Introduction

The Classification, Labelling, and Packaging (CLP) Regulation is a critical part of the European Union’s strategy to manage chemical risks. It aligns the EU with the Globally Harmonized System (GHS) of classification and labelling of chemicals. As scientific understanding and industry practices evolve, the CLP Regulation is periodically updated to address emerging hazards. Recent amendments have introduced new hazard classes: Endocrine Disruptors (EDs), Persistent, Bioaccumulative, and Toxic (PBT) substances, Very Persistent and Very Bioaccumulative (vPvB) substances, and Persistent, Mobile, and Toxic (PMT) substances along with Very Persistent and Very Mobile (vPvM) substances. This report explores these new hazard classes, their significance, and their implications for regulation and industry.

Endocrine Disruptors

Definition and Criteria

Endocrine disruptors (EDs) are chemicals that can interfere with the endocrine (hormone) system, potentially causing adverse health effects in an organism or its progeny, as well as affecting populations or sub-populations. The criteria for identifying EDs under the CLP Regulation include:

– Evidence of an adverse effect in an intact organism or its progeny.

– Evidence of endocrine activity, primary focus on interactions with the EATS pathways: estrogenic, androgenic, thyroidal, and steroidogenic modalities.

– A plausible link between the endocrine activity and the adverse effect.

These criteria are based on a weight-of-evidence approach, considering various lines of scientific evidence (see link for OECD guidance for evaluating EDs). A resulting classification meeting the above criteria will fall under category 1 (known or presumed) or category 2 (suspected) endocrine disruptors. Differentiation between each category is currently contentious as no clear guidance currently exists to conclusively classify a substance. It is expected that final guidance will be published in Autumn 2024.

Importance and Implications

Endocrine disruptors are of significant concern because they can lead to a wide range of health issues, including reproductive disorders, developmental abnormalities, neurological problems, and immune system dysfunctions. Their effects can be subtle and manifest long after exposure, complicating risk assessment and management.

Regulatory Implications

The inclusion of EDs in the CLP Regulation means that chemicals identified as endocrine disruptors must be appropriately classified, labelled, and communicated to users. This requires updating safety data sheets and product labels to reflect the endocrine-disrupting properties of substances. Regulatory authorities must also develop new testing and assessment methods to identify EDs accurately as current test guideline rely heavily on animal testing.

Industry Implications

For industry, the classification of EDs imposes additional testing and compliance costs. Manufacturers and importers need to assess their products for endocrine-disrupting properties and may need to reformulate products or find safer alternatives.

Persistent, Bioaccumulative, and Toxic (PBT) and Very Persistent and Very Bioaccumulative (vPvB) Substances

Definition and Criteria

PBT substances are chemicals that are:

– Persistent: They do not break down easily in the environment.

– Bioaccumulative: They accumulate in living organisms.

– Toxic: They cause harmful effects to living organisms.

The table below outlines the criteria to fulfil PBT classification criteria.

vPvB substances are those that are:

– Very Persistent: They remain in the environment for extended periods.

– Very Bioaccumulative: They have a high potential to accumulate in living organisms.

The table below outlines the criteria to fulfil vPvB classification criteria.

Importance and Implications

PBT and vPvB substances pose long-term risks to the environment and human health. Because they do not degrade easily and accumulate in living organisms, they can lead to chronic exposure and adverse effects, even at low concentrations.

Regulatory Implications

Classifying substances as PBT or vPvB requires stringent regulatory controls to limit their release into the environment. This includes restrictions on their use, production, and disposal, as well as requirements for environmental monitoring and reporting.

Industry Implications

For industry, the identification of PBT and vPvB substances necessitates comprehensive testing and documentation. Companies may need to phase out or replace these substances with safer alternatives, which can involve significant research and development costs.

Persistent, Mobile, and Toxic (PMT) and Very Persistent and Very Mobile (vPvM) Substances

Definition and Criteria

PMT substances are chemicals that are:

– Persistent: They do not degrade easily in the environment.

– Mobile: They can move easily through water and soil.

– Toxic: They cause harmful effects to living organisms.

The table below outlines the criteria to fulfil PMT classification criteria.

vPvM substances are those that are:

– Very Persistent: They remain in the environment for very long periods.

– Very Mobile: They have a high potential to move through the environment.

The table below outlines the criteria to fulfil vPvM classification criteria.

Importance and Implications

PMT and vPvM substances are particularly concerning because their mobility allows them to spread widely in the environment, contaminating water sources and ecosystems far from their point of release. Their persistence ensures that they remain a threat for extended periods.

Regulatory Implications

Regulating PMT and vPvM substances requires comprehensive risk assessment and management strategies to prevent their release and mitigate their impacts. This involves restrictions on their use, enhanced environmental monitoring, and measures to reduce contamination.

Industry Implications

For the chemical industry, identifying and managing PMT and vPvM substances entails significant effort in terms of testing and compliance. Companies may need to develop new materials or processes to replace these substances and minimize their environmental footprint.

Key Deadlines

Conclusion

The introduction of new hazard classes in the CLP Regulation reflects the EU’s commitment to addressing emerging chemical risks comprehensively. By including endocrine disruptors, PBT/vPvB, and PMT/vPvM substances, the regulation enhances the protection of human health and the environment. The guidance surrounding these new hazards are currently undergoing development, but it is expected that the final guidance will be published by ECHA in Autumn 2024.

Published June 18, 2024

Text and image generated with the assistance of Artificial Intelligence