HCPC Brands EuropeThe Expanded Cosmetics Fragrance Allergen List
Commission Regulation (EU) 2023/1545 significantly expanded the list of fragrance allergens that must be individually named on a cosmetic product's ingredient list, amending Annex III of the Cosmetics Regulation (EC) 1223/2009. The update adds 56 further substances that require individual disclosure once a set concentration threshold is crossed. Annex III mixes individual substances, grouped entries and prescribed label names, so a single headline total would be misleading - what governs are the entries, thresholds and prescribed names set out in Annex III itself.
Regulatory Background
The update followed a formal request to the EU's Scientific Committee on Consumer Safety (SCCS) to review the existing allergen list. The SCCS confirmed the substances already listed remained relevant, and separately identified 56 additional fragrance ingredients with a clearly demonstrated history of causing allergic reactions in humans, but which carried no individual labelling requirement at the time. That finding is the direct basis for the expanded Annex III.
Concentration Thresholds
| Product type | Individual labelling threshold |
|---|---|
| Leave-on products | Above 0.001% (10 ppm) |
| Rinse-off products | Above 0.01% (100 ppm) |
Below these thresholds, an ingredient that forms part of the perfume or aroma composition can remain folded into the generic "parfum" or "aroma" listing rather than being named individually. This does not apply to an ingredient added for another function, which is listed under its own name, and it leaves every other mandatory labelling requirement in place.
Compliance Deadlines
The Annex III entries introduced by Regulation (EU) 2023/1545 set two separate transitional dates for products that do not yet meet those amended entries: such products could be placed on the Union market until 31 July 2026, and may be made available on the Union market until 31 July 2028. The first of these dates has now passed, so any cosmetic product newly placed on the EU market - including further units of an existing product - must already carry the expanded fragrance allergen declaration. These transitional provisions relax only the amended Annex III requirements; all other applicable requirements continue to apply unchanged.
| Date | What applies |
|---|---|
| 31 July 2026 | Last date on which products not yet meeting the amended Annex III entries could be placed on the Union market. Passed - new products must now comply. |
| 31 July 2028 | Last date on which such products already placed on the market may still be made available (sold through), provided they meet all other applicable requirements. |
Prehaptens and Prohaptens
A notable technical addition: certain fragrance substances that are not themselves classified allergens - known as prehaptens and prohaptens - can convert into recognised contact allergens through air oxidation or through bioactivation once on the skin. The updated Annex III treats these substances as equivalent to fragrance allergens for restriction and labelling purposes, closing a gap where a technically "non-allergenic" ingredient could still cause allergic reactions in practice.
Naming & Consistency Updates
- Common names for already-listed substances were aligned to the current version of the Common Ingredients Glossary referenced in Article 33 of the Cosmetics Regulation.
- Similar substances were grouped into single entries for clarity, with guidance on which common name to use in the ingredient list where multiple names exist for the same substance.
- CAS and EC numbers were completed and corrected across existing entries, and isomers were added where relevant - reducing ambiguity for both economic operators and enforcement authorities.
What This Means in Practice
If your product's CPSR or ingredient list was compiled before this update, it is worth checking your fragrance supplier's allergen declaration against the current Annex III list - particularly for any prehaptens or prohaptens that may not have been flagged under the older, shorter list. HCPC Brands can review your existing CPSR and labelling against the updated Annex III as part of a standard CPSR review.
Source
Commission Regulation (EU) 2023/1545 of 26 July 2023, amending Regulation (EC) No 1223/2009 as regards labelling of fragrance allergens in cosmetic products, Official Journal of the European Union, L 188.
Frequently Asked Questions
How many fragrance allergens must now be individually labelled on cosmetic products?
Commission Regulation (EU) 2023/1545 introduces individual labelling requirements for 56 additional fragrance allergens identified by the Scientific Committee on Consumer Safety, on top of those already listed. A single headline total is misleading, because Annex III mixes individual substances, grouped entries and prescribed label names - these are not the same counting object. What governs in practice are the entries, thresholds and prescribed names set out in Annex III.
At what concentration does an allergen need to be individually listed?
Above 0.001% in leave-on products, and above 0.01% in rinse-off products. Below those thresholds, an allergen that is part of the perfume or aroma composition can remain within the generic "parfum" or "aroma" listing; a substance added for another function is named separately in any case.
What are "prehaptens" and "prohaptens," and why do they matter here?
These are fragrance substances that are not allergens in their original form but can be transformed into known contact allergens through air oxidation or bioactivation on the skin. The updated Annex III treats them as equivalent to fragrance allergens, subject to the same labelling and restriction requirements.
Does this affect the existing CPSR for a product already on the market?
Potentially, yes. A Cosmetic Product Safety Report must be kept up to date in light of new relevant safety information - an expanded allergen disclosure requirement is exactly the kind of development that can require a CPSR and ingredient list to be revisited.
What are the compliance deadlines, and have they already passed?
The first deadline has already passed. Regulation (EU) 2023/1545 allowed cosmetic products that do not yet meet the amended Annex III entries to be placed on the Union market up to and including 31 July 2026. Units lawfully placed on the market within that transitional period may continue to be made available until 31 July 2028. In practice, any product newly placed on the market today - including further units of an existing product - must already carry the expanded allergen declaration, while units lawfully placed on the market within the transitional period may still be made available until 31 July 2028. The transition covers only the amended requirements: it does not legalise any other non-compliance, and the product must still meet all other applicable requirements. Only the allergens present above the relevant threshold have to be declared separately.
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