Summary of requirements for toxicological test data for filing/registration of new cosmetic raw materials

Release time:

2020-12-21 17:40

Among the requirements for the registration of new cosmetic raw materials, the requirements for toxicological test data are one of the most concerned by the industry, because they involve large costs and long test cycles. In the November 2020 edition of the "Specification for Registration and Filing of New Raw Materials for Cosmetics and Cosmetics (Draft for Comments)" (hereinafter referred to as the "November Draft of the Specification"), the raw materials are divided into several categories according to their function, source and use, and different requirements are made for toxicological test data as shown in Table 1.

Table 1 Requirements for Registration and Filing Materials of New Raw Materials for Cosmetics

Situation classification Information Requirements		A	B	C③	D	E	F⑤
1. Information Table	1. Registration or filing information form	○	○	○	○	○	○
2. Development Report	2. R & D background	○	○	○	○	○	○
	3. Basic information	○	○	○	○	○	○
	4. R & D Purpose	○	○	○	○	○	○
	5. Overseas use ①
3. preparation process	6. Brief description and sketch of preparation process	○	○	○	○	○	○
4. Quality Control Standards	7. Stability test data	○	○	○	○	○	○
	8. Quality specification indicators and their inspection methods.	○	○	○	○	○	○
	9. Information on possible safety risk substances and their control ②
5. safety evaluation	10. Overview of toxicological safety evaluation.	○	○	○	○	○	○
	11. Acute oral or acute transdermal toxicity test	○	○	○	○
	12. Skin and Eye Irritation/Corrosion Tests	○	○	○	○	○	○
	13. Skin allergy test	○	○	○	○	○
	14. Skin phototoxicity test ④
	15. Skin photoallergy test ⑤
	16. Mutagenic test	○	○	○	○
	17. Subchronic oral or transdermal toxicity test	○	○		○
	18. Teratogenic Test	○
	19. Chronic Toxicity/Carcinogenicity Combination Test	○
	20. Toxic Metabolism and Kinetics Test ⑥	○
	21. Inhalation toxicity test ⑦
	22. Long-term human trial safety test	○			○
	23. Other toxicological tests
	24. Safety Assessment Report	○	○	○	○	○	○
6. Function Basis	25. Functional basis	○	○	○	○	○	○
7. Technical Requirements	26. Technical requirements for new raw materials	○	○	○	○	○	○
8. other information	27. Other information that may contribute to the registration and filing of new ingredients for cosmetics ⑧

A: New raw materials used for the first time at home and abroad, as well as new raw materials with anti-corrosion, sun protection, coloring, hair dyeing, freckle whitening, hair loss prevention, acne removal, anti-wrinkle (except for physical anti-wrinkle), anti-dandruff and antiperspirant functions.

NOTE: The toxicological test data of this category of raw materials are relatively high. In addition to the "anti-corrosion, sun protection, coloring, hair dyeing, freckle removal and whitening" that need to be registered and managed, the raw materials of "anti-alopecia, acne removal, anti-wrinkle (except physical anti-wrinkle), dandruff removal and antiperspirant function" that are subject to record management are also included in this category. In addition, compared with the September edition of the "Code" draft, the new "domestic and foreign first use of new raw materials".

B: New raw materials other than anti-corrosion, sun protection, coloring, hair dyeing, freckle whitening, hair loss prevention, acne removal, anti-wrinkle (except physical anti-wrinkle), anti-dandruff and antiperspirant functions, as well as new raw materials for cosmetics that do not need to be included in the list of restricted substances in the Technical Code for Cosmetic Safety from a safety point of view.

NOTE: Compared with the draft of the September edition of the Code, this article adds "new raw materials for cosmetics that do not need to be included in the list of restricted substances in the Technical Code for Cosmetic Safety from a safety point of view". The judgment of raw materials that may be included in the list of restricted substances from a safety point of view can be judged by existing reports, literature judgment or toxicological test data.

C: New raw materials other than anti-corrosion, sun protection, coloring, hair dyeing, freckle removal and whitening, hair loss prevention, acne removal, anti-wrinkle (except physical anti-wrinkle), dandruff removal and antiperspirant functions, as well as new raw materials for cosmetics that do not need to be listed in the list of restricted substances in the Technical Code for Cosmetic Safety from a safety point of view, and can provide sufficient evidence to prove that the raw materials have a safe use history of more than three years.

NOTE: This item has been used for more than three years. The following conditions must be met:

(1) The new raw materials and the raw materials used in overseas listed cosmetics have the same quality specifications, purpose of use, application or scope of use, and the safe use of new raw materials is not higher than the use of overseas listed cosmetics.

(2) The cosmetics containing the raw materials shall not be less than 3 years in the overseas market;

(3) The sales volume of cosmetics containing the raw materials abroad shall not be less than 2000 pieces, or the number of consumers shall not be less than 2000;

(4) No adverse reactions have occurred in the overseas listed cosmetics containing the raw materials.

(5) the raw materials involved in the possible harm to human health related literature reports.

D: With freckle whitening, anti-wrinkle (except for physical anti-wrinkle), anti-dandruff, antiperspirant function, can provide sufficient evidence to prove that the raw material in overseas marketing cosmetics has more than five years of safe use of new raw materials.

E: New cosmetic raw materials that can provide sufficient evidence to prove that they have a history of safe consumption (the parts used for the raw materials should be consistent with the edible parts).

F: Chemically synthesized polymers composed of one or more structural units, linked by covalent bonds, with an average molecular weight of more than 1000 Daltons, and a molecular weight of less than 1000 Daltons, with a content of oligomers of less than 10%, and stable in structure and properties (except for raw materials with high biological activity).

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