State Food and Drug Administration Xu [2010] 397
September 30, 2010 release
Provinces, autonomous regions and municipalities Food and Drug Administration (SDA):
To further strengthen the administrative licensing declaration accepting cosmetic work, strictly regulate the acceptance review of the administrative licensing requirements of cosmetics, is to perform "cosmetic declaration of acceptance of administrative licensing requirements" (State Food and Drug Administration promised 〔2009〕 856) (hereinafter referred to as "accepted rule") matters related to the process of further clarified as follows:
First, reporting on the admissibility of cosmetic related to the administrative licensing matters
(A) The application for modification, correction and other relevant requirements. The applicant shall continue to apply for, change, replacement, error correction and other matters, to complete an application in the matter, may apply for other matters. Applications for changes to the administrative licensing matters, can apply changes to multiple items.
For application for modification, correction cosmetics administrative permit this document (the record evidence) and not in the "accepted rule" renewal application within the prescribed time limit, it shall receive changes, cosmetic correction of administrative licensing approval document (record certificate) within 15 days after the filing of a continuation application, but the change, correction of the cosmetic application for administrative license shall be in the documents of approval (for the record certificates) 4 months before the expiration.
(B) to apply to return information about the time the requirements. The applicant received a "no decision of administrative licensing" or "non-renewal / change of administrative licensing decision," the date of 6 months can be written to the State Food and Drug Administration review of the bodies returned data applications.
(C) of the time the request for additional information. The applicant received a notice of extension of the technical review of administrative license, it should be specified in the notice to submit additional information on time limits for additional information. On overdue and should not be permitted to make a decision.
Second, the requirements for disclosure of information on matters related to
(A) of the administrative license on the new ingredients of cosmetics such information requirements. First application of new cosmetic ingredients administrative license shall submit 1 original dossier, a copy of 4 copies with the original copy should be clear and consistent.
(B) reporting on the cosmetic agent documents of approval of administrative licensing (for the record certificates) error correction information request. Except in accordance with "accepted rule" for disclosure of information on request, shall be submitted to the administrative licensing has been filed in China, a copy of authorization to declare the responsible units, and reporting responsibilities of the administrative licensing unit in China stamped copy of business license.
(C) on the inspection reports and other relevant requirements. Talc-based products containing the first report not submitted when the asbestos inspection report, when applying for renewal shall be submitted to meet the "administrative license cosmetics testing management practices" (State Food and Drug Administration promised 〔2010〕 82) Asbestos inspection required report.
Outside the laboratory test report issued by the sample has been clear for inspection and test reports of the parts (such as inspection reports issued outside the laboratory has indicated the product name, product name and the name of the same sample with the inspection), do not need to be inspection reports issued by the corresponding sample and test the relationship between documents.
Administrative license application for change of cosmetics manufacturer in the inspection report the name, address of manufacturer, product name in Chinese, the relevant license issued by the appropriate inspection agencies should complement each inspection report and the reasons. Inspection reports prior to the change management department of the provincial food and drug products issued an audit opinion on health conditions, as well as production, market, supervision submissions or products listed on the audit opinion is not valid.
(D) the same manufacturer to declare two or more than 2 special use cosmetics made administrative permit this document, the provincial food and drug administration department shall be issued separately for each product audit opinion hygiene products, or production, market, supervision submissions or products not listed on the audit opinion.
(E) the same manufacturer reported two or more than 2 of the original packaging and foreign names are the same, but different morphology of imported products, should be in the application form and supporting documents production and sales increase of foreign names in the form of words that appearance of the product to show difference, along with instructions.
(Vi) no administrative license on again after the declaration of the information requirements. No administrative license again after the declaration, except in accordance with "accepted rule" required to declare relevant information should be submitted to the administrative licensing reasons not related to product safety is a written description.
(G) reporting responsibilities of administrative licensing unit in China should be imported cosmetics manufacturer authorization or import of new raw materials of cosmetics or the legal representative of the legal representative of the manufacturer's authorized signatory signature or official seal cover manufacturer.
Guarantee administrative permit application form should be imported cosmetics production enterprises or imported raw materials of cosmetics companies new legal representative or authorized signatory of the manufacturer or its authorized units in China and reporting responsibilities signatory signature; no official seal, should be manufacturing enterprises in the bond to be signed at the state.
Undertaking the administrative licensing application by the reporting responsibilities of the administrative licensing unit in China, the legal representative or legal representative of the authorized signatory of the unit signed and stamped declaration of responsibility for the administrative license in China, the official seal.
Power of Attorney signed, notarized power of attorney should be provided and its Chinese translation, Chinese translation, and to do the same with the original notary. According to "cosmetics administrative license requirements for disclosure of information" requirements of the twenty-four in each application should be submitted to the administrative licensing power of attorney and submit original or certified copy, and original power of attorney signed a written statement in which commissioned the report product name. Power of Attorney signed by the contents of the report should not be included in the responsible unit in China authorization.
In addition to inspection reports, notarial documents, official documents and third party documents, the administrative licensing deal in China, imported cosmetics unit reporting responsibilities (new material) the original by-page dossier stamped reporting responsibilities of the administrative license in China, the official seal or Jifeng.
(H) due to domestic enterprises (groups) to restructure and change the administrative licensing application, except in accordance with "accepted rule" requires the application of modification to submit declarations, it should to the State Food and Drug Administration issued by the administration for industry and commerce the relevant supporting documents, before and after restructuring enterprises (groups) of the Constitution and other related documents.
(I) due to objective reasons (not the applicant is for change, replacement, correction of administrative licensing matters) can not make an application within the prescribed time limit administrative license renewal documents of approval of cosmetics (for the record certificate) is valid, the applicant should be in the cosmetics executive Permit Document (record certificates) before the expiration of 4 months (except force majeure), the State Food and Drug Administration to submit a written application, and explain the reasons and delayed the time to apply for renewal by the State Food and Drug Administration approval to Application for renewal only after delay.
(X) for reporting responsibilities in China, when the unit power of attorney for the record, in addition to submission of the relevant provisions of the relevant documents, should also submit their reporting responsibilities in China, a copy of business license. Power of attorney in China reporting the contents of the responsible units shall meet the "administrative license cosmetic requirements for disclosure of information" requirements of Article three, it should also indicate the manufacturer and reporting responsibilities in China, Address information. Production should be imported cosmetics business address (new material) in the corresponding administrative licensing application form consistent, responsible reporting in China, with business units address should be the same as the corresponding license, the production company should address the authenticity of the information and address information related to reporting data consistency responsible.
(K) for the first time did not submit the declaration of security risks there may be material information concerning the product safety assessment, when applying for renewal shall submit the following relevant information:
1. Hazard identification by the applicant to determine the products that contain possible security risk materials should be submitted to the appropriate undertaking. April 1, 2011, the undertaking can not contain the product of hazard identification process and the product does not contain security risks that may exist in such material reasons.
2. Hazard identification by the applicant to determine the products contain possible security risk substances should be in accordance with the "safety of cosmetics that may exist in the risk assessment guidelines of risk material" requirements, the information submitted to the appropriate risk assessment.