UK Regulatory News

On August 14, 2023, the Office for Product Safety and Standards (OPSS) of the United Kingdom issued a notification to submit any scientific information relevant to the safety assessment of cosmetic in...

On August 14, 2023, the Office for Product Safety and Standards (OPSS) of the United Kingdom issued a notification to submit any scientific information relevant to the safety assessment of cosmetic ingredients in the list below. Interested parties, including academia, cosmetic product manufacturers, and producers of the substances can submit the information before 15 December 2023. 

List of Chemicals 

The OPSS wants to evaluate the safety of these chemicals in cosmetic products due to their potential endocrine-disrupting properties. Any pertinent data to support the safety and exposure estimates for children and expectant women should be included if components are used in products that are likely to be used by these groups of people. 

Any scientific data submitted for the safety assessment must include all relevant elements as prescribed in the Scientific Committee on Consumer Safety Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation. 

All data used in the safety evaluation must be submitted in full, original study reports and literature. This is crucial for pivotal studies that support the key No Observed Adverse Effect Level (NOAEL) and point of departure as well as the dermal absorption value. The analysis of data is a major undertaking for OPSS, and they will make sure that any material provided to them is subjected to an impartial scientific study. Emails with pertinent information should be sent to opss.safetyassessment@beis.gov.uk.  

Note: 

The Scientific Advisory Group on Chemical Safety (SAG-CS) will use 70 kg as the default body weight for adults in new safety assessments, aligning with other UK groups like the UK Committee on Toxicity of Chemicals.  

The Office for Product Safety and Standards processes information in compliance with UK General Data Protection Regulation (GDPR) and Data Protection Act 2018 (DPA 2018) regulations. Personal data collected is securely held and used for administrative purposes. 

On 14 August 2023, the UK’s Office for Product Safety and Standards (OPSS) published a call for submission of any scientific information relevant to the safety assessment of nanomaterials used in co...

On 14 August 2023, the UK’s Office for Product Safety and Standards (OPSS) published a call for submission of any scientific information relevant to the safety assessment of nanomaterials used in cosmetics.

Details of the call

Any interested parties, including academia, manufacturers of cosmetic products / raw materials, and consumer associations are invited by the OPSS to submit any scientific information relevant to the safety assessment of the following nanomaterials used in cosmetics.

1. Platinum (nano)

2. Copper (nano)

3. Silver (nano), colloidal silver (nano)

4. Gold (nano), colloidal gold (nano), gold thioethylamino hyaluronic acid (nano)

5. Silica (nano), hydrated silica (nano), silica silylate (nano), silica dimethyl silylate (nano)

6. Lithium magnesium sodium silicate (nano)

7. Hydroxyapatite (nano)

Any scientific data submitted for the safety assessment must include all relevant elements as prescribed in the Scientific Committee on Consumer Safety Guidance on the Safety Assessment of Nanomaterials in Cosmetics.

The deadline for submission of data on silica (nano), hydrated silica (nano), silica silylate (nano), and silica dimethyl silylate (nano) is 27 June 2025. Data on all other substances must be submitted by 22 December 2023. Relevant data can be submitted by email to opss.safetyassessment@beis.gov.uk

Background

Article 16 of the UK Cosmetics Regulation mandates the prior notification of cosmetic items that incorporate nanomaterials to the Secretary of State, a minimum of six months before being placed on the market. This obligation can be fulfilled through the utilization of the Submit Cosmetic Product Notification (SCPN) portal.

When dealing with nanomaterials not listed in Annexes IV, V, and VI, these notifications must include additional data on the safety of the nanomaterial for use in cosmetic products.

Notes regarding the call

The Scientific Advisory Group on Chemical Safety (SAG-CS) will use 70 kg as their default bodyweight assumption for adults in new safety assessments. This aligns with other UK groups, carrying out chemical risk assessments across a range of sectors that have agreed that a default adult body weight of 70 kg is representative of the UK adult population. 

The OPSS is asking for original study reports and literature in full to be submitted for all data relied upon in the safety assessment. This is particularly important for the pivotal studies, those which support the critical No Observed Adverse Effect Level (NOAEL) and point of departure and the dermal absorption value.

The office takes the examination of data very seriously and commits to subjecting all provided information to independent scientific review. Cosmetic products available to consumers must be safe for human health. Following the conclusion of the review process the OPSS will take the necessary action to ensure the safety of consumers. This could include but is not limited to prohibiting or restricting specific ingredients if a risk to human health is identified.

On 9 August 2023, the British Health and Safety Executive (HSE) issued an e-bulletin inviting companies to notify the HSE of exports of chemicals in the Great Britain Prior Informed Consent (PIC) List...

On 9 August 2023, the British Health and Safety Executive (HSE) issued an e-bulletin inviting companies to notify the HSE of exports of chemicals in the Great Britain Prior Informed Consent (PIC) List anticipated to occur in 2024.

PIC – Prior Informed Consent

The Prior Informed Consent (PIC) regime in GB regulates the export and import of certain hazardous chemicals listed in 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.

The GB PIC Regulation requires that the initial export of a listed chemical to any country, in any calendar year, to 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.

How to apply for Export Notifications

• Complete a GB PIC export notification form

• Send completed forms to ukdna@hse.gov.uk with the following details in the subject line of the email: GB PIC - notification - company name - chemical/mixture - importing country name - 2024

• Attach only one export notification form and accompanying safety data sheet (SDS) to each email.

• In addition to an SDS in English, an SDS in the official language of the importing country should be provided if available, or in one of its principal languages. 

How to apply for Special Reference Identification Numbers

When exporting PIC chemicals for the purpose of research or analysis in quantities of 10 kg or less per exporter, per year and per importing country, Special Reference Identification Numbers (RINs) are required. A Special RIN is also required where an importing country has waived its right to receive an export notification and has notified a positive import response under the Rotterdam Convention for the chemical being exported. 

Special RIN requests for 2024 can now be submitted as follows:

• Complete a Special RIN request form

• Send the completed forms to ukdna@hse.gov.uk with the following details in the subject line of the email: GB PIC – Special RIN request - company name – chemical/mixture – importing country name – 2024

For exports of PIC chemicals to the EU, each Special RIN covers exports of up to 10kg of the substance for research and analysis purposes to each EU importing country.

Background – The Rotterdam Convention

The UK is a Party to the Rotterdam Convention on the Prior Informed Consent (PIC) procedure for certain hazardous chemicals and pesticides in international trade. The aims of the Rotterdam Convention are:

• To promote shared responsibility and cooperation in international trade of listed hazardous chemicals - through export notifications and the pic procedure.

• To protect human health and the environment by providing countries with information on how to store, transport, use and dispose of hazardous chemicals safely.

The PIC Regulation implements the Rotterdam Convention in GB but goes further by applying the requirements to chemicals that are banned or severely restricted in GB not just those listed in the Convention. You can find further information on the Rotterdam Convention website, including the latest PIC circular.

On 18 August 2023 the Health and Safety Executive (HSE) the United Kingdom (UK) issued an ebulletin listing 15 active substance that must be phased out from biocidal products on the market in Great Br...

On 18 August 2023 the Health and Safety Executive (HSE) the United Kingdom (UK) issued an ebulletin listing 15 active substance that must be phased out from biocidal products on the market in Great Britain (i.e. England, Scotland, and Wales). The decision comes after the active substances have been evaluated under the Great Britain Biocidal Products Regulation (GB BPR).

Biocidal products containing the active substances listed in the table below will no longer be approved in the product types listed in the table. Such biocidal products can no longer be supplied in GB after 15 August 2024 and will be prohibited to use in GB after 15 February 2025. Companies must ensure to remove affected products from the GB supply chain by 15 August 2024. New treated articles containing active substances listed in the table cannot enter the supply chain or be imported into GB after 11 February 2024.

After Brexit an independent biocides regulatory regime, GB BPR, is now in operation in Great Britain (England, Scotland and Wales). The existing EU Biocidal Products Regulation (EU BPR) was copied into GB law and amended to enable it to operate effectively in GB. This means that most aspects of EU BPR continue in the same way under GB BPR that came into force at 11pm on 31 December 2020.

On 6 July 2023 the UK Government published an amendment, the Cosmetic Products (Restriction of Chemical Substances) Regulations 2023, to the retained EU legislation, Regulation (EC) No 1223/2009 (the ...

On 6 July 2023 the UK Government published an amendment, the Cosmetic Products (Restriction of Chemical Substances) Regulations 2023, to the retained EU legislation, Regulation (EC) No 1223/2009 (the Cosmetics Regulation). The amendment is applicable in England, Scotland, and Wales and regards permitted levels of Methyl-N-methylanthranilate (M-N-MA), Bis-(Diethylaminohydroxybenzoyl Benzoyl) Piperazine (HAA299), and HAA299 (nano).

The following restrictions regarding the fragrance ingredient M-N-MA are added to Annex 3 which is a list of substances which cosmetic products must not contain except subject to the restrictions laid down. The regulation comes into force on 6 July 2024 however a cosmetic product that is placed on the market prior to 6 July 2024 can continue to be made available on the market until 6 July 2026.

• For leave-on products the maximum threshold for M-N-MA is 0.1 % and for rinse-off products it is 0.2 %

• M-N-MA is not to be used in leave-on sunscreen products and products marketed for exposure to natural or artificial UV light

• M-N-MA should not be used with nitrosating agents

• Maximum nitrosamine content is 50 µg/kg

• Keep in nitrite-free containers

HAA299 and HAA299 (nano) are added to the list of UV filters allowed in cosmetic products (Annex 6). This regulation comes into force on 28 July 2023.

• The maximum threshold for both substances is 10 %

• In case of combined use of HAA299 and HAA299 (nano), the sum shall not exceed 10 %.

• For HAA299 (nano) only nanomaterials with a purity ≥ 97 % and a median particle size D50 (50 % of the number below this diameter): ≥ 50 nm of number size distribution are allowed.

• HAA299 (nano) is not to be used in applications that may lead to exposure of the end user’s lungs by inhalation.  

On 29 June 2023, the Retained EU Law (Revocation and Reform) Act 2023 received royal assent and is now act of parliament (law). Schedule 1 of the Act lists approximately 600 retained EU laws that will...

On 29 June 2023, the Retained EU Law (Revocation and Reform) Act 2023 received royal assent and is now act of parliament (law). Schedule 1 of the Act lists approximately 600 retained EU laws that will be revoked on 31 December 2023. More details on the amendment can be found here.

The Act revokes Annex VIII of the classification, labelling and packaging (CLP) regulation (poison centres) in Great Britain which had been carried over into GB law in error following the UK’s departure from the EU (Brexit). It had been the plan of the UK government to implement a voluntary scheme for poison centre notifications after Brexit instead of the mandatory provisions under Annex VIII of the EU CLP. Annex VIII requires importers and downstream users in the EU to submit information on hazardous mixtures in form of a Poison Centre Notification (PCN) which allows poison centres to advice citizens or medical personnel in the event of a poisoning.

It is expected that the revocation will have the following implications:

• UK companies will no longer be obligated to provide the full Poison Centre data as specified in Annex VIII.

• The administrative burden for companies will be reduced since compliance with the detailed requirements of Annex VIII can be complex and time-consuming for companies.

• Clarification for the chemical industry in the UK that they will not be required to comply with the specific poison centre data submission requirements outlined in Annex VIII eliminating any potential confusion that may have arisen from its accidental inclusion.

It is expected that a voluntary scheme for poison centre notifications will be implemented where importers and downstream users are encouraged to voluntarily submit information to the National Poison Information Service (NPIS) by using a Safety Data Sheet (SDS).

The full text of the Retained EU Law (Revocation and Reform) Act 2023 can be found here.

The UK Government recently informed Parliament that they will no longer grant licenses for animal testing of chemicals that are exclusively intended for use in cosmetic products. The licensing ban cam...

The UK Government recently informed Parliament that they will no longer grant licenses for animal testing of chemicals that are exclusively intended for use in cosmetic products. The licensing ban came into force on 17 May 2023.

The UK Government is fully committed to minimizing the use of animals in scientific research, whenever scientifically viable, and holds strong confidence in the capabilities of the UK science sector and industry to provide alternative solutions.

This move has positioned the UK at odds with the EU, as the European Chemicals Agency (ECHA) mandates the testing of cosmetics-only ingredients on animals as a last resort to ensure worker and environmental safety within the framework of REACH.

Regarding cosmetic regulations, manufacturers are obligated to demonstrate the safety of their products for consumer use. In 1998, the UK implemented a ban on animal testing for consumer safety of cosmetics and their ingredients, which remains in effect to this day.

However, under the chemicals regulations, known as the Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) regime, chemical manufacturers and importers must prove the potential hazards of the chemicals they place on the market to human health and the environment. This requirement encompasses chemicals utilized as ingredients in cosmetics. In certain instances where no validated alternatives exist, animal testing has been employed as a last resort in the past.

It's important to note that the REACH regime operates separately from consumer cosmetics regulations, serving a distinct purpose. This distinction has allowed for the possibility of animal testing when it comes to chemicals used in cosmetics production. As a result, a limited number of time-limited licenses were issued between 2019 and 2022. The government acknowledges the public's concerns regarding animal testing of cosmetic ingredients and recognizes the newfound opportunities to diverge from the EU testing regime.

Recently, the UK High Court dismissed a legal challenge brought forth by an animal rights organization, which claimed that the government had neglected to communicate its alignment with the EU's approach.