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China Cancels Overseas Laboratory Qualification Certificates for Submission of Overseas Testing Reports

On Nov 29, China NMPA announced the cancellation of certificates related to overseas laboratory qualification. This certification was previously a mandatory requirement for cosmetic companies that wanted to use testing reports from overseas labs detailing sun-protection effects as required for registration of sunscreens.

With an aim to cancel unnecessary certifications and simplify the administrative procedures as requested by the China State Council, on Nov 29, China NMPA released the list of the third batch of certifications canceled. [1] In the list one cosmetic certification is included: overseas laboratory qualification certificates or certificates of compliance with relevant regulations.

According to Provisions for Application and Acceptance of Administrative Licensing for Cosmetics, cosmetic companies are permitted to submit testing reports of sun-protection effect (SPF, PFA or PA) from overseas laboratories without the need to conduct the same testing domestically when applying for registration of sunscreens. In such a case, a qualification certificate of the corresponding overseas laboratory shall be submitted simultaneously. Detailed requirements are as follows:

  • If laboratories that issued the testing report have been accredited already, the qualification certificate shall be submitted.

  • If laboratories that issued the testing report have not been accredited, the certificate/document proving their compliance with "Good Clinical Practices" (GCP) or "Good Laboratory Practice" (GLP) shall be submitted.

  • Other documents that describe laboratory qualification.

Starting from the date of issuance of the list, the qualification certificates mentioned above are no longer required. The change will facilitate cosmetic companies using testing reports generated by overseas laboratories.

Collection of Cosmetic Certifications Cancelled

Batch NumberRelease DateNo.CertificationRequirements after cancellation
First Batch [2]April 28, 20191Inspection results of production hygiene conditions of domestic special use cosmeticsNo need to submit
2Supervision comments of manufacture and sale of domestic special use cosmeticsNo need to submit
3Statement of loss of cosmetic production licenseNo need to submit
Second batch [3]July 11, 20191Certified documents of the name or address change of the domestic product manufacturer, issued by the local industrial and commercial administration departmentNo need to submit, change to online verification
2Certified documents of the name or address change of the responsible agency in China for imported cosmetics, issued by the local industrial and commercial administration departmentNo need to submit, change to online verification
Third BatchNovember 29, 20191Overseas laboratory qualification certificates or certificates of compliance with relevant regulationsNo need to submit
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