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Cosmetovigilance requirements in China

ONLINE REPORTING OF UNDESIRABLE EFFECTS

Cosmetics Supervision and Administration Regulations
Source: National Bureau Release Date: 2020-07-22
Order of the State Council of the People's Republic of China
No. 727

The "Regulations on the Supervision and Administration of Cosmetics" were adopted at the 77th executive meeting of the State Council on January 3, 2020. They are hereby promulgated and will come into force on January 1, 2021.

总 理  Li Keqiang
June 16, 2020

Article 52 The country establishes a cosmetics adverse reaction monitoring system. Cosmetic registrants and record-holders shall monitor the adverse reactions of their cosmetics on the market, carry out evaluations in a timely manner, and report to the cosmetics adverse reaction monitoring agency in accordance with the regulations of the drug regulatory department of the State Council. Entrusted production enterprises, cosmetics operators and medical institutions shall report to the cosmetics adverse reaction monitoring agency if they discover adverse reactions that may be related to the use of cosmetics. Encourage other units and individuals to report adverse reactions that may be related to the use of cosmetics to the cosmetics adverse reaction monitoring agency or the department responsible for drug supervision and management.
The cosmetics adverse reaction monitoring agency is responsible for the collection, analysis and evaluation of cosmetics adverse reaction information, and provides treatment suggestions to the department responsible for drug supervision and management.
Cosmetics manufacturers and operators shall cooperate with the cosmetics adverse reaction monitoring agency and the department in charge of drug supervision and management to carry out cosmetic adverse reaction investigations.
Cosmetic adverse reactions refer to skin and its accessory organs caused by normal use of cosmetics, as well as local or systemic damage to the human body.
Article 53 The state establishes a cosmetics safety risk monitoring and evaluation system to monitor and evaluate the risk factors that affect the quality and safety of cosmetics, and provide scientific basis for formulating cosmetics quality and safety risk control measures and standards, and conducting cosmetic sampling inspections.

The national cosmetics safety risk monitoring plan is formulated, promulgated, and organized for implementation by the drug regulatory department of the State Council. The national cosmetics safety risk monitoring plan shall specify the types, items and regions to be monitored.
The State Council’s drug regulatory authority establishes a cosmetics quality and safety risk information exchange mechanism, and organizes cosmetic manufacturers, inspection agencies, industry associations, consumer associations, and the news media to communicate on cosmetics quality and safety risk information.
Article 54: For cosmetics that cause harm to the human body or that there is evidence to prove that they may harm human health, the department responsible for drug supervision and administration may take emergency control measures to order the suspension of production and operation, and issue safety warning information; for imported cosmetics, the state The entry-exit inspection and quarantine department may suspend imports.
Article 55 According to the development of scientific research, if there is a change in the understanding of the safety of cosmetics or cosmetic raw materials, or if there is evidence that cosmetics or cosmetic raw materials may have defects, the drug regulatory department of the people's government at or above the provincial level may order Registrants and record holders of cosmetics and new cosmetic raw materials carry out safety reassessments or directly organize safety reassessments. If the result of the reassessment shows that the safety of cosmetics and cosmetic raw materials cannot be guaranteed, the original registration department will cancel the registration and the filing department will cancel the filing, and the drug regulatory department of the State Council will include the cosmetic raw materials in the list of raw materials prohibited from use in cosmetics and announce to the public.
Article 56  The department in charge of drug supervision and management shall promptly publish the supervision and management information of cosmetics administrative license, filing, daily supervision and inspection, investigation and punishment of illegal acts in accordance with the law. When publishing supervision and management information, the parties’ commercial secrets shall be kept.
The department in charge of drug supervision and administration shall establish credit files for cosmetics producers and operators. Increase the frequency of supervision and inspection for cosmetics producers and operators with bad credit records; and implement joint punishments in accordance with regulations for producers and operators with serious bad credit records.
Article 57   If there are hidden safety hazards in the production and operation of cosmetics, and measures are not taken to eliminate them in time, the department in charge of drug supervision and administration may conduct accountability interviews with the legal representative or main person in charge of the cosmetics manufacturer. Cosmetics producers and operators shall immediately take measures to make rectifications and eliminate hidden dangers. Responsibility interviews and rectification should be included in the credit files of cosmetics producers and operators.
Article 58   The department in charge of drug supervision and administration shall publish its website address, email address or telephone number, accept consultation, complaint, and report, and respond or deal with it in a timely manner. For reports verified to be true, the reporter will be rewarded in accordance with relevant state regulations.