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).
l 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:
Purposes of Use
Purposes of Use
Purposes of Use
Cutin softening agent
Nail care agent
Skin sensation regulator
Oil control agent
ethylene glycol distearate
l 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.