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FDA Guidance on China Food Facility Registration

  • We have previously blogged about the General Administration of Customs China’s (GACC’s) publication of registration requirements applicable to all foreign food companies that manufacture, store, or process food exported to China. The regulations (Decree 248 – Regulations on Registration and Administration of Overseas Manufacturers of Imported Food) will take effect on January 1, 2022. An English translation of the regulations is available here.

  • Yesterday, FDA announced the steps that it is taking to help industry comply with the new requirements. By way of background, Articles 7 and 8 of the Decree require that the countries’ competent authorities recommend registration of facilities involved in the export of the following categories of food: (1) Meat and meat products, (2) Aquatic products, (3) Dairy products, (4) Bird nests and bird nest products, (5) Casings, (6) Bee products, (7) Eggs and egg products, (8) Edible oils and fats, (9) Stuffed wheaten products, (10) Edible grains, (11) Milled grain industry products and malt, (12) Fresh and dehydrated vegetables and dried beans, (13) Condiments, (14) Nuts and seeds, (15) Dried fruits, (16) Unroasted coffee beans and cocoa beans, (17) Foods for special dietary purposes, and (18) Functional food.

  • GACC has indicated that existing registrations for the first four categories of products will continue to be recognized. Further, FDA already facilitates registration of seafood, dairy, and infant formula, and firms that are already certified by FDA to export these products to China need not take further action with regard to facility registration; however, all other requirements mandated under Decree 248, e.g., declaring the facility registration number on the food package, must be followed. Additionally, Article 9 of Decree 248 mandates that facilities that manufacture, process, or store all food other than those in the 18 categories referenced above must self-register.

  • In contrast, all U.S. establishments that manufacture, process, or store products in categories five through eighteen for export to China may now submit an application via FDA’s Export Listing Module (ELM) to facilitate registration of these facilities with China; step-by-step instructions are available. Applications to the ELM should be submitted by December 17, 2021.

 

© 2022 Keller and Heckman LLPNational Law Review, Volume XI, Number 341
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About this Author

Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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