European Union will ban and restrict new substances in cosmetics – Omnibus Act VIII
Ingredients: CMR substances; Hexyl Salicylate; Silver; o-Phenylphenol

Data de publicação: 21 Maio 2025

The European Commission notified the WTO about draft Omnibus Act VIII, proposing amendments to Annexes II-V of the EU Cosmetics Regulation, including restrictions for Hexyl Salicylate and Silver nanomaterials, applicable from 1 May 2026.

What’s new?

On 21 May 2025, the European Commission notified the World Trade Organization (WTO) about draft Omnibus Act VIII, proposing amendments to Annexes II, III, IV, and V of the EU Cosmetics Regulation. This act implements Delegated Regulation (EU) 2024/2564, introducing newly classified CMR (Carcinogenic, Mutagenic or toxic for Reproduction) substances, and incorporates the SCCS’s findings on ingredient safety.

Amendments to Annex II – List of substances prohibited in cosmetic products

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

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:

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

Amendments to Annex III – List of substances restricted in cosmetic products

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 cosmetic products

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 cosmetic products

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”.

What now?

The draft is open for public comments until July 20 2025.

Omnibus Act VIII will apply from 1 May 2026, with no distinction between placing on the market and making available, requiring withdrawal of non-compliant products before this date.

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

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