China released new dossier requirement for cosmetic raw material notification and registration as part of Rules for Cosmetic Notification and Registration for cosmetic industry.

SAFEGUARDS | Cosmetics, Personal Care & HouseholdNO. 064/21

 SG 06421 Creams

China National Medical Products Administration, NMPA, issued Notice No. 31, namely Provisions for Management of Cosmetic New Raw Material Registration and Notification Dossiers, providing detailed requirement on documents and process of New Cosmetic Ingredients.

Here are the highlights in this new provision. Such as:

  • Depending on the intended function of the new cosmetic ingredients, they are required to complete notification or registration process in NMPA before launching to the market. With this implementation, it will facilitate the application of new raw material in cosmetic industry. 

Registration Scope
Previous Scope New Scope
Natural or synthesized raw materials used in the manufacture of cosmetics for the first time in China. Only raw material with intended function of preservative, sunscreen, colorant, hair dye, skin-whitening
Notification Scope
Previous Scope New Scope
N/A

Raw materials except those with intended function of preservative, sunscreen colorant, hair dye, skin-whitening. Examples are,

  • Antioxidant
  • Bulking
  • Emulsion Stabilizing
  • Film Forming
  • Humectant
  • Skin conditioning - Emollient
  • Upon completion of notification or registration of a new cosmetic ingredient, suppliers shall provide annual report in specific format provided by NMPA for the first 3 years.
  • Safety assessment report according to relevant guideline is required for notification and registration.
  • Relevant test report(s) is/are required based on the type of raw materials.

Type Remark
Type I                     For the first time use in China and other countries, with functions of preservatives, sunscreen, colorant, hair dye, skin whitening, anti-hair loss, anti-acne, anti-wrinkle (except physical wrinkle resistance), anti-dandruff and deodorization, new cosmetics materials with high biological activity
Type II For the first time use in China and other countries, without functions of preservatives, sunscreen, colorant, hair dye, skin whitening, anti-hair loss, anti-acne, anti-wrinkle (except physical wrinkle resistance), anti-dandruff and deodorization
Type III Already safely used in other countries more than 3 years, without functions of preservatives, sunscreen, colorant, hair dye, skin whitening, anti-hair loss, anti-acne, anti-wrinkle(except physical wrinkle resistance), anti-dandruff and deodorization, new cosmetics materials with high biological activity
Type IV Already safely used in other countries more than 3 years, with functions of preservatives, sunscreen, colorant, hair dye, skin whitening, anti-hair loss, anti-acne, anti-wrinkle(except physical wrinkle resistance), anti-dandruff and deodorization, new cosmetics materials with high biological activity
Type V New cosmetics raw materials with safe edible history (the parts used for raw materials shall be consistent with the edible parts)
Type VI Polymers with an average MW of more than 1000 Dalton and the content of oligomer with a MW of less than 1000 Dalton less than 10%
  • This provision strengthens the requirements of teratogenicity test, chronic toxicity/carcinogenicity combination test and long-term human trial safety test.

The provision is implemented since 1 May 2021.

Reference

  1. https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20210304140454159.html 

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