New Endocrine, PBT/vPvB, and PMT/vPvM endpoints

In October 2020, new hazard classes for the European Union (EU) Classification Labelling and Packaging Regulation (CLP) were proposed by the EU commission in the Chemical Sustainability Strategy. On 31 March 2023, Commission Delegated Regulation (EU) 2023/707 formally implemented the new hazard classes for (i) endocrine disruptors; (ii) persistent, bioaccumulative, and toxic/very persistent and very bioaccumulative (PBT/vPvB) substances; and (iii) persistent, mobile, and toxic/very persistent and very mobile (PMT/vPvM) substances. The regulation includes new label elements, appropriate EUH phrases, and classification limits for mixtures.

Endocrine Disruptors

Substances and mixtures with endocrine-disrupting properties pose a concern to public health and the environment, and are separated by effects on human health and effects on the environment in the Regulation. The Regulation further subdivides the two groups into two categories: Category 1 for known or presumed endocrine disruptors, and Category 2 for suspected endocrine disruptors, with generic concentration limits of ≥0.1% and ≥1%, respectively, triggering classification of a mixture.

PBT/vPvB

Substances and mixtures with PBT or vPvB properties represent a very high concern, as they do not easily break down in the environment and tend to accumulate in living organisms. A PBT or vPvB classification takes into account degradation rates, bioaccumulation/bioconcentration factors, and the human and/or marine or freshwater organism toxicity of a given substance or mixture. Both classifications are triggered by the generic concentration limit of ≥0.1%.

PMT/vPvM

PMT and vPvM substances pose concerns. Their high persistence combined with their high mobility (the latter resulting from their low adsorption potential) can cause them to enter the water cycle, including drinking water, and spread over long distances. The persistence and toxicity criteria for PMT and vPvM substances are the same as those for PBT and vPvB substances. Mobility is assessed by the Log Koc value, and as with the PBT and vPvB classifications, both PMT and vPvM classifications are triggered by the generic concentration limit of ≥0.1%.

Application Dates

The following application dates are in place for the new classification and labelling requirements:

• Substances placed on the market prior to 01 May 2025: effective as of 01 November 2026
• Substances placed on the market after 01 May 2025: effective as of 01 May 2025
• Mixtures placed on the market prior to 01 May 2026: effective as of 01 May 2028
• Mixtures placed on the market after 01 May 2026: effective as of 01 May 2026

Next Steps

In light of these new hazard class endpoints, amendments to both the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) and Biocidal Products regulations are anticipated. While these new categories have not been adopted into the United Nations’ Globally Harmonized System of Classification and Labelling of Chemicals (GHS), they have been brought up for consideration in the 2023 to 2024 biennium by the EU.

These new hazard classes were added to the EU CLP with unusual speed. Previously, changes of this magnitude were required to go through the standard legislative procedure before being published as a Commission Regulation. In this instance, a less rigorous approach was applied to quicken the process, and the changes were published as a delegated act.

The expediting of these significant legislative changes has created a precedent that may be repeated for other EU chemical legislations, such as REACH. 

Companies should proactively monitor EU chemical legislation consultation periods to ensure they stay abreast of potential changes that impact their business and have their voice heard by regulators. Companies should also review their chemical portfolio to determine if these new hazard classes apply to their product lines, and ensure they take appropriate actions prior to the deadlines.

Do you have questions about the new CLP hazard classes and how they impact your business? Do you require services related to chemical classification and/or labeling? Contact Global Standards —we’re here to help!