New CLP Hazard Classes: Key Changes and Obligations for Companies

In April 2023, the European Commission introduced three new hazard classes under the Classification, Labelling and Packaging (CLP) Regulation. These new classifications aim to better protect human health and the environment by addressing specific hazards that were not fully covered under the existing Regulation.

New Hazard Classes Defined

The new hazard classes are: 

- Endocrine Disrupting Properties: Affects hormones and can cause reproductive, developmental and neurodevelopmental problems in humans and wildlife.

- Persistent, Bioaccumulative, and Toxic (PBT) or very Persistent and very Bioaccumulative (vPvB) Properties: These substances persist in the environment, accumulate in organisms and are not easily broken down.

- Persistent, Mobile, and Toxic (PMT) or very Persistent and very Mobile (vPvM) Properties: These chemicals are highly mobile and persistent in the environment, with long-term effects that are still difficult to predict.

These hazards were introduced into the CLP Regulation because they were not adequatly covered by existing classifications. However, they are not entirely new to the Regulation. Endocrine disrupting and persistent, bioaccumulative and toxic properties have already been assessed under other regulatory frameworks, such as the Substance of Very High Concern (SVHC) process of the REACH Regulation, as well as the Biocides Products Regulation (BPR) and the legislation on plant protection products regulations. However, mobility is a relatively new considerationin European legislation.

New Obligations for Companies

With the addition of these new hazard classes, companies must assess their substances and mixtures to determine if they meet the new classification criteria. If they do, the following actions are required:

- Inform the European Chemicals Agency (ECHA): Update REACH registration dossiers with the new classification information.

- Notify Classifications: If a substance or mixture was not previously classified but now meets the new criteria, companies must notify the Classification and Labelling Inventory on the ECHA website.

- Poison Centre Notifications: Companies must also submit new poison centre notifications for mixtures that meet the criteria of the new hazard classes.

- Revise Safety Data Sheets: Safety data sheets must be updated to reflect the new classification, ensuring that accurate safety information is passed along the supply chain.

The IUCLID software was updated to include the new hazard classes on 29 April 2024. Since then, companies have been able to submit dossiers to ECHA containing information related to these new classifications.

Compliance Deadlines

To help companies adapt, the ECHA has set transition periods for the application of the new classifications as follows: 

- New substances: Compliance required by 1 May 2025. 

- Existing substances: Compliance required by 1 November 2026. 

- New mixtures: Compliance required by 1 May 2026. 

- Existing mixtures: Compliance required by 1 May 2028.

Support and Guidance

ECHA is currently updating its guidance to incorporate the new hazard classes, which is expected to be published in autumn 2024. In the meantime. companies can refer to existing guidance, such as the EFSA-ECHA guidance for endocrine disruptors and the REACH guidelines for PBT/vPvB assessments. The ECHA website also provides detailed support material, including main obligations, to help companies prepare or update their notifications.

Ongoing CLP Revisions 

An update of the CLP Regulation is also underway to further clarify classification rules and improve hazard communication. These changes will improve poison centre notifications, harmonised classification proposals, and online sales rules.