In 2023, Delegated Regulation 2023/707 was published, amending CLP Regulation (EC) No 1272/2008, setting out new hazard classes and criteria for the classification, labelling and packaging of substances and mixtures.

The New Hazard Classes

• ED HH in Category 1 and Category 2 (Endocrine disruption for human health)
• ED ENV in Category 1 and Category 2 (Endocrine disruption for the environment)
• PBT (persistent, bioaccumulative, toxic), vPvB (very persistent, very bioaccumulative)
• PMT (persistent, mobile, toxic), vPvM (very persistent, very mobile)

Whilst these rules have been in force since April 2023, for substances placed on the market before 1st May 2025, implementation of these new hazard classes is not mandatory until 2026. Whereas any substances placed on the market after 1st May 2025 must be classified and labelled in accordance with the new hazard classes, as applicable.

ECHA has clarified on their website that this distinction applies not only to substances new to the market as of 1st May 2025, but also any new quantities/production batches placed on the market after that date.

Blue Frog Scientific note though that this clarification was only added to the ECHA website relatively recently, in Autumn 2024, giving industry little time to conduct the relevant classification assessments.

ECHA’s interpretation is also not explicit in the legislation (Commission Delegated Regulation (EU) 2023/707, Section 3.11.2.4.) which states, “…substances which were placed on the market before 1st May 2025 are not required to be classified in accordance with criteria laid down in Sections 3.11.2.1 to 3.11.2.3 until 1 November 2026.”

CLP Updates Trigger REACH Registration Dossier Updates

An update to classification and labelling, in turn, triggers an update to REACH registration dossiers. In accordance with the Commission Implementing Regulation (EU) 2020/1435 (Article 6 Point 2), these updates should be submitted within 6 months from the date when the decision to change the classification and labelling of the substance had been taken.

The “date when the decision (was taken)” could in itself be open to some interpretation – but if the decision to change the classification was taken e.g. on the 1st May 2025, then certainly an update to the REACH registration dossier would be due by 10 November 2025.

No New Data Required for Health or Environmental Hazards Under CLP

It is worth noting that the CLP Regulation does not trigger a need to generate any new data for the purpose of health or environmental hazards.

For these hazards, the classification is based on relevant available information. For P, B, M and T, depending on the tonnage band the substance is registered under, the REACH endpoints feeding into these hazard classes may already be filled, allowing a conclusion to be reached.

Where data-gaps or inconclusive results do not permit a conclusion on PBT or PMT, further testing must be conducted or proposed, as a valid conclusion for these hazard classes is mandatory for all substances registered at >10 tonnes per year.

Tiered Approach to Endocrine Disruption

For endocrine disruption, the assessment follows a tiered approach and is based on a weight-of-evidence focusing on endocrine activity and associated adverse effects.

There are currently no mandatory data requirements for endocrine disruption under REACH but compliance with the new CLP hazard classes requires an assessment to be made based on existing data in accordance with ECHA/EFSA Guidance for the identification of endocrine disruptors (2018).

Where data-gaps do not permit robust conclusions on endocrine disruption to be drawn, targeted testing can be conducted or proposed in a technical dossier depending on the nature of the studies needed to reach a conclusion.

Now is the Time to Review Your Portfolio

Blue Frog Scientific advise that companies who have not yet assessed their substances in relation to the new hazard classes but intend to place new quantities of substances on the market following 1st May 2025 review their portfolio. Particularly where there is suspicion that the substance may meet one of the criteria for the new hazard classes, conducting a full assessment as soon as possible in order to meet the C&L requirements is strongly recommended.

Blue Frog Scientific can support companies to assess and classify their substances under these new hazard classes, and with the related REACH dossier updates. If you have any queries relating to REACH Regulatory Compliance, call today and speak with one of our expert REACH consultants.