China Allows Low-risk General Cosmetics Stakeholders to Submit Self-testing Reports When Applying for Notification

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.

Cosmetic notifiers or entrusted manufacturers carrying out self-inspection shall:

• Obtain a cosmetics production license in accordance with the law, have corresponding testing capabilities, have and continue to implement the testing management system and laboratory management system, and carry out testing and issue reports per the testing items and relevant testing requirements stipulated in the Working Rules;

• Incorporate the self-testing work into the cosmetics quality management system, be equipped with testing equipment and facilities that meet product testing requirements, have corresponding quality testing departments or full-time testing personnel, and strictly control the testing process.

Notifiers shall strengthen the management of testing samples, be responsible for the authenticity of the samples and the scientificity and rationality of the testing items, as well as ensure that the testing results are true, accurate, complete, and traceable.

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

Provincial medical products administration authorities shall strengthen the in-process and post-market supervision measures, organize and carry out the post-notification technical review on dossiers, strengthen supervision and inspection on the notifiers or entrusted manufacturers carrying out the self-testing, inspect the situation and implementation of the enterprise's testing management system and laboratory management system, with focus on the inspection on its testing capabilities, testing records, etc. If the notifier is found to have any illegal acts, such as providing false self-testing reports, it shall be seriously investigated and dealt with according to law.

ChemLinked Comments

NMPA's relaxation of the restrictions on notification testing aims to delegate the right of notification testing to enterprises, let enterprises more deeply involved in the supervision of cosmetics, and promote enterprises to improve self-discipline.

In addition, this loosening mainly targets Chinese domestic general cosmetics with low risk and does not apply to imported products. The main reason is that the production process of imported cosmetics happens overseas, which is inconvenient for supervision, so higher supervision requirements are required for the imported products.