Functional basis of new raw materials for cosmetics Coping strategies

Release time:

2021-08-06 17:59

The Provisions on the Administration of Registration and Filing Materials of New Raw Materials for Cosmetics requires that functional basis materials should be provided when filing and registering new raw materials for cosmetics.

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

Function information (purpose of use)

In the NMPA cosmetic new raw material registration management system, the new raw material registration can choose to use the following purposes:

Serial Number	Purpose of use	Serial Number	Purpose of use	Serial Number	Purpose of use
1	Preservative	19	Keratolytic agent	37	Slip Aid
2	sunscreen	20	Anti-knot	38	light stabilizer
3	Colorant	21	emollients	39	Mascara conditioner
4	whitening agent	22	astringent	40	nail care agent
5	spot-eradicator	23	Fillers	41	skin sensation regulator
6	Hair dye	24	Propellant	42	Lipid excipient
7	anti-alopecia agent	25	Adsorbent	43	oil control agent
8	Deodorant	26	Absorbents	44	cracking agent
9	pH regulator	27	denaturant	45	Sanding agent
10	hair conditioner	28	Defoamer	46	skin protectant
11	hair styling agent	29	suspending agent	47	Foaming agent
12	Fragrance	30	Oxidant	48	Perm agent
13	Dispersant	31	antiperspirant	49	film-forming agent
14	Sealant	32	Thickener	50	Soluble agent
15	chelating agent	33	Solubilizer	51	Softener
16	Reducing agent	34	Adhesive	52	depilatory agent
17	Buffer	35	pearlescent agent	53	Plasticizer
18	exfoliating agent	36	surface modifier

Data Requirements

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

* The functional basis materials of new raw materials that claim to have the functions of anti-corrosion, sun protection, freckle whitening, hair loss prevention, acne removal, anti-wrinkle (except physical anti-wrinkle), dandruff removal and deodorization shall at least include laboratory research data or human efficacy evaluation test data.

* Functional evaluation reports other than anti-corrosion, sun protection, freckle whitening, hair loss prevention, etc. can be issued by the registrant and recordholder of new cosmetic raw materials or by an inspection and testing agency with corresponding inspection capabilities.

* Inspection reports for anti-corrosion, sun protection, freckle whitening, anti-alopecia efficacy evaluation and other items shall be issued by inspection agencies that have obtained the qualification accreditation (CMA) of inspection and testing institutions in the cosmetics field or the China National Accreditation Service for Conformity Assessment (CNAS), or comply with internationally accepted good clinical practice (GCP) or good laboratory practice (GLP) and other qualification accreditation or accreditation.

Data Preparation Strategy

* For the efficacy evaluation of anti-corrosion, sun protection, spot whitening and anti-hair loss raw materials, it is required to provide at least laboratory research data or human body efficacy evaluation test data. The inspection report shall be issued by a qualified inspection agency (CMA, CNAS, GLP, GCP). Antiseptic, sunscreen, whitening efficacy of existing national standards for cosmetics (human trials) are as follows.

Sunscreen Efficacy-Safety Technical Specification for Cosmetics, 2015 Edition

Moisturizing Efficacy-Guidelines for the Evaluation of Moisturizing Efficacy of Cosmetics (QB/T 4256-2011)

Anti-hair loss efficacy-"cosmetic anti-hair loss efficacy test method"

Freckle whitening efficacy-"cosmetic freckle whitening efficacy test method"

* After the completion of toxicological testing and human patch testing, human testing can only be carried out after laboratory evaluation. And because the raw materials cannot be directly applied to the human body, the raw materials need to be made into a cosmetic product formula before human body testing.

For new raw materials with anti-acne, anti-wrinkle (except physical anti-wrinkle), anti-dandruff and deodorization functions, it is required to provide at least laboratory research data or human efficacy evaluation test data. The functional evaluation report, etc. may be issued by the registrant of the new raw material of cosmetics, the filing person himself or by an inspection and testing institution with the corresponding inspection capacity.

This recommendation is to use in vitro testing to reduce the filing test cycle.

For other functional and non-functional raw materials, you can choose to carry out tests on your own or entrust them or submit them on your behalf with existing literature or regulatory materials.

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