China Cosmetic Product Registration and Filing

Cosmetics:An Overview

Cosmetic are industrially produced chemical products or substances subject to daily use, intended to be put in contact with any external part of the human body (skin, hair system, nails, lips and oral cavity) by spreading, rubbing, spraying, sprinkling etc., to enhance or alter their appearance.

Cosmetics have various definitions in different countries (regions). To determine whether a product falls in the scope of cosmetics in China, the following three aspects may be taken into consideration:

Aspects

Yes

No

Usage

Smearing, spraying or other similar ways like rubbing

Oral administration or injection­­­

Applied body parts

Any external part of the human body, such as skin, hair, nails, lips

Teeth or oral mucosa

Functions and purposes of use

Skin care, to make the body hygienic, to eliminate undesirable odors, to enhance the beauty of the appearance

Prevent and treat diseases

In China, cosmetics are classified into special use and non-special use products based on their specific function.

Non-special Use Cosmetics (Non-SUC) include:

  • Skin care products
  • Hair care products
  • Nail (toe) care products
  • Make-up
  • Fragrance.

On the other hand, special use cosmetics (SUC) currently include 10 types of products, namely:

  • Hair growth products
  • Hair dyes
  • Hair perming products
  • Hair removal products
  • Breast beauty products
  • Body fitness products
  • Deodorants
  • UV protection products
  • Anti-spot and
  • Whitening products.

Additionally, according to the place of origin, cosmetics are further classified into imported and domestic products.

Competent Authority in China

Administrative department

National Medical Products Administration (NMPA) and local Food and Drug Administration (local ) FDA

Approval System

Special use - Registration

Non-special use - Notification

Relevant Regulations

  • Regulations concerning the Supervision and Administration of Cosmetics
  • Rules on Administrative Approval for Cosmetics
  • Cosmetic Safety Technical Standard
  • Guidance for Risk Assessment of Risk Concern Substance in Cosmetic
  • Inventory of Existing Cosmetic Ingredient in China
  • National Standard GB 5296.3-2008 Instruction on Consumer Products - Cosmetic General Label

Registration or filling process

REACH24H Services

Regulatory consultation

  • Cosmetic registration and filing process
  • Registration required documents and testing items
  • Customized solution for cosmetic registration and filing, timeline and cost assessment

Responsible Agent for Special Use Cosmetics

  • Responsible for registration
  • Prepare the administrative approval documents and certificate
  • Cooperate with customers works or the assigned importer/distributor

Product Pre-Review

  • Define product category
  • Check whether all ingredients are allowable
  • Check whether all claims are compliant

Application and Follow-up

  • Application documents review
  • Complete registration dossier
  • Test arrangement and supervision
  • Follow up experts review comments
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