How to Comply with Cosmetics Regulations in China

Cosmetics

How to Comply with Cosmetics Regulations in China

Little Pro on 2019-06-22

In China, the most important cosmetic legislation is Regulations on Supervision and Administration of Cosmetics coming into force on 1 Jan 2021. It contains several big changes that will impact current cosmetic companies and cosmetic ingredient suppliers.. 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: general use cosmetics and special use cosmetics. Special use cosmetics include hair dyes, hair perms, whitening products, sunscreen products, anti-hair loss and products with new efficacy. General use cosmetics include other cosmetic products.

Regulatory requirements for general use cosmetics and special use cosmetics are different. General use cosmetics only require filling notifications while special use cosmetics must be approved before they can be marketed in China.

Record-Keeping Notification of General 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 or safety assessment report
Proof of efficacy claim
Power of attorney and certificate of free sale (for imported products only)

For general use cosmetics (excluding cosmetics for children and infants), relevant animal tests can be waived if the manufacturer of ordinary cosmetics has obtained Good Manufacture Practice (GMP) certificate or equivalent production quality management system certification at the country of origin and can provide a product safety assessment report demonstrating the safety of a product.

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 filling notification or registration for new cosmetic ingredients. 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).

New cosmetic ingredients will be classified into ordinary new cosmetic ingredients and risky new cosmetic ingredients (i.e, those used for antiseptic, sunscreen, colorant, hair dye, and freckle whitening purpose). Ordinary new cosmetic ingredients only need to go through filling procedure and data requirement is also more resonable. Only more risky new cosmetic ingredients require NMPA’s approval before they can be used

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).

Introduction to Safety and Technical Standards for Cosmetics

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

Positive lists of colorant, preservative 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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