United States of America – Export requirements for processed egg

CFIA, in consultation with the Food Safety Inspection Service (FSIS), has initiated a comprehensive review of the Export library for the United States of America (USA) to remove outdated requirements and ensuring that this page reflects their updated United States (US) Egg Products Inspection Regulations that came into effect in 2020.

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

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: please 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:

Please 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 categories

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.

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 (PDF) Import Inspection Application (Meat, Poultry & Egg Products)
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.

Table 1. Former Pasteurization Requirements for Liquid Egg Products That Could Be Used as Safe Harbors
Liquid Egg Products	Minimum Temperature Requirements (°F)	Minimum Holding Time Requirements (Minutes)
whole egg	140	3.5
whole egg blends (less than 2% added nonegg ingredients)	142 140	3.5 6.2
fortified whole egg and blends (24–38% egg solids, 2–12 percent added nonegg ingredients)	144 142	3.5 6.2
salt whole egg (with 2% or more salt added)	146 144	3.5 6.2
sugar whole egg (2–12% sugar added)	142 140	3.5 6.2
plain yolk	142 140	3.5 6.2
sugar yolk (2% or more sugar added)	146 144	3.5 6.2
salt yolk (2–12% salt added)	146 144	3.5 6.2

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.

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.

Please 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, please 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

Please 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

The USDA-FSIS considers the failure to provide notification or to present shipped product at an import inspection establishment as a violation.
Please consult the USDA-FSIS Fact Sheet: FSIS Import Inspection and Failure to Present (FTP) document for more information.

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. Please 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 (CFIA/ACIA 2684) 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 remarks section of the export certificate CFIA/ACIA 2684 as well as on the USDA-FSIS: Form 9540-1 (PDF) Import Inspection Application (Meat, Poultry & Egg Products).

5. Documentation requirements

Certificate

Certificate of Inspection for Processed Egg (CFIA/ACIA 2684)
The following statements and information must be written in the remarks section:
1. "The product described was produced in accordance with the regulatory requirements in 9 CFR 590.910."
2. Process Category^Footnote 1
3. Product Category^Footnote 1
4. Species^Footnote 1
5. Product group^Footnote 1
6. Shipping marks
7. "The results were obtained from a lab that is accredited by the Standards Council of Canada or the Canadian Association for Laboratory Accreditation" (if applicable)
8. Temperature of the product when shipped in °F or °C
9. Temperature at time of loading in °F for export tankers
10. "Diversion set point for this product was 134°F" (for shipments of liquid or frozen pasteurized albumen)
11. "Samples only – No commercial value" (for shipments of samples)
12. CFIA official seal number, and date and time of sealing
13. "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

Licensed processed egg establishments in Canada can ship samples of processed egg to customers for their personal use, display or laboratory analysis in the USA.
Samples should not exceed 22.6 kg (50 lbs) of liquid, frozen or dried egg product, unless otherwise authorized by the USDA.
The procedure that must be followed for these samples is as follows:
1. Customer(s) in the USA must notify USDA prior to importing processed egg samples.
2. Documentation for this notification shall be submitted to importinspection@usda.gov, in advance of the shipments arrival.
3. The applicant must provide a USDA-FSIS: Form 9540-5 (PDF) Notification of Intent to Import Meat, Poultry or Egg Products "Samples for Laboratory Examination, Research, Evaluative Testing, or Trade Show Exhibition"
4. If the sample has received continuous inspection coverage by the CFIA, a Certificate of Inspection for Processed Egg (CFIA/ACIA 2684) will be issued.
5. Plants must also complete a USDA-FSIS: Form 9540-1 (PDF) Import Inspection Application (Meat, Poultry & Egg Products) when applicable.
6. Certificates are to say clearly state "Samples only – No commercial value" in the remarks section.

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)

Date modified:: 2024-04-18

Language selection

Search