Action Required: All manufacturers that are currently, or have the potential to, contribute dairy ingredients to non-shelf-stable composite products or shelf-stable composite products containing meat exported to the European Union (EU) must now register with the Food and Drug Administration (FDA) to be added to the EU-approved plant list. Please note that there is no change to the plant registration requirements for non-composite products using one of the dairy product certificates; the EU will continue to require plants exporting dairy products to the EU to appear on the EU-approved list.

Regulatory Change: The new composite health certificates, for non-shelf stable products, included in Chapter 50 of Commission Implementing Regulation (EU) 2020/2235 require identification of either the EU list plant number or the FDA Establishment Identification number (FEI) of the company making the final composite product. In addition, the EU list plant number of the manufacturers of the dairy inputs included in the final composite product must now be identified. The latter of which is a new requirement.

Please note that all dairy facilities contributing dairy ingredients to non-shelf stable composite products must be on the EU-approved list. We encourage companies to register with the FDA to be added to this list as soon as possible to ensure that non-shelf stable composite product manufacturers remain eligible to receive the composite certificates when this transition to the new certificates takes place.

Given the very close proximity of the FDA's December 31, 2021, deadline for registering for the EU list before the new EU certificates' January implementation date, USDEC strongly encourages members to register their facilities with FDA no later than November 30, 2021. We have asked FDA to consider sending an interim updated list of U.S. establishments eligible to export to the EU in December. FDA will still be sending to the EU the normally scheduled list of U.S. establishments eligible to export to the EU at the end of the 4th quarter, which will be December 31, 2021. However, due to shipping delays, the holidays, and the potential for delays in the registration process, USDEC is strongly recommending that members not wait until the December 31 deadline to register their facilities with FDA. In order to be included on the FDA list of registered plants,  manufacturers must file an application with FDA using the FDA Unified Registration and Listing Systems (FURLS) Export Listing Module (ELM). ELM users should contact the FDA directly with any questions on the ELM system.

EU Transiting Products: Inclusion on the FDA's list of EU approved establishments is not necessary for dairy products or ingredients used in products merely transiting through an EU port. In order to demonstrate compliance with animal health attestations of (EU) 2020/2235, records must be maintained to verify that the individual farm milk supply has been produced under the FDA Grade 'A' Pasteurized Milk Ordinance (PMO) or USDA's Milk for Manufacturing Purposes (MMP) farm production requirements. Record keeping requirements may be met by maintaining a Certificate of Conformance on file for dairy ingredients used within the composite product. Records may also include farm permits or farm inspection records to verify farm milk production under a regulatory standard.

Please contact Bryan Jacoby at bjacoby@usdec.org with any questions.