Cosmetics administrative licensing declaration accepting the notice required under
State Food and Drug Administration Xu [2009] 856
December 25, 2009 release
Provinces, autonomous regions and municipalities health department (bureau), Food and Drug Administration (Drug Administration), the unit:
To further standardize the administrative licensing declaration accepting cosmetic work, the Bureau developed a "declaration of acceptance of administrative licensing requirements cosmetics", is hereby issued, please comply. Problems encountered in the implementation, please timely feedback Bureau of Food License Division.
Accessories: cosmetic administrative licensing requirements for disclosure of information
State Food and Drug Administration
December 25, 2009
Declaration of acceptance of administrative licensing requirements cosmetics
The first declaration of administrative licensing to regulate cosmetics accept work, accept work to ensure that the administrative licensing declaration of openness, fairness, justice, the enactment of this provision.
Article cosmetics cosmetics new administrative licensing refers to the use of raw materials, domestic special purpose imported cosmetics and cosmetics for the first time such approvals.
This Article shall apply to "cosmetics Health Supervision" and its implementing regulations permit the executive to declare acceptance of cosmetic work.
Fourth of the State Food and Drug Administration is responsible for administrative licensing declaration accepting cosmetic management.
Article applicant for administrative license shall be made cosmetics cosmetics manufacturers. China-made cosmetics, new materials should be the administrative license applicant or cosmetic manufacturer cosmetic raw material manufacturer.
Imported cosmetics administrative license applicant must be imported cosmetics manufacturers. New raw materials imported cosmetics administrative license applicant must be imported cosmetics raw materials to produce a new business or cosmetics manufacturers. The applicant should be entrusted to the same a legally registered in China, and has independent legal personality of the reporting unit as the responsible units in China, responsible for the agency to declare the matter. The applicant can change the declaration of the responsible units in China.
Article 6 The applicant and the responsible units reporting in China shall, in accordance with relevant state laws, regulations, standards and specifications to declare cosmetics administrative licensing, responsible for reporting information and bear the corresponding legal responsibility.
Article 7 The applicant shall provide the State Food and Drug Administration cosmetic applications for administrative license, in accordance with the requirements to submit relevant information.
Article VIII for the first time to declare before the administrative licensing unit in China reporting responsibilities original power of attorney at the national Food and Drug Administration accepted the executive agency (hereinafter referred to as receiving institutions) for the record.
Administrative license applicants to declare cosmetics, should log the State Food and Drug Administration cosmetic administrative license online reporting system, and fill out the cosmetics administrative licensing application form.
Article IX cosmetics administrative permit approval document (filing certificate) is valid for four years.
Cosmetics executive applicant for extension of Permit Document (record certificate) is valid, it should be in the cosmetics executive Permit Document (record certificate) before the expiration of four months to apply.
Administrative permit approval document for a replacement cosmetics (for the record evidence) and not within the prescribed time limit extension application should be receiving a replacement cosmetics administrative permit approval document (record certificate) within 15 days after the filing of a continuation application, but the reissue application should be in the cosmetics executive Permit Document (record certificate) before the expiration of four months.
Article cosmetics executive applicant Permit Document (document filing) apply for permission to change the life of the matter shall be in accordance with the requirements of the application and submit relevant information. Formula may involve cosmetic changes or other changes to security, should be restated under the new product. Change after using the original name, logo on the product packaging should be marked to distinguish them from pre-change product.
Article XI cosmetics administrative permit approval document (record certificate) damaged or lost, a replacement shall promptly make application, but may not make application for renewal or change.
Article XII of the State Food and Drug Administration received the cosmetic administrative permit approval document issued (for the record evidence), the following circumstances, the correction should be made one-time application:
(A) the cosmetics executive Permit Document (record certificate) printing errors;
(B) cosmetic administrative permit approval document (record certificate) number error;
(C) cosmetics administrative permit approval document (record certificate) in relation to other errors.
Range of error correction required by this section does not include the applicant to declare an error.
Article XIII, one of the following conditions are met, the applicant can re-declare the same product name:
(A) is not within the prescribed time limit continues to apply cosmetics administrative permit approval document (filing certificate) validity;
(B) Termination of declaration declared again;
(C) initiative to apply for cancellation of the original cosmetic administrative permit approval document (record certificates);
(D) shall not be declared again after the administrative license.
Because it contains prohibited substances, restricted substances in excessive or substandard health and safety of the test results and other reasons related to product safety has not been approved product, not again declare.
Article XIV commissioned the production of cross-border production enterprises (including packing) cosmetics, and its last contact with the contents of the process completed in the territory declared by the domestic product, finished outside the declaration of the imported products.
Administrative permit this document has been cosmetic (for the record certificates) after cross-border trust relationships change, the change should be re-declaration of production site requirements.
Article XV two or two or more must be used in conjunction with the product, a product should be declared. By the domestic and foreign products of different manufacturers as part of the production, and declarations were made and imported products according to relevant provisions provided. Declaration should indicate the product of its products by domestic or imported products to declare. In the cosmetics executive Permit Document (record certificate) should be separately stated in remarks column in the domestic formulations and dosage forms of the name of the import, production companies and the actual production of address.
Article XVI accepted the administrative licensing agencies in receiving claims data cosmetics, the applicant should be issued "a single sign for disclosure of information", the form of review of claims data, and within five working days to decide whether to accept or make corrections.
Reporting information is available, to meet the requirements, receiving institutions should be made to accept the decision and issue a "notice of acceptance." Does not meet the requirements, accepting institution shall issue a "notice of correction for disclosure of information," one told the applicant to be supplemented in its entirety. Fails to do so, since the date of receipt of declarations shall be accepted. The correction is still not meet the requirements for disclosure of information, the receiving agency may require to continue to make corrections.
Article XVII of the following circumstances, the appellate body shall make a decision of rejection, and issue a "refusal notice":
(A) shall not apply for the matter to obtain an administrative license;
(B) for matters not within the State Food and Drug Administration administrative licensing terms of reference;
(C) In addition to the provisions of Article IX of the cases, exceeding the prescribed period make continuation of application;
(D) the range of other applications are not accepted.
Article 18 The appellate body issued a "notice of acceptance," "Notice of corrections for disclosure of information", "refusal notice" shall specify the date issued, and stamped with the State Food and Drug Administration received special seal of the administrative licensing . Notice in duplicate, a cross-applicant, an archive.
Article 19 The disclosure of information received, the applicant based on review comments to add, modify reporting information should be submitted directly to the State Food and Drug Administration review body. Agent declared, should have been filed with the administrative license in China, power of attorney to declare a copy of the responsible units. For additional information should review comments, all at once submitted, additional information and indicate the date, unit and official seal. Additional information may also change the review comments are not involved in the claims data and other content.
Diershitiao applicant to the State Food and Drug Administration report submitted to the administrative licensing information, the State Food and Drug Administration before the decision on admissibility, written application may terminate the declaration and recover the full disclosure of information. Has been accepted, the applicant in the technical review comments prior to making a written request to withdraw application for administrative license may be required to return all the information. Applicant received a "non-administrative licensing decision" or "not extend / change the decision" within 6 months, may request in writing to return the following information:
(A) the product in the producing country (region) to allow the production and sales documents, cosmetics business documents and good manufacturing practice certificate, but the number of products at the same time to declare and use the same except for the original documents;
(B) within the validity period of the former cosmetics executive Permit Document (record certificate);
(C) the continuation of the declaration submitted information.
Article 21 The State Food and Drug Administration shall, within sixty days from the date of acceptance, the organization submitted its report to the applicant that may exist in the product material safety risk assessment of the safety review of the information.
Article 22 The responsibility of the applicant and the reporting unit in China to provide information and samples of false declaration, the State Food and Drug Administration based on "PRC Administrative Licensing Law," the provisions of Article 78, on the application inadmissible or not to permit, the applicant and the reporting responsibilities of units in China to give a warning, and will not be accepted within one year of the administrative license.
Article 23 The State Food and Drug Administration responsible for the interpretation.
Article 24 These Regulations shall April 1, 2010 shall come into force. Previously released cosmetic health declaration accepting the administrative licensing requirements and inconsistent with the provisions of this order to the latter shall prevail.
Attachment:
Cosmetics administrative licensing requirements for disclosure of information
The first cosmetic application of administrative licensing shall be in accordance with "cosmetic declaration accepting the administrative licensing requirements," the request for information, general requirements for disclosure of information is as follows:
(A) for the first time to apply for special use cosmetics administrative license, submit one original copy, four copies, with original copies should be clear and consistent;
(B) for the record, continuation, change, replacement of documents relating to, submit the original one;
(C) In addition to inspection reports, notary documents, official documents and third-party documents, the information submitted by the applicant by the original page with official seal or Jifeng Zhang;
(D) the use of A4 size paper to print, use the clear distinguishing mark, according to the provisions of the order, and bound into books;
(E) the use of Chinese legal units of measurement;
(Vi) to declare the content should be complete, clear, complete the same project should be consistent;
(7) All foreign language (foreign address, website, registered trademarks, patents, names, SPF, PFA, or PA, UVA, UVB and other foreign languages must be excluded) should be translated into standard Chinese and foreign language translation attached to the corresponding data before;
(H) product formulations should be submitted text and electronic versions;
(Ix) the text version and electronic version of the complete content should be consistent.
The second application for special use cosmetics made an administrative license shall submit the following information:
(A) made special use cosmetics administrative license application form;
(B) the name based on the product name;
(C) product quality and safety control requirements;
(D) packaging design (including product labels, product brochures);
(E) by the State Food and Drug Administration identified the license inspection agency issued the inspection report and related information;
(F) products may be security risks with the safety assessment of material information;
(G) the provincial food and drug administration issued an audit opinion on the production of sanitary conditions;
(H) Application of Hair, body, breast products, the effect of composition and its use should be submitted based on the scientific literature;
(IX) may help to administrative licensing and other information.
Attached provincial food and drug administration sealed and unsealed samples one does not.
Third application for special use cosmetics import license administration shall submit the following information:
(A) special purpose imported cosmetics administrative license application form;
(B) the Chinese name of the product name basis;
(C) product formulation;
(D) of the production process description and diagram;
(5) Product quality and safety control requirements;
(F) products of the original packaging (including product labels, product instructions); to be designed specifically for the Chinese market, packaging, product design and packaging to be submitted at the same time (including product labels, product brochures);
(G) by the State Food and Drug Administration identified the license inspection agency issued the inspection report and related information;
(H) the product may be security risks with the safety assessment of material information;
(Ix) Application of Hair, body, breast products, the effect of composition and its use should be submitted based on the scientific literature;
(X) has filed administrative licensing unit in China reporting responsibilities and powers of attorney a copy of their reporting responsibilities on the administrative licensing unit in China business license and official seal;
(Xi) use of raw materials and cosmetic raw materials meet the high risk of BSE infected material requirements of the Restriction of the undertaking;
(Xii) product in the producing country (region) or country of origin (region) production and sales documents;
(XIII) may contribute to the administrative licensing and other information.
Attached permit inspection agency did not break the seal of the commercial seal-like sample 1.
Article apply to import non-special use cosmetics for the record, should submit the following information:
(A) imports of non-special use cosmetics administrative license application form;
(B) the Chinese name of the product name basis;
(C) product formulation;
(D) Product quality and safety control requirements;
(E) products of the original packaging (including product labels, product instructions); to be designed specifically for the Chinese market, packaging, product design and packaging to be submitted at the same time (including product labels, product brochures);
(F) by the State Food and Drug Administration identified the license inspection agency issued the inspection report and related information;
(G) products may be security risks with the safety assessment of substances in materials;
(H) has filed administrative licensing unit in China reporting responsibilities and powers of attorney a copy of their reporting responsibilities on the administrative licensing unit in China business license and official seal;
(I) cosmetic raw materials and raw materials in line with the high risk of BSE infected material requirements of the Restriction Undertaking;
(J) products in the producing country (region) or country of origin (region) production and sales documents;
(K) may help record other information.
Attached permit inspection agency did not break the seal of the commercial seal-like sample 1.
Article administrative license application for new cosmetic ingredients, and should submit the following information:
(A) the new cosmetic raw materials, administrative license application form;
(B) development report
1. Materials research and development background, process and related technical information;
2. Source of raw materials, physical and chemical properties, chemical structure, molecular formula, molecular weight;
3. Raw materials used in cosmetics purposes, basis, scope and use of limited.
(C) the production process description and diagram;
(D) raw material quality and safety control requirements, including specifications, test methods, there may be a security risk substances and their control;
(E) toxicological safety assessment, including raw materials, there may be security risks in the safety assessment of material information;
(F) reporting agency, shall be submitted to the administrative licensing has been filed to declare the responsible units in China, power of attorney a copy of the administrative licensing and reporting responsibilities in China, a copy of business license and official seal;
(G) may contribute to the administrative licensing and other information.
Attached a sample sent for screening.
Article reporting products are the following circumstances, in addition to the above requirements to submit information, should also submit the following information separately:
(A) declare the product produced by processing the commission shall submit the following information:
1. The commissioning party and the commission signed by the commissioning party processing agreement;
2. Imported products should be submitted to be commissioned by producers of quality management system or good manufacturing practice certificate or meet the manufacturer country (region) regulatory requirements for cosmetics production qualification documents;
3. Foreign manufacturers commissioned the production of domestic-made products in China should also declare the administrative licensing unit responsible for the record, submitted to the administrative licensing unit of power of attorney in China reporting responsibilities;
4. Domestic producers outside the company commissioned the production of imported products in China may submit their reporting responsibilities on the administrative licensing unit of power of attorney, production and sale of original documents and product packaging, product packaging design should be submitted.
(B) the actual manufacturer and cosmetics manufacturer (applicant) belong to the same group of companies, should be submitted to the actual manufacturer and cosmetics manufacturer (applicant) belong to the same group of companies and business groups supporting documents issued by the company's product quality assurance documents .
Article number of the actual production company producing the same product can also make a declaration, one of the actual manufacturer of these products should be provided all the information submitted, in addition, shall submit the following information:
(A) the commission involving the relationship between production and processing, production and processing agreement submitted to commission, commissioned by imported products should also be submitted by the production quality management system or good manufacturing practice certificate or meet the manufacturer country (region) regulatory requirements for cosmetics production qualification documents;
(B) the manufacturer of the same group of companies, manufacturing enterprises are submitted to the same group of companies and enterprise groups supporting documents issued by the product quality assurance documentation;
(C) the actual production of production of other products of the original packaging, packaging design of domestic products can be submitted;
(D) the actual producers of other products, hygiene (microbiological, chemical health) inspection reports;
(E) domestic product, should be submitted to the actual producers of other provincial food and drug administration issued an audit opinion on the production of sanitary conditions;
(Vi) imported products, should be submitted to the actual producers of other raw materials and cosmetic raw materials used meet the high risk of BSE infected material requirements of the Restriction Undertaking.
Article VIII of the termination of the applicant to declare or not declare the administrative re-licensed products, it shall re-apply and submit claims data. Again after the declaration of the termination declaration, should be declared and again declare the termination reason; not return again after the administrative licensing should not be submitted to the administrative licensing (change / extension) a copy of the written decision and explain the reasons for re-declare .
Non-administrative licensing reasons not related to product safety, can be used to re-declare a copy of the original inspection report, made special use cosmetics, health conditions can also be produced using the original copy of the audit opinion, but the original has been returned to the applicant for disclosure of information except .
Article IX administrative license renewal application (filing) period, shall submit the following information:
(A) the administrative license renewal application form cosmetics;
(B) cosmetic administrative permit approval document (record certificate) original;
(C) the product name based on the Chinese name (first report has been submitted and no change, except the product name);
(D) product formulation;
(5) Product quality and safety control requirements;
(F) commercial product packaging (including product labels, product instructions), without domestic product market, product design and packaging can be submitted (including product labels, product brochures);
(Vii) domestic product, the applicant should submit the provincial food and drug administration issued on production, market, opinion or product is not listed supervise the audit opinion;
(H) reporting agency, shall be submitted to the administrative licensing has been filed to declare the responsible units in China, power of attorney a copy, and reporting responsibilities of the administrative licensing unit in China business license and official seal;
(IX) may help to administrative licensing and other information.
Unopened attach a commercially available product.
Article apply to change the administrative licensing matters, should submit the following information:
(A) cosmetic changes to the administrative licensing application form;
(B) cosmetic administrative permit approval document (record certificate) original;
(C) the agency declared, should be submitted to the administrative licensing has been filed to declare the responsible units in China, power of attorney and copy of business license and official seal;
(D) According to submit an application to change the contents of the following information:
1. Product name change:
(1) Application to change the Chinese name of the product should be reasons to change the application form and submit the proposed name change of the Chinese name of the product based on the proposed changes to product design and packaging (including product labels, product instructions); imported products may not foreign names change;
(2) An application to change sunscreen SPF, PFA or PA, it shall submit the appropriate SPF, PFA or PA inspection reports, and submit proposed changes to the design of packaging products (including product labels, product instructions).
2. Manufacturer name, address change (including self-change or merger and acquisition):
(1) domestic production business name or address changes should be submitted to the local industrial and commercial administration department issued the original documents or notarized copies of manufacturer health permit;
(2) the imported product manufacturer name or address changes should be submitted to the government department in charge of production or the agency issued the relevant documents, which, due to inter-firm acquisitions, mergers and the proposed legal changes to name of manufacturer, and may also be submitted to both sides acquisition or merger contract signed copies of documents to be translated into standard Chinese, the Chinese Chinese translation should be notarized notary public;
(3) within the group of domestic enterprises to adjust, and should be submitted to the administrative department for industry and commerce issued by the relevant supporting documents; involving Taiwan, Hong Kong-invested enterprises or foreign-invested enterprises, can submit a notarized "PRC foreign investment enterprise approval certificate" or "People's Republic of Taiwan, Hong Kong overseas investment enterprise approval certificate," a copy;
(4) involves changing the production site, the proposed changes should be submitted to the production company's hygiene products (microbial, chemical health) inspection reports; for domestic products, should also submit the proposed changes to the production enterprises at the provincial level food and drug administration issued by the audit opinion on the production health conditions.
3. Chinese imports of the product manufacturer name change (the name of the same foreign language):
(1) Chinese manufacturers to change the name of reason;
(2) is intended to change product design packaging (including product labels, product instructions).
4. Responsibility of the administrative licensing unit in China reporting changes:
(1) to submit proposed changes to the administrative licensing unit in China reporting responsibilities original power of attorney for the record;
(2) to be changed reporting responsibility for the administrative licensing unit in China a copy of power of attorney;
(3) The responsibility of the administrative licensing unit in China reporting the name or address changes should be submitted to the local industry and commerce administration department of the change issued by the original documents or notarized copies;
(4) The manufacturer issued by the administrative license revocation of the original declaration of the responsible units in the case of China and by the notary public note.
5. Actual manufacturer of the changes:
(1) The commission involved the relationship between production and processing, production and processing agreement submitted to commission, commissioned by imported products should also be submitted by the production quality management system or good manufacturing practice certificate or meet the manufacturer country (region) regulatory requirements for cosmetics production qualification documents;
(2) producers of the same group of companies, manufacturing enterprises are submitted to the same group of companies and business groups supporting documents issued by the company's product quality assurance documentation;
(3) The proposed changes to the actual manufacturer of the products original packaging;
(4) is intended to change the actual production of production of hygiene products (microbial, chemical health) inspection reports;
(5) domestic product, should also submit the proposed changes to the actual manufacturer of the provincial food and drug administration issued an audit opinion on the production of sanitary conditions;
(6), imported products, should be submitted to the actual production of products used in the production of raw materials and raw materials in line with a high risk of BSE infected material requirements of the Restriction of the undertaking.
6. Change the special use cosmetics categories, each category shall submit the appropriate information required.
7. Apply for other changes, should detail the reasons and submit the relevant documents.
Administrative permit approval document for the replacement of Article XI (for the record certificates) should submit the following information:
(A) the cosmetics executive Permit Document (record certificate) replacement application form;
(B) the administrative permit approval document (record certificate) apply for a replacement of damaged, shall be submitted to the administrative licensing documents issued cosmetics (for the record certificate) original;
(C) the administrative permit approval document (record certificate) apply for a replacement of lost, should be submitted to the provincial level above (including provincial) newspaper published in the original statement of loss, loss reissue application should be lost in a statement published after the date of the timely submission of 20 ;
(D) reporting agency, shall be submitted to the administrative licensing has been filed to declare the responsible units in China, power of attorney a copy, and reporting responsibilities of the administrative licensing unit in China business license and official seal.
Article 12 Applications for Administrative Permit Document (record certificate) error correction, should submit the following information:
(A) the cosmetics executive Permit Document (record certificate) correction application form;
(B) signed by the applicant's cosmetics administrative permit approval document (record certificate) copy;
(C) cosmetics administrative permit approval document (record certificate) to receive the new documents issued in the original (record certificate) to return.
Article XIII of the State Food and Drug Administration to review agency for additional information, should submit the following information:
(A) the notice of review comments;
(B) the review comments, ask questions in order of additional information.
Article XIV product formulation data should meet the following requirements:
(A) should be in table form is provided in a table contains the same number of raw materials, raw materials INCI name (the name of the international cosmetics raw materials) (domestic products), the standard Chinese name, percentage content, purpose, etc. using the formula sheet, size is not small for small V Arial;
(B) all raw materials should be provided the name of the actual content in percentage, and indicate the effective content (unspecified caught in an effective matter content 100%); compound to compound in the form of raw materials must be declared, and should indicate in which the content of each component (in percentage); special circumstances, such as those containing crystal water, raw materials, there are different formula or structure type, and so should be described, all materials in descending order according to content;
(C) the formulation of raw materials (including compound ingredients in each component) of the Chinese name should be "international standard Chinese name cosmetics raw materials directory" using a standard Chinese name, no INCI name or included in the "International Chinese name of the directory standard cosmetic ingredients "should be used" Chinese Pharmacopoeia "in the chemical name or plant name or Latin name, trade name or common name not be used, but except for compound materials;
(D) coloring agent should provide a "Hygienic Standard for Cosmetics" on the coloring agent contained in the index number (referred to as CI No.), except no CI number;
(E) containing animal tissues and extracts of blood products, should be submitted to the source of raw materials, quality specifications and allows the use of raw materials to produce proof of the country;
(F) Where the use of the product formulations derived from petroleum, coal tar hydrocarbons (except for a single component), should be indicated in the product formulation of the Chemical Abstracts index of raw materials (referred to as CAS number);
(G) "Hygienic Standard for Cosmetics" on the restricted substances in raw materials specifications, and should be submitted by the manufacturers of raw materials issued by the proof of the quality specifications of raw materials;
(H) packing group with the multi-dose products (such as hair, perm class), or exist in the same package can not split the contents of a combination of different formulations of the product should be listed separately each part of the formula;
(Ix) permit inspection agency for import of formulations of the confirmation of their test samples to confirm the date of acceptance should be the same date;
(J) Where the claim for pregnant women, lactating women, children or infants of the product, safety considerations should be based formula design principles (including the overall analysis formula), the choice of the principles and requirements of raw materials, production processes, quality control, etc. content information.
Article XV of the product may exist in the security risk assessment material safety data should be based on cosmetic features make use of raw materials and products, and include the following:
(A) the product may exist and have the name of security risk substances (including raw materials into the production of substances generated in the process), the relevant test methods and test data;
(B) for products in the security risk may exist material safety risk assessment report;
(C) the existing technical conditions, the product can reduce the security risk that may exist in the material content of the technical information necessary, to process improvement initiatives;
(D) plant sources of raw materials should be submitted may contain pesticide residues and other contaminants into the processing or extraction of the impurity.
Article XVI product quality and safety control requirements should include the following:
(A) the color, odor, character and other sensory indicators;
(B) microbial indicators (except without testing), chemical health indicators;
(C) the perm type, hair type, freckle-containing products and claims, though not of α-hydroxy acid or α-hydroxy acid containing claims, but the total amount of ≥ 3% (w / w) of the product should have a pH value indicator ( water in oil (oil-like product), powder, powder type, wax-based classes) and their detection methods;
(D) of imported products, should be submitted to the implementation of the country of origin of product quality and safety control requirements (foreign language version and Chinese translation). Implementation of country of origin product quality and safety control requirements in the non-paragraphs (a), (b), (c) the content, should be submitted simultaneously with the corresponding indicator of product quality and safety control requirements information;
(E) The applicant shall submit the product line, "Hygienic Standard for Cosmetics" requires commitment.
Article XVII of domestic special cosmetics production hygiene audit opinion shall include the following information:
(A) cosmetics hygiene audit application form;
(B) the cosmetic product sanitation audit form;
(C) product formulation;
(D) of the production process description and diagram;
(E) production equipment list;
(F) a copy of health permit producers.
Article 18 The State Food and Drug Administration identified the license inspection agency issued the inspection report and related materials shall meet the following requirements:
(A) licensing inspection reports, including cosmetics, health and safety tests (microbiological, chemical hygiene, toxicology) reports and human safety inspection report, which subjects the sample for the same product name, the same production date / batch number of products;
(B) the use of outside laboratories issued by the SPF (SPF, PFA or PA) or a new material inspection reports, and shall submit the following information:
1. The lab report has been issued by accredited laboratories, should be submitted to qualification certificate;
2. The lab report has not been issued by accredited laboratories, the laboratory should be submitted strictly follow the "Good Clinical Practice" (Good Clinical Practice, GCP) or "good laboratory practice" (Good Laboratory Practice, GLP) certificate;
3. Other help to explain the laboratory qualification information.
Where for the first time outside the inspection reports submitted, shall submit the original or information issued by a laboratory report where the country (region) Industry Association, China to make (consulate), notary approved copy of the confirmation (with translation ), the State Food and Drug Administration approved, again, simply submit a copy of the declaration.
Outside the original laboratory report should be submitted, sampling products meet the requirements, submit at least one of the original product, other products may submit a copy of the declaration and description of where the original product name.
Use outside the laboratory test report issued by, the laboratory should be submitted simultaneously issued by the relevant inspection reports and test samples corresponding to the relationship between documents.
(3) to authorize inspection agency issued the inspection report should include the following information:
1. Examination application form;
2. Notice of acceptance testing;
3. Product description;
4. Health and safety inspection reports (microbiological, chemical hygiene, toxicology);
5. If the following information should be submitted to:
(1) human safety inspection report (skin patch, human trial);
(2) SPF SPF, PFA or PA inspection reports;
(3) Other new projects test report (such as cosmetics in the asbestos testing reports, etc.).
Article 19 of the cosmetic use of raw materials and raw materials in line with a high risk of BSE infected material requirements of the Restriction of the relevant provisions of the undertaking shall be issued.
Diershitiao imported products are submitted to the original packaging and foreign original Chinese translation, and in line with relevant Chinese laws and regulations of the Chinese label products (including product data sheet).
Twenty-one producing country (region) the production and sale of documents shall meet the following requirements:
(A) by the producing country or country of origin (regional) government authorities or industry associations issued. Can not submit original documents, and may submit a copy of a copy shall be issued by the institution or country that (consulate) to confirm;
(B) shall contain the product name, manufacturer name, issued by the file name of the institution and an institution seal or the legal representative (or authorized) signature and document issuance date;
(C) set forth in the product name and manufacturer name should be exactly as declared; such as processed or otherwise produce, the documents set forth in the manufacturers declared to be inconsistent with the time, should be description of the applicant to be issued documents; be used in conjunction with the multi-dose products can be submitted only imports some of the production and sale of documents;
(D) the production and sale of documents such as a foreign language should be translated into standard Chinese, Chinese translation by Chinese notary public.
Article 22 was commissioned by producers of quality management system or good manufacturing practice certificate or meet the manufacturer country (region) regulatory requirements for cosmetics production qualification documents must meet the following requirements:
(A) issued by the certification or accreditation agencies or third parties. Can not submit the original, may submit a copy of a copy notarized by a notary public or by the Chinese to make our country (consulate) to confirm;
(B) set forth in the manufacturer name and address should be exactly as declared.
Article 23 The import of cosmetics in China and reporting responsibilities of administrative licensing unit of power of attorney shall meet the following requirements:
(A) the authorization by the administrative licensing and cosmetics manufacturers in China to sign joint declaration of the responsible units (cosmetics manufacturers responsible for the signature or seal may, reporting responsibilities of administrative licensing unit in China signed and stamped by the legal representative of the ) and by the notary public; power of attorney as a foreign language, should be translated into Chinese, and Chinese translations notarized;
(B) the power of attorney should include the following: the name of authority, reporting responsibilities on the administrative licensing unit in China, the name of authorization is valid (at least four years), the range of licensed product, license rights, etc.; mandate entrusted to the administrative licensing authority should be included in China reporting agency to declare the responsible units, can also include representatives of cosmetics manufacturers to confirm information submitted under seal;
(C) the original power of attorney should be submitted (including the Chinese translation) records.
Article 24 The production and sale documents, the quality management system or proof of good manufacturing practice, manufacturers in different countries belong to a group of proven, processing agreements and other documents may also states that more than one product. These products, such as the same time declare a product to the original documents, copies of other products available, and to declare in writing where the original product name; these products, if not simultaneously declare a product to the original documents, and other products to be used after a copy of a notarized and to declare in writing where the original product name.
Article 25 The provincial food and drug supervision and management department or agency letters kind of permission to trial test sample, the sample should be with the submission name, production date / batch number (or shelf life / restricted period), the same inspection acceptance number The complete package samples package should contain the product manual. Because of their size too small (such as lipstick, lip balm, etc.) and no description of the contents of the product manual or printed on the product container should be some disclosure of information submitted in the product packaging for instructions. Samples imported Chinese products on the packaging shall bear the name of the label, identification may not cover all the foreign language. Domestic production and processing enterprises overseas enterprises entrusted to import samples, submit to trial by domestic product samples.
Article 26 of the following types of samples should be packaged to declare the following provisions:
According to many formulations are mixed with the actual situation, to submit inspection reports or mixed formulations were submitted to their inspection reports.
Each product dossier should be accompanied by a list of products, basic recipes and a list of colorants and sampling the product list.
Each product dossier should be accompanied by a list of products, basic recipes and a list of colorants and sampling the product list.
Schedule:
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