COMMISSION REGULATION (EU) 2023/1545 of 26 July 2023 amending Regulation (EC) No 1223/2009 of the European Parliament and of the Council as regards labelling of fragrance allergens in cosmetic products.
By July 31, 2026, the EU will implement a massive expansion of mandatory fragrance allergen labeling for cosmetic products.
Labelling of fragrance allergens – major regulatory update for industry!
Key regulatory change
The number of allergens requiring declaration increases: from 26 to 82 substances.
A total of 56 new fragrance allergens must now be disclosed in the ingredient list.
These allergens must be listed in the INCI ingredients list when exceeding the established thresholds under the Cosmetics Regulation.
Regulatory timeline
The regulation provides two distinct transitional deadlines, depending on the market status of the product: 31 July 2026 – Placing on the market
From this date: Only compliant products may be placed on the EU market. Applies to new products or new batches released/imported. Non-compliant products cannot be newly introduced into the supply chain.
31 July 2028 – Making available on the market
From this date: Only compliant products may be sold / supplied / distributed. Applies to distributors, retailers, remaining stock
After this date: No sell-through of old (non-compliant) stock allowed.
Impact on the cosmetics industry
This regulatory change introduces a substantial compliance burden across the sector:
– Product formulation review – Companies must assess existing formulations for the presence of newly listed allergens
Reformulation may be required where allergen levels are high
– Labelling and packaging updates
Significant increase in label complexity. Potential need for:
redesign of packaging
optimisation of label space (especially for small formats)
multilingual updates
– Supplier data and supply chain communication
Companies must obtain updated allergen data from fragrance suppliers
Increased need for: detailed composition data and improved supplier cooperation
– CPSR and Product Information File (PIF)
Safety assessments must be updated: reassessment of allergen exposure; update of toxicological profiles = impact on: Cosmetic Product Safety Reports (CPSR); Product Information Files (PIF)
– Market access and transition risks
As of 31 July 2026, only compliant products may be placed on the EU market. Key risks include:
non-compliant stock remaining in supply chains
delays in label updates
insufficient supplier data
Recommended actions for companies
To ensure timely compliance, companies should:
! Conduct a portfolio gap analysis
! Request updated allergen composition data from suppliers
Update: ingredient lists (INCI); labels and packaging artwork; CPSR and PIF documentation.
Plan transition strategy for non-compliant products
Coordinate regulatory, R&D, and packaging teams early
How Ekotox can support you: Regulatory gap analysis; Fragrance allergen screening; CPSR preparation and updates; Label compliance and artwork review.
Full support with EU Cosmetics Regulation obligations
Explore our services: https://ekotox.eu/cosmetics-2/
COMMISSION REGULATION (EU) 2023/1545: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32023R1545
! Ekotox Centers experts are ready to assist !
Ekotox webpages: https://ekotox.eu/cosmetics-2/
