Notice on administrative approval for changes of domestic special-use cosmetics

I.Project name: Administrative approval for domestic special-use cosmetics

II.Contents of licensing: Domestic special-use cosmetics health administrative approval change

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) The application for changes shall Submit the following information:
1.Name changes:
(1)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;
(2)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 domestic manufacturer’s name or address, the applicant should submit the original certifying documents issued by local industry and commerce administration department or notarized documents and hygienic licenses;
(2)For internal adjustment within the enterprise group, the applicant should submit relevant documents issued by the administration department of industry and commerce; if these changes involve Taiwan, Hong Kong and Macao-invested enterprises or foreign-invested enterprises, the applicant may submit the copies of notarized “Certificate of approval for foreign-invested enterprises in People’s Republic of China” or “Certificate of Approval for Taiwan, Hong Kong and Macao-invested enterprises in People’s Republic of China”;
(3)Applications for changing the production site shall submit the product’s hygienic (microbiological, hygienic chemistry) testing reports; For domestic products, the applicant should submit in addition the opinions issued by the provincial Food and Drug Administration departments in jurisdiction of the manufacturer on the inspection of hygienic conditions of the production sites.
3.Changes of the actual production enterprises:
Commissioned production and process agreement shall be provided if commissioned production and process is involved.
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;
Opinions issued by provincial food and drug administration department on the sanitary conditions of production sites of other actual production enterprises.
4.If the categories of special cosmetics are changed, the applicant should the appropriate dossier in accordance with the requirements of each category.
5.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 testing report, notarized document, and official and third party certifying document, the original of application documents shall be affixed with official seal page by page or with across-page seal of the applicant.
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. Both the text version and the electronic version of the product formula should be submitted.
10. The contents of the two should be consistent.
11. 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.
12. 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. While applying for changes of administrative approval, one can apply to change multiple issues.
13. The electronic version of the technical requirements of the product should be filled in by the applicant by logging on CFDA cosmetic administrative approval online application system.

(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. Product quality and safety control requirements should include the commitment that the product meets the “Hygienic Standards for Cosmetics”.
4. The application dossier for small size products without package inserts (such as lipstick, lip balm, etc.) or products whose instructions are printed on the containers should submit relevant explanations in the section of product package 
5. Review opinions of marketing and supervision or pre-marketing issued by the provincial food and drug administration department in jurisdiction of the applicant for inspection of production; 
(1) If a manufacturer applies for administrative approval documents for two or more domestic special-use cosmetics, inspection decisions shall be issued separately for each product; 
(2) Inspection decision of provincial Food and Drug Administration departments before the change is still valid.

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