U.S. exporters of dairy products to the European Union, China, and Chile are subject to importing country listing requirements for manufacturers/processors as a precondition for market access. Please note that the scope of products for which importing authorities impose listing requirements may differ from FDA's definition of “milk product” as established in 21 CFR 1240.3(j). You may wish to consult the regulatory authorities in the country to which you intend to export to determine whether your products are subject to listing requirements.
Industry may apply for inclusion on these lists 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. More information on specific country requirements is included below.
Industry may request export certificates produced by listed manufacturers/processors from the United States Department of Agriculture, Agricultural Marketing Service, Dairy Grading Branch (Dairy Grading Branch).
Additional Information on the China Dairy Export List
- 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) to determine whether the products you intend to export are subject to China's listing requirements.
- Please be advised that China requires that firms obtain third-party certification of compliance with Chinese laws and standards prior to being listed. 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. Establishments that wish to be newly added to the China dairy export list may upload evidence of third-party certification in the "Additional Documents" section of their ELM application. Once listed, all establishments are required to reapply with FDA and submit a new third-party certification report every two years.
- China also requires that firms exporting dairy products that China considers to be high-risk submit an Establishment Registration Application with additional information to Chinese regulatory authorities. These products include pasteurized milk, fermented milk, flavored fermented milk, modified milk, other disinfection milk, and sterilized milk. Please review the guidance for links to these applications. Once completed, these applications may be submitted to USDA at DairyExportsQuestions@ams.usda.gov. Please do not apply to be listed for the products listed above until you have submitted the necessary application to USDA.
- Memorandum of Understanding between FDA and Certification and Accreditation Administration of the People’s Republic of China Regarding Registration of U.S. Food Manufacturers Exporting to China
- 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
- Constituent Update: FDA Signs MOU with China to Outline Certification Process for Certain Exports
Additional Information on the Chile Dairy Export List
- Please be advised that Chile requires that the company information (name, address, plant/approval number) on all labels match the information on the export certificate. This requirement applies to the labels for individual products, boxes of individual products, and other bulk packaging. If the company information on the labels does not match the information on the export certificate, shipments are likely to be rejected.
- Guidance for Industry and FDA: Establishing and Maintaining a List of U.S. Dairy Product Manufacturers/Processors with Interest in Exporting to Chile
- List of U.S. Dairy Product Manufacturers/Processors With Interest in Exporting to Chile
Additional Information on the EU Dairy Export List
- Any product that contains processed milk or dairy products may be subject to EU listing and certification requirements. Please visit the website of USDA/AMS EU Dairy Export Certification Programs for more information.
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