UK Regulatory News

On 10 November 2023, the UK Department for Environment, Food & Rural Affairs (DEFRA) issued a call for information on a number of proposed persistent organic pollutants (POPs) in advance of a meeting ...

On 10 November 2023, the UK Department for Environment, Food & Rural Affairs (DEFRA) issued a call for information on a number of proposed persistent organic pollutants (POPs) in advance of a meeting of the POPs Review Committee (POPRC). DEFRA is seeking information on chlorpyrifos, medium-chain chlorinated paraffins (MCCPs) and long-chain perfluorocarboxylic acids (LC-PFCAs).

Stockholm Convention

The UK is a party to the UN Stockholm Convention on Persistent Organic Pollutants (POPs), which are substances that persist in the environment, accumulate in living organisms and pose a risk to human health and the environment. POPs can be transported by air, water or by migratory species across international borders, reaching regions where they have never been produced or used. The substances listed in the Convention are generally banned from production, marketing or use, unless specific exemptions or acceptable purposes for continued use are agreed. 

There is a process for Parties to propose a substance for listing if they have gathered evidence suggesting that it may be a POP. The technical scientific committee of the Stockholm Convention (POPRC) will then consider reviews and further develop the evidence that the substance has POP characteristics. 

If there is evidence that a substance has POP characteristics, the POPRC then considers the social and economic impacts of banning or restricting that substance and makes recommendations to the Conference of the Parties of the Stockholm Convention, which is held every 2 years. 

Chlorpyrifos

Chlorpyrifos is an organophosphate pesticide widely used as an insecticide in agriculture and as a biocide to control non-agricultural pests. Chlorpyrifos was banned in the UK in 2016 and in the EU in 2020.  

The POPRC has requested additional information on the socio-economic considerations for chlorpyrifos to support the preparation of a risk management evaluation as specified in Annex F of the Stockholm Convention. The deadline for comments is 24 November 2023 and the request form should be sent to POPs@defra.gov.uk.

Medium chain chlorinated paraffins

Chlorinated paraffins are used as plasticisers for polyvinyl chloride, as extreme pressure additives in metal-machining fluids, as additives to paints, coatings, and sealants to improve their resistance to chemicals and to water, and as flame retardants for plastics, fabrics, paints, and coatings.

Medium-chain chlorinated paraffins (MCCPs) were recommended for listing as POPs under the Stockholm Convention at the 19^th meeting of the POPRC (POPRC-19) in October 2023. The Committee decided to recommend to the Conference of the Parties to consider listing chlorinated paraffins with carbon chain lengths in the range C14–17 and chlorination levels of 45 % chlorine by weight or more in Annex A to the Convention with specific exemptions for some applications.

The Committee has invited Parties and observers to provide information that would assist it in the possible strengthening of the recommendations. The deadline is 24 January 2024 and the information submission forms for MCCPs can be found here.

Long-chain perfluorocarboxylic acids

Long-chain perfluorocarboxylic acids (LC-PFCAs), their salts and precursors have water, oil, dirt and grease repellent properties and can be found in a wide range of products, including personal care products, cleaning products, and surface treatments for textiles, upholstery, leather, automotive parts, carpet and paper products, and packaging. They belong to the group of per- and polyfluorinated substances (PFAS). 

The POPRC has adopted the Risk Management Evaluation of LC-PFCAs, their salts, and related compounds, and recommended that the substances be listed for elimination in Annex A to the Stockholm Convention. The Committee invited Parties and observers to provide information that would assist in the possible definition of specific exemptions for the production and use of LC-PFCAs, their salts and related compounds. The deadline for comments is 24 January 2024 and the information submission forms for LC-PFCAs can be found here.

On 9 November 2023, the UK Department for Environment Food & Rural Affairs (DEFRA) published a policy paper introducing an alternative transitional registration model (ATRm) for chemicals which aims t...

On 9 November 2023, the UK Department for Environment Food & Rural Affairs (DEFRA) published a policy paper introducing an alternative transitional registration model (ATRm) for chemicals which aims to reduce costs for businesses while maintaining DEFRA’s commitment to protecting human health and the environment.

UK-REACH

Following UK’s withdrawal from the EU, a regulatory framework for chemicals in Great Britain (England, Scotland and Wales), known as the UK Registration, Evaluation, Authorisation and Restriction of Chemicals (UK-REACH), was put in place. UK-REACH retains the key principles of EU-REACH and aims to maintain high standards of protection of human health and environmental in Great Britain. EU-REACH continues to apply in Northern Ireland under the terms of the Northern Ireland Protocol.

The Alternative Transitional Registration Model

DEFRA, in collaboration with the Health and Safety Executive (HSE) and the Environment Agency, has introduced an Alternative Transitional Registration Model (ATRm) in response to concerns from UK industry about the financial burden of accessing EU data packages for UK-REACH transitional registrations. The ATRm aims to reduce business costs while prioritising the commitment to protect human health and the environment.

The ATRm is the result of an intensive review process involving industry experts and stakeholders. DEFRA’s aim is to take a more targeted approach using existing information already available in the EU and globally to develop the detailed information held on chemical substances in a more focused way. The review has shown that UK regulators do not need to maintain a full replica of all chemical registration data under EU-REACH in order to carry out their regulatory work effectively.

The Government's ambition is to have a comprehensive view of the use of chemicals in Great Britain to ensure that industry complies with the safe use of chemicals. This approach will enable regulators to assess the risks associated with chemicals and take targeted action where risks are deemed unacceptable. The success of the strategy was demonstrated by the release of the risk management analysis for per- and polyfluoroalkyl substances (PFAS) earlier this year.

DEFRA’s progress to date

DEFRA has made progress in the areas listed below. Proposals are being developed and will be subject of consultation.   

• Refining the details of the 'use and exposure' information required from Great Britain registrants.

• Reducing the hazard information required for transitional registrations and intermediates to the essential minimum so that UK-REACH registrants will not generally need to access and pay for data packages from the EU.

• Significantly reduce the cost to industry associated with buying or accessing EU hazard information.

• Improve the powers of regulators to quickly request and receive data from registrants for regulatory or risk prioritisation purposes, ensuring the ability to respond quickly to new or emerging risks.

• Undertake a review of the current fee structure for UK-REACH to establish a more sustainable funding model, including a possible reduction in the current level of UK-REACH registration fees.

• Revise the UK-REACH restriction processes to provide greater flexibility to respond quickly to identified risks.

Conclusion

The introduction of the ATRm and associated changes will provide a stronger basis for identifying and managing high risk chemicals in Great Britain while addressing the financial burden on businesses during the transition to UK-REACH. Consultations on the detailed policy are expected to take place in early 2024.

On 27 October 2023, the UK Department for Business and Trade notified the World Trade Organisation (WTO) of an amendment to the Cosmetics Regulation to change the permitted levels for the use of butyl...

On 27 October 2023, the UK Department for Business and Trade notified the World Trade Organisation (WTO) of an amendment to the Cosmetics Regulation to change the permitted levels for the use of butylated hydroxytoluene (BHT) in personal care products such as toothpaste and mouthwash. The notification is open for comments for 60 days.

Cosmetics Regulation

The Cosmetics Regulation (1223/2009) contains technical annexes that set out restrictions and prohibitions on the use of certain chemicals. The UK Government has the authority to amend these annexes under certain conditions. The aim of this measure is to ensure that only cosmetic products that are considered safe can be placed on the market in Great Britain (i.e. England, Scotland and Wales).

The amendment

The decision to amend the regulations to change the permissible levels of BHT in various cosmetic products comes after careful consideration of expert advice from the Scientific Advisory Group on Chemical Safety (SAG-CS), a body responsible for providing independent scientific advice on chemical risk.

As a result of the latest assessment and recommendation from the SAG-CS, the UK Government has decided to amend the Regulation concerning the use of butylated hydroxytoluene (BHT), an antioxidant and preservative commonly used in cosmetics. The new amendment allows the use of BHT up to a maximum concentration of 0.1% in toothpastes, 0.001% in mouthwashes and other leave-on oral care products, and 0.8% in all other cosmetic products.

This decision to adjust the permitted levels of BHT in various cosmetic products is in line with the objective of ensuring that only safe cosmetic products are placed on the GB market. It reflects a balance between the use of the chemical and safety considerations for consumers.

Timeline

The proposed date for adoption of the amendment is 16 January 2024. Cosmetic products containing BHT that were already on the market before 6 October 2024, will be allowed to remain on the market until 6 February 2025.

The UK Minister for Social Mobility, Youth and Progress (MfSMYP) has, taken a key decision on the classification and labelling of 98 chemical substances in Great Britain (England, Scotland and Wales)....

The UK Minister for Social Mobility, Youth and Progress (MfSMYP) has, taken a key decision on the classification and labelling of 98 chemical substances in Great Britain (England, Scotland and Wales). This decision was taken after the Secretary of State accepted the recommendations of the Health and Safety Executive (HSE), with the agreement of the Scottish and Welsh Ministers. This move brings significant changes to the GB Mandatory Classification and Labelling (GB MCL) list, which was officially updated on 20 October 2023 under Article 37 of the GB CLP Regulation.

Details of the decision

The Ministerial decision, taken in consultation with the devolved governments, falls under Article 37 of the GB CLP Regulation. This process primarily involves the administrative task of incorporating new and revised GB MCLs into the existing list. Summaries of these updated classifications are now available in the GB CLP publication table which can be found here together with the date of entry into force (20 October 2023) and the date of compliance (20 April 2025).

This decision is based on the scientific and technical evaluation of the available information which identified the intrinsic hazards of these 98 substances. The technical reports of the Health and Safety Executive (HSE) have highlighted these intrinsic hazards, while the impact and policy assessments outlined in the Agency's opinions have not identified any significant impacts.

First proposal

This is the first batch of substances added to the GB MCL after Brexit. The classifications are based on opinions published by the European Chemicals Agency’s (ECHA) risk assessment committee (RAC) in 2019 and 2020 before the end of the Brexit transition period. The proposal was notified to the World Trade Organisation (WTO) in April 2023.

Future proposals

On 24 August 2023, the HSE notified the WTO of their intention to add a second batch of 26 substances to the GB MCL. The list of substances can be found here. The proposed date of adoption for these substances is the first quarter of 2024. The classification would come into force on a voluntary basis at the time of adoption and become mandatory in the third quarter of 2025. A third proposal is expected to come soon.

The UK government published the Guidance on the Management of CMR substances under the UK Cosmetics Regulation, on 5 October 2023. The regulation was published under the guidance of the Office for Pro...

The UK government published the Guidance on the Management of CMR substances under the UK Cosmetics Regulation, on 5 October 2023. The regulation was published under the guidance of the Office for Product Safety and Standards (OPSS) and consists of a guidance document on the management of CMR (carcinogenic, mutagenic, or toxic for reproduction) chemicals present in cosmetics and the application for the exemption process for their continued use. England, Scotland, and Wales come under the scope of these regulations.

The UK Cosmetics Regulation can allow the use of CMRs in cosmetic products with an exemption from the Secretary of State. The regulation essentially covers the exemption procedure and associated timescales for the continued use in cosmetic goods of compounds categorized as carcinogenic, mutagenic, and toxic for reproduction (CMR) under the GB CLP Regulations. These exemptions are granted under the UK Cosmetics Regulation and can only be granted by the Secretary of State (SoS).

The Health and Safety Executive (HSE) has published the two procedures for GB mandatory classification and labeling under Article 37 and Article 37A. The deadline for applications to OPSS for cosmetic product chemicals is 18 months after the Technical Report is published on the HSE GB CLP Publication table. If the submitted exemption dossier needs to be updated, then interested parties can continue to check the data using the following links:

• ECHA website

• ECHA Registry of CLH Intentions until outcome

• ECHA Weekly Newsletter

• HSE GB CLP e-Bulletin

• HSE GB CLP publication table

The OPSS will not send a separate notification for this.

OPSS requests that the original report study and literature review be submitted with the application. OPSS is also committed to maintaining the confidentiality of submitted data.

Exemption applications can be submitted to cmrenquiries@beis.gov.uk via email.

On 11 October 2023, the UK’s Health and Safety Executive (HSE), in collaboration with the Environment Agency published its risk assessment analysis of the risks to humans and the environment from le...

On 11 October 2023, the UK’s Health and Safety Executive (HSE), in collaboration with the Environment Agency published its risk assessment analysis of the risks to humans and the environment from lead in ammunition. The publication follows a consultation to which the HSE received more than 2500 responses. In the risk assessment, the HSE recommends a restriction on the use of lead shot and lead bullets, with some exceptions, for example for outdoor target shooting in international competitions.

Following the publication of the analysis, the HSE's draft socio-economic opinion on the issue has been opened for a 60-day public consultation, and public comments can be submitted via the HSE’s official website.

HSE conclusions

The HSE has concluded that the following risks are not adequately controlled:

• Environment: lead shot (primary and secondary exposure), lead bullets (secondary exposure), and airgun ammunition (primary exposure and secondary exposure).

• Humans: for people who frequently consume large quantities of game shot with lead ammunition (shot or bullets), there is a health risk to vulnerable people, particularly young children and women of childbearing age, which is not being effectively managed.

The HSE is therefore recommending measures to restrict the use and placing on the market of some types of lead ammunition.

Uses and proposed restriction measures

The table below summarises the different uses of lead ammunition and the measures proposed by the HSE. The HSE emphasises that these restrictions do not amount to a total ban on live quarry shooting or target shooting in Great Britain.

Transitional periods

A transitional period of five years is proposed for the placing on the market and use of lead shot cartridges. This will give the manufacturers time to scale up production to replace the quantity of lead shot currently on the market. A transition period of 2 years is proposed for lead bullets for target shooting.

In August 2023, the UK Health and Safety Executive (HSE) recommended not to propose mandatory classification and labelling (MCL) for lithium carbonate, lithium chloride, and lithium hydroxide at this ...

In August 2023, the UK Health and Safety Executive (HSE) recommended not to propose mandatory classification and labelling (MCL) for lithium carbonate, lithium chloride, and lithium hydroxide at this time. This is in contrast to the Opinion on lithium carbonate, lithium chloride and lithium hydroxide adopted by the European Chemicals Agency (ECHA) Committee for Risk Assessment (RAC). The HSE concluded that further assessment of the three substances was necessary.

RAC Opinion on the classification of the three lithium salts

In September 2021 ECHA’s risk assessment committee published the RAC opinion which concluded  that the three lithium salts should be classified under the Classification, Labelling and Packaging Regulation (CLP) as follows:

• Reprotoxic Category 1A; H360D (May damage the unborn child)

• Reprotoxic Category 1B; H360F (May damage fertility)

• Effects on or via lactation; H362 (May cause harm to breast-fed children)

Agency technical report on the classification and labelling of lithium carbonate, lithium chloride, and lithium hydroxide

The HSE Agency Technical Report was published in August 2022. The RAC opinion was used as the basis for this report. The Agency agrees with the RAC that the data presented in the EU Harmonized Classification and Labelling (CLH) report support classification of the lithium salts as Reprotoxic 1A; H360D and Lactation; H362. However, the Agency did not agree that the criteria for classification as Reprotoxic 1B; H360F were also met. Instead, the Agency considered that the available data were more supportive of classification as Reprotoxic 2; H361f (Suspected of damaging fertility).

The Agency Technical Report identified additional information, relevant to the assessment of reproductive toxicity, that was not considered by the RAC during the preparation of the RAC Opinion. The Agency Technical Report also concluded that the inclusion of lithium hydroxide as an entry in the GB MCL list should be further considered in the Agency Opinion. This meets the criteria for triggering the Article 37A procedure and therefore the proposed classification for the three lithium substances requires further consideration and assessment under the Article 37A procedure of the GB CLP Regulation

Agency Opinion

In August 2023 the HSE published the Agency Opinion on the classification and labelling of lithium carbonate, lithium chloride, and lithium hydroxide. In the Agency Opinion it was concluded that the proposed mandatory classification and labelling for the three lithium salts requires further consideration under Article 37A of the GB CLP Regulation. Therefore no mandatory classification and labelling was proposed at that time. The justification for this is based on the need to consider the scientific issues raised in the Agency Technical Report in respect of reproductive toxicity. Furthermore new information that require further assessment has been identified and this information could affect the classification of the three lithium substances.

Facts about the three lithium salts