UK Regulatory News

The UK Health and Safety Executive (HSE) has published its annual UK REACH Article 83 Report (2023–2024) and Work Programme for 2024–2025, highlighting ongoing regulatory work and outlining upcomi...

The UK Health and Safety Executive (HSE) has published its annual UK REACH Article 83 Report (2023–2024) and Work Programme for 2024–2025, highlighting ongoing regulatory work and outlining upcoming priorities under the UK REACH framework.

PFAS and Lead Under Regulatory Focus

HSE continues to assess the risks of per- and polyfluoroalkyl substances (PFAS), with work ongoing to investigate their use as processing aids in the manufacture of fluoropolymers. In parallel, the Agency is preparing a restriction dossier on PFAS in firefighting foams, which is expected to be submitted for public consultation in 2024/25.

The HSE is also finalising its restriction opinion on lead in ammunition used in outdoor shooting, covering both human health and environmental risks. This follows a public consultation completed in 2023.

Upcoming Work in 2024–2025

The Work Programme outlines the continuation of nine Regulatory Management Options Analyses (RMOAs), including substances such as:

• Benzene-1,2,4-tricarboxylic acid 1,2-anhydride (trimellitic anhydride) – investigated for respiratory sensitisation risks.

• Bisphenol S (BPS) and Bisphenol F (BPF) – evaluated for endocrine disrupting properties.

• Octamethylcyclotetrasiloxane (D4) and Decamethylcyclopentasiloxane (D5) – investigated for persistence and potential environmental concerns.

No new RMOAs are planned for 2024/25.

Additionally, the HSE will assess up to six substances proposed as Substances of Very High Concern (SVHCs) under EU REACH for their relevance to the UK market. One such substance that has already been evaluated in 2023/24 was melamine, due to concerns over reproductive toxicity and widespread use.

Key Activities in 2023-2024

During 2023/24, the HSE:

• Processed all new UK REACH registrations and Article 26 inquiries within the statutory three-week timeframe.

• Carried out compliance checks on at least 20% of registration dossiers.

• Evaluated all submitted testing proposals to avoid unnecessary animal testing.

• Issued authorisation opinions on time, including assessments of trichloroethylene uses.

• Published the UK REACH evaluation report under Article 54 by the February 2024 deadline.

For 2024/25, the HSE will maintain these operational targets and continue to invest in IT systems and stakeholder engagement efforts to support future evaluations and restrictions.

The work programme was developed in collaboration with the Environment Agency and the Appropriate Authorities (Defra, the Scottish Government, and the Welsh Government) and reflects previously established regulatory priorities.

Access the full 2023-2024 Annual Report here and the 2024-2025 Work Programme here.

The United Kingdom and the European Union have launched public consultations on draft risk profiles for polybrominated dibenzo-p-dioxins and dibenzofurans (PBDD/Fs), including mixed polybrominated/chl...

The United Kingdom and the European Union have launched public consultations on draft risk profiles for polybrominated dibenzo-p-dioxins and dibenzofurans (PBDD/Fs), including mixed polybrominated/chlorinated dibenzo-p-dioxins and dibenzofurans (PBCDD/Fs). These consultations are part of the process under the Stockholm Convention on Persistent Organic Pollutants (POPs) to evaluate and possibly regulate these substances due to their persistence in the environment and potential health risks.

Background on PBDD/Fs and PBCDD/Fs

PBDD/Fs and PBCDD/Fs are unintentional by-products of various industrial processes, including the combustion of materials containing brominated flame retardants and certain metallurgical processes. Due to their persistence in the environment and their potential to bioaccumulate, these substances are of concern for both the environment and human health.

UK Consultation Details

The UK Department for Environment, Food & Rural Affairs (DEFRA) has published a draft risk profile for PBDD/Fs and PBCDD/Fs and is inviting stakeholders to comment. The consultation period is open from 17 March to 19 May 2025. Stakeholders are encouraged to review the draft risk profile and provide feedback by email to POPs@defra.gov.uk within the specified timeframe.

EU Consultation Details

The European Chemicals Agency (ECHA) has also published a draft risk profile for the same group of substances and is seeking input from interested parties. The EU consultation is open until 20 May 2025 and comments can be submitted here.

Next Steps in the Stockholm Convention Process

Feedback from these consultations will contribute to discussions at the upcoming 20th meeting of the Stockholm Convention POPs Review Committee (POPRC-20), scheduled for 29 September to 3 October 2025. The Committee will review the draft risk profiles and stakeholder comments to determine the need for global regulatory actions on these substances.

On 20 March 2025, the United Kingdom notified the World Trade Organization (WTO) of a draft regulation proposing to update the maximum levels for certain contaminants and pesticide residues in food. T...

On 20 March 2025, the United Kingdom notified the World Trade Organization (WTO) of a draft regulation proposing to update the maximum levels for certain contaminants and pesticide residues in food. The measure aims to better protect public health and reflects the latest scientific assessments.

Proposed Amendments to Contaminants and MRLs

The draft legislation introduces new and revised maximum levels (MLs) for various chemical contaminants in food and updates to the Maximum Residue Levels (MRLs) for certain pesticides. Key changes include:

• Mycotoxins: Introduction of new MLs for deoxynivalenol (DON), zearalenone, and T-2/HT-2 toxins in cereals and cereal-based foods, especially those intended for infants and young children.

• Tropane alkaloids: New MLs for atropine and scopolamine in cereal-based products.

• Nitrate: Updates of the permitted levels in spinach and lettuce, including adjustments for seasonal variations.

• Pesticide residues: Adoption of 58 new or revised MRLs for active substances such as:

  • Abamectin, cyazofamid, fludioxonil, mandestrobin, and spinetoram.

  • Affected foods include a wide range of foods, including fruits, vegetables, herbs, and spices.

Implementation Timeline

• Deadline for comments: Stakeholders are encouraged to review the proposed changes and submit comments via the WTO ePing portal by 5 May 2025

• Planned adoption and entry into force: 30 June 2025

The proposed regulation will apply in England, with corresponding legislation to follow in Scotland, Wales, and Northern Ireland to ensure UK-wide alignment.

A detailed list of the proposed MRLs can be found here.

On 17 March 2025, the UK Health and Safety Executive (HSE) announced an important update to its guidance on health surveillance for workers exposed to respirable crystalline silica (RCS) - a hazardous...

On 17 March 2025, the UK Health and Safety Executive (HSE) announced an important update to its guidance on health surveillance for workers exposed to respirable crystalline silica (RCS) - a hazardous substance linked to serious lung diseases, including silicosis, chronic obstructive pulmonary disease (COPD), and lung cancer.

The revised guidance aims to help employers understand when health surveillance is legally required and how to implement effective surveillance programs in accordance with the Control of Substances Hazardous to Health (COSHH) Regulations 2002.

What’s New in the Updated Guidance?

• Clearer Requirements: The guidance now provides improved explanations of when health surveillance is required for workers exposed to RCS and how employers should assess the risk.

• Structured Approach: HSE outlines a step-by-step process for setting up a health surveillance scheme, including:

  • Identifying the risk of exposure.

  • Arranging for appropriate health checks.

  • Keeping appropriate records.

  • Acting on the results to protect workers’ health.

• Emphasis on Legal Obligations: Employers are reminded that health surveillance is not optional where there is a reasonable probability that RCS exposure is causing harm. The updated guidance helps to clarify these obligations.

• Alignment with HSE’s Inspection Focus: The update comes as the HSE continues to prioritise workplace inspections in sectors such as construction, manufacturing, and stonework, where exposure to RCS is more common. Poor management of RCS risks can lead to enforcement action.

Why Health Surveillance for RCS Is Important

Respirable crystalline silica is a fine dust generated by cutting, grinding, drilling, or sanding materials such as concrete, brick, stone, or mortar. Prolonged or repeated inhalation of RCS can lead to irreversible lung damage. Early detection through health surveillance is essential to prevent long-term disease and ensure timely intervention.

Access the Updated Guidance

The revised guidance on RCS health surveillance is available here on the HSE website as part of the G series of publications. Employers, occupational health providers, and safety professionals are encouraged to review the material and update their policies and procedures as necessary.

On 10 March 2025, UK Government laid before Parliament the REACH Fees and Charges (Amendment of Commission Regulation (EC) No 340/2008) Regulations 2025, which will apply from 1 April 2025. This statu...

On 10 March 2025, UK Government laid before Parliament the REACH Fees and Charges (Amendment of Commission Regulation (EC) No 340/2008) Regulations 2025, which will apply from 1 April 2025. This statutory instrument revises the fees and charges associated with the Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) regime to align them more closely with the actual costs incurred by the Health and Safety Executive (HSE) in administering these regulatory activities.

Key Changes

• Standard Registration Fees: A flat standard fee of £2,222 will apply to large companies for both full and intermediate registrations. This adjustment is intended to better align fees with the costs of processing registrations and maintaining the REACH IT system.

• Authorisation Fees: The base authorisation fee will increase by £10,460, bringing the standard fee from £47,229 to £57,689. Additional fees per substance and per use will continue to be calculated as a percentage of the base fee, specifically 20% and 90% respectively.

• Fees for Product and Process Oriented Research and Development (PPORD): The standard fee for a PPORD notification will increase from £475 to £751 to reflect previously unrecovered costs associated with the Environment Agency's involvement in PPORD applications.

• Updates to Registrations: A flat standard fee of £2,222 will be implemented for large companies updating their tonnage bands reflecting the actual costs of processing these updates and maintaining the REACH IT infrastructure.

• Change of Identity/Legal Personality: The fee for processing changes of identity or legal personality will be significantly reduced from £1,424 to £290, reflecting the actual costs associated with these administrative updates.

Discounts for Small and Medium-Sized Enterprises

Small and medium-sized enterprises (SMEs) will continue to benefit from reduced fees. For all fee types except applications for authorisations, SMEs will either retain their current fee if it is lower than the new standard fee, or receive a discount of 10%, 20%, or 30% for medium, small, and micro enterprises, respectively. For authorisations, the existing SME discounts of 25%, 55%, and 90% for medium, small, and micro enterprises respectively will be maintained to avoid a disproportionate burden on smaller companies.

Consultation and Implementation

An informal consultation was held from 14 August to 16 September 2024, involving the main industry trade associations and non-governmental organisations. While industry broadly welcomed the changes, concerns were raised about the increased registration fees for large companies submitting joint registrations for substances in the 1-10 tonne range. The Government took these concerns into account but emphasised the need to align fees with the actual costs of regulatory activities, as required by HM Treasury's Managing Public Money guidelines.

The revised fees and charges are designed to ensure that the HSE recovers the full economic costs of providing regulatory services under UK-REACH, thereby maintaining the sustainability and effectiveness of the UK's chemicals regulatory framework.

Further details can be found in the official legislation here and the Explanatory Memorandum here.

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 ...

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.

On 15 February 2025, the UK Health and Safety Executive (HSE) published the 6th edition of the Great Britain (GB) Mandatory Classification and Labelling (MCL) list. This update includes new and revise...

On 15 February 2025, the UK Health and Safety Executive (HSE) published the 6th edition of the Great Britain (GB) Mandatory Classification and Labelling (MCL) list. This update includes new and revised classifications for 46 substances, following the fourth GB CLP Agency recommendation approved by Ministers in January 2025.

Background on the GB MCL

The GB MCL list is a legally binding list managed by the HSE, serving as a cornerstone for the classification and labelling of substances and mixtures in Great Britain (England, Scotland, and Wales). It ensures that manufacturers, importers, downstream users, and distributors adhere to consistent standards, protecting public health and the environment. The list is regularly updated to reflect new scientific data, regulatory decisions, and to align with international standards. These updates may include the addition of new substances, revisions to existing classifications, and editorial changes for clarity. Stakeholders are encouraged to stay informed about these changes to maintain compliance and safety protocols.

Key Highlights of the 6th Edition:

• New Substance Classifications: The update includes substances such as nonylphenol ethoxylates, hydrogen sulfide, diuron, and 1-phenylethylidene hydrazone. These substances have an entry into force date of 15 February 2025, with a compliance deadline of 15 August 2026. The full list, along with specific classifications and hazard information can be downloaded from the HSE website.

• Corrections and Clarifications: This update also includes a number of editorial corrections, correcting previously reported errors such as typographical mistakes. Full details of the Agency’s recommendations and updated classifications can be found in the HSE GB CLP Publication Table.

Stakeholders are encouraged to review the updated GB MCL list to ensure compliance with the new classifications by the specified deadlines.