UK Regulatory News

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.

On 22 October 2024, the Health and Safety Executive (HSE) published an update on biocide regulation in Great Britain (England, Scotland and Wales), including important deadlines for dossier submission...

On 22 October 2024, the Health and Safety Executive (HSE) published an update on biocide regulation in Great Britain (England, Scotland and Wales), including important deadlines for dossier submissions and renewals in relation to active substance approvals under the GB Biocidal Products Regulation (GB BPR).

Upcoming Dossier Submission Deadlines

In order to keep active substances in the GB Review Programme, specific dossier submission deadlines are approaching. The following active substance/product type combinations, which have already been successfully notified into the Programme, require full dossiers to be submitted by:

• 5 January 2025: N-didecyl-N-dipolyethoxyammonium borate / didecylpolyoxethylammonium (polymeric betaine) (CAS No 214710-34-6) in product type 8.

• 17 April 2025: Active chlorine generated from sodium chloride by electrolysis (CAS No 7782-50-5) in product types 2, 3, 4, 5 and 11.

Only designated notifiers or consortia may submit dossiers for these combinations. Stakeholders with a vested interest are encouraged to engage with notifiers and possibly join them in dossier submissions. Failure to meet the submission deadline will result in a GB non-approval decision, effectively banning these substances from biocidal products in the specified categories within the GB.

Consequences of Non-Approval

Without dossier submissions, the affected active substances cannot be used in biocidal products, nor can articles treated with these products be sold on the GB market. Separate updates will be provided for articles affected by non-approval decisions.

Active Substance Renewal Submission Deadline

Under the GB BPR, active substance approvals require a renewal submission 550 days before expiry. The next critical deadline is:

• 29 April 2025:  Polyhexamethylene biguanide hydrochloride (PHMB (1415;4.7)) (CAS No 1802181-67-4 / 32289-58-0) in product types 2 and 4. 

Any interested party may submit a renewal application, even if they are not the original supporter. Industry members should consult the GB Article 95 List to verify the original supporters and determine if collaboration is feasible.

Failure to renew by the deadline will result in expired approvals and the removal of these substances from the list of approved biocides in the relevant categories for the GB market.

The UK has made an amendment to its Cosmetic Products (Restriction of Chemical Substances) (No. 2) Regulations 2024, which it notified to the World Trade Organization (WTO) in an addendum on 3 October...

The UK has made an amendment to its Cosmetic Products (Restriction of Chemical Substances) (No. 2) Regulations 2024, which it notified to the World Trade Organization (WTO) in an addendum on 3 October 2024. This latest amendment introduces restrictions on 13 additional chemicals classified as carcinogenic, mutagenic or reprotoxic (CMR) substances under the GB Classification, Labelling and Packaging (CLP) Regulation (Regulation (EC) No 1272/2008). These changes extend the initial list of 52 prohibited substances to further protect the health and safety of consumers of cosmetic products sold in Great Britain (England, Wales and Scotland).

Original WTO Notification

This addendum builds on the UK's original notification of April 2024, which included:

- Kojic Acid: Allowed at a maximum concentration of 1% in face and hand products, following recommendations from the UK’s Scientific Advisory Group on Chemical Safety (SAG-CS).

- Initial CMR Restrictions: This notification already suggested to prohibit a number of chemicals classified as CMRs under the CLP Regulation, with plans to amend the relevant technical Annexes of the GB Cosmetics Regulation.

Newly Added CMRs

The following table lists the 13 CMRs added in the addendum.

Transitional Provisions

The updated Regulation is expected to be adopted by 25 January 2025. Cosmetic products placed on the market on or before 20 April 2025 may continue to be made available on the market until 20 October 2025. For products containing kojic acid, the corresponding deadlines are 20 June 2025 for placing on the market and 1 November 2025 as the last available date.

Public Consultation

The WTO notification is open for comments for 60 days from the date of notification. More details on the amendments and the full list of chemicals affected can be found here.

On 16 August 2024, the UK Health and Safety Executive (HSE) published a bulletin on the export of hazardous chemicals under the Prior Informed Consent (PIC) Regulation. Companies are now invited to su...

On 16 August 2024, the UK Health and Safety Executive (HSE) published a bulletin on the export of hazardous chemicals under the Prior Informed Consent (PIC) Regulation. Companies are now invited to submit notifications of their planned exports of PIC chemicals for the year 2025.

Prior Informed Consent

The Prior Informed Consent (PIC) regime in Great Britain (England, Scotland and Wales) regulates the export and import of certain hazardous chemicals on the PIC list. The HSE is the PIC Designated National Authority (DNA) for Great Britain and administers the GB PIC regime including the export notification system and providing information on GB PIC.

Export Notification Requirements

The GB PIC Regulation requires that the first export of a listed chemical to any country in any calendar year must be notified to the HSE at least 35 days before the planned date of export. This includes the transfer of a listed chemical from Great Britain to Northern Ireland. Early notification allows the HSE to process requests and obtain the necessary consent from importing countries.

How to Submit Export Notifications

To submit export notifications, companies should:

• Complete the GB PIC export notification form, available on the HSE PIC website.

• Email the completed form to ukdna@hse.gov.uk.

• Include detailed information in the subject line of the email.

• Attach only one notification form and the relevant safety data sheet (SDS) per email. If available, provide an SDS official language or principal languages of the importing country.

• Describe in detail the intended use of the chemical to ensure proper handling by the importing country authority.

Special Reference Identification Numbers

For exports intended for research or analysis in quantities of 10kg or less, Special Reference Identification Numbers (RINs) are required. These RINs are also required if an importing country has waived its right to receive an export notification. For exports of PIC chemicals to the EU, each Special RIN covers exports of up to 10 kg of the substance for research and analysis purposes to each EU importing country.

Requests for Special RINs for 2025 can now be submitted as follows:

- Complete a Special RIN Request Form or use the BULK Special RIN option for multiple requests.

- Email the form to ukdna@hse.gov.uk with specific details (GB PIC  - Special RIN request - company name – chemical/mixture – importing country name – 2025) in the subject line.

The UK Health and Safety Executive (HSE) is inviting businesses involved in the chemical supply chain to provide feedback on potential changes to the Great Britain Classification, Labelling and Packag...

The UK Health and Safety Executive (HSE) is inviting businesses involved in the chemical supply chain to provide feedback on potential changes to the Great Britain Classification, Labelling and Packaging (GB CLP) Regulation. The proposed revisions aim to align with international legislation and recent updates to the United Nations' Globally Harmonised System of Classification and Labelling of Chemicals (UN GHS).

Key Areas for Feedback

The HSE is seeking feedback on key areas including notification processes, explosives not in transport configuration, ‘keep out of reach of children’ pictogram, relabelling, label formatting, chemicals under pressure and precautionary statements.

Survey Details and Participation

The survey is open to manufacturers, importers, downstream users and distributors in Great Britain and Northern Ireland. However, consumer groups and trade associations are excluded from the survey.  The HSE encourages participants to take 10 -15 minutes to complete the survey, which closes on 18 September 2024. The survey can be found here.

Responses will help shape future GB CLP policy, impact assessments, and future consultations. Participation is voluntary, and all responses will remain anonymous. No information provided will be used for regulatory inspection purposes.

On 26 June 2024, the UK Health and Safety Executive (HSE) announced a significant update to the Great Britain Mandatory Classification and Labelling (GB MCL) list, giving legal effect to the inclusion...

On 26 June 2024, the UK Health and Safety Executive (HSE) announced a significant update to the Great Britain Mandatory Classification and Labelling (GB MCL) list, giving legal effect to the inclusion of 88 chemical substances. This update is in line with the 14th and 15th EU Adaptations to Progress (ATP), updating the Classification, Labelling and Packaging (CLP) Regulation.

Ministerial Approval

The decision, approved by the Minister for Lords (MfL) with the consent of the Scottish and Welsh Ministers, ensures that the 88 substances are now officially listed in the GB MCL under Article 37 of the GB CLP Regulation. This action was necessary to include entries from the EU classification that were not retained in GB law after Brexit ended on 31 December 2020.

Key Changes and Compliance Dates

The updated GB MCL list was published on 26 June 2024 and includes legally binding entries for the 88 substances. The entry into force and compliance date for these substances is also 26 June 2024. This update is critical to ensure that the GB MCL list accurately reflects substances that have not been incorporated into GB law post-Brexit. The detailed GB MCL consolidated summary, which includes the 88 substances, is available here.

Impact on Duty Holders

For most duty holders, this update will not require any additional action. The classifications and labelling requirements for these 88 substances remain unchanged. However, two substances, titanium dioxide (in powder form) and granulated copper, have been removed from the list pending further assessment.

Future Assessments and Notifications

The HSE has indicated that further assessments will be carried out for titanium dioxide and granulated copper under Article 37A of the GB CLP Regulation, as additional information has been identified that requires further assessment. Duty holders affected by the declassification of these two substances should self-classify in accordance with the GB CLP Regulation while the HSE continues to review the GB MCLs for these two substances under the Article 37A procedure. No timetable has yet been agreed for the Article 37A assessment of titanium dioxide (in powder form) and granulated copper.