Cosmetic regulation in China

In publication #006 of KosmetikOn Education we deal in depth with cosmetic regulations in China. We start with the current cosmetic standards followed by their definition, and their annexes. We continue with all the information you will need to register your cosmetic product. Finally, we finish with the labelling section.

Cosmetics standards and regulation in force

In China, the Department of Drug Supervision and Administration of the State Council is responsible for the supervision and administration of cosmetics. On June 29, Decree No. 727 of the State Council of P.R. China on the new Cosmetics Supervision and Administration Regulation (CSAR) [1] was published and came into effect on January 1, 2021. The new regulation replaces the previously applied Cosmetics Hygiene Supervision Regulation and provides stronger supervision measures.

The summary of the CSAR regulations are:

Chapter 1: General Provisions

Chapter 2: Raw Materials and Products

Chapter 3: Production and Operation

Chapter 4: Supervision and Management

Chapter 5: Legal Liability

Chapter 6: Complementary Provisions

The State Food and Drug Administration and an Expert Committee on Cosmetic Standards also published the Safety and Technical Standards for Cosmetics [2]. This document gathers the lists of prohibited, restricted, specific ingredients... The summary of these standard are as follows:

Chapter 1: Overview (scope of application, terminology, interpretation, general requirements for cosmetic safety)

Chapter 2: Requirements for prohibited and restricted cosmetic components, including 1388 prohibited and 47 restricted cosmetic components

Chapter 3: Requirements for permitted cosmetic components, including 51 permitted preservatives, 27 permitted sunscreens, 157 permitted colorants and 75 permitted hair colorants

Chapter 4: Physical and chemical test methods, including 77 methods

Chapter 5: Microbiological test methods, including 5 methods

Chapter 6: Toxicological test methods, including 16 methods

Chapter 7: 2 methods for safety testing in humans

Chapter 8: 3 methods for the evaluation of efficacy in humans

Definition

First, a cosmetic refers to everyday industrial chemicals that are applied to the surface of the human body, such as skin, hair, nails, lips, etc., by rubbing, spraying or other similar methods for the purpose of cleansing, protecting, beautifying and modifying. Cosmetics are divided into special cosmetics and ordinary cosmetics. There are two categories of cosmetics in China:

Special cosmetics used for hair coloring, perming, freckle whitening, sun protection and hair loss, and which claim new effects

Ordinary cosmetics

They also divide raw materials into new raw materials and used raw materials. Natural or artificial raw materials used in cosmetics for the first time in the territory of China are new raw materials for cosmetics.

Register your cosmetic product

Which Product?

The raw material registration process has been simplified. Now a simple declaration is sufficient for new ingredients and ordinary cosmetics. In addition, this declaration has no expiration date. But special cosmetics can only be produced and imported after they have been registered with the drug regulation department of the State Council. Also, new cosmetic raw materials with anti-corrosion, sun protection, coloring, hair coloring, freckle removal and whitening functions can only be used after registration with the drug regulation department of the State Council, that is valid for 5 years.

Who can register?

Cosmetic registrants and declarants are responsible for cosmetic quality, safety and efficacy claims must comply with the following conditions:

It is legally established company or other organization

Has a quality management system appropriate to the products for which registrations are submitted

Is able to monitor and evaluate adverse reactions of cosmetics

Article 23 of the CSAR imposes a corporate legal entity within China to manage the registration and filing of cosmetics.

How to register?

To apply for the registration of special cosmetics or the presentation of ordinary cosmetics, the following information must be submitted:

Name, address and contact information of registrant

Name, address and contact information of the manufacturer

Name of the product

Product formula or the complete composition of the product

Standards for product implementation

Product label samples

Product inspection report

Product safety evaluation materials

According to Article 21 of the CSAR, prior to the registration and filing of new cosmetic raw materials and cosmetics, the registrant must conduct a safety assessment by themselves or on behalf of a professional institution. The personnel involved in the safety assessment must have professional knowledge related to the quality and safety of cosmetics, and have more than 5 years of relevant professional experience.

To register an imported product, submit the certification documents that the products have been marketed in the country (region) of production and the certification that the production enterprises abroad comply with the quality management of cosmetics production.

Labelling

General information

Cosmetic raw materials and packaging materials in direct contact with cosmetics must comply with mandatory national standards and technical specifications (Articles 35, 36 of the CSAR).

Cosmetic labels must indicate the following:

Name of the product, special cosmetic registration certification number

Name and address of the registrant, applicant party and entrusted production enterprise

Cosmetics production license number

Standard product number

All ingredients

Net content

Period of use, mode of use and necessary safety warnings

Other contents to be marked according to national laws, administrative regulations and mandatory national standards

There are also prohibited on the labels:

Content that expressly or impliedly medical effects

False or misleading content

Content that violates social order and morality

Other contents prohibited by laws and administrative regulations

Ingredient List

Article 16 of the Measures for the Administration of Cosmetic Label [3] imposes the conditions of the labels, cosmetic labels must indicate the standard Chinese names of the raw materials of all cosmetic ingredients on the visible surface of the sales package, with ingredients.

The list shall be established in descending order of weight. All ingredients not exceeding 0.1% (w/w) should be marked with other trace ingredients as a guide, and may not be listed according to ingredient content. If the formula is completed in the form of compound or mixed raw materials, the content of each ingredient in the formula shall be used as a basis for classifying the ingredient content and judging whether it is a trace ingredient.

Language

Regarding language, Article 6 of the Measures for the Administration of Cosmetic Labels, states that cosmetics must have Chinese labels. Chinese labels must use standard Chinese characters, and if other characters or symbols are used, corresponding explanations in standard Chinese characters shall be used on the visible side of the product sales package, except for websites, names and addresses of foreign companies and conventional, professional terms which should use other words.

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In the labeling, advertisements and publicity of cosmetic products, product claims must have sufficient scientific basis, according to Chinese cosmetic regulations [3] Article 43.

References