In April 2016, China confirmed the new regulation measures requiring all cross-border e-commerce (CBEC) products to obtain the same CFDA (China Food and Drugs Administration) approval as products sold in traditional retail markets. With a grace period extended until the end of 2017, industries have been fervently scrambling to register their products under the time constraint in order to maintain market access to one of the world’s largest consumer markets. If products do not obtain certification by the end of the grace period, they are no longer legally allowed to sell their products through traditional retails channels, e-commerce platforms, or CBEC platforms.

SHANGHAI PUDONG FILING SYSTEM

On January 17, 2017, the CFDA and AQSIQ (General Administration of Quality Supervision, Inspection, and Quarantine) announced a new filing regulation meant to ease the transition into the new regulation measures for one industry – cosmetics. Expanding rapidly as China continues to hold the world’s largest middle class, the cosmetic industry was hit especially hard by the 2016 certification regulations announcement. The new filing regulation allows first-time imported non-special use cosmetics to obtain CFDA approval directly through the Shanghai Pudoing filing management system.

While domestic companies can expect a wait of around 4-6 months for CFDA approval of non-special use cosmetics, approval of imported cosmetics of the same type can take around 8-12 months. With the grace period’s deadline rapidly approaching, foreign companies are desperate to register their products in time. This announcement has sparked a frenzy within the cosmetics industry as companies hope to find a quick solution to the lengthy and complicated CFDA approval process.

Considering the implications of the approaching deadline, it is important to understand what opportunities the new Shanghai Pudong filing system actually offers. Effective from March 1, 2017 to December 21, 2018 the new system still requires the same documentation and testing certifications as the previous system — but promises a shorter application process. Previously, the required testing and application processes took a combined 4-6 months. This new system offers a shortened application (filing) process of one month. Combined, the testing and application processes are shortened to about 2-4 months. As the grace period rapidly comes to a close, this could potentially make or break a product meeting the CFDA registration deadline.

RESTRICTIONS

Like most loopholes offered by the CFDA, this system comes with constraints. Importation must be done solely through the Pudong Port with the responsible agent registered in Shanghai Pudong. If a company wishes to import through other Chinese ports in the future, they would have to cancel the cosmetic filing record through Shanghai Pudong and apply for a CFDA cosmetics registration a second time.

While the filing time is indeed shorted, the testing and documentation requirements remain the same. While import agents will now be able to submit the required documentation online and through the Shanghai Pudong Market Supervision Bureau, companies themselves are still required to perform the same amount of testing. Companies should carefully consider the benefits of a shorted filing timeline against the limitation of Shanghai Pudong-restricted imports.

KNUDSEN&CO RECOMMENDATIONS

If foreign companies choose to take advantage of the Shanghai Pudong filing system, they should still prepare their sample tests in advance as the testing time remains at 2-3 months. Since the filing process will be simplified, Knudsen&Co recommends preparing the product’s Chinese label in advance to take advantage of the saved filing time. Knudsen&Co has listed the documents required for the Chinese label for CIQ Inspection below for.

As an CFDA certification agent registered in Shanghai Pudong, Knudsen&Co is happy to answer any questions relating to the new Shanghai Pudong filing system or certification and registration in general, Our contact information is listed at the end of this article.

REQUIREMENTS FOR CHINESE LABEL

  1. DOCUMENTS:
    1. Application form
    2. Product formula
    3. Instruction materials for Labeling contents
    4. Test certificate materials for special use product;
    5. Certificate of free sale or certificate of original, need to be notarized;
    6. Hygiene license;
    7. Business license of imported distributors or imported agent;
    8. 6 samples of Chinese label。
    9. Copy of bank remittance (T/T Proof) certificate for Audit fees, including Invoice’s title, contact address, postal code, contact number.
  1. POINTS OF ATTENTION:
    1. Documents 1-7 (as listed above) should be prepared in duplicate, one for Acceptance agency and one for AQSIQ
    2. Document 8 (the label samples) should be prepared in 6 copies, one for Acceptance agency and five for AQSIQ
    3. The Label samples used for application: prepare one digital and colorful sample of selling package.

For imported product with Chinese stickers, you need to provide one original package with product instruction and the Chinese translation of the package and product instruction.

  1. The Label samples used for making AQSIQ certification: prepare the 4 copies of colorful sample of selling package (7 inch sized), attach them on Paper A4 and mark the application No. on top right corner of the page.
  2. Each document should to be sealed with chops (the company stamp).
  3. All the contents in English need to be translated into Chinese.

 

CFDA Announcemen No. 7 (2017)