Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                CFSAN Constituent Updates

CFSAN Constituent Updates Home
          Food
          News & Events from CFSAN
          CFSAN Constituent Updates
          FDA Signs MOU with China to Outline Certification Process for Certain ExportsCFSAN Constituent Updates FDA Signs MOU with China to Outline Certification Process for Certain Exports
  
  	
    Share
    Post
    Linkedin

    Email
    PrintWhat's New

**November 27, 2018**

The FDA is reminding U.S. establishments that are currently listed on the dairy, seafood, and infant formula exports lists for China that the Certification and Accreditation Administration of the People’s Republic of China (CNCA) requires them to obtain third-party certification of compliance with the relevant standards, laws, and regulations of China by June 15, 2019 if they wish to maintain continued access to the Chinese market. In order to remain on the lists, establishments need to submit evidence of third-party certification via the Export Listing Module (ELM) before the June 15 deadline.

In addition, the FDA has updated Guidance for Industry: Establishing and Maintaining a List of U.S. Milk and Milk Product, Seafood, Infant Formula and Formula for Young Children Manufacturers/Processors with Interest in Exporting to China to further explain how establishments should apply to be included on FDA’s lists of exporters to China using the new ELM, how FDA intends to determine whether the establishment should be recommended for inclusion for specific products, and how FDA intends to update this information.

**June 28, 2017**

This MOU formalizes a new registration procedure, and the FDA has published Guidance for Industry: Establishing and Maintaining a List of U.S. Milk and Milk Product, Seafood, Infant Formula and Formula for Young Children Manufacturers/Processors with Interest in Exporting to China to further explain what information exporting establishments should provide to the FDA to register under this new arrangement. The FDA will use the information received to establish and update a list of eligible exporters in a manner consistent with the MOU, and the agency will update the list of establishments and products four times per year.

Original Constituent Update

June 15, 2017

The U.S. Food and Drug Administration has signed a Memorandum of Understanding (MOU) with the Certification and Accreditation Administration of the People’s Republic of China (CNCA), formally establishing a registration process for U.S. food manufacturers who export certain foods to China. The FDA is taking this action in response to China’s State General Administration of the People’s Republic of China for Quality Supervision and Inspection and Quarantine (AQSIQ) issuance of Administrative Measures for Registration of Overseas Manufacturers, known as AQSIQ Decree 145.

AQSIQ Decree 145 requires that CNCA receive certification of compliance with the relevant standards, laws, and regulations of China for the following products as of June 15, 2017: milk and milk products, seafood, infant formula, and/or formula for young children. The MOU provides for a third-party certification process to ensure that manufacturers and products satisfy relevant food safety requirements of China, as specified in Decree 145. In accordance with the MOU, CNCA expects all eligible exporters to provide the FDA with information concerning the third-party certification by a firm approved by China. Pursuant to the MOU, the FDA will also evaluate and provide CNCA with information about whether relevant U.S. establishments are in good standing with the FDA.

This MOU formalizes a new registration procedure. The details about how the agency intends to implement this process and what information exporting establishments should provide to the FDA to register under this new procedure will be provided in a forthcoming FDA Guidance for Industry. The FDA will use the information it receives to establish and update a list of eligible exporters in a manner consistent with the MOU. The FDA intends to update the list of establishments and products four times per year.

The FDA understands that U.S. exporters want continued and uninterrupted access to the Chinese market, and the agency is working expeditiously to provide CNCA with the assurances it requires for the FDA to establish and maintain a list of U.S. milk and milk product, seafood, infant formula, and formula for young children manufacturers/processors eligible for exporting to China.

**Additional Resources**

Previous Constituent Update
	Memorandum of Understanding (MOU) with the Certification and Accreditation Administration of the People’s Republic of China (CNCA)
	Guidance for Industry: Establishing and Maintaining a List of U.S. Milk and Milk Product, Seafood, Infant Formula, and Formula for Young Children Manufacturers/Processors with Interest in Exporting to China

                                                                                  Content current as of:
      11/28/2018
              
              
Regulated Product(s)
		 Food & BeveragesCFSAN Constituent Updates
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop