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Functional basis data of new cosmetic raw materials

"Regulations on the administration of the registration and filing materials of new cosmetic raw materials" require that the functional basis materials shall be provided when the new cosmetic raw materials are filed and registered.

Different from the efficacy evaluation of cosmetics, the functions of new raw materials not only include efficacy (such as whitening, acne removal, and oil control), but also include the role of raw materials in cosmetic formulations (such as pH regulator and dispersant).

Function information (purpose of use)

In NMPA cosmetics new raw material registration management system, the new raw material registration optional use purpose is as follows:

Serial number

Purposes of Use

Serial number

Purposes of Use

Serial number

Purposes of Use

one

preservative

19

Cutin softening agent

37

Slip aid

2

sun-screening agent

20

Anti-knot

38

light stabilizer

three

stain

21

emollient

39

Mascara conditioner

four

Whitening agent

22

astringent

40

Nail care agent

five

Antiplaque

23

filler

41

Skin sensation regulator

six

Hair dye

24

propellant

forty-two

Lipotropic agent

seven

Anti-alopecia agent

25

Adsorbent

43

Oil control agent

eight

Deodorant

26

absorber

forty-four

Cracking agent

nine

PH regulator

27

denaturant

45

Abrasive

10

Hair conditioner

28

Defoaming agent

46

Skin protectant

11

Hair fixative

29

suspending agent

47

foaming agent

12

Aromatic

30

Oxidizing agent

48

perm agent

13

Dispersant

31

Antiperspirant

forty-nine

filmogen

14

Blocking agent

32

Thickener

50

Dissolution aid

15

chelating agent

33

solubilizer

51

Fabric softener

16

Reducing agent

34

adhesive

fifty-two

depilatory

17

Buffer

35

ethylene glycol distearate

53

Plasticizer.

18

Exfoliating agent

36

Surface modifier



Data requirements

ü The functional basis materials of new raw materials generally included scientific literature, regulatory data, laboratory research data, and human efficacy evaluation test data.

ü Claims with anti-corrosion, sunscreen, freckle whitening, anti hair loss, acne, wrinkle (except physical anti-wrinkle), dandruff, deodorization function of new raw materials of functional basis materials shall include at least laboratory research data or human efficacy evaluation test data.

ü Anti-corrosion, sunscreen, freckle whitening, anti hair loss in addition to the function of the evaluation report can be issued by the cosmetics new raw material registration, filing or commissioned by the corresponding inspection ability of the inspection and testing institutions.

ü The inspection report on such items as anti-corrosion, anti-sunburn, anti-freckle and whitening, and anti-alopecia efficacy evaluation shall be issued by an inspection institution that has obtained the qualification accreditation (CMA) of inspection and testing institutions in the cosmetics field or the accreditation of China National Accreditation Committee for Conformity Assessment (CNAS), or that has met the international prevailing qualification accreditation or accreditation such as Good Clinical Practice Regulations (GCP) or Good Laboratory Practice Regulations (GLP).

 

Data preparation strategy

ü For the efficacy evaluation of anti-corrosion, anti-sunburn, anti-spot whitening and anti-alopecia raw materials, it is required to provide at least laboratory research data or human efficacy evaluation test data. Inspection reports shall be issued by qualified inspection institutions (CMA, CNAS, GLP, GCP). Anticorrosion, Sunscreen and Whitening Effects The national standards (human test) for the efficacy of existing cosmetics are as follows.

² Sunscreen Effect-2015 Edition of Safety Technical Specifications for Cosmetics

² Moisturizing Effect-Guidelines for Evaluating the Moisturizing Effect of Cosmetics QB/T 4256-2011

² Anti-alopecia effect-test method for anti-alopecia effect of cosmetic

² Freckle whitening efficacy-the cosmetics freckle whitening efficacy test method

* after the completion of the toxicity test and human patch test, the laboratory evaluation rear available for human test. Besides, since the raw materials cannot be directly applied to human bodies, the human body test can be conducted only when the raw materials are prepared into a cosmetic finished product formula.

 

 

ü For new raw materials with functions of acne removal, anti-wrinkle (except for physical anti-wrinkle), dandruff removal and deodorization, it is required to provide at least laboratory research data or human efficacy evaluation test data. The function evaluation report can be issued by the cosmetics new raw materials registration, filing or entrust the inspection and testing institutions with the corresponding inspection capacity.

In vitro testing is recommended to reduce filing test cycles.

For other functional raw materials with efficacy and non-efficacy categories, the tests can be conducted by oneself or entrusted, or the existing literature or regulatory information can be submitted on behalf of the test materials.



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