CSAR Subsidiary Regulations: China Finalizes the Regulations for Cosmetic Adverse Reaction Monitoring

Cosmetic registrants and notifiers ²

• Establish a monitoring and evaluation system inside the company,

• Be equipped with departments and personnel that suit the products to monitor the cosmetic adverse reactions,

• Take the initiative to collect and report cosmetic adverse reactions,

• Analyze and evaluate the cosmetic adverse reactions found or learned in time, and take measures to control risks based on the evaluation results,

• Cooperate with the medical products administration departments in carrying out cosmetic adverse reaction investigations,

• Establish and keep the cosmetic adverse reaction monitoring records.

Overseas cosmetic registrants and notifiers

Establish an assistance mechanism for active collection, reporting, analysis and evaluation, and investigation and handling of adverse reactions with their domestic responsible persons.

Cosmetic e-commerce platform operators

• Record the cosmetic adverse reaction information learned and timely transfer to the cosmetic operators on the platform,

• Urge the cosmetic operators on the platform to perform the reporting obligations,

• Cooperate with the monitoring institutions and medical products administration departments in carrying out cosmetic adverse reaction investigations and handling.

Entrusted production enterprises, cosmetic operators

• Report the adverse reactions found or learned,

• Cooperate with the monitoring institutions and the medical products administration departments in carrying out cosmetic adverse reaction investigations and handling.

Adverse Reaction Collection

Cosmetics registrants and notifiers shall publish current contact information such as telephone number and e-mail to the public through product labels, official websites, etc. They shall actively collect adverse reaction information and report them in a timely manner.

Adverse Reaction Reporting

1. Reporting principles

The principle of reporting when they are suspicious, that is, any human damage suspected to be caused by the use of cosmetics can be reported as cosmetic adverse reaction.

2. Reporting approaches

• Cosmetic stakeholders can report adverse reactions online through the National Cosmetic Adverse Reaction Monitoring Information System;

• Cosmetic operators that currently lack the capacity for online reporting can report to city or county level monitoring institutions in hard copy. The institution will report online on their behalf.

Adverse Reaction Analysis and Evaluation

Cosmetic registrants and notifiers shall analyze and evaluate the collected or learned adverse reactions, and if necessary, conduct self-inspection on product ingredients, formula, production process, production quality management, storage and transportation and other aspects that may cause adverse reactions.

Cosmetic adverse reactions that are serious and that may cause a greater social impact should be analyzed and evaluated within 20 days and 10 days respectively after being informed. A corresponding self-inspection report should be compiled and submitted to the relevant monitoring institutions and medical products administration departments.

Adverse Reaction Investigation and Handling

• For the products found to have quality defects or other problems that may endanger human health based on the investigation results, the cosmetic registrant and notifier shall recall products and notify the entrusted production enterprises and cosmetic operators to stop production and operation.

• For the products found to cause harm to human body or there is evidence that it may endanger human health based on the investigation results, the cosmetic registrant and notifier and relevant enterprises will be ordered to suspend production and operation.

Adverse Reaction Monitoring Records

Cosmetic registrants, notifiers, entrusted production enterprises and medical institutions shall establish and keep cosmetic adverse reaction monitoring records. The records shall be kept for not less than 3 years from the reporting date. Domestic responsible person shall assist in the establishing and keeping the records.

The adverse reaction monitoring records shall include at least the information of the reporter; the information, symptoms or signs of the person experienced the adverse reaction; the severity of the adverse reaction; the occurrence date of the adverse reaction; the discovery date of the adverse reaction; the reporting date of the adverse reaction; and the name of the cosmetics used.

General cosmetic adverse reactions

To be reported within 30 days from the date of discovery

To be reported within 30 days from the date of discovery

Serious cosmetic adverse reactions

To be reported within 7 days from the date of discovery

To be reported within 15 days from the date of discovery

Cosmetic adverse reactions that may cause significant social impacts

To be reported immediately upon discovery

To be reported within 3 days from the date of discovery

Imported cosmetics’ adverse reactions found on the overseas market

To be reported immediately upon discovery

To be reported within 7 days from the date of discovery

Cosmetic adverse reaction information found or complaints received by cosmetics e-commerce platform operators

To be record and transferred to the cosmetics operator on the platform for processing within 3 days

To be record and transferred to the cosmetics operator on the platform for processing within 7 days

Major information about product quality and safety found or complaints received by cosmetics e-commerce platform operators

To be reported to the local provincial medical products administration departments in writing within 7 days from the date of discovery

To be reported to the local provincial medical products administration departments in writing within 15 days from the date of discovery