Action Required: All manufacturers that are currently or have the potential to contribute dairy ingredients to composite products (see below) exported to the EU or transiting the EU must now register with FDA to be added to the EU-approved plant list.

Regulatory Change: The new composite health and transit certificates included in Chapters 50 and 52 of Commission Implementing Regulation (EU) 2020/2235, and the Private Attestation in Annex V, require identification of both the plant number of the company making the final composite product (which was already required) and the plant number of the manufacturers of the dairy inputs included in the final composite product, which is a new requirement. The plant of both the final manufacturer and all companies providing dairy ingredients to the final manufacturer must be listed on the EU-approved list. The EU requires issuance of the new EU composite certificates by August 21, 2021. 

Please note that all dairy facilities contributing dairy ingredients to composite products must be on the EU-approved list at the time of production. We encourage companies to register with FDA to be added to this list as soon as possible to ensure that composite product manufacturers remain eligible to receive the composite certificates when this transition to the new certificates takes place. The FDA sends the EU updated lists every quarter. The deadlines for registration with FDA for the quarterly updates prior to the launch of the new certificates are March 31 and June 30.

FDA Plant Registration: 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). The dairy plant registration is the top right option. FDA includes step-by-step instructions for the ELM and additional information on plant list registration on its Online Applications for Export Lists website. ELM users should contact FDA directly with any questions on the ELM system. Contact details for the Help Desk are half-way down the FDA Industry Systems page.

Composite Products: The EU defines composite products as foodstuffs "intended for human consumption that contains both processed products of animal origin and products of plant origin and includes those where the processing of primary product is an integral part of the production of the final product." The HS codes listed on the composite certificates (other than meat and fisheries products of Chapter 16) and are:

• 19.01 - Food preparations of flour, groats, meal, starch or malt extract, not containing cocoa or containing less than 40% by weight of cocoa calculated on a totally defatted basis, not elsewhere specified or included; Food preparations of goods of heading 04.01 to 04.04, not containing cocoa or containing less than 5% by weight of cocoa calculated on a totally defatted basis, not elsewhere specified or included
• 19.02 - Pasta, whether or not cooked or stuffed (with meat or other substances) or otherwise prepared, such as spaghetti, macaroni, noodles, lasagna, gnocchi, ravioli, cannelloni; couscous, whether or not prepared
• 19.05 - Bread, pastry, cakes, biscuits and other bakers' wares, whether or not containing cocoa; communion wafers, empty cachets of a kind suitable for pharmaceutical use, sealing wafers, rice paper and similar products
• 20.04 - Other vegetables prepared or preserved otherwise than by vinegar or acetic acid, frozen, other than products of heading 20.06
• 20.05 - Other vegetables prepared or preserved otherwise than by vinegar or acetic acid, not frozen, other than products of heading 20.06
• 21.03 - Sauces and preparations therefor; mixed condiments and mixed seasonings; mustard flour and meal and prepared mustard
• 21.04 - Soups and broths and preparations therefor; homogenized composite food preparations
• 21.05 - Ice cream and other edible ice, whether or not containing cocoa
• 21.06 - Food preparations not elsewhere specified or included

Scope Clarification: USDEC has asked FAS to clarify whether the requirement for all manufacturers of composite products and dairy ingredients in those products to be on the EU list for goods that only transit the EU was intentional or in error as the EU has historically not required manufacturing plants to be on the EU list for goods that transit the EU but have a final destination outside the EU. Until we receive clarification, exporters should assume that inclusion on this list will be required as published in the regulation. Please note that this question involves only transit certificates; the composite health certificate and private attestation are expected to continue to require all plants contributing ingredients to composite products entering the EU to be on the EU-approved list.

There is no change to the plant registration requirements for products certified with the dairy certificate. The EU will continue to require plants exporting dairy products to the EU to appear on the EU-approved list.

Please contact Sandra Benson at sbenson@usdec.org or Bryan Jacoby at bjacoby@usdec.org with questions.