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

  •   4 Dec 2019
  •    Angelita Hu
  •  451
  •   Post a comment

    Takehome:
    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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    Comments


    A bit misleading considering NMPA has mandated CMA accreditation for all testing labs since Nov. 1st. Previous qualification certificate has become useless. But there's no process for foreign labs to get CMA accreditation so far. https://cosmetic.chemlinked.com/news/cosmetic-news/china-implements-new-testing-regulations-cosmetic-registration-and-filing
    Wednesday, 4 December 2019
    Hi, thanks for your comment. The policy in this article is applicable to the situation that companies want to use overseas testing reports. The qualification certificate of the foreign labs conducted the testing, which should be issued in the country of origin, is no longer required.
    Thursday, 5 December 2019