Recently, the first registered new cosmetic ingredient under the Cosmetic Supervision and Administration Regulation(CSAR) since 2021—a whitening agent Isobutylamido Thiazolyl Resorcinol (Thiamidol 630)—has been successfully approved, marking a significant milestone and offering hope for the registration of new cosmetic ingredients(NCI). See previous report.
In addition to whitening, new hair dye ingredients are also worth noting. According to relevant data, the global hair dye market was valued at approximately $12.6 billion in 2022 and is expected to grow at a compound annual growth rate (CAGR) of 5.3% from 2023 to 2027. Similarly, the Chinese hair dye market is projected to continue its steady growth, with the market size expected to reach approximately RMB 45 billion by 2024.
Approved List of Hair Dyes in China
According to the Safety and Technical Standards for Cosmetics 2015 (hereinafter referred to as the "Standards"), hair dyes are substances added to cosmetics to change hair color. Currently, Chapter 3, Table 7 of the Standards includes 74 approved hair dyes and other permitted colorants for use in hair dye products. (Note: 2-Chloro-p-phenylenediamine and 2-Chloro-p-phenylenediamine sulfate have been included in the Inventory of Prohibited Ingredients for Cosmetics.) The use of these dyes must comply with the requirements outlined in the table.
If a hair dye intended for hair products is not listed in the Approved List, it must be submitted as a new cosmetic ingredient in accordance with the CSAR and related laws. CSAR specifies that NCI with higher-risk functions, such as preservation, sun protection, coloring, hair dyeing, or skin whitening, can only be used after registration with the National Medical Products Administration (NMPA).
Henna: the First New Hair Dye Ingredient ?
Lawsonia Inermis Leaf Powder (commonly known as Henna) is not currently included in the Inventory of Existing Cosmetic Ingredients in China (IECIC) or the Approved List in the Standards. Therefore, Henna cannot be used as a hair dye ingredient.
Referring to the registration timeline of Thiamidol 630 (retrieved from the NMPA website), its first rejection occurred in 2018, followed by a second denial in 2023, and its approval was finally granted on November 4, 2024. As for Lawsonia Inermis Leaf Powder, a record shows a registration rejection decision dated in January 2023. Thus, whether this hair dye will become the second approved NCI remains uncertain.
Nevertheless, the European Union’s Scientific Committee on Consumer Safety (SCCS) issued a final opinion on Lawsonia Inermis (Henna) hair dye (C169) in document SCCS/1511/13. The SCCS is of the opinion that the information provided is sufficient to assess the safe use of Henna as a hair dye. The assessment is based on the Henna batches 1271 and 830.72 under functions and uses, e.g. 100 g Henna powder mixed with 300 ml boiling water Henna is considered safe for the consumer. Other kinds of extracts of Henna that may have different compositions are not covered by this assessment. See official document.
While it remains uncertain whether Henna will become the second registered NCI, relevant companies can follow the registration procedure for new hair dye ingredients outlined below. Successfully registering a new hair dye ingredient would allow companies to broaden the range of available options for hair dye products.
Registration Procedure for New Hair Dye Ingredients in China
Testing and Documentation Requirements for the Registration Procedure
Situation 1: NCI that are being used for the first time globally, including those with preservative, sunscreen, coloring, hair dyeing, freckle-removing and whitening, anti-hair loss, anti-acne, anti-wrinkle (excluding physical anti-wrinkle), anti-dandruff, deodorizing functions, or other functions with higher biological activity used for the first time.
Situation 4: NCI with preservative, sunscreen, coloring, hair dyeing, freckle-removing and whitening, anti-hair loss, anti-acne, anti-wrinkle (excluding physical anti-wrinkle), anti-dandruff, deodorizing functions, that can provide sufficient evidence demonstrating a safety use history of over three years in marketed cosmetics outside of China.
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Documentation Requirements |
Situation 1 |
Situation 4 |
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I. Basic Information |
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1. List of Basic Information on Ingredients |
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2. Research Report |
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3. Basic Information on Ingredients |
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II. Research Report |
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4. Ingredient Use Information |
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5. Functional Claims Support Documentation |
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6. Manufacturing Process-Related Use Information |
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III. Manufacturing Process and Quality Control Standards |
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7. Manufacturing Process Description |
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8. Manufacturing Process-Related Safety Data and Test Methods |
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9. Quality Control Standards |
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10. Toxicological Test Methods and Quality Standards of Potentially Hazardous Substances |
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IV. Safety Assessment |
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11. Acute Toxicity Test Data |
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12. Skin and Mucous Membrane Irritation Test Data |
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13. Eye Irritation Test Data |
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14. Skin Sensitization Test Data |
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15. Phototoxicity/Photosensitization Test Data |
When the ingredient has UV absorption properties |
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16. Subacute Toxicity Test Data |
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17. Subchronic Toxicity Test Data |
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18. Chronic Toxicity Test Data |
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19. Teratogenicity Test Data |
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20. Mutagenicity/Genotoxicity Test Data |
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21. Carcinogenicity Test Data |
When the ingredient has potential inhalation exposure |
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22. Skin Absorption Test Data |
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× |
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23. Photo Absorption Safety Data |
Based on actual circumstances |
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24. Human Safety Test Data |
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V. Other Documents |
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25. Other Test Data |
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26. Statement of Ingredient Registration in Other Countries |
Based on actual circumstances |
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Navigating the Complexities of China's Cosmetic Compliance
Compared to NCI notification, registration is more complex and challenging. It remains crucial for companies to conduct thorough research into the ingredient's safety, intended use, and composition to ensure full compliance with regulatory requirements and review standards.
According to information released by China’s National Medical Products Administration (NMPA), Beiersdorf initiated the registration process for Thiamidol 630 early on and ultimately succeeded. While the registration procedure for new ingredients is typically lengthy and poses considerable challenges for cosmetic companies, success is achievable with sufficient patience and robust scientific support.
ZMUni Compliance Centre is a professional provider of compliance solutions with extensive experience in assisting with numerous NCI applications in China. For more information or assistance with NCI applications, please contact us at info@zmuni.com.
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