Establishment Listing and Registration Requirements
FDA requires exporters to submit production plan details, including product types, packaging specifications, and processing methods, to comply with China's Decree 24.
The General Administration of Customs of China (GACC) has implemented registration requirements affecting all overseas food manufacturers, processors, and storage facilities exporting to China. These requirements are outlined in China’s Decree 248. Articles 7 and 8 of the Decree mandate that the competent authorities of exporting countries recommend the registration of enterprises involved in certain food categories. As the competent authority in the United States, the FDA oversees many of the product categories requiring registration and collaborates with businesses to collect relevant information. U.S. establishments that produce or store FDA-regulated products within the specified categories must provide information to the FDA to meet China’s registration requirements.
FDA and USTR Push GACC to Confirm U.S. Food Enterprise Registration Eligibility
Requesting GACC to Confirm Registration Eligibility Under Bilateral Agreements to Ensure Market Access.
The U.S. government, in accordance with the Phase One Economic and Trade Agreement and other U.S.-China bilateral agreements and facility registration arrangements, has requested the General Administration of Customs of China (GACC) to confirm the registration of U.S. enterprises. This aims to minimize the impact on U.S. exporters. Meanwhile, the FDA is actively taking measures to ensure market access for U.S. food enterprises under its regulation in China.
New Product Categories for Registration Under Articles 7 and 8 of China's Decree 248
We specialize in providing application services that comply with the latest regulations of the U.S. FDA and China Customs, fully covering the latest guidelines and compliance review standards of both regulatory agencies.
| Product Categories | GACC Description (Unless Otherwise Specified) |
|---|---|
| 1. Casings | Made from the small intestine, large intestine, and bladder of healthy livestock, processed through degreasing, scraping, and other specialized treatments, then salted or air-dried for use as sausage casings. |
| 2. Bee Products | Natural sweet substances collected by bees from nectar, secretions, or honeydew, mixed with their own secretions, as well as edible substances naturally formed during reproduction or produced through special processing techniques. This includes royal jelly, royal jelly powder, bee pollen, and freeze-dried royal jelly powder. |
| 3. Eggs and Egg Products | Note: The FDA understands that, based on the HS codes referenced in the GACC system, this category includes shell eggs and other FDA-regulated egg products. However, GACC's initial description did not explicitly include these products. Additionally, the FDA has learned that egg products regulated by the USDA’s Food Safety and Inspection Service (USDA/FSIS) are currently not eligible for export to China. |
| 4. Edible Fats and Oils | Vegetable oils and edible plant-based oils intended for processing or consumption, as well as single or blended vegetable fats processed through one or more methods such as refining and fractionation. |
| 5. Stuffed Wheaten Products | Cooked or uncooked frozen products made with various fillings and wheat flour as the outer layer, such as steamed buns, dumplings, or pies. |
| 6. Edible Grains | Food products made from the seeds, roots, or tubers of cereal and tuber crops, such as rice, oats, and sorghum. |
| 7. Milled Grain Products and Malt | Edible powdered products obtained by grinding and screening the seeds, roots, and tubers of cereals, tubers, fruits, and nuts, or malt products formed through hydrolysis processing. |
| 8. Fresh and Dehydrated Vegetables, and Dried Beans | Fresh or dried vegetable products processed through preservation, dehydration, or drying techniques, as well as dried bean products. |
| 9. Condiments | Natural plant products with aromatic, flavoring, or seasoning functions, including fruits, seeds, flowers, roots, stems, leaves, peels, or whole plants. |
| 10. Nuts and Seeds | Nuts include walnuts, chestnuts, almonds, pecans, pistachios, torreya grandis, macadamia nuts, pine nuts, and other similar varieties. Seeds include watermelon seeds, pumpkin seeds, and other edible plant seeds. |
| 11. Dried Fruits | Dried fruit products made from fresh fruits through sun drying, dehydration, or other drying processes. |
| 12. Unroasted Coffee Beans and Cocoa Beans | Note: The FDA has learned that GACC has not provided a detailed description for this category. |
| 13. Foods for Special Dietary Purposes | Includes soy-based infant formula, special medical-use formula, infant and toddler complementary foods, and other special dietary foods such as supplemental nutrition products and sports nutrition foods. |
| 14. Health Foods / Functional Foods | Foods that claim to have specific health functions or supplement vitamins and minerals. These products are intended for specific groups of people to help regulate bodily functions, but they are not intended for disease treatment and do not pose acute, subacute, or chronic harm to the human body. |
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