On 28 November 2025, Great Britain notified the WTO of a new amendment to the GB Cosmetics Regulation. This amendment introduces updated restrictions on the use of hexyl salicylate in cosmetic products and expands the list of substances prohibited due to their classification as carcinogenic, mutagenic, or toxic to reproduction (CMRs).
Hexyl Salicylate restrictions: harmonisation and divergence with the EU
Harmonisation
The amendment adds a new entry for hexyl salicylate to Annex III of the GB Cosmetics Regulation. This change is based on the safety opinion issued by the SAG-CS earlier in November.
Although the SAG-CS opinion – unlike the SCCS opinion – did not propose specific restrictions for products intended for young children, the official GB amendment ultimately includes detailed limits for cosmetic products intended for children under three years of age, aligning with the EU approach under Omnibus Act VIII.
Divergence
Despite the overall alignment, some differences remain between the UK and EU approaches:
- More granular product categorisation:
The UK amendment introduces a more extensive set of product categories than its EU counterpart.
- Broader allowances for oral care products for children under 3 years:
In oral care products, the UK permits the use of hexyl salicylate in both toothpastes and mouthwashes for children under three.
In contrast, the EU restriction allows its use only in toothpastes for this age group.
- Warning requirement:
The EU mandates the following warning statement for mouthwashes containing hexyl salicylate: “Not to be used for children under 3 years of age”. This requirement is not included in the UK amendment.
New Annex II entries: additional CMR bans
In addition to the hexyl salicylate restrictions, the amendment introduces 13 new entries to Annex II, banning the use of substances recently classified as CMRs. The new prohibited ingredients are:
- N,N’-methylenediacrylamide (CAS 110-26-9; EC 203-750-9)
- Reaction mass of 1,3-dioxan-5-ol and 1,3-dioxolan-4-ylmethanol
- 1,4-dichloro-2-nitrobenzene (CAS 89-61-2; EC 201-923-3)
- Pyraclostrobin (ISO); methyl N-{2-[1-(4-chlorophenyl)-1H-pyrazol-3-yloxymethyl]phenyl}(N-methoxy)carbamate (CAS 175013-18-0; EC 605-747-1)
- tert-butyl 2-ethylperoxyhexanoate (CAS 3006-82-4; EC 221-110-7)
- Fenpropidin (ISO); (R,S)-1-[3-(4-tert-butylphenyl)-2-methylpropyl]piperidine (CAS 67306-00-7)
- 2-ethylhexanoic acid, monoester with propane-1,2-diol (CAS 85114-00-7; EC 285-503-5)
- α,α’-propylenedinitrilodi-o-cresol (CAS 94-91-7; EC 202-374-2)
- Ozone (CAS 10028-15-6; EC 233-069-2)
- 2-phenylpropene; α-methylstyrene (CAS 98-83-9; EC 202-705-0)
- Silver (nano) [particle diameter > 1 nm and ≤ 100 nm] (CAS 7440-22-4; EC 231-131-3)
- Silver (massive) [particle diameter ≥ 1 mm]
- Dinitrogen oxide (CAS 10024-97-2; EC 233-032-0)
Compliance deadlines
Annex II (CMR bans):
- Products placed on the market before 23 March 2027 that contain any of the newly banned substances may continue to be made available until 22 September 2027.
Annex III (hexyl salicylate restrictions):
- Products placed on the market before 15 August 2026 that contain hexyl salicylate under the previous conditions may continue to be made available until 14 February 2027.
References
WTO. (2025). Draft of the The Cosmetic Products Regulation (Restriction of Chemical Substances) (Amendment and Transitional Provisions) (No.2) Regulations 2026 amending Annexes II & III with new restrictions on Hexyl Salicylate (hexyl 2-hydroxybenzoate) and CMR bans
WTO. (2025). Draft Commission Regulation amending Regulation (EC) No 1223/2009 of the European Parliament and of the Council as regards the use in cosmetic products of certain substances classified as carcinogenic, mutagenic or toxic for reproduction. Retrieved on 21/05/2025.
WTO. (2025). Draft Annex to the Commission Regulation amending Regulation (EC) No 1223/2009 of the European Parliament and of the Council as regards the use in cosmetics products of certain substances classified as carcinogenic, mutagenic or toxic for reproduction. Retrieved on 21/05/2025.
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