Infant Formula Exports to China
U.S. exporters of infant formula products to China are subject to importing country listing requirements for manufacturers/processors as a precondition for market access.
Establishments may apply for the China infant formula export list or update existing listing information via the Export Listing Module (ELM). Please visit Online Applications for Export Lists for a link to this electronic system and step-by-step instructions.
While U.S. regulations define infant formula as food intended for children up to 12 months of age, please note that the China Certification and Accreditation Administration (CNCA) defines infant formula as food intended for children up to 36 months of age, known as 'infant and young children formula'. Please refer to the Implementation Catalogue for Registration of Overseas Manufacturers of Imported Food released by the General Administration of Quality Supervision, Inspection and Quarantine of the People’s Republic of China (AQSIQ) for more information. Establishments manufacturing these products should apply to be listed as infant formula manufacturers.
Please be advised that CNCA requires new applicants to submit evidence of third-party certification of compliance with Chinese laws and regulations as part of the application process. For more information, please consult 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: Guidance for Industry. All currently-listed establishments that wish to remain on the China infant formula export list should provide evidence of third-party certification through the ELM by June 15, 2019. Establishments that wish to be newly added to the China infant formula export list will also be able to upload evidence of third-party certification when they submit an application in the ELM. Once listed, applicants are required to reapply with FDA and submit a new third-party certification report every two years.
CNCA also requires that infant formula manufacturers/processors submit an Establishment Registration Application with additional information to CNCA. Please review the guidance for links to this application. Once completed, this application may be submitted to USDA at DairyExportsQuestions@ams.usda.gov.
Additional Information on the China Infant Formula Export List: