Fragrance is one of the top five allergens in cosmetic ingredients. For sensitive consumers, even trace amounts can trigger allergic reactions. To enhance transparency and help consumers make informed choices, regulators worldwide are tightening fragrance allergen labeling requirements. Countries and regions such as the EU, US, and China have been revising their policies to reflect growing safety concerns.
To support businesses stay compliant, ZMUni Compliance Centre has compiled fragrance allergen labeling requirements across key global markets.
China currently requires fragrance allergen labeling only for children's cosmetics. Technical Guidelines for Children Cosmetics, issued on August 31, 2023, emphasize that formulations for children's cosmetics should minimize or avoid the use of fragrance ingredients. The Guidelines also advise against using complex ingredients that may contain any of the 26 recognized allergenic components.
If a children's cosmetic product contains fragrance ingredients with any of the 24 allergenic components, the manufacturer must conduct a comprehensive safety assessment to ensure product safety. Additionally, if the concentration exceeds 0.001% in leave-on products or 0.01% in rinse-off products, the label must include a warning stating "Contains allergenic components," followed by the specific names of the allergens to ensure consumers are fully informed.
Figure: Potential Allergenic Fragrance Components listed in the Annex of theTechnical Guidelines for Children Cosmetics
On January 21, 2025, Taiwan Food and Drug Administration (TFDA) issued a draft amendments to the Labeling Requirements for Cosmetic Packaging, Containers, Labels or Directions. The amendment clarifies the existing rule, which allows fragrance and flavor ingredients to be labeled as 香精, 香料, Flavor, Fragrance, Parfum, Perfume or Aroma. The new provision specifies that if certain fragrance ingredients are subject to separate regulations, those regulations shall take precedence.
On the same day, TFDA also released a draft regulation titled Ingredients of Specific Fragrances or Flavorings That Should Be Labeled in Cosmetics was also published. It requires cosmetics to list specific fragrance ingredients from the annex if their concentrations exceed 0.01% in rinse-off products or 0.001% in leave-on products. Instead of generic terms 香精, 香料, Flavor, Fragrance, Parfum, Perfume or Aroma, the exact ingredient names must be disclosed. The annex includes 24 fragrance allergens, aligning with China's Technical Guidelines for Children Cosmetics.
Comments on both drafts can be submitted until March 24, 2025. They will take effect one year after their official announcement, with cosmetics manufactured or imported before the effective date allowed to be sold until the end of their shelf life.
Under the 7th Amendment to the EU Cosmetics Directive (2003/15/EC), cosmetics sold in the EU must disclose fragrance allergens on their labels if their concentrations exceed 0.001% in leave-on products or 0.01% in rinse-off products.
On July 26, 2023, the EU issued Regulation (EU) 2023/1545, updating Annex III of the EU Cosmetics Regulation (EC) No. 1223/2009 to include 56 additional substances on the allergen list, requiring their declaration when present above specified concentrations. A transition period has been established: from July 31, 2026, all newly marketed products must feature compliant labeling, and by July 31, 2028, non-compliant products must be removed from the market.
The Modernization of Cosmetics Regulation Act (MoCRA), enacted in December 2022, requires fragrance allergens to be disclosed on cosmetic labels. However, the U.S. FDA has yet to issue specific regulations regarding fragrance allergens. The FDA website lists common allergens, including fragrance allergens, and references the 26 allergens identified in the 7th Amendment to the EU Cosmetics Directive (76/768/EEC).
Meanwhile, state-level regulations in the U.S. are becoming increasingly stringent, imposing additional restrictions on cosmetic ingredients. For instance, California Safe Cosmetics Act and the Fragrance and Flavor Ingredient Right to Know Act mandate that any cosmetics sold in California containing known or suspected harmful ingredients, including fragrance allergens, must be reported under the California Safe Cosmetics Program (CSCP).
Canada has introduced SOR/2024-63, a regulation amending certain provisions on cosmetic ingredient disclosure. Under this rule, fragrance allergens must be listed in the ingredient list if their concentrations exceed 0.001% in leave-on products or 0.01% in rinse-off products. The labeling requirement for fragrance allergens will take effect on April 12, 2026.
A transition period has been established:
From April 12, 2026, both existing and new products must label 24 fragrance allergens.
From August 1, 2026, new products must label 81 fragrance allergens.
From August 1, 2028, existing products must also comply with the 81-allergen labeling requirement.
Since January 1, 2020, South Korea's Enforcement Rules of the Cosmetics Act require that when a cosmetic product contains any of the 25 fragrance allergens (which includes Lilial, an allergen banned in the EU), the allergens must be labeled in the "full ingredients" section of the product if their concentrations exceed certain thresholds. Specifically, fragrance allergens must be labeled if their concentration exceeds 0.001% in leave-on products or 0.01% in rinse-off products.
Currently, Japan, ASEAN countries, and other regions have not yet implemented mandatory fragrance allergen labeling requirements for cosmetics. However, with increasing awareness of fragrance allergens and evolving global regulations, it is crucial for cosmetic companies to stay informed and prepared. As these requirements may soon be enforced in various markets, businesses must closely monitor updates to ensure compliance.
