Registration with the United States Food and Drug Administration

Establishments that export or supply food or beverage products to the United States (US) are required to register with the US Food and Drug Administration (FDA). Registration must be renewed between 1 October and ending 31 December of each even-numbered year. FDA encourages facilities to renew their registrations early in the three-month renewal period.

The regulation (21 CFR 170.3) that mandates types of food to be subject to FDA registration is inclusive and defines food as human food, substances migrating to food from food-contact articles, pet food, and animal feed. Registration of food establishments must use the food categories classified under the Public Health Security and Bioterrorism Preparedness and Response Act 2002 (the Bioterrorism Act).

Food facility registrations can be made on the FDA website at registration of food facilities and other submissions.

Additional information can be found on the FDA website at Guidance for industry: Questions and answers regarding food facility registration (seventh edition) – August 2018.

FDA also has three guidance documents available to provide assistance to registrants with the registration process, including information on biennial registration renewal, as follows:

• Small entity compliance guide: Registration of food facilities
• Guidance for industry: questions and answers regarding food facility registration (seventh edition)
• Guidance for industry: necessity of the use of food product categories in food facility registration and updates to food product categories (2016 edition)

Exceptions (ships stores)

Export certification is not issued for ships stores as the Export Control (Milk and Milk Products) Rules 2021 do not apply. Ships stores are milk and milk products on ships or aircraft for the use of passengers and crew or for the service of the ships or aircraft on a voyage from Australia.

There are no known products that are prohibited for export to this market.

The US has implemented new food safety legislation in 2011, the Food Safety Modernisation Act (FSMA) (PDF 350 KB). Under the FSMA, establishments must be listed with the US FDA and may be subject to inspections by the FDA.

Information about registration including questions and answers for industry (PDF 150 KB) are available on the FDA website as well as FSMA rules & guidance for industry.

Milk and milk products of bovine origin are defined as prescribed goods under the Export Control Act. Production of these products for export is regulated under the Export Control (Milk and Milk Products) Rules 2021.

Milk and milk products manufactured from non-bovine species, for example buffalo, goat and sheep, may also need to be regulated through the Export Control (Milk and Milk Products) Rules 2021, though this is only required when export registration and health certification from the department is required by the USA.  

We are not aware that the USA has any known additional requirements for the production and export of non-bovine milk and milk products.

Unless technical products and pharmaceutical material are prepared at an establishment that produces milk and milk products for export as food, these products are non-prescribed goods. They are not regulated by the Export Control (Milk and Milk Products) Rules 2021.

Unless animal food is prepared at an establishment that produces milk and milk products for export as food, these products are non-prescribed goods.

In accordance with the Export Control (Milk and Milk Products) Rules 2021, animal food must be clearly identified as animal food and not for human consumption. It must also be segregated from and not contaminate milk and milk products that are for human consumption.

The US has no known additional requirements for Manufacturing Grade milk and milk products that differ from the Export Control (Milk and Milk Products) Rules 2021.

Manufacturing Grade products are defined in the Export Control (Milk and Milk Products) Rules 2021.

The US has no known additional requirements for microbial sampling of milk and milk products that differ from those required in the Export Control (Milk and Milk Products) Rules 2021.

The US residue standards

Maximum residue limits (MRLs) or import tolerances for residues of specific agricultural and veterinary chemicals approved for use in Australia may not exist in the US or may be established at levels lower than those established in Australia. Maximum Limits (MLs) for contaminants may also vary between ​the US and Australia.

Food business operators should note that:

• These differences can be interrogated case-by-case by considering the US standards and the Australian standards.
• Any detection of a residue above the US MRLs/MLs (as applicable) at the border may result in rejection of the consignment.

Note

Importing country residue standards can usually be found via the official webpages of their competent authority. Links to a limited number of export markets and Australia are provided on the DAFF website.

The US has no known additional requirements for general operations that differ from those required in the Export Control (Milk and Milk Products) Rules 2021.

Specific testing requirements for dry milk products

Australia has agreed under a Memorandum of Understanding (MoU) (PDF 65 KB) with the US Food and Drug Administration, which was signed in 1979, that dry milk products will be accompanied by results of pre-export testing for salmonella, phosphatase and penicillin, so that the products are not subject to extensive testing on arrival in the US.

Dry milk products include dry whole milk, non-fat dry milk, low-fat dry milk, dry cream, dry whey, dry buttermilk, casein; caseinates and co-precipitates. Dry milk products which are marked "FOR NON-EDIBLE USE ONLY" are excluded from this definition.

Samples must be taken from each batch of export product. Batches are defined as a lot in the MOU.

Testing for Salmonella, phosphatase and penicillin

NATA certification must be provided that demonstrates that 30 subsamples of 25g each (total 750g composited) were free of Salmonella, penicillin and phosphatase.

Salmonella testing must be undertaken in accordance with AS 1766.2.5; Food microbiology; Examination for specific organisms; Salmonella (using XLD agar and CLED medium and other media specified in the standard), Negative in 750g.

Phosphatase testing must be undertaken in accordance with AS 2300.1.10; Methods of chemical testing for the dairying industry: General methods and principles; Determination of phosphatase activity. (Aschaffenberg and Mullen method), <10g/ml p-nitrophenol

For penicillin–AS 1766.3.11: Food microbiology, Dairy products, Test for penicillin. (B stearothermophilus disk assay method). <0.003 g/ml penicillin G.

Further information about the requirements of the MoU are in the following attachments to the MOU:

• Attachment A (PDF 6 KB)
• Attachment B (PDF 80 KB)
  

The US has no known additional hygiene requirements that differ from those required in the Export Control (Milk and Milk Products) Rules 2021.

Milk and milk products that are prescribed under Australia's export rules

1. a) are milk or milk products derived from a bovine animal; and
2. b) are intended to be exported as food.

Milk and milk products that are not prescribed under Australia's export rules

Milk and milk products which do not meet the criteria under the Export Control (Milk and Milk Products) Rules 2021 are classified by Australia as non-prescribed goods. It is the responsibility of the exporter to confirm with the importing country if there are any specific requirements for the import of these products. Typically, non-prescribed goods include ice-cream, non-bovine milk products, colostrum and products with a minor component of dairy.

Further information on exporting non-prescribed goods from Australia is available on the Department's website.

In some cases, an importing country requires specific health certification and government oversight for what would typically be non-prescribed milk and milk products. When required, these products become prescribed under export legislation and must meet all export and importing country requirements. This includes the products being manufactured and stored at an export registered establishment and must have a valid export permit and health certificate for each consignment. Guidance on export registration can be found at Dairy export registered establishments.

For further information on export registration and exporting non-bovine milk and milk products for human consumption to the USA contact the Dairy Eggs and Fish Program at DairyEggsFish.agriculture.gov.au 

5.1.1 Health certification for milk and milk products

For milk and milk products produced for human consumption (including milk and milk products classified as a prescribed good by an importing Country), use health certificate template ZD035.

The ZD035 Certificate contains the following attestations:

I hereby certify that to the best of my knowledge the conditions or restrictions applicable under the particular inspection system prescribed under the Export Control Act have been complied with in respect of the prescribed good described above, being goods that are:

1. In sound condition
2. Fit for human consumption
3. Of Australian origin.
   

Endorsement 490 – DAIRY – USA Australian or NZ origin and disease free statement and Department or Australia PI seals applied (edible product)

As a full time salaried veterinary officer of Australia, I declare from the information provided to me that the following is true and correct:

The milk/milk product was processed in Australia a region listed in 9 CFR 94.1(a) (2) from milk produced in Australia and/or New Zealand a region listed in 9 CFR 94.1(a) (2) as free of foot-and-mouth disease and rinderpest. The milk/milk product has never been in any region where foot-and-mouth disease or rinderpest exists except when moving under seal as described in 9 CFR 94.16 (c).

Whenever export documentation is obtained, the exporter must provide a declaration stating that all the information provided in the permit is true and complete. They must also state that they are in possession of a declaration of compliance that:

1. applies to the milk and milk products
2. complies with the requirements of the Export Control (Milk and Milk Products) Rules 2021.

Dried milk products

For dried milk products (with CAS, DML, INF, MEM and WEY product codes), use the E236A Certificate as to Condition of Dry Milk Products to the US.

The E236A Certificate contains the following attestations:

I hereby certify that the produce described above was

1. (1) Examined and found to be
   1. (a) Suitable for human consumption
   2. (b) Negative for penicillin, salmonella and phosphatase in accordance with the requirements of the Memorandum of Understanding between the Department and the Food and Drug Administration
2. (2) Manufactured to the conditions and restrictions applicable under the Export Control Act in respect of the goods have been complied with
3. (3) Was processed, packaged and stored in dairy premises registered under the Export Control Act.

Endorsement 490 – DAIRY – USA, Australian or NZ origin and disease-free statement and Department or Australia PI seals applied (edible product)

As a full-time salaried veterinary officer of Australia, I declare from the information provided to me that the following is true and correct:

The milk/milk product was processed in Australia a region listed in 9 CFR 94.1(a) (2) from milk produced in Australia and/or New Zealand a region listed in 9 CFR 94.1(a) (2) as free of foot-and-mouth disease and rinderpest. The milk/milk product has never been in any region where foot-and-mouth disease or rinderpest exists except when moving under seal as described in 9 CFR 94.16 (c).

The E236A Certificate is to be substantiated by NATA certification of 30 subsamples of 25g each (total 750g composited) certifying that the product is free of Salmonella, Penicillin and Phosphatase as per the Memorandum of Understanding (MOU) with the USA.

Other milk and milk products

For milk and milk products (except CAS, DML, INF, MEM and WEY product codes), use the ZD035 health certificate.

The ZD035 certificate contains the following attestations:

I hereby certify that to the best of my knowledge the conditions or restrictions applicable under the particular inspection system prescribed under the Export Control Act have been complied with in respect of the prescribed good described above, being goods that are:

1. In sound condition
2. Fit for human consumption
3. Of Australian origin

Endorsement 490 – DAIRY – USA, Australian or NZ origin and disease-free statement and Department or Australia PI seals applied (edible product)

As a full time salaried veterinary officer of Australia, I declare from the information provided to me that the following is true and correct:

The milk/milk product was processed in Australia a region listed in 9 CFR 94.1(a) (2) from milk produced in Australia and/or New Zealand a region listed in 9 CFR 94.1(a) (2) as free of foot-and-mouth disease and rinderpest. The milk/milk product has never been in any region where foot-and-mouth disease or rinderpest exists except when moving under seal as described in 9 CFR 94.16 (c).

Whenever export documentation is obtained, the exporter must provide a declaration stating that all the information provided in the permit is true and complete. They must also state that they are in possession of a declaration of compliance that:

1. applies to the milk and milk products
2. complies with the requirements of the Export Control (Milk and Milk Products) Rules 2021.

NATA certificates

NATA certificates should indicate the following methods and results:

• Salmonella – AS 1766.2.5; Food microbiology; Examination for specific organisms; Salmonella. (using XLD agar and CLED medium and other media specified in the standard), Negative in 750g.
• Phosphatase – AS 2300.1.10; Methods of chemical testing for the dairying industry: General methods and principles; Determination of phosphatase activity. (Aschaffenberg and Mullen method), <10g/ml p-nitrophenol
• Penicillin – AS 1766.3.11: Food microbiology, Dairy products, Test for penicillin. (B stearothermophilus disk assay method). <0.003 g/ml penicillin G.

NATA certification should be made available at audit.

Export declaration for milk products (other than dry milk products)

For milk products (other than dry milk products) the following words should be included in the Exporter Declaration section of the Request for Permit:

Milk products in this shipment has been transported to the USA under Departmental seal, applied as part of an approved sealing program, or by a Departmental officer.

Export declaration for dry milk products

The following products are subject to a MOU between Australia and the US (PDF 65 KB):

• dry whole milk
• non-fat dry milk
• low-fat dry milk
• dry cream
• dry whey
• dry buttermilk
• casein
• caseinates and co-precipitates (which includes all products in Casein, Milk Powder, Infant Powder, Membrane and Ultra Filtration Products and Why Powder EXDOC product types).

For dry milk products (products covered by the MOU) the following words should also be included in the Exporter Declaration section of the Request for Permit:

Milk powder in this shipment has been transported to the USA under Departmental seal, applied as part of an approved sealing program, or by a Departmental officer, and covered by NATA certification.

Transit certification requirements

The US transit certificate is the ZDUS01 health certificate transit certificate.

Milk and milk products transiting the European Union (EU) or the US may require transit documentation. These certificates are available as additional certificates through the EXDOC system. If the product is transiting the US, a ZDUS01 health certificate transit certificate is required. If the product is transiting an EU member state, see the particular EU member state regarding the certificate template to select.

When product transits a US port and the 'country of final destination' is not US, US transit certification, including sealing details, is required in addition to the 'country of final destination' certification.

If the product is transiting a US port and Department seals are applied, the US should be included as the discharge country or a transit country or a reference should be included in the exporter declaration or inspector comments to indicate that the product may be transiting a US port.

The US aims to prevent entry of Foot and Mouth Disease and Rinderpest and their certification and sealing requirements reflect this. All dairy products to the US should be only of Australian or New Zealand origin and only processed in Australia or New Zealand. Enquiries for export of products containing raw milk produced or not wholly processed in Australia or New Zealand should be forwarded to the Dairy Review Unit.

For Manufacturing Grade milk and milk products, use the ZD016 certificate as to condition for Manufacturing Grade products.

The ZD016 certificate as to condition contains the following attestations:

I hereby certify that to the best of my knowledge the conditions or restrictions applicable under the particular inspection system prescribed under the Export Control Act have been complied with in respect of the prescribed good described above, being goods that are:

1. In sound condition.
2. Of Australian origin.

Endorsement 490 – DAIRY – USA, Australian or NZ origin and disease free statement and Department or Australia PI seals applied (edible product)

As a full time salaried veterinary officer of Australia, I declare from the information provided to me that the following is true and correct:

Raw milk contained in this product was produced and processed in Australia and/or New Zealand which are countries recognised as free from Rinderpest and Foot and Mouth disease according to United Regulations 9CFR94.1.

The product has been sealed as regulated under United States regulation 9CFR94.16 (C), with serially numbered Department or Australia PI /s, (see over page).

The ZD001 Certificate as to Condition may be issued for technical products and pharmaceutical material.

The ZD001 Certificate contains the following attestations:

I certify to the best of my knowledge that the information on this form is true and correct in every particular details and that the product described above is of Australian origin and is acceptable for sale in Australia.

Endorsement 490 – DAIRY – USA, Australian or NZ origin and disease free statement and Department or Australia PI seals applied (edible product)

As a full time salaried veterinary officer of Australia, I declare from the information provided to me that the following is true and correct:

Raw milk contained in this product was produced and processed in Australia and/or New Zealand which are countries recognised as free from Rinderpest and Foot and Mouth disease according to United Regulations 9CFR94.1.

The product has been sealed as regulated under United States regulation 9CFR94.16 (C), with serially numbered Department or Australia PI seal/s, (see over page).

The ZD015 certificate as to condition for stockfood can be issued for stockfood made from milk and milk products.

The ZD015 certificate contains the following attestations:

I hereby certify that to the best of my knowledge the conditions or restrictions applicable under the particular inspection system prescribed under the Export Control Act have been complied with in respect of the prescribed good described above, being goods that are:

1. In sound condition.
2. Of Australian origin.

Endorsement 491 – DAIRY – USA, Australian or NZ origin and disease free statement for DSL and DSP (sealed with Department or Australia PI seals)

As a full time salaried veterinary officer of Australia, I declare from the information provided to me the following is true and correct:

This product:

1. was derived from bovine animals that have never been in;
2. did not originate in and was never stored, rendered or otherwise processed in;
3. was not otherwise physically associated with a facility located in; and
4. has not been otherwise physically associated with or exposed to, or commingled with ruminant material from;

any region listed in Code of Federal Regulations part 94.18(a).

Raw milk contained in this product was produced and processed in Australia and/or New Zealand which are countries recognised as free from Rinderpest and Foot and Mouth disease according to United Regulations 9CFR94.1.

The product has been sealed as regulated under United States regulation 9CFR94.16 (C), with serially numbered Department or Australia PI seal/s, (see over page).

It is the responsibility of exporters to determine through their importers if export certification is required for consignments and trade samples that are less than 10 kilograms or 10 litres, as an export permit is not required for such consignments.

The ZX01 certificate as to dioxinstatus of Australian dairy products is available on request.

European Union (EU) transit certificates are available for consignments transiting the EU. Refer to the EU documentation requirements for edible products for the reference numbers and attestations in these certificates.

Exporters should ensure that their importer complies with any requirements to obtain a permit for imports into the US.

Import Permit for pasteurised milk and cream products

An import permit is required for pasteurised (not sterilised) milk and cream products imported into the US in accordance with the US Federal Import Milk Act 1927. Import permits are valid for 12 months.

In accordance with the US Animal and Plant Health Inspection Service (APHIS) regulation 94.16, cheese is exempt from requiring an import permit. This excludes cheese with liquid or cheese containing meat; these products will still require an import permit.

The US has no known specific requirements for packaging in addition to those provided in the Export Control (Milk and Milk Products) Rules 2021.

The US has no known specific requirements for labelling in addition to those provided in the Export Control (Milk and Milk Products) Rules 2021.

The US has no known specific requirements for shelf life restrictions other than those provided in the Export Control (Milk and Milk Products) Rules 2021.

The US has no known specific requirements for shipping marks (port marks).

Specific requirements for inedible dry milk products

Inedible dry milk products must be labelled with the words "FOR NON-EDIBLE USE ONLY" so that they are exempt from the US salmonella, phosphatase and penicillin testing requirements.