Filing Management for Non-special Imported Cosmetics: Shanghai FDA Clarify Dossier Preparation

  •   26 Jul 2017
  •    Jo Zhou

    Take home:

    Shanghai Pudong has implemented filing management for first imported non-special use cosmetics for almost half a year (See News on CL). According to the latest data, 202 types of products have successfully filed a record (data resourced from CFDA). Although the pass rate is high, plenty of problems occurred during technical review. Therefore, Shanghai FDA has clarified dossier preparation instructions.

    Q1: How to define “imported” cosmetics for OEM companies?

    A1: For enterprises who entrust a 3rd party manufacturer to manufacture cosmetics, if the last production procedure is completed abroad, then the product is subject to imported cosmetic requirements. For example, if the product is prepared and manufactured in China but encapsulated abroad, it is an imported cosmetic.

    Q2: How to provide “testing report” for Pudong imported non-special use cosmetics filing management?

    A2: The testing report for filing management should meet the same requirement as cosmetic registration. In this situation, when recording the information, the “responsible person” should be filled out in the blank for “responsible agent” and followed by the sentence “here refers to responsible person”. If an imported non-special cosmetic has completed the testing report for registration, the report can be also be used for Pudong filing management. In this situation, if the original responsible agent for the report is different from newly designated responsible person, the applicant should provide documentary evidence to prove that the product applying for filing management is the same as the one used to obtain the testing report, and submit an acknowledgement letter from the original responsible agent to permit the use of the testing report.

    Q3: Can imported non-special children cosmetics go through Pudong filing management?

    A3: Any product complies with the definition of first imported non-special use cosmetics (in CFDA official document: translated version) can apply for filing management.

    Q4: What are basic requirements for “description of the production process” and “production diagram”?

    A4:1. All ingredients indicated in the product formula should appear in the description and the diagram, and functions of ingredients should be identical with those described in formula; 2. If there are technologies such as warming and pressuring, data detailing the exact temperature and pressure should be provided.

    Q5: If several cosmetics share an identical formula, but use different fragrance types, can they be applied as one product?

    A5: No, although the basic formula is the same, products with different fragrance or colorants should apply for separate filing management.

     

    If you want more reference to related information on fling management:

    China Releases Enforcement Rules for Filing of First Import Non-special Use Cosmetics through Shanghai Pudong;

    Shanghai FDA Release Filing Management Guidance for Importation of Non-special use Cosmetics through Pudong;

    Updated Guidance on Importing “Non-Special Use Cosmetics” Through Pudong, Shanghai;

    Practical Implementation of Cosmetic Filing in Pudong Shanghai: Several Things You May Know;

    China Release Testing Report Requirement to Support Pudong Imported Non-special Cosmetics Filing Management System

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