UK Regulatory News

The UK Scientific Advisory Group on the Chemical Safety of Non-Food and Non-Medicinal Consumer Products (SAG-CS) published its final opinion on methyl salicylate in cosmetics on 8 March 2024. The opin...

The UK Scientific Advisory Group on the Chemical Safety of Non-Food and Non-Medicinal Consumer Products (SAG-CS) published its final opinion on methyl salicylate in cosmetics on 8 March 2024. The opinion sets specific concentration limits for a range of products and age groups and aims to ensure consumer safety.

SAG-CS

The SAG-CS is the UK equivalent of the EU Scientific Committee on Consumer Safety (SCCS) and is responsible for advising the Office for Products Safey and Standards (OPSS) on risk management measures for cosmetic ingredients.

Methyl Salicylate

Methyl salicylate (methyl 2-hydroxybenzoate; CAS No. 119-36-8) is used in a variety of cosmetic products as a flavouring or soothing agent in oral hygiene products or as a fragrance ingredient. It can be found in hair, bath and oral hygiene products, as well as in perfumes and make-up.

Under the GB Classification, Labelling and Packaging (CLP) Regulation, methyl salicylate has recently been classified as follows:

• Reproductive toxicity – category 2

• Acute toxicity – category 4

• Skin sensitiser – category 1B

As the use of substances classified as CMR (Carcinogenic, Mutagenic and Reprotoxic) Category 1A, 1B and 2 (CMR) in cosmetic products is prohibited under the GB CLP Regulation, the UK cosmetics industry submitted a dossier to OPSS to support the safe use of methyl salicylate at certain concentration levels.

Conclusion of the SAG-CS

In its deliberations, the SAG-CS acknowledged the findings of respected bodies such as the Joint FAO/WHO Expert Committee on Food Additives (JECFA), the United States Environmental Protection Agency (US-EPA), the Biopesticides and Pollution Prevention Division of the Norwegian Food Safety Authority (NFSA) and the European Food Safety Authority (EFSA). These organisations have established an Acceptable Daily Intake (ADI) for methyl salicylate of 0.5mg/kg bw/day based on extensive research and toxicity studies.

In addition, the opinion reflects extensive discussions by the SAG-CS on critical aspects such as dermal absorption rates, oral absorption values, metabolism and excretion pathways of methyl salicylate. The Committee also discussed concerns about total exposure to salicylates and emphasised the need for rigorous safety assessments taking into account exposure routes and sources of exposure.

In particular, the safety assessment differentiated between age groups, with particular attention to infants, toddlers, children and adolescents. For example, infants aged 0-0.5 years were excluded from the safety assessment due to insufficient data, while concentration limits were adjusted to ensure adequate safety margins for different age groups.

A summary of the acceptable concentrations of methyl salicylate agreed by the members of the SAG-CS is given in the table below.

Conclusion

In conclusion, the final opinion of the SAG-CS provides a comprehensive framework for the safe use of methyl salicylate in cosmetic products, reflecting a balance between consumer protection and industry interests. Stakeholders are urged to adhere to the prescribed concentration limits in order to effectively maintain consumer safety standards.

For more details  please refer to the SAG-CS opinion here.  

On 10 April 2024, the UK Department for Business and Trade formally notified the World Trade Organization (WTO) of its intention to amend the GB Cosmetics Regulation (Regulation (EC) No 1223/2009), wh...

On 10 April 2024, the UK Department for Business and Trade formally notified the World Trade Organization (WTO) of its intention to amend the GB Cosmetics Regulation (Regulation (EC) No 1223/2009), which applies in England, Wales and Scotland. The proposed amendments aim to regulate the use of certain chemical substances in cosmetic products. The amended regulations will be known as the Cosmetic Products (Restriction of Chemical Substances) (No. 2) Regulations 2024.

The Notice is open for comment for 60 days from the date of notification.

Proposed Regulatory Amendments

Among the proposed amendments, the UK plans to allow the use of kojic acid at a maximum concentration of 1% in certain cosmetic products, namely face and hand products. This follows the publication of the Final Opinion of the Scientific Advisory Group on Chemical Safety in Consumer Products (SAG-CS).

In addition, the amendments will prohibit the use of 52 chemicals that are classified as carcinogenic, mutagenic and reprotoxic (CMR) under the GB Classification, Labelling and Packaging (CLP) Regulation (Regulation (EC) No 1272/2008). The list of chemicals is available here.

The aim of these amendments is to ensure the safety of cosmetic products on the market by adjusting the permitted use of certain chemicals.

Timetable

The amendment is expected to be adopted on 25 June 2024.  Cosmetic products placed on the market on or before 20 April 2025 may continue to be made available on the market until 20 August 2025.

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 in...

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.