Notice on administrative approval of initial imported special-use cosmetics

时间： 2022-03-03 作者：来源：

导读： I.Project name: Administrative approval for imported special-use cosmeticsII.Contents of licensing: Administrative approval of initi

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

II.Contents of licensing: Administrative approval of initial 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 of imported special-use cosmetics;
Data number (2) Rationale for nomenclature of the product’s Chinese name;
Data number (3) Product formulas.
Data number (4) Descriptions and diagrams of the production process.
Data number (5) Product quality and safety control requirements; 
Data number (6) Original package (including product labels and product brochures); Package design intended specifically for the Chinese market shall be submitted (including product labels and product brochures);
Data number (7) Testing report issued by CFDA-accredited testing institutions and related dossier;
Data number (8) Safety evaluation data of the product’s potential safety hazards; 
Data number (9) For application of products for hair growth, fitness, breast-beautification, the scientific literature for effective ingredients and rationale for use shall be submitted; 
Data number (10)Copies of the certificate of entrustment and business licenses of recorded units responsible for Administrative approval in China, the copies shall be stamped with the official seal
Data number (11)Letter of commitment ensuring that the cosmetic materials and sources of materials are in line with the requirements for restriction and prohibition of substances from BSE affected high risk areas;
Data number (12)Documents proving production and sales of the product in the producing country (region) or country (region) of origin;
Data number (13)Additional information that may be useful for administrative approval;
Data number (14)Text version and electronic version of the product technical requirements.
Attached with 1 sample of marketed product sealed by designated test institutions.

VII.Requirements for application dossier:
(I) General requirements for the dossier:
1. For initial application for special use cosmetics administrative approval, 1 full set of original application dossier and 4 copies, which should be clear and consistent with the originals 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. Both the text version and the electronic version of the product formula should be submitted.
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 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.

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(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. 
Letter of commitment (LOC) in the Administrative approval application form should be signed by legal representative of the manufacturer of imported cosmetics or new materials, or signed by the manufacturer’s authorized signatory or by the signatory of the units responsible for authorized administrative approval; the absence of official seal should be noted in the LOC’s textual place for the seal of the manufacturer.
LOC in the Administrative approval application form should be signed by legal representative, or signatory authorized by the legal representative of the units responsible for administrative approval in China, and stamped with its official seal.
The signing of the authorization and entrustment shall be accompanied with the notarized certificate of entrustment and its Chinese translation, which shall also be notarized to prove consistency with the original text. According to Article 24 of the “Requirements for Application Dossier for Cosmetics Administrative Approval “(hereinafter referred to as “Dossier Requirements”), each application for administrative approval shall be accompanied by the original certificate of entrustment or a notarized copy with written indication of the name of the product for which the original certificate of entrustment has been submitted. The contents of the signed authorization entrustment should not be included in the certificate of entrustment for units responsible for administrative approval in China.
3. The formulation of imported products should be confirmed by designated test institutions, the date of confirmation shall be consistent with the date of acceptance of the test samples. 

4. Product quality and safety control requirements should include those performed in the country of origin (English version and Chinese translation), and the commitment ensuring compliance with “Hygienic Standards for Cosmetics”.

5. 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 

6. Testing report issued by CFDA-accredited testing institutions, related dossier or Sun Protect Factor testing report (SPF, PFA or PA) issued by overseas laboratories shall meet the following requirements:
(1) Testing reports issued by licensing test institutions should include the following information: 
1) The testing application form; 
2) Notice of acceptance for test; 
3) Package inserts; 
4) Health & Safety testing report (microbiology, hygienic chemistry, toxicology);
5) The following information, if any, should be submitted: 
① Human safety testing report (skin patch, human trial testing);
② SPF, PFA or PA testing reports; 
③ Testing report of other new projects (such as cosmetics asbestos testing reports, etc.).
(2) If the application used SPF (SPF, PFA or PA) testing report issued by overseas laboratories, the following information shall be submitted: 
6) If the laboratories that issued the report are accredited laboratories, the qualification certificate should be submitted; 
7) If the laboratories that issued the report are not accredited, the certificate proving strictly compliance of “Good Clinical Practices” (GCP) or “Good Laboratory Practice” (GLP) should be submitted; 
8) Other documents that describe laboratory qualification.
For initial submission of offshore test report, the applicant shall submit the original documents of the above information; or the certificates issued by Industry Association, Chinese Embassy (consulate) and notary offices of the country (region) where the laboratory is located, to confirm the copies. After CFDA confirmation, copies of the documents would suffice in the next application.
Overseas laboratory testing report shall be submitted in original dossier, if a series of products meet the sampling test requirements, at least one product should submit the originals, other products may submit copies with description of the name of the applied product in original dossier. 
If the testing report is issued by an overseas laboratory, the applicant shall submit its certifying documents issued by related laboratories to prove the correspondence of the test samples with the testing reports 
If the testing report issued by overseas laboratories has clarified the correspondence of the test samples with the testing reports (For instance, the overseas testing reports have indicated the product name, which is consistent with the name of the test samples), there is no need to submit a separate certificate proving this correspondence.
(3) For application of changing the name and address of manufacturer and the product’s Chinese name in the testing report for cosmetic administrative approval, the relevant test institution shall issue the appropriate supplementary testing report and explain the reasons.

7. The documents proving the production and sales of the product in the producing country (region) or country (region) of origin shall meet the following requirements: 
(1) Shall be issued by the government departments or industry associations of the producing country (region) or country (region) of origin. Copies can be submitted if the originals are unavailable, and shall be confirmed by the issuance institution or Chinese Embassy (consulate) in the country.
(2) Shall contain the product name, manufacturer name, issuance organization name, date of issuance, and shall be stamped with official seals or signed by the legal representative (or authorized person). 
(3) The recorded name of the product and the manufacturers shall be consistent with those applied; for commissioned processing, or otherwise, if the name of the manufacturer is inconsistent with that applied, the applicant shall explain in written documents; for multi-dosage-form products that must be used in combination, the applicant can merely submitted the certifying documents for production and sales of imported products 
(4) If the production and sales documents are in foreign language, they should be translated into standard Chinese, which shall be notarized in China.

8. On the following circumstances of product application, the applicant shall provide, in addition to the above dossier, the following information separately:
(1) If the applied product is produced upon entrustment, the following information shall be submitted
1) commission processing agreement signed by the entrusting / entrusted parties; 
2) 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.
3) Imported products produced by overseas manufacturers entrusted by domestic enterprises can dispense with the submission of the certificate of entrustment of the unit responsible for administrative approval in China, the certifying documents for production and sales, and the original package of the product, but the product package design shall be submitted
4) 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.
(2) If the actual manufacturer and the production enterprise of cosmetics (applicant) 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.

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9. Multiple actual manufacturers of the same product can apply at the same time, one of which shall submit all the information specified above, and additionally the following: 
(1) 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.
(2) 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. 
(3) The original package of products produced by other actual manufacturers.
(4) Hygienic (microbiological, hygienic chemistry) testing reports of the products of other enterprises
(5) Letter of commitment ensuring that the cosmetic materials used by other actual manufacturers and sources of materials are in line with the requirements for restriction and prohibition of substances from BSE affected high risk areas.

10. The application for samples packaged in the following specifications shall meet the following requirements:
(6) The product formulas and testing reports shall be separately submitted for samples packaged in more than two (including two) independent sub-packages or separated samples (such as eye shadow, powder, blusher, etc.) that are applied and named as a single product; non-independently packaged or inseparable samples should be submitted in one test report, while the formulas for each component shall be separately submitted. 
(7) If the samples are packaged in combination that can be divided, and are applied in the name of one product, product formulation sent testing reports for its different physical states and ingredients should be submitted separately.
(8) Product with two or more dosage forms which must be used in conjunction should be applied as a single product. Mixture testing reports or separate testing reports of multiple dosage forms shall be submitted according to the actual situation of whether they are used in mixture or separately.
(9) If one production enterprise applied two or more imported products with the same foreign package name but different appearances, the application form and proof of sales and production should add, beside the foreign name, words and instructions of the product appearance, to show the difference.

11. For multicolor suncare cosmetics series, if their basic formula are the same, they can be applied simultaneously as one group of products for sampling in sunscreen (SPF, PFA or PA) tests. The application dossier of each product should attach a list of product series, basic formulas and coloring agents, and product sampling lists.

12. The samples of imported products produced by overseas manufacturers upon entrustment of domestic enterprises shall be submitted as domestic products.
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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:
Cosmetics administrative approval documents shall be valid for four years.
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

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