New EU Regulation Omnibus CMR VIII

IMPORTANT: New EU Regulation "Omnibus CMR VIII" Entered into Force – What Must the Cosmetics Industry Implement Immediately?

The European Commission has officially adopted the new regulation Omnibus CMR VIII (EU 2026/78), introducing key amendments to the Cosmetics Regulation (EC) No 1223/2009. These changes concern restrictions and prohibitions on substances classified as CMR (carcinogenic, mutagenic, or toxic to reproduction).

The rules entered into force on May 1, 2026, meaning that all products placed or already available on the European Union market must be fully compliant with the new standards.

Key Raw Materials and New Allowed Concentrations

The regulation brings strict limitations for several frequently used components. Below are the detailed compliance limits:

1. Hexyl Salicylate

Classified as a CMR category 2 substance (toxic to reproduction). Based on the SCCS assessment, strict limitations have been defined depending on the product type and target group:

• Up to 2.0%: In hydroalcoholic-based fragrance products.
• Up to 0.5%: In rinse-off products.
• Up to 0.3%: In leave-on products.
• Up to 0.1%: In products intended for children under 3 years of age (subject to additional specific restrictions and a ban on use in products that may lead to inhalation).
• Up to 0.001%: In oral hygiene products (toothpastes and mouthwashes).

2. Silver (Silver / CI 77820)

The regulation now strictly relies on the particle size of silver:

• Completely Prohibited: Nano-silver (particles from 1 to 100 nm) and bulk silver (particles larger than 1 mm).
• Micron-sized Silver (particles between 100 nm and 1 mm): Allowed in restricted concentrations:
• Up to 0.05%: In oral hygiene products (toothpastes and mouthwashes).
• Up to 0.2%: As a colorant (CI 77820) exclusively in lip products and eye shadows.

3. o-Phenylphenol and its salts (Sodium o-Phenylphenate)

As a preservative, this raw material has been reclassified, and its maximum concentrations (expressed as phenol) are:

• Up to 0.2%: In rinse-off products.
• Up to 0.15%: In leave-on products.
• Note: If used together, the total concentration must not exceed these limits. The substance must not be used in products where there is a risk of lung exposure through inhalation, and the warning "Avoid contact with eyes" is mandatory on the packaging.

Unintentional Ingredients Under Scrutiny

This regulation does not only target ingredients intentionally added to the formulation. Special attention is paid to impurities, contaminants, and residues from production processes. Manufacturers must strictly monitor the presence of trace substances such as methyl eugenol and estragole (in fragrance compositions) or heavy metals like nickel and cobalt (in pigments).

Action Steps for Manufacturers and Responsible Persons:

1. Formulation Review: Urgent verification with raw material suppliers regarding the exact share of hexyl salicylate and the specific form of silver in raw materials.
2. Documentation Update: Revision of the Cosmetic Product Safety Report (CPSR).
3. Packaging Correction: Aligning INCI lists and adding mandatory safety warnings to labels.

Regulatory compliance is no longer a matter of prestige, but a prerequisite for market survival. Ensure the safety of your formulations in time.