Global Cosmetic Fragrance and Flavor Ingredients Compliance Guide
- Lucia
- Jul 24
- 5 min read
Fragrances play an indispensable role in cosmetics, enhancing user experience through pleasant scents and strengthening product recall. However, the complex fragrance ingredients introduce potential safety risks: natural or synthetic aromatic substances may contain common allergens such as cinnamaldehyde or geraniol.
How to ensure product sensory appeal while minimizing allergenic risk? The safe use of fragrances represents a critical balancing act between art and science within the cosmetics industry. The following part will outline compliance requirements for fragrance allergens in key markets including the EU, China, Taiwan of China, the US, and Canada, aiding enterprises in reducing compliance risks for global distribution.
Global Fragrance Safety Standard Framework: The Central Role of IFRA
The International Fragrance Association (IFRA), as the global standard-setter for fragrance safety, provides standards that serve as key references for national regulations worldwide. IFRA categorizes fragrance application into 12 major product types (covering leave-on, rinse-off, and non-skin direct contact products), establishing independent usage restrictions for each category.
The IFRA Certificate is the core compliance document for fragrance safety, containing four key elements:
1. Statement of Conformity: Confirms the fragrance’s compliance with the latest IFRA Standards；
2. Concentration Limits: Lists the maximum permitted use concentration for each product category；
3. Ingredient Restrictions: Includes a list of restricted or prohibited ingredients；
4. Scope of Application: Specifies the applicable product categories.
This certificate is not only essential for safety assessment processes including the EU CPSR, but also serves as crucial compliance proof for e-commerce platforms such as Amazon US. Enterprises must ensure suppliers provide valid #IFRA Certificates (typically valid for 1-2 years). For in-house produced fragrances, third-party professional assessment and certificate are required.
IFRA Standards and related documents are periodically updated as new safety information on fragrance ingredients emerges. The latest versions are available on the IFRA website.
IFRA Standards-51st amendment, effective from July 2023, mandated that enterprises update standards and ensure product compliance within specified transition periods. By October 2025, all products must comply with all requirements set forth in the 51st amendment.
IFRA Standards-51st amendment link:
Analysis of Key Market Compliance Requirements
EU
In July 2023, the EU published Regulation (EU) 2023/1545, amending the List of Restricted Substances (Annex III ) of the Cosmetic Regulation (EC) No 1223/2009. It significantly expanded the list of fragrance allergens subject to mandatory labeling from 26 to 81 substances (adding 57 new allergens including menthol and cinnamon leaf oil), maintaining strict thresholds:
Specific allergen names must be listed on the label if their concentration exceeds 0.001% in leave-on products and exceeds 0.01% in rinse-off products.
Butylphenyl methylpropional (Lilial/BMHCA) banned since 2022 and Hydroxyisohexyl 3-cyclohexene carboxaldehyde (HICC) banned since 2021 under the original 26 substances whose prohibition remains unchanged.
Key notes on newly added allergens:
1) Lippia citriodora Kunth. absolute is permitted as a fragrance, but other Lippia citriodora essential oils and derivatives associated with the same CAS number (8024-12-2) remain prohibited.
2) Myroxylon Balsamum extracts, distillates, oils, etc. are permitted as fragrances, but the exudate associated with the CAS number (8007-00-9) remains prohibited.
Transition Period includes two steps: Non-compliant products will be prohibited from being placed on the market starting July 31, 2026. They will be completely prohibited from being sold starting July 31, 2028.
Enterprises should make early packaging updates with over a year remaining until the placement ban.
China
Current allergen management primarily focuses on children’s cosmetics and imported products.
According to the Technical Guidelines for Children’s Cosmetics, if fragrances or aromatic plant oils used in children’s cosmetics contain allergens listed in the appendix and exceed thresholds (>0.001% in leave-on or >0.01% in rinse-off products), safety assessment and specific labeling are required.
Imported Products, if fragrance allergens are declared on the original packaging per the country of origin requirements, corresponding cautionary statements must be added to the Chinese label.
In addition, the Provisions for the Registration or Filing Dossier of Cosmetics offer two options for Fragrance Ingredient Disclosure:
1. If the formula table only lists “Fragrance”, individual component information is not necessary. However, if specific fragrance components are declared on the product label (or original label for imports), this must be noted in the formula remarks;
2. If the formula table lists both “Fragrance” and specific components, all documents of detailed types and concentrations of fragrance components from the fragrance supplier should be submitted.
Taiwan， China
On January 21, 2025, the Ministry of Health and Welfare of Taiwan, China, released two draft amendments: Draft Amendment to the Regulations Governing the Labeling of Cosmetics Packaging, Containers, Labels, or Instructions for Use and the Draft Regulation on the Labeling of Specific Fragrance Ingredients in Cosmetics.
According to drafts, Terms like “Fragrance,” “Flavor,” or their equivalents can generally be used. However, if a cosmetic contains any of the 24 specific fragrance allergens listed in the appendix (identical to those requiring labeling under Chinese Mainland’s Technical Guidelines for Children Cosmetics) exceeding defined thresholds (>0.01% in rinse-off or >0.001% in leave-on products), the specific ingredient name(s) must be declared on the label. Using only generic terms like “Fragrance” is not permitted.
The two drafts will take effect one year after their official announcement. Cosmetics produced or imported before the effective date can continue to be sold until the end of their originally labeled shelf life.
Canada
On April 24, 2024, the government of Canada published Notice SOR/2024-63, amending cosmetic ingredient disclosure regulations to clarify fragrance allergen labeling rules: Fragrances can generally be listed collectively as “parfum” or other general term.However, if the product contains a listed allergenic fragrance ingredient exceeding >0.01% in rinse-off products or >0.001% in leave-on products, its specific ingredient name(s) must be declared on the label.
USA
At present, there is no federal mandate requiring the labeling of specific fragrance allergens on cosmetic products.
However, the Modernization of Cosmetics Regulation Act (MoCRA), enacted in December 2022, has initiated a transformation in industry regulation. Section 609 of MoCRA mandates that cosmetic labels must disclose all fragrance allergens. The FDA is required to develop draft regulations for fragrance allergen labeling after considering international, state, and local regulations (such as EU standards) in order to specify the specific scope of allergens and thresholds. Furthermore, if the FDA has reasonable grounds to believe that a fragrance ingredient is causing serious adverse reactions, it may, pursuant to Section 605(f), require the responsible person to submit a list of specific fragrance ingredients.
Although current U.S. regulations permit the simplified labeling of fragrance ingredients as “Fragrance” or “Flavor” on cosmetic products, with the implementation of MoCRA, enterprises must proactively plan compliance adjustments to address the impending regulatory shifts.
Global fragrance regulation is undergoing profound transformation, characterized by IFRA standard updates and the expansion of allergen labeling requirements in markets like the EU and US. Enterprises must prioritize fragrance compliance management through source control, formula optimization, and pre-emptive labeling compliance to enhance their competitiveness. In the trend of “sense of smell economy,” safety compliance is no longer merely a cost burden; it is the core of brand responsibility and market competitiveness. Enterprises that strategically plan their compliance approach will gain greater trust and more business opportunities in the global market.
If you have any questions related to global cosmetic fragrance and flavor ingredients compliance, please contact us via info@enter-co.com.
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