UK Regulatory News

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.

The UK Government has announced plans to end the use of harmful neonicotinoid pesticides in England, a major step towards fulfilling an election commitment to protect bees and other pollinators. The p...

The UK Government has announced plans to end the use of harmful neonicotinoid pesticides in England, a major step towards fulfilling an election commitment to protect bees and other pollinators. The policy, published by the Department for Environment, Food and Rural Affairs (DEFRA) on 21 December 2024, aims to legally ban three neonicotinoids: clothianidin (CAS no 210880-92-5), imidacloprid (CAS no 138261-41-3), and thiamethoxam (CAS no 153719-23-4). These chemicals, which are known to threaten pollinators, have been used under emergency authorisations for the past four years despite their general ban.

Neonicotinoids and Their Impact on Pollinators

Neonicotinoids are highly toxic to bees, even at sub-lethal doses, impairing their cognitive abilities and reducing hive productivity. Additionally, these chemicals persist in the soil, posing long-term environmental risks. Pollinators such as bees and butterflies play a vital role in agriculture, contributing an estimated £500 million annually to UK crop production.

Legislative Actions and Future Plans

The Government’s next steps include identifying legislative measures to enforce the complete ban on the three neonicotinoids. These efforts are in line with the upcoming UK National Action Plan (NAP) for sustainable use of pesticides. Additionally, the government will continue to support farmers with alternative pest control solutions, such as virus-resistant crop varieties and sustainable pesticide options.

Broader Environmental Commitments

This announcement is part of a wider strategy to enhance environmental protection. Recent measures include:

• A rapid review of the Environmental Improvement Plan.

• Implementation plans for air quality, water pollution, and a circular economy.

• Initiatives to address the impacts of extreme weather, including tree planting and flood resilience projects.

A Sustainable Future for Agriculture

The Government remains committed to supporting farmers through sustainable food production practices. As part of this commitment, £5 billion has been allocated to farming over two years to support both nature restoration and agricultural resilience.

This policy applies to England, with efforts underway to work with the devolved governments of Scotland, Wales and Northern Ireland to ensure a unified approach.

For more details, see the full Neonicotinoids Policy Statement here.

The UK Department for Environment, Food and Rural Affairs (DEFRA) has issued a call for information on two types of chemical substances proposed as Persistent Organic Pollutants (POPs) under the Unite...

The UK Department for Environment, Food and Rural Affairs (DEFRA) has issued a call for information on two types of chemical substances proposed as Persistent Organic Pollutants (POPs) under the United Nations' Stockholm Convention. This initiative aims to gather data to support the development of a draft risk profile and risk management evaluation for these substances.

Understanding the Stockholm Convention

The Stockholm Convention on Persistent Organic Pollutants is a global treaty that aims to protect human health and the environment from harmful chemicals that persist in the environment, accumulate in living organisms and pose significant risks to human health and ecosystems. Due to their ability to travel long distances through air, water, or migratory species, POPs can affect regions far from their original source.

The Convention requires the Parties to take measures to eliminate or restrict the production, use and release of listed POPs and to reduce unintentional releases. As a signatory, the UK plays a proactive role in reviewing and managing chemicals proposed for inclusion in the Convention.

Substances under Review

The substances currently under consideration are:

• Polyhalogenated Dibenzo-p-dioxins and Dibenzofurans (PXDD/Fs): DEFRA id seeking information to assist in the preparation of a risk profile for these chemicals, as required by Annex E of the Stockholm Convention.

• Chlorinated Paraffins with Carbon Chain Lengths C14-17: Information is sought to support the risk management assessment, with a focus on socio-economic factors and potential exemptions for continued use.

Further details on the substances and their assessment can be found in the associated Defra publication here.

How to Contribute

Stakeholders are encouraged to submit relevant information by completing the relevant submission forms available on the UK Government website here. All responses should be sent to POPs@defra.gov.uk by the deadline of 29 November 2024.

Implications for Environmental Policy

The data collected will play a crucial role in shaping the UK's approach to managing these substances, ensuring compliance with international obligations under the Stockholm Convention and protecting public health and the environment.

The UK Department for Environment, Food and Rural Affairs (DEFRA) has recently published a report setting out a new set of recommendations for the integration of New Approach Methodologies (NAMs) into...

The UK Department for Environment, Food and Rural Affairs (DEFRA) has recently published a report setting out a new set of recommendations for the integration of New Approach Methodologies (NAMs) into UK chemical regulations. These methodologies support a transition away from traditional animal testing by relying on advanced scientific approaches, including in vitro and in silico methods. The new recommendations mark an important step in improving the reliability of chemical safety testing, while aligning with the UK’s post-Brexit regulatory landscape.

Key Recommendations for NAM Integration

The report sets out DEFRA's strategy for the progressive adoption of NAMs, detailing a framework to enhance chemical safety through:

• Technology Agnostic NAMs: DEFRA proposes a broad definition of NAMs, focusing utility of the data in assessing the mode of action of chemicals.

• Progressive Regulatory Framework: Phased implementation would allow NAMs to progressively replace animal testing as scientific certainty increases.

• Investment in UK Centres of Excellence: The establishment of dedicated NAMs research centres is recommended to ensure regulatory alignment and technological advancement within the UK.

Benefits of Early Adoption of NAMs

By adopting NAMs, the UK will gain ethical and economic benefits and position itself as a global leader in chemical safety. Early adoption is also in line with the “3Rs” principle (Reduce, Refine and Replace animal testing), further strengthening public trust in the UK’s regulatory framework. The report highlights that NAMs enable high confidence safety evaluations and support group-based testing and prioritization, reducing the need for traditional methods.

Challenges and Future Outlook

While the integration of NAMs holds great promise, DEFRA notes the need for robust acceptance criteria to ensure scientific reliability. As NAMs continue to develop, the UK is encouraged to take a lead in establishing reporting standards, drawing on international research and collaboration. With the progressive framework, NAMs are expected to play a greater role in chemical safety assessments, promising a safer and more sustainable future for the industry.

DEFRA’s latest recommendations underline the UK’s commitment to scientific innovation in chemical regulation and highlight a strategic shift towards a safer and more ethical approach to chemical safety assessment.