The EU is banning new substances in cosmetics – Omnibus Act VIII

Today, 21 May 2025, the European Commission informed the World Trade Organization of the draft Omnibus Act VIII, which proposes amendments to Annexes II, III, IV, and V of the Cosmetics Regulation.

The Omnibus Act aims to implement Delegated Regulation (EU) 2024/2564, which introduced newly classified substances as CMR (Carcinogenic, Mutagenic, or Reprotoxic), and incorporates findings from the SCCS on the safety of ingredients and their concentration limits.

Amendments to Annex II – List of banned ingredients

Entry 1397 have been updated to include:

• Perboric acid (H3BO2(O2)), monosodium salt trihydrate [1] – CAS 13517-20-9
• Perboric acid, sodium salt, tetrahydrate [2] – CAS 37244-98-7
• Perboric acid (HBO(O2)), sodium salt, tetrahydrate [3] – CAS 10486-00-7
• Sodium peroxoborate, hexahydrate [4]
• Sodium perborate [5] – CAS 15120-21-5
• Sodium peroxometaborate; sodium peroxoborate [6] – CAS 7632-04-4 / 10332-33-9 / 10486-00-7
• Perboric acid, sodium salt [7] – CAS 11138-47-9
• Perboric acid, sodium salt, monohydrate [8] – CAS 12040-72-1, EC 234-390-0
• Perboric acid (HBO(O2)), sodium salt, monohydrate [9] – CAS 10332-33-9

Similarly, entry 1727 has been amended to include:

• Silver (nano) [1 nm < particle diameter ≤ 100 nm] – CAS 7440-22-4
• Silver (massive) [particle diameter ≥ 1 mm] – CAS 7440-22-4

Additionally, the following substances will be added to Annex II:

1. 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, including Multi-Walled Carbon Nanotubes (MWCNT)
2. Reaction mass of 1,3-dioxan-5-ol and 1,3-dioxolan-4-ylmethanol
3. Acetone oxime – CAS 127-06-0
4. 2-(Dimethylamino)-2-[(4-methylphenyl)methyl]-1-[4-(morpholin-4-yl)phenyl]butan-1-one – CAS 119344-86-4
5. 2,3-Epoxypropyl neodecanoate – CAS 26761-45-5
6. Benthiavalicarb-isopropyl (ISO) – CAS 177406-68-7
7. 7-Oxabicyclo[4.1.0]hept-3-ylmethyl 7-oxabicyclo[4.1.0]heptane-3-carboxylate – CAS 2386-87-0
8. Sodium 3-(allyloxy)-2-hydroxypropanesulphonate – CAS 52556-42-0
9. 1,4-Dichloro-2-nitrobenzene – CAS 89-61-2
10. Fenpropidin (ISO) – CAS 67306-00-7
11. N,N’-Methylenediacrylamide – CAS 110-26-9
12. Tert-butyl 2-ethylperoxyhexanoate – CAS 3006-82-4
13. Trimethyl borate – CAS 121-43-7
14. S-Metolachlor (ISO) – CAS 87392-12-9
15. Pyraclostrobin (ISO) – CAS 175013-18-0

Amendments to Annex III – List of restricted substances

The following entries have been added to Annex III:

1. Silver (powder) [100 nm < particle diameter < 1 mm] – CAS 7440-22-4
   • (a) Toothpaste: Maximum concentration 0.05%
   • (b) Mouthwash: Maximum concentration 0.05%
2. Hexyl 2-hydroxybenzoate (Hexyl Salicylate) – CAS 6259-76-3
   • (a) Hydroalcoholic-based fragrances: Maximum concentration 2%
   • (b) All rinse-off products (except for shower gel, hand wash, hair conditioner and shampoo intended for children under 3 years of age): Maximum 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): Maximum concentration 0.3%
   • (d) Toothpaste: Maximum concentration 0.001%
   • (e) Mouthwash: Maximum concentration 0.001%
   • (f) 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: Maximum concentration 0.1%

Amendments to Annex IV – List of colourants allowed in cosmetics

Entry 42 of Annex IV is updated as follows:

• Silver (powder) [100 nm < particle diameter < 1 mm] – CAS 7440-22-4
  • (a) Lip products: Maximum concentration 0.2%
  • (b) Eye shadow: Maximum concentration 0.2%

Amendments to Annex V – List of preservatives allowed in cosmetics

Entry 7 of Annex V is updated as follows:

• Biphenyl-2-ol; 2-Phenylphenol; 2-Hydroxybiphenyl (o-Phenylphenol) – CAS 90-43-7
• Sodium 2-Biphenylolate; Sodium o-Phenylphenate – CAS 132-27-4
  • (a) Rinse-off products: Maximum concentration 0.2% (as phenol)
  • (b) Leave-on products: Maximum concentration 0.15% (as phenol)
  • Combined concentration must not exceed 0.2% in rinse-off and 0.15% in leave-on products.
  • Not to be used in products with potential inhalation exposure or in oral products.
  • The label should bear the following wording: “avoid contact with eyes”.

Timeline for compliance

Omnibus Act VIII will take effect on 1 May 2026, with no distinction between placing products on the market and making them available. This means that, from the application date, non-compliant cosmetics can no longer be sold in the EU market and must be recalled beforehand.

Do you have questions on compliance of cosmetics in the EU, UK, USA, and Canada?  Contact us here or at coslaw@obelis.net.

References

WTO. (2025). Draft Commission Regulation 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. Retrieved on 21/05/2025.

WTO. (2025). Draft Annex to the Commission Regulation amending Regulation (EC) No 1223/2009 of the European Parliament and of the Council as regards the use in cosmetics products of certain substances classified as carcinogenic, mutagenic or toxic for reproduction. Retrieved on 21/05/2025.