FDA amends export procedures to China for dairy and infant formula firms

The US Food and Drug Administration (FDA) has announced changes to its export listing procedures for dairy and infant formula firms seeking to export their products to China.  

In the 15 January 2020 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), China agreed to recognise the US dairy safety system as providing at least the same level of protection as China’s dairy safety system. 

As a result of the Economic and Trade Agreement, facilities seeking to be listed as eligible to export dairy and infant formula products to China are no longer required to provide confirmation to FDA – and vice versa – 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.  

On 24 June, in an action taken as the result of the Economic and Trade Agreement, the US Department of Agriculture (USDA) Agricultural Marketing Service announced that it will eliminate plant audits for dairy and infant formula firms seeking to export to China as of 1 July 2020. 

FDA has reminded 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 1 July 2020.