Background:

On the 13^thof January 2026, the European Commission published Commission Regulation (EU) 2026/78. This amendment to the EU Cosmetics Regulation addresses the use of Silver, Hexyl Salicylate and o-Phenylphenol, as well as other substances with were classified as CMR.  

These regulatory updates align with SCCS opinions issued concerning the safety assessments of those substances as cosmetic ingredients. 

The amendment impacts Annexes II (substances prohibited in cosmetics), III (substances that may be used provided they comply with specified restrictions),IV (colorants allowed in cosmetics) and V (preservatives allowed in cosmetics).  

What’s new?

Amendments to Annex II: 

• Entry 1397 will be amended to include the substances of entry 1398 and 1399, with these last 2 being deleted, combining all the prohibited Perboric acids and its salts in the same entry; 

• Entry 1727 is replaced by the following: 

Silver (nano) [1 nm < particle diameter ≤ 100 nm] 

Silver (massive) [particle diameter ≥ 1 mm] 

The following entries will be added: 

• 1752 – Multi-walled Carbon Tubes (synthetic graphite in tubular shape) with a geometric tube diameter range ≥ 30 nm to < 3 μm and a length ≥ 5 μm and aspect ratio > 3:1, including Multi-Walled Carbon Nanotubes, MWC(N)T; 

• 1753 – reaction mass of 1,3-dioxan-5-ol and 1,3-dioxolan-4-ylmethanol; 

• 1754 – Acetone oxime; 

• 1755 – 2-(dimethylamino)-2-[(4-methylphenyl)methyl]-1-[4-(morpholin-4-yl)phenyl]butan-1-one; 

• 1756 – 2,3-epoxypropyl neodecanoate; 

• 1757 – Benthiavalicarb-isopropyl (ISO); isopropyl [(S)-1-{[(R)-1-(6-fluoro-1,3-benzothiazol-2-yl)ethyl]carbamoyl}-2-methylpropyl]carbamate; 

• 1758 – 7-oxabicyclo[4.1.0]hept-3-ylmethyl 7-oxabicyclo[4.1.0]heptane-3-carboxylate; 

• 1759 – Sodium 3-(allyloxy)-2-hydroxypropanesulphonate; 

• 1760 – 1,4-dichloro-2-nitrobenzene; 

• 1761 – Fenpropidin (ISO); (R,S)-1-[3-(4-tert-butylphenyl)-2-methylpropyl]piperidine; 

• 1762 – N,N’-methylenediacrylamide; 

• 1763 – tert-butyl 2-ethylperoxyhexanoate; 

• 1764 – Trimethyl borate; 

• 1765 – S-metolachlor (ISO); 2-chloro-N-(2-ethyl-6-methylphenyl)-N-[(2S)-1-methoxypropan-2-yl]acetamide; (RaSa)-2-chloro-N-(6-ethyl-o-tolyl)-N-[(1S)-2-methoxy-1-methylethyl]acetamide [contains 80-100 % 2-chloro-N-(2-ethyl-6-methylphenyl)-N-[(2S)-1-methoxypropan-2-yl]acetamide and 0-20 % 2-chloro-N-(2-ethyl-6-methylphenyl)-N-[(2R)-1-methoxypropan-2-yl]acetamide]; 

• 1766 – Pyraclostrobin (ISO); methyl N-(2-{[1-(4-chlorophenyl)-1H-pyrazol-3-yl] oxymethyl}phenyl) N-methoxy carbamate 

Amendments to Annex III (added): 

• Silver (powder) [100 nm < particle diameter < 1 mm] (maximum concentration of 0,05% for toothpaste and mouthwash) 

• Hexyl Salicylate: 

1. Hydroalcoholic-based fragrances (except hydroalcoholic-based fragrances intended for children below 3 years of age) – maximum 2%; 

2. All rinse-off products (except shower gel/bath products, hand wash, hair conditioner and shampoo intended for children below 3 years of age) – maximum 0.5%; 

3. 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) – maximum 0.3%; 

4. Toothpaste – maximum 0.001%; 

5. Mouthwash – maximum 0.001%; 

6. Shower gel/bath products, 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 – maximum 0,1%. 

Amendments to Annex IV (added): 

• Silver (powder) [100 nm < particle diameter < 1 mm] (maximum concentration of 0,2% for lip products and eyeshadow). 

Amendments to Annex V (replaced): 

• o-Phenylphenol and Sodium o-Phenylphenate (maximum concentration of 0,2% as phenol for rinse-off products and 0,15% as phenol for leave-on products). 

• 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. 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. 

What now?

The Regulation will apply from the 1^st of May 2026, and there will be no transition period for the disposal of products already on the market that contain the above ingredients above the maximum permitted concentrations. 

References:

COMMISSION REGULATION (EU) 2026/78 of 12 January 2026 amending Regulation (EC) No 1223/2009 of the European Parliament and of the Council as regards the use in cosmetic products of certain substances classified as carcinogenic, mutagenic or toxic for reproduction.