EU Cosmetics Update – Omnibus Regulation VIII (EU) 2026/78 | Entry into force: 1 May 2026

The European Union has recently approved Regulation (EU) 2026/78, also known as Omnibus Regulation VIII. This Regulation amends the current Regulation (EC) No 1223/2009, introducing updates regarding the use of certain substances classified as CMR (carcinogenic, mutagenic, or toxic to reproduction).

Entry into force / compliance deadline: 1 May 2026

From this date, no cosmetic products may be placed on the EU market if they do not comply with the restrictions listed below or if they contain substances newly included in Annex II (prohibited substances).

Below you can find a summary of the main changes:

ANNEX II: Prohibited Substances

Not permitted in cosmetic products from 1 May 2026

Substance / Group	Key comment
Perboric acid and its salts (incl. perborates)	Reorganization and unification of existing entries
Silver - Solid silver (particle diameter ≥ 1 mm)	Explicitly prohibited
Silver - Silver in the form of nanoparticles (1 nm < particle diameter ≤ 100 nm)	Clear prohibition as a nanomaterial
Carbon nanotubes (various specific types)	CMR Classified and forbidden
Acetone Oxime	New inclusion by CMR classification
N,N’-methylenediacrylamide	New CMR substance
Trimethyl Borate	New CMR substance
Other CMR substances listed in the Regulation	Compounds with chemical names, rarely used in cosmetics. Please refer to the full regulatory table (available upon request / attached).

ANNEX III: Restricted Substances

Permitted only under the following specific conditions

Substance	Main Restrictions
Silver (powder form) [100 nm < particle diameter ≤ 1 mm]	Toothpaste and Mouthwash – 0.05% max concentration in the final cosmetic product.
Hexyl Salicylate	a) Hydroalcoholic-based fragrances (except those intended for children <3) – 2% max  \n b) Rinse-off products (except shower gel/bath, hand wash, hair conditioner and shampoo intended for children <3) – 0.5% max  \n c) Leave-on products (except hair conditioner, body lotion, face cream, hand cream, lipstick/lip balm and fragrance products intended for children <3) – 0.3% max  \n d) Toothpaste – 0.001% max  \n e) Mouthwash – 0.001% max  \n f) Shower gel/bath products, hand wash, shampoo, hair conditioner, body/face/hand (skin) care, lipstick/lip balm and fragrance products intended for children <3 – 0.1% max  \n Note: Not to be used in preparations for children under 3 years of age, with the exception of (d) “Toothpaste” and (f).

ANNEX IV: Allowed Colorants

Permitted only under the uses indicated below

Substance	Main Restrictions
CI 77820 – Silver (powder form) [100 nm < particle diameter ≤ 1 mm]	Lip products and Eye shadow – 0.2% max concentration in the final cosmetic product.

ANNEX V: Allowed Preservatives

Permitted only under the uses indicated below

Substance	Main Restrictions
o-Phenylphenol / Sodium o-phenylphenate	a) Rinse-off products – 0.2% max (as phenol) \n b) Leave-on products – 0.15% max (as phenol) \n When used together, the combined concentration (as phenol) shall not exceed 0.2% in rinse-off and 0.15% in leave-on. \n 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. \n Label warning required: Avoid contact with eyes

ANNEX VI: UV Filters Allowed

✅ No changes have been introduced.

Important note (market placement)

On this occasion, no distinction has been made between newly launched products and products already on the market.Therefore, from 1 May 2026, NO cosmetic products may be placed on the market that do not comply with the restrictions above, or that contain substances newly included in Annex II.