UK Regulatory News

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.

The UK Registration, Evaluation, Authorisation, and Restriction of Chemicals (UK-REACH) serves as the legal framework for regulating chemicals in Great Britain (England, Scotland, and Wales) following...

The UK Registration, Evaluation, Authorisation, and Restriction of Chemicals (UK-REACH) serves as the legal framework for regulating chemicals in Great Britain (England, Scotland, and Wales) following the UK’s withdrawal from the European Union. UK-REACH was established on January 1, 2021, under the European Union (Withdrawal) Act 2018, UK-REACH and retains the core principles of EU-REACH while making changes to make it workable in the UK. The Regulation applies to chemical substances manufactured or imported in quantities of one tonne per year or more, whether as individual substances, mixtures (e.g. paints, inks) or components of articles (e.g. furniture, clothing, vehicles). To legally place chemicals on the UK market, manufacturers, importers, and distributors must register their substances under UK-REACH, with transitional arrangements in place to support businesses affected by the repeal of EU-REACH in the UK. Northern Ireland continues to follow EU-REACH under the Northern Ireland Protocol.

Certain substances are exempt from UK-REACH, including radioactive substances, waste, non-isolated intermediates, and substances under customs supervision. Additionally, some substances are regulated under more specific legislation, such as human and veterinary medicines, food additives, plant protection products, and biocides. In addition to UK-REACH, the Great Britain Classification, Labelling, and Packaging (GB CLP) Regulation came into force on January 1, 2021, requiring manufacturers, importers, and downstream users to properly classify, label, and package hazardous substances before placing them on the market. Unlike the EU CLP Regulation, the GB CLP allows the UK to make independent decisions on mandatory hazard classifications and labelling, deciding whether to align with EU decisions or introduce its own classification system.

Key News from 2024

DEFRA Proposes Alternative Transitional Registration Model for UK REACH

On May 6, 2024, the UK Department for Environment, Food and Rural Affairs (DEFRA) launched a consultation on an Alternative Transitional Registration Model (ATRm) for UK REACH. The ATRm aims to reduce costs for companies transitioning from EU REACH to UK REACH, while maintaining the protection of for human health and the environment. Key proposals include reducing hazard information requirements for transitional substances, enhancing use and exposure data, and formalizing data sharing arrangements between registrants. The outcome of the consultation is expected in 2025. Read more here.

UK Extends Restrictions on Chemicals in Cosmetics

The United Kingdom has expanded its list of prohibited substances in cosmetic products, to include 13 new chemicals identified as carcinogenic, mutagenic, or toxic for reproduction (CMR). This action is in line with the latest scientific assessments and aims to enhance consumer safety by preventing the use of these hazardous substances in cosmetics. Companies are advised to review the updated regulations to ensure compliance and avoid potential market withdrawals. Read more here.

UK Updates to the Mandatory Classification and Labelling (GB MCL) List

The United Kingdom has recently updated its Mandatory Classification and Labelling (GB MCL) list to reflect the latest scientific assessments and enhance consumer safety. On January 11, 2024, the Health and Safety Executive (HSE) proposed to update the status of 90 substances on the GB MCL list from the 14th and 15th Adaptations to Technical Progress (ATPs) to the CLP Regulation. Subsequently, on March 12, 2024, the HSE announced the addition of 25 chemical substances to the GB MCL list with an effective date of March 2, 2024, and a compliance date of September 2, 2025. In addition, on June 26, 2024, the GB MCL list was updated to give legal effect to the GB MCLs for 88 substances, while removing entries for titanium dioxide (in powder form) and granulated copper. These updates are intended to ensure accurate hazard communication and regulatory compliance. Companies are advised to review the updated list to ensure compliance and avoid potential market withdrawals. Read more here, here and here.

On 16 January 2025, the UK notified the World Trade Organization (WTO) of its draft Cosmetic Products (Restriction of Chemical Substances) Regulations 2025. The regulation, which is expected to be ado...

On 16 January 2025, the UK notified the World Trade Organization (WTO) of its draft Cosmetic Products (Restriction of Chemical Substances) Regulations 2025. The regulation, which is expected to be adopted on 31 March 2025 and come into force on 30 September 2025, will restrict the use of methyl salicylate in cosmetic products in Great Britain (England, Scotland and Wales). A transitional period will allow products placed on the market before 30 September 2025 to remain available until 31 March 2026.

Methyl Salicylate: Uses and Regulatory Status

Methyl salicylate (CAS No. 119-36-8), also known as wintergreen oil, is widely used in topical analgesics, cosmetics, and personal care products for its soothing and aromatic properties. It is commonly found in pain relieving creams, mouthwashes, deodorants, and food flavouring agents. However, methyl salicylate is classified as a Category 2 CMR (Carcinogenic, Mutagenic, or Reproductive Toxicant) under the EU’s Classification, Labelling and Packaging (CLP) Regulation (Regulation (EC) No 1272/2008), leading to regulatory restrictions to ensure consumer safety. Appropriate use and concentration limits are essential to prevent potential health risks associated with overexposure.

Scope and Regulatory Amendments

The Regulation will amend Annex 3 of the Cosmetics Regulation (Regulation (EC) No 1223/2009) by adding new restrictions on methyl salicylate in various cosmetic products, including:

• Rinse-off products (except hand wash products): Maximum concentration of 0.02% for children aged 0.5 to 1 year and 0.06% for older children and adults.

• Hand wash products: 0.02% for children aged 0.5 to 1 year and 0.6% for older children and adults.

• Leave-on skin products: 0.02% for children aged 0.5 to 1 year and 0.06% for older children and adults.

• Lipsticks and lip balms: 0.02% for children aged 0.5 to 1 year and 0.03% for older children and adults.

• Face makeup products: Maximum concentration of 0.05%.

• Eye makeup products and makeup removers: Maximum concentration of 0.002%.

• Toothpaste: Maximum concentration of 2.5%.

• Mouthwash: 0.1% for children aged 6 to 10 years and 0.4% for older children and adults.

• Deodorant spray/aerosol products: Maximum concentration of 0.003%.

• Hair products: Maximum concentration of 0.009%.

Scientific Basis and Justification

The restrictions follow the recommendations of the Scientific Advisory Group on Chemical Safety of Non-Food and Non-Medicinal Consumer Products (SAG-CS), which considered methyl salicylate to be safe for use in cosmetics at certain concentration limits, despite its classification as a Category 2 CMR substance under Regulation (EC) No 1272/2008.

Comment Period and Availability of Documents

Stakeholders have 60 days from the date of notification to submit comments. For further details, visit the official WTO notification page here.