The regulatory framework for cosmetic labelling has changed significantly with the introduction of new requirements for the disclosure of fragrance allergen ingredients. These changes aim to improve consumer safety and transparency and have a direct impact on cosmetic formulation, testing, and labelling practices, particularly within the European Union (EU).
Manufacturers placing cosmetic products on the EU market must now adapt to stricter allergen disclosure rules to remain compliant with EU cosmetic legislation.
The Expanded Fragrance Allergen List and Regulatory Background
Previously, EU cosmetic legislation required the individual labelling of 24 specific fragrance allergens. Concerns raised by the Scientific Committee on Consumer Safety (SCCS) regarding consumer sensitization risks led to a regulatory review of this approach.
As a result, Regulation (EU) 2023/1545 was published, significantly expanding the list of fragrance allergens subject to mandatory disclosure. The number of allergens that must now be individually declared has increased from 24 to 80, with some interpretations referring to 81 or 82 substances depending on how certain isomers and substance groups are counted.
This expanded allergen list provides consumers who suffer from contact allergies with clearer information, enabling them to identify and avoid substances that may cause adverse skin reactions.
New Labelling Thresholds for Fragrance Allergens
The concentration thresholds that trigger mandatory allergen disclosure have not changed. However, their practical impact has increased substantially due to the broader list of regulated substances.
For leave-on cosmetic products such as creams, lotions, and makeup, manufacturers must list an allergen individually when its concentration exceeds 0.001 percent (10 ppm).
For rinse-off products such as shampoos and shower gels, individual labelling becomes mandatory when the allergen concentration exceeds 0.01 percent (100 ppm).
If any of the listed allergens exceed these thresholds, manufacturers must include them on the ingredient list using their INCI names. This requirement applies even when the allergen is present only as part of a fragrance mixture declared as “Parfum” or “Aroma.”
The Role of IFRA Standards in Fragrance Compliance
EU cosmetic regulations define the legal requirements for allergen disclosure, while IFRA Standards establish safety limits for the use of fragrance materials in cosmetic formulations.
The International Fragrance Association (IFRA) restricts the maximum allowable concentration of potentially sensitizing fragrance ingredients based on product type. These limits vary depending on exposure scenarios, such as lip products, body lotions, or rinse-off cleansers.
Manufacturers must therefore ensure compliance on two levels. First, fragrance raw materials must meet IFRA safety standards. Second, finished cosmetic products must comply with EU allergen labelling requirements. Both elements are essential for lawful market access in the EU.
Transition Periods and Compliance Deadlines
To account for the impact of these changes on product formulation, safety assessment, and packaging redesign, the EU has introduced a phased transition period.
From August 1, 2026, all new cosmetic products placed on the EU market must comply with the expanded fragrance allergen labelling requirements.
By July 31, 2028, cosmetic products already on the market that do not meet the new requirements must be withdrawn.
These deadlines require cosmetic brands to begin reviewing formulations, updating safety assessments, and redesigning labels well in advance. Early action helps ensure uninterrupted market access and long-term compliance with EU cosmetic regulations.
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