European Union (EU)

Considerations prior to updating of establishment details (added 3 June 2021)

The following should be considered prior to updating establishment details:

When an establishment notifies the Department of an administrative change (that is, a change of occupier, company name, address, or in some instances product specific changes), the Department will amend the establishment record in the system.
The establishment's amended details will appear on applicable export documentation including health certification from the date that the Department amends the establishment record
When relevant changes are made to an establishment's details, the Department will advise trading partners that maintain establishment lists of the change of details; however, the Department is unable to guarantee a timeframe as to when trading partners will update the establishment's overseas listing details they maintain. This means that there may be a period in which export certification issued by the Department does not match the trading partner's official published listing, which may result in clearance issues at the port of entry.
Establishments should be aware that their ability to export to some countries may be impacted during this transition period and may include issues with goods in transit.
Exporters and manufacturers are encouraged to check that their establishment's details are recorded accurately where they appear on trading partners' lists and to contact the Department if errors are found.

1.1 Establishment registration

Table 1: EU member states, dependencies and other European countries that adopt EU requirements
Relationship with the EU	Relationship with the EU
Member states	Austria (AT), Belgium (BE), Bulgaria (BG), Croatia (HR), Cyprus (CY), Czech Republic (CZ), Denmark (DK), Estonia (EE), Finland (FI), France (FR), Germany (DE), Greece (GR), Hungary (HU), Italy (IT), Latvia (LV), Lithuania (LT), Luxembourg (LU), Malta (MT), Netherlands (NL), Poland (PL), Portugal (PT), Republic of Ireland (IE), Romania (RO), Slovakia (SK), Slovenia (SI), Spain (ES) and Sweden (SE). Note These member states adopt all EU requirements for products that have been harmonised throughout the EU and may have additional requirements for products are not yet harmonised. Refer to individual country requirements.
EU dependencies	France French Guiana (Cayenne)(GF), Guadeloupe (GP), Mayotte (YT), Martinique (MQ), Reunion Island (RE), and St Pierre and Miquelon (PM) Portugal Azores (PT), Madeira (PT) Spain Canary Islands (ES) Note These countries adopt all EU requirements for products that have been harmonised throughout the EU, and adopt requirements of the country they are a dependency of for products are not yet harmonised. Refer to individual country requirements.
Other European countries that adopt EU requirements	Albania (AL), Faroe Islands (FO), Iceland (IS), Liechtenstein (LI), Macedonia (MK), Norway (NO), United Kingdom including Gibraltar and the Channel Islands, Switzerland (CH) and Türkiye (TR) Note These countries may not adopt all EU requirements for products that have been harmonised throughout the EU. Refer to individual country requirements.

The Department of Agriculture, Fisheries and Forestry (the Department) is the Australian government authority responsible for export registration, inspection and certification of Australian food and agricultural exports.

All premises involved in the production of bovine milk and milk products for export must be registered with the Department. Premises involved in the production of non-bovine products may also need to be registered, however this is only when required by an importing country, product information is available at Dairy product codes. For more information or assistance with the export registration process contact the Department's Dairy, Eggs and Fish Program at dairyeggsfish@aff.gov.au. The Department encourages exporters to work with their importer to clarify any specific import conditions for exported products.

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.

1.2 Overseas listing

Table 2: Establishment listing for edible products
Initial listing procedure for edible products	Required?
Establishment listing with the EU	Yes
Establishments that want to export edible products to the EU must apply to the department before they can be included on the lists on the European Commission's (EC) website. Listing of new establishments that produce edible products for export to the EU can take up to 2 months, because they require approval by the European Commission (EC) and notification of individual EU member state. Production of edible products intended for export to the EU may start from the 'validity date' of the updated list on the EC website. 'Dates of publication' are usually 3-4 weeks after the 'validity dates'. When an establishment has been placed on the EU list then the establishment register is updated to indicate the establishment is approved for 'EU – dairy'. The registration certificate for the establishment will also indicate this notation.

How to apply for EU listing

If you are seeking listing for the EU, you will need to complete the EU checklist, and submit it, along with applicable amended Approved Arrangement procedures, to the department for review and assessment. Please contact dairyeggsfish@aff.gov.au.

Once the department deems an establishment as meeting all elements of the checklist and that the Approved Arrangement has successfully documented all relevant EU controls, the department will lodge a listing request to the EU authority seeking approval. Once the EU approves, and only when they approve, can an establishment begin to manufacture dairy products for export to the EU.

Listing modifications

Establishments requesting modifications to their existing EU listing (for example, establishment name) must ensure that all export documentation and labelling does not include new details until the EU list is amended to reflect the new information and the listing validity date has been updated. Consignments sent with documentation where the establishment details do not match the EU listing may be detained or refused entry to the EU. Please contact dairyeggsfish@aff.gov.au for further listings information.

Information for exporters who are non-manufacturers

Non-manufacturing exporters must wait until the details of the export registered dairy establishment/s that they source product from appear on the EU TRACES website prior to exporting. Product produced prior to the date of validity of the manufacturing establishment entry in this list is not eligible to be exported to the EU.

The link that exporters need to follow to check if the relevant dairy establishment/s details have been added is:

European Union Establishment Lists - TRACES NT (europa.eu)

Table 3: Initial listing procedure for inedible products exported to or transited through the EU
Initial listing procedure	Required?
Export registration	Yes, only establishments processing: Manufacturing Grade (DM) milk - export registered for human consumption Refer to notes
EU listing	Yes, refer to notes and table below
Department listing audit	Yes, refer to notes and table below
EU inspection for listing	No
EU listing approval	No
Notes Establishments that export some inedible products to the EU must be included on the lists on the EC website, and listing requirements differ according to the risk posed by each type of inedible product (see the following table). Listing for inedible products can take up to 5 weeks. As the EU does not officially approve establishments producing inedible products, production and certification may start from the date that an establishment appears on the updated list on the EC website (that is, 'validity dates' for lists of establishments producing inedible products on the EC website are the same as 'dates of publication'). Trade samples and products used for research, education, diagnostic or museum purposes do not need to originate from export registered or EU listed establishments.

Table 4: Inedible products - listing and auditing requirements
Type of inedible product	Listing required?	Audit prior to listing required?
Notes Establishments exporting pet milk and milk-based pet food must be listed on the EC website as a pet food processing establishment. Establishments must be audited against the EU requirements for pet milk and milk-based pet food and recommended for EU pet food listing by PFIAA or other Department-approved auditor.
Manufacturing Grade (DM) milk/ colostrum for further processing in the EU	Yes	Only if establishment is not export registered
Milk/ colostrum for use in animal food	Yes	Only if establishment is not export registered
Pet milk and milk-based pet food	Yes	Yes, refer to notes
Milk/ colostrum for use in technical products	Yes	Only if establishment is not export registered
Trade samples	No	No
Milk/ colostrum for use in research or diagnostic for purposes	No	No

1.3 Prohibited products

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

1.4 General information

Australian products that do not meet European Union official requirements

The following animal products do not meet EU official requirements:

Edible and inedible products containing sheep and goat milk.

Export Destination Residues Warning – EU 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 EU or may be established at levels lower than those established in Australia. Respective maximum limits (MLs) for contaminants may also vary between the EU and Australia.

Food business operators who are eligible to export to the EU should note that:

a) These differences can be interrogated case-by-case by considering the EU standards (here for pesticides, veterinary drugs and contaminants) and the Australian standards (here for pesticides & veterinary drugs and here for contaminants).
b) Any detection of a residue above the EU MRLs/MLs (if applicable) at the EU border would result in rejection of the consignment and trigger an information, alert and/or border rejection notification in the (public) EU Rapid Alert System for Food and Feed (RASFF).

2.1 Milk and milk products

Sourcing of milk and milk products

If intended for export to countries that adopt EU requirements, the following milk and milk products must be only processed in establishments that are on the EU list of approved dairy establishments:

milk, including milk powder, condensed milk
cream, including UHT and cream products
buttermilk, curdled milk and cream
yoghurt
butter, dairy spreads, and other fats and oils derived from milk
cheese (including fresh cheese, canned cheese, hard cheese, processed cheese, semi-hard cheese, and cheese powder)
ice cream and ice-cream mix
infant powder
casein, caseinates and other casein derivatives
lactose and lactose syrup
whey and whey powder albumins (including concentrates of two or more whey proteins, containing by weight more than 80% whey proteins, calculated on the dry matter)
milk proteins (including concentrated milk proteins with a protein content of more than 85% by weight, calculated on the dry matter)
processed dairy ingredients that are used in composite products

Final product testing for microbiological pathogens

Milk and milk products must be tested for the following microbiological pathogens and found to comply with the EU's food safety criteria. Testing must involve taking of random samples of each batch at the end of the manufacturing process. Only batches of product that are found to meet the EU food safety criteria are eligible for export to the EU.

Table 6: Microbiological pathogens and the EU's food safety criteria
Micro-organism	Type of final product	EU food safety criteria (See note 1)
Notes Where n = number of samples, and M = maximum number of bacteria allowed in a sample. Testing for L. monocytogenes is not required for ready-to-eat products that are either have been processed to eliminate L. monocytogenes, or are unable to support the growth of L. monocytogenes (that is, products with pH 4.4 or a_w = 0.92, or pH 5.0 and a_w = 0.94). If manufacturers are able to demonstrate that products will not exceed 100 cfu/g throughout their shelf-life, they do not need to demonstrate absence in a 25g sample. This testing is not required for products where the a_w = 0.95. Testing is not required for products where the manufacturing process or composition of product will eliminate the risk of Salmonella in the product. Testing is not required for products where the manufacturing process or composition of the product results in the product having coagulase positive staphylococci < 100,000 cfu/g, and this eliminates the risk of staphylococcal enterotoxins in the product. Manufacturers that respond to detections of coagulase positive staphylococci in accordance with National Guidelines - Pathogen Management, do not need to undertake this testing. For information on how to meet these requirements, refer to Exporting dairy products to the European Union.
Listeria monocytogenes	Ready-to-eat products intended for infants and special medical purposes (See note 2)	n = 10, absence in 25g
Listeria monocytogenes	Other ready-to-eat products (See notes 2 and 3)	n = 5, absence in 25g
Salmonella	Infant formulae and dried dietary foods for special medical purposes	n = 30, absence in 25g
	Milk powder and whey powders (See note 4)	n = 5, absence in 25g
	Ice cream and other frozen dairy desserts (See note 5)	n = 5, absence in 25g
Enterobacter sakazakii	Infant formulae and dried dietary foods for special medical purposes	n = 30, absence in 10g
Staphylococcal enterotoxins	Ripened cheese and unripened soft cheeses (See note 6)	n = 5, absence in 25g
Staphylococcal enterotoxins	Milk powder and whey powder that is not intended for further processing prior to consumption (See note 6)	n = 5, absence in 25g

2.2 Compositional requirements

Composite products

Composite products are defined as products containing both products of plant origin and products of animal origin such as chocolate bars, biscuits, soups, frozen cakes and pies.

Commission Delegated Regulation (EU) 2019/625 stipulates the following categories for composite products:

(1) non shelf stable composite products;

(2) shelf stable composite products that contain meat products; and

(3) shelf stable composite products that do not contain meat products.

A non shelf-stable composite product needs to be transported or stored under controlled temperature. It is not the case for shelf-stable composite products which can be kept at ambient temperature.

All processed products of animal origin (meat, dairy, eggs and fish), regardless of their percentage as an ingredient in the product, are required to be sourced from EU listed establishments to be eligible for import.

The Import of Composite Products into the EU Q & A (PDF 840 KB), dated 11 July 2022, is a useful reference document:

To export categories 1 and 2, a health certificate is required. Detail on available certificate template M492 (12/22) is provided below under section 5. Documentation requirements.

The Manufacturer's Private Attestation is for shelf stable composite products that do not contain meat products. It is required to be prepared and signed by the representative of the importing food business operator (in case of exemption from control at the border, it may accompany the products only at the time of the placing on the market). The Private Attestation is found in Annex V of Commission Implementing Regulation (EU) No 2022/2504. It is not an Australian Government document.

All export establishments must be listed with the EU and establishments supplying ingredients must also be EU listed. The composite products in these categories are subject to veterinary inspection at Border Control Posts.

Note: Please note Australia does not currently maintain an EU approved residue plans for porcine or poultry and therefore is not permitted to export those commodities or products containing these ingredients to the EU. However, Australia does maintain EU approved residue plans for meat, dairy and fish products and can export these products, and products containing these ingredients, to the EU provided the establishments are EU listed.; Details of EU-listed establishments are available on the EU website.

Composite products exempt from Border Control Post inspection

As per the Commission Delegated Regulation (EU) 2021/630 of February 2021, certain lower risk shelf-stable composite products not containing processed meat are exempted from official controls at border control posts (BCPs).

Instead, EU member states' competent authorities shall perform official controls on such composite products on a risk basis with appropriate frequency at:

the place of destination
the point of release for free circulation in the Union, or
the warehouses or the premises of the operator responsible for the consignment.

The categories of products affected by this Regulation are:

Confectionery (including sweets), chocolate and other food preparations containing cocoa
Pasta, noodles and couscous
Bread, cakes, biscuits, waffles and wafers, rusks, toasted bread and similar toasted products
Olives stuffed with fish
Extracts, essences and concentrates, of coffee, tea or maté and preparations with a basis of these products or with a basis of coffee, tea or maté thereof
Roasted chicory and other roasted coffee substitutes, and extracts, essences and concentrates thereof
Soup stocks and flavourings packaged for the final consumer
Food supplements packaged for the final consumer, containing processed animal products (including glucosamine, chondroitin or chitosan)
Liqueurs and cordials.

The applicable CN codes for products within these categories are listed in the Annex to the Regulation.

Composite products that must have an EU milk and milk product certificate

Some composite products need an EU Milk and Milk Product Certificate, because they are described as dairy products and classified under the customs tariff codes 04.01 to 04.06, 17.02. 21.05, 21.06 and 35.02.

The table below provides additional information about these products.

Table 7: Composite products under tariff codes
Tariff codes	What products are under this tariff code?
04.01-04.06	Milk, cream, condensed milk, buttermilk, yogurt, kephir, fermented milk and cream, whey, butter, cheese and curd
17.02	Lactose
21.05	Ice cream and edible ice
21.06	Protein concentrates, textured protein substances
35.02	Milk albumins

The only products under these tariff codes that need to be exported with an EU composite product certificate, are edible ice that contains dairy and meat, and protein concentrates or textured protein substances, such as cheese fondue that contain meat.

Dairy products needing an EU composite product certificate

Information in the certificate for composite foods imported into the EU

This certificate includes four sections that have attestations about the compliance of any processed meat ingredients, any processed dairy ingredients, processed fish ingredients, and processed egg ingredients. These sections should be crossed out if they do not apply.

Table 8: How to complete certificates for some examples of products
Type of product and customs tariff codes	Examples	How to complete Section II.2.A Meat products	How to complete Section II.2.B Dairy products	How to complete Section II.2.C Fish products	How to complete Section II.2.D Egg products
16.01 Meat sausages and 16.02 Prepared or preserved meat	Beef, lamb, goat, horse, wild boar, venison or kangaroo meat sausages, meals and preparations such as casseroles, curries, pies, and crumbed meat.	Include one of the codes BOV, OVI, EQI, RUF, SUW, RUW for the species, include A as the treatment, a country ISO code for the origin, and the EU meat product establishment number.	Only complete if food needs to be refrigerated and includes dairy products (such as such as milk, cream, cheese, butter), otherwise cross out section. Include the country ISO code for the origin and the EU establishment number.	Cross out section	Cross out section
16.01 Meat sausages and 16.02 Prepared or preserved meat	Emu or ostrich meat sausages, meals and preparations such as casseroles, curries, pies, and crumbed meat.	Include the code PFG details of the species, D as the treatment, the country ISO code for the origin, and EU meat product establishment number.	Only complete if food needs to be refrigerated or frozen and includes dairy products. Include the country ISO code for the origin and the EU establishment number.	Cross out section	Cross out section
16.03 Extracts and juices of meat, fish, crustaceans, molluscs & other aquatic invertebrates	Extracts, juices or concentrates of meat or seafood.	Only complete if the food is an extract or juice of meat, and include information as per tariff code 16.02, otherwise cross out section.	Only complete if food needs to be refrigerated or frozen and includes dairy products. Include the country ISO code for the origin and the EU establishment number, otherwise cross out section.	Only complete if the food is an extract, juice or concentrate that contains seafood, otherwise cross out section. Include the country ISO code for the origin, and EU establishment number.	Cross out section
16.04 Prepared or preserved fish, caviar & fish egg caviar substitutes 16.05 Prepared or preserved crustaceans, molluscs & aquatic invertebrates	Meals and preparations containing seafood, fish or fish eggs such as casseroles, curries, pies.	Cross out section	Only complete if food needs to be refrigerated or frozen and includes dairy products. Include the country ISO code for the origin and the EU establishment number, otherwise cross out section.	Only complete if the food contains fish, caviar or fish eggs, otherwise cross out section. Complete as for tariff code 16.03.	Cross out section
19.01 Food preparations containing cereals, flour, starch & malt	Infant preparations and meals, frozen pizza and other dough based products containing meat, seafood, dairy or eggs.	Only complete if the product includes any meat, and include information as per tariff code 16.02, otherwise cross out section.	Only complete if food needs to be refrigerated or frozen and includes dairy products. Include the country ISO code for the origin and the EU establishment number, otherwise cross out section.	Cross out section	Cross out section
19.02 Pasta & couscous	Pasta and couscous meals that may contain ingredients of animal origin Stuffed pasta can have meat.	Only complete if the product includes any meat, and include information as per tariff code 16.02, otherwise cross out section.	Only complete if food needs to be refrigerated or frozen and includes dairy products. Include the country ISO code for the origin and the EU establishment number, otherwise cross out section. Note Pasta that does not contain meat may be exempt from certification.	Cross out section	Cross out section
19.05 Pastries	Pastries and pastry based meals that may contain ingredients of animal origin.	Only complete if the product includes any meat, and include information as per tariff code 16.02, otherwise cross out section.	Only complete if food needs to be refrigerated or frozen and includes dairy products. Include the country ISO code for the origin and the EU establishment number, otherwise cross out section.	Cross out section	Cross out section
20.04 Frozen vegetable preparations	Frozen meals, and vegetable preparations that may contain ingredients of animal origin such as curries and casseroles.	Only complete if the product includes any meat, and include information as per tariff code 16.02, otherwise cross out section.	Only complete if food includes dairy products. Include the country ISO code for the origin and the EU establishment number, otherwise cross out section.	Cross out section	Cross out section
20.05 Unfrozen vegetable preparations	Chilled or shelf-stable meals, and vegetable preparations that may contain ingredients of animal origin such as curries and casseroles.	Only complete if the product includes any meat, and include information as per tariff code 16.02, otherwise cross out section.	Only complete if food needs to be refrigerated and includes dairy products. Include the country ISO code for the origin and the EU establishment number, otherwise cross out section.	Cross out section	Cross out section
21.03 Sauces, condiments & mixed seasonings	Sauces, condiments and flavourings that may contain ingredients of animal origin.	Only complete if the product includes any meat, and include information as per tariff code 16.02, otherwise cross out section. Note: Meat extracts, concentrates and flavourings may be exempt from certification.	Only complete if food needs to be refrigerated or frozen and includes dairy products. Include the country ISO code for the origin and the EU establishment number, otherwise cross out section. Note Dairy based flavourings may be exempt from certification.	Cross out section	Cross out section
21.04 Soups, broths & homogenous food preparations	Soups, broths and homogenous food preparations containing ingredients of animal origin.	Only complete if the product includes any meat, and include information as per tariff code 16.02, otherwise cross out section. Note: Soups may be exempt from certification.	Only complete if food needs to be refrigerated or frozen and includes dairy products. Include the country ISO code for the origin and the EU establishment number, otherwise cross out section. Note Soup may be exempt from certification.	Cross out section	Cross out section
21.05 Ice cream & other edible ice	Ice cream and edible ice containing ingredients of animal origin.	Cross out this section.	Include country ISO code for the origin and the EU establishment number.	Cross out section	Cross out section
21.06 Food preparations not elsewhere specified	Protein concentrates and textured protein substances, such as cheese fondue that may contain meat and other animal products.	Only complete if the product includes any meat, and include information as per tariff code 16.02, otherwise cross out section.	Only complete if food needs to be refrigerated or frozen and includes dairy products Include country ISO code for the origin and the EU establishment number.	Cross out section	Cross out section
21.06 Food preparations not elsewhere specified				Cross out section	Cross out section	Note All products may contain grain products (flour, starch, breadcrumbs) or vegetables. The country of origin stated on a composite product certificate may be Australia or any country that is able to export the specific type of animal product directly to the EU. The ISO code for Australia is AU. If the ingredients are sourced from two or more countries, both countries should be included. For example products that contain Australian and New Zealand origin meat products should state AU/NZ. This table applies to category 1 and 2 composite products where an export health certificate is required.

2.3 Further information

3.1 Technical grade and pharmaceutical products

The raw milk/ colostrum must have been collected from cows or buffaloes in accordance with requirements for human consumption.

Note: Sheep and goat milk does not meet EU animal by-product requirements.

The raw milk/ colostrum may be either:

that which is downgraded after collection so it is no longer fit for human consumption for commercial reasons or due to problems of manufacturing or packaging defects or other defects from which there will be no risk to public or animal health
centrifuge, separator sludge from milk processing, and
milk from catering sources; for example, household kitchens, catering establishments, restaurants, etc.

The milk and colostrum must be subjected to pasteurisation that is equivalent to that specified for milk for human consumption in the Export Control (Milk and Milk Products) Rules 2021 or recognised in Australia as equivalent to 72°C for 15 seconds (that is, batch pasteurisation at 60°C for 30 minutes). If an alternative pasteurisation process that is not recognised in Australia as equivalent to 72°C for 15 seconds is used to achieve a negative reaction to a phosphatase test, evidence of phosphatase levels equal to or less than 10 ug/ml of p-nitrophenol and time and temperature of heat treatment is required to be made available at audit.

After completion of the processing, every precaution must be taken to prevent contamination of the products.

This processing must occur at establishments on the

EU list of approved animal by-product establishments

that are export listed to produce dairy technical products for the EU. These establishments do not need to be approved to process milk for human consumption.

During transport and storage, products that are imported into the EU must have a label attached to the packaging, container or vehicle that:

clearly indicates the category of the inedible by-products or of the derived products;
describes the nature of the product;
bear the following words visibly and legibly displayed on the packaging, a container or vehicle, as applicable: not for human consumption.

Provided the products meet the requirements listed above, they may be exported as Category 3 material.

Note

Technical products include products intended for manufacture of biomedical, pharmaceutical or industrial products. There is an exemption from the requirements listed above for technical products that are intended for use as trade samples, in research, as educational products, as diagnostic products, or in museum displays.
Consignments of inedible by-products that are not fully finished and still considered a risk must clearly indicate their EU category after entry into the EU.
Milk/colostrum is NOT eligible to be exported as a Category 3 material, if it is:

collected from animals treated with substances prohibited under Directive 96/22/EC(for example, hormonal growth promotants and beta-agonists)
known to contain residues of environmental contaminants and other substances listed in Group B3 of Annex I of Council Directive 96/23/EC (for example, organochlorine compounds including PCBs, organophosphorus compounds, chemical elements, etc.)
known to contain residues of authorised substances (such as antibiotics) or contaminants exceeding the permitted levels as referred to in Article 15 (3) of Directive 96/23/EC
declared unfit for human consumption due to the presence of foreign bodies in the product.

There are no additional hygiene, traceability or processing requirements for establishments that are already approved process milk for human consumption.
Establishments that are NOT approved to process milk for human consumption must be subject to initial and ongoing audit by a Department-approved auditor against the requirements listed above and the following additional requirements:

premises must be constructed in a way permitting their effective cleaning and disinfection, where appropriate
premises must have appropriate arrangements for protection against pests, such as insects, rodents and birds
installations and equipment must be kept in hygienic condition, where necessary
products must be stored under conditions preventing contamination.

3.2 Animal feed

The raw milk/ colostrum must have been collected from cows or buffaloes in accordance with requirements for human consumption.

Note: Sheep and goat milk does not meet EU animal by-product requirements.

The raw milk/ colostrum may be either:

that which is downgraded after collection so it is no longer fit for human consumption for commercial reasons or due to problems of manufacturing or packaging defects or other defects from which there will be no risk to public or animal health
centrifuge, separator sludge from milk processing, and
milk from catering sources; for example, household kitchens, catering establishments, restaurants, etc.

The milk and colostrum must be subjected to pasteurisation that is equivalent to that specified for milk for human consumption in the Export Control (Milk and Milk Products) Rules 2021 or recognised in Australia as equivalent to 72°C for 13 seconds (that is, batch pasteurisation at 60°C for 30 minutes). If an alternative pasteurisation process that is not recognised in Australia as equivalent to 72°C for 15 seconds is used to achieve a negative reaction to a phosphatase test, evidence of phosphatase levels equal to or less than 10 ug/ml of p-nitrophenol and time and temperature of heat treatment is required to be made available at audit.

After completion of the processing, every precaution must be taken to prevent contamination of the products. The requirement in Regulation 142/2011 for milk to be held for 21 days prior to export to mitigate the risk of foot-and-mouth disease (FMD) does not apply because of Australia's official FMD freedom.

This processing must occur at establishments on the

EU list of approved animal by-product establishments

that are export listed to produce dairy stockfeed for the EU. These establishments do not need to be approved to process milk for human consumption.

During transport and storage, products that are imported into the EU must have a label attached to the packaging, container or vehicle that:

clearly indicates the category of the inedible by-products or of the derived products;
describes the nature of the product;
bear the following words visibly and legibly displayed on the packaging, a container or vehicle, as applicable: not for human consumption.

Provided the products meet the requirements listed above, they may be exported as Category 3 material.

Notes

Consignments of inedible by-products that are not fully finished and still considered a risk must clearly indicate their EU category after entry into the EU.
Milk/colostrum is NOT eligible to be exported as a Category 3 material, if it is:

collected from animals treated with substances prohibited under Directive 96/22/EC(for example, hormonal growth promotants and beta-agonists)
known to contain residues of environmental contaminants and other substances listed in Group B3 of Annex I of Council Directive 96/23/EC (for example, organochlorine compounds including PCBs, organophosphorus compounds, chemical elements, etc.)
known to contain residues of authorised substances (such as antibiotics) or contaminants exceeding the permitted levels as referred to in Article 15 (3) of Directive 96/23/EC
declared unfit for human consumption due to the presence of foreign bodies in the product.

There are no additional hygiene, traceability or processing requirements for establishments that are already approved process milk for human consumption.
Establishments that are NOT approved to process milk for human consumption must be subject to initial and ongoing audit by a Department-approved auditor against the requirements listed above and the following additional requirements:

premises must be constructed in a way permitting their effective cleaning and disinfection, where appropriate
premises must have appropriate arrangements for protection against pests, such as insects, rodents and birds
installations and equipment must be kept in hygienic condition, where necessary
products must be stored under conditions preventing contamination.

Pet milk and milk-based pet food

The EU requirements for animal food apply to pet milk or milk-based pet food. In addition, pet milk and milk-based pet food must meet the following specific requirements.

Note: Sheep and goat milk does not meet EU animal by-product requirements.

The processing establishment must be on the , in particular for pet food processing and export listed to export dairy pet food. These establishments do not need to be approved to process milk for human consumption. The processing establishment must be subject to initial and ongoing audit by a Pet Food Industry Association of Australia or Departmental auditor

Note: Accreditation to AS5812 Australian Standard Manufacturing and marketing of pet food is not a pre-requisite for listing).

The final product must be subjected to the following testing protocols:

a random sample must be taken from processed pet food during or after storage from each batch and found to comply with the standards in the following standards.

Table 9: Test protocol standards
Type of final product	Micro-organism	Standard
n = number of samples to be tested m = threshold value for the number of bacteria; the result is considered satisfactory if the number of bacteria in all samples does not exceed m M = maximum value for the number of bacteria; the result is considered unsatisfactory if the number of bacteria in one or more samples is M or more and c = number of samples. For tests where there is a threshold and maximum level, the bacterial count of which may be between m and M, the sample still considered acceptable if the bacterial count of the other samples is m or less
Processed pet milk or milk-based ingredients in pet food	Salmonella	n = 5, c = 0, absence in 25g
Processed pet milk or milk-based ingredients in pet food	Enterobacteriaceae in 1g	n = 5, c = 2, m = 10, M = 300

3.3 Manufacturing grade products

All milk, milk products, colostrum and colostrum products that are not fit for human consumption, including those classified in Australia as Manufacturing Grade (DM) must be exported under the EU's animal by-product requirements (Regulation 142/2011). The raw milk/ colostrum must have been collected in Australia from cows or buffaloes in accordance with requirements for human consumption.

Note: Sheep and goat milk does not meet EU animal by-product requirements.

The raw milk/ colostrum may be downgraded after collection so it is no longer fit for human consumption. This may be for commercial reasons or due to problems of manufacturing or packaging defects or other defects from which there will be no risk to public or animal health once the milk has been further processed in the EU.

This processing must occur at establishments on the

EU list of approved animal by-product establishments

that are export registered.

Pasteurisation must be equivalent to that specified for milk for human consumption in the Export Control (Milk and Milk Products) Rules 2021 or recognised in Australia as equivalent to 72°C for 15 seconds (that is, batch pasteurisation at 60°C for 30 minutes). If an alternative pasteurisation process that is not recognised in Australia as equivalent to 72°C for 15 seconds is used to achieve a negative reaction to a phosphatase test, evidence of phosphatase levels equal to or less than 10 ug/ml of p-nitrophenol and time and temperature of heat treatment is required to be made available at audit.

During transport and storage, products that are imported into the EU must have a label attached to the packaging, container or vehicle that:

clearly indicates the category of the inedible by-products or of the derived products
describes the nature of the product
bear the following words visibly and legibly displayed on the packaging, a container or vehicle, as applicable: not for human consumption.

Provided the products meet the requirements listed above, they may be exported as Category 3 material.

Note: Consignments of inedible by-products that are not fully finished and still considered a risk must clearly indicate their EU category after entry into the EU.

3.4 Processing

Raw milk

The EU's raw milk processing requirements in Regulation 853/2004 can be met by complying with the Export Control (Milk and Milk Products) Rules 2021.

Pasteurisation and heat treatment

The raw milk must be subjected to pasteurisation that is equivalent to that specified for milk for human consumption in the Export Control (Milk and Milk Products) Rules 2021 or recognised in Australia as equivalent to 72°C for 15 seconds (i.e. batch pasteurisation at 60°C for 30 minutes).

Hazard Analysis Critical Control Point (HACCP)

The EU's HACCP compliance requirements in Regulation 852/2004 can be met by complying with the Export Control (Milk and Milk Products) Rules 2021.

Refrigeration, transfer and loadout

Establishments are required to undertake their own checks to ensure that milk and milk products are fully compliant with EU requirements at the point of dispatch from the manufacturing establishment.

The EU requires the Department to undertake random inspections of container loadouts to verify the effectiveness of the establishment checks and accuracy of information on health certificates. This means exporters must lodge requests to process Requests for Permits (RFP) with the Dairy Export Program with sufficient time to enable arrangements to be made for the inspection (ideally at least 3 days notice). The load out inspection will need to occur at the establishment at which the goods will be loaded into the container.

Containers must be sealed prior to export of milk and milk products to the EU, and container and seal numbers must be included on EU health certificates.

3.5 Further information

4.1 Microbial and residue sampling

To maintain access to the EU for milk products, Australia is required to implement a national residue monitoring plan. This national residue monitoring plan, the Australian Milk Residue Analysis (AMRA) Survey must be annually approved by the EU and shown to comply with Council Directive 96/23/EC. Australia's system must also be assessed by the EU as complying with the maximum residue levels for pesticides laid down in Regulation 396/2005, and maximum levels for contaminants laid down in Regulation 1881/2006.

All edible milk and milk products exported to the EU must have been tested for residues of antibiotic drugs in accordance with Regulation 853/2004, and be found to comply with the maximum residue limits for residues of antibacterial veterinary medicinal products laid down in Regulation 37/2010. This means that milk and milk products for export to the EU must not originate from any raw milk with a positive detection from farm vat and tanker testing for antibiotic residues.

Note: Testing is required to be performed on raw milk. Establishments must ensure that testing protocols do not include any processing steps that interfere with the detectability of antibiotic residues.

For more information, refer to Exporting dairy products to the European Union.

Microbial testing of milk

All edible milk and milk products exported to the EU must meet the plate and somatic cell count criteria laid down in Regulation 853/2004. This means that raw milk must meet the following criteria:

Table 5: Microbial milk testing criteria
Type of product	Test	Standard
Raw cows' milk	Plate count at 30°C (per ml)	= 100,000
Raw cows' milk	Somatic cell count (per ml)	= 400,000
Raw milk collected from other species	Plate count at 30°C (per ml)	= 1,500,000

Each farm that supplies milk for export to the EU must meet these standards.

Processing establishments that receive raw milk directly from farms the establishment must test somatic cell counts and total plate counts, maintain records of the test results and ensure farms take corrective action when requirements are not met.
Somatic cell counts must be determined by rolling geometric average over a period of 3 months with at least one sample per month per farm.
Total plate count must be determined by rolling geometric average over a period of 2 months with at least 2 samples per month per farm.
Processing establishments that receive milk from suppliers other than farms must ensure that the supplier has systems in place to ensure that the raw milk meets EU requirements for total plate counts and somatic cell counts.

In addition, there are specific microbiological tests for finished products. Refer to Milk and milk products in section 5.1.

For information on how to meet these requirements, refer to Exporting dairy products to the European Union.

4.2 Operational requirements additional to Australia's export legislation

Sourcing of raw milk and dairy ingredients

Establishments that export milk and milk products to the EU must be able to state, through a declaration of compliance that the product that is exported is only made from dairy ingredients that meet EU requirements. So that they can make a declaration of compliance, establishments must ensure that they have systems in place that demonstrate that all dairy ingredients (even if imported or used as part of contract manufacturing arrangement) used to produce milk and milk products for export to the EU meet EU requirements.
Establishments that source milk directly from farms must have systems in place to ensure that the milk is collected in accordance with the EU's specific requirements for monitoring and controlling the temperatures and quality of raw milk. These systems must also ensure that raw milk collected for processing into products intended for export to the EU has been sampled at the tanker level for and tested negative for the presence of antibiotic residues.
Establishments that source dairy ingredients or liquid milk from other establishments, or from overseas, need to obtain documentary evidence from their suppliers that confirms that the milk used in the production of dairy products complies with all relevant EU requirements. These systems must include the use of documents that specifically state whether the ingredients were produced in accordance with EU requirements.
For information on how to comply with the requirement for declarations of compliance, use of documentary evidence, raw milk temperatures and raw milk quality, refer to Exporting dairy products to the European Union.

4.3 Hygiene

Milk cooling

This means that milk must be produced, collected, cooled, stored and transported in accordance with the milk cooling conditions laid down in Regulation 853/2004.

This means the following:

if milk is collected from farms on a daily basis, the raw milk must be cooled to no more than 8°C within 2 hours of milking; or
if milk is not collected from farms on a daily basis, The raw milk must be cooled to no more than 6°C within 2 hours of milking;

During transport, the cold chain must be maintained such that on arrival at the processing establishment, the raw milk temperature is no more than 10°C.

For information on how to meet these requirements, refer to Exporting dairy products to the European Union.

Water used during processing

Establishments must ensure that quality of water used in the processing of milk and milk products meet requirements that are equivalent to the EU's potable water requirements. This means that processing establishments must be aware of the parameters for, and frequency of, water testing being undertaken by municipal water suppliers to ensure compliance with the Australian Drinking Water Guidelines 6, 2011.

If results of water testing undertaken by municipal water suppliers identify risks that could affect food safety, EU listed processing establishments are required to undertake their own risk assessment and implement actions, which may include testing, to prevent contamination of dairy products as outlined in the Australian Drinking Water Guidelines 6, 2011.

For information on how to meet these requirements, refer to Exporting dairy products to the European Union.

5.1 Milk and milk products

Certificates for milk and milk products

Milk and milk products

This information applies to the export of the following milk and milk products from cows or buffaloes for human consumption:

milk, including milk powder, condensed milk
cream, including UHT and cream products
buttermilk, curdled milk and cream
yoghurt
butter, dairy spreads, and other fats and oils derived from milk
cheese (including fresh cheese, canned cheese, hard cheese, processed cheese, semi-hard cheese, and cheese powder)
ice cream and ice-cream mix
infant formula
casein, caseinates and other casein derivatives
lactose and lactose syrup
whey and whey powder albumins (including concentrates of two or more whey proteins, containing by weight more than 80% whey proteins, calculated on the dry matter) and
milk proteins (including concentrated milk proteins with a protein content of more than 85% by weight, calculated on the dry matter).

Commodity	Previous template name	eCert extract name
For the export of milk and milk products (intended for human consumption)	ZDENH1	EUEXH1

Use of transit certificates for milk and milk products

Transit certificates for product transiting through the EU did not move onto eCert and remain paper based, through the department’s NEXDOC system. The dairy transit certificate for product transiting through the EU is ZDEUHT. The title of the certificate is Animal health Certificate for dairy for human consumption intended for transit through or storage in the EU.
Transit certificates are required for all milk and milk products (including those made from non-bovine milk) that transit the EU or are stored in the EU.

The transit certificate template only includes the attestations on the certificate for milk and milk products intended for import into the EU that relate to animal health (that is, diseases present in Australia).

Northern Ireland
- Northern Ireland continues to use EU paper certificates. Please contact foodexports@aff.gov.au if you intend to export to Northern Ireland.

Countries included in the move to eCert

The eCert arrangement extends to:

countries in the EU (Austria, Belgium, Bulgaria, Croatia, Republic of Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain and Sweden).
countries in the EU single market (Iceland, Liechtenstein, Norway and Switzerland).
The overseas territories of France (Reunion, French Guiana, Guadeloupe, Martinique, Mayotte) have yet to be included in the move to eCert. There are currently no export certificates available for prescribed milk and milk products to these markets.

Milk and milk products from sheep or goats

Certificate templates are not available for the export of milk and milk products from sheep or goats or for the transit of these products through the EU. If exporters wish to export or transit these products through the EU, they may contact the Department to request that a certificate template be developed.

Accessing TRACES-NT

To access TRACES NT you first need to set up an account. This link will outline the process to set up an EU log in and to create an account in TRACES-NT:Getting started (europa.eu).

TRACES users will need a two-factor authentication. This can be done in several ways, however, for Australian residents the EU Login mobile phone app is the most reliable option.

TRACES NT users should set up the two-factor authentication as soon as possible. To do so, users should go to https://webgate.ec.europa.eu/cas, log in with the username and password they use for TRACES-NT (EU Login account) and follow the instructions.

The European Commission (EC) have created a video guide explaining the set-up of the two-factor authentication.

A step-by-step guide can be viewed or downloaded in PDF and Word formats here: EU Login - European Commission Authentication Service - Erasmus+ & European Solidarity Corps guides - EC Public Wiki (europa.eu). Please refer to the section:

“Set up Two-factor authentication with the EU Login Mobile app”, which is on page 11 of the PDF document.

A user guide and frequently asked questions relating to EU Login additional instructions can be found on the EU Login Help page.

Once you have created your account in TRACES you need to set up a user role or operator profile. Once this is done please send an email to the EXDOC Help Desk (EXDOC.Helpdesk@aff.gov.au) to let us know so we can validate this for you (it is a requirement that all user roles/operator profiles are validated by the Australian Competent Authority (the department).

When raising your export documentation

Exporters are required to provide the following information when raising a RFP/REX

Place of destination - This is compulsory for all consignments, not just those in transit across the EU.
- This field will require the Name, Address, Registration/Approval Number (if applicable) and country of the place in the EU where the consignment is being delivered for final unloading (the EXDOC system will then automatically provide the ISO country code for this field).
- If the intended destination changes after the certificate has been signed, then the importer can update this information in the Common Health Entry Document (CHED). This is the responsibility of the importer and certificates should not be replaced after departure unless requested by the border control post.
CN code - this was provided as the Harmonized System (HS) code previously but this will be entered in EU format as 4, 6 or 8 digit number as stipulated in Council Regulation EU 2021/632.
Batch number – Batch number will be required for each line of product on a certificate. This number should match what is labelled on the cartons or commercial documents. The EXDOC system can accommodate up to 17 characters in the batch number field that can be a combination of numbers, letters and the symbols ( / ), ( : ) or ( - ). For fish which typically applies the processing date as the batch or lot number, the batch or lot number may be entered in the format of DD-MMM-YYYY (i.e. 29-MAY-2020).
Final consumer - the certificate will require an indication of whether the products are packaged for final consumers so that the EU can check that the labelling complies with EU law.
- This should be “Yes” if the commodity is packaged for final consumers. This includes product packaged for retail sale i.e. a supermarket or packed in individual portions for consumer use.
- This should be “No” if the products are packed in bulk and to be separated for sale to individual consumers by the retailer.

For an eCert to be lodged successfully, valid exporter (consignor), consignee (importer), and Place of Destination TRACES IDs must be supplied. You should work closely with your importer to ensure you have the correct TRACES-NT IDs for the Consignee and the Place of Destination.

If your company is wanting to also be included as the exporter of the products on export documentation (as well as being the manufacturer/processor) you will need to create an account to log in to TRACES NT. The log on will give you the access that you need to register for or look up your TRACES NT identifier code (exporter ID) that will be needed when you raise your request for permit in EXDOC (or REX in NEXDOC). Section 6 contains more information on how to do this.

For additional information refer to: 2022-08: European Union: Fish: Paperless trade eCert commences from 31 May 2022 - DAFF (agriculture.gov.au).

2024-05: Fish and Fish Products: European Union: Changes to European Commission TRACES-NT access from 11 June 2024 - DAFF (agriculture.gov.au).

As TRACES NT is managed by the EU, if you have any further questions the department encourage you to work with your importer to clarify any EU import requirements.

If you have any questions in relation to raising export certification please contact the EXDOC Help Desk (EXDOC.Helpdesk@aff.gov.au) or the Dairy, Eggs and Fish Export Program (dairyeggsfish@aff.gov.au).

Certificate for composite foods containing processed dairy products

The only template currently available for composite products is:

M492 (12/22) – English only. This is a manual certificate.

Note: This certificate is only available in a manual format as it is difficult for EXDOC to automatically incorporate information from several export programs. The manual certificate will be issued from the Department regional offices after an assessment of the composite food's ingredients has been conducted to ensure they have been sourced from EU-listed establishments. Exporters are advised that this assessment may be a lengthy process and it is strongly recommended that exporters make allowances for the time this assessment will take when preparing composite foods for export. The Department will provide exporters with instructions on how to complete this certificate on request. Some guidance is provided at section 2 above.

If exporters are interested in having certificate template M492A made available, please contact the department at exportstandards@aff.gov.au.

5.2 Manufacturing grade products

Transition to eCert

From 29 April 2022, health certificates for milk and milk products exported to the European Union (EU) have been issued via the EU Trade Control and Export System (TRACES-NT) as an eCert (through the department’s Next Export Documentation (NEXDOC) system. Certificate templates have been re-named due to the move to eCert. The new eCert extract name is provided in the following table:

Commodity	Previous template name	eCert extract name
For the export of milk and milk products (not for human consumption)	ZDENS1	EUEXS1

For more information regarding the eCert arrangement, refer to MAA 2022-08.

Manufacturing Grade (DM) milk and milk products

For export of Manufacturing Grade (DM) milk and milk products from cows or buffaloes, use EUEXS1 or bilingual templates with the same endorsements as the EUEXS1.

The 'F' product use indicator must be selected so that the commodity is certified for further processing.

Certificate templates are not available for transit of manufacturing grade milk and milk products through the EU. If exporters wish to transit these products through the EU, they may contact the Department to request the development of a certificate template.

Manufacturing Grade colostrum and colostrum products

Certificate templates are no longer available for export or transit of manufacturing grade colostrum and colostrum products. If exporters wish to export these products to the EU, or transit them through the EU, they may contact the Department to request the development of a certificate template.

Provision of certificates for Manufacturing Grade (DM) milk, milk products, colostrum and colostrum products

EU export and transit certificates must be signed on, or prior to, the nominated date of departure of the vessel.

EU transit certificates for inedible by-products contain the same endorsements as EU export certificates for these by-products.

5.3 Technical grade and pharmaceutical products

Transition to eCert

Commodity	Previous template name	eCert extract name
For the export of milk and milk products (not for human consumption)	ZDENS1	EUEXS1

For more information regarding the eCert arrangement, refer to MAA 2022-08.

Milk, milk-based products, and milk-derived products for use in technical products (including pharmaceuticals)

For export of milk, milk-based products and milk-derived products from cows or buffaloes, use EUEXS1 or bilingual templates with the same endorsements as the EUEXS1.

The 'T' product use indicator must be selected so that the commodity is certified for technical use.

Certificate templates are not available for transit of milk, milk-based products, and milk-derived products for use in technical products (including pharmaceuticals) through the EU. If exporters wish to transit these products through the EU, they may contact the Department to request the development of a certificate template.

Colostrum and colostrum-based products for use in technical products (including pharmaceuticals)

Certificate templates are no longer available for export or transit of colostrum and colostrum-based products for use in technical products (including pharmaceuticals). If exporters wish to export these products to the EU, or transit them through the EU, they may contact the Department to request the development of a certificate template.

Products used for research, education, diagnostic or museum purposes

An export certificate is not required for products exported for research or diagnostic purposes.

Exporters may be required to provide commercial documents that include sourcing and processing declarations.

Trade samples of technical products (including pharmaceuticals)

For export of trade samples, use M448 or bilingual templates with the same endorsements as M448.

Certificate templates are not available for transit of trade samples. If exporters wish to transit trade samples through the EU, they may contact the Department to request that a certificate template be developed.

5.4 Animal feed

Transition to eCert

Commodity	Previous template name	eCert extract name
For the export of milk and milk products (not for human consumption)	ZDENS1	EUEXS1

For more information regarding the eCert arrangement, refer to MAA 2022-08.

Milk, milk-based products, and milk-derived products for use in animal food

For export of milk, milk-based products and milk-derived products from cows or buffaloes, use EUEXS1 or bilingual templates with the same endorsements as the EUEXS1.

The 'A' product use indicator must be selected so that the commodity is certified for animal food.

Certificate templates are not available for transit of milk, milk-based products, and milk-derived products for use in animal food through the EU. If exporters wish to transit these products through the EU, they may contact the Department to request the development of a certificate template.

Colostrum and colostrum-based products for use in animal food

Certificate templates are no longer available for export or transit of colostrum and colostrum-based products for use in animal food. If exporters wish to export these products to the EU, or transit them through the EU, they may contact the Department to request the development of a certificate template.

Trade samples of animal food

For export of trade samples, use M448 or bilingual templates with the same endorsements as M448.

Provision of certificates for animal food

EU export and transit certificates must be signed on, or prior to, the nominated date of departure of the vessel.

EU transit certificates for inedible by-products contain the same endorsements as EU export certificates for these by-products.

Pet milk and processed milk-based pet food

Certificate templates are no longer available for export or transit of pet milk and processed milk-based pet food. If exporters wish to export these products to the EU, or transit them through the EU, they may contact the Department to request the development of a certificate template.

5.5 Consignments under 10 kilograms and trade samples

Carry-on packs, personal consignments and trade samples

Carry-on packs, personal consignments and trade samples of milk and milk products must be fully compliant with EU requirements and bear a health certificate verifying this eligibility. This includes products that are part of traveller's luggage, or are sent as consignments to private persons.

The requirement also applies to product under 10 kg in weight.

5.6 Additional certification/letters

The ZX01 Certificate as to Dioxin Status of Australian Dairy Products can be issued as an additional export certificate.

Additional certificate option for EU quota consignments only

The IMA1 Certificate – Cheese for Processing, should be used for cheese processing (Common Customers Tariff 04069001).
The IMA1UK Certificate – Cheddar Cheese, should be used for cheddar cheese (Common Customs Tariff 04069021).

6.1 Import permit

There are no generic permits required for products imported into the EU, but individual member states may have permit requirements for imported products.

Exporters should ask their importer whether they need to obtain an import permit.

6.2 Port-of-entry inspection and testing

Consignments of imported animal products receive a documentary, identity, and physical checks at an EU Border Control Post (BCP) according to the frequency specified in the table below before being cleared for free circulation.

Table 13: Frequency of checks
Type of product	Frequency of documentary and identity checks	Frequency of physical checks
Note The European Commission website includes , lists of approved warehouses and ships suppliers, and an
Milk and milk products for human consumption	100%	Not less than 50% of consignments
Milk and milk products not for human consumption	100%	Not less than 1% and not more than 10% of consignments

Intensified controls border control posts

From 14 December 2019 onwards, REGULATION (EU) 2019/1873 of 7 November 2019 on the procedures at Border Control Posts for a coordinated performance by competent authorities of intensified official controls on products of animal origin, germinal products, animal by-products and composite products, will implement the following intensified border controls for goods following a non-compliance notified to the European Commission. Following the notification, official controls on consignments, with the same use or origin and with an identifiable listed establishment of origin, including third country vessels, will be intensified at all border control posts (BCPs) in all member states of the EU.

Assessment of non-compliance

The Commission shall assess the non-compliance against the following requisite conditions, whether:

suspected fraudulent or deceptive practices, or
a potentially serious or repeated infringement of EU food and food safety rules Eg. where products of animal origin contain levels of contaminants or residues of veterinary medicinal products which exceed MRLs, or products do not comply with EU microbiological criteria,

Consignments excluded from the intensified controls

The competent authorities may exclude a consignment from the intensified controls, if the consignment is to be refused on grounds other than the infringement for which intensified controls are performed.

Identity and physical checks

Following a non-compliance deemed to be subject to EU Regulation 2019/1873, the Member State competent authorities shall carry out identity and physical checks on:

each consignment coming from the same establishment of origin, and
containing the same category of goods, for the same type of infringement, as indicated in the EU's Integrated Management System for Official Controls (IMSOC). IMSOC is an internal EU IT system that coordinates reporting between RASFF, EUROPHYT and TRACES.

If, during the intensified controls, three consignments entering the Union reveal the same type of infringement, the Commission shall request the competent authority of the third country (for Australia this is the Department):

make the necessary investigations to identify the reasons for the infringements (called 'imposed checks')
adopt an action plan to remedy the situation, and
report back, including the results of the action plan.

Termination of the intensified controls

The intensified controls shall end under only one of the following three different sets of circumstances:

A Member State Competent Authority decides to withdraw its notification, reasons must be given
An uninterrupted sequence of 10 satisfactory results has been recorded in IMSOC [The results do not need to be from the first 10 consignments to be tested but from the first results to be known and submitted in IMSOC], AND
The total weight of the consignments with satisfactory results reaches 10 times the weight of the consignment that caused the intensified controls procedure or reaches a net weight of 300 tons, whichever is the lowest.
Where 'imposed checks' have been requested, an uninterrupted sequence of at least 30 satisfactory results has been recorded in IMSOC, AND
The competent authority of the third country has adopted a satisfactory action plan.

Costs

The costs of the coordinated performance of intensified official controls shall be at the expense of the operator responsible for the consignments that are subject to those controls. This could be anywhere from 10 to 30 tests.

7.1 Packaging

7.2 Labelling

Labels on foodstuffs intended for human consumption

The EU has published a new regulation (EU Regulation 1169/2011) which combines two existing Directives on labelling - Directive 2000/13/EC (labelling, presentation, and advertising) and Directive 90/496/EEC (nutritional labelling).

Some of the key requirements in the new EU legislation include:

allergen information (for example, listing eggs, milk and/or gluten in the list of ingredients);
ensuring that labels are legible (for example, having a minimum size of text);
having labels in languages understood by consumers (that is, allows EU Member State countries to nominate languages required on labels); and
mandatory nutrition information on processed foods.

The new rules will apply from 13 December 2014. The obligation to provide nutrition information will apply from 13 December 2016.

Timeline for implementation of this regulation

There is a transitional period in the new regulation which may allow for foods labelled prior to 13 December 2014 to be accepted by EU authorities until stocks are exhausted. While the Department's understanding is outlined below, exporters are encouraged to check the details of this transitional period with their importers, as it is likely that this ruling may be interpreted differently in various EU destinations.

Exporters and manufacturers should work closely with their customers to ensure they understand the requirements so that labels on exported foods continue to comply with EU requirements.

Prior to 13 December 2014:

All labels on food sold in the EU must comply with existing labelling EU directives (2000/13/EC and 90/496/EEC);
Food labelled before 13 December 2014 can continue to be exported to the EU after this date, but the establishment will need to maintain robust, auditable records that demonstrate the food was, in fact, labelled before 13 December 2014.

From 13 December 2014 and up to 13 December 2016:

Labels on food manufactured from 13 December 2014 and up to 13 December 2016 (that is, new stock) must include all specifications in the new regulation (EU Regulation 1169/2011), but do not need to include nutritional information.
Labels on food manufactured prior to this date can continue to comply with existing labelling EU directives.

After 13 December 2016:

Labels on food manufactured from 13 December 2016 must include all specifications in the new regulation (EU Regulation 1169/2011), including nutritional information.

Further information

The EU has developed guidance material on these changes, including a list of frequently asked questions: Food information to consumers - legislation.

The tables below provide a summary of the requirements in the regulation as they apply to retail-ready finished foods and bulk-packed finished foods and a non-exhaustive list of the countries and language(s) each requires, and whether the requirement will be specified in new, special legislation or covered by existing consumer laws.

Note: If the foodstuff is a beverage which contains more than 1.2% alcohol by volume, the actual alcoholic strength by volume must be included.

Table 10: Differences in requirements for retail-ready and bulk packed finished foods
Mandatory Information to be Included on Retail-Ready Finished Foods	Mandatory Information to be Included on Bulk Packed Finished Foods
EU Regulation 1169/2011 includes detailed specifications for the following: A declaration about the presence of substances used as ingredients or processing aids identified as causing food allergies or intolerances (see table 11) Name of the food List of ingredients, and quantity of certain ingredients or categories of ingredients Net quantity of the food Date of minimum durability or the 'use by' date Any special storage conditions and/or conditions of use, and instructions for use where it would be difficult to make appropriate use of the food in the absence of such instructions Name or business name and address of the importer Country of origin or place of provenance, and A nutrition declaration Note There is an extended transitional period until 13 December 2016 for providing this information). Additional mandatory labelling particulars (detailed in Annex III of EU Regulation 1169/2011) apply to pre-packed foods that: are packaged under modified atmospheric conditions contain sweeteners contain liquorice contain caffeine contain phytosterols, phytosterol esters, phytostanols or phytostanol esters, and are frozen meat, meat preparations and fishery products (freeze dates).	EU Regulation 1169/2011 includes detailed specifications for the following: A declaration about the presence of substances used as ingredients or processing aids identified as causing food allergies or intolerances (see table 11). Information that is required to be on labels of retail-ready finished foods should be provided to importers so it can be displayed on labels when the food is packaged for sale or consumption. Member States may develop National legislation that requires labels of bulk packed finished foods to include information required on labels of retail-ready finished foods.

Table 11: Substances used as ingredients or food manufacture identified in EU Regulation 1169/2011 as causing food allergies and intolerances
Substances used
Eggs and egg products Milk and milk products (some minor exceptions) Crustaceans and crustacean products Fish and fish products (some minor exceptions) Molluscs and mollusc products Cereals containing gluten (some minor exceptions) Lupin and lupin products Mustard and mustard products Sesame seeds and sesame seed products Soybeans and soyabean products (some minor exceptions) Nuts and nut products, namely: peanuts, almonds, hazelnuts, walnuts, cashews, pecan nuts, Brazil nuts, pistachio nuts, macadamia or Queensland nuts (some minor exceptions) Celery and celery products Sulphur dioxide and sulphites at concentrations of more than 10 mg/kg or 10 mg/litre in terms of the total SO2 which are to be calculated for products as proposed ready for consumption or as reconstituted according to the instructions of the manufacturers.

Table 12: Known EU language requirement for mandatory labelling information (Current as at 12 September 2014)
EU Member States and European countries adopting EU requirements	Labelling language	New national legislation implemented to define required language(s) on labels
* No official confirmation has been provided to the Department. Exporters should clarify language requirements through commercial channels.
Austria	German	Yes
Belgium	Dutch, French, German	No
Bulgaria	Bulgarian*	Unconfirmed
Croatia	Croatian (& Latin script)	Yes
Cyprus	Greek	Yes
Czech Republic	Czech	Yes
Denmark	Danish*	Unconfirmed
Estonia	Estonian	Yes
Finland	Finnish, Swedish	Yes
France	French*	Unconfirmed
Germany	German	Yes
Greece	Greek*	Unconfirmed
Hungary	Hungarian	No
Iceland	Icelandic	Unconfirmed
Ireland	English	Yes
Italy	Italian*	Unconfirmed
Latvia	Latvian	Yes
Lithuania	Lithuanian	Yes
Luxembourg	French, German, Luxemburgois	No
Malta	Maltese*	Unconfirmed
Macedonia	Macedonian	Unconfirmed
Norway	Norwegian	No
Netherlands	Dutch*	Unconfirmed
Poland	Polish	Yes
Portugal	Portuguese*	Unconfirmed
Slovakia	Slovak*	Unconfirmed
Spain	Spanish	Yes
Slovenia	Slovenian language	Yes
Sweden	Swedish, Norwegian, Danish	Yes
Switzerland	French, German, Swiss, Italian*	Unconfirmed
United Kingdom	English	No

Labels on inedible by-products

Inedible by-products

During transport and storage, inedible by-products that are imported into the EU must have a label attached to the packaging, container or vehicle that:

clearly indicates the category of the inedible by-products or of the derived products
describes the nature of the product
bear the following words visibly and legibly displayed on the packaging, a container or vehicle, as applicable:

general Category 3 material where there are no other labels required: not for human consumption
research and diagnostic samples: for research and diagnostic purposes
trade samples: trade sample not for human consumption

7.3 Shelf life

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

7.4 Shipping marks

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

7.5 Further information

Use-by date

Labels on consumer-ready edible products must include the date of minimum durability or, in the case of foodstuffs which, from a microbiological point of view are highly perishable, the 'use-by' date and any special storage conditions or conditions of use.

The EU has no known specific requirements for shipping and airfreight. Milk and milk products must be transported to ensure their condition and integrity is maintained in accordance with the requirements of the Export Control (Milk and Milk Products) Rules 2021.

8.1 Refrigeration, transfer and loadout

Table 15: Definitions of terms used to describe dairy exports to the EU
Term	Definitions
Animal by-products	Entire bodies or parts of animals, products of animal origin or other products obtained from animals, which are not intended for human consumption.
Batch	A unit of production produced in a single plant using uniform production parameters, such as the origin of the materials, or a number of such units, when produced in continuous order in a single plant and stored together as a shipping unit.
Border Inspection Post (BIP)	An approved port-of-entry into the EU that has veterinary controls to manage the risks posed by imported live animals and products of animal origin, as these goods can transmit serious human and animal diseases.
Category 3 animal by-product (containing milk or colostrum)	Raw milk or colostrum originating from live animals that did not show any signs of disease communicable through that product to humans or animals. This can be either Manufacturing Grade (DM) milk and milk products exported for further processing, dairy stockfeed exported for use as animal food, or milk and milk products exported for use in technical products, including pharmaceuticals.
Clearance	The process by which a consignment of live animals or product of animal origin can enter into the EU, after it has satisfactorily undergone the specific checks and a Common Veterinary Entry Document (CVED) has been issued.
Competent authority	The central authority of a country which is able to ensure compliance with the requirements of EU regulations or any authority to which that competence has been delegated.
Composite products	Foods that contain a mixture of processed animal products (such as meat, dairy, fish, egg, gelatine and honey) and processed plant products (grains, seeds, fruit or vegetables).
Documentary check	The examination of commercial documents and, where appropriate, of documents required under EU law that are accompanying the consignment at a BIP.
EU dependency or dependent state	A country that is governed by a Member State and is subject to EU legislation.
EU listing	An establishment that has been approved to export to the EU. To be EU listed, an establishment must be in a country approved to export a specific category of food of animal origin Note This approval also involves having a residue monitoring plan for this category of food of animal origin).
EU member state	A country that has signed the treaties of the EU and is subject to the privileges and obligations of EU membership, including EU legislation.
Export to the EU	The movement of goods from Australia to the EU.
Identity check	A visual inspection at a BIP to ensure certificates or other documents accompanying the consignment tally with the labelling and the content of the consignment.
Import into the EU	The movement of goods on arrival at an EU Border Inspection Post.
Ingredient	Any substance, including additives, used in the manufacture or preparation of a foodstuff and still present in the finished product, even if in altered form.
Milk and milk products	The following dairy products from cows, buffaloes, sheep and goats are considered to be milk and milk products and must be certified as such: milk, including milk powder, condensed milk; cream, including UHT and cream products; buttermilk, curdled milk and cream; yoghurt; butter, dairy spreads, and other fats and oils derived from milk; cheese (including fresh cheese, canned cheese, hard cheese, processed cheese, semi-hard cheese, and cheese powder); ice cream and ice-cream mix; infant powder; casein, caseinates and other casein derivatives; lactose and lactose syrup; whey and whey powder albumins (including concentrates of two or more whey proteins, containing by weight more than 80% whey proteins, calculated on the dry matter); and milk proteins (including concentrated milk proteins with a protein content of more than 85% by weight, calculated on the dry matter).
Pasteurisation	High Temperature Short Time pasteurisation at 72°C for at least 15 seconds or equivalent pasteurisation effect.
Physical check	A check on the feed or food itself at a BIP. This may include checks on the means of transport, the packaging, labelling and temperature, the sampling for analysis and laboratory testing and any other check necessary to verify compliance with EU law.
Pre-packaged foodstuff	Any single item for presentation as such to the ultimate consumer and to mass caterers, consisting of a foodstuff and the packaging into which it was put before being offered for sale, whether such packaging encloses the foodstuff completely or only partially, but in any case in such a way that the contents cannot be altered without opening or changing the packaging.
Research and diagnostic samples of animal by-products	By-products and derived products intended for the following purposes: examination in the context of diagnostic activities or analysis for the promotion of progress in science and technology, in the context of educational or research activities
Somatic cell count	The number of leukocytes and epithelial cells in a millilitre of raw milk. This is used to measure milk quality changes due to mastitis. Leukocytes (white blood cells) increase due to an immune response to a mastitis-causing pathogen, and epithelial cells (milk-producing cells) are shed from inside the udder when an infection occurs.
Total plate count	The number of bacteria in a millilitre of raw milk incubated at 30°C. This is used to measure milk quality changes due to poor hygiene and mastitis.
Trade samples of animal by-products	By-products or derived products intended for particular studies or analyses with a view to carrying out a production process or developing feeding stuffs or other derived products, including testing of machinery, for use in an establishment or plant which is producing feeding stuffs, or products for uses other than food and feed; or processing animal by-products or derived products
Transit through the EU	Movement of goods through EU territory, other than by sea or by air, as part of the export of goods from Australia to a non-EU country.

Relevant EU Legislation

Table 14: Relevant EU Legislation
Topic	Legislation	Requirements
Animal health	Directive 2002/99/EC	Animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumption
Microbiological testing	Regulation 2073/2005	Microbiological criteria for foodstuffs
Residues and prohibited substances	Decision 2009/800/EC	Approval of residue monitoring plans submitted by third countries in accordance with Council Directive 96/23/EC
Residues and prohibited substances	Regulation 1333/2008	Requirements for food additives
Food hygiene	Regulation 178/2002	General food law
	Regulation 852/2004	General hygiene requirements for foodstuffs
	Regulation 853/2004	Hygiene rules for food of animal origin
	Regulation 854/2004	Official controls
Labelling of food	Directive 2000/13/EC	Labelling, presentation and advertising of foodstuffs
Edible products	Regulation 914/2011	Certification for milk and milk products for human consumption
Inedible by-products	Regulation 1774/2002	Rules for inedible by-products and derived products not intended for human consumption
	Regulation 1069/2009	Replaces Regulation 1774/2002 from 22 July 2011- Rules for inedible by-products and derived products not intended for human consumption
	Regulation 142/2011	Implements Regulation 1069/2009and updates certificates
	Regulation 183/2005	Feed hygiene
Marketing of animal feed	Regulation 767/2009	Placing on the market and use of feed (including pet food)
Principles of certification	Directive 96/93/EC	Certification of animals and animal products
Border inspection checks and ships stores	Directive 97/78/EC	Veterinary checks on products entering the EU
	Decision 94/360/EC	Frequency of physical checks of consignments of certain products
	Decision 2011/215/EU	Implements Council Directive 97/78/EC as regards transhipment
Personal consignments	Regulation 206/2009	Introduction into the EU of personal consignments of products of animal origin

11/02/2025 - Updated information for non-manufacturers and TRACES (sections 1.2 and 5.1).
22/01/2025 - Updated information on countries included in the move to eCert (section 5.1).
04/06/2024 - Updated changes to templates for eCert (sections 5.2, 5.3 and 5.4).
23/10/2023 - Added information on electronic certification (section 5.1).
02/06/2023 - Updated composite products certificate information (sections 2.2 and 5.1).
22/04/2022 - Added warning regarding existing EU residues requirements (section 2).
20/02/2022 - Content on this page may have changed location to conform to standard Dairy headings.
20/07/2021 - Amendments to documentation requirements on inedible products (sections 8.2 and 8.3).
20/07/2021 - Amendments to documentation requirements on inedible products (sections 5.3 and 5.4).
26/05/2021 - References to export legislation have been updated.

Dairy

European Union (EU)

Considerations prior to updating of establishment details (added 3 June 2021)

1. Preconditions for market access

1.1 Establishment registration

Exceptions (ships stores)

1.2 Overseas listing

How to apply for EU listing

Listing modifications

Information for exporters who are non-manufacturers

1.3 Prohibited products

1.4 General information

Australian products that do not meet European Union official requirements

2. Production of products for human comsumption

Export Destination Residues Warning – EU residue standards

2.1 Milk and milk products

Sourcing of milk and milk products

Final product testing for microbiological pathogens

2.2 Compositional requirements

Composite products

Composite products exempt from Border Control Post inspection

Composite products that must have an EU milk and milk product certificate

Dairy products needing an EU composite product certificate

Information in the certificate for composite foods imported into the EU

2.3 Further information

3. Production of products not for human consumption

3.1 Technical grade and pharmaceutical products

3.2 Animal feed

Pet milk and milk-based pet food

3.3 Manufacturing grade products

3.4 Processing

Raw milk

Pasteurisation and heat treatment

Hazard Analysis Critical Control Point (HACCP)

Refrigeration, transfer and loadout

3.5 Further information

4. Operational requirements

4.1 Microbial and residue sampling

Microbial testing of milk

4.2 Operational requirements additional to Australia's export legislation

Sourcing of raw milk and dairy ingredients

4.3 Hygiene

Milk cooling

Water used during processing

5. Documentation requirements

5.1 Milk and milk products

Certificates for milk and milk products

Milk and milk products

Use of transit certificates for milk and milk products

Countries included in the move to eCert

Milk and milk products from sheep or goats

Accessing TRACES-NT

When raising your export documentation

Certificate for composite foods containing processed dairy products

5.2 Manufacturing grade products

Transition to eCert

Manufacturing Grade (DM) milk and milk products

Manufacturing Grade colostrum and colostrum products

Provision of certificates for Manufacturing Grade (DM) milk, milk products, colostrum and colostrum products

5.3 Technical grade and pharmaceutical products

Transition to eCert

Milk, milk-based products, and milk-derived products for use in technical products (including pharmaceuticals)

Colostrum and colostrum-based products for use in technical products (including pharmaceuticals)

Products used for research, education, diagnostic or museum purposes

Trade samples of technical products (including pharmaceuticals)

5.4 Animal feed

Transition to eCert

Milk, milk-based products, and milk-derived products for use in animal food

Colostrum and colostrum-based products for use in animal food

Trade samples of animal food

Provision of certificates for animal food

Pet milk and processed milk-based pet food

5.5 Consignments under 10 kilograms and trade samples

Carry-on packs, personal consignments and trade samples

5.6 Additional certification/letters

Additional certificate option for EU quota consignments only

6. Import procedures

6.1 Import permit

6.2 Port-of-entry inspection and testing

Intensified controls border control posts