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Breaking News: China Proposes New Facility Registration Requirements for Overseas Food Producers

On November 26, 2019, the General Administration of the Customs of the People's Republic of China (GAC) issued the Revised Draft Management Rules for the Registration of Overseas Production Enterprises of Imported Food (hereinafter "the Draft") for public comments, due December 25, 2019. Specifically, GAC proposes to expand the facility registration scope from the current inventory-based food categories to, potentially, all food categories. This could have a significant impact on overseas food producers who may have to register their facilities in the future, should GAC's net cast wide enough to capture a broader base of food categories.

By way of background, since China's government reshuffle in March 2017, GAC has taken charge of all import and export responsibilities, including the registration and supervision of overseas food production enterprises. At present, only certain foods on the inventory are subject to manufacturing facility registration before one can export to China, such as meat, aquatic, and dairy products. However, under the Draft, GAC will classify all foods in terms of their risks and implement a risk-based registration scheme.

Specifically, GAC, per risk level of the imported food, will determine the key control points, methods and frequency of supervision and inspection on overseas food production enterprises.  For imported foods with high risk and high consumer sensitivity, GAC is proposing, for the first time, an annual review and reporting system for overseas food manufacturers. As it relates to other food safety regulations in China, the authorities have classified foods like meat and dairy as "high risk" and infant formula as a food with "high consumer sensitivity," but it remains to be seen how GAC will define these categories under the new proposal. We expect the specific risk classification of different foods and more detailed implementation measures to be revealed and announced in 2020.

In addition, the Draft requires that the name and address of the manufacturer, as well as the registration number, shall be labeled on the minimum sales package of food exported to China. Notably, the validity period of the registration is proposed to be extended from the current four years to five years.

© 2020 Keller and Heckman LLPNational Law Review, Volume IX, Number 343

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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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