UPDATED June 29, 2017

The Food and Drug Administration 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. FDA will use the information received to establish and update a list of eligible exporters in a manner consistent with the Memorandum of Understanding, and the agency will update the list of establishments and products four times per year.

June 21, 2017
The U.S. Food and Drug Administration signed a Memorandum of Understanding (MOU) last week with the Chinese government to establish a formal registration process for U.S. food manufacturers who export milk and milk products to China, one of the fastest growing dairy export markets and the third largest market for U.S. dairy products. The agreement will increase access for more than 200 U.S. dairy exporters to the 1.3 billion potential Chinese consumers and paves the way for future exporters to the country.

Dr. Stephen Ostroff, M.D., deputy commissioner of food and veterinary medicine for the Food and Drug Administration, announced the news to dairy professionals in his keynote speech at IDFA’s Regulatory RoundUP last week.

“We appreciate Dr. Ostroff’s leadership on this issue on behalf of the U.S. dairy industry,” said Michael Dykes, D.V.M, IDFA president and CEO. “The registration process had been a long-standing issue for exporters to China until Dr. Ostroff made it a priority for the agency over the past few months. We look forward to working closely with FDA to assure that the certification process works well for companies looking to the Asia Pacific region for new markets.”

Memorandum of Understanding

Because China requires FDA to certify that U.S. dairy products and companies meet Chinese food safety standards, the MOU provides a process for third parties to complete the necessary audits and allow FDA to issue the required export certificates to dairy companies.

FDA plans to issue industry guidance with more details on how the agency is implementing the registration process and the types of information exporters should provide to the FDA to be registered. FDA says it will use the information it receives to establish and update a list of eligible exporters in a manner consistent with the MOU, and will update the list of establishments and products four times per year.

For more information, contact Beth Hughes, IDFA director of international affairs, at bhughes@idfa.org.