May 24, 2022

Volume XII, Number 144

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FDA Update on China Food Facility Registration

 

  • In a December 21 Constituent Update, the FDA announced that they provided the General Administration of Customs of China (GACC) lists of U.S. establishments that sought to be recommended for registration in China via the FDA’s Export Listing Module (ELM). We have previously blogged about the GACC’s registration requirements applicable to all foreign food companies that manufacture, store, or process food exported to China. See our October 25 and December 7 posts for further detail.

  • The FDA has requested that the GACC promptly register these establishments so they can continue to export their goods after January 1, 2022, when the applicable regulations (Decree 248 – Regulations on Registration and Administration of Overseas Manufacturers of Imported Food) will take effect.

  • The Constituent Update noted that the “U.S. government continues to engage with Chinese officials to express concern about the nature of the requirements and gain clarity about how China will apply the new requirements to U.S. products.” Specifically, the U.S. is asking for confirmation that competent authority recommendation is not a requirement for U.S. facilities to register with China. And given the lack of clarity, the U.S. is urging China to delay the implementation of the Decrees by a minimum of 18 months.

 

© 2022 Keller and Heckman LLPNational Law Review, Volume XI, Number 356
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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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