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U.S. FDA Recognizes Australia as Having Comparable Food Safety System

  • Today, the U.S. Food and Drug Administration (FDA) announced that the Agency has signed an arrangement with the Australian Department of Agriculture and Water Resources recognizing each other’s food safety systems as comparable to one another. This follows FDA’s decision to recognize New Zealand and Canada as comparable foreign food safety systems in 2012 and 2016, respectively. In recognizing each other’s systems as comparable, the FDA and Australian Department of Agriculture and Water Resources have expressed confidence that they can leverage each other’s science-based regulatory systems to help ensure food safety.

  • Imports from Australia must continue to comply with U.S. statutory and regulatory requirements to ensure safety and proper labeling, including the new standards adopted under the FDA Food Safety Modernization Act.  As a practical matter, however, FDA’s recognition of Australia’s food system as comparable means that importers of certain foods originating in Australia will face less of a compliance burden with respect to FDA’s Foreign Supplier Verification Program (FSVP) Rule. Under FSVP, certain types of foods originating from “comparable” countries are excluded from most of the standard FSVP requirements (including hazard analysis and verification requirements) provided that:

    • The food is within the scope of the relevant official recognition or equivalency determination;

    • The importer determines that the foreign supplier of the food is in good compliance standing with the relevant food safety authority; and

    • The food is not intended for further processing in the United States, e.g., packaged food products and raw agricultural commodities (RACs) that will not be processed further before consumption.

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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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