UK Regulatory News

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 extension of the UK REACH registration deadlines is now official! The legislation necessary to implement the extension was laid in Parliament by the Department of Environment, Food & Rural Affairs...

The extension of the UK REACH registration deadlines is now official! The legislation necessary to implement the extension was laid in Parliament by the Department of Environment, Food & Rural Affairs (DEFRA) on 20^th April 2023 and the Statutory Instrument (S.I.) 2023 No. 722 that brings it into force was made available from 28^th June 2023. The S.I. 2023/722 will come into force on 19^th July 2023. 

Extensions to the current UK REACH Registration deadlines are as follows:

More information on the extensions can be viewed by visiting the S.I 2023/722 here: The REACH (Amendment) Regulations 2023 (legislation.gov.uk)

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.

On 8 June 2023 UK’s Health and Safety Executive (HSE) published its recommendation to restrict the use of hazardous substances in ink used for tattooing and permanent make-up (PMU) in Great Britain....

On 8 June 2023 UK’s Health and Safety Executive (HSE) published its recommendation to restrict the use of hazardous substances in ink used for tattooing and permanent make-up (PMU) in Great Britain.  The recommendation follows the publication of the final risk assessment opinion in February 2023 and a 60-day public consultation on the draft socio-economic (SE) opinion which ended on 14 April 2023. The Secretary of State for the Department of Environment, Food & Rural Affairs (DEFRA) and the Welsh and Scottish ministers will now have to decide if the restriction should be brought into law.

The proposed restriction aims to protect people from potential harmful effect that can be caused tattoo and PMU ink.  It targets substances with the following classifications:

• CMR (carcinogenic, mutagenic, and reprotoxic)

• Skin sensitisation

• Skin corrosion

• Serious eye damage

The restriction, however, includes a derogation for 19 pigments including Pigment Blue 15:3 and Pigment Green 7. The fact that HSE’s review of these 19 pigments did not find evidence indicating that they are unsafe if used in tattoo or PMU ink combined with the lack of identified alternatives means that it was deemed appropriate to allow the continued use of these 19 pigments. Originally the derogation also included Pigment Red 83 and Solvent Violet 13, but these two substances were removed because the review identified data indicating potential concern for skin sensitisation for these substances.

In the EU restrictions apply to more than 4000 hazardous chemicals contained in mixtures for tattoo inks and permanent make-up since 4 January 2022 and exactly one year later the ban on Pigment Blue 15:3 and Pigment Green 7 came into force.  

This recommendation of restriction is the first made by the HSE after it became the authority in charge of UK-REACH in Great Britain when the UK left the EU. The HSE recommends a transition period of two years to give manufacturers and suppliers time to adapt to the new legal requirements and to test new inks. Furthermore, artists will have one more year to use up old stock and switch to new inks.

On 10 May 2023 the British government presented an amendment to the Retained EU Law (Revocation and Reform) Bill removing the sunset clause that would automatically revoke most retained EU law on 31 D...

On 10 May 2023 the British government presented an amendment to the Retained EU Law (Revocation and Reform) Bill removing the sunset clause that would automatically revoke most retained EU law on 31 December 2023.

Originally the Retained EU Law (REUL) was established by the European Union (Withdrawal) Act 2018 to guarantee legal certainty and continuity in the period after Brexit by keeping all EU and EU-derived law as it was on 31 December 2020 when the UK left the EU.  On 22 September 2022 the Government presented the Retained EU Law (Revocation and Reform) Bill to Parliament. The Bill contains a sunset clause that would revoke the majority of REUL on the 31 December 2023 unless positive steps were taken by the government to keep it. REUL consists of around 4,800 pieces of legislation that must be reviewed before it can be decided if they should be preserved, reformed, or revoked.

The amendment to the Retained EU Law (Revocation and Reform) Bill presented on 10 May removes the sunset clause from the Bill. Instead it presents a list of approximately 600 retained EU laws that the government intends to revoke at the end of 2023. The list contains REUL that is obsolete now that the UK has left the EU. The remaining legislation will be retained but can be revoked or reformed later after proper assessment and consultation. The full list can be found here. It contains a variety of legislation concerning biocides, persistent organic pollutants (POPs), import and export of substances subject to the prior informed consent (PIC) regulation, CLP Annex VIII obligation related to poison centers, food additives and environmental permits.