UK Regulatory News

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.

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.

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.

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

On 5 September 2023, the UK Health and Safety Executive (HSE) announced the publication of new guidance on how to meet aspects of the residue data requirements. The new guidance will apply from 1 Janu...

On 5 September 2023, the UK Health and Safety Executive (HSE) announced the publication of new guidance on how to meet aspects of the residue data requirements. The new guidance will apply from 1 January 2024. The guidance is referred to as the ‘GB Extrapolation Guidance 2024’ and only applies to Great Britain (England, Scotland, and Wales).

GB Extrapolation Guidance 2024

The purpose of GB Extrapolation Guidance 2024 is to advice applicants on the requirements for residue trials data to support the registration of plant protection products (PPP) and for setting maximum residue levels (MRLs) in Great Britain (GB). The guidance sets out the technical requirements in the following areas:

• the data and information requirements for residue trials, e.g. trial location, number of residue trials, etc

• the comparability of residue trials and deviations from Good Agricultural Practice (GAP)

• the extrapolation of residue data for products of plant and animal origin

• the establishment of maximum residue levels (MRLs)

The preview of the GB Extrapolation Guidance 2024 can be found here. It replaces the previous version of the extrapolation document SANCO 7525/VI/95 Rev. 10.3.

On 24 August 2023, the United Kingdom’s Health and Security Executive (HSE) notified the World Trade Organization (WTO) on the amendment of the Great Britain mandatory classification and labelling l...

On 24 August 2023, the United Kingdom’s Health and Security Executive (HSE) notified the World Trade Organization (WTO) on the amendment of the Great Britain mandatory classification and labelling list (the GB MCL list), following review, by introducing new and revised entries for the mandatory classification and labelling of 26 hazardous chemical substances. The last day for comments is 60 days from the notification date.

Classification in Great Britain

Substances and mixtures placed on the GB market must be classified and labelled in line with the GB Classification, Labelling and Packaging (CLP) Regulation. There are two kinds of classification:

• Mandatory classification stands for a classification that has been made legally binding within Great Britain. It aligns with the 'harmonised classifications' established under EU CLP. The mandatory classifications and the accompanying hazard labelling (MCL) are listed in the GB mandatory classification and labelling list (GB MCL list). In cases where a substance possesses an MCL for some or all hazard classes, suppliers to the GB market are obligated to implement this classification.

• Self-classification involves the supplier collecting and assessing all accessible data, subsequently matching it against the classification criteria. Self-classification applies to all mixtures, and to substances which do not have a mandatory classification. Substances which do have a mandatory classification are still subject to self-classification for any hazard classes not covered by that mandatory classification.

GB MCL Technical Reports

Links for the GB MCL technical reports for the 26 hazardous substances can be found here. A GB MCL technical report is an independent scientific evaluation of the information submitted under the GB MCL process or as part of the EU harmonised classification and labelling process. The reports outline if there is adequate scientific evidence to support a new or revised GB MCL of a substance. 

This batch of GB MCL technical reports relate to substances for which the Committee for Risk Assessment (RAC) published a RAC Opinion under Article 37(4) of EU CLP during 2022 and 2023, based on information submitted under the EU CLP Regulation. The scientific information supporting the RAC Opinion is evaluated under the GB MCL system. 

Next steps

The amendment is expected to be adopted in the first quarter of 2024 and is expected to become mandatory by the third quarter of 2025. 

The next batch of technical reports is expected to be published in late November 2023. CLP ebulletin alerts will be issued when technical reports are published on the HSE website.