United States of America – Export requirements for processed egg

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1. Eligible/ineligible product

Eligible

  • All processed egg products, including:
    • Freeze dried egg products: egg product that is flash frozen and placed in a vacuum chamber
    • Egg substitutes: egg whites with added color, mineral, or vitamin, and sold as a low-cholesterol alternative to whole egg products
    • Egg products (defined as Processed egg products under Safe Food for Canadians Regulations): shell eggs that are broken and processed into liquid, frozen, or dried egg white, egg yolk, or whole egg products (full definition may be found in 9 CFR 590.5)

Additional information can be found at Egg Product and Food Safety.

Note: Canada is considered one of the countries that have a system of inspection equivalent to the United States of America (USA).

Ineligible

  • Quail eggs are not eligible for breaking under United States Egg Products Inspection Act.
  • Some examples of products exempt from FSIS oversight are as follows:
    • cooked eggs
    • dietary foods
    • dried no-bake custards, egg nog mixes
    • acidic dressings
    • noodles
    • milk and egg dip
    • cake mixes
    • French toast and
    • sandwiches containing eggs or egg products

These export requirements do not apply to the above products. The US FDA is responsible for the inspection of these type of products.

Find more information on the US FDA requirements or call 1-888-463-6332

2. Pre-export approval by competent authority of the importing country

Country

Canada is considered eligible to export processed egg to the US.

Establishments

  • Establishments exporting processed egg must be under the official supervision of the Canadian Food Inspection Agency (CFIA) and be authorized under the Safe Food for Canadians Regulations (SFCR)
  • Establishments exporting to the USA must also be on the Eligible Foreign Establishments list of approved establishments that is administered by the United States Department of Agriculture (USDA) – Food Safety and Inspection Service (FSIS)
  • Establishments seeking addition to the FSIS list must contact their CFIA regional office and submit the following documents
    • letter to the CFIA on company letterhead, signed by the responsible company official, formally requesting addition to the FSIS list and include the following information;
      • name of establishment
      • establishment identification number (previously called registration number)
      • physical location of establishment
      • type of operations – breaking / processing
      • species: includes specific poultry (for example, chicken)
      • product categories: specific details on different types of products (for example, unpasteurized liquid whole egg without added ingredients, pasteurized liquid egg white (albumen) without added ingredients
      • effective date: specify
    • copy of the establishment licence and registration certificate (now called establishment ID number); and
    • details of different egg product categories intended for export (see Egg product categories)
      • Should an establishment currently exporting to the US want to add a different egg product group/category, this should be notified to CFIA, who will notify the FSIS so that the Public Health Information System (PHIS) is updated. This should be done, before the establishment begins preparing; and exporting product to the US. If not, the exporter is responsible for any cost associated with the product being rejected by the FSIS

Note that any establishment on the USDA FSIS approval list may be selected for audit by FSIS. As a regulated party, you have an obligation to inform CFIA if you wish to maintain or remove your establishment from the FSIS list.

In addition, CFIA reserves the right to periodically verify the eligibility of listed establishments and may remove from the list establishments that are not actively exporting to the U.S. and/or do not meet U.S. requirements.

Note

  • Note that FSIS has added the letter "E" to the registration numbers of Canadian processed egg products establishments to distinguish them from Canadian establishments producing meat/poultry products
  • The CFIA recommends listing to the FSIS once information received from establishments is reviewed and considered complete
  • Exporters are responsible for verifying the establishment listing, before requesting an export certificate from the CFIA

Egg product categoriesFootnote 1

HACCP process category

  • eggs/egg products

Finished product category

  • egg products

Species

  • chicken
  • duck
  • goose
  • guinea
  • turkey

Product group

  • Pasteurized (frozen or liquid)
    • whole egg, with or without added ingredients
    • egg whites, with or without added ingredients
    • egg yolk, with or without added ingredients
    • egg products (blends of whole egg, egg whites and/or yolks), with or without added ingredients
  • Pasteurized (tanker or large totes)
    • whole egg, with or without added ingredients
    • egg whites, with or without added ingredients
    • egg yolk, with or without added ingredients
    • egg products (blends of whole egg, egg whites and/or yolks), with or without added ingredients
  • Unpasteurized (frozen or liquid)
    • whole egg, with or without added ingredients
    • egg whites, with or without added ingredients
    • egg yolk, with or without added ingredients
    • egg products (blends of whole egg, egg whites and/or yolks), with or without added ingredients
  • Unpasteurized (tanker or large totes)
    • whole egg, with or without added ingredients
    • whole egg, with or without added ingredients
    • egg whites, with or without added ingredients
    • egg yolk, with or without added ingredients
    • egg products (blends of whole egg, egg whites and/or yolks), with or without added ingredients
  • Dried
    • whole egg, with or without added ingredients
    • egg whites, with or without added ingredients
    • egg yolk, with or without added ingredients
    • egg products (blends of whole egg, egg whites and/or yolks), with or without added ingredients

Labelling

Some of types of labels and labelling claims (for example, cage free whole egg) will need to be submitted to FSIS for pre-approval. Pre-approval for such label claims would need to be made, irrespective of whether the product is going for further processed or retail sale. For details, refer to the FSIS website at FSIS Guideline for Label Approval.

Prior notice

  • The USA requires prior notice to import, which includes providing information on all food for use, storage or distribution in the United States

3. Production controls and inspection requirements

  • Products to be exported to the USA must be prepared under continuous supervision of an inspector as per 1034 (a) of Chapter 15 – Egg Products Inspection under Title 21 – Food and Drugs in the United States Code. Products under continuous supervision must be inspected, as per the Safe Food for Canadian Regulations (SFCR); and agreed upon by FSIS as being equivalent to the FSIS' New egg products rule

  • As per the new Egg products rule, FSIS now interprets "continuous inspection" in an egg products establishments as at least once per shift inspection. This equivalent to the processed egg product establishment receiving at least one visit by a CFIA inspector during each twelve (12) hour window of operation, every day while the establishment is in production. This is defined as Daily Shift Inspection Presence (DSIP) and will be implemented as a condition for export of egg products to the US

    Note: DSIP does not apply to establishments when they are only producing processed egg based products that fall under the sole jurisdiction of the Food and Drug Administration (FDA), for example, cooked eggs, and egg nog mixes.

  • Processed egg produced at one station and shipped to another for processing is considered to be product from a feeder station. If the final product is processed for export to the USA, the production of the egg at the feeder station must also have received DSIP coverage

    Note: if an inactive but eligible establishment plans to export to the US, it will be required to provide CFIA one month notice prior to their first date of production for the US. The CFIA will inform the establishment when the inspection oversight to meet FSIS requirements is in place, at which point production may begin for export to the US.

  • The processed egg products for exports should use the FSIS list of safe and suitable ingredients during the preparation of the product

    Note: any lot of pasteurized processed egg that has tested positive for a pathogen of human health concern and is subsequently reprocessed must not be exported to the United States.

Pasteurized products

  • Exporters of pasteurized, finished processed egg products are required to schedule an inspection at an FSIS import inspection establishment at the United States-Canada border in advance
  • The USDA-FSIS PHIS requires United States importers (or designated agents) to complete USDA-FSIS: Form 9540-1 Import Inspection Application (Meat, Poultry & Egg Products) (PDF)
  • Notification will occur when the United States importer (or its designated agent) files entry with Custom and Border Protection (CBP), provided this entry is made through the Automated Commercial Environment (ACE)
  • ACE will transmit data to PHIS, including the Customs Entry Number (CEN), Bill of Lading (BOL) number and the Harmonized Tariff Schedule (HTS) number
  • This information will provide FSIS with advance notice of the egg products shipment. Based on the notification, FSIS will generate inspection assignments through PHIS
  • The liquid egg products were pasteurized at the minimum time and temperature requirements below
Table 1. Pasteurization requirements for liquid egg products
Liquid egg products Minimum temperature requirements (°C) Minimum holding time requirements (minutes)
Albumen (without use of chemicals) 56.6
55.5		 3.5
6.2
Whole egg 60 3.5
Whole egg blends (less than 2% added nonegg ingredients) 61.1
60		 3.5
6.2
Fortified whole egg and blends (24-38% egg solids, 2-12 percent added nonegg ingredients) 62.2
61.1		 3.5
6.2
Salted whole egg (with 2% or more salt added) 63.3
62.2		 3.5
6.2
Sugar whole egg (2–12% sugar added) 61.1
60		 3.5
6.2
Plain yolk 61.1
60		 3.5
6.2
Sugar yolk (2% or more sugar added) 63.3
62.2		 3.5
6.2
Salted yolk (2–12% salt added) 63.3
62.2		 3.5
6.2
Table 2. APHIS Pasteurization requirements for Dried Egg Products
Dried egg products Minimum temperature requirements (°C) Minimum holding time requirements (minutes)
Dried egg albumen 67 10

Unpasteurized products

  • Exporters of unpasteurized egg products will be permitted to move their product directly to an official USDA processed egg establishment for inspection, rather than having to stop for inspection at an FSIS import inspection house
  • All bulk shipments of unpasteurized egg products exported should meet the requirements under 9 CFR 590.410(c). If the unpasteurized shipment is sent via tanker trailers, all relevant documentation needed to meet this requirement should accompany with the documentation package carried by the transport company

Imported shell egg/processed egg products ingredients

The use of imported egg ingredients (breaking stock or processed egg) from certain countries (other than the US) may limit the ability of export to the US.

  • For shell egg and/or breaking stock, CFIA recommends working with your importer regarding US import requirements
  • For processed egg intended for export to the United States, it must originate from an eligible establishment in a country eligible to export to the US

Note: It is the responsibility of the exporter to confirm the use of imported ingredients and the requirements of each responsible regulatory body in the US. The inspector reserves the right to request any other information that they think is necessary for the final certification of the product.

Sampling of egg product for export

  • All lots must be sampled by the establishment for:
    • Salmonella
    • Listeria
    • aerobic colony count (ACC)
    • coliforms
    • solids (where applicable)
    • moisture (where applicable)
    • odour
  • Sample testing may be performed by the CFIA or a lab accredited by the Standards Council of Canada (SCC) or the Canadian Association for Laboratory Accreditation (CALA)

  • The results of the lab analysis must be provided to the CFIA for review, prior to, any export certification being completed

    As of February 21, 2020, the CFIA has obtained equivalency with the United States Department of Agriculture – Food Safety and Inspection Service (USDA-FSIS) for Salmonella, Listeria monocytogenes, and Listeria spp. qualitative methods published in Health Canada's Compendium of Analytical Methods (CAM). These methods can be obtained from the Health Canada Compendium of Analytical Methods site. Note that the most recent published version of the method should be used. The "application" section of the method chosen must be appropriate for the intended purpose.

    Industry must ensure that their laboratories and/or private accredited laboratories contracted for testing are informed of this equivalency.

    Industry must inform their private laboratories that testing is submitted for a US eligible establishment and to follow these testing method(s).

    • Health Canada Compendium of Analytical Methods (qualitative methods)
    • USDA FSIS Microbiology Laboratory Guidebook

    Should industry wish to use other methods, they must contact the Food Safety Science Services Division (FSSSD) of the CFIA, for FSSSD to determine equivalency and fitness for use.

    Note the following US import requirements for sample testing sizes

    For Listeria testing in RTE meats and egg products, a 125 g portion must be analyzed. Swabs of environmental surfaces may be tested individually or composited (up to 10 swabs).

    For Salmonella testing in egg products, a 100 g portion must be analysed.

    In addition, FSIS will accept all methods for the above pathogens published in the USDA/FSIS Microbiology Laboratory Guidebook. Previous versions of MLG screening methods (specifically Listeria monocytogenes (8A.06), and Salmonella (4C.07) may continue to be used. To obtain copies of these versions of the screening methods, contact FSIS Laboratory Quality Assurance, Response and Coordination Staff by mail or telephone:

    FSIS Microbiology Section
    Laboratory Quality Assurance Response and Coordination Staff, USDA/FSIS/OPHS
    950 College Station Road
    Athens GA 30605
    Phone: 706-546-3559

    Direct questions or comments to FSSSD at the following e-mail address: cfia.labcoordination-coordinationdeslaboratoires.acia@inspection.gc.ca

Export tankers

  • In order to prevent contamination of processed egg product, tankers that are to be used to transport processed egg products must have been previously used to transport food products only
  • These tankers must be thoroughly washed, rinsed and sanitized. If the tanker has been cleaned in a place other than the processed egg product establishment, the wash certificate must be made available to the inspector
  • Tankers should be verified by the establishment for cleanliness, prior to loading product, to ensure that the cleaning process has been effective and that the tankers are visually clean
  • Although many tankers are now insulated, the product temperature of liquid egg may rise during transport. The processor should be aware of the maximum product temperature upon arrival at the customer
  • The USDA has stated that the temperature of liquid egg arriving by tanker must be at 4.4°C (40°F) or less upon arrival. This may mean loading the liquid egg at a temperature lower than 4.4°C (40°F) in Canada to ensure it meets the temperature requirement upon arrival in the United States

Natural proportion whole egg

  • Licenced or registered processed egg product establishments in Canada can export natural proportion whole egg to the USA
  • Natural proportion whole egg is the product that results from the unaltered break of shell eggs in a breaking station
  • This means that yolk or albumen is neither added nor removed from the liquid whole egg.
  • This product does not have to meet the 24.2% solids requirement

Failure to present

Canadian product returning from the United States

  • Egg products enter the United States from Canada either as raw (unpasteurized) products intended for further processing or as pasteurized egg products for use directly as food or for use in the food system
  • Product may be rejected and returned to the Canada for the following reasons
    • incomplete and/or incorrect paperwork
    • company name and/or product not recognized/listed as eligible to export to the USA
    • failure to comply with standards based on inspection and/or
    • failure to comply with standards based on product testing

Note: the exporter should notify the CFIA of the returning product and the reason it was refused. The exporter is responsible to arrange for the return of the product.

4. Labelling, packing and marking requirements

  • All labelling, packing and marking criteria must meet the USDA requirements (FSIS Guideline for Label Approval), as per the applicable regulations. Work with your importer

Shipping marks

  • Shipping marks are used to associate a product with a certificate and are required by FSIS
  • Use the CFIA export certificate number or an approved alternative as the unique shipping mark for each shipment
  • The shipping marks may be applied on the shrink wrapped pallet for customers when the individual containers cannot be marked (for example, frozen pails). For example, if a plant is shipping a pallet of pails and one tote to a customer, the pallets would be labelled with a shipping mark and the tote with the shipping mark followed by a "B"
  • Information on the shipping mark should be stated in the additional information section of the export certificate as well as on the USDA-FSIS: Form 9540-1 Import Inspection Application (Meat, Poultry & Egg Products) (PDF)

5. Documentation requirements

Canada has a negotiated certificate with the United States. Request for any additional statements must be confirmed by CFIA's Food Import Export Division (FIED).

Certificate

  • Health certificate for export of egg products from Canada to the United States (CFIA/ACIA FA1024)
  • The following statements and information must be written included additional information section
    1. Diversion set point for this product was 134°F / 56.6°C OR 132°F / 55.5°C (as applicable)"
    2. Samples only – No commercial value" (for shipments of samples)
    3. CFIA official seal number, and date of sealing
    4. Natural proportion whole egg" (if applicable). The statement "eggs were broken in natural proportion" should also be included

6. Other information

Samples to the United States

Re-inspection of products at entry

  • All shipments of meat, poultry, and egg products that are offered for import into the United States must be presented for reinspection at a FSIS official import inspection establishment or at an alternative inspection location authorized by FSIS at the time of importation

Relevant links

United States Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS)

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