UK Regulatory News

The UK government has extended the deadline of the public consultation on proposals to amend the current transitional provisions under UK-REACH by introducing an Alternative Transitional Registration ...

The UK government has extended the deadline of the public consultation on proposals to amend the current transitional provisions under UK-REACH by introducing an Alternative Transitional Registration model (ATRm) until 25 July 2024. Launched on 16 May 2024, the consultation seeks to gather stakeholder opinions on proposed changes to the UK-REACH framework, aiming to reduce costs for businesses transitioning from the EU- REACH regime while maintaining health and environmental protections.

Key Proposals to Improve UK-REACH

Key proposals include reducing duplication, speeding up decision-making, and introducing measures to minimize animal testing. The consultation also addresses changes to the restriction and reporting processes and assesses impacts on trade.

Stakeholders, particularly those from chemical businesses and related sectors, are encouraged to participate and provide their views. The feedback will inform future legislative changes, supported by a Statutory Instrument and impact assessment, to be introduced after a second consultation.

For more information and to participate, visit the Defra website here.

On 1 May 2024, the UK Department for Environment, Food and Rural Affairs (DEFRA) notified the World Trade Organization (WTO) of the draft Producer Responsibility Obligations (Packaging and Packaging W...

On 1 May 2024, the UK Department for Environment, Food and Rural Affairs (DEFRA) notified the World Trade Organization (WTO) of the draft Producer Responsibility Obligations (Packaging and Packaging Waste) Regulations 2024, which aims to improve recycling and waste reduction efforts in the UK. Stakeholders and interested parties are invited to submit comments on the draft regulations within 60 days of the date of notification.

Some Background

The regulations heave been developed following extensive consultations, which took place in May 2019, March 2021, and July 2023. These consultations incorporated feedback from a range of stakeholders and focused on reforming the UK's packaging producer responsibility system and aligning it with wider environmental objectives.

Objectives

The UK Government's primary objective is to protect the environment by encouraging better use of resources and reducing waste. The introduction of a single, widely recognised recycling label, will make it easier for consumers to recycle correctly, ultimately supporting the country's environmental objectives.

Scope and Requirements

The new regulations will require businesses to label packaging with either "Recycle" or "Do Not Recycle" next to a specified logo. This requirement will apply to certain categories of businesses, including importers and manufacturers of packaged products in the UK. The intention is to provide clear and consistent recycling information to consumers, thereby improving recycling rates and reducing environmental impact.

• Products covered: The Regulation covers a wide range of packaging materials including plastics, paper, glass, textiles, ceramics, and metals.

• Primary and shipment packaging: The labelling requirement applies to both primary packaging (packaging that constitutes a sales unit to consumers) and shipment packaging (additional packaging used for online and mail order sales).

• Recyclability information: Manufacturers and importers of unfilled packaging for supply to another business must inform the businesses about the recyclability of their packaging to ensure accurate labelling.

Implementation Timeline

The adoption date for this regulation is set for 1 January 2025. The regulation will come into force on 1 April 2027. However, businesses will have the option to comply earlier if they wish. This phased timeline is designed to give businesses sufficient time to adapt to the new requirements and ensure a smooth transition.

The UK Department for Environment, Food and Rural Affairs (DEFRA) published a consultation on 6 May 2024 on proposals to amend the current transitional provisions under UK REACH by introducing an Alte...

The UK Department for Environment, Food and Rural Affairs (DEFRA) published a consultation on 6 May 2024 on proposals to amend the current transitional provisions under UK REACH by introducing an Alternative Transitional Registration model (ATRm). This initiative aims to reduce costs for companies transitioning from the EU REACH system to the UK REACH system, while maintaining existing protections for human health and the environment. The consultation will run for 8 weeks and will close on 11 July 2024.

Proposals for the Alternative Transitional Registration Model

DEFRA, in collaboration with the Health and Safety Executive (HSE) and the Environment Agency (EA), has developed the Alternative Transitional Registration model (ATRm) for UK REACH. This model aims to maintain current health and environmental protections by improving the quality of information on substance use and exposure in Great Britain. The ATRm aims to reduce business costs through a number of specific measures as follows:

Hazard requirements:

• Significantly reduce the hazard information required in registrations for transitional substances.

• Apply these revised hazard requirements to substances on the market before the end of the Exit Implementation Period.

• Maintain full hazard information requirements for new substances placed on the market after this date.

Use and exposure information:

• Improve the level of detail required on the use and exposure of substances in Great Britain.

Chemical Safety Reports:

• Propose reduced hazard requirements in Chemical Safety Reports (CSRs) for substances manufactured or imported in quantities above 10 tonnes per year.

Transitional evaluations:

• Allow the regulatory agency (HSE) to request and receive data from registrants for regulatory or risk prioritization purposes to respond to new or emerging risks.

Compliance checks:

• Conduct compliance checks on at least 20% of registrations.

• Focus on specific uses, exposures or other parameters to ensure compliance with hazard and new use and exposure information requirements.

Publication of data:

• Review and revise the “hazard data” included in the Public Register for substances under the ATRm.

Substance groups, data sharing, and joint data submission:

• Organize registrants of the same substance into Substance Groups for data sharing and joint submission of intrinsic properties, including hazard classifications.

• Formalize practical arrangements already in place under the EU-REACH registration process.

Stakeholder feedback on these detailed proposals is being sought in order to refine and implement these changes effectively. Further details of the ATRm policy proposals and the corresponding consultation questions can be found in the consultation document.

Improving UK-REACH restriction and reporting processes and protection against animal testing

In addition to the ATRm, the consultation also addresses potential improvements to the UK-REACH restriction and reporting processes. Proposals include streamlining the statutory consultation requirements to speed up decision-making and reducing the administrative burden on the regulatory agency. Specific measures are also proposed to further protect against unnecessary animal testing, either through legislation or supporting guidance. These measures will reinforce the principle of animal testing as a last resort, ensuring that such tests are only used when absolutely necessary.

Consultation and Legislative Process

This consultation provides an opportunity for stakeholders to express their views on significant policy changes. The feedback will be used to develop the legislative changes needed to implement these proposals. This initial consultation, will be followed by a second round, supported by a Statutory Instrument and a comprehensive impact assessment. This process is part of a wider effort to ensure that UK-REACH remains effective and aligned with the objectives set out in the Environment Act 2021. Before or alongside the second consultation, the Government will publish an explanation of why the proposed regulations are consistent with Article 1 of UK REACH, ensuring transparency and alignment with legislative standards.

Background and context

Since leaving the EU, the UK has established its own independent chemicals management system, including UK-REACH. This system retains the basic approach and key principles of the EU-REACH Regulation and aims to ensure a high level of protection for human health and the environment. Companies have been given a transitional period to submit their data to the HSE, but the high cost of purchasing or accessing EU hazard data has raised concerns about the potential impact on the availability of substances on the Great Britain market. The Government’s proposals, including the ATRm, aim to address these issues by reducing costs and maintaining regulatory protection.

More information is available in the consultation document: UK REACH Consultation 2024.

The Department for Environment, Food and Rural Affairs (Defra) has published the UK Government's official response to the consultation on potential amendments to the Persistent Organic Pollutants ...

The Department for Environment, Food and Rural Affairs (Defra) has published the UK Government's official response to the consultation on potential amendments to the Persistent Organic Pollutants (POPs) Regulation. The consultation was held from 2 March to 27 April 2023 and received extensive feedback from stakeholders across a range of sectors.

Description of Consultation

The proposed changes and calls for evidence in the consultation were as follows:  

• Amend and/or add POPs waste concentration limits for several POPs.

• Remove specific exemptions for several POPs.

• Add unintentional trace contaminant (UTC) exemption levels for at least two POPs.

• Amend and/or remove UTC exemptions for perfluorooctanoic acid (PFOA).

• Add a new toxic equivalency factor (TEF) for a POP (dioxin-like polychlorinated biphenyls (PCBs)).

• Amend maximum concentration limits (derogations for permanent waste storage) for several POPs.

Consultation Outcome

The newly published response provides a comprehensive overview of the outcome of the consultation, including a detailed summary of all responses received. It underlines the UK Government's commitment to take forward several of the proposed amendments to the POPs Regulation, reflecting its commitment to protecting the environment and public health.

DEFRA’s analysis showed that the majority of respondents supported the proposed amendments outlined in the consultation, with some providing supplementary evidence to assess potential impacts. However, there was some opposition to some of the proposals, which prompted careful consideration of the feedback. Although calls for further evidence resulted in some additional information, areas of evidence gaps and uncertainty were highlighted. Details of the responses and the government’s response can be found here.

Next Steps

Having considered all the responses and taking into account the global context and developments in international conventions, DEFRA intends to proceed with a number of proposed changes to the POPs Regulation as soon as parliamentary time allows. These changes include:

• New waste concentration limits for PFOA, PFHxS, PCP and Dicofol, and revised limits for PBDEs.

• New maximum concentration limits for PFOA, PFHxS, PCP and Dicofol and revised limits for PBDEs, and additional European Waste Catalogue (EWC) codes in Annex V.

• New UTC limits or amendments to existing limits for PFOA, PCP and HCB.

• Finalisation of expiry dates for existing specific exemptions for PFOA.

DEFRA will continue to consider further potential amendments to the POPs Regulation in the future, taking into account new evidence and relevant international decisions and guidance, e.g. from the Stockholm and Basel Conventions.

On 15 April 2024, the Health and Safety Executive (HSE) launched a call for comments and relevant information on a number of copper substances. The reason for the consultation is that the Great Britai...

On 15 April 2024, the Health and Safety Executive (HSE) launched a call for comments and relevant information on a number of copper substances. The reason for the consultation is that the Great Britain Mandatory Classification and Labelling (GB MCL) process includes consideration of information gathered from public consultations conducted by the HSE or international bodies such as the European Chemicals Agency (ECHA). Comments can be submitted to the online survey here until 16 June 2024.

Substances covered 

The copper substances that are the focus of this MCL consultation (see table below) all have entries on the GB MCL list and are all classified for acute toxicity. However, they have not been assigned Acute Toxicity Estimate (ATE) values. The GB MCL proposal was developed using information submitted as part of the EU harmonised classification and labelling process. References can be found here in section 11 of the MCL report.

Stakeholder involvement

The HSE encourages anyone with relevant information such as scientific or technical information relating to the proposed classification, as well as positive and negative information about the potential impacts of the classification, to participate in the consultation. For more information on how to submit information to the public consultation, please visit the GB MCL web pages on the HSE website.

Under the GB Classification, Labelling and Packaging (CLP) Regulation, the HSE will consider all public consultation submissions before publishing Agency Technical Reports and Agency Opinions on the substances, so any information provided will be important in any final GB MCL decision.

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.