On November 4, China's National Medical Products Administration (NMPA) approved the registration of a new cosmetic ingredient submitted by Beiersdorf: Isobutylamido Thiazolyl Resorcinol (Thiamidol 630). See previous report.
Yet, what are the requirements for registering whitening and freckle-removal ingredients? ZMUni Compliance Centre has compiled the key compliance points to serve as a reference for global stakeholders.
Under Technical Guidelines for Research on Functional Ingredients of Freckle-removing and Whitening Cosmetics (Draft for Comments)(hereinafter referred to as Guidelines), whitening and freckle-removal ingredients refer to any ingredient listed in the formulation of whitening or freckle-removal special cosmetics as a "freckle-removal agent" or "whitening agent" with the intended function of brightening or removing dark spots. For blended formulations, this term specifically applies to the active components that provide the freckle-removal or whitening effect. Ingredients that act solely by physical coverage are not included.
Currently, there is no official list of approved whitening and freckle-removal agents for cosmetics. When selecting these agents, companies often refer to the three types outlined in the Guidelines:
1. Using Registered Cosmetic New Ingredients with Freckle-removing and Whitening Effects
For example, using phenylethyl resorcinol (377) should meet the specified purpose, application range, safe usage limits, and other regulatory requirements for registered new ingredients. If using ingredients under a 3-year safety monitoring period, such as Thiamidol 630, authorization from the original registrant is required, along with timely feedback on its usage and safety status in line with relevant regulations.
2. Referencing Relevant Regulatory or Technical Standards Approved Globally
For example, companies can refer to whitening ingredient standards from South Korea or Taiwan, China.
3. Conducting Independent Research on Whitening and Freckle-removing Agents
Research should focus on the mechanism of action to demonstrate the safety and effectiveness of whitening and freckle-removal ingredients.
Care should be taken to distinguish the ingredient's intended whitening and freckle-removal effects from other purposes, such as sun protection, exfoliation, hydration, or cleansing. Research and evaluations should be based on the ingredient’s dosage in the formulation. For efficacy testing, human trials may be performed, referencing the whitening efficacy testing methods outlined in the Safety and Technical Standards for Cosmetics 2015. This approach helps validate both the safety and effectiveness of whitening ingredients.
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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● (Indicate the ingredient’s use history in foreign cosmetics) |
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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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× |
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20. Mutagenicity/Genotoxicity Test Data |
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× |
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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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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.
Since the new regulations implemented in 2021, ZMUni Compliance Centre has assisted in the applications of dozens of NCI. For further inquiries or assistance with NCI applications, please contact us at info@zmuni.com.
