We started the new year with a legislative bang! 😉 We have a new, freshly published – on January 12, 2026 – Commission Regulation (EU) 2026/78, the so-called Omnibus VIII on CMR substances. What changes does this legislation bring to the cosmetics industry? I invite you to read it.
Changes in the use of Silver
Silver has been recently particularly analysed for its safety in cosmetics. This substance, with a particle diameter of:
1) equal to or larger than 1 mm (silver massive),
2) larger than 100 nm and smaller than 1 mm (silver powder),
3) larger than 1 nm and smaller than or equal to 100 nm (silver nano)
has been finally classified as a CMR category 2 (reproductive toxicity).
Currently, silver is listed in the entry 142 of Annex IV to Regulation (EC) No. 1223/2009 as an permitted colourant (CI 77820), while its colloidal nanoform (1–100 nm) is prohibited in cosmetic products (entry 1727 in Annex II).
Current changes to the use of silver in cosmetics include:
– Entry 1727, Annex II (prohibited substances): In addition to nano-colloidal silver (Colloidal Silver (nano)), Silver (massive) [particle diameter ≥ 1 mm] will be added, and for nano-colloidal silver, the appropriate particle sizes will be included: Silver (nano) [1 nm < particle diameter ≤ 100 nm],
– New entry 379, Annex III (permitted substances with restrictions): Silver (powder) [100 nm < particle diameter < 1 mm] will be permitted in toothpastes and mouthwashes, at a maximum concentration of 0.05%.
– Entry 142, Annex IV (permitted colourants): Permitted silver sizes, product types, and permitted concentrations will be specified, i.e.: Silver (powder) [100 nm < particle diameter < 1 mm] permitted for use in: lip products and eye shadows at a maximum concentration of 0.2%.
Changes in the use of hexyl salicylate
Hexyl salicylate (INCI: Hexyl Salicylate) is primarily used as a fragrance in cosmetics (providing a floral-fruity scent). It was not previously regulated by Regulation 1223/2009. Due to its classification as CMR 2 (reproductive toxicity) and the SCCS opinion, Hexyl Salicylate will be added to the list of substances subject to restrictions on use in cosmetics.
This ingredient will therefore occupy position 380 in Annex III, where it will be permitted in the following products:
a) Hydroalcoholic-based fragrances (except hydroalcoholic-based fragrances intended for children below 3 years of age); max. concentration = 2%;
b) All rinse-off products (except shower gel/bath products, hand wash, hair conditioner, and shampoo intended for children below 3 years of age); max. concentration = 0.5%;
c) All leave-on products (except hair conditioner, body lotion, face cream, hand cream, lipstick/lip balm, and fragrance products intended for children below 3 years of age); max. concentration = 0.3%;
d) Toothpaste; max. concentration = 0.001%;
e) Mouthwash; max. concentration = 0.001%;
f) Shower gel/bath products, hand wash, shampoo, hair conditioner, body, face, and hand (skin) care products, lipstick/lip balm, and fragranced products intended for children below 3 years of age; max. concentration = 0.1%.
Furthermore, hexyl salicylate will not be allowed to be used in products for children under 3 years of age, with the exception of item d) “toothpaste” and item f).
Changes in the use of o-phenylphenol
Another change concerns the substance biphenyl-2-ol (INCI: o-Phenylphenol), which has also been classified as a CMR substance category 2 (carcinogen category 2). O-Phenylphenol is now listed in entry 7 of Annex V to the Cosmetics Regulation as a preservative permitted in rinse-off and leave-on products at maximum permitted concentrations of 0.2% and 0.15% (expressed as phenol), respectively, provided that eye contact is avoided.
The SCCS concluded in its opinion of October 25, 2024, that o-Phenylphenol and its derivative, Sodium o-Phenylphenate, can be considered safe under certain conditions of use in cosmetic products. Therefore, entry 7 of Annex V will be amended as follows:
– next to o-Phenylphenol, its sodium salt, Sodium o-Phenylphenate, will be added,
– the condition of use will be added: When o-Phenylphenol and Sodium o-Phenylphenate are used together, the combined concentration (as phenol) shall not exceed 0,2 % in rinse-off and 0,15 % in leave-on products,
– and a further condition: Not to be used in applications that may lead to exposure of the end-user’s lungs by inhalation. Not to be used in oral products.
The permitted products and concentrations for these preservatives will remain unchanged.
New Prohibited Substances
In addition to the above changes, a number of new ingredients will be added to the list of prohibited substances, including: acetone oxime, trimethyl borate, fenpropidin, and 2,3-epoxypropyl neodecanoate. Furthermore, perboric acid and its salts have been consolidated into a single group, meaning entries 1397, 1398, and 1399 have been combined into a single entry – 1397. Annex II will now contain 1766 entries.
Summary
There are therefore many changes to the Cosmetics Regulation. For more details, I encourage you to read the text of the new regulation https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202600078
It is worth noting that the regulation will enter into force on February 2, 2026, but will apply from May 1, 2026. Are you ready for new changes?
