| I.Project name: Administrative approval for imported special-use cosmetics
II.Contents of licensing: Change of administrative approval for imported special-use cosmetics
III.Legal basis for establishment and implementation of the licensing: “Regulations on Cosmetics Hygiene Supervision”, “Detailed Rules for the Implementation of Regulations on Cosmetics Hygiene Supervision”, “Health Administrative Approval Procedures for Health-Related Products”, “Regulations for the Application & Acceptance of Cosmetics Administrative Approval”, and “Essentials for Acceptance & Review of Cosmetics Administrative Approval ”
IV.Fees: No charge
V.Quantity restrictions: No quantity limit for the licensing
VI.List of application documents:
Data number (1) application form for administrative approval for changes of domestic special-use cosmetics ;
Data number (2) original approval documents for cosmetics administrative approval (Filing certificates);
Data number (3) Application agencies shall submit the copies of entrustment certificates and business licenses of the units responsible for administrative approval in China, which shall be stamped in official seal;
Data number (4) The application for changes shall Submit the following information:
1.Name changes:
Application for changing the Chinese name of the products shall state the reasons for change in the application form, and submit the rationale for nomenclature of the Chinese name and packaging design (including product labels and product brochures) of the product;
Application for changing the sunscreen product’s SPF, PFA or PA values shall submit the appropriate SPF, PFA or PA testing reports, and the product packaging design (including product labels and product brochures).
2.Changes of manufacturer name and address (including self-change or changes as a result of merger and acquisition):
(1)For changes of the name and address of the manufacturer of imported products, the applicant shall provide related certifying documents issued by government authorities or relevant institutions. For legal change of manufacturer due to acquisitions and mergers between enterprises, the applicant can submit copies of the acquisition or merger contracts signed by the two sides, the certifying documents need to be translated into standard Chinese, which shall be notarized in China;
(2)For applications changing the production sites, the hygiene (microbiological, hygienic chemistry) testing reports of the manufacturer should be submitted.
3.Changes of Chinese name of the manufacturer of imported products (foreign name unchanged):
Reasons for changing the Chinese name;
Packaging design (including product labels and product brochures) for products with changed.
4.Change of the units responsible for application of Administrative approval in China:
The applicant shall submit first record of the original entrustment certificate of the unit responsible for administrative approval application in China;
A copy of the entrustment certificate of the unit responsible for administrative approval application in China;
For changes of the name or address of the units responsible for administrative approval application in China, the applicant shall submit the original certifying documents issued by the local industry and commerce administration allowing changes, or notarized copies;
Notarized explanations issued by the manufacturer for revoking the previous units responsible for administrative approval application in China.
5.Changes of the actual production enterprises:
If commission processing is involved, the applicant shall submit the agreement for commissioned production and processing. For imported products, the applicant shall submit documents proving QMS or GMP of the entrusted manufacture, or its compliance with the laws and regulations of the country (region) where the manufacturer is located.
If the manufacturers belong to the same group of enterprises, the relevant certifying documents shall be submitted along with the quality assurance documents issued by the enterprises group.
The original package of the products produced by the actual manufacturer with proposed changes
The hygienic (microbiological, hygienic chemistry) testing report of the products of the actual manufacturer with proposed changes;
Letter of commitment ensuring that the actual manufacturer’s cosmetic materials and sources of materials are in line with the requirements for restriction and prohibition of substances from BSE affected high risk areas.
6.If the categories of special cosmetics are changed, the applicant should the appropriate dossier in accordance with the requirements of each category.
7.Application for other changes should detail the grounds and submit relevant documents.
VII.Requirements for application dossier:
(I) General requirements for the dossier:
1. 1 set of original application dossier shall be submitted.
2. Except for the testing reports, notarized documents, official documents and third-party documents, the original dossier should be stamped page by page or cross-page stamped by the applicant; and the original dossier of imported cosmetics (with new material) should be stamped page by page or cross-page stamped by the units responsible for administrative approval in China.
3. The application dossier shall be printed in A4 size paper, marked with clear distinction signs, arranged in a predetermined order, and bound into a book.
4. Chinese legal units of measurement shall be used.
5. The contents of application should be complete, clear, and consistent.
6. All foreign languages (excl. overseas addresses, URLs, registered trademarks, patent names, SPF, PFA or PA, UVA, UVB, etc., which must be in foreign language) should be translated into standard Chinese, the translated test shall be attached to the corresponding foreign materials.
7. For re-registration after termination of application, the grounds for application termination and re-registration shall be provided; for re-registration after disapproval of administrative approval, the applicant should submit a copy of the written decision for disapproval of administrative approval (change/renewal) and a written explanation stating whether the disapproval was concerned with product safety reasons, and state the reasons for re-registration.
8. If the applicants failed to apply for renewal within the time line stipulated in the “Regulations for Application & Acceptance of Cosmetics Administrative Approval” (SFDA Department of administrative approval 856 [2009] No.) (hereinafter referred to as the “Regulations for Acceptance”) due to the changes, correction, replacement of cosmetics administrative approval documents (Record keeping certificates), they shall apply for renewal within 15 days after obtaining the cosmetics administrative approval documents (Record keeping certificates) for changes, correction and replacement, but such applications shall be made four months before the expiry of the cosmetics administrative approval documents (Record keeping certificates).
9. The contents of the two should be consistent.
10. Multiple products can be listed simultaneously in the certifying documents for production and sales, QMS or GMP, entrusted processing, and the documents proving manufacturers in different countries belong to the same group of companies If these products are applied simultaneously, one product may use the original documents, other products can use copies with a written statement of the name of the product using originals; if these products are not applied simultaneously, one product may use the original documents, while other products should use notarized copies, with a written statement of the name of the product using originals.
11. The applicant shall apply for renewal, change, replacement, correction and other issues respectively, one application shall be proposed only after the completion of a previous application
(II) Specific requirements for application document:
1. The dossier shall be submitted item by item.
2. The entries of the application form shall be filled in as per the instructions.
3. Documents for QMS or GMP of the entrusted manufacture, or its compliance with the laws and regulations of the producing country (region) shall meet the following requirements:
(1) Issued or confirmed by the certification or accreditation agencies or third parties.Copies can be submitted if the originals are unavailable, and shall be confirmed by Chinese notary institutions or Chinese Embassy (consulate).
(2) The name and address of the manufacturer should be fully consistent with the stated content in application.
VIII.Application process diagram:
IX.Approval procedures:
(I)Acceptance:
After the application is filed to the Administrative Acceptance Service Center, and the application dossier submitted is in accordance with the list in VI of this Notice, the format examination shall be conducted by the work staff of the Center in line with the “Regulations for Application & Acceptance of Cosmetics Administrative Approval” and relevant requirements. Where the application item is not subject to administrative approval according to law, a decision of non-acceptance shall be notified to the applicant immediately. Where the application item is not within the functions of the administrative authority, a decision of non-acceptance shall be made immediately, and the applicant shall be informed to launch the application to relevant administrative authority. Where in the application dossier, there are errors that can be corrected on the spot, the applicant shall be allowed to make the corrections on the spot. Where the application dossier is incomplete or does not meet the statutory format, the applicant shall be informed of all the supplements and amendments to be made once and for all on the spot or within five days. If the applicant is not informed within the above-mentioned period, the application shall be deemed as accepted from date of receipt of application materials. Where the application dossier is within the functions of the administrative authority, the application materials are complete and comply with the statutory format, or where the applicant has submitted all supplements and amendments in accordance with the requirements of the administrative authority, the application for administrative approval shall be accepted.
(II)Technical review:
CFDA Center for Health Food Evaluation shall organize relevant experts and technical personnel to conduct technical review for the application dossier within 90 days. If the applicant applies for re-examination of the technical review decision of proposed disapproval of administrative approval (Notice on disapproval of administrative approval), Center for Health Food Evaluation (CHFE) shall extend the timeline of technical review and organize experts for re-examination; when necessary, CHFE shall review the product again and issue the decision of technical review according the results of re-examination.
(III)Decision of administrative examination and approval:
CFDA shall complete the administrative inspection within 20 days after receipt of the technical review conclusions, and make decision for approval or disapproval of administrative approval according to law; if a decision cannot be made within 20 days, CFDA shall grant an extension of 10 days, and issue a “Notice on the Extension of Administrative Approval” to inform the applicant of the grounds for extension.
(IV)Delivery:
CFDA shall, within 10 days as from the decision of administrative approval, issue and deliver the related certificates for administrative approval.
X.Commitment time frame:
(I)Acceptance: Administrative Acceptance Service Center shall make a decision of acceptance or rejection within 5 days upon receipt of the application dossier.
(II)Technical review: 90 days
(III)Administrative approval decision: CFDA shall make the approval decision within 20 days; if a decision cannot be made within 20 days, CFDA shall grant an extension of 10 days, and issue a “Notice on the Extension of Administrative Approval” to inform the applicant of the grounds for extension.
(IV)Delivery: CFDA shall, within 10 days as from the decision of administrative approval, issue and deliver the related certificates for administrative approval.
XI.Authority of Implementation:
Implemented by: CFDA
Accepted at: CFDA Administrative Service Center
XII.License validity and renewal:
The same with the original administrative approval documents.
For extension of the validity of cosmetics administrative approval documents, the applicant shall apply in 4 months before the expiry of the approval documents
XIII.Annual inspection or annual review of the license: None
XIV.Institutions for inquiries and complaints:
Inquiries: CFDA
Complaints: CFDA Bureau of Investigation and Enforcement, Department of Legal Affairs
Note: The time frame of this Notice counts on working days, excluding legal holidays |
