Health bureaus (departments) and food and drug administrations (drug administration) in all provinces, autonomous regions and municipalities, and the organizations concerned,
To further regulate the acceptance and process of applications for the cosmetics administrative licences, we formulated the Cosmetics Administrative Licence Application and Acceptance Rules (“the Rules”), which is hereby issued to you for your compliance and implementation. In case of any issue arising from implementation of the Rules, please promptly report it to the Department of Food Safety Coordination of the SFDA.
Appendix: Required Materials for Application for the Cosmetics Administrative Licence
State Food and Drug Administration (SFDA)
25 December 2009
Cosmetics Administrative Licence Application And Acceptance Rules
Article 1 These Rules are formulated to regulate the work associated with the acceptance of applications for the cosmetics administrative licences and ensure the openness, fairness and justness of the work.
Article 2 The term “Cosmetic Administrative Licence(s)” as used herein refers to the requirement of examining and approving use of new cosmetic ingredients, production of domestic special-purpose cosmetics, first import of cosmetics and others.
Article 3 These Rules apply to the work associated with the acceptance of applications for the cosmetics administrative licences as detailed in the Regulations Concerning the Hygiene Supervision over Cosmetics and the detailed rules for its implementation.
Article 4 The SFDA is in charge of the work associated with the acceptance of applications for the cosmetics administrative licences.
Article 5 An applicant for the administrative licence for domestic cosmetics shall be manufacturer of the cosmetics. An applicant for the administrative licence for a new domestic cosmetics ingredient shall be manufacturer of the new ingredient or manufacturer of the cosmetics.
An applicant for the administrative licence for imported cosmetics shall be manufacturer of the imported cosmetics. An applicant for the administrative licence for a new imported cosmetic ingredient shall be manufacturer of the new imported cosmetic ingredient or manufacturer of the cosmetics. If a manufacturer of new imported cosmetic ingredients is also manufacturer of the cosmetics, the applicant shall entrust a Chinese legally registered organization with independent legal status to act as its responsible agency in China to cope with the matters in relation to the application. An applicant may change its responsible agency in China.
Article 6 Applicants and responsible agencies in China shall apply for the cosmetics administrative licences in compliance with the provisions of the applicable laws, regulations, standards and norms of the State, be liable for authenticity of the application materials and assume the corresponding legal liability for the materials.
Article 7 An applicant shall file an application for the cosmetics administrative licence with the State Food and Drug Administration by presenting the required materials in accordance with the provisions hereof.
Article 8 The original of an applicant’s letter of authorization for its responsible agency in China shall be filed with the SFDA’s administrative service centre (“the Administrative Service Centre”) before the first application.
For application of the cosmetics administrative licence, an applicant shall log on the cosmetics administrative licence application online system of the SFDA and fill out the relevant forms.
Article 9 A cosmetic administrative license (instrument for filing) is valid for four years.
If an applicant applies for renewal of its cosmetics administrative license (instrument for filing), it shall file an application four months prior to the expiry thereof (instrument for filing).
In the event of failure to file a renewal application within the prescribed period as a result of replacement of the cosmetics administrative license (instrument for filing), the renewal application shall be filed within 15 days of the replacement, provided that an application for replacement shall be filed four months prior to the expiry thereof (instrument for filing).
Article 10 If an applicant applies for a change of any licensed item within the validity of the cosmetics administrative license (instrument for filing), it shall file an application and present the corresponding materials in compliance with the applicable requirements. In case of a change in the formula or any other change that may concern safety of the cosmetics, another application shall be filed for the cosmetics as new product. If, upon the change, the name of the cosmetics remains unchanged, the change shall be stated in the outer packing of the product so as to distinguish it from the product before the change.
Article 11 In the event of any damage to or loss of the cosmetics administrative license (instrument for filing), an application for replacement of the same shall be filed on a timely basis, provided that it shall not be filed simultaneously with an application for renewal or change.
Article 12 An application for correction of errors shall be filed only at one time in the event of any of the following circumstances upon receipt of the cosmetics administrative license (instrument for filing) issued by the SFDA:
(i) any print error in the cosmetics administrative license (instrument for filing);
(ii) any code error in the cosmetics administrative license (instrument for filing);
(iii) other errors in the cosmetics administrative license (instrument for filing)
The scope of error correction as set forth in this Article shall exclude errors in the application of an applicant.
Article 13 An applicant may file another application under the name of the same product as long as meeting any of the following conditions:
(i) failure to file an application for renewal of the cosmetics administrative license (instrument for filing) within the prescribed period;
(ii) filing another application after termination of an application;
(iii) voluntarily applying for cancellation of the original administrative license (instrument for filing);
(iv) filing another application after failure to obtain the administrative license with the previous application.
No second application shall be filed for any product not approved for any reason involving safety of the product, such as containing any prohibited substance or any out-of-limit restricted substance, failure to pass through the hygiene and safety tests, etc.
Article 14 If a cosmetics manufacturer makes a cross-border cosmetic manufacturing (including prepackaging) entrustment, when the process of the last content is finished within China, the cosmetics shall be filed as domestic product, and when finished outside China, as imported product.
Where the cross-border entrustment relationship has been subject to any change after the applicant obtains the cosmetics administrative license (instrument for filing), the applicant shall file another application in accordance with the provisions concerning the change in the production site.
Article 15 For any product comprising two or more agents, the application shall be filed as one single product. For a product of which the constituting parts are produced by different manufacturers at home and abroad, the application materials shall be filed in accordance with the applicable provisions on domestic product and provisions on imported product respectively. And the application shall have a clear indication clarifying the product is filed as domestic product or imported product. Names, manufacturers and actual production addresses of both domestic agent and imported agent shall be made available on the remark column of the cosmetics administrative license (instrument for filing).
Article 16 At the time of receiving the application materials for the cosmetics administrative licence, the administrative service centre shall issue the applicant the “application material receipt acknowledgement”, conduct a formal examination on the application materials, and decide within five working days whether to accept the application or make the correction.
If the application materials are complete and meet the requirements, the administrative service centre shall make a decision of accepting the application and produce the “notification of acceptance”. If they fail to meet the requirements, the administrative service centre shall issue the “notification for supplement or correction of application materials” to notify the applicant only at one time of all the contents required to be supplemented or corrected. If no such notification is made within the prescribed period, the application materials shall be deemed to have been accepted on the date of receipt of the same. Where the supplemented or corrected application materials still fail to meet the requirements, the administrative service centre may request a further supplement or correction thereof.
Article 17 The administrative service centre shall make a decision of not accepting an application and issue the “notification of refusal of acceptance” in the event of any of the following circumstances:
(i) no administrative licence is required pursuant to law, ;
(ii) the application is beyond the SDFA's jurisdiction over administrative licensing under law;
(iii) the renewal application is filed beyond the prescribed period, except for the circumstances set forth in Article 9 hereof; or
(iv) other applications within the scope of refusal.
Article 18 Notification of acceptance, notification for supplement or correction of application materials and notification of refusal of acceptance issued by the administrative service centre shall have a clear indication of the date of issuance and bear the special seal of the SDFA for administrative licensing. Any notification shall be made in two originals, with one original issued to the applicant, and the other kept on file.
Article 19 If, after the application materials are accepted, the applicant makes any supplement or amendment to the application materials in pursuance of the review opinions of the administrative service centre, such supplemented or revised application materials shall be directly submitted to the examination and review division of the SDFA. Where the application is filed by the responsible agency in China, the application materials shall be attached with the copy of the letter of authorization for the agency. Any supplementary material shall be made in response to the review opinions and submitted entirely only at only one time, with a clear indication of the date and the organization and bearing the seal. Supplementary materials shall not have revision to other content of the application materials that is not mentioned in the review opinions.
Article 20 An applicant may file a written application at a time after submission of the application materials to the SDFA and before the SDFA makes the decision of acceptance to terminate the administrative licence application and reclaim all the application materials. Where the materials have been accepted, the applicant may, before the SFDA issues the technical review opinions, ask for a revocation of the administrative licence application and return of all the materials. An applicant may, within six months as of the date of receiving the “letter of decision not granting the administrative licence” or the “letter of decision not approving the renewal/change”, ask for return of the following materials:
(i) document proving that the country (region) where the product is manufactured or processed permits the sale of the product without any restriction, document supporting the good manufacturing practice of the cosmetics manufacturer and its notarization, unless the application is filed for two or more products simultaneously and uses original of the same supporting documents;
(ii) the valid administrative license (instrument for filing);
(iii) application materials required for renewal.
Article 21 The SFDA shall, within 60 days as of the date of acceptance, organize and conduct the examination on the documents submitted by the applicant relevant to the safety assessment of the potential hazardous substances in the filed product.
Article 22 If an applicant or its responsible agency in China provides any false application material and/or sample, the SFDA will, in accordance with the provisions of Article 78 of the Administrative Licensing Law of the People’s Republic of China, refuse to accept the application or grant the license to the applicant, give warnings to the applicant and its responsible agency in China and not accept any administrative licence application of the applicant within one year.
Article 23 The responsibility to interpret these Provisions is vested in the SFDA.
Article 24 These Rules shall come into force as of 1 April 2010. In the event of any discrepancy between any provision of the previously released cosmetics administrative acceptance and application rules and these Rules, these Rules shall prevail.
Appendix:
Required Materials for Application for the Cosmetics Administrative Licence
Article 1 An application for the cosmetics administrative licence shall be supported with the relevant materials in accordance with the Cosmetics Administrative Application and Acceptance Rules, and the general requirements for the application materials are as follows:
(i) in case of the first application for the administrative licence for special-purpose cosmetics, one original and four copies of the required materials shall be submitted, and the copies shall be clear and consistent with the original;
(ii) in case of an application for filing, renewal, change, or replacement of the license, one original shall be submitted;
(iii) Except for testing reports, documents of notarization, official supporting documents and supporting documents provided by any third party and originals of the application materials shall be affixed with common seal or seal on the perforation by the applicant page by page;
(iv) printed with A4 sized papers, distinguished with obvious marks, arranged in the prescribed order and bound up;
(v) using Chinese legal measuring units;
(vi) the contents of an application shall be complete and clear, and the contents filled out for the same item shall be kept consistent;
(vii) Any foreign language material (except for those that must use foreign language such as overseas addresses, web addresses, registered trademarks, SPF, PFA or PA, UVA, UVB) shall be translated into official Chinese language, with the translation attached before the corresponding foreign language materials;
(viii) for product formula, both the text version and electronic version shall be provided;
(ix) The contents filled out for both the text version and the electronic version shall be kept consistent.
Article 2 An applicant applying for the administrative licence for domestic special-purpose cosmetics shall present the following materials:
(i) the application form for the administrative licence for domestic special-purpose cosmetics;
(ii) the basis of naming the product;
(iii) the product quality and safety control requirements;
(iv) the designed product package (including product label, product description);
(v) The testing reports and relevant materials issued by a licensed testing institution recognized by the SDFA;
(vi) documents relevant to the safety assessment of the potential hazardous substances in the product;
(vii) the examination opinions on the sanitary conditions issued by the provincial-level cosmetics supervisory authorities;
(viii) in case of any product for hair growing, fitness and breast beauty, scientific references relevant to the functional elements and the basis of use shall be presented;
(ix) Other materials that may support the application.
A sample that remains sealed by the provincial-level food and drug regulatory authorities.
Article 3 An applicant applying for the administrative licence for imported special-purpose cosmetics shall present the following materials:
(i) the application form for the administrative licence for the imported special-purpose cosmetics;
(ii) the naming basis of the product’s Chinese name;
(iii) formula of the product;
(iv) the brief description and simplified drawing of the manufacturing process;
(v) the product quality and safety control requirements;
(vi) the original product package (inclusive of product label) and, if the package is designed exclusively for China's market, the designed product package (inclusive of product label);
(v) The testing reports and relevant materials issued by a licensed testing institution recognized by the State Food and Drug Administration;
(vi) documents relevant to the safety assessment of the potential hazardous substances in the product;
(ix) in case of any product for hair growing, fitness and breast beauty, scientific references relevant to the functional elements and the basis of use shall be presented;
(x) a copy of the filed letter of authorization for the responsible agency in China and a sealed copy of the said agency’s business license;
(xi) letter of commitment undertaking that the ingredients used in the product as well as the sources of such ingredients meet the requirements for the prohibited or restricted use of highly risky substances in the mad cow disease infected areas;
(xii) documents proving that the country (region) where the product is manufactured or processed permits the sale of the product without any restriction;
(xiii) Other materials that may support the application.
A sample of the finished product that remains sealed by the testing organization.
Article 4 An applicant applying for filing of imported non-special purpose cosmetics shall present the following materials:
(i) the application form for filing of imported non-special purpose cosmetics;
(ii) the naming basis of the product’s Chinese name;
(iii) formula of the product;
(iv) the product quality and safety control requirements;
(vi) the original product package (including product label, product description) and, if the package is designed exclusively for China's market, the designed product package (including product label, product description);
(vi) The testing reports and relevant materials issued by a licensed testing institution recognized by the State Food and Drug Administration;
(vii) documents relevant to the safety assessment of the potential hazardous substances in the product;
(xiii) a copy of the filed letter of authorization for the responsible agency in China and a sealed copy of the said agency’s business license;
(ix)the letter of commitment undertaking that the ingredients used in the product as well as the sources of such ingredients meet the requirements for the prohibited or restricted use of highly risky substances in the mad cow disease infected areas;
(x) documents proving that the country (region) where the product is manufactured or processed permits the sale of the product without any restriction;
(xi) Other materials that may support the application.
A sample of the finished product that remains sealed by the testing organization.
Article 5 An applicant applying for the administrative licence for a new cosmetic ingredient shall present the following materials:
(i) the application form for the administrative licence for the new cosmetic ingredient;
(ii) the research report;
a. the background and process of the research and development of the ingredient as well as the relevant technical materials;
b. source of the ingredient as well as its physical and chemical features, chemical structure, molecular formula and mass;
c. purpose of using such ingredient in the product as well as its basis, scope and maximum usage;
(iii) the brief description and simplified drawing of the manufacturing process;
(iv) the ingredient quality and safety control requirements, including its specification, testing method, potential hazardous substances and their control;
(v) documents relevant to the toxicological safety assessment, including documents relevant to the safety assessment of the potential hazardous substances in the ingredient;
(vi) a copy of the filed letter of authorization for the responsible agency in China and a sealed copy of the said agency’s business license;
(vii) Other materials that may support the application.
A sample for further examination
Article 6 Apart from the materials set forth above, an applicant shall also present the following materials where the filed product falls into any of the following situations:
(i) where the filed product is manufactured through a consignment processing way:
a. the consignment processing agreement entered into by and between the consignor and the consignee;
b. in case of imported product, the quality control system of the consigned manufacturer or the document supporting the good manufacturing practice of the manufacturer (or document certifying the cosmetics manufacturing qualifications thereof meet the requirements of laws and regulations of the country (region) where the manufacturer is located);
c. in case of any domestic product manufactured by a resident enterprise with the entrustment of an overseas manufacturer, the letter of authorization for the responsible agency in China, and the responsible agency in China shall be filed;
d. in case of any imported product manufactured by an overseas enterprise with the entrustment of a resident manufacturer, it may not be necessary to provide the letter of authorization for the responsible agency in China, the production and sale supporting documents and the original product package, instead, the designed product package shall be provided;
(ii) where the actual manufacturer is under the same control of a group company with the applicant: the documents certifying the actual manufacturer is under the same control of the group company with the applicant as well as the quality assurance documents.
Article 7 The application for the administrative licence for any one single product manufactured in several countries may be filed at the same time, provided that the application for the administrative licence for the said product manufactured in one of the several countries shall be supported with, in addition to all the materials set forth above, the following materials:
(i) the consignment processing agreement in case of involving a consignment processing relation and, in case of imported product, the quality control system or documents supporting the good manufacturing practice (or documents proving the qualifications for manufacturing the cosmetics meet the requirements of laws and regulations of the country (region) where the manufacturer is located);
(ii) where the manufacturers are under the same control of a group company: the documents proving the manufacturers are under the same control of the group company as well as the quality assurance documents;
(iii) the original package of products manufactured by other actual manufacturers, in case of domestic product, the package design;
(iv) hygienic (microbiological, chemical) testing reports on the products manufactured by other actual manufacturers;
(v) in case of domestic products, the examination opinions on the sanitary conditions issued by the provincial-level cosmetics supervisory authorities in the places where other actual manufacturers is located; and
(vi) in case of imported products, the letter of commitment undertaking that the ingredients used in the product as well as the sources of such ingredients meet the requirements for the prohibited or restricted use of highly risky substances in the mad cow disease infected areas.
Article 8 If an applicant files for a product for which the applicant has terminated the previous filing or failed to obtain the administrative licence with the previous filing, the applicant shall file a second application by presenting the required materials for the filing. If the applicant terminates a filing and then files a second application, it shall specify the reason of the termination and the second filing; if the applicant files a second application on account of failure to obtain the administrative licence, it shall submit the copy of the decision not granting (changing/renewing) the administrative licence and specify the reason for the filing.
In the event that failure to obtain the administrative licence is not concerned with the product safety, for a second application, the copies of original testing reports may be used; in case of domestic special-purpose cosmetics, copies of the original examination opinions on the sanitary conditions may be used, unless the original application materials have been returned to the applicant.
Article 9 An applicant applying for renewal of the validity of the administrative license (filing) shall present the following materials:
(i) the application form for renewal of the cosmetics administrative license;
(ii) the original of the cosmetics administrative license (instrument for filing);
(iii) the basis of naming the product (except for the product of which the naming basis has been furnished in the first application and the name remains unchanged);
(iv) formula of the product;
(v) the product quality and safety control requirements;
(vi) packing of the product sold in the market (including product label, product description), in case of domestic product that has not come on the market, the designed product package (including product label, product description);
(vii) in case of domestic product, the opinions on the product manufacturing, marketing and supervision or the examination opinions on failure of the product to go on the market issued by the provincial-level cosmetics supervisory authorities in the place where the applicant is located;
(viii) a copy of the filed letter of authorization for the responsible agency in China and a sealed copy of the said agency’s business license;
(ix) Other materials that may support the application.
A sample of the product sold in market that remains sealed
Article 10 An applicant applying for change of any administrative licence item shall present the following materials:
(i) the application form for change of cosmetics administrative licence items;
(ii) the original of the cosmetics administrative license (instrument for filing);
(iii) a copy of the filed letter of authorization for the responsible agency in China and a sealed copy of the said agency’s business license;
(iv) the following materials subject to the contents to be changed with the application:
a. change of the product name:
(i) if an applicant files an application for change of the Chinese name of the product, it shall detail the reason in the application form for change and provide the naming basis of the new name and the designed product package after the change of the name (including product label and product description), provided that the foreign language name of an imported product shall not be changed;
(ii) an application for change of the SPF, PFA or PA values appeared in the name of sunscreen products shall be supported with the testing report of the SPF, PFA or PA and the designed product package upon the change (including product label and product description).
b. change of name or address of the manufacturer (including a self-made change or a change due to a merger and acquisition):
(i) in case of a change of the name or address of a domestic cosmetics manufacturer , the original or notarized copy of the certification issued by the local administrative authorities for industry and commerce and a copy of the manufacturer’s hygienic license;
(ii) in case of a change in the name or address of an imported cosmetics manufacturer, the relevant documents issued by the competent government authorities or the relevant agency of the country where the product is manufactured; where an application for a legitimate change of the name of the manufacturer is filed as a result of a merger or acquisition: the copy of the contract for merger or acquisition entered into by and between the two parties. The said documents shall be translated into official Chinese language, and the Chinese version shall be notarized by a notary organ in China;
(iii) where the resident enterprise group conducts an internal restructure: the relevant documents issued by the administrative authorities for industry and commerce; in the case of involving any enterprise with investment of Taiwan, Hong Kong or Macro or any foreign-invested enterprise: the notarized copy of the Certificate of Approval for Establishment of Enterprises with Foreign Investment in the People’s Republic of China or the Certificate of Approval for Establishment of Enterprises with Investment of Taiwan, Hong Kong, Macao and Overseas;
(iv) in the case of involving a change to the production site: the hygienic (microbiological, physical and chemical) testing reports on the product of the manufacturer upon the change; in case of domestic products, the examination opinions on the hygienic conditions issued by the provincial-level cosmetics supervisory authorities in the place where the manufacturer is located.
c. Change of the Chinese name of the import cosmetics manufacturer (the foreign name remains unchanged):
(i) reasons for changing the Chinese name of the manufacturer;
(iv) the designed product package to be changed (including product label, product description);
d. change in the responsible agency in China:
(i) original of the letter of authorization for the responsible agency in China to be changed;
(ii) copy of the letter of authorization for the responsible agency in China to be changed;
(iii) in case of a change of the name or address of the responsible agency in China itself, the original or the notarized copy of the document proving the change issued by the local administrative authorities for industry and commerce;
(iv) circumstances leading to the cancellation of the original responsible agency in China and the notarization thereof
e. Change in the actual manufacturer:
(i) the consignment processing agreement in the case of involving a consignment processing relationship and, in case of imported products, the quality control system or documents supporting the good manufacturing practice (or documents proving the qualifications for manufacturing the cosmetics meet the requirements of laws and regulations of the country (region) where the manufacturer is located);
(ii) where the manufacturers are under the same control of a group company: the documents proving the manufacturers are under the same control of the group company as well as the quality assurance documents;
(iii) the original package of the product manufactured by the actual manufacturer to be changed;
(iv) hygienic (microbiological, chemical) testing reports on the products manufactured by the actual manufacturer;
(v) in case of domestic products, the examination opinions on the sanitary conditions issued by the provincial-level cosmetics supervisory authorities in the places where the actual manufacturer is located; and
(vi) in case of imported products, the letter of commitment undertaking that the ingredients used by the actual manufacturer as well as the sources of such ingredients meet the requirements for the prohibited or restricted use of highly risky substances in the mad cow disease infected areas.
f. for a change of the category of a special-purpose cosmetic product, it is required to furnish the relevant materials according to the requirements of various categories.
g. an application for any other change shall be supported with detailed reasons and the relevant supporting documents.
Article 11 An applicant applying for replacement of the administrative licence (instrument for filing) shall present the following materials:
(i) the application form for re-issuance of cosmetics administrative license (instrument for filing);
(ii) where the application for re-issuance of the cosmetics administrative license (instruments for filing) is filed due to destruction of the approval: the original of the cosmetics administrative license (instrument for filing);
(iii) where the application for re-issuance of the cosmetics administrative license (instrument for filing) is filed due to loss of the approval (instrument for filing), the original of the loss statement published on a provincial-level or above newspaper or magazine, and such application shall be filed on a timely basis twenty days after publication of the loss statement;
(iv) a copy of the filed letter of authorization for the responsible agency in China and a sealed copy of the said agency’s business license;
Article 12 An applicant applying for correction of any error in the administrative licence approval (instrument for filing) shall present the following materials:
(i) the application form for correction of errors in the cosmetics administrative license (instrument for filing);
(ii) the copy of the cosmetics administrative license (instrument for filing) signed and sealed by the applicant;
(iii) original of the cosmetics administrative license (instrument for filing) shall be returned at the time of drawing the new approval/instrument for filing.
Article 13 In case of supplementing materials to the review division of the SDFA, an applicant shall present the following materials:
(i) notification of the review opinions;
(ii) the supplementary materials arranged in the order of the questions raised in the examination opinions.
Article 14 Materials relevant to the formula of a cosmetic product shall meet the following requirements:
(i) providing the formula table comprising such contents as include the serial number of ingredients, ingredients’ INCI (the International Nomenclature of Cosmetic Ingredients) (except for domestic products), standard Chinese name, percentage composition, purpose of usage, etc., with the size no less than smaller 5 Song font;
(ii) providing the name and actual content of each ingredient (expressed with percentage), indicating the content of effective substance (otherwise, it is 100%); in case of a compound ingredient, the application shall be made in a combined way, with the content of each component therein indicated (expressed with percentage); in special case of containing crystal water, having different molecular formula or structure, a detailed specification is required, and all the ingredients shall be arranged in a descending order by content;
(iii) in naming an ingredient (including various components in compound ingredient), its standard Chinese name listed in the Catalogue of Standard Chinese Names of International Cosmetics Ingredients shall be used. Where the name of an ingredient can neither be found in the International Nomenclature of Cosmetic Ingredients (INCI) nor is listed in the Catalogue of the Standard Chinese Names of International Cosmetic Ingredients, the name listed in the Chinese Pharmacopoeia or the chemical name or Latin name of the ingredient shall be used, provided that neither commercial name nor popular name thereof can be used, except for compound ingredient;
(iv) in case of a colouring agent, providing the index number of the colouring agent specified in the Hygienic Standard for Cosmetics (“CI No.”), except for those without CI No.
(v) in case of an ingredient containing any animal organ extract, providing the source and quality requirement of the ingredient as well as the usage permissible certificate issued by the country where the ingredient is manufactured;
(vi) with respect to a cosmetic product the formula of which uses hydrocarbon derived from oil or coal oil (except for any single component), clearly showing the chemical abstracts service registry number (“CAS No.”) of the relevant ingredients in the formula of the product;
(vii) should the Hygienic Standard for Cosmetics set out any requirement on any restricted ingredient, the applicant shall also present the certification issued by the ingredient supplier that certifies the quality requirement of the ingredient;
(viii) in case of any multi-agent product the formula of which is a combination of subpackaged ingredients (such as hair dye products or permanent waves), or any product comprising different formulas kept in a single inseparable package, specifying the formula of each part respectively:
(ix) the date of confirming the formula of the imported product by the licensed testing institution shall conform to the date of accepting the sample;
(x) providing the materials relevant to safety-based formula design principle (including the analysis report of the formula as a whole), principle and requirements for selection of ingredients, production process, quality control, etc. in case of any product allegedly designed exclusively for pregnant and lactating women, children or infants.
Article 15 Documents relevant to the safety assessment of the potential hazardous substances in the product shall be prepared on the basis of ingredients and features of cosmetics, including the following:
(i) name of any substance that probably exists as a hazard to the cosmetic product (including any substance carried into from an ingredient or generated in the process of the manufacturing), the related testing methodologies and testing data;
(ii) safety assessment reports in response to the potential hazardous substances;
(iii) the materials relevant to the technology that may reduce the content of the substance carried into or generated during the manufacturing process of the cosmetic product under the current technical conditions, and if necessary, the process improvement measures;
(iv) in case of plant ingredients, the information relevant to the pollutant or impurities, such as pesticide residue, heavy medal and so on, or the information relevant to the impurities brought in during the process of refinement or production.
Article 16 The product quality and safety control requirements shall include the following:
(i) sensory indicators such as colour, odour, properties, etc.;
(ii) microbiological indicators (except for those for which no test is required), hygienic and chemical indicators;
(iii) in case of any product for permanent, depilation, elimination of freckles as well as any product containing hydroxy acid or any product allegedly containing no hydroxy acid but its content ≥3%(w/w), the pH value indicators (except for water-in-oil) and the testing methodologies;
(iv) in case of imported products, the product quality and safety control requirements executed in the country of origin (both the foreign language version and the Chinese translation);Where the product quality and safety control requirements executed in the country of origin specify no content as described in paragraphs (i), (ii) and (iii) of this Article, the materials relevant to the product quality and safety control requirements that specify the corresponding indicators;
(v) the letter of commitment undertaking the product is in line with the requirements of the Hygienic Standard for Cosmetics.
Article 17 The examination opinions on the hygienic conditions for production of domestic special-purpose cosmetics shall comprise the following materials:
(i) the application form for examination of hygienic conditions of cosmetics production;
(ii) the examination form for the hygienic conditions of cosmetics production;
(iii) formula of the product;
(iv) the brief description and simplified drawing of the manufacturing process;
(v) list of the production equipment;
(vi) copy of the manufacturer’s hygienic license
Article 18 The testing reports and relevant materials issued by a licensed testing institution recognized by the SDFA shall meet the following requirements:
(i) the testing reports for cosmetic licence shall include the hygiene and safety testing report (microbiology, hygienic chemistry, toxicology) and the human safety testing report, and the samples subject to the testing shall be the product of the same name with the same production date/batch number;
(ii) an applicant using the sun protection factor (SPF, PFA or PA values) and new ingredient testing reports provided by a laboratory abroad shall present the following materials:
a. where the laboratory has passed through the laboratory qualification authentication, the qualification authentication certificate;
b. where the laboratory has not passed through the laboratory qualification authentication, the certification of the laboratory’s strict compliance with the Good Clinical Practice (“GCP”) or the Good Laboratory Practice (“GLP”);
c. other materials that may support the qualifications of the laboratory.
In case of submission of overseas testing reports for the first time, originals of the aforesaid materials or their copies confirmed by the local industry association, embassy or notarial office (including the translation) shall be provided, and upon approval of the SFDA, only copies thereof are required in a re-application.
The testing reports issued by a laboratory abroad shall be originals; where series products meet the random inspection requirements, testing reports on at least one of the products shall be provided in original form, with copies of the testing reports on other products, and the product for which the testing reports are provided in original form shall be specified.
An applicant using the testing reports issued by a laboratory abroad shall also present the document issued by the relevant laboratory that proves the name (or number) of the sample submitted for testing matches to the number of the testing reports.
(iii) the testing reports issued by a licensed testing institution shall comprise the following materials:
a. the testing application form;
b. the testing acceptance notification;
c. manufacturer’s instruction;
d. the hygiene and safety testing report (microbiology, hygienic chemistry, toxicology);
e. the following materials if made available:
f. the human safety testing report (patch test, human using test);
(ii) the testing report on SPF, PFA or PA values;
(iii) the testing report on other newly added items (such as testing report on asbestos in talcum powder).
Article 19 Letter of commitment undertaking that the ingredients used in the product as well as the sources of such ingredients meet the requirements for the prohibited or restricted use of highly risky substances in the mad cow disease infected areas shall be provided in accordance with the relevant provisions.
Article 20 For the original package of imported product, both its original foreign language version and the Chinese translation shall be provided, together with the Chinese product label (including the product description) that complies with the applicable laws and regulations of China.
Article 21 Documents proving that the country (region) where the product is manufactured or processed permits the sale of the product without any restriction shall meet the following requirements:
(i) issued by the competent government authorities or industry association of the country (region) where the product is manufactured or processed; if originals of the documents are unavailable, copies confirmed by the issuing agency or the embassy (consulate) in China are acceptable;
(ii) showing the product name, name of the manufacturer, name of the issuing agency, affixed with the seal of the agency or the signature of the legal representative (or its authorized person) as well as the issuing date;
(iii) the product name and the name of the manufacturer appeared thereon shall completely conform to the filed contents; if the name of the manufacturer appeared on the supporting document fails to conform to that indicated in the application materials when the production is conducted in an entrustment processing way or otherwise, the applicant shall produce a document to make a clarification, and, with respect to any multi-agent product that must be used in a combined way, the free sales certificate can be provided only for the imported products;
(iv) if the free sales supporting document is in foreign language, it shall be translated into the standard Chinese language, and such Chinese translation shall be notarized by a notary organ in China.
Article 22 The quality control system or the documents supporting the good manufacture practice of the entrusted manufacturer or the documents proving compliance with the cosmetics production qualification prescribed by the country (region) where the manufacturer is located shall meet the following requirements:
(i) issued or approved by a certification authority or a third party; if the documents cannot be provided in their originals, their copies may be furnished, provided that the authenticity of the said copies shall be notarized or confirmed by the Chinese embassy (consulate);
(ii) The carried name and address of the manufacturer shall conform to those filed.
Article 23 The letter of authorization for the imported cosmetics responsible agency in China shall meet the following requirements:
(i) cosigned by the applicant and its responsible agency in China (signed or sealed by the responsible person in case of the applicant, signed or sealed by the legal representative in case of the responsible agency in China) and notarized by the notary organ. Where the letter of authorization is made in foreign language, it shall be translated into Chinese language and then notarized;
(ii) cover the following contents: name of the applicant, name of the responsible agency in China, period of validity of the authorization (at least four years), scope of the product under the authorization, authority, etc; the authority may include affixing seals on the application materials to confirm the same, filing application, etc.;
(iii) original of the letter of authorization (including its Chinese translation) shall be submitted for filing and future reference.
Article 24 Supporting documents like free sales certificate, documents relevant to quality control system, certificate of good manufacture practice, document certifying manufacturers in different countries are under the same control of a group company, entrustment processing agreement, etc. may specify more products together. Should those products be filed together, the application materials for one of them shall be provided in original form, and for others, copies are acceptable, provided that a written statement of the product for which the application materials are presented in original form is provided; where the said products are not filed together, originals of the application materials for one of them and notarized copies for others shall be provided, with a written statement of the product for which the application materials are presented in original form. Article 25 A sample sealed by a licensed testing institution and submitted for approval shall be a completely packed sample conforming to the sample submitted for testing in terms of name, date of production/batch number, the guarantee period/restricted-use period and the testing acceptance number, with the product instruction contained in the packaging. Where no product instruction is made available for reason of the undersized bulk (such as lipstick, lip gloss, etc.) or the contents of the product instruction are printed on the product containers, the relevant statement shall be submitted. The outer packing of import product shall be attached with a label bearing the Chinese name of the product, and all the labels in foreign language shall be left uncovered. Sample of any imported product manufactured by an overseas enterprise under the entrustment of a resident enterprise shall be submitted as domestic product.
Article 26 Samples in the following packaging shall be filed according to the following provisions:
(i) where the packing of one single sample contains two or more individual fractional packs or separations (such as eye shadow, puff cake, rouge) and the application is filed with name of one of the products, the formula of every product included in the said sample shall be provided; in case of any sample that contains no individual fractional pack nor separation but, except for pigment, is made up of the same ingredients, the formula of every part constituting the sample shall be provided;
(ii) where a sample in an inseparable collective packing comprising products that vary from each other in specification, the state of matter and ingredient and the application is filed with the name of one of the products, the formula and the testing reports on each of the said products shall be provided;
(iii) for a product to be used in combination with two or more agents, the application therefor shall be filed as one single product, with the combined testing report or the testing report of each agent submitted respectively according to the actual situation of whether several agents are used in a combined way
Article 27 Non-special-purpose varicoloured series products may be filed as a group when they share the basic formula and toxicological testing on them are applied. And application materials for each product shall be attached with the name list of the series products, the basic formula, list of the colouring agents and the list of the products that have been subject to the random inspection.
With respect to the toxicological testing on varicoloured series sun-proof cosmetics, the percentage of random testing shall be 20%, and in case of not reaching ten in total, the quantity shall be counted as ten; for random inspection, products containing organic colouring agent or with a higher content of colouring agent shall be selected.
Article 28 Non-special-purpose varicoloured series products may be filed as a group when they share basic formula and sun protection (SPF, PFA or PA) testing on them are applied. And application materials for each product shall be attached with the name list of the series products, the basic formula, list of the colouring agents and the list of the products that have been subject to the random inspection.
For the sun protection factor testing on varicoloured series sun-proof cosmetics, the percentage of random testing shall be 20%, and in case of not reaching five in total, the quantity shall be counted as five; for random inspection, products with the lowest content of colouring agent (or the product of which the basic formula contains no colouring agent) shall be selected.
Article 29 In case of cosmetics of the same name with different odour type or sun protection factor (SPF, PFA or PA), the application for the licensing approval shall be filed for every product according to the different types by presenting the application materials respectively.
Forms:
1. Application Form for the Administrative Licence for Domestic Special-purpose Cosmetics;
2. Application Form for the Administrative Licence for the Imported Special-purpose Cosmetics;
3. Application Form for Filing of Imported Non-special-purpose Cosmetics
4. Application form for the Administrative Licence for the New Cosmetic Ingredient;
5. Application Form for Change of Cosmetics Administrative Licence Items;
6. Application Form for Renewal of the Cosmetics Administrative Licence;
7. Application Form for Re-issuance of cosmetics administrative license (Instrument for Filing);
8. Application form for Correction of Errors in the cosmetics administrative license (Instrument for Filing)
Form 1 Application Form for the Administrative Licence for Domestic Special-Purpose Cosmetics
Product Name_________
Prepared by the State Food and Drug Administration (SFDA)
Instructions
1. This Form can be downloaded for use from the website of the SFDA: HTTP：//WWW.SFDA.GOV.CN
2. Contents filed with this Form and all the application materials must be printed.
3. Contents filed with this Form shall be complete, clear and free from any alternation.
4. Before filling out this Form, please carefully read the applicable laws and the rules governing acceptance of the applications.
5. For the product category, please fill out the specific category of special-purpose cosmetics such as sun protection, hair growing, etc.
6. Please submit an electronic form that conforms to its paper counterpart in data at the time of filing the application.
Product Name
Product Category
Product Testing Acceptance Number
Manufacturer
Name
Address
Zip Code
Tel
Contact
Manufacturer’s hygienic licence No.
Validity
Until this___ day of____, ____
Letter of Assurance
Manufacturer of the product hereby warranties that: contents filed with this Form and all the materials attached herewith are authentic and legitimate, with the copy thereof identical to the original. The data in the any attached material is derived from research and testing of the product and complies with the requirements of the Hygienic Standard for Cosmetics. In the event of any falseness, the manufacturer agrees to assume the corresponding legal liability and all the consequences caused thereby.
Manufacturer (Seal) Legal representative (Signature)
This___ day of____, ______
Attached materials (please tick √ in the □ before the materials you provide)
□ 1.Application Form for the Administrative Licence for Domestic Special-Purpose Cosmetics
□ 2. Basis of Naming the Product
□ 3. Product Quality and Safety Control Requirements
□ 4. Designed Product Package (Including Product Label, Product Description)
□ 5.Testing Reports and Relevant Materials Issued By A Licenced Testing Institution Recognized by The SFDA
□ 6. Documents Relevant to Safety Assessment Of Potential Hazardous Substances in The Product
□ 7. The Examination Opinions on The Sanitary Conditions Issued by The Provincial-level Cosmetics Supervisory Authorities
□ 8. in case of products for hair growing, fitness and breast beauty, the Scientific References Relevant to the Functional Elements and the Basis of Use
□ 9. A Sample that Remains Sealed by the Provincial-level Food and Drug Regulatory Authorities and other Materials that may Support the Application.
Please fill out the following items where the actual manufacturer is not the aforesaid manufacturer or there are several actual manufacturers:
Name of the product’s actual manufacturer(s):
Address of the product’s actual manufacturer(s):
Hygienic licence No. of the actual manufacturer(s):
Relationship between the manufacturer and the product’s actual manufacturer: □ entrusted production □ under the same control
Other issues needed to be clarified:
Form 2
Application Form for the Administrative Licence for Imported Special-Purpose Cosmetics
Product Chinese Name _____
Prepared by the State Food and Drug Administration (SFDA)
Instructions
1. This Form can be downloaded for use from the website of the SFDA: HTTP: //WWW.SFDA.GOV.CN
2. Contents filed with this Form as well as all the application materials must be printed.
3. Contents filed with this Form must be complete, clear and free from any alternation.
4. Before filling out this Form, please carefully read the applicable laws and the rules governing the acceptance of applications.
5. For the product category, please fill out the specific category of special-purpose cosmetics such as sun protection, hair growing, etc.
6. Please submit an electronic form that conforms to its paper counterpart in data at the time of filing the application.
Product Name
In Chinese Language
In Foreign language
Product Category
Product Testing Acceptance Number
Manufacturer
Chinese
Foreign language
Address
Country (region) of origin
Tel
Contact
Responsible Agency in China
Name
Address
Fax
Zip Code
Tel
Contact
Letter of Assurance
Manufacturer of the product hereby warranties that: contents filed with this Form and all the materials attached herewith are authentic and legitimate, with the copy thereof identical to the original, and the data in any material attached herewith is derived from research and testing on the product and complies with the requirements of the Hygienic Standard for Cosmetics. In the event of any falseness, the manufacturer agrees to assume the corresponding legal liability and all the consequences caused thereby.
Manufacturer (Seal) Legal representative (Signature)
This___ day of____, ______
Letter of Commitment
The responsible agency in China hereby solemnly represents that we understand the requirements of the Cosmetics Administrative Application and Acceptance Rules including the cosmetics administrative licence shall be applied in accordance with the provisions of the State’s applicable laws, regulations, standards and norms and the corresponding legal liability shall be held for the application materials. We have reviewed the filed contents and the materials attached herewith, promising that all the application materials we submit are authentic and legitimate, with the copy thereof identical to the original, and the data in any material attached herewith is derived from the research and testing on the product and complies with the Hygienic Standard for Cosmetics. In the event of any falseness, we agree to assume the corresponding legal liability and all the consequences caused thereby.
Responsible agency in China (Seal) Legal representative (Signature)
Dated this____ day of____, ____
Materials Attached (please tick √ in the □ before the materials you provide):
□ 1. Application Form for the Administrative Licence for Imported Special-Purpose Cosmetics
□ 2. Naming Basis of the Product’s Chinese Name
□ 3. Product Formula
□ 4. Brief Description and Simplified Drawing of the Manufacturing Process
□ 5. Product Quality and Safety Control Requirements
□ 6. Original Product Package (Including Product Label) And, If the Package is Designed Exclusively for China's Market, the Designed Product Package (Including Product Label)
□ 7.Testing Reports and Relevant Materials Issued By A Licenced Testing Institution Recognized by The SFDA
□ 8. Documents Relevant to Safety Assessment of Potential Hazardous Substances in The Product
□ 9. Scientific References Relevant to the Functional Elements and the Basis of Use in Case of Products for Hair Growing, Fitness and Breast Beauty
□ 10. Copy of the Filed Letter of Authorization for the Responsible Agency in China and a Sealed Copy of the Said Agency’s Business Licence
□ 11 Letter of Commitment Undertaking that the Ingredients Used in The Product As Well As the Sources of Such Ingredients Meet The Requirements for The Prohibited or Restricted Use of Highly Risky Substances in The Mad Cow Disease Infected Areas
□ 12 Documents Proving that the Country (Region) Where the Product Is Manufactured Or Processed Permits The Sale of The Product without Any Restriction
□ 13. A Sample of the Finished Product that Remains sealed by the Licenced Testing Organization and Other Materials That May Support the Application
Please fill out the following items where the origin of the product i.e. the country (region) where the product is manufactured is not the country where the aforesaid manufacturer is located or the product is manufactured in several countries or there are several responsible agencies in China:
Name of the product’s actual manufacturer(s):
Address of the product’s actual manufacturer(s):
Country of the product’s actual manufacturer(s):
Relationship between the aforesaid manufacturer and the product’s actual manufacturer: □ entrusted production □ under the same control
Others issued needed to be clarified:
Form 3
Application Form for Filing of Imported Non-Special-Purpose Cosmetics
Product Chinese Name _____
Prepared by the State Food and Drug Administration (SFDA)
Instructions
1. This Application Form can be downloaded for use from the website of the SFDA: HTTP: //WWW.SFDA.GOV.CN
2. Contents filed with this Form as well as all the application materials must be printed.
3. Contents filed with this Form must be complete, clear and free from any alternation.
4. Before filling out this Form, please carefully read the applicable laws and the rules governing the acceptance of applications.
5. Please submit an electronic form that conforms to its paper counterpart in data at the time of filing the application.
Product Name
Chinese
Foreign language
Product Testing Acceptance Number
Manufacturer
Name in Chinese
Name in Foreign language
Address
Country (region) of origin
Tel
Contact
Responsible Agency in China
Name
Address
Fax
Zip Code
Tel
Contact
Letter of Assurance
Manufacturer of the product hereby warranties that: contents filed with this Form and all the materials attached herewith are authentic and legitimate, with the copy thereof identical to the original, and the data in any material attached herewith is derived from research and testing on the product and complies with the requirements of the Hygienic Standard for Cosmetics. In the event of any falseness, the manufacturer agrees to assume the corresponding legal liability and all the consequences caused thereby.
Manufacturer (Seal) Legal representative (Signature)
This___ day of____, ______
Letter of Commitment
The responsible agency in China hereby solemnly represents that we understand the requirements of the Cosmetics Administrative Application and Acceptance Rules including the cosmetics administrative licence shall be applied in accordance with the provisions of the State’s applicable laws, regulations, standards and norms and the corresponding legal liability shall be held for the application materials. We have reviewed the filed contents and the materials attached herewith, promising that all the application materials we submit are authentic and legitimate, with the copy thereof identical to the original, and the data in any material attached herewith is derived from the research and testing on the product and complies with the Hygienic Standard for Cosmetics. In the event of any falseness, we agree to assume the corresponding legal liability and all the consequences caused thereby.
Responsible agency in China (Seal) Legal representative (Signature)
Dated this____ day of____, ____
Materials Attached (please tick √ in the □ before the materials you provide):
□ 1. Application Form for the Administrative Licence for Imported Non-Special-Purpose Cosmetics
□ 2. Naming Basis of the Product’s Chinese Name
□ 3. Product Formula
□ 4. Product Quality and Safety Control Requirements
□ 5. Original Product Package (Including Product Label and Product Description) And, If the Package is Designed Exclusively for China's Market, the Designed Product Package (Including Product Label and Product Description)
□ 6.Testing Reports and Relevant Materials Issued By A Licenced Testing Institution Recognized by The SFDA
□ 7. Documents Relevant to Safety Assessment of Potential Hazardous Substances in The Product
□ 8. Copy of the Filed Letter of Authorization for the Responsible Agency in China and a Sealed Copy of the Said Agency’s Business Licence
□ 9. Letter of Commitment Undertaking that the Ingredients Used in The Product As Well As the Sources of Such Ingredients Meet The Requirements for The Prohibited or Restricted Use of Highly Risky Substances in The Mad Cow Disease Infected Areas
□ 10. Documents Proving that the Country (Region) where the Product Is Manufactured or Processed Permits The Sale of The Product without Any Restriction
□ 11. A Sample of the Finished Product that Remains sealed by the Licenced Testing Organization and Other Materials That May Support the Application
Please fill out the following items where the origin of the product i.e. the country (region) where the product is manufactured is not the country where the aforesaid manufacturer is located or the product is manufactured in several countries or there are several responsible agencies in China:
Name of the product’s actual manufacturer(s):
Address of the product’s actual manufacturer(s):
Country of the product’s actual manufacturer(s):
Relationship between the aforesaid manufacturer and the product’s actual manufacturer: □ entrusted production □ under the same control
Others issued needed to be clarified:
Form 4
Application Form for the Administrative Licence for New Cosmetic Ingredient
Product Chinese Name _____
Prepared by the State Food and Drug Administration (SFDA)
Instructions
1. This Application Form can be downloaded for use from the website of the SFDA: HTTP: //WWW.SFDA.GOV.CN
2. Contents filed with this Form as well as all the application materials must be printed.
3. Contents filed with this Form must be complete, clear and free from any alternation.
4. Before filling out this Form, please carefully read the applicable laws and the rules governing the acceptance of applications.
5. Please submit an electronic form that conforms to its paper counterpart in data at the time of filing the application.
Name of the New Ingredient
In Chinese
In Foreign language
Purpose of the New Ingredient
Manufacturer
Name in Chinese Language
Name in Foreign language
Address
Country (region) of origin
Tel
Contact
Responsible Agency in China
Name
Address
Fax
Zip Code
Tel
Contact
Letter of Assurance
Manufacturer of the product hereby warranties that: contents filed with this Application Form and all the materials attached herewith are authentic and legitimate, with the copy thereof identical to the original, and the data in any material attached herewith is derived from research and testing on the product and complies with the requirements of the Hygienic Standard for Cosmetics. In the event of any falseness, the manufacturer agrees to assume the corresponding legal liability and all the consequences caused thereby.
Manufacturer (Seal) Legal representative (Signature)
This___ day of____, ______
Letter of Commitment
The responsible agency in China hereby solemnly represents that we understand the requirements of the Cosmetics Administrative Application and Acceptance Rules including the cosmetics administrative licence shall be applied in accordance with the provisions of the State’s applicable laws, regulations, standards and norms and the corresponding legal liability shall be held for the application materials. We have reviewed the filed contents and the materials attached herewith, promising that all the application materials we submit are authentic and legitimate, with the copy thereof identical to the original, and the data in any material attached herewith is derived from the research and testing on the product and complies with the Hygienic Standard for Cosmetics. In the event of any falseness, we agree to assume the corresponding legal liability and all the consequences caused thereby.
Responsible agency in China (Seal) Legal representative (Signature)
Dated this____ day of____, ____
Note: the Letter ofCommitment is required where the application is made by the Responsible Agencyin China
Materials Attached (please tick √ in the □ before the materials you provide):
□ 1. Application Form for the Administrative Licence for A New Cosmetic Ingredient
□ 2. Research Report
□ 3. Brief Description and Simplified Drawing of the Manufacturing Process
□ 4.Ingredient’s Quality and Safety Control Requirements
□ 5. Information on The Toxicological Safety Assessment
□ 6. Copy of the Filed Letter of Authorization for the Responsible Agency in China and a Sealed Copy of the Said Agency’s Business Licence
□ 7. A Sample for Further Examination and Other Materials That May Support the Application
Others issued needed to be clarified:
Form 5
Application Form for Change of Cosmetic Administrative Licence Items
Product Chinese Name _____
Prepared by the State Food and Drug Administration (SFDA)
Instructions
1. This Form can be downloaded for use from the website of the SFDA: HTTP: //WWW.SFDA.GOV.CN
2. Contents filed with this Form as well as all the application materials must be printed.
3. Contents filed with this Form must be complete, clear and free from any alternation.
4. Before filling out this Form, please carefully read the applicable laws and the rules governing the acceptance of applications.
5. For the product category, please fill out the specific category of special-purpose cosmetics such as sun protection, hair growing, etc.
6. Please submit an electronic form that conforms to its paper counterpart in data at the time of filing the application.
Product Name
Product Testing Acceptance Number
Manufacturer
Name in Chinese Language
Name in Foreign language
Address
Tel
Contact
Responsible Agency in China
Name
Address
Fax
Zip Code
Tel
Contact
Manufacturer’s Hygienic Licence No.
Validity
Until this___ day of____, ____
Original Approval Number
Validity
Until this__ day of___, ____
Materials Attached and List of Supporting Documents:
□ 1. Application Form for Change of Cosmetic Administrative Licence Items
□ 2. Original of the Cosmetic Administrative Licence (Instrument for filing)
□ 3. Copy of the Filed Letter of Authorization for the Responsible Agency in China and a Sealed Copy of the Said Agency’s Business Licence in Case of Being Filed by the Agency
□ 4. Other Materials Required for the Specific Change
Letter of Assurance
Manufacturer of the product hereby warranties that: contents filed with this Form and all the materials attached herewith are authentic and legitimate, with the copy thereof identical to the original, and the data in any material attached herewith is derived from research and testing on the product and complies with the requirements of the Hygienic Standard for Cosmetics. In the event of any falseness, the manufacturer agrees to assume the corresponding legal liability and all the consequences caused thereby.
Manufacturer (Seal) Legal representative (Signature)
This___ day of____, ______
Letter of Commitment
The responsible agency in China hereby solemnly represents that we understand the requirements of the Cosmetics Administrative Application and Acceptance Rules including the cosmetics administrative licence shall be applied in accordance with the provisions of the State’s applicable laws, regulations, standards and norms and the corresponding legal liability shall be held for the application materials. We have reviewed the filed contents and the materials attached herewith, promising that all the application materials we submit are authentic and legitimate, with the copy thereof identical to the original, and the data in any material attached herewith is derived from the research and testing on the product and complies with the Hygienic Standard for Cosmetics. In the event of any falseness, we agree to assume the corresponding legal liability and all the consequences caused thereby.
Responsible agency in China (Seal) Legal representative (Signature)
Dated this____ day of____, ____
Note: the Letter of Commitment is necessary where the application is made by the Responsible Agency in China
Changes Applied:
Reasons and Contents for the Change Applied (Additional page may be attached if necessary):
Form 6
Application Form for Renewal of Cosmetic Administrative Licence
Product Chinese Name _____
Prepared by the State Food and Drug Administration (SFDA)
Instructions
1. This Form can be downloaded for use from the website of the SFDA: HTTP: //WWW.SFDA.GOV.CN
2. Contents filed with this Form as well as all the application materials must be printed.
3. Contents filed with this Form must be complete, clear and free from any alternation.
4. Before filling out this Form, please carefully read the applicable laws and the rules governing the acceptance of the applications.
5. For the product category, please fill out the specific category of special-purpose cosmetics such as sun protection, hair growing, etc.
6. Each item in the Form shall be the corresponding item specified in the hygienic licence approved by the SFDA or the MOH.
7. Please submit an electronic form that conforms to its paper counterpart in data at the time of filing the application.
Product Name
Name in Chinese Language
Name in Foreign Language
Product Category
Manufacturer
Name in Chinese Language
Name in Foreign Language
Address
Country (Region)
Tel
Contact
Responsible Agency in China
Name
Address
Tel
Contact
Fax
Zip Code
Manufacturer’s Hygienic Licence No.
Validity
Until this___ day of____, ____
Original Approval Number
Validity
Until this__ day of___, ____
Letter of Assurance
Manufacturer of the product hereby warranties that: the contents filed with this Form and all the materials attached herewith are authentic and legitimate, with the copy thereof identical to the original, and the data in any material attached herewith is derived from research and testing on the product and complies with the requirements of the Hygienic Standard for Cosmetics. In the event of any falseness, the manufacturer agrees to assume the corresponding legal liability and all the consequences caused thereby.
Manufacturer (Seal) Legal representative (Signature)
This___ day of____, ______
Letter of Commitment
The responsible agency in China hereby solemnly represents that we understand the requirements of the Cosmetics Administrative Application and Acceptance Rules including the cosmetics administrative licence shall be applied in accordance with the provisions of the State’s applicable laws, regulations, standards and norms and the corresponding legal liability shall be held for the application materials. We have reviewed the filed contents and the materials attached herewith, promising that all the application materials we submit are authentic and legitimate, with the copy thereof identical to the original, and the data in any material attached herewith is derived from the research and testing on the product and complies with the Hygienic Standard for Cosmetics. In the event of any falseness, we agree to assume the corresponding legal liability and all the consequences caused thereby.
Responsible agency in China (Seal) Legal representative (Signature)
Dated this____ day of____, ____
Materials Attached (please tick √ in the □ before the materials you provide):
□ 1. Application Form for Renewal of Cosmetics Administrative Licence
□ 2. Original of the Cosmetics Administrative Licence (Instrument for Filing)
□ 2. Naming Basis of the Product’s Chinese Name ( (except for the product of which the naming basis has been furnished in the first application and the name remains unchanged);
□ 4. Product Formula
□ 5. Product Quality and Safety Control Requirements
□ 6. Package of the Product Sold in the Market (including product label and product description), in case of domestic product that has not gone on the market, Designed Product Package (including product label and product description)
□ 7. In case of domestic product, the Opinions on The Product Manufacturing, Marketing and Supervision or the Examination Opinions on Failure of the Product to Go on the Market Issued by The Provincial-Level Cosmetics Supervisory Authorities in the Place Where the Applicant is Located
□ 8. Copy of the Filed Letter of Authorization for the Responsible Agency in China and a Sealed Copy of the Said Agency’s Business Licence in case of being applied by the Agency
□ 9 A Sample of the Finished Product that Remains sealed and Other Materials that May Support the Application
Other issues needed to be clarified:
Note: the Letter of Commitment is required where the application is made by the Responsible Agency in China
Form 7
Application Form for Re-issuance of Cosmetics Administrative Licence (Instrument for Filing)
Product Chinese Name _____
Prepared by the State Food and Drug Administration (SFDA)
Instructions
1. This Form can be downloaded for use from the website of the SFDA: HTTP: //WWW.SFDA.GOV.CN
2. Contents filed with this Form as well as all the application materials must be printed.
3. Contents filed with this Form must be complete, clear and free from any alternation.
4. Before filling out this Form, please carefully read the applicable laws and the rules governing the acceptance of applications.
5. Each item in the Form shall be the corresponding item specified in the hygienic licence approved by the SFDA or the MOH.
6. Please submit an electronic form that conforms to its paper counterpart in data at the time of filing the application.
Product Name
Reason for Reissuance
□ Damaged □ Lost
Manufacturer
Name
Address
Tel
Contact
Responsible Agency in China
Name
Address
Fax
Zip Code
Tel
Contact
Manufacturer’s Hygienic Licence No.
Validity
Until this___ day of____, ____
Original Approval Number
Validity
Until this__ day of___, ____
Attached Materials:
□ 1. Application Form for Re-issuance of Cosmetics Administrative Licence (Instrument for Filing)
□ 2. Original of the Cosmetics Administrative Licence (Instrument for Filing) in case of damage
□ 3. If the application for re-issuance of the cosmetics administrative licence (instrument for filing) is filed due to loss of the same (instrument for filing), the original of the loss statement published on a provincial-level or above newspaper or magazine, and such application shall be filed on a timely basis twenty days after publication of the loss statement
□ 4. Copy of the Filed Letter of Authorization for the Responsible Agency in China and a Sealed Copy of the Said Agency’s Business Licence in case of being applied by the Agency
Letter of Assurance
Manufacturer of the product hereby warranties that: contents filed with this Form and all the materials attached herewith are authentic and legitimate, with the copy thereof identical to the original, and the data in any material attached herewith is derived from research and testing on the product and complies with the requirements of the Hygienic Standard for Cosmetics. In the event of any falseness, the manufacturer agrees to assume the corresponding legal liability and all the consequences caused thereby.
Manufacturer (Seal) Legal representative (Signature)
This___ day of____, ______
Letter of Commitment
The responsible agency in China hereby solemnly represents that we understand the requirements of the Cosmetics Administrative Application and Acceptance Rules including the cosmetics administrative licence shall be applied in accordance with the provisions of the State’s applicable laws, regulations, standards and norms and the corresponding legal liability shall be held for the application materials. We have reviewed the filed contents and the materials attached herewith, promising that all the application materials we submit are authentic and legitimate, with the copy thereof identical to the original, and the data in any material attached herewith is derived from the research and testing on the product and complies with the Hygienic Standard for Cosmetics. In the event of any falseness, we agree to assume the corresponding legal liability and all the consequences caused thereby.
Responsible agency in China (Seal) Legal representative (Signature)
Dated this____ day of____, ____
Note: the Letter of Commitment is required where the application is made by the Responsible Agency in China
Form 8
Application Form for Correction of Errors in Cosmetics Administrative Licence (Instrument for Filing)
Original Acceptance Number
Product Name
Name in Chinese Language
Name in Foreign Language
Licence (filing) Number
Name of the Manufacturer or the Responsible Agency in China
Contact
Tel
Errors in the Licence (instrument for filing):
Requirements for correction of the Licence (instrument for filing):
Seal of the Manufacturer or Signature of the Legal Representative:
the Responsible Agency in China
This___ day of____, ______
