UK Regulatory News

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. 

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.