To further regulate the cosmetic market and protect the health and rights of consumers, our government has formulated a series of regulations and stipulations to strictly manage the cosmetic products imported from abroad (including Hong Kong, Macao, and Taiwan) for sale in the domestic market. The following is a detailed introduction to these regulations and provisions, their scope of application, filing process, required information, and filing cycle.
First, the regulations and provisions
Regulations on the Supervision and Administration of Cosmetics
The Regulation on the Supervision and Administration of Cosmetics is an essential statute for China’s government to regulate the cosmetics market. The regulations provide for the definition, classification, regulatory responsibilities, filing process, evaluation specifications, and other cosmetics content. Among them, it is required that all cosmetics entering the domestic market for sale from abroad (including Hong Kong, Macao, and Taiwan) must complete the filing at the Drug Administration and obtain the electronic certificate for filing of imported general cosmetics or the certificate of registration of imported unique cosmetic products.
Cosmetics Registration and Filing Management Measures
Measures for the Administration of Cosmetics Registration and Filing” is a refinement and supplement to the “Regulations for the Supervision and Administration of Cosmetics.” The measures provide for the specific process of cosmetic registration filing, required information, evaluation specifications, and other content. Among them, special categories of cosmetics must complete the registration and obtain the product registration certificate of imported unique cosmetics before average customs clearance, inspection, and marketing.
Classification Rules and Classification Catalog of Cosmetics
The Classification Rules and Classification Catalog of Cosmetics is a document that regulates the classification of cosmetics. The catalog classifies cosmetics into two categories, ordinary and extraordinary, based on factors such as efficacy, usage, and parts of use of cosmetics. Unique cosmetics include hair dyeing, perming, spot-removing and whitening, sunscreen, anti-hair loss, and other products.
Evaluation Code for Cosmetic Efficacy Claims
The Specification for the Evaluation of Cosmetic Efficacy Claims is a regulation on evaluating cosmetic efficacy claims. The specification requires cosmetic manufacturers to assess the efficacy claims of their products and provide the corresponding evaluation basis and information. Among them, strict scientific experiments must verify the efficacy claims of special cosmetics.
Technical Guidelines for Cosmetic Safety Assessment (2021 Edition)
The Technical Guidelines for the Safety Assessment of Cosmetics (2021 Edition) is a technical guidance document for the safety assessment of cosmetics. The Guidelines stipulate the basic principles of cosmetics safety assessment, assessment methods, assessment process, and other contents. Among them, cosmetic manufacturers must assess product safety and provide corresponding assessment reports and information.
Second, the scope of the application
The above regulations and provisions apply to all cosmetic products entering the domestic market for sale from abroad (including Hong Kong, Macao, and Taiwan), including ordinary and extraordinary cosmetics categories. Products with different formulations, brands, and names are required to obtain electronic certificates for filing or special cosmetic product registration certificates, respectively. Among them, unique cosmetics include products used for hair coloring, perming, spot whitening, sunscreen, anti-hair loss, and so on.
Third, the filing process
Imported ordinary cosmetics for the record process:
(1) Domestic and foreign authorization and notarization (domestic entrusted overseas does not need to apply for authorization and notarization);
(2) First time filing;
(3) Account application;
(4) Determine the formula, labeling;
(5) Sample testing;
(6) Organizing other information;
(7) Submitting filing information to the information service platform of the State Drug Administration;
(8) Uploading a summary of the basis for product efficacy claims on the website designated by the State Drug Administration;
(9) Completing the filing;
(10) Annually report to the Drug Administration to undertake the filing of the import situation, as well as compliance with laws and regulations, mandatory national standards, and technical specifications.
Import of special categories of cosmetics registration process:
(1) Domestic and foreign authorization and notarization (domestic entrusted outside the country does not need to apply for authorization and notarization);
(2) First declaration;
(3) Account application;
(4) Determine the formula, labeling;
(5) Sample testing;
(6) Organizing other information;
(7) Submission to the State Drug Administration;
(8) Formal review (decide whether to accept);
(9) Technical review of the evaluation center (expert review);
(10) Administrative approval (to decide whether to approve);
(11) Issuance of registration certificate.
Fourth, the information required
Imported ordinary cosmetics for the record information required:
(1) registrant filer information sheet and quality and safety responsible person resume;
(2) Overview of the quality management system and an overview of the adverse reaction monitoring and evaluation system;
(3) Domestic responsible person information sheet;
(4) The original authorization letter of the responsible person in the territory and its original notarized certificate;
(5) Product formulations;
(6) Front plan and back plan of the sales package of the product (including the contents of the label);
(7) A copy of the commissioned processing agreement (if commissioned);
(8) product inspection report.
Imported special categories of cosmetics registration information required:
(1) “Cosmetics Registration Record Information Form” and related information;
(2) Product name information;
(3) Product formula;
(4) Product implementation standards;
(5) Product sales package front plan, back plan (including labeling content);
(6) A copy of the commissioned processing agreement (if commissioned);
(7) Product inspection report;
(8) claims based on the efficacy of the summary and related scientific literature, research data, or product efficacy claims to evaluate the summary of test results.
Fifth, the record cycle and costs
The filing cycle for imported general cosmetics is 2-4 months, depending on the completeness of the information and the progress of the Food and Drug Administration review. The filing fee varies according to the selected service organization and the number of product types.
Imported particular cosmetics registration cycle according to the specific types of product efficacy is generally 6-20 months, also affected by the completeness of the information and the progress of the Food and Drug Administration review. Registration fees also vary according to the selected service organization and the number of product types.
Sixth, Precautions
The labeling of all imported cosmetics must comply with the requirements of relevant laws, regulations, and standards in China and must be labeled in simplified Chinese. For imported unique cosmetics, the imported particular cosmetics product registration certificate number also needs to be marked on the product packaging.
Imported cosmetics in the record to obtain electronic certificates or special cosmetic product registration certificates before regular customs clearance inspection and marketing. For failure to obtain the record or registration certificate of the product, the Customs and Excise Department will be detained by the law and do further processing.
Manufacturers of imported cosmetics should establish and implement the purchase inspection record system, truthfully record the name of cosmetics, specifications, quantity, production date or production lot number, shelf life, date of purchase, as well as the supplier’s name, address, contact information, and other content, and save the relevant documents. Records and vouchers should be kept in line with applicable regulatory requirements.
The record or registration certificate obtained for imported cosmetics, such as formula changes, brand name changes, etc., must be re-filed or registered. For product quality and safety issues due to product recall required by the Drug Administration, the enterprise should immediately stop selling by the requirements of the Drug Administration for recall and disposal.