxic (PBT); very persistent, very bioaccumulative (vPvB); persistent, mobile, toxic (PMT); and very persistent, very mobile (vPvM).

Pillar of the EU Chemicals Strategy for Sustainability

This amendment to the CLP Regulation represents a pivotal aspect of the EU Chemicals Strategy for Sustainability (CSS), aligning closely with the ambitious goals of the Green Deal.

Understanding the New Hazard Classes

The newly introduced hazard classes encompass a range of criteria aimed at better categorizing substances

Endocrine Disruption for Human Health and Environment

Categories 1 and 2 for endocrine disruption in both human health and the environment.

PBT/vPvB (Persistent, Bioaccumulative, Toxic/Very Persistent, Very Bioaccumulative):

These substances are defined by their poor degradation in the environment, accumulation in organisms, and toxicity to humans or the environment.

PMT/vPvM (Persistent, Mobile, Toxic/Very Persistent, Very Mobile):

These substances are characterized by their resistance to environmental degradation, mobility in water cycles, and toxicity.

Classifying Endocrine Disruptors (EDs)

The impact of endocrine disruptors on the natural hormone systems of humans and animals can have significant adverse effects on health and development.

Classification into the two categories within the endocrine hazard classes follows a process akin to carcinogenic and mutagenic substances:

- Category 1: Known or presumed endocrine disruptors with demonstrated evidence of endocrine activity and adverse effects.
- Category 2: Suspected endocrine disruptors for human health, classified when there is reasonable doubt about effects or evidence.

Data Requirements and REACH Regulation

The classification and labeling of substances rely heavily on understanding their intrinsic properties. The REACH Regulation (EC) No. 1907/2006 has played a crucial role in improving data availability for substances. For PBT and PMT hazard classes, substantial data is already accessible, as these properties are typically part of a REACH assessment.

Challenges with Endocrine Disruption Categories

However, data availability for categories related to endocrine disruption for human health and the environment is comparatively limited. Establishing these classifications relies on established scientific criteria (WHO/IPCS), which may require additional toxicological tests and alternative methods under upcoming amendments to REACH.

Transition Periods and Compliance

Delegated Regulation (EU) 2023/707, effective since April 20, 2023, sets deadlines for compliance:

- Substances placed on the market for the first time must be classified and labeled by May 1, 2025.
- Transition periods for mixtures extend until May 1, 2026.
- Deadlines for substances and mixtures already on the market are November 1, 2026, and May 1, 2028, respectively.

Towards a Safer Chemical Environment

The implementation of these new hazard classes signifies a concerted effort by the EU to strengthen regulations, protect human health, and preserve the environment. As the chemical landscape evolves, compliance with these classifications will be essential for companies placing substances and mixtures on the market within the EU.


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