Initial administrative approval for domestic special-use cosmetics application documents
List of application documents :
Data number (1) Application form for domestic special-use cosmetics administrative approval;
Data number (2) Product name nomenclature principle
Data number (3) Product quality and safety control requirements;
Data number (4) Product packaging design (including product labels and product brochures);
Data number (5) Testing report issued by CFDA-accredited testing institutions, related dossier or Sun Protect Factor testing report (SPF, PFA or PA) issued by overseas laboratories;
Data number (6) Safety evaluation data of the product’s potential safety hazards;
Data number (7) Review opinions of production sanitary issued by issued by provincial food and drug administration department;
Data number (8) For products of hair growth, fitness, breast-beautification, the scientific literature for effective ingredients and rationale for use shall be submitted;
Data number (9) Additional information that may be useful for administrative approval;
Data number (10)Text version and electronic version of the product technical requirements.
Attached with 1 sample sealed by provincial food and drug administration departments
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 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. 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.
(II) Specific requirements for application document:
1. The document 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. 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.).
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.
(2) For the provision of SPF (SPF, PFA or PA) testing report issued by overseas laboratories, the following information shall be submitted:
1) If the laboratories are accredited laboratories, the qualification certificate should be submitted;
2) If the laboratories are not accredited, the certificate for the compliance with "Good Clinical Practices" (GCP) or "Good Laboratory Practice" (GLP) should be submitted;
3) Other laboratory qualification documents.
For initial submission of offshore test report, the applicant shall submit the original of the above documents or the copies (incl, translation documents) confirmed and issued by Industry Association, Chinese Embassy (consulate) and notary offices of the country (region) where the laboratory is located. After CFDA confirmation, the copies of the documents would suffice for the renewal of application.
The original of overseas laboratory testing report shall be submitted. If a series of products meet the sampling test requirements, the originals for one product should be submit at a minimum, and the copies for other products may be submitted 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.
6. Review opinions of production sanitary issued by issued by provincial food and drug administration department;
(1) Cosmetics hygiene inspection application form.
(2) Cosmetics hygiene inspection table.
(3) Product formulas.
(4) Descriptions and diagrams of the production process.
(5) List of production equipment.
(6) Copies of manufacturer’s hygienic license.
If one production enterprise applied two or more domestic special-use cosmetics’ administrative approval, the provincial food and drug administration department shall separately issue inspection opinion on hygienic production conditions for each product.
Opinions issued by provincial food and drug administration department on the production hygienic conditions before the changes of testing reports are still valid.
7. 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 domestic products produced by Chinese enterprises upon overseas entrustment, the agency responsible for application of administrative approval in China shall be kept in record, and agency’s letter of authorization shall be submitted.
(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.
8. 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) Commissioned production and process agreement shall be provided if commissioned production and process is involved.
(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) Packaging design (including product labels and product brochures) of products produced by other actual manufacturers.
(4) Hygienic (microbiological, hygienic chemistry) testing reports of the products of other enterprises
(5) Opinions issued by provincial food and drug administration department on the sanitary conditions of production sites of other actual production enterprises.
9. The application for samples packaged in the following specifications shall meet the following requirements:
(1) 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.
(2) 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.
(3) 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.
10. 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.
Application process diagram：
