Information about Chinese law on cosmetics

Obligations of the notifier/registrant

The duties of the notifier/registrant under the Cosmetic Supervision and Administration Regulation (CSAR):

1. is a company or other organisation established in accordance with the law
2. has a quality management system that complies with the cosmetic products to be notified/registered
3. has monitoring and evaluation capability for the adverse reactions of cosmetic products
4. Be responsible for the quality, safety and efficacy claims of cosmetic products.
5. be responsible for the truthfulness and scientific validity of the dossier or documents submitted.
6. the foreign notifier/registrant of cosmetic products shall designate a domestic legal person in China to carry out the notification/registration and assist in the monitoring of adverse reactions and recalls of cosmetic products.

Liabilities of a domestic responsible person

From the ‘Administrative Measures on Cosmetic Registration and Notification’ (2021),

contain the liabilities of a domestic responsible person in China:

1. conduct notification/registration of cosmetics and cosmetic raw materials in the name of notifier/registrant
2. assist the notifier/registrant in the monitoring of cosmetic adverse reactions, safety monitoring and reporting of new cosmetic raw materials
3. support of the notifier/registrant in the recall of cosmetics and cosmetic raw materials
4. in accordance with the agreement with the notifier/registrant, assume the corresponding responsibilities of quality and safety for cosmetic products and cosmetic new raw materials in the domestic (Chinese) market
5. co-operation with the supervision and inspection department of the pharmaceutical administration and monitoring for control and monitoring of cosmetic products

Submission Code and Annex 14 of the cosmetic raw material – Safety information

According to the Chinese cosmetics provisions, from 01 January 2023, the safety information, i.e. submission code or Annex 14 of each raw material of a cosmetic product registered or notified in China must be submitted or uploaded to the NMPA portal.

Previously, this was only required for high-risk raw materials such as preservatives, UV filters, whitening raw materials, etc.

The safety information of the raw material contains confidential information about the manufacturing process including e.g. derivatisation, the exact percentage of each component etc. The manufacturer or a company authorised by the manufacturer may apply for the submission codes for the raw materials on the Cosmetic Ingredient Submission Platform. The submission code is generated automatically after all required information has been entered or uploaded. The code consists of 14 digits. The first 5 digits identify the manufacturer. The next 6 digits identify the raw material and the last 3 digits indicate the quality specification.

By applying for the submission code, the manufacturer or supplier of the raw material can protect the confidential information about the raw material and save the time required to repeatedly fill out forms such as Safety Information Annex 14, which would be necessary for each new use of the raw material, by applying once.

Partial exemption from animal testing

Paragraph 33 in the ‘Administrative Measures for Cosmetic Registration / Notification Dossiers’ clearly defines the conditions under which a toxicological test is no longer required for normal cosmetic products such as shampoo, lipstick, day cream, etc. The Measures came into force on 1 May 2021.

Toxicological tests, which in China are always associated with animal testing, are no longer required for normal (general-use) cosmetic products if the notifier/registrant can guarantee product safety in the following way:

1. the manufacturer has an official quality certificate for production management such as GMP from the competent authority in the country of origin.
2. the safety assessment of the cosmetic product can prove the safety of the product

There are 3 exceptions to the animal testing exemption for normal (general-use) cosmetic products. These are:

1. baby products
2. cosmetic products with new raw materials that are in the 3-year monitoring period
3. according to the results of the quantitative classification, the notifier, or the domestic responsible person, or the manufacturer is classified as an important monitoring object.

For special-use cosmetic products such as sun protection, whitening products, etc. the toxicological tests with animal experiments remain in place.

Information on the Chinese label

1. Chinese product name
2. Name and address of notifier/registrant and RP
3. Name and Address of manufacturer, if the notifier/registrant doesn‘t produce the product
4. Product Executive Standard Number: notification no.
5. complete INCI list and “other trace ingredients “, if die concentration less than 0.1 % (w/w)
6. Filling quantity in national legal unit
7. Period of use: expiry date / lot. No. or production date + expiry duration
8. Application or how to use:
9. Necessary precautions and safety instructions, especially for baby cosmetics
10. Logo for baby cosmetics:
11. Other content should be labelled in accordance with laws, administrative regulations and mandatory national standards