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On February 25, 2025, the UK Health and Safety Executive (HSE) released two reports on evaluation activity in the year of 2024. Evaluation activity is a core part of HSE's work to ensure the compliance of chemical registration and human and environmental health.
Similar to EU REACH, evaluation activity under UK REACH includes dossier evaluation and substance evaluation. Dossier evaluation comprises of compliance checks of registration dossiers and assessment of testing proposals. The evaluation activity has always attracted close attention from the industry. It may result in additional testing requirements and costs, and even lead to changes in the classification of substances, i.e., subsequent inclusion in the SVHC list, authorization list or restriction list, etc. Below summarizes the main points of the reports.
Compliance checks of registration dossiers
The first deadline for transitional registration data submission has been extended to October 27, 2026. Most registration dossiers submitted by the end of 2024 contain little data due to the transitional provisions for data submission that still apply to grandfathered registrations and downstream user import notifications. Consequently, HSE indicates in the report that the compliance checks concentrated on dossiers for novel substances*.
*Novel substances refer to substances not registered under EU REACH before January 1, 2021. They are not subject to the transitional provisions from EU REACH to UK REACH.
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From 2021 to 2024, HSE received dossiers for 82 registrations of novel substances. Compliance checks had been completed on dossiers for 38 registrations. Detailed statistics are shown in the table below. Evidently, the submitted registration dossiers for novel substances generally demonstrate high quality. Among the 38 completed compliance checks, only 6 substances (low tonnage) are required for further data.
Screenshot of HSE Webpage
For substances registered at over 10 tons per year, all dossiers strictly adhere to the requirements set out in Annexes 7-10 of UK REACH, providing complete information that effectively safeguards human health and environmental safety. This implies that the potential of further data requests will be significantly reduced for other companies registering these substances in the future.
Assessment of testing proposals
In 2024, HSE only received testing proposals for 2 substances, relating to toxicological and ecotoxicological information requirements. Supported the principles of the 3Rs (Replacement, Reduction and Refinement), HSE adopted decisions for the registrant’s proposal for the ecotoxicological testing. However, priority shall be given to non-vertebrate testing such as read-across options to meet human health information requirements before conducting toxicology tests OECD TG 408 and OECD TG 414.
Substances evaluation
In 2024, no new substance evaluations were conducted. HSE focused on the evaluation of the following two substances.
N-butylbenzenesulphonamide (EC 222-823-6, CAS No. 3622-84-2)
HSE has completed the evaluation and concluded that the substance is very persistent (vP) in the environment with a likelihood of widespread distribution. HSE is expected to propose a mandatory classification and labelling proposal under GB CLP in 2025 to assess whether classification is appropriate.
Paraffin waxes and hydrocarbon waxes, chloro (LCCPs)
HSE is assessing the information in 2024 submitted by the registrants to clarify the identity of the substance. Further decision will be issued to clarify whether LCCPs meet the UK REACH Annex 13 criteria for being bioaccumulative (B) / very bioaccumulative (vB) and toxic (T).
