UK HSE Publishes 2024 UK REACH Dossier and Substances Evaluation Reports

On 25 February 2025, the UK Health and Safety Executive (HSE) published two reports detailing its 2024 evaluation activities under UK REACH, covering dossier evaluation and substance evaluation. This annual report, required by Article 54 of UK REACH, provides insight into the compliance and safety of chemical substances in the UK market.

Dossier Evaluation: Compliance Checks for Novel Substances

The HSE dossier evaluation focuses on the review of registration dossiers to assess compliance with UK REACH requirements. It involves two main activities: assessing testing proposals submitted by registrants and conducting compliance checks on registration dossiers. Between 1 January 2021 and 31 December 2024, the HSE received 82 registration dossiers for novel substances - chemicals that were not previously registered under EU REACH before 1 January 2021.

Key findings from the 38 compliance checks completed in 2024:

• 32 dossiers met the compliance standards without further requirements.

• 6 dossiers required additional data, resulting in 36 requests covering:

  • 16 requests for physicochemical data

  • 10 requests for toxicological data

  • 10 requests for ecotoxicological data

While no additional vertebrate animal testing was requested, the HSE emphasized alternative methods for data generation in line with the 3Rs principle (Replacement, Reduction, and Refinement of animal testing).

Substance Evaluation: Persistent and Bioaccumulative concerns

The HSE did not initiate any new substance evaluations in 2024, but continued to review the following chemicals under assessment:

• N-Butylbenzenesulphonamide (EC 222-823-6, CAS 3622-84-2)

  • Classified as very persistent (vP) in the environment.

  • Potential for widespread environmental distribution.

  • HSE intends to propose mandatory classification under GB CLP in 2025 to assess potential reproductive toxicity.

• Paraffin Waxes and Hydrocarbon Waxes, Chloro (LCCPs)

  • Registrants submitted additional data in 2024 to clarify substance identity.

  • HSE will assess whether LCCPs meet the criteria for bioaccumulation (B/vB) and toxicity (T) under UK REACH Annex 13, with regulatory decisions expected in 2025.

These evaluations underline the HSE's commitment to ensuring chemical safety and compliance in the UK, reflecting its proactive approach to protecting the environment and public health.

Implications for Industry

The HSE's dossier compliance checks highlight the importance of robust data submission under UK REACH. The evaluations of N-Butylbenzenesulphonamide and LCCPs signal potential future regulatory action, including classification updates and restrictions.

Companies registering chemicals in the UK should closely monitor these developments to ensure their registration dossiers meet evolving regulatory expectations.

The full reports are available here and here.