CFDA registration in China

CFDA registration and licenses for food products in China

By C.i. Process (Shanghai)
 
.
CFDA licensing in China

In recent years, ensuring food safety and implementing robust regulatory measures have become critical concerns for nations worldwide. Recognizing the importance of a reliable food safety system, China has taken significant steps to strengthen its food regulatory framework.

Since 2018, the CFDA (China Food and Drugs Administration) is the Chinese authority responsible for controlling the safety and issuing licenses for the production and distribution of food commodities, beverages, wines and spirits. It also has regulatory prerogatives over these products. This article presents the CFDA's competencies and a regulatory update for conformity and approval in 2024.

/
China FDA regulations
 
  Publication updated on June 26, 2024      
 
Home > regulations and news > Guide to CFDA food licenses and permits in China
 


1. Introducing the new CFDA 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).
  • In 2020, these two agencies merged again to form a unified entity, the CFDA. Doing so helped streamlining the regulatory oversight and eliminating redundancy.


    CFDA China Food and Drug Administration
     
    The CFDA keeps its prerogatives over hygiene monitoring and supervision for foodstuffs only. It is an integrated entity of the State Administration for Market Regulation (SAMR).


  • This new CFDA is headquartered in Beijing and manages provincial and municipal branches. Its establishment marks a transformative milestone in the nation's commitment to improving food safety, enhancing public health, and bolstering consumer confidence.

  • The other 3 families come under the control of the NMPA (National Medical Products Administration).

 


2. Responsibilities and scope of control

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.


3. China customs (GACC) registration for 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 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 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.

This decree divides all edible products into 2 categories :

The first category concerns food commodities classified as high-risk or medium risk. For them, a registration procedure applies, with a logic to approval and validation. Manufacturing or processing companies must first be inspected by the health authorities in the country of origin. These authorities shall 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 manufacturers, exporters and their governments in a global chain of responsibility for food safety.


  1. Meat and meat produces
  2. Natural guts (casings)
  3. Aquatic products (seafood)
  4. Dairy products
  5. Bird nests and products that incorporate them in their products
  6. Honey and other bee products
  7. Eggs and egg products
  8. Edible oils and fats
  9. Stuffed wheat products
  10. Edible cereals
  11. Products of the cereal milling industry and malt
  12. Preserved and dehydrated vegetables and dried beans
  13. Seasonings
  14. Nuts and seeds
  15. Dried fruits
  16. Unroasted coffee beans and cocoa beans
  17. Special dietary food products
  18. Functional health food

 

The second category is reserved for low-risk foodstuffs as well as wines & spirits. For these products, only a declaration logic and regular registration 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.

example of GACC registration certificate issued by China customs

Registration with the China customs is done online.

There are 2 distinct platforms depending on whether the applicant is an exporting trader or a producer (manufacturer, agricultural or wine estate, processing sites, warehouse).

Exporters and producers can conduct these formalities themselves or require the services of a service provider.

Following registration, the applicant is issued a GACC registration certificate by the Chinese customs (see example). Valid for 5 years.

The company is registered as an authorized export operator in China. Before shipping, you may ensure that the obligatory markings in Chinese also comply with the labeling rules.


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.

 

[ contact us ]


4. Licenses SC to manufacture and permits to import and sell food in China

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. Manufacturing facilities of fresh food, processed food, bakery kitchen and other food preparation sites all need a SC License. It comes in addition to a company's regular Business License (certificate of incorporation).
  • 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 employees responsible for catering (restaurants and bars), distribution (wholesale and retail) and production (food laboratories, manufacturing or processing sites and warehouses).

 

b. Examples of distribution permits and production licenses

 

food distribution license for ready-made meals in China
 

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.


catering license for food production and distribution (bakery) in China
 

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 and 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.

 


5 . Our services related to allow sensitive commodities selling in China



 


Top of the China FDA page
.
| any reproduction prohibited without the express authorization of the author | content &  design 2024 by C.i. Process (Shanghai)|