Regulation (EU) 2023/1545 has already been in force for some time, and the transitional period is now entering its decisive phase: companies are required to assess the actual level of compliance of their product lines. For the substances concerned, the Regulation establishes precise deadlines for placing non-compliant products on the market and making them available, with the final deadline set for July 31, 2028.
Regulatory background
With Regulation (EU) 2023/1545, the European Commission significantly updated the rules governing fragrance allergens in cosmetic products by amending Annex III of Regulation (EC) No 1223/2009.
The objective is to strengthen consumer protection, particularly for sensitized individuals, by increasing label transparency and introducing new labeling obligations for a wider number of allergens.
This measure represents one of the most significant updates in recent years regarding cosmetic labeling and ingredient safety, with a cross-functional impact on formulation, packaging, technical documentation, and supply chain management.
Summary of the main updates
The Regulation introduces concrete operational changes:
- Significant expansion of the list of allergens to be declared: from 26 to 82 substances.
- Update of Annex III entries of Regulation (EC) No 1223/2009to (CE) n. 1223/2009.
Companies are therefore required to review not only labels, but also composition information and technical documentation throughout the entire supply chain, ensuring consistency between formula, dossier, and labeling.
The Regulation provides for a transitional period:
- From July 31, 2026: only compliant products may be placed on the market.
- From July 31, 2028: non-compliant products may no longer be made available on the market.
This means that by 2028, all products already available on the market must be fully compliant, with no possibility of selling remaining non-compliant stock after that date.
Impact on companies
The operational impact is extensive and involves multiple business functions:
Research & Development: formula review and possible reformulation to manage critical allergens.
Regulatory Affairs: update of safety assessments and technical documentation.
Packaging & Marketing: label revision.
Supply Chain: request for updated documentation from suppliers
Although the 2028 deadline may still seem distant, compliance requires time and strategic planning. It is essential to start a structured process immediately:
- Map product lines to identify affected products.
- Request updated allergen data from fragrance suppliers.
- Verify concentrations against regulatory thresholds.
- Plan possible reformulations.
- Update labels and verify artwork compliance.
- Review the PIF and safety assessments.
- Coordinate timelines across production, marketing, and regulatory teams
Allergens REG. (EU) 2023/1545
Update to Annex III Reg. (EC) No. 1223/2009
– 82 allergens.
– Thresholds to be declared: 0.001% leave-on / 0.01% rinse-off.
Deadline for placing on the market: 31 July 2026.
Deadline for making available on the market: 31 July 2028.
Impact on label, formula, and technical documentation..
Have you already assessed the impact of the Regulation on your products? We support you in planning the updates required to meet the upcoming deadlines