[Full English Version] Provisions for Supervision and Administration of Manufacturing and Marketing of Cosmetics in China

Provisions for Supervision and Administration of Manufacturing and Marketing of Cosmetics

(Promulgated by Decree No. 46 of the State Administration for Market Regulation on August 2, 2021, these Provisions shall be effective as of January 1, 2022.)

Chapter I General Provisions

Article 1 These Provisions are formulated in accordance with the Regulations on Supervision and Administration of Cosmetics for the purpose of regulating manufacturing and marketing of cosmetics, strengthening supervision and administration of cosmetics, and ensuring quality and safety of cosmetics.

Article 2 These Provisions shall apply to manufacturing and marketing of cosmetics, supervision and administration in this respect within the territory of the People’s Republic of China.

Article 3 The National Medical Products Administration (NMPA) shall be responsible for supervision and administration of cosmetics nationwide.

The department in charge of drug supervision and administration of local people’s governments at or above the county level shall be responsible for supervision and administration of cosmetics within their administrative areas.

Article 4 The registrant and the filing entity of cosmetics shall establish a quality management system for cosmetics manufacturing according to law, perform obligations related to product including adverse reaction monitoring, risk control, recall etc, and shall be responsible for their quality, safety and efficacy claims of cosmetics. Manufacturers and marketers of cosmetics shall comply with laws, regulations, provisions, mandatory national standards and technical specifications in engaging in manufacturing and marketing activities and conduct vigorous management, maintain integrity and practice self-discipline, thus to ensure the quality and safety of cosmetics.

Article 5 The state exercises licensing management for the manufacturing of cosmetics. To engage in manufacturing of cosmetics, the Cosmetics Manufacturing License shall be obtained in accordance with the law.

Article 6 Manufacturers and marketers of cosmetics shall establish, in accordance with the law, documentation system for the check and test of purchases, and product sales record, and other systems, to ensure traceability of the products.

Manufacturers and marketers of cosmetics are encouraged to adopt information technology to collect and store information on manufacturing and marketing, and establish a traceability system for quality and safety of cosmetics.

Article 7 The NMPA shall enhance informatization construction, to provide convenient services for the public in inquiring information on cosmetics.

The department in charge of drug supervision and administration shall, in accordance with the law, promptly publish regulatory information on cosmetics manufacturing license, supervision and inspection, and administrative penalty, etc.

Article 8 The department in charge of drug supervision and administration shall give full play to the role of the associations of cosmetics industry, the associations of consumers and other consumer organizations, news media, etc., promote the construction of industry integrity system, and advance social co-governance for cosmetics safety.

Chapter II  Manufacturing License

Article 9 Applicants for the cosmetics manufacturing license shall meet the following requirements:

(1) being an enterprise established according to law;

(2) having the manufacturing premises that are appropriate to the varieties, quantity and manufacturing licensed items, etc. of the cosmetics produced, and being kept prescribed distance from toxic and hazardous premises and other sources of pollution;

(3) having the manufacturing facilities and equipment that are appropriate to the varieties, quantity and manufacturing licensed items, etc. of the cosmetics produced, and having a reasonable layout thereof, and the air purification, water treatment facilities and equipment, etc. that meet the specified requirements;

(4) having technicians who are suited to the varieties, quantity and manufacturing licensed items, etc. of the cosmetics manufactured;

(5) having the staff members and equipment that are appropriate to the varieties and quantity of the cosmetics produced and that can perform inspection of the cosmetics produced;

(6) having a management system for guaranteeing the quality and safety of the cosmetics.

Article 10 The applicants for cosmetics manufacturing license shall submit an application to the drug regulatory department of the province, autonomous region or municipality directly under the central government, where it is located, submit the documents proving that they meet the requirements as specified in Article 9 of these Provisions, and shall be accountable for the authenticity of the documents.

Article 11 Regarding the application submitted by applicants for cosmetics manufacturing license, the drug regulatory department of the province, autonomous region, or municipality directly under the central government shall handle respectively according to the following circumstances:

(1) If the application items do not require the licensing in accordance with the law, the relevant department shall make a decision of non-acceptance, and issue a notification of non-acceptance;

(2) If the application items are not within the scope of authority of drug regulatory department in accordance with the law, the relevant department shall make a decision of non-acceptance, issue a notification of non-acceptance, and inform the applicant to resubmit the application to the applicable administrative authority;

(3) If the application documents contain errors that can be corrected on site, the applicant shall be allowed to make corrections on site, affix signature or seal to the correction, and indicate the date of correction thereon;

(4) If the application documents are incomplete or do not conform to statutory form, the applicant shall be notified of all contents ought to be supplemented and corrected on site or within 5 working days one-off. If no notification is made within the prescribed time limit, the application shall be deemed to have been accepted upon receipt of the application documents;

(5) The application for cosmetics manufacturing license shall be accepted if the documents are complete and conforming to statutory form, or if the applicant has submitted all the supplementary and corrected documents as required.

For acceptance or non-acceptance of the application for cosmetics manufacturing license, the drug regulatory department of the province, autonomous region, or municipality directly under the central government shall issue an acceptance or non-acceptance notice. If non-acceptance is determined, the reason for non-acceptance shall be given, and the applicants shall be informed of being entitled to apply for administrative reconsideration or file an administrative litigation according to law.

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