进口化妆品申报资料及要求(2011年英文版).doc

进口化妆品申报资料及要求(2011年英文版).docApplication dossiers for administrative licensing of imported cosmetic required by SFDA
PART ONE: Imported cosmetics classification
The imported cosmetics are divided into two major categories by SFDA: imported cosmetic for particular purpose, and imported cosmetic for non- particular purpose. The detailed description about the classification is set forth in Appendix 3.
PART TWO: Administrative licensing of imported cosmetic for particular purpose
Administrative licensing of imported cosmetic for particular purpose for the first time, the application dossiers should be provided as follows,
(1) Application form of administrative licensing of imported cosmetic for particular purpose,
(2) The reason for name of the imported products in Chinese,
(3) Product formula,
(4) Briefly description and schematics about the manufacturing processes,
(5) Requirements in quality control to ensure the safety of the product,
(6) Original packaging of the product (including the direction and the lable). In case of the product with a proprietary packaging for marketing in China, the intended packaging design (including the direction and the lable) should be provided simultaneously.
(7) The certificate of analysis and relevant dossiers issued by the inspection agency which must be recognized and accepted by SFDA, or the certificate of analysis on SPF, PFA or PA value issued by abroad laboratory,
(8) Safety evaluation date on materials that maybe exist in the finished products which have the safety risk.
(9) Application for products used in nurturing hair, bodybuilding and breast, the effective constituent and the reference literatures containing the scientific proofs should be provide,
(10) The letter of authority for the applicant in China (copy), which has been recorded by SFDA, and the business licence of the applicant in China (copy with official seal),
(11) The letter mitment that the raw material and the source of the raw material in production should meet