Reference source : Official Journal of the European Union
Prohibited Substances Restricted Substances EU Cosmetics Regulation Annex II Cosmetics Regulation CMR Substances Adaptation to Technical Progress 22nd ATP Commission Regulation (EU) 2026/78 Annex III, IV, V Cosmetics Regulation
On 12 January 2026, the European Commission adopted Commission Regulation (EU) 2026/78, amending the Cosmetics Regulation (Regulation (EC) No 1223/2009) with regard to the use of certain substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR) in cosmetic products. The regulation was published in the Official Journal on 13 January 2026 and will apply from 1 May 2026.
This amendment brings the Cosmetics Regulation into line with the harmonised CMR classifications introduced under the 22nd Adaptation to Technical Progress (ATP) to the Classification, Labelling and Packaging (CLP) Regulation, as set out in Commission Delegated Regulation (EU) 2024/2564.
Automatic CMR alignment under the Cosmetics Regulation
Article 15 of the Cosmetics Regulation states that substances classified as CMR under the CLP Regulation are, in principle, prohibited in cosmetic products unless specific conditions for derogation are fulfilled. Regulation (EU) 2026/78 implements this mechanism by updating Annexes II, III, IV and V of the regulation.
Substances added to Annex II
In the absence of requests for use in cosmetic products, several substances newly classified as CMR under CLP ATP 22 are added to Annex II (List of substances prohibited in cosmetic products). The table below presents a selection of substances added to Annex II under this amendment.
|
Substance name |
CAS No |
Notes |
|
Perboric acid and its sodium salts (group entry) |
Multiple (see Annex II entry 1397) |
Consolidation of former entries 1397–1399 covering perborate derivatives |
|
Silver (nano) |
7440-22-4 |
Particle diameter 1–100 nm |
|
Silver (massive) |
7440-22-4 |
Particle diameter ≥ 1 mm |
|
Multi-walled carbon tubes (MWCNTs) |
- |
Group entry with defined dimensional criteria |
|
Sodium 3-(allyloxy)-2-hydroxypropanesulphonate |
52556-42-0 |
Newly prohibited CMR substance |
|
N,N’-methylenediacrylamide |
110-26-9 |
Newly prohibited CMR substance |
|
Acetone oxime |
127-06-0 |
Newly prohibited CMR substance |
|
2-(Dimethylamino)-2-[(4-methylphenyl)methyl]-1-[4-(morpholin-4-yl)phenyl]butan-1-one |
119344-86-4 |
Newly prohibited CMR substance |
|
2,3-Epoxypropyl neodecanoate |
26761-45-5 |
Newly prohibited CMR substance |
|
1,4-Dichloro-2-nitrobenzene |
89-61-2 |
Newly prohibited CMR substance |
|
Trimethyl borate |
121-43-7 |
Newly prohibited CMR substance |
Substances subject to restrictions or specific conditions (Annexes III–V)
For a limited number of substances, requests for use in cosmetic products were submitted and assessed positively by the Scientific Committee on Consumer Safety (SCCS). These substances remain permitted under strictly defined conditions and are regulated under Annexes III, IV and V, and are listed in the table below.
|
Substance name |
CAS No |
Annex |
Regulatory status |
Key conditions |
|
Silver (powder) |
7440-22-4 |
Annex III / Annex IV |
Restricted / authorised colourant |
Annex III: toothpaste and mouthwash up to 0.05 %; Annex IV (CI 77820): lip products and eye shadow up to 0.2 % |
|
Hexyl 2-hydroxybenzoate (Hexyl Salicylate) |
6259-76-3 |
Annex III |
Restricted |
Product-specific limits depending on product type and target population, including restrictions for products intended for children under 3 years |
|
Biphenyl-2-ol (o-Phenylphenol) |
90-43-7 |
Annex V |
Restricted preservative |
Maximum 0.2 % (rinse-off) and 0.15 % (leave-on), as phenol |
|
Sodium o-Phenylphenate |
132-27-4 |
Annex V |
Restricted preservative |
Combined concentration limits apply; inhalation and oral uses prohibited; mandatory warning applies |
Silver: particle-size dependent regulatory treatment
Silver (CAS No. 7440-22-4) is subject to a regulatory approach based on particle-size. Silver nano and silver massive are prohibited under Annex II, while micron-sized silver powder is permitted under restricted conditions following a positive SCCS opinion. In addition to the restrictions in Annex III, silver powder is authorised as a colourant (CI 77820) under Annex IV for specific product categories.
Application date
The Regulation will apply from 1 May 2026. As the amendment is based on CMR classifications under the CLP Regulation, no extended transitional period is provided. Cosmetic products placed on the EU market from that date must comply with the updated entries in the annexes.
If you want to access the GHS report, please Register here in GPC Intelligence Portal click here