With the implementation of new regulations, exemption from animal testing for new cosmetic ingredient (NCI) notification has been a key focus for ingredient manufacturers, especially those from Europe and America.
Under what circumstances can animal testing be exempted?
With regard to the Regulations on the Administration of Registration and Notification Documents for New Cosmetic Ingredients, combined with the methods included in the Technical Standards for Cosmetic Safety, animal alternative methods can be used in the following two conditions to exempt animal testing.
1. New cosmetic ingredients with a food safety history and no UV absorbance properties. It is worth noting that the part used for cosmetic ingredients shall be consistent with the part used for food.
2. Chemically synthesized polymers of one or more building blocks connected by covalent bonds, with an average relative molecular mass over 1000 daltons, and less than 10% low molecular weight oligomers under 1000 daltons, with stable structure and properties (excluding highly bioactive ingredients)
Table 1 specifies the toxicological testing required for each condition of NCI notification. However, among all the listed tests, only the Skin and Eye Irritation/Corrosion Test and the Skin Sensitization Test currently have validated alternative methods that can replace animal testing. For conditions 1-4, the requirements include more tests beyond these two. Therefore, only ingredients meeting conditions 5 or 6 can be fully exempt from animal testing based on the availability of replacement methods. For other conditions, additional animal tests would still be needed to meet the notification requirements in Table 1.
Table 1 Toxicological Testing Required for NIC Notification
Condition | Scope | Required Toxicological Testing |
Condition 1 | New ingredients used for the first time domestically and abroad, with preservative, sunscreening, coloring, hair dyeing, whitening, hair loss prevention, acne removal, anti-wrinkle (except physical), dandruff removal, deodorization functions, and other new ingredients with high bioactivity used for the first time domestically and abroad | *Acute oral or dermal toxicity test *Skin and eye irritation/corrosion test *Skin sensitization test *Mutation test *Subchronic oral or dermal toxicity test *Teratogenicity test *Chronic/carcinogenicity combined test *Long-term human safety test |
Condition 2 | New ingredients used for the first time domestically and abroad, without preservative, sunscreening, coloring, hair dyeing, whitening, hair loss prevention, acne removal, anti-wrinkle (except physical), dandruff removal, deodorization functions | *Acute oral or dermal toxicity test *Skin and eye irritation/corrosion test *Skin sensitization test *Mutation test *Subchronic oral or dermal toxicity test |
Condition 3 | New ingredients without preservative, sunscreening, coloring, hair dyeing, whitening, hair loss prevention, acne removal, anti-wrinkle (except physical), dandruff removal, deodorization functions, with over 3 years of proven safe use in overseas marketed cosmetics | *Acute oral or dermal toxicity test *Skin and eye irritation/corrosion test *Skin sensitization test *Mutation test |
Condition 4 | New ingredients with preservative, sunscreening, coloring, hair dyeing, whitening, hair loss prevention, acne removal, anti-wrinkle (except physical), dandruff removal, deodorization functions, with over 3 years of proven safe use in overseas marketed cosmetics | *Acute oral or dermal toxicity test *Skin and eye irritation/corrosion test *Skin sensitization test *Mutation test *Subchronic oral or dermal toxicity test |
Condition 5 | New cosmetic ingredients with food safety history (ingredient source should match food source) | *Skin and eye irritation/corrosion test *Skin sensitization test |
Condition 6 | Chemically synthesized polymers of one or more building blocks connected by covalent bonds, with average relative molecular mass over 1000 daltons, and less than 10% low molecular weight oligomers under 1000 daltons, with stable structure and properties (excluding highly bioactive ingredients) | *Skin and eye irritation/corrosion test |
Table 2 Animal Alternative Methods
No. | Alternative Method | Testing Purpose |
1 | In vitro 3T3 neutral red uptake phototoxicity test for cosmetic ingredients | Potential phototoxicity of cosmetic ingredients |
2 | Ex vivo skin corrosion resistance test in rats for cosmetic ingredients | Corrosive potential on mammalian skin |
3 | In vitro short-time exposure test with rabbit corneal epithelial cells for cosmetic ingredients | Eye irritation or corrosion potential of cosmetic ingredients |
4 | Skin sensitization: Local lymph node assay: DA | Skin sensitization potential of cosmetic ingredients in mammals upon repeated exposure |
5 | Skin sensitization: Local lymph node assay: BrdU-ELISA | Skin sensitization potential of cosmetic ingredients in mammals upon repeated exposure |
6 | In vitro skin sensitization: Direct peptide reactivity assay | Skin sensitization potential of cosmetic ingredients |
Table 2 provides a summary of the non-animal test methods included in the Technical Standards for Cosmetic Safety that can serve as replacements for animal testing to assess skin sensitization and skin/eye irritation/corrosion of cosmetic ingredients. These methods include in vitro cell culture assays and ex vivo tests using animal tissues. By utilizing the alternative tests listed in Table 2, certain toxicity endpoints can be evaluated without the use of live animals.
In summary, by meeting certain conditions and utilizing validated animal alternative methods, new cosmetic ingredients can be exempt from animal testing during notification in China. This aligns with the global trend of promoting animal welfare through the 3Rs (replacement, reduction, and refinement) in cosmetic safety assessments.
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