The expanded EU rules on the individual labelling of fragrance allergens affect formulas, INCI lists, packaging, the PIF, the CPSR and change control across an entire portfolio.
What Regulation (EU) 2023/1545 changed
Regulation (EU) 2023/1545 amended Annex III to the Cosmetics Regulation and expanded the number of fragrance allergens that must be individually identified in the ingredient list. Some entries group several substances under a common labelling name.
Correct implementation requires more than an allergen statement from the fragrance supplier. The identity of each substance, the applicable label name, the fragrance dosage in the finished product and any additional sources of the allergen in the formula must be considered together.
Thresholds for leave-on and rinse-off products
A fragrance allergen covered by Annex III must be listed when its concentration exceeds 0.001% in a leave-on product or 0.01% in a rinse-off product. The calculation is performed for the finished cosmetic product, not only for the fragrance composition.
The product category must reflect actual and reasonably foreseeable use. Where use is not unambiguous, the chosen approach should be documented and aligned with directions, application conditions and the safety assessment.
Practical checkpoint
Every conclusion should be linked to the exact formula, document and market-material version. This makes it possible to demonstrate which evidence supported the regulatory decision.
The 31 July 2026 and 31 July 2028 deadlines
From 31 July 2026, products that do not comply with the new requirements may no longer be placed on the market for the first time. Products lawfully placed on the market before that date may, under the conditions of the Regulation, continue to be made available until 31 July 2028.
Businesses should distinguish placing on the market from subsequent making available. The transition plan should cover artwork approval, packaging procurement, depletion of existing stock and evidence of distribution dates.
Documents to request from suppliers
For each fragrance composition and relevant raw material, obtain an up-to-date allergen statement, an identifiable document version and data that allow calculation in the finished product. A supplier, fragrance code or use-level change requires a fresh review.
Supplier documentation must be linked to the exact formula version used in the PIF and CPSR. An outdated statement or inconsistent name can lead to an incorrect INCI list even when the artwork itself is technically accurate.
A practical portfolio implementation plan
Segment the portfolio by product type, fragrance composition, documentation status, next production date and packaging stock. Prioritise products with large packaging inventories, frequent fragrance changes or complex supplier chains.
Final approval should confirm that the formula, allergen calculation, CPSR, PIF, CPNP data and marketed label all describe the same version of the product. A documented pre-print review significantly reduces costly corrections.
Frequently asked questions
Do the new requirements apply only to new products?
No. Transitional rules must also be assessed for existing products that will remain available on the market.
Does the presence of an allergen mean the product is unsafe?
No. Individual labelling primarily enables sensitised consumers to identify ingredients to which they may react.
Is an old fragrance supplier declaration sufficient?
Not necessarily. The document must match the current composition and support application of the new entries and labelling names.
Official sources and further reading
- Regulation (EU) 2023/1545 on fragrance allergen labelling
- Regulation (EC) No 1223/2009 on cosmetic products
This article is for general information and does not replace an assessment of the specific product, formula and supply chain. Legislation and guidance may change after publication.