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China Releases New Regulation on Adverse Reactions in Cosmetics

April 19 2022

China has released its first regulation establishing detailed requirements on adverse reactions for the cosmetics industry.

China has released its first regulation establishing detailed requirements on adverse reactions for the cosmetics industry.

On February 12, 2022, the National Medical Products Administration (NMPA) issued Notice No. 16 to release Management Measures for Monitoring Adverse Reactions in Cosmetics according to the requirements of the Cosmetics Supervision and Administration Regulation. This is China’s first regulation regarding adverse reactions from cosmetic products.

Under the terms of the regulation, effective contact information for the responsible person – telephone number and e-mail address – must be promoted to the public through product labels, official websites, and other ways that are convenient to consumers. They must also take the initiative in collecting adverse reactions reported by OEM/ODM manufacturers, distributors, hospitals and consumers.

Records of adverse reactions to cosmetics must contain, as a minimum, the following information:

  1. Information on the reporter
  2. Information on the person with the adverse reaction
  3. Symptoms or signs
  4. Severity of adverse reaction
  5. Date of occurrence for the adverse reaction
  6. Date of discovery or knowledge of the adverse reaction
  7. Date of adverse reaction report
  8. The name of the cosmetic used 

For imported cosmetic products, overseas manufacturers must establish an assistance mechanism with a domestic responsible person. They will be responsible for the collecting, reporting, analysis and evaluation, investigation and handling of adverse reactions to ensure the fulfillment of the obligations specified in this regulation.

When an imported cosmetics product is required to have risk control measures, such as the stopping of production or distribution, implementation of product recalls and issuing of safety warning information due to adverse reactions, the overseas manufacturer must, within seven days of the date of discovery, report the relevant adverse reaction information and the risk control measures taken to the national monitoring institution in writing. The domestic responsible person shall assist the overseas cosmetics manufacturer in fulfilling their reporting obligations.

This new regulation will enter into force on October 1, 2022.

.Reference Source:

https://www.nmpa.gov.cn/hzhp/hzhpjgdt/20220221165805149.html 

Next step:
The industry shall be aware of the new regulation and be prepared for any necessary changes to the products.

Denny Li
Cosmetics & Hygiene - Technical Support Manager


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Tags: cosmetics-hygiene

    

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