United States of America - Export requirements for milk and dairy products

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1. Eligible/ineligible products

1.1 Eligible

All dairy products (Grade A and Grade B) as well as infant formula.

  • Grade A milk products such as fluid milk, cream products, yogurt, cottage cheese, eggnog, buttermilk, dried dairy products and some whey products. These products are subject to the provisions of the "Grade A Pasteurized Milk Ordinance" (PMO) (PDF). See section 2 below
  • Grade B or non-classified A products such as milk, industrial quality cream, cheeses, frozen dairy desserts, butter

Examples of dairy products that have already been exported to United States of America (US):

  • milk
  • cream
  • cheese (cheddar and cheddar types, specialty cheese, processed cheese, fresh cheese)
  • ice cream (dairy based edible ice)
  • yogurt
  • butter and other fats and oils derived from milk
  • evaporated milk
  • condensed milk
  • skim milk powder
  • whole milk powder
  • casein and casein products
  • products consisting of natural milk constituents
  • infant formula
  • others (for example: lactose and lactose syrup, milk albumin and butter milk products)

1.2 Ineligible

No information is known regarding ineligible products.

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

2.1 Country

Canada is authorized to export dairy products.

2.2 Establishments

No information is known regarding an approved list of eligibility for establishments.

The manufacturing of dairy products must be under the official oversight of the Canadian Food Inspection Agency (CFIA) and be licensed under the Safe Food for Canadian Regulations (SFCR).

Note that to carry out certain provisions of the Bioterrorism Act, the Food and Drug Administration (FDA) established regulations requiring that food facilities register with the FDA and provide advance notice regarding shipments of imported food products. For more information refer to the following website Online Registration of Food Facilities.

Furthermore, the US FDA can evaluate the system of the importing country to guarantee the safety of dairy products and compare the effect of this system with that of the American system on the safety of locally produced dairy products.

Regarding, Grade A" milk and milk products, the system of controls used to provide the U.S.'s appropriate level of protection for "Grade A" dairy products is described in the current edition of the "Grade A Pasteurized Milk Ordinance" (PMO) (PDF) and related documents. The PMO prohibits the importation of "Grade A" milk and milk products from establishment are not certified as "substantially equivalent" to the PMO.

The National Conference on Interstate Milk Shipments (NCIMS) Memoranda of Information M-I-00-4 (PDF) identifies the options available which are consistent with NCIMS procedures and allow States to receive "Grade A" milk and milk products produced outside of the USA. A dairy firm outside of the United States could contract with any current NCIMS member's regulatory/rating agency to provide the "Grade A" milk safety program in total. Additional information can be found on the US FDA website Coded Memoranda Issued by Milk Safety Branch.

Regarding Infant formulas that are sold in the U.S., whether manufactured in the U.S. or imported, must meet the requirements of the Infant Formula Act (section 412 of the Food, Drug, and Cosmetic Act) and associated regulations in 21 CFR 106 and 21 CFR 107, including the requirement for premarket registration and notification to FDA (see 21 CFR 106.110 and 21 CFR 106.120). The failure to provide the premarket notice required by the Infant Formula Act is a prohibited act per the Food, Drug, and Cosmetic Act (21 U.S.C. 331(s)), (Infant Formula Registration & Submissions | FDA).

The FDA requires that manufacturers of infant formula undergo an annual inspection. In general, the FDA schedules this inspection during the first production of a formula run whose notification has been accepted. The CFIA is not involved in this process.

2.3 Products

No information is known regarding dairy products registration. For infant formula, the FDA must be notified before a new formula or a modified formula is marketed.

2.4 Import permit

An import permit may be required. Exporter should work with the importer to verify this condition.

For certain products, an import permit (VS Form 16-6A) is required by the Animal and Plant Health Inspection Services (APHIS) of the United States Department of Agriculture (USDA).

More information can be found here Animal Product Imports | Animal and Plant Health Inspection Service (usda.gov).

3. Product specifications

No information is known regarding product specifications. Microbiological requirements and maximum residue limits in United-States of America may differ from those in Canada. Failure to comply with these standards could result in a shipment being rejected at the border control port.

4. Production controls and inspection requirements

The manufacturer must be aware of the standards and requirements of the importing country. A specific export procedure must be in place.An export control plan must (ECP) be in place to demonstrate that your products meet the requirements of the importing country.

Manufacturer's declaration

Note: inspectors will verify that the manufacturer's declaration is completed appropriately and reserve the right to request any other information that they think is necessary for the final certification of the product.

Certification requirements

The health certificate CFIA/ACIA 5813 contains animal health and public health requirements.

Animal health attestations

The animal health requirements on the health certificate CFIA/ACIA 5813 are met based on Canadian regulations. In Canada, foot and mouth disease, rinderpest, Rift Valley fever and la peste des petits ruminants are reportable disease under the Health of Animals Act.

Public health attestations

The public health requirements on the health certificate CFIA/ACIA 5813 are met based on Canadian regulations.

Dairy products manufactured in Canada and destined for the market of Unites-States of America are also subject to pasteurization or any combination of control measures with equivalent level of performance, in accordance with the recommendations of World Organization for Animal Health and/or as indicated in the Codex Alimentarius code of hygienic practice for milk and milk products.

5. Labelling, packaging, and marking requirements

It is the exporter's responsibility to meet all the requirements for labelling, packaging and marking requirements as required by the importing country.

6. Required documents

Canada does not have a negotiated certificate with the United States of America. Generally, no certification is required. If requested, the dairy standard certificate (CFIA/ACIA 5813) is recommended.

Request for any additional statement to the certificate must be confirmed at the national level by the CFIA's food export section.

The certificate below is accepted by the USA, however, it is highly recommended to the exporter to verify this information with its importer.

Certificate

Health certificate for the export of dairy products and dairy based products for human consumption (CFIA/ACIA 5813)

Note: in the case where Canadian dairy ingredients are used to manufacture products in a foreign country and these will be subsequently shipped to the EU, the foreign country operator may request Canadian documentation to support export certification. The model "Health certificate for dairy products manufactured in Canada and used in foreign countries for export to the European Union" (accessible only on the Government of Canada network – RDIMS 15883053). The statements on this document are taken from the model dairy certificates that are in Regulation (EU) 2020/2235. Contact your local CFIA office to obtain this certificate.

  • The health certificate is signed by the CFIA official veterinarian and official inspector
  • This country accepts the digital certificate signed electronically
  • The health certificate is written in three languages: Spanish, English and French
  • Export certificates cannot be issued for products that have left Canada

7. Other information

Exported products transiting through a country may require transit documentation. It is the responsibility of the exporter to ensure that the shipment will be accompanied by all necessary certificates.

Samples (personal or commercial) may be subject to the same requirements as a regular shipment. It is strongly recommended that the exporter verify these requirements with their importer.

Relevant links

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