China Permits Low-Risk General Cosmetic Stakeholders to Submit Self-Testing Reports for Notification Applications

May. 31st, 2023
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Under certain conditions, notifiers or entrusted manufacturers of Chinese domestic low-risk cosmetics are allowed to conduct self-testing and submit the product self-testing reports as part of notification dossiers.
On January 18, 2023, China’s National Medical Products Administration (NMPA) issued a notice, further optimizing the management measures for the notification testing of general cosmetics. Specifics are as follows:

1. The notice allows domestic low-risk general cosmetics to conduct self-testing and issue reports for notification.

Cosmetics notifiers who meet the following prerequisites can conduct self-testing per relevant requirements for cosmetics technical specifications, and submit the self-testing reports issued by themselves or the entrusted manufacturers when applying for notification.

  • For general cosmetics, the company adopts testing methods as the quality control measures, rather than non-testing methods;
  • The general cosmetics’ production process has been included in the scope of daily supervision of provincial medical products administration authorities;
  • The product safety risk assessment results can fully confirm the product’s safety.

Cosmetic notifiers who submit the self-testing reports at the time of applying for notification shall also submit a statement proving the corresponding testing capabilities stipulated in the Working Rules for Cosmetic Registration and Notification Testing (the Working Rules) for cosmetics notification testing, and provide information on the testing personnel, equipment, facilities, and site environment for self-inspection. The notifier shall also commit to being responsible for the authenticity and accuracy of the testing report.

It is worth noting that, due to the high safety risk, the self-testing reports will not be accepted at the time of notification for cosmetics with the following circumstances:

  • The product claims to be used by infants and children;
  • The product contains new cosmetic ingredients that are still under safety monitoring;
  • The product claims to have the efficacies of acne-removing, nourishing, repairing, anti-wrinkle, anti-dandruff, deodorant, etc.;
  • Other circumstances where the product may have relatively high safety risks.

2. The notice clarifies the qualification requirements and related rules for enterprises’ self-test.

3. The notice sets out the responsibilities of the regulatory authorities.

[Read more at ChemLinked]

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