On January 3, 2025, the Chinese General Administration of Customs (GAC) published a draft amendment to the Regulations on Registration and Administration of Overseas Manufacturers of Imported Food (“Registration Regulations,” known as GAC Decree 248)[1] for public comments, due by February 19, 2025. China also notified the World Trade Organization (WTO) of the draft through G/SPS/N/CHN/1324.[2]

In 2021, China issued GAC Decree 248 in 2021, which requires that all overseas food manufacturers exporting food products to China to register with GAC.[3] After three years of implementation, GAC has identified areas for refinement and optimization of the framework, aiming to address practical challenges and enhance the efficiency of the registration process for overseas manufacturers.

Notably, the draft newly introduces a regulatory pathway for overseas facility registration, namely, system recognition, which allows the competent authorities of the manufacturing facility’s home country (region) to obtain recognition from GAC.[4]

Under this new pathway, the competent authorities of recognized countries (regions) may submit a list of recommended manufacturers to GAC. Upon receiving these recommendations, GAC will register the listed enterprises and assign them official registration numbers. It appears that manufacturers may not be required to submit individual applications directly to GAC; however, enterprises from recognized countries may need to coordinate with their competent authorities to ensure their information (e.g., enterprise name, facility address, and contact details) is included in the list submitted to GAC.

This proposed approach represents a significant shift from the current framework under GAC Decree 248, which regulates imported food products based on their risk level and establishes two registration pathways, one for “specified foods” (e.g., milk, meat, aquatic products (typically known as high-risk foods)) and another for “others” (e.g., confectionary and solid beverage). More details concerning GAC Decree 248 can be found in our newsletter: Breaking News: China Imposes New Registration Requirements for All Foreign Food Companies. The draft, however, proposes a classification system at the national level, focusing on whether the competent authorities of the manufacturing facility’s home country (region) can obtain recognition from GAC. Therefore, it is likely that the competent authorities at home countries may have to undertake a higher level of responsibility to supervise the companies exporting foods to China.

On the other hand, the draft also specifies dossier requirements for enterprises whose competent authorities are not recognized by GAC. These enterprises must apply for registration with GAC by themselves or through an agent. We note that the dossier requirements differ based on the category of food involved. Specifically, manufacturers of the specified foods under Catalogue of Foods that Require Official Recommendation Registration Letters (“Catalogue”) will need to provide official inspection reports and recommendation letters issued by their competent authority.

The draft further proposes to update the Catalogue, listing 11 categories of high-risk foods subject to government-recommended registration, along with their corresponding risk assessments. Compared with GAC Decree 248, 8 types of food may no longer be subject to the current recommended registration requirements, covering health foods (including dietary supplements), special dietary foods, unroasted coffee beans and cocoa beans, edible fats and oils, etc. For example, previously, health food manufacturers were required to undergo a government-recommended registration process, [5] which often involved lengthy procedures. Under the proposed revisions, health food manufacturers will be able to process facility registrations by themselves, which will greatly simplify the process, leading to faster market entry and reduced compliance costs. Per GAC’s announcement, the Catalogue will be subject to dynamic adjustments. This flexible approach empowers the authority to adapt quickly to evolving dynamics within the food industry and shifts in the regulatory landscape.

In addition, the draft removes the requirements for overseas manufacturers to reapply for registration in certain scenarios, such as changes to the legal representative or changes to the registration number granted by the country (region). Instead, it specifies that reapplying for registration is necessary when such changes have a significant impact on the enterprise’s sanitation management and control for food safety – for example, in the event of a production site relocation.

Importantly, GAC removes the provision that mandates overseas producers to file their renewal applications three to six months before the registration expires. It also clarifies specific food categories that are exempt from facility registration, including food sent by mail or express delivery, cross-border e-commerce retail items, food carried by travelers, as well as samples, etc. It is worth noting that food additive manufacturers exporting products to China are excluded from the facility registration requirement under Decree No. 248; this remains the same in the draft.

Overall, the proposed changes underscore China’s ongoing efforts to strengthen food safety oversight while simplifying administrative procedures for the registration of overseas manufacturers of imported foods. However, there are certain remaining issues that may require further clarification. For instance, it is unclear how the new system recognition mechanism will integrate with the existing framework under GAC Decree 248. One key question is whether companies that have already registered with GAC still need to coordinate with their competent authorities to be included in the list provided to GAC. Such ambiguity could create challenges for businesses navigating the transition between the current and proposed systems.

[1] http://www.customs.gov.cn/customs/302452/302329/zjz/6297231/index.html; Non-official English translation prepared by United States Department of Agriculture (USDA) is available at: https://apps.fas.usda.gov/newgainapi/api/Report/DownloadReportByFileName?fileName=Amended%20Overseas%20Food%20Producer%20Registration%20Regulation%20Notified_Beijing_China%20-%20People%27s%20Republic%20of_CH2025-0005.pdf  

[2] https://eping.wto.org/en/Search/Index?countryIds=C156%2CC764%2CC704%2CC458%2CC360%2CC608%2CC410%2CC392%2CC702%2CC158&viewData=G%2FSPS%2FN%2FCHN%2F1324; All comments should be submitted before March 11, 2025.  

[3] https://www.gov.cn/gongbao/content/2021/content_5616161.htm

[4] Such recognition is granted under specific conditions, including (1) accepting and passing the inspection of the food safety management system of the country (region) by GAC; (2) signing a food safety cooperation agreement with GAC; (3) signing a mutual recognition agreement of Authorized Economic Operator (AEO) with GAC; and (4) signing other cooperation agreements or joint statements with Chinese government departments that include food safety cooperation content.

[5] Please note that the term “registration” mentioned in this context pertains solely to overseas facility registration under GAC Decree 248 and does not refer to the “blue hat” registration required for health foods in China.