The regulatory landscape for cosmetic ingredients continues to evolve in both Europe and the United Kingdom. Among the substances subject to stricter assessment is Methyl Salicylate, a well-known aromatic compound valued for its distinctive scent and soothing properties.
At the end of 2023, the United Kingdom announced amendments to its Cosmetics Regulation, introducing specific concentration limits for Methyl Salicylate across several product categories. While many of these restrictions are consistent with the European Union (EU) framework and the opinions of the Scientific Committee on Consumer Safety (SCCS), there are notable differences—particularly concerning products intended for infants and young children.
Understanding these divergences is essential for manufacturers, importers, and responsible persons seeking to ensure compliance, maintain product safety, and secure seamless market access across both regions.
Regulatory Limits for Methyl Salicylate in the UK
The UK Office for Product Safety and Standards (OPSS) notified the World Trade Organization (WTO) of an amendment to the UK Cosmetics Regulation following the final opinion issued in December 2023 by the Scientific Advisory Group on Chemical Safety of Non-Food and Non-Medicinal Consumer Products (SAG-CS).
This amendment establishes specific maximum concentration limits for Methyl Salicylate (CAS 119-36-8, EC 204-317-7) across cosmetic product categories, taking into account the product’s risk profile and the target population (infants, children, or adults).
Methyl Salicylate: Key UK Concentration Limits
| Cosmetic category | Infants (6–12 months) | Children/adults |
| Rinse-off skin/hair products (except hand wash) | 0.02% | 0.06% |
| Hand wash products | 0.02% | 0.6% |
| Leave-on products (non-aerosol) and non-aerosol hair products | 0.02% | 0.06% |
| Lipsticks and balms | 0.02% | 0.03% |
| Face make-up | — | 0.05% |
| Eye make-up and removers | — | 0.02% |
| Toothpaste | — | 2.5% |
| Mouthwash | — | 0.1–0.4% |
| Hydroalcoholic perfumes | — | 0.6% |
| Deodorant aerosols | — | 0.003% |
| Hair sprays | — | 0.009% |
| Body lotion sprays | — | 0.04% |
Implementation deadlines:
- From 30 September 2025: non-compliant products may no longer be placed on the UK market.
- By 31 March 2026: all non-compliant products already available must be withdrawn.
Comparison With The European Framework
Within the European Union, Methyl Salicylate is regulated under Annex III of Regulation (EC) No 1223/2009, based on the scientific opinions of the SCCS, which set concentration limits by product category but generally without age segmentation.
Main Limits In The European Union
- 1- Up to 0.06% in leave-on skin and hair products (non-aerosol).
- 2- 0.05% in face make-up.
- 3- 0.002% in eye make-up and removers.
- 4- Up to 0.009% in hair sprays, 0.003% in deodorant aerosols, 0.04% in body sprays, and 0.6% in hydroalcoholic fragrances.
- 5- Up to 0.6% in hand wash and rinse-off products.
- 6- Up to 2.52% in toothpaste.
The UK adopts most of these maximum levels but introduces tighter limits in categories intended for infants (6–12 months)—a level of detail not explicitly present in the EU framework.
Children’s Products: The Most Significant Divergence
The main regulatory differences between the EU and UK frameworks are found in products for children.
- In the EU, according to the SCCS opinion (2023), Methyl Salicylate at 0.02% is considered safe for children aged 0.5 to 3 years across various product types (such as shower gels, lip balms, or lotions), excluding toothpaste, which may contain up to 2.52%.
- In contrast, the UK introduces a more granular system, defining separate limits for infants (6–12 months) and older children, depending on the cosmetic category.
This approach demonstrates a more conservative risk assessment by UK authorities, reflecting their focus on enhanced protection for vulnerable age groups.
SCCS Update In 2025
In May 2025, the SCCS released updated scientific advice confirming and expanding on its 2023 conclusions:
- Except for toothpaste, Methyl Salicylate concentrations should not exceed 0.02% in cosmetics intended for children aged 0 to 3 years.
- For toothpaste, concentrations up to 0.4% are considered safe for this age group.
This update reinforces the EU’s position and provides a stronger scientific foundation for maintaining the 0.02% limit in children’s cosmetics.
📄 Read the full SCCS Opinion (2025)
Methyl Salicylate: CMR Classification and Use Conditions
Methyl Salicylate is classified as a Category 2 reproductive toxicant (CMR 2) both in the EU and in the UK.
Under Regulation (EC) No 1223/2009, ingredients classified as CMR are prohibited, unless an exemption is granted following a positive SCCS safety assessment.
The UK follows a similar approach under its GB CLP Regulation, allowing the use of Methyl Salicylate in cosmetics only under specific exemption conditions with strict concentration limits.
Compliance Deadlines for Methyl Salicylate Rules
- European Union: the Omnibus V regulation (December 2022) established that non-compliant products could no longer be marketed or made available after that date.
- United Kingdom: provides a longer transitional period (September 2025 / March 2026), giving companies more time to reformulate products—but requiring early planning to ensure compliance.
This discrepancy means that manufacturers aiming to operate in both markets must align production and labeling strategies in advance.
Strategic Recommendations For The Cosmetics Industry
Companies operating in both jurisdictions must pay close attention to the regulatory differences between the EU and the UK to avoid compliance gaps.
- Review Formulations
Ensure that Methyl Salicylate concentrations comply with the most restrictive applicable limit in each market. - Plan For Dual Compliance
Products designed for infants and children may require specific formulations for the UK and EU to meet respective regulatory thresholds. - Update Safety Dossiers
Safety assessments should explicitly consider cumulative exposure to salicylates across multiple product types, as emphasized by the SCCS. - Start Compliance Reviews Early
With UK deadlines approaching, companies should begin regulatory reviews and toxicological validations as soon as possible. - Maintain Continuous Monitoring
Regulatory updates from the SCCS and UK advisory groups may lead to further changes. Ongoing vigilance is essential to anticipate new obligations.
Conclusion
The new restrictions on Methyl Salicylate in the United Kingdom—alongside the already established framework in the European Union—illustrate how scientific risk assessments rapidly translate into regulatory obligations.
For cosmetic companies, this evolution requires anticipation, reformulation, and continuous regulatory monitoring. While managing two sets of standards can be complex, it also provides an opportunity to strengthen compliance strategies and build consumer trust through transparency and proactive adaptation.
At SHAPYPRO, we specialize in regulatory consultancy for the cosmetics industry. We help laboratories and brands adapt formulations, ensure compliance with both UK and EU regulations, and plan ahead for upcoming implementation deadlines.
If you need personalized guidance to secure compliance and market access, visit our certificates section or contact our regulatory team.