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UK Proposes Ban of 4-MBC and 16 CMR Substances in Cosmetics, and Tightening of Labelling Requirements for Formaldehyde-Releasing Substances

from CIRS by

On October 31, 2025, the UK Government submitted notification G/TBT/N/GBR/107 to the World Trade Organization (WTO), announcing the draft Cosmetic Products (Restriction of Chemical Substances) Regulations 2026 and proposing amendments to the Regulation (EC) No 1223/2009.

The draft proposes the prohibition of 4-Methylbenzylidene Camphor in cosmetic products, the banning of 16 CMR substances, and the tightening of the labelling requirements for formaldehyde-releasing substances. Stakeholders can accept feedback until December 30, 2025.

UK,Ban,Cosmetic,Substance,CMR,Labeling,Formaldehyde

Key Revisions

1. Prohibition of the Use of 4-Methylbenzylidene Camphor in Cosmetic Products

4-Methylbenzylidene Camphor (4-MBC) (CAS Nos. 36861-47-9, 38102-62-4) is currently listed in Annex VI (List of UV filters Allowed in Cosmetic Products) of the UK Regulation No. 1223/2009, with a maximum concentration in ready-for-use preparation of 4% in cosmetic products.

In May 2025, the Scientific Advisory Group of Chemical Safety of Non-food and Non-medicinal Consumer Products (SAG-GS) issued an opinion on 4-Methylbenzylidene Camphor (4-MBC) as a UV Filter in Cosmetic Product. The Members noted concerns with regard to the safety of 4-MBC, including the lack of a robust genotoxicity and reproductive/developmental toxicity package, and concerns with regard to endocrine disruption properties. The Members were not able to derive a safe level for the use of 4-MBC in cosmetics. Given the limited data package available for review, and potential concerns for genotoxicity and endocrine disruption, the SAG-CS could not conclude that 4-MBC is safe for use in sunscreen products and other cosmetic products.

Based on the above assessment opinion, the UK intends to prohibit the use of 4-Methylbenzylidene Camphor in cosmetic products by removing it from Annex VI and including it in Annex II (List of Substances Prohibited in Cosmetic Products) of the Regulation (EC) No 1223/2009.

No.

Chemical Name/INN

CAS No.

EC No.

1744

3-(4-Methylbenzylidene)-d1

camphor/Enzacamene

38102-62-4/36861-47-9

253-242-6

  • Transitional Provision: Cosmetic products containing 4-Methylbenzylidene Camphor cannot be placed on the market in England, Wales, and Scotland from July 15, 2026, and cannot be made available on the market in these regions from January 15, 2027.

2. Prohibition of 16 CMR Substances

The UK intends to include the following 16 substances, classified as CMR (Carcinogenic, Mutagenic, or Reprotoxic) category 1B or 2, in Annex II of the Regulation (EC) No 1223/2009. These substances will be prohibited for use in cosmetic products.

No.

Chemical Name/INN

CAS No.

EC No.

1745

Diphenyl(2,4,6-trimethylbenzoyl)phosphineoxide

75980-60-8

278-355-8

1746

clothianidin (ISO); (E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3

-methyl-2-nitroguanidine

210880-92-5

433-460-1

1747

Dimethyl propylphosphonate

18755-43-6

242-555-3

1748

Dibutyltin maleate

78-04-6

201-077-5

1749

Dibutyltin oxide

818-08-6

212-449-1

1750

2,2’, 6,6’-tetrabromo-4,4’-isopropylidenediphenol; tetrabromobisphenol-A

79-94-7

201-236-9

1751

1,4-Benzenediamine, N,N'-mixed Ph and tolylderivs.

68953-84-4

273-227-8

1752

4-Methylimidazole

822-36-6

212-497-3

1753

Acetone Oxime

127-06-0

204-820-1

1754

Benthiavalicarb isopropyl (ISO); isopropyl [(S)-1-{[(R)-1-(6-

fluoro-1,3-benzothiazol-2-yl)ethyl]carbamoyl}-2-methylpropyl]carbamate

177406-68-7

 

1755

2,3-epoxypropyl neodecanoate

26761-45-5

247-979-2

1756

Multi-walled carbon tubes (synthetic graphite in tubular shape) with a geometric tube diameter range≥ 30 nm to < 3 µm and a length≥ 5 µm and aspect ratio > 3:1, including

MultiWalled Carbon Nanotubes, MWC(N)T

  

1757

7-oxabicyclo[4.1.0]hept-3-ylmethyl 7-oxabicyclo [4.1.0] heptan- 3-carboxylate

2386-87-0

219-207-4

1758

2-(dimethylamino)-2-[(4-methylphenyl)methyl]-1-[4- (morpholin-4-yl)phenyl]butan-1-one

119344-86-4

438-340-0

1759

  1. metolachlor (ISO); 2-chloro-N-(2-ethyl-6-methylphenyl)-N -[(2S)-1-methoxypropan-2-yl]acetamide; (R a S a)-2-chloro-N

-(6-ethyl-o-tolyl )-N-[(1S)-2-methoxy-1-methylethyl]acetamide

[contains 80-100 % 2-chloro-N-(2-ethyl-6-met hylphenyl)-N

-[(2S)-1-methox-ypropan-2-yl]ace tamide and 0-20 % 2-chloro

-N-(2-ethyl-6-met hylphenyl)-N-[(2R)-1-methoxypropan-2

-yl]ace tamide]

87392-12-9

 

1760

Trimethyl borate

121-43-7

204-468-9

  • Transitional Provision: Cosmetic products containing any of the above CMR substances cannot be placed on the market in England, Wales, and Scotland from August 15, 2026, and cannot be made available on the market in these regions from February 15, 2027.

3. Lower Labelling Threshold for Formaldehyde-Releasing Substances

In May 2025, SAG-CS issued an opinion on formaldehyde-releasing substances. Members agreed that a threshold of labelling of formaldehyde-releasing preservatives of 10 mg/kg (10 ppm) or 0.001% would be appropriate to protect consumers based on current scientific evidence when using leave-on or rinse-off products.

Based on the above assessment opinion, for the text in paragraph 2 substitute of Annex V (List of Preservatives Allowed in Cosmetic Products), it would be replaced into the following: “All finished products containing substances in this Annex and which release formaldehyde must be labelled with the warning ‘releases formaldehyde’ where the concentration of formaldehyde in the finished product exceeds 0.001%.”.

  • Transitional Provision: Cosmetic products containing formaldehyde-releasing substances listed in the Annex cannot be placed on the market in England, Wales, and Scotland from July 15, 2026, and cannot be made available on the market in these regions from January 15, 2027.

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Further Information

https://members.wto.org/crnattachments/2025/TBT/GBR/25_07356_00_e.pdf

  

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