EU Plans to Approve Hexyl Salicylate as Fragrance Component and Adjust Regulatory Requirements for Silver
On May 21, 2025, the World Trade Organization (WTO) issued Notification G/TBT/N/EU/1140 submitted by the European Commission, disclosing details of the revised draft of the EU Cosmetic Regulation (EC) No. 1223/2009 regarding a new batch of CMR substances. The components covered by this draft amendment (including hexyl salicylate, silver, o-phenylphenol, perboric acid, etc.) were confirmed by EU Commission Delegated Regulation (EU) 2024/2564 and will be regulated as CMR substances effective May 1, 2026. Below are partial entries from the published notification.
Hexyl Salicylate
Hexyl salicylate, INCI name Hexyl salicylate, CAS No. 6259-76-3, is classified as a Category 2 CMR substance (reprotoxic) under Delegated Regulation (EU) 2024/2564. At present, there are no regulatory provisions related to hexyl salicylate in the EU cosmetics regulations.
Regarding the safety of hexyl salicylate in cosmetics, the EU Scientific Committee on Consumer Safety (SCCS) issued Opinion SCCS/1668/24 in October 2024 (Supplement to SCCS/1658/23 on the Scientific Opinion on hexyl salicylate - exposure for children aged 0-3), that, considering toxicological endpoints including endocrine disruption, products containing hexyl salicylate at the following concentrations are safe for children aged ≤3 years:
- Maximum 0.1% (w/w) in shower gel, hand soap, shampoo, conditioner, body lotion, face cream, hand cream, lipstick/lip balm, perfume.
- Maximum 0.001% (w/w) in toothpaste.
Since hexyl salicylate meets the conditions for exemption from the use of CMR substances in cosmetics (i.e., Category 2 CMR substances deemed safe by SCCS assessment), the EU will regulate it under the List of Restricted Substances effective May 1, 2026.
Silver
Silver, English name Silver, CAS number 7440-22-4, is an approved colorant (Colour Index No. 77820) for cosmetics authorized by the EU, and is regulated by the EU Cosmetics Regulations. In March 2024, the EU adopted Amendment (EU) 2024/858, prohibiting nano colloidal silver (particle size 1–100 nm).
Three forms of silver were identified as Category 2 CMR substances (reprotoxic) under Delegated Regulation (EU) 2024/2564:
- Massive silver (particle size ≥ 1 mm)
- Silver powder (100 nm < particle size < 1 mm)
- Nano silver (1 nm < particle size ≤ 100 nm)
In July 2024, SCCS issued Opinion SCCS/1665/24 on the safety of silver in cosmetics, pointing out that micron-sized particulate silver is safe at the following concentrations when used alone or in combination in eye shadow and oral products (lip balm, toothpaste, mouthwash):
| Product Type | Max. Allowed Concentration |
|---|---|
| Eye shadow | 0.2% |
| Lip balm | 0.2% |
| Adult toothpaste | 0.05% |
| Children's toothpaste | 0.05% |
| Mouthwash | 0.05% |
However, SCCS also stated that micron-sized silver at 0.2% (rinse-off) / 0.3% (leave-on) concentrations is unsafe when used alone or in combination.
Given that massive silver, silver powder, and nano silver are classified as CMR substances and do not meet cosmetic exemption criteria, the EU Commission will prohibit massive silver and nano silver effective May 1, 2026.
Based on the safety assessment conclusion of SCCS on micrometer level silver, micron-sized silver, the EU will regulate it under the List of Restricted Substances effective May 1, 2026. Concurrently, micron-sized silver will be added to the List of Authorised Colorants effective May 1, 2026.
(The Original of Notification G/TBT/N/EU/1140: https://docs.wto.org/imrd/directdoc.asp?DDFDocuments/t/g/tbtn25/eu1140.docx)
