China has passed new regulations on imported food, affecting overseas food manufacturers, processors, and storage facilities. These regulations include requirements regarding registration, labelling and packaging, as well as supply chain trackability, and enhance the General Administration of Customs’ enforcement powers to mitigate food safety risks.
Specifically, the following two regulations issued by the General Administration of Customs of China (GACC) took effect on January 1, 2022:
Decrees 248 and 249 (collectively, New Regulations) together set forth a broad range of requirements on food imports to China, including overseas producer registration, record filing by importers and exporters, product labelling, quarantine, and inspection, etc. Summarized below are some key takeaways.
New Registration Requirement
Under the New Regulations, all overseas food manufacturers, processors, and storage facilities (collectively, Overseas Food Producers) must be registered with GACC before exporting food to China. Unlike the original law where only the producers of four categories of food products (e.g., meat and meat products, seafood products, dairy products, and bird nest products) were required to register with GACC, the new requirement now covers all food products except for food additives and “food-related products.” (Notably, the New Regulations are silent on the definition and scope of “food-related products,” which will need further clarification from GACC.)
Two Registration Pathways
Depending on the product category, there are two pathways for the Overseas Food Producers to register with GACC:
Specifically, unless the exporting country has an agreement otherwise with China on a registration pathway and/or application documents, Overseas Food Producers engaged in any one of the following 18 Product Categories generally must be registered with GACC through Recommendation Pathway,[1] while Overseas Food Producers of food products outside of the 18 Product Categories may register with GACC directly via the Self-application Pathway:[2]
|
Registration Pathway |
Food Categories |
|
Recommendation Pathway |
(collectively, 18 Product Categories) |
|
Self-application Pathway |
Food products that fall outside of the 18 Product Categories |
The procedures and documentation requirements under the Self-application Pathway are generally simpler than those under the Recommendation Pathway.
In late December 2021, the US Food and Drug Administration (USFDA) provided GACC lists of US establishments that sought to be recommended for registration in China via the USFDA’s Export Listing Module (ELM). In its communication to GACC, the USFDA requested that GACC register these establishments without delay so these establishments could continue to export their goods after January 1, 2022 and to minimize disruption in trade.
It should be noted that Decree 248 further grants an adjustment power to GACC. It provides that if GACC finds with evidence or risk assessment that the safety risk of a specific category of food products changes, GACC may adjust the applicable registration pathway and/or documentation requirements subjecting the Overseas Food Producers of such category of products.
Labelling and Packaging
The New Regulations also set forth several labelling and packaging requirements for products to be imported to China. For example, under Decree 248, the Chinese registration number or the registration number approved by the exporting country’s competent authority must be included on both the inner and outer packages, which GACC’s local counterparts will examine and verify at the import border during customs clearance. In addition to reiterating that food packaging and labelling must meet Chinese requirements, Decree 249 further provides specific labelling and packaging requirements for functional food, foods for special dietary purposes, cold fresh meat products, and aquatic products. According to another clarification notice issued by GACC, these new labelling and packaging requirements only apply to the products produced on and after January 1, 2022.
Supply Chain Safety Trackability
The New Requirements also call for supply chain trackability. Specifically, according to Decree 249, domestic food importers must, among other things, establish an audit system for overseas exporters and Overseas Food Producers, reviewing their food safety risk control measures, and ensuring that the food complies with Chinese laws and standards.[3] Overseas Food Producers are also required to set up a complete and traceable control system for food safety and sanitation and ensure that the food to be exported to China is produced, processed, and stored in compliance with Chinese laws and regulations.[4]
Enhanced Powers of GACC and Stricter Legal Liability
The New Regulations further enhance GACC’s powers in enforcement to mitigate food safety risks, which includes overseas food facilities examination, safety inspection, assessment, and import clearance inspection. The New Regulations also present various forms of examination for GACC, including documentation review, video inspection, on-site inspection, and combinations thereof.
According to the New Regulations, noncompliance with Chinese laws or nonconformities in the products discovered at the import clearance or market circulation stage may not only have legal implications to Chinese importers, but also potentially impact Overseas Food Producers, as GACC may suspend the imports to China, order to recall products, downgrade their credential status, or even revoke their registration in China.
Therefore, to avoid supply chain disruption for businesses or a violation of Chinese laws, it is advisable for foreign food companies to carefully consider the requirements under the New Regulations, make any necessary updates or improvements in each relevant aspect—such as manufacturing, quality control, storage, distribution, labelling, and packaging—and develop a more comprehensive compliance program to ensure the sustainability and ability to track safety aspects of the overall supply chain.
If you have any questions or would like more information on the issues discussed in this LawFlash, please contact any of the following Morgan Lewis lawyers:
Shanghai
Todd Liao
K. Lesli Ligorner
Washington
Kathleen M. Sanzo
[1] Decree 248, art. 7.
[2] Decree 248, art. 9.
[3] Decree 249, art. 22.
[4] Decree 249, art. 44.