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In the post-Brexit era, the United Kingdom has transitioned from a follower of EU mandates to a proactive legislator.
Early 2026 has already proven to be a watershed year for regulatory updates. In February, the UK government promptly introduced a second major update: The Statutory Instruments 2026 No. 109.
This update provides implications for CMR substances, the specific case of Hexyl Salicylate, and the critical timelines your brand must adhere to maintain market access.
The landscape of UK cosmetic autonomy in 2026
Since the end of the Brexit transition period, the Office for Product Safety and Standards (OPSS) has been busy establishing its own scientific review processes. SI 2026/109 is a direct output of this independent oversight. It reflects the UK’s commitment to consumer safety, particularly regarding substances classified as Carcinogenic, Mutagenic, or toxic for Reproduction (CMR).
Under Article 15 of the UK Cosmetics Regulation (Regulation (EC) No 1223/2009 as it applies in GB), the use of CMR substances is generally prohibited unless a specific exemption is granted. SI 2026/109 formalizes these prohibitions for a new batch of substances and, crucially, establishes the conditions for an exemption that industry has fought hard to secure.
The CMR framework: why it matters
A CMR classification is one of the most significant hurdles for a cosmetic ingredient. When the GB CLP Regulation (Classification, Labelling and Packaging) updates its list of hazardous substances, the cosmetic industry must react. If an ingredient used in your formulations is newly classified as a CMR, it will be automatically banned from cosmetics unless a safety dossier is submitted and approved by the UK’s Scientific Advisory Group on Chemical Safety (SAG-CS).
Hexyl Salicylate: a case study in regulatory defense
The most significant portion of SI 2026/109 concerns Hexyl Salicylate (CAS 6259-76-3), a popular fragrance ingredient with a sweet, floral, and fruity aroma.
Hexyl Salicylate was classified as a CMR Category 2 (suspected of damaging fertility or the unborn child) and a skin sensitizer. Under normal circumstances, this would lead to a total ban (Annex II). However, the industry submitted a robust safety dossier to the OPSS. After a thorough review, the SAG-CS issued an opinion concluding that the substance is safe for consumers under specific conditions.
As a result, SI 2026/109 does not ban Hexyl Salicylate but instead adds it to Annex III (Restricted Substances). This is a major win for fragrance houses, but it comes with strict concentration limits that vary by product type and consumer age.
New concentration limits for Hexyl Salicylate
- a) Fragrance products (spray and non-spray).
- (1) 0.1% (products intended for children 0–3 years).
- (2) 2% (products intended for children above 3 years and adults).
- b) Rinse off skin and hair products.
- (1) 0.1% (products intended for children 0–3 years).
- (2) 0.5% (products intended for children above 3 years and adults).
- c) Leave-on skin products (except fragrance products, face makeup products, lip products, and deodorants (spray and non-spray)).
- (1) 0.1% (products intended for children 0–3 years).
- (2) 0.3% (products intended for children above 3 years and adults).
- (d) Lip products.
- (1) 0.1% (products intended for children 0–3 years).
- (2) 0.3% (products intended for children above 3 years and adults).
- e) Deodorant (spray and non-spray).
- 0.3% (products intended for children above 3 years and adults).
- f) Leave-on hair products (spray and non-spray).
- 0.3% (products intended for children above 3 years and adults).
- g) Face makeup products.
- 0.3% (products intended for children above 3 years and adults).
- h) Toothpaste and mouthwash.
- 0.001%
- i) Nail products.
- 0.5% (products intended for children above 3 years and adults).
Note: The UK’s limit of 0.5% for nail products is a specific divergence from the EU’s recent restrictions. If you are a global brand, you must ensure your “Global Formula” satisfies both the EU and the UK’s varying thresholds.
Annex II: the new prohibitions
While Hexyl Salicylate found a home in Annex III, 17 other substances were not so fortunate. SI 2026/109 adds these to Annex II, making them strictly prohibited in cosmetic products placed on the GB market.
These substances were classified as CMRs and did not meet the criteria for exemption (often because no industry defense was mounted or the safety data was insufficient). The entries to be inserted into Annex 2 are:
- 1761 – Sodium 3-(allyloxy)-2-hydroxypropanesulphonate
- 1762 – N,N’-Methylenediacrylamide
- 1763 – Reaction mass of 1,3-dioxan-5-ol and 1,3-dioxolan-4-ylmethanol
- 1764 – 1,4-Dichloro-2-nitrobenzene
- 1765 – Pyraclostrobin (ISO); methyl N-{]2-{[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxymethyl}phenyl[} N-methoxy carbamate
- 1766 – Tert-Butyl 2-ethylperoxyhexanoate
- 1767 – Fenpropidin (ISO); (R,S)-1-[3-(4-tert-butylphenyl)-2- methylpropyl]piperidine
- 1768 – 2-Ethylhexanoic acid, monoester with propane-1,2-diol
- 1769 – α,α’-Propylenedinitrilodi-o-cresol
- 1770 – Ozone
- 1771 – 2-Phenylpropene; α-methylstyrene
- 1772 – Silver (nano) [particle diameter > 1 nm ≤ 100 nm] and Silver (massive) [particle diameter ≥ 1 mm]
- 1773 – Dinitrogen oxide
While many of these are not “mainstream” cosmetic ingredients, they can appear as impurities or residuals in raw materials. Don’t just check your INCI list; check your raw material specifications and “Trace Impurities” sections of your Safety Data Sheets (SDS).
Timelines: the critical compliance windows
One of the most complex aspects of SI 2026/109 is its “staggered” implementation. The UK government provides two different sets of dates depending on whether the substance is a restriction (Hexyl Salicylate) or a total prohibition (Annex II CMRs).
- Hexyl Salicylate (Annex III)
- Placing on the Market: From 15th August 2026, any new products containing Hexyl Salicylate must comply with the new concentration limits.
- Making Available (Withdrawal): From 15th February 2027, any products already on the shelves that exceed the limits must be withdrawn.
- New CMR Prohibitions (Annex II)
- Placing on the Market: From 23rd March 2027, no new products containing these 17 substances can be introduced to the GB market.
- Making Available (Withdrawal): From 22nd September 2027, all such products must be removed from the supply chain.
Divergence: UK vs. EU (the Omnibus VIII factor)
For years, the industry relied on “Omnibus” regulations from the EU to update CMRs. Now, we are seeing the emergence of UK-specific “Omnibus” updates.
While the EU’s Regulation (EU) 2026/78 covers similar ground, the UK’s SI 2026/109 creates a “time lag” and specific technical differences. For example, the UK’s review of Hexyl Salicylate took a slightly different approach to exposure margins than the EU’s SCCS, resulting in the 0.5% limit for nail products mentioned earlier.
This divergence means that a product compliant in Paris might be non-compliant in London by the end of 2026. As your UK Responsible Person, Cosmeservice ensures that your portfolio is audited against both sets of criteria to avoid costly customs rejections or product recalls.
Conclusion: navigating 2026 with confidence
Statutory Instrument 2026 No. 109 is a clear signal that the UK regulatory environment is maturing. While the rules are becoming more complex, they also offer opportunities for proactive brands. The exemption for Hexyl Salicylate shows that the UK is willing to listen to industry scientific evidence, provided it is robust. To ensure your brand remains compliant with SI 2026/109, we recommend auditing your portfolio, identifying any products containing Hexyl Salicylate or the 17 newly banned CMRs.
At Cosmeservice, we don’t just tell you what the law is; we help you implement it. From acting as your legal UK Responsible Person to conducting technical PIF and safety assessments, we are the bridge between you and the market. Don’t let the 2026 deadlines catch you off guard. The “Great British Divergence” is here, and your brand deserves an expert guide.
FAQs
What is UK SI 2026/109?
SI 2026/109 is a Statutory Instrument that amends the retained UK version of the Cosmetics Regulation (EC) No 1223/2009. It restricts Hexyl Salicylate under Annex III and bans 17 other substances newly classified as CMR under Annex II, following review by the OPSS and the SAG-CS.
When do the new Hexyl Salicylate limits apply in the UK?
New products containing Hexyl Salicylate must comply with the new concentration limits from 15 August 2026. Products already on the market that exceed the limits must be withdrawn by 15 February 2027.
When do the 17 newly banned CMR substances take effect?
No new products containing these substances may be placed on the GB market from 23 March 2027, and any remaining products must be withdrawn from the supply chain by 22 September 2027.
Is Hexyl Salicylate banned in the UK?
No. Unlike a full CMR ban, Hexyl Salicylate was granted a conditional exemption after industry submitted a safety dossier to the OPSS. It is now a restricted substance under Annex III, with concentration limits that vary by product type and the age of the intended user.
Does SI 2026/109 match the EU’s CMR rules for Hexyl Salicylate?
Not exactly. While the EU’s Regulation (EU) 2026/78 covers similar ground, the UK’s SAG-CS took a different approach to exposure margins, resulting in a 0.5% limit for nail products that diverges from the EU’s threshold. Brands selling in both markets need a formula that satisfies both sets of limits.
