Great Britain: Updates on mandatory classification and labelling of 46 hazardous chemical substances under CLP.

 

Great Britain has published a new ministerial decision regarding the mandatory classification and labelling of 46 hazardous chemical substances under the Regulation (EC) No. 1272/2008 (the GB CLP Regulation).

The Ministerial decision, made with consent of the Devolved Governments (Scottish and Welsh Government Ministers), was adopted on 15 January 2025, published on 15 February 2025, and enters into force on 15 February 2025 (voluntary), 15 August 2026 (mandatory). The classification (Article 15 of the GB CLP Regulation) and labelling (Article 30 of the GB CLP Regulation) of the new/revised GB MCLs for the 46 substances should be reviewed and updated by duty holders without undue delay. Compliance with the amended 46 GB MCLs must be completed by 14 August 2026.

Updating the GB MCL List follows a process similar to that of the EU’s harmonized classification and labelling system, though key differences exist. The list can be updated by either revising an existing classification or introducing a new classification for a substance.

Stages of Introducing or Revising a GB MCL

The process of establishing a new or updated GB MCL includes the following steps:

• GB MCL Proposal
• Public Consultation
• GB MCL Technical Report
• GB MCL Impact and Policy Assessment
• GB MCL Agency Opinion
• GB MCL Recommendation and Decision
• Amendment of the GB MCL List

The GB MCL Proposal

A GB MCL Proposal is submitted under the following conditions:

GB-Based Businesses

Manufacturers, importers, and downstream users based in Great Britain have a legal duty to inform HSE (as the GB CLP Agency) and submit a GB MCL Proposal when:

• There is evidence of a classification change for a priority hazard class, such as:
  • Carcinogenicity (Category 1A, 1B, or 2)
  • Germ cell mutagenicity (Category 1A, 1B, or 2)
  • Reproductive toxicity (Category 1A, 1B, or 2)
  • Respiratory sensitisation (Category 1)
• New scientific data or evidence emerges that could justify a new or revised GB MCL.

For other hazard classes, GB-based manufacturers, importers, and downstream users may submit proposals if they have access to the necessary scientific data and evidence.

Competent Authorities

Under the GB CLP Regulation, the Secretary of State, as well as Scottish and Welsh ministers, serve as GB CLP competent authorities and have the authority to propose new or updated GB MCL classifications.

HSE (as the GB CLP Agency)

If HSE obtains evidence that could lead to a new or revised GB MCL, it has the scientific and regulatory expertise to prepare a GB MCL Proposal. HSE also monitors international forums, including the ECHA Committee for Risk Assessment (RAC), for relevant information.

When a RAC opinion is published, HSE, as the GB CLP Agency, must form its own opinion on whether to align with RAC, following the Article 37 procedure outlined in the GB CLP Regulation. However, GB has the autonomy to determine its own MCLs based on supporting scientific data and broader policy considerations. Over time, this may result in GB having different MCLs from the EU CLH for the same substance.

Drafting a GB MCL Proposal requires technical expertise and a thorough understanding of the scientific data and classification criteria set out in the GB CLP Regulation. The individual preparing the proposal must be able to interpret the evidence effectively to ensure compliance with regulatory requirements.

To find out more about chemical compliance in Great Britain and on other markets, please do not hesitate to contact the Product Compliance Institute.