The European Union is introducing significant changes to cosmetic ingredient regulations under Omnibus Act VIII, which will take effect on May 1, 2026.

The above Act expands the list of substances classified as Carcinogenic, Mutagenic, or Toxic for Reproduction (CMRs) that are either banned or subject to strict restrictions in cosmetic products. All non-compliant cosmetic products must be removed from the EU market by May 1, 2026. To be considered that Omnibus Act VIII does not distinguish between “placing on the market” and “making available on the market.”, which means that all non-compliant products—regardless of when they were first placed on the market—must be withdrawn by the effective date.

Omnibus Act VIII amends Annexes II to V of Regulation (EC) No 1223/2009, specifically:

• Annex II – Substances prohibited in cosmetic products

• Annex III – Substances permitted only under specific restrictions

• Annex IV – Approved colorants

• Annex V – Approved preservatives

A significant number of cosmetic products currently on the EU market may become non-compliant, including products that have recently undergone safety assessments or regulatory reviews.