Key takeaway
What This Development Means
Commission Regulation (EU) 2026/78 amends the EU Cosmetics Regulation to reflect new CMR classifications, adding prohibitions and setting specific use conditions for several ingredients. It applies from 1 May 2026, giving manufacturers a clear compliance date for reformulation and documentation updates.
What Is The EU Cosmetics CMR Substances Update In Regulation (EU) 2026/78?
Regulation (EU) 2026/78 is a Commission amendment to the EU Cosmetics Regulation (EC) No 1223/2009 that aligns cosmetic ingredient rules with updated harmonised CMR classifications under the CLP Regulation. It updates multiple annexes to prohibit certain substances and set precise conditions for others, with application from 1 May 2026.
What Practical Steps Should Compliance Teams Take Before 1 May 2026?
Start by mapping every formula, raw material, and impurity profile against the amended annex entries, paying close attention to ingredient form (such as particle size ranges). Confirm product category placement (rinse-off, leave-on, oral, lip, eye) and check concentration limits. Update safety assessments, product information files, and supplier declarations early.
Source basis: EUR-Lex (CELEX:32026R0078)
Commission Regulation (EU) 2026/78 amends the EU Cosmetics Regulation to implement updated CMR classifications and set new ingredient conditions for cosmetics on the EU and EEA market. The changes apply from 1 May 2026 and affect formulation, safety assessment, and compliance across colour cosmetics, oral care, fragrances, and preservatives.
What Regulation (EU) 2026/78 Changes In The Cosmetics Regulation
The Regulation updates Annexes II, III, IV and V of Regulation (EC) No 1223/2009, reflecting CMR classifications introduced by Commission Delegated Regulation (EU) 2024/2564. In practice, this means some substances are added to the prohibited list, while others move into restricted or conditionally permitted use where the Cosmetics Regulation allows exemptions.
It also streamlines existing prohibited entries for perboric acid and related salts by consolidating Annex II entries, and updates how silver is treated based on particle size categories.
Silver Limits For Oral Care And Colour Cosmetics
Silver is now differentiated by particle diameter. In Annex II, the prohibited entry for silver nanoform is updated to include both silver (nano) with particle diameter greater than 1 nm and up to 100 nm, and silver (massive) with particle diameter at least 1 mm. Micron-sized silver powder (greater than 100 nm and below 1 mm) is managed through restrictions rather than a blanket ban.
For oral care, Annex III introduces a restriction for silver (powder) in toothpaste and mouthwash, with a maximum concentration of 0.05% in ready-to-use products. For colour cosmetics, Annex IV updates the authorised colourant entry for CI 77820 (silver powder), limiting use to lip products and eye shadow at up to 0.2%.
Hexyl Salicylate And Preservatives: Tighter Conditions
Hexyl 2-hydroxybenzoate (Hexyl Salicylate) is added to Annex III with product-specific limits. Hydroalcoholic-based fragrances (excluding products intended for children below 3 years) may contain up to 2%. Other rinse-off products are limited to 0.5%, and other leave-on products to 0.3%. Toothpaste and mouthwash have a much lower limit of 0.001%. Most categories are not to be used in preparations for children under 3, with exceptions for toothpaste and specified child-intended product types that are capped at 0.1%.
Annex V also updates preservative rules: entry 7 is replaced to include both o-Phenylphenol and Sodium o-Phenylphenate with maximum concentrations of 0.2% in rinse-off and 0.15% in leave-on products (as phenol). Where used together, combined concentration limits apply, and additional use limitations cover inhalation exposure and oral products.
If you sell into the EU or EEA, it is time to inventory affected SKUs, verify particle size specifications with suppliers, and confirm that product category assignments match the new annex conditions.
In summary, Commission Regulation (EU) 2026/78 updates the EU cosmetics framework to reflect new CMR classifications and adds specific restrictions for silver, Hexyl Salicylate, and preservatives. With application from 1 May 2026, manufacturers should prioritise formula checks, supplier confirmations, and documentation updates to avoid market disruption and enforcement risk.
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