China GACC Decree 248 — New UNPA Registration Service
Jan 20, 2022
Dear Colleagues —
After discussions with the U.S. Embassy Beijing and after evaluating the requirements for registration under China’s GACC Decree 248, we are pleased to announce a new service offering for UNPA members as well as all other U.S. dietary supplement companies to assist in getting through this registration process.
The attached memo provides all pertinent details, but the short version is this (full details below):
This registration requirement became effective January 1, 2022. Unfortunately, there has been a lot of confusion or uncertainty as to how to complete this registration process and what information and documents are required or acceptable.
Recently the U.S. FDA has launched an export listing module (see the link in the attached memo). This is where you would provide FDA with the necessary information to complete Part I — that is the FDA registration.
Then, you have to register using China’s GACC registration on their online platform. This is where things get more complicated and where UNPA will be able to help companies get through the system. Our Beijing-based team speaks both English and Chinese. We are in frequent contact with the U.S. Embassy, which is providing technical assistance, and we are urging all companies to get registered as soon as possible, as we do not know when China will actively enforce this requirement, thus denying you entry to the China market.
PLEASE NOTE: We encourage you to complete the FDA registration process on your own. You will have to disclose confidential information, and the FDA’s system is manageable. We encourage you to work with us as you begin the FDA process so that we can guide you through the sequencing as you begin the process.
Please contact Daniel Mabey, our Asia Regional President, by email (Daniel@unpa.com) if you wish to participate in this new service. You may also direct any other questions you have to Daniel to get started.
Kind regards,
LDI
Full Details
Need to register under China’s Decree 248?
Let UNPA help you navigate this important new requirement.
What is GACC Decree 248?
The General Administration of Customs China (GACC) “Regulations on the Registration and Administration of Overseas Producers of Imported Food” (Decree 248) went into effect on January 1, 2022.
Who Has to Register?
Think of Decree 248 as China’s FSMA, to improve the quality and safety of foods exported to China. Decree 248 requires all overseas food manufacturers, processors, and storage facilities to be registered with the GACC to export products to China. Dietary supplements and nutritional products are listed as medium-risk food categories in Decree 248 in Article 7 as:
Foods for Special Dietary Purposes
Functional Foods
What’s the Process to Register?
Letter of recommendation by the competent authority of the country/region;*
List of recommended manufacturers and the manufacturers’ application for registration;
Documents certifying identification of the manufacturers, such as the business license issued by the competent authority of the country/region;
Statement that the manufacturer recommended by the competent authority of the country/region conform with requirements of these Regulations;
Reports of examinations/inspections/review conducted by the competent authority of the country/region to relevant manufacturers.
If necessary, the GACC may request documents related to the manufacturer’s food safety, health, and protection systems, such as the plan of the enterprise’s plant area, workshop, and cold storage, as well as the process flow chart.
Through our UNPA-Eurofins joint venture office in Beijing, we will work with your company to complete the Decree 248 registration process. We’re in close contact with the U.S. Embassy in Beijing and have prioritized helping the U.S. dietary supplement industry register with GACC to ensure continued market access. Failure to receive your registration will likely block your exports to China. We urge U.S. companies to act quickly to avoid export interruptions.
UNPA recommends that companies first complete the FDA Export Listing Module as it requires detailed company and product information. UNPA-Eurofins can assist with any questions you may have.
Once the FDA Export Listing Module is completed, UNPA-Eurofins will complete the GACC registration on your behalf. A CDA will be signed for confidentiality.
UNPA Member: $1195 – Non-UNPA Member: $1495
Contact Person: Daniel Mabey, UNPA Asia President: daniel@unpa.com
616, Beijing Silver Tower, No.2 Dong San Huan North Road, Chaoyang District, Beijing
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