CFDA Food Registration and Licensing in China

• In 2013, the SFDA (State Food and Drugs Administration) was renamed CFDA (China Food and Drugs Administration). It is the agency responsible for the safety and supervision of 4 product categories: food produts, medical devices, pharmaceuticals and cosmetics.

• A 2018 reform gave it limited responsibilities. Previously, it operated under two separate agencies, namely the State Food and Drug Administration (SFDA) and the China Food and Drug Administration (CFDA).
  

The China Food and Drug Administration operates under the SAMR which oversees all matters related to food safety throughout China. Its responsibilities and activities include regulation, supervision, inspection, control and issuance of licenses and approvals for all families of food products.

2.1. Strengthened food safety measures

The Chinese government has consistently prioritized food safety, recognizing its critical role in public health and social stability. The new CFDA administration builds on existing policies and introduces enhanced regulatory mechanisms to strengthen the food safety ecosystem. Here are some further insights and key aspects of this new administration.

2.2. Strengthened regulatory oversight

The CFDA consolidates the authority's power by unifying regulatory efforts, optimizing resource allocation, and avoiding duplication of tasks. It enables more effective enforcement of food safety laws and regulations throughout the entire food supply chain, from production to distribution.

2.3. Risk assessment and early warning system

The new CFDA authority emphasizes the establishment of robust risk assessment and early warning systems. Through the use of advanced technologies, data analysis and risk prediction models, the administration can proactively identify potential food safety hazards and take timely action to mitigate risks.

2.4. Stringent quality control standards

The administration is placing a strong emphasis on establishing and enforcing strict quality control standards for food. This includes improved inspection methods, expanded testing capabilities, and enhanced surveillance to identify and address issues related to food adulteration, contamination, and mislabeling.

2.5. Strengthening food traceability

Traceability is a key aspect of food safety, enabling rapid identification and removal of unsafe products from the market. The new CFDA administration is promoting the implementation of advanced traceability systems using technologies such as blockchain, radio frequency identification (RFID), and QR codes. These systems enhance transparency and accountability throughout the supply chain, facilitate efficient recall management, and improve consumer confidence.

2.6. International cooperation and harmonization of standards

Recognizing the global nature of food production and trade, the CFDA administration actively participates in international cooperation and harmonization efforts. By aligning with international food safety standards and sharing best practices, China aims to enhance its export competitiveness, ensure the safety of imported food and contribute to global food security.

3. China customs (GACC) registration for food producers and exporters

 

Your company is based outside of China and you are already selling or planning to export to China. Customs now requires you to register your company and products on one of their online platforms. The General Administration of Customs of China (GACC) has issued two regulations on this issue, which will take effect on January 1, 2022. Decree 248 is the Regulation on the registration and administration of foreign producers of food Iiported into China. It stipulates that food manufacturers and traders exporting to China must register with local customs. Article 15 of this decree states that the GACC registration number of food manufacturers must appear on the back label in Chinese. This means that if the product label does not contain the number, the import clearance process cannot be completed at the Chinese port of destination. This regulation divides all food products into 2 categories: The first category concerns food products classified as high or medium risk. They are subject to a registration procedure with a logic of approval and validation. Manufacturing or processing companies must first be inspected by the health authorities in the country of origin. These authorities then recommend the company to the GACC and its products can be registered on the Chinese customs platform. For overseas companies already exporting to China, there is little risk of refusal. These additional procedures and formalities reflect the Chinese authorities' desire to involve foreign producers, exporters and their governments in a global chain of responsibility for food safety. Meat and meat products Natural guts (casings) Aquatic products (seafood) Dairy products Bird nests and products that contain them Honey and other bee products Eggs and egg products Edible oils and fats Stuffed wheat products Edible cereals Grain milling products and malt Canned and dried vegetables and beans Spices and seasonings Nuts and seeds Dried fruits Coffee and cocoa beans, unroasted Special dietary foods Functional health foods   The second category is reserved for low-risk foods and wines and spirits. These products are subject to a declaration logic and regular registration procedure. Producers and processing centers can register directly with Customs. No prior inspection is required. The process is carried out in stages on the dedicated GACC online platform. Registration with the China Customs is done online. There are 2 different platforms depending on whether the applicant is an exporting trader or a producer (manufacturer, farm or wine, processing plant, warehouse). Exporters can complete these formalities themselves or use the services of a service provider. Upon registration, the applicant will receive a GACC Registration Certificate from Chinese Customs (see example). Valid for 5 years. The company is registered as an authorized exporter in China. Before shipping, you can ensure that the required Chinese markings also comply with labeling regulations. Decree 249 concerns the Administrative Measures on Import and Export Food Safety. It sets the requirements for exporting food to China. It covers the registration of production facilities and the traceability of quality records by both the importers and exporters. Finally, it covers some quarantine measures, inspection(s) and mandatory labeling on the packages.

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The authorities stipulate that operators in this sector must have some additional licenses or sanitary permits before they can produce for export, import and distribute in the Chinese territory. The formalities for obtaining licenses and permits must first be completed with the CFDA.

The formalities differ depending on whether the operator is a manufacturer in China, an importer or a retailer (shop, restaurant, bar). They are required to certify the conformity and operating conditions of each product sold and to authorize its distribution.

Please note that this CFDA registration process is different from the one described in the previous section regarding registration of foreign manufacturers, exporters and importers with the General Administration of Customs of China (GACC).

 

4.1. Five (5) types of approvals to be obtained for each business model

• A specific business license for importers, distributors and restaurants dealing with food products. Beverages (soft drinks) are included for catering services.

• A license to produce food preparations on the territory of China. It authorizes the activity of food preparation in a laboratory, a central kitchen or a cooking corner in a shop. It is called SC License (生产 "Shēng Chǎn" in Chinese). It contains a unique 14-digit number that enables traceability and identification of the manufacturer and the location of the production site. Fresh food manufacturing facilities, processed food manufacturing facilities, bakery kitchens and other food preparation sites all require a SC license. It is in addition to a company's regular business license (certificate of incorporation).
  

• A certificate of registration for imported infant formula ingredients.

• Separate registration for establishments producing or importing health products, including dietary food supplements.
  
  
• Individual permits issued to employees responsible for catering (restaurants and bars), distribution (wholesale and retail) and production (food laboratories, manufacturing or processing plants and warehouses).

 

4.2. Examples of Distribution Licenses and Production Licenses

 

The license shown here is an example of a food distribution license. The license shown was issued to a 100% foreign-owned LLC company (ex WFOE). It is authorized to sell prepared, packaged and frozen food. It contains: company name, address, name of legal representative, type of business and business scope, valid for 2 years, renewable.

The permit shown here is an official duplicate of a Catering License for the preparation and sale of bakery and pastry products. It was issued to open one of the Shanghai domestic branches of a foreign-owned bakery and pastry shop. The company is authorized to prepare and sell bread, cakes, pastries, sandwiches and beverages on site. Valid for 3 years, renewable.

 

Each food product must be meticulously classified according to its exact nature to ensure up-to-date conditions for sale and distribution to Chinese consumers.

• Regulatory analysis and approval files before selling food products or dangerous goods and substances.

• Compliance monitoring + registration & licensing for food, medical equipment and beauty care products.
  
  
• China customs registration for foreign exporters.
  
  
• Reports on market trends, competition, pricing, positioning.
  
  
• Product compliance review when looking for a China distributor or agent.
  
  
• Feasibility report for overseas projects and comparative investment terms between multiple locations.
  
  
• Negotiation services for disputes with the government agencies.
  
  
• Business registration of fully foreign-owned LLC companies in China. Licenses, certificates and permits required to conduct the targeted activities.
  
  
• Handling logistics and transportation solutions: optimizing the efficiendy of storage and shipping for dry, temperature-sensitive and chemically hazardous products.

   

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