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New ingredients of cosmetic filing and registration

In order to standardize the registration and filing management of new cosmetic ingredients and ensure the quality and safety of cosmetics, the National Medical Products Administration has formulated the announcement of the "Regulations on the Administration of New Cosmetic ingredients Registration and Filing Documents" (No. 31 of 2021), which will come into force on May 1, 2021.

New ingredients definition

1. The new ingredients used in cosmetics for the first time in China are not in the list of used cosmetic ingredients.

2. To adjust the purpose of use and safe use of the ingredients in the list of currently used cosmetic ingredients, it must be applied by the newingredients registration and filing requirements and can be included in the usable cosmetic ingredients after approval.

Requirements for new cosmetic ingredients

Data request
1.Basic information	1. Registration or record ofingredients information form
2. Research and development report	2. Research and development background
	3. Basic information of ingredients
	4.ingredients usage information①
	5. Function basis data
	6. Development of other related materials
3.The preparation process And quality control standards	7. Brief description of preparation process
	8. Stability test data
	9. Quality specifications and inspection methods
	10. Information on possible safety risk substances and their control
4.Safety evaluation	11.Overview of toxicological safety evaluation
	12. Acute oral or acute dermal toxicity test ③
	13. Skin and eye irritation/corrosion test
	14. Skin allergy test
	15. Skin phototoxicity test④
	16. Skin photoallergic test ⑤
	17. Mutagenicity test
	18. Subchronic oral or dermal toxicity test
	19. Teratogenic test
	20. Chronic toxicity/carcinogenicity combined test
	21. Inhalation toxicity test ⑥
	22. Long-term human trial safety test
	23. Other toxicological tests⑦
	24. Safety assessment report
5. Other information	25. Technical requirements for new ingredients
5. Other information	26. Other materials that may help the registration and filing of new cosmetic ingredients⑦