Monday, November 15, 2021

New European Union Import Requirements for Composite Products

US Food and Drug Administration

U.S. Food Exporter News from FDA

Center for Food Safety and Applied Nutrition 

News and updates for U.S. exporters of FDA-regulated food products


New European Union Import Requirements for Composite Products

November 15, 2021

The European Union (EU) regulates food products containing both products of plant origin and processed products of animal origin as composite products. All processed products of animal origin that are used as ingredients in composite products exported to the EU must come from EU-approved establishments.  Effective January 15, 2022, composite products are subject to new certification requirements for export to the EU. Exports of non-shelf-stable composite products and shelf-stable composite products that contain meat products other than gelatin, collagen, or highly refined products derived from meat must be accompanied by an official certificate that identifies the approved establishment(s) that supplied each processed product of animal origin. Exports of shelf-stable composite products that do not contain meat products except gelatin, collagen, or highly refined products derived from meat do not need an official certificate and must be accompanied by a private attestation established in Annex V of Commission Implementing Regulation (EU) No 2020/2235.

FDA encourages U.S. exporters to prepare for the new requirements by confirming the EU approval numbers for any establishments that supply processed products of animal origin that are used as ingredients in the manufacturing of composite products intended for export to the EU. Establishments that manufacture composite products do not need to be approved by the EU, unless the processing of the ingredients of animal origin occurs during the manufacture of the final composite product. U.S. establishments that produce processed products of animal origin may contact the relevant U.S. competent authority to request inclusion on the EU's lists of approved establishments.

FDA is the U.S. competent authority for providing updates to the EU lists of approved establishments for dairy, seafood, bivalve molluscan shellfish, collagen, gelatin, shell eggs, and FDA-regulated egg products. Industry stakeholders may apply for inclusion on the EU's lists of approved establishments for these products via FDA's Export Listing Module. Visit Online Application for Export Lists for more information. To allow adequate time for processing of applications, FDA advises all establishments that wish to be included in FDA's next update to the lists to apply by November 30, 2021. Note: The ELM will be updated later this month to accommodate applications to be listed for shell eggs and FDA-regulated egg products.

USDA's Food Safety Inspection Service (FSIS) is the U.S. competent authority for providing updates to the EU lists of approved establishments for FSIS-regulated egg products, meat, and poultry. For more information on how to export FSIS-regulated products to the EU, visit FSIS's Export Library.

For more information on the EU's import requirements for composite products, visit EU import conditions for composite products.

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