Fragrance Allergens
Specific fragrance substances identified as common causes of allergic contact dermatitis that must be individually declared on cosmetic product labels when present above specified concentrations. The EU currently requires declaration of 80+ fragrance allergens under updated EC 1223/2009 Annex III rules.
Fragrance allergens are specific fragrance substances that have been identified as common causes of skin sensitization (allergic contact dermatitis) in consumers. Unlike most cosmetic ingredients, fragrance allergens must be individually declared by their INCI name on the product label — they cannot be hidden under the generic term "Parfum" or "Fragrance."
The original EU requirement (in place since 2005) mandated individual declaration of 26 fragrance allergens when present above 0.001% in leave-on products or 0.01% in rinse-off products. In 2023, the European Commission adopted Regulation (EU) 2023/1545, expanding the list to over 80 fragrance allergens based on the SCCS Opinion on Fragrance Allergens in Cosmetic Products (SCCS/1459/11). The expanded requirements apply from July 2026 for new products and July 2028 for existing products.
In the US, fragrance ingredients are not currently required to be individually declared — they are listed under the collective term "Fragrance." However, MoCRA directs the FDA to issue rules for fragrance allergen disclosure on cosmetic labels, and FDA rulemaking is underway. Industry expects US fragrance allergen labeling requirements to take effect by 2027-2028.
Common fragrance allergens that frequently appear in declarations include linalool, limonene, citronellol, geraniol, hexyl cinnamal, and coumarin. These substances are naturally present in many essential oils and botanical extracts, meaning even "naturally fragranced" products may require allergen declarations.
Related Terms
EU Cosmetics Regulation (EC 1223/2009)
The primary European Union law governing cosmetic products, establishing requirements for safety assessment, CPNP notification, responsible person designation, ingredient restrictions (Annexes II-VI), labeling, and post-market surveillance across all EU/EEA member states.
IngredientAnnex III — EU Restricted Substances List
The list of substances restricted to specific conditions of use in cosmetic products under EC 1223/2009. Annex III specifies maximum concentrations, product types, warnings, and other conditions under which listed substances may be used.
ProcessInternational Nomenclature of Cosmetic Ingredients (INCI)
A standardized system of ingredient naming developed by the Personal Care Products Council (formerly CTFA), used worldwide for cosmetic ingredient labeling. INCI names are required on product labels in the EU, US, Canada, and most other regulated markets.
RegulationModernization of Cosmetics Regulation Act (MoCRA)
A US federal law (Public Law 117-328, Title XXXV) signed on December 29, 2022, that gives the FDA new authority over cosmetics including mandatory facility registration, product listing, adverse event reporting, safety substantiation, and recall authority.
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