Cosmetics

How to Comply with Cosmetics Regulations in China

Little Pro on 2019-06-22 Views:  Update:2019-06-22

In China, the most important cosmetic legislation is Regulations Concerning the Hygiene Supervision over Cosmetics, which is currently being revised. The main authority for cosmetics is National Medical Products Administration (NMPA), previous called CFDA. Both domestic and imported cosmetic products require pre-market approval or notification before they can be placed on Chinese market. In this article, we will summarize how to comply with cosmetics regulations in China.

Classification of Cosmetics in China

Cosmetic products are divided into two categories: non-special use cosmetics and special use cosmetics.  Non-special use cosmetics include hair care, nail care, skin care, perfumes, and makeup. Special use cosmetics include products with claims for hair growth, hair dye, hair perm, hair removal, breast shaping, fitness, deodorizing, spot removal, whitening and sun block.

Regulatory requirements for non-special use cosmetics and special use cosmetics are different depending on whether they are domestic or imported products.

Type Domestic Imported
Non-special Use
  • Notify their product info to provincial Medical Products Administration
  • Obtain a record-keeping certificate prior to marketing.
  • 1~3 weeks after notification
  • Appoint a domestic Responsible Person
  • Notify their product info to NMPA's online notification platform
  • Obtain a record-keeping certificate prior to import (from Nov 2018). 
  • 1~3 weeks after notification
Special Use 
  • Submit product registration to NMPA
  • Obtain an administrative license prior to marketing
  • More info needed and more time-consuming
 
  • Appoint a domestic Responsible Person 
  • Submit product registration to NMPA
  • Obtain an administrative license prior to import
  • More info needed and more time-consuming
 

Note: A new cosmetic ingredient must also be approved by NMPA first before it can be used in cosmetics in China.

Record-Keeping Notification of Non-special Use Cosmetics

The following info is required for the record-keeping notification of non-special use cosmetics.

  • Product recipe
  • Product package, labeling and manuals
  • Product safety evaluation info
  • Manufacturing process info
  • Product technical specification
  • Product testing report
  • Power of attorney and certificate of free sale (for imported products only)

Product testing report must be issued by authorized test institutes in China. Testing items include physio-chemical test, microbial test and toxicological test.

For domestic non-special use cosmetics, toxicological tests (animal test) can be waived if a product can be demonstrated to be safe via safety evaluation report. For imported non-special use cosmetics, animal tests are currently still required. Some alternative methods are available. NMPA is working on a revised regulation to allow animal toxicological tests to be waived from some imported non-special use cosmetics. 

Registration Requirement for Special-use Cosmetics

In addition to what is required for non-special use cosmetics, the following info needs to be submitted for special use cosmetics. Toxicological tests cannot be waived. 

  • Efficacy data to support product claims
  • Human safety tests

Requirements on Ingredients

You are only allowed to use those cosmetic ingredients listed in the Inventory of Existing Cosmetic Ingredients in China (China IECIC). Otherwise, you have to submit new cosmetic ingredient registration. In addition, you need to comply with the following regulatory lists set out in Safety and Technical Standards for Cosmetics (化妆品安全技术规范).

List of banned substances and restricted substances

The list of banned and restricted substances is given in Safety and Technical Standards for Cosmetics (化妆品安全技术规范).

Example: 1,4-dioxane (<30mg/kg), Pb (<10mg/kg), As (<2mg/kg), Cd (<5mg/kg)

Positive lists of colorantpreservative and UV filter

For special functional ingredients such as colorant, preservative and UV filter, you can only use those approved and listed in Safety and Technical Standards for Cosmetics (化妆品安全技术规范). 

Labelling Requirements

The following information needs to be indicated on product labels:

  • Product name
  • Ingredients
  • Net content
  • Shelf life
  • Manufacturer address
  • Country of origin (for imported products)
  • Contact info of domestic legal entity or Responsible Person
  • Batch no.
  • Administrative license no. or record-keeping certificate no.

Labeling shall not imply that these products have characteristics or functions which they do not have.

References

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 Tags: Topics - CosmeticsCosmetics Regulation Overview

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