The U.S. Food and Drug Administration (FDA) has announced changes to the agency’s export procedures for dairy and infant formula firms seeking to export their products to China.

The Economic and Trade Agreement Between the Government of the United States and the Government of the People’s Republic of China (Economic and Trade Agreement), dated January 2020,  states that China agreed to recognize the U.S. dairy safety system as providing at least the same level of protection as China’s dairy safety system.

Now, the result of that agreement is as follows: 

  • Facilities seeking to be listed as eligible to export dairy and infant formula products to China should no longer provide to FDA any confirmation that a third-party auditor has found the firm to be in compliance with the relevant standards, laws, and regulations of China for dairy and infant formula firms.  
  • FDA will no longer provide to China any confirmation that a third-party auditor has found the firm to be in compliance with the relevant standards, laws, and regulations of China for dairy and infant formula firms.  
  • Plant audits will be eliminated for dairy and infant formula firms seeking to export to China as of July 1, 2020. ​

The decision comes under the authority of the U.S. Department of Agriculture Agricultural Marketing Service, the agency in charge of facilitating the efficient marketing of milk and dairy products worldwide.

FDA reminds firms intending to export dairy and infant formula products to China that the agency will include firms on export lists only if the firm is in substantial compliance with applicable FDA regulations.  

Firms may apply to be included on these lists via the FDA’s Export Listing Module (ELM).

This process applies to all ELM applications received for these export lists on or after July 1, 2020.


Author(s): Staff