CFDA registration and licenses for foodstuffs in China

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

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

The China Food and Drugs Administration operates under the SAMR which oversees all matters related to food safety all over China. Its field of competence and action covers regulation, supervision, inspection, controls and the issuance of licenses and permits for all families of food commodities.

a. Enhanced food safety Measures

The Chinese government has continually prioritized food safety, recognizing its crucial role in public health and social stability. The new CFDA administration builds upon existing measures and introduces enhanced regulatory mechanisms to strengthen the food safety ecosystem. Hereunder are some further insights and key aspects of this new administration.

b. 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 across the entire food supply chain, from production to distribution.

c. Risk assessment and early warning system

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

d. Stringent quality control standards

The administration places a strong emphasis on setting and enforcing stringent 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.

e. Strengthened 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 promotes the implementation of advanced traceability systems, utilizing technologies such as blockchain, RFID (Radio Frequency Identification), and QR codes. These systems enhance transparency and accountability throughout the supply chain, facilitating efficient recall management and improving consumer trust.

f. International collaboration and standards harmonization

Recognizing the global nature of food production and trade, the CFDA administration actively engages in international collaboration 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.

 

Attention to food producers and exporters Your company is based outside China, and you already sell or wish to export to China. The customs now require prior registration of your company and products on one of their online platforms. About this subject, the China customs administration (GACC) has published 2 decrees that came into force on January 1st, 2022. Decree 248 is the "Regulations on the Registration and Administration of Foreign Producers of Food Imported into China". It stipulates that food manufacturers and traders exporting to China must register with local customs. This decree divides all edible products into 2 categories : The 1st category concerns foodstuffs classified as "high-risk". For these, a registration procedure applies, with a logic to approval and validation. It includes seafood, meat, dairy products, cereals, honey, eggs, pasta, nuts and beans, fresh and dried vegetables, dried fruit, tobacco, dietary and health supplements. 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 western companies already exporting to China, there is little risk. These additional procedures and formalities reflect the Chinese authorities' desire to involve manufacturers, exporters and their governments in a global chain of responsibility for safety. The 2nd category is reserved for "low-risk" foodstuffs and wines & spirits. For these products, only a declaration logic and procedure applies. 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. Article 15 of this decree states that the GACC registration number of food producers must appear on the back label in Chinese language. This means that if the product marking does not contain the number, the import clearance process at the Chinese port of destination cannot be completed. Consult the page explaining these customs procedures. Decree 249 concerns the "Administrative Measures on Import and Export Food Safety". It sets the requirements for exporting foodstuffs 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 packagings.

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The authorities stipulate that operators in this sector must hold some additional licenses or hygiene permits before they can produce for export, import and distribute in the chinese territory. The formalities to obtain licenses and permits shall first be conducted 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 compulsory to certify any sold product conformity and operating conditions, and to authorize their distribution.

Please note that this CFDA registration procedure differs from the one described in the previous section concerning the registration of foreign manufacturers, exporters and importers with the China customs (GACC).

 

a. Five (5) types of approvals to seek upon each business model

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

• A license to manufacture food preparations on the Chinese territory. It authorizes the activity of food preparation in a laboratory, a central kitchen or a cooking corner within a shop. It is called the SC License (生产 "Shēng Chǎn" in Chinese). It contains a specific 14-digit number enabling traceability and identification of the manufacturer and location of the production site.
  

• A certificate of registraton for imported infant milk powder's ingredients.

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

 

b. Examples of distribution permits and production licenses

 

The license shown here is an example of a food distribution license. The license opposite 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 corporate purpose, valid for 2 years, renewable.

The permit shown here is the official duplicate of a catering license for the preparation and sale of bakery and pastry products. It was issued in order to open one of the Shanghai outlets of a foreign owned bakery & pastry shop. The company is authorized to prepare and sell bread, cakes, pastries, sandwiches and beverages on site. Valid for 3 years, renewable.

 

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

• Regulatory reviews and draft approval files for distribution of medical, pharmaceutical, food, dangerous or highly regulated products.

• Regulations monitoring + registration and licenses for food but also for drugs, beauty and medical devices.
  
  
• China customs registration for overseas exporters and manufacturers.
  
  
• Market analysis, pricing, positioning and competition survey reports.
  
  
• Products compliance review in the context of a search for a China agent or distributor.
  
  
• Feasibility reports for foreign investment projects and compare the investment conditions in several areas.
  
  
• Negotiation service assistance during denunciations or disputes with the authorities.
  
  
• Incorporation of fully foreign owned LLC companies in China. Licenses, certificates and permits needed to conduct the targeted activities.
  
  
• Handling logistics and warehousing solutions : optimize the storage and distribution fluidity for dry, temperature sensitive and hazardous products.

   

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