Regulation (EU) 2026/78: New CMR Restrictions in Cosmetic Products
Commission Regulation (EU) 2026/78, of 12 January 2026, amends Annexes II, III, IV and V to Regulation (EC) No 1223/2009 on cosmetic products. The regulation concerns the use in cosmetic products of certain substances classified as carcinogenic, mutagenic or toxic for reproduction, commonly referred to as CMR substances.
The regulation applies from 1 May 2026. From that date, cosmetic products affected by the amendments must comply with the updated provisions.
Why Regulation (EU) 2026/78 Was Adopted
Regulation (EC) No 1223/2009 generally prohibits the use in cosmetic products of substances classified as CMR category 1A, 1B or 2 under the CLP Regulation.
However, in specific cases, certain CMR substances may be used in cosmetic products if the conditions set out in Article 15 of the Cosmetics Regulation are met.
Regulation (EU) 2026/78 updates the annexes to Regulation (EC) No 1223/2009 in order to reflect the classifications introduced by Delegated Regulation (EU) 2024/2564. The amendments affect prohibited substances, restricted substances, authorised colorants and authorised preservatives.
Which Annexes Are Amended
The regulation amends:
- Annex II, concerning substances prohibited in cosmetic products;
- Annex III, concerning substances subject to restrictions;
- Annex IV, concerning authorised colorants;
- Annex V, concerning authorised preservatives.
The main substances affected include:
- perboric acid and its salts;
- silver in different particle size forms;
- Hexyl Salicylate;
- o-Phenylphenol;
- Sodium o-Phenylphenate;
- additional CMR substances added to Annex II.
Perboric Acid and Its Salts
Perboric acid and its salts were already listed in Annex II to the Cosmetics Regulation as prohibited substances.
Regulation (EU) 2026/78 reorganises the existing entries by grouping structurally related substances into a single entry. In particular, entry 1397 is replaced with a broader wording, while entries 1398 and 1399 are deleted.
This amendment aims to improve regulatory clarity and to treat as a group substances that share similar structure, mechanism of action and health risks.
Silver: New Distinction Between Nanosilver, Silver in Powder Form and Bulk Silver
One of the most relevant amendments concerns silver.
The regulation distinguishes silver according to particle size:
- nanosilver, with particle diameter greater than 1 nm and equal to or less than 100 nm;
- silver in powder form, with particle diameter greater than 100 nm and less than 1 mm;
- bulk silver, with particle diameter equal to or greater than 1 mm.
The regulation amends entry 1727 of Annex II, including nanosilver and bulk silver among prohibited substances.
By contrast, silver in powder form is regulated under specific conditions in Annexes III and IV.
Silver in Powder Form: Limits for Oral Care and Make-Up Products
Silver in powder form is added to Annex III as a restricted substance.
It is allowed in the following products:
| Product category | Maximum concentration |
|---|---|
| Toothpastes | 0.05% |
| Mouthwashes | 0.05% |
In addition, entry 142 of Annex IV is replaced to authorise silver in powder form as the white colorant CI 77820 in the following products:
| Product category | Maximum concentration |
|---|---|
| Lip products | 0.2% |
| Eyeshadow | 0.2% |
This amendment is particularly relevant for companies formulating oral care products, make-up, lip products and eyeshadows containing silver or metallic pigments.
Hexyl Salicylate: New Conditions of Use
2-Hydroxybenzoic acid hexyl ester, known by its INCI name Hexyl Salicylate, is added to Annex III as a restricted substance.
The substance has been classified as CMR category 2, toxic for reproduction. However, the SCCS concluded that Hexyl Salicylate can be considered safe under specific conditions of use.
The new limits are:
| Product category | Maximum concentration |
|---|---|
| Hydroalcoholic fragrances, except those intended for children under 3 years of age | 2% |
| Rinse-off products, with certain exceptions | 0.5% |
| Leave-on products, with certain exceptions | 0.3% |
| Toothpastes | 0.001% |
| Mouthwashes | 0.001% |
| Certain products intended for children under 3 years of age, including shower gels, bath products, shampoos, hair conditioners, body/face/hand care products, lip products and perfumes | 0.1% |
The regulation also provides the condition: “Not to be used in preparations intended for children under 3 years of age”, with specific exceptions for toothpastes and for the product categories expressly indicated.
o-Phenylphenol and Sodium o-Phenylphenate
The regulation also amends entry 7 of Annex V, concerning preservatives.
The entry is updated to include:
- o-Phenylphenol;
- Sodium o-Phenylphenate.
The limits are:
| Product category | Maximum concentration |
|---|---|
| Rinse-off products | 0.2% as phenol |
| Leave-on products | 0.15% as phenol |
When o-Phenylphenol and Sodium o-Phenylphenate are used together, the combined concentration, expressed as phenol, must not exceed:
- 0.2% in rinse-off products;
- 0.15% in leave-on products.
Additional conditions also apply:
- 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 care products;
- the warning “Avoid contact with eyes” must be indicated.
New Prohibited Substances in Annex II
Regulation (EU) 2026/78 adds new entries to Annex II, the list of substances prohibited in cosmetic products.
The newly added substances include, among others:
- multi-walled carbon nanotubes;
- acetoxime;
- N,N’-methylenediacrylamide;
- glycidyl neodecanoate;
- 1,4-dichloro-2-nitrobenzene;
- trimethyl borate;
- Pyraclostrobin;
- S-metolachlor;
- other substances classified as CMR under Delegated Regulation (EU) 2024/2564.
For these substances, unless specific exceptions apply under the legislation, use in cosmetic products is not permitted.
What Cosmetic Companies Should Do
Cosmetic companies, brand owners, manufacturers, importers and Responsible Persons should assess the impact of Regulation (EU) 2026/78 on products already on the market and on products under development.
Recommended actions include:
- reviewing cosmetic formulations;
- checking whether substances added or amended in Annexes II, III, IV and V are present;
- verifying ingredients such as Hexyl Salicylate, silver, o-Phenylphenol and Sodium o-Phenylphenate;
- checking concentrations of use;
- requesting updated supplier documentation;
- verifying the possible presence of CMR substances;
- updating the PIF and CPSR, where necessary;
- reviewing labelling and mandatory warnings;
- updating the CPNP notification, where required;
- managing any non-compliant stock.
Regulatory Monitoring and Documentation Update
Regulation (EU) 2026/78 confirms the importance of continuously monitoring updates to the annexes of the Cosmetics Regulation.
Amendments to Annexes II, III, IV and V may directly affect the compliance of products already notified, marketed or under development.
An updated review of formulation, ingredients, concentrations, PIF, CPSR, labelling and CPNP allows the Responsible Person to manage the obligations of European cosmetics legislation more safely and consistently.