UK Regulatory News

Update: The deadline on this consultation has been extended until 24 June 2024.   On 4 April 2024, the UK Health and Safety Executive (HSE) announced its initiative to seek information and evid...

Update: The deadline on this consultation has been extended until 24 June 2024.

On 4 April 2024, the UK Health and Safety Executive (HSE) announced its initiative to seek information and evidence on firefighting foams containing per- and polyfluoroalkyl substances (PFAS). This initiative aims to gather information to prepare an Annex 15 restriction dossier in collaboration with the Environment Agency to assess the risk to the environment and human health from PFAS in firefighting foams. This Annex 15 dossier will assess whether a restriction on the use of PFAS in firefighting foams should be introduced in Great Britain (GB; England, Scotland and Wales).

Stakeholder Engagement Key to UK PFAS Restriction Process

In an effort to address the significant environmental emissions from PFAS in firefighting foams, the UK government has initiated steps towards restriction. Stakeholders including manufacturers, importers, distributors, and environmental organisations are invited to come forward for further dialogue with the Agency. The call for evidence, which is part of the UK's REACH regulation, aims to inform the development of a restriction report and will require comprehensive data and evidence from respondents.

The HSE is interested in relevant information on all aspects of firefighting foams, particularly those containing PFAS, including the following:

• Manufacture of firefighting foams: substances used, processes, quantities.

• Import of firefighting foams of all types: quantities, suppliers.

• Use: quantities, sector of use, frequency, on-site storage, products used.

• Alternatives to PFAS in firefighting foams: availability, cost, performance compared to PFAS-containing foams, barriers to switching.

• Hazardous properties: safety data sheets, new studies on intrinsic properties and exposure, recommended risk management measures.

• Environmental fate: what happens to the foam after use, where does it go?

• Waste: disposal requirements, recycling options, remediation.

• Standards: including product specific legislation, performance, certification.

Background: UK Authorities Act after Identifying Risks

Following the identification the adverse environmental and human health properties of PFAS, the UK Environment Agency published a Risk Management Options Analysis (RMOA) in April 2023.

This analysis concluded that PFAS have a number of properties which, taken together are of concern to the environment and human health, in particular:

• Persistence of these substances or their breakdown products in the environment.

• The potential for high mobility leading to widespread distribution and the risk of contamination including of the aquatic environment.

• Uncertainties about long-term adverse effects on the environment and human health

As a result, one of the RMOA’s key recommendations was to initiate a restriction proposal to address the significant emissions from the use of PFAS in firefighting foams.

With the Health and Safety Executive (HSE) leading the preparation of the Annex 15 restriction dossier, the UK is seeking to mitigate the risks posed by PFAS in firefighting foams, emphasising transparency and stakeholder engagement throughout the process.

Submitting Comments: How to Respond to the PFAS Consultation

To submit comments, respondents can provide basic information in the survey, which can be found here and attach detailed documents at the end. Respondents are encouraged to provide as much evidence as possible. By submitting information, participants agree that data (excluding personal data) may be shared with relevant authorities for the development of the Annex 15 restriction dossier. The consultation closes on 3 June 2024 at 23:59 London time (BST).

On 12 March 2024, the UKs Health and Safety Executive (HSE) announced that 25 chemical substances have been added to the Great Britain Mandatory Classification and Labelling List (GB MCL). These addit...

On 12 March 2024, the UKs Health and Safety Executive (HSE) announced that 25 chemical substances have been added to the Great Britain Mandatory Classification and Labelling List (GB MCL). These additions came into force on 2 March 2025 and summaries have been published in the GB CLP publication table. The compliance date for the 25 substances is 2 September 2025. The additions were made after the Secretary of State accepted HSE’s recommendations, with the agreement of the Scottish and Welsh Ministers. The GB MCL list now contains a total of 123 entries.

Scientific Basis

The inclusion of these substances is based on the scientific and technical evaluations that identified the intrinsic hazards of these 25 substances. Whilst the HSE’s technical reports highlighted these intrinsic hazards, the impact and policy assessments set out in the Agency's opinions did not identify any significant impacts.

Post-Brexit Additions to the GB MCL

This is the second batch of substances to be added to the GB MCL after Brexit. The first batch of 98 substances was added on 20 October 2023. The HSE notified the World Trade Organization (WTO) of its intention to add this second batch on 24 August 2023. A list of the substances can be found here.

On 15 February 2024, the UK Department for Environment, Food and Rural Affairs (DEFRA) published the UK REACH Work Programme which describes the operational work planned for the 2023/2024 financial ye...

On 15 February 2024, the UK Department for Environment, Food and Rural Affairs (DEFRA) published the UK REACH Work Programme which describes the operational work planned for the 2023/2024 financial year. The work programme was expected to be published in June 2023, which is a significant delay. The financial year ends on 5 April 2024. Several of the objectives described in the Work Programme have, however, already been achieved.

Key activities in the work programme

The UK REACH Work Programme for 2023/24 prioritises a number of key activities to ensure effective regulation of chemicals. The table below lists more detail on the priorities outlined in the program:

The Work Programme can be accessed here.

Restriction Priorities in the Work Programme

In addition to the Work Programme, DEFRA has published the rationale for financial year he prioritisation of substances in the UK REACH work programme. The rationale identifies the following 5 substances/substance groups as priorities for 2023/2024:

• Per- and polyfluoroalkyl substances (PFAS):

  • Start preparation of a restriction dossier on PFAS in fire-fighting foams (FFFs)

  • Assess potential additional restrictions on further wide dispersive uses of PFAS and PFAS likely to be released from consumer articles.

• Formaldehyde and formaldehyde releasers in articles: Continue the Regulatory Management Options Analysis (RMOA) initiated under the 2022/2023 work programme and consider its recommendations.

• Bisphenols in thermal paper: Continue the RMOA initiated under the 2022/2023 work programme and consider its recommendations.

• Hazardous flame retardants: Further develop the risk assessment on flame retardants and consider the recommendations on completion.

• Intentionally added microplastics; Monitor progress of the evidence project initiated and commissioned under the 2022 to 2023 work programme.

The rationale also includes a list of 15 proposals that are not considered a priority for 2023/2024.

The full text of the rationale is available here.

UK-REACH Report 2022/2023

Also on 15 February 2024, the UK-REACH Report 2022/2023 was published, outlining the relevant activities in 2022/2023. The Report can be accessed here.

The UK Health and Safety Executive (HSE) is urging all 'Comply with UK-REACH' users to log in to their Government Gateway accounts immediately. The 'Comply with UK-REACH IT' service, w...

The UK Health and Safety Executive (HSE) is urging all 'Comply with UK-REACH' users to log in to their Government Gateway accounts immediately. The 'Comply with UK-REACH IT' service, which has been operational for three years on 1 January 2024, requires users to log in at least once every 3 years to keep their accounts active.

Some users may not have accessed their Government Gateway accounts since meeting their initial regulatory obligations. Assistance is available from the UK Chemicals Helpline at 0330 159 1985 for those experiencing problems accessing 'Comply with UK REACH.'

HSE emphasises the importance of assigning multiple administrators to each 'Comply with UK REACH' account to prevent loss of access if an administrator leaves. It is important to note that data previously submitted via 'Comply with UK REACH' will no be deleted, but loss of access to the Government Gateway account means that previous submissions cannot be updated or progressed.

On 15 February 2024, the UK Department for Environment, Food and Rural Affairs (DEFRA) notified the World Trade Organization (WTO) of its decision to withdraw the approval for the active substance Fam...

On 15 February 2024, the UK Department for Environment, Food and Rural Affairs (DEFRA) notified the World Trade Organization (WTO) of its decision to withdraw the approval for the active substance Famoxadone in Great Britain (England, Scotland and Wales. Famoxadone is commonly used in plant protection products, regulated under the retained Regulation 1107/2009 (concerning the placing of plant protection products on the market).

This decision follows the non-renewal of the approval of Famoxadone in the European Union in 2021, due to the identification of a critical concern related to the high long-term risk to mammals, the high risk to aquatic organisms and the estimated exposure levels of workers during manual harvesting of crops exceeding the acceptable operator exposure level.

Assessment and Regulatory Context

Famoxadone, assessed for its effect on human health and ecotoxicological aspects, did not meet the requirements for approval under Article 4 of the retained Regulation No 1107/2009. The Health and Safety Executive (HSE) carried out an independent review, taking into account the risks to birds and other environmental factors.

Clear Risks and Expiring Authorisations

The decision shows that Famoxadone does not have a safe use that presents an acceptable risk to birds, leading to its withdrawal in Great Britain. The HSE stressed that the risks to birds were sufficiently clear that independent scientific advice was not required.

Existing authorisations for plant protection products containing Famoxadone will be withdrawn six months after the withdrawal of the active substance approval. A grace period for storage, disposal and use of the products will expire twelve months after the withdrawal. The decision reflects a comprehensive assessment of management of the risks associated with the use of Famoxadone in these products.

Staying Informed 

Stakeholders and the public are encouraged to stay informed of the changes as the GB Approvals register will be updated to reflect this latest decision by the HSE. The proposed commencement date is the second quarter of 2024 with implementation expected in the fourth quarter of 2025.

Further details of the assessment and decision can be found in the full report.

On 19 February 2024, the UK Health and Safety Executive (HSE) announced the postponement of active substance expiry dates for all biocidal active substance/product type combinations due to expire betw...

On 19 February 2024, the UK Health and Safety Executive (HSE) announced the postponement of active substance expiry dates for all biocidal active substance/product type combinations due to expire between 1 January 2024 and 31 December 2026. The new deadline for these expirations will be 31 January 2027.

The decision follows challenges beyond the control of the applicants, where approvals were at risk of expiring before a renewal decision could be taken under the GB Biocidal Products Regulation (GB BPR). In addition, this extension will allow time to consider possible reforms to the GB BPR. The HSE plans to publish detailed information on this development in the near future.

Impact on Active Substances/Product Type Combinations

Up to 110 active substance/product type combinations will be affected by this decision, subject to timely submission and acceptance of renewal applications. Currently, 46 combinations listed on the HSE website have met the renewal requirements, resulting in their expiry dates being postponed to 31 January 2027.

For those wishing to introduce new biocidal products containing these active substances, applications for GB BPR product authorisation are still open. However, it is emphasised that new products, including those with new trade names, should not be supplied in Great Britain (England, Scotland and Wales) until proper product authorisation has been granted.

Future Updates

The HSE assures stakeholders that there will be future updates on future postponements of expiry dates under this umbrella decision as they become relevant.

On 23 January 2023, the UK Health and Safety Executive (HSE) issued a reminder to all companies involved in the export and import of Prior Informed Consent (PIC) chemicals. Companies are required to s...

On 23 January 2023, the UK Health and Safety Executive (HSE) issued a reminder to all companies involved in the export and import of Prior Informed Consent (PIC) chemicals. Companies are required to submit detailed reports of their activities in 2023 by 31 March 2024. This annual reporting is a legal requirement under Article 10 of the GB PIC Regulation.

Detailed reporting required

Companies must provide the HSE with the exact quantities, measured in kilograms, of PIC chemicals they have either exported from or imported into Great Britain (England, Scotland, and Wales) during the previous year. The HSE has made templates available on its website to facilitate this process and  ensure that companies can efficiently comply with the reporting requirements.

This annual report must also include the movement of PIC chemicals to or from Northern Ireland (NI). When reporting exports and imports within the European Union, companies are not required to specify the EU country involved. However, reporting the movement of these chemicals to or from Northern Ireland will be useful for record-keeping purposes.

Exemptions from reporting

It is important to note that not all PIC chemical transactions are subject to this reporting requirement. Exemptions include:

• Special reference identification number (RIN) requests for exports for research and analysis purposes in quantities not exceeding 10 kg per year to each importing country.

• Imports for research and analysis purposes in quantities not exceeding 10 kg per year from any country.

For mixtures and articles, companies are only required to report the quantity of the PIC chemical contained in the mixtures and articles.

NIL returns

In cases where a company has not exported a particular PIC-listed chemical in 2023, despite having submitted an export notification for it, it must submit a NIL return to confirm this.

Submission guidelines

Completed templates should be sent to ukdna@hse.gov.uk no later than the 31 March 2024. The subject line of the email should include the text "GB PIC - Annual Reporting - Article 10 - 2023 - [company name]" to ensure the correct categorisation of the submission.

Publication of data

Later in the year, the HSE plans to publish the aggregated and anonymised data on its website, providing an insight into the trends and volumes of PIC chemical trade in 2023.