21 October 2024
Omnibus VIII Regulation
June 2025 - Notification of the Omnibus VIII Regulation
The European Commission notified to the World Trade Organization (WTO) the “Omnibus VIII” regulation. The adoption is expected to take place during the 1st quarter of 2026.
This regulation incorporates substances classified CMR by the Regulation EU 2024/2564, a.k.a. the 22nd Adaptation to Technical Progress (ATP) amending the CLP regulation (see IL-135 for more details) into the European Cosmetic Regulation 1223/2009.
3 of those substances have been defended by the industry and a favorable SCCS opinion has been issued. The SCCS conclusions will be integrated into the cosmetic regulation as follows:
- HEXYL SALICYLATE
| Product type | Maximum concentration (% w/w) | Additional restrictions |
|---|---|---|
| Hydroalcoholic-based fragrances | 2 | Not to be used in preparations for children under 3 years of age |
| All Rinse-off products (except shower gel, hand wash, hair conditioner and shampoo intended for children below 3 years of age) | 0.5 | Not to be used in preparations for children under 3 years of age |
| 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) | 0.3 | Not to be used in preparations for children under 3 years of age |
| Toothpaste | 0.001 | |
| Mouthwash | 0.001 | Not to be used in preparations for children under 3 years of age. Warning to display: “Not to be used for children under 3 years of age”. |
| Shower gel, hand wash, shampoo, hair conditioner, body, face and hand (skin) care products, lipstick/lip balm and fragrance products intended for children below 3 years of age | 0.1 |
- O’PHENYLPHENOL and SODIUM O-PHENYLPHENATE:
| Product type (as a preservative) | Maximum concentration (% w/w) | Additional restrictions (% w/w) |
|---|---|---|
| Rinse-off products | 0.2 (as phenol) | 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. Warning to be displayed: “Avoid contact with eyes”. |
| Leave-on products | 0.15 (as phenol) |
Moreover, O-Phenylphenol and Sodium o-Phenylphenate, when used together, the combined concentration (as phenol) should not exceed 0.2% in rinse-off and 0.15% in leave-on products.
- SILVER (powder) [100 nm < particle diameter < 1 mm]:
| Product type | Maximum concentration (% w/w) |
|---|---|
| Lip products (as colorant) | 0.2 |
| Eye shadow (as colorant) | 0.2 |
| Toothpaste | 0.05 |
| Mouthwash | 0.05 |
The other CMR classified substances are rarely used in cosmetics or present as impurities in raw materials and will be banned under annex II of Regulation 1223/2009:
- Perboric acid (H3BO2(O2)), and its sodium salts (9 CAS numbers)
- Trimethyl borate
- Silver Massive and nano
- 2,3-epoxypropyl neodecanoate (impurity)
- Sodium 3-(allyloxy)-2-hydroxypropanesulphonate (impurity)
- N,N’-methylenediacrylamide (impurity)
- … and a bunch of other CMR ingredients not used in cosmetics (pesticides, …)
This regulation will apply from May 1st 2026.
This application date applies to products on shelves. Non-compliant products on the EU market after that date will have to be withdrawn.
We hope that this will be of help and stay at your disposal for any questions related to this topic. Should you have any question, please, feel free to contact your dedicated Customer Relationship Manager.
| Ingredient | Conditions of Use by product type | Maximum concentration permitted |
|---|---|---|
| Retinol and its esters | a) Leave-on products intended for full body application | 0.2% total retinol equivalents |
| b) Other cosmetics | 1.0% total retinol equivalents |
Author
Stéphanie Annet
Stéphanie is Biorius's Cosmetic Regulatory Affairs Lead and works in the cosmetic industry for almost 10 years.
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