On September 24, 2025, China's National Institutes for Food and Drug Control (NIFDC) issued the Technical Guidelines for Dossier Requirements on the Registration and Notification of New Cosmetic Ingredients (Draft for Comment) and opened them for public consultation. The consultation period will remain open until October 19, 2025.
The Draft Guidelines introduce further improvements and clarifications in key areas, including the classification of application scenarios, dossier submission requirements, use of existing data, adoption of new technologies and methodologies, and recordkeeping obligations. One of the most noteworthy updates is the optimized classification of new cosmetic ingredient (NCI) application scenarios, which also allows for the streamlining or waiver of certain toxicological and human safety testing requirements.
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classification of scenarios |
Definition in Provisions for Management of New Cosmetic Ingredient Registration and Notification Dossiers (May 1st, 2021) |
Definition in Draft Guidelines(September 24th, 2025) |
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Scenario 1 |
No prior cosmetic use history, and possessing functions such as preservative, sunscreen, coloring, hair dyeing, whitening/freckle-removal, anti-hair loss, anti-acne, anti-wrinkle (excluding physical effects), anti-dandruff, antiperspirant/deodorant (AP/Deo), or other highly bioactive functions. |
NCIs with functions such as preservation, UV protection, coloring, hair dyeing, whitening/freckle-removal. |
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Scenario 2 |
No prior cosmetic use history and does not possess functions such as preservative, sunscreen, coloring, hair dyeing, whitening/freckle-removal, anti-hair loss, anti-acne, anti-wrinkle (excluding physical effects), anti-dandruff, or antiperspirant/deodorant (AP/Deo). |
NCIs do not serve functions such as preservation, UV protection, coloring, hair dyeing, whitening/freckle-removal. |
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Scenario 3 |
HoSU of over 3 years outside China, without functions such as preservative, sunscreen, coloring, hair dyeing, whitening/freckle-removal, anti-hair loss, anti-acne, anti-wrinkle (excluding physical effects), anti-dandruff, or antiperspirant/deodorant (AP/Deo). |
HoSU of over 3 years outside China, with functions such as preservative, sunscreen, coloring, hair dyeing, or whitening/freckle removal. |
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Scenario 4 |
HoSU of over 3 years outside China, and have functions such as preservative, sunscreen, coloring, hair dyeing, whitening/freckle-removal, anti-hair loss, anti-acne, anti-wrinkle (excluding physical effects), anti-dandruff, or antiperspirant/deodorant (AP/Deo). |
HoSU of over 3 years outside China, without functions such as preservative, sunscreen, coloring, hair dyeing, or whitening/freckle-removal. |
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Scenario 5 |
HoSU in food/nutrients, with the same part used and similar intended functions in cosmetics. |
History of safe use (HoSU) in food/nutrients with sufficient supporting evidence. |
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Scenario 6 |
Chemically synthesized polymers composed of one or more structural units linked by covalent bonds, with an average relative molecular mass greater than 1,000 Da, and oligomer content (with relative molecular mass below 1,000 Da) less than 10%, having stable structure and properties (excluding ingredients with high biological activity). |
Stable polymers meeting the polymer definition, with an average molecular weight (MW) > 1,000 Da and less than 10% of molecules with MW < 1,000 Da. |
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NCIs with high biological activity are no longer classified under Scenario 1, but toxicological testing can still be conducted in accordance with the relevant requirements for Scenario 1.
*Note: (1) NCIs: New Cosmetic Ingredients (2) HoSU: History of Safe Use |
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The new classification continues to emphasize the five high-risk functions—preservative, sunscreen, coloring, hair dyeing, and whitening/freckle-removal—as key criteria for distinguishing ingredient application scenarios. Based on this classification and actual risk, the Draft Guidelines also reasonably streamline and optimize certain toxicological and human safety testing requirements.
1. Exemptions for four high-risk ingredients
Except for ingredients with a whitening/freckle-removal function, the following three toxicological tests for the other four high-risk ingredients—preservative, sunscreen, coloring, and hair dye—may be waived if sufficient scientific evidence and research data are provided:
Reproductive and developmental toxicity tests
Combined chronic toxicity/carcinogenicity tests
Long-term human use safety tests
2. Exemptions for medium-risk ingredients
For NCIs with medium-risk functions—such as anti-hair loss, anti-acne, anti-wrinkle, anti-dandruff, and deodorizing—the following toxicological tests are no longer mandatory at the time of submission:
lReproductive and developmental toxicity tests
Combined chronic toxicity/carcinogenicity tests
Long-term human use safety tests
The Draft Guidelines'scenario classification and optimized toxicological testing aim to address key challenges in new cosmetic ingredient registration and notification. Their core goals are to reduce compliance costs by cutting redundant tests and shortening R&D timelines, strengthen oversight of high-risk ingredients to ensure safety and protect consumers, and improve regulatory efficiency through a risk-based, scenario-adapted approach that focuses resources on higher-risk areas.
Overall, the new changes in the Draft Guidelines represent a science-based approach that balances innovation and safety, and are expected to promote the healthy development of China's new cosmetic ingredient industry.
https://www.nifdc.org.cn/nifdc/bshff/hzhpjssp/hzpsptzgg/202509241041591736034.html
