Oct-25-2024
On 22 October 2024, the Health and Safety Executive (HSE) published an update on biocide regulation in Great Britain (England, Scotland and Wales), including important deadlines for dossier submissions and renewals in relation to active substance approvals under the GB Biocidal Products Regulation (GB BPR).
Upcoming Dossier Submission Deadlines
In order to keep active substances in the GB Review Programme, specific dossier submission deadlines are approaching. The following active substance/product type combinations, which have already been successfully notified into the Programme, require full dossiers to be submitted by:
5 January 2025: N-didecyl-N-dipolyethoxyammonium borate / didecylpolyoxethylammonium (polymeric betaine) (CAS No 214710-34-6) in product type 8.
17 April 2025: Active chlorine generated from sodium chloride by electrolysis (CAS No 7782-50-5) in product types 2, 3, 4, 5 and 11.
Only designated notifiers or consortia may submit dossiers for these combinations. Stakeholders with a vested interest are encouraged to engage with notifiers and possibly join them in dossier submissions. Failure to meet the submission deadline will result in a GB non-approval decision, effectively banning these substances from biocidal products in the specified categories within the GB.
Consequences of Non-Approval
Without dossier submissions, the affected active substances cannot be used in biocidal products, nor can articles treated with these products be sold on the GB market. Separate updates will be provided for articles affected by non-approval decisions.
Active Substance Renewal Submission Deadline
Under the GB BPR, active substance approvals require a renewal submission 550 days before expiry. The next critical deadline is:
29 April 2025: Polyhexamethylene biguanide hydrochloride (PHMB (1415;4.7)) (CAS No 1802181-67-4 / 32289-58-0) in product types 2 and 4.
Any interested party may submit a renewal application, even if they are not the original supporter. Industry members should consult the GB Article 95 List to verify the original supporters and determine if collaboration is feasible.
Failure to renew by the deadline will result in expired approvals and the removal of these substances from the list of approved biocides in the relevant categories for the GB market.
Oct-08-2024
The UK has made an amendment to its Cosmetic Products (Restriction of Chemical Substances) (No. 2) Regulations 2024, which it notified to the World Trade Organization (WTO) in an addendum on 3 October 2024. This latest amendment introduces restrictions on 13 additional chemicals classified as carcinogenic, mutagenic or reprotoxic (CMR) substances under the GB Classification, Labelling and Packaging (CLP) Regulation (Regulation (EC) No 1272/2008). These changes extend the initial list of 52 prohibited substances to further protect the health and safety of consumers of cosmetic products sold in Great Britain (England, Wales and Scotland).
Original WTO Notification
This addendum builds on the UK's original notification of April 2024, which included:
- Kojic Acid: Allowed at a maximum concentration of 1% in face and hand products, following recommendations from the UK’s Scientific Advisory Group on Chemical Safety (SAG-CS).
- Initial CMR Restrictions: This notification already suggested to prohibit a number of chemicals classified as CMRs under the CLP Regulation, with plans to amend the relevant technical Annexes of the GB Cosmetics Regulation.
Newly Added CMRs
The following table lists the 13 CMRs added in the addendum.
Ref. |
Chemical Name |
CAS no |
1732 |
Benzyl(diethylamino)diphenylphosphonium 4-[1,1,1,3,3,3-hexafluoro-2-(4-hydroxyphenyl)propan-2-yl] phenolate |
577705-90-9 |
1733 |
Benzyltriphenylphosphonium, salt with 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]bis[phenol] (1:1) |
75768-65-9 |
1734
|
Reaction mass of 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol and benzyl(diethylamino)diphenylphosphonium 4-[1,1,1,3,3,3-hexafluoro-2-(4-hydroxyphenyl)propan-2-yl]phenolate (1:1 |
- |
1735
|
Reaction mass of 4,4'-[2,2,2-trifluoro1-(trifluoromethyl)ethylidene] diphenol and benzyltriphenylphosphonium, salt with 4,4'-[2,2,2-trifluoro-1- (trifluoromethyl)ethylidene]bis[phenol] (1:1) |
- |
1736
|
Reaction mass of 1-(2,3-epoxypropoxy)-2,2-bis ((2,3-epoxypropoxy)methyl) butane and 1-(2,3-epoxypropoxy)-2-((2,3-epoxypropoxy)methyl) -2-hydroxymethyl butane |
- |
1737 |
4,4'-[2,2,2-trifluoro-1- trifluoromethyl)ethylidene]diphenol; bisphenol A |
1478-61-1 |
1738 |
Transfluthrin (ISO); 2,3,5,6-tetrafluorobenzyl trans-2-(2,2-dichlorovinyl)-3,3-dimethylcyclopropanecarboxylate |
118712-89-3 |
1739 |
Salts of 2-ethylhexanoic aci |
- |
1740 |
Benfluralin (ISO); N-butyl-N-ethyl-α,α,α-trifluoro-2,6-dinitro-p-toluidine |
1861-40-1 |
1741 |
N,N-dimethyl-p-toluidin |
99-97-8 |
1742 |
4-nitrosomorpholine |
59-89-2 |
1743 |
3,3'-dimethylbiphenyl 4,4'-diyl diisocyanate |
91-97-4 |
1744 |
Foramsulfuron (ISO); 2-{[(4,6-dimethoxypyrimidin-2-yl)carbamoyl]sulfamoyl}-4-formamido-N,N dimethylbenzamide; 1-(4,6-dimethoxypyrimidin-2-yl)-3-(2-dimethylcarbamoyl-5-formamidophenylsulfonyl)urea |
173159-57-4 |
Transitional Provisions
The updated Regulation is expected to be adopted by 25 January 2025. Cosmetic products placed on the market on or before 20 April 2025 may continue to be made available on the market until 20 October 2025. For products containing kojic acid, the corresponding deadlines are 20 June 2025 for placing on the market and 1 November 2025 as the last available date.
Public Consultation
The WTO notification is open for comments for 60 days from the date of notification. More details on the amendments and the full list of chemicals affected can be found here.
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