The Provisions for Registration and Filing of Cosmetics

Chapter V Legal Liability

Article 56 If the registrant of cosmetics and new cosmetic ingredients fails to apply for the change of registration for special cosmetics and new cosmetic ingredients in accordance with the requirements of these Provisions, the drug regulatory department that originally issued the license shall give an order for rectification, give a disciplinary warning, and impose a fine of not less than 10,000 yuan but no more than 30,000 yuan.

If the filing person of cosmetics and new cosmetics ingredients fails to update the filing information of general cosmetics and new cosmetics ingredients in accordance with the requirements of these Provisions, the drug regulatory department responsible for the filing administration shall order corrections, give warnings, and impose a fine of no less than 5,000 yuan but no more than 30,000 yuan.

If the registrant of cosmetics and new cosmetic ingredients fails to re-register in accordance with requirements of these Provisions, it shall be punished in accordance with Article 59 of the Regulations on Supervision and Administration of Cosmetics; if the filing person of cosmetics or new cosmetic ingredients fails to re-file the filing in accordance with requirements of these Provisions, fines shall be imposed as in the first paragraph of Article 61 of the Regulations on Supervision and Administration of Cosmetics.

Article 57 If the registrant or filing person of new cosmetic ingredients violates the requirements of Article 21 of these Provisions, the drug regulatory department of the province, autonomous region, or municipality directly under the central government shall give an order for rectification; the person that refuses to do so shall be fined not less than 5,000 yuan but no more than 30,000 yuan.

Article 58 If the filing drug regulatory department finds that the dossiers of filed cosmetics or new cosmetic ingredients do not meet the requirements, the filing management department shall order that correction be made within a specified timeline; where the data filed that relate to the safety of cosmetics and new cosmetic ingredients do not meet the requirements, the filing management department may at the same time order suspension of their sales and use.

For cosmetics and new cosmetic ingredients that have been filed but the filing dossiers has not yet been released to the public, if the filing drug regulatory department finds that the filing dossiers do not meet the requirements, they may order the filing person to make corrections and release the information to the public when the requirements are met.

Article 59 If the filing person is involved in the following circumstances, the filing drug regulatory department shall cancel the filing of cosmetics and new cosmetic ingredients:

(1) Providing fake filing documents;

(2) The filing dossiers submitted do not meet the requirements, fail to make corrections within the specified timeline or suspend the sale and use of cosmetics or new cosmetic ingredients as required; and

(3) Those that do not fall into the filing scope of new cosmetic ingredients or cosmetics.

Chapter VI Supplementary Provisions

Article 60 The time limit involved in the filing of registration acceptance, filing of technical evaluation opinions, issuance of registration license and release of filing information, registration re-review, and submission of new cosmetic ingredients usage reports shall be subject to the time of submission or issuance on the information service platform.

Article 61 Cosmetics of which the last process touching the contents completes in China are domestic products, and those that completes overseas are imported products. Those that completes in Taiwan, Hong Kong SAR and Macau SAR shall be regulated by the reference of imported products.

For products used in conjunction or combination products that apply for registration or file for filing under one product name, if any of the last process touching the contents are produced overseas, the set shall be regulated as imported products.

Article 62 The numbering format of cosmetics and new cosmetic ingredients after registration or filing shall comply with the following rules:

(1) The numbering rule for the filing of new cosmetics ingredients: 国妆原备字 + year (four digits) + serial number of new cosmetic ingredients filed this year.

(2) The numbering rules for the registration of new cosmetic ingredients: 国妆原注字 + year (four digits) + serial number of new cosmetic ingredients registered this year.

(3) The numbering rules for the filing of general cosmetics:

Domestic products: the abbreviation of provinces, autonomous regions, and municipalities + G妆网备字 + year (four digits) + serial number of products filed in the administrative area this year;

Imported products: 国妆网备进字 (the abbreviation of the province, autonomous region or municipality directly under the Central Government where the domestic responsible person is located) + year (four digits) + serial number of products filed nationwide this year;

Products from Taiwan, Hong Kong SAR and Macau SAR: 国妆网备制字 (the abbreviation of province, autonomous region or municipality directly under the central government where the domestic responsible person is located) + year (four digits) + serial number of products filed nationwide this year.

The numbering rules for the registration licenses of special cosmetics;

Domestic products: 国妆特字 + year (four digits) + serial number of products registered this year;

Imported products: 国妆特进字 + year (four digits) + serial number of products registered this year;

Products from Taiwan of, Hong Kong SAR and Macau SAR: 国妆特制字 + year (four digits) + serial number of products registered this year.

Article 63 These Provisions shall go into effect as of May 1, 2021.

Note: In case of any difference in interpretation between the English version and the Chinese version, the Chinese version shall prevail.