China Releases Exact Procedures for Filing Management of First Import Non-special Use Cosmetics through Shanghai Pudong

CFDA has announced a pilot implementation rule that from Mar.1st 2017 to Dec.21st 2018  the international companies can comply with filing management instead of registration when importing non-special cosmetics through Shanghai Pudong New District for the first time (see news on CL). Following the announcement, CFDA released exact procedures on Jan 18th 2017 to guide international companies how to file a record with FDA.

General process is:

Most Important Stipulations

1. Local authorized responsible person

To import non-special use cosmetics through the Pudong New District importation channel, foreign manufacturers should authorize a responsible person located in the Pudong District. The local responsible person is fully empowered to deal with filing management and take care of product importation and operation on behalf of international companies. The responsible person is also responsible for product safety and quality. Each individual product should have a single designated responsible person.

REACH24H interpretation:

It is the first time that China has implemented the designation "responsible person" which deviates from "responsible agent" in terms of practical responsibilities and definition. In comparison with "responsible agent", "responsible person" will shoulder the responsibility of controlling product quality and safety and coordinating with local FDA during the product compliance review process. The "responsible person" should have knowledge of chemistry, competence understanding product safety/risk, and be acquainted with domestic distribution channels.

2. User registration and the online filing system

Foreign manufacturers should provide a notarized authorization certificate to designate the local responsible person. The certificate should be translated into Chinese and should also be notarized. Then the local responsible person will submit a stamped and signed application form and business license. These three documents should be submitted online as well as submitted to Shanghai FDA in paper format, after which the Shanghai FDA will provide an account and a login password to the online filing system.

3. Product filing

Documentation should be submitted online and in paper format to Shanghai FDA by the local responsible person.

Documents required include:

1) Application form of imported non-special use cosmetics (fill out online);

2) Chinese product name and basis of nomenclature (fill out online);

3) Product formula (fill out online);

4) Requirement for quality and safety control;

5) Graphical representation of the original product package (including the product labels and instructions); if -there is a packaging specially designed for the Chinese market, the applicant shall also present the packaging design of the products (including labels and instructions);

6) Basic description of the production process

7) Technical requirements of the product

8) Testing report and relevant data from testing institutions approved by CFDA;

9) Safety assessment data of possible substance with safety risk in the products;

10) Letter of commitment that the ingredients meet the forbidden or restricted requirements for high risk substances from the regions with high incidence of mad cow disease;

11) Certificate of Free Sale (CoFS) of the products in the producing country (region) or original country (region);

12) Supporting documentation relating to production quality management from overseas manufacturers

13) Other documents for filing referring to "Provisions for Application and Acceptance of Administrative Licensing for Cosmetics" (File No.856 of CFDA, hereafter mentioned as "provisions")

REACH24H interpretation:

Compared to the necessary documents prescribed by the normal requirements for imported non-special use cosmetics, filing requires submission of extra supporting documentation relating to production quality management from overseas manufacturers. In addition, the above requirements indicate that companies shall submit full testing report and relevant data from testing institutions, which indirectly means animal testing is still required. Since 2014 domestic non-special use cosmetics can be exempted from animal testing if safety assessment can prove their safety. Although this rule has been implemented for over 2 years, the guidance and standards for safety assessment are still under formulation. It is assumed that the exemption rules aren't extended to first import non-special use cosmetics in Shanghai Pudong New Area due to the lack of finalized regulatory requirements in this area.

4. Filing certificate requirements

 Shanghai FDA will check the following 1) if the product falls within the scope of filing management 2) if all documents (e-copies and hard copies) are complete 3) if documents are compliant with requirements. Once compliance is established, FDA will generate a digital filing certificate, which can be downloaded and printed. After these prerequisites are complete, the cosmetic can be sold in the Chinese market.

5. Review of hard copies

Shanghai FDA will review all materials (e-copies and hard copies) within 3 months after filing. Assessment emphasis will be placed on ingredients, manufacturing procedures, inspection items, risk assessment etc.

• In the following conditions applicants must submit supplementary documents within 30 days:

         1)    Irregular Chinese name and spelling error;

         2)    Omission or error in package and label;

         3)    Detailed ingredients with several spelling error in Chinese name / translation, INCI, omission of colorant CI;

         4)    Only minor amendments are required, e.g minor spelling errors.

• If documentation cannot ensure the safety of products, importation and sale must be stopped until the responsible person submits relevant documents.
• Once a violation or a quality/safety problem occurs, all products on the market will be investigated and recalled immediately.

REACH24H interpretation:

Technical Review is conducted after obtaining the filing certificate. This is the most significant change in this filing management trial. The current rule for importation of non-special cosmetics requires pre-market review and submission of all paper documents to the central FDA. Decentralization and devolution of regulatory power into the hands of Shanghai FDA is a key component of the new system.

6. Importation through Shanghai Pudong Special Zone

For importation of a non-special cosmetic that has already obtained a filing certificate, any amendments to specifications / materials must be accompanied by resubmission of amended documentation. If the local responsible person is changed, informed consent from the original responsible person and clear acceptance of transfer of responsibility must be provided.

Notes: