EU Omnibus Regulation (EU 2026/78) – Key Cosmetic Compliance Updates Effective 1 May 2026

The European Union has recently adopted Commission Regulation (EU) 2026/78, a major update to the EU Cosmetics Regulation 1223/2009, specifically targeting carcinogenic, mutagenic, or toxic for reproduction (CMR) substances. This amendment, commonly referred to as the “Omnibus VIII” update, comes into force for all cosmetic products placed on the EU market from 1 May 2026. The update significantly impacts formulation, labeling, safety assessments, and product notifications, making it critical for cosmetic manufacturers, importers, and responsible persons to act proactively.

Key Changes

1. Prohibited Substances

• New CMR substances added: For example, N,N’-methylenediacrylamide, trimethyl borate, and specific forms of silver (nano and massive particles).

• Prohibition of perboric acid and salts in cosmetic applications.

2. Restricted Substances

• Conditional use only: Some CMR substances remain allowed, but with strict concentration limits and product-type restrictions.

• Examples:

  • Silver powder (100 nm < diameter < 1 mm) – allowed in oral care products at ≤ 0.05%.

  • Hexyl salicylate – limited to specific product types (fragrances, rinse-off/leave-on, baby products) with lower limits for children’s products.

3. Allowed Colorants

• Silver powder (CI 77820) – retained as a permitted colorant but now restricted to lip products and eye shadows, with maximum concentration limits (0.2%).

4. Allowed Preservatives

• o-Phenylphenol and sodium o-phenylphenate – permitted under strict conditions:

  • Max concentrations (0.2% rinse-off, 0.15% leave-on).

  • Mandatory labeling, e.g., “Avoid contact with eyes.”

  • Restrictions on inhalation and oral exposure.

Compliance Implications

The Omnibus VIII update requires comprehensive action across the cosmetic value chain:

1. Formulation Review – Identify prohibited substances and reformulate affected products.

2. Safety Documentation – Update Cosmetic Product Safety Reports (CPSRs) and Product Information Files (PIFs) for restricted ingredients.

3. Labeling & Warnings – Apply mandated warnings for restricted preservatives and restricted use colorants.

4. Market Surveillance Preparedness – Ensure that all products placed on the EU market after 1 May 2026 are fully compliant, including any remaining inventory.

Non-compliance may result in product recalls, market withdrawal, and regulatory fines enforced by EU Member States.