New Allergen Labelling

The regulatory landscape for cosmetic labelling has undergone a significant overhaul with the introduction of new rules regarding the disclosure of fragrance allergen ingredients.¹ This shift, driven by consumer safety and transparency, impacts how manufacturers formulate, test, and label their products, particularly within the European Union (EU).²

The Expanded Allergen List and Regulatory Basis

Historically, only 24 specific fragrance allergens required individual disclosure on the cosmetic label.³ However, due to concerns raised by the Scientific Committee on Consumer Safety (SCCS), Regulation (EU) 2023/1545 was published, dramatically expanding this list.⁴

The total number of fragrance allergens that must now be individually declared when present above a specific limit has increased from 24 to 80 (or 81/82, depending on how specific isomers and groups are counted).⁵ This change ensures consumers who suffer from contact allergies have the information necessary to avoid substances that could trigger a reaction.⁶

New Labelling Limits (Thresholds)

The regulatory limit (threshold) that triggers the mandatory disclosure on the cosmetic packaging remains the same, but its application is now far wider due to the expanded list of substances:

• Leave-on products (e.g., creams, lotions, makeup): Individual labelling is required if the concentration of the allergen exceeds ⁷$0.001\%$ (⁸$\mathbf{10 \text{ ppm}}$).⁹
• Rinse-off products (e.g., shampoos, shower gels): Individual labelling is required if the concentration of the allergen exceeds ¹⁰$0.01\%$ (¹¹$\mathbf{100 \text{ ppm}}$).¹²

If any of the 80 designated allergens are present above these tiny thresholds, they must be listed by their INCI name alongside other cosmetic ingredients, even if they are only present as a component of the “Parfum” or “Aroma” mixture.

The Role of IFRA Standards

While the EU Regulation sets the legal requirement for labelling, the IFRA (International Fragrance Association) Standards set the safety limits for the use of fragrance materials within a cosmetic product.¹³

• IFRA restricts the maximum permissible concentration of potentially sensitizing materials in a formula based on the product type (e.g., lip products, body lotions, rinse-off cleansers).¹⁴
• Manufacturers must first ensure their fragrance raw materials comply with IFRA standards, and then ensure their final product label elements comply with the new EU allergen disclosure rules. Both compliance pathways are essential for market access.

Transition Deadlines

Recognizing the significant impact of this change on formulation, testing, and cosmetic packaging redesign, the EU has implemented a phased transition period:¹⁵

• August 1, 2026: New cosmetic products placed on the EU market must comply with the new, expanded allergen labelling requirements.¹⁶
• July 31, 2028: Products already on the market that do not comply must be withdrawn by this date.¹⁷

This extended timeline requires brands to begin re-testing and potentially reformulating their products immediately to ensure a smooth transition and continuous market compliance.