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Dairy

Austria (AT)

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1. Preconditions for market access

1.1. Import permit

This country adopts EU importing country requirements, including EU certification.

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.

1.2. Establishment listing

Ships stores

This country adopts EU importing country requirements, including EU certification.

Establishment listing

This country adopts EU importing country requirements, including EU certification.

Initial listing procedure for edible products exported to the EURequired?
Export registrationYes
EU listingYes, refer to notes
EU inspection for listingNo
EU listing approvalYes, refer to notes
Notes:
  • Establishments that export edible products to the EU must 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 5 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 AQIS establishment register is updated to indicate the establishment is approved for ‘EU – dairy’. The registration certificate for the establishment will also indicate this notation.
Inedible products
Initial listing procedure for inedible products exported to or transited through the EURequired?
Export registration Yes, only establishments processing:
  • manufacturing grade milk - export registered for human consumption
  • animal food that includes milk or colostrum - export registered for stockfood

Refer to notes

EU listingYes, refer to notes and table below
DAFF listing auditYes, refer to notes and table below
EU inspection for listingNo
EU listing approvalNo
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 table below).
  • 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 (i.e. ‘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.
Type of inedible productListing required?Audit prior to listing required?
Manufacturing grade milk/colostrum for further processing in the EUYesOnly if establishment is not export registered
Milk/colostrum for use in animal foodYesOnly if establishment is not export registered
Pet milk and milk-based petfoodYesYes, refer to notes
Milk/colostrum for use in technical productsYesOnly if establishment is not export registered
Trade samplesNoNo
Milk/colostrum for use in research or diagnostic for purposesNoNo
Notes:
  • Establishments exporting pet milk and milk-based petfood must be listed on the EC website as a petfood processing establishment.
  • Establishments must be audited against the EU requirements for pet milk and milk-based petfood and recommended for EU petfood listing by PFIAA or other DAFF approved auditor.

1.3. Prohibited products

This country adopts EU importing country requirements, including EU certification.

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

1.4. Australian products that do not meet Austrian official requirements

This country adopts EU importing country requirements, including EU certification.

The following animal products do not meet EU official requirements:

  • inedible products containing sheep and goat milk.

2. Operational requirements

2.1. General operational requirements

This country adopts EU importing country requirements, including EU certification.

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

2.2. Hygiene

This country adopts EU importing country requirements, including EU certification.

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 the following DAFF document: Raw milk temperatures: Understanding & complying with EU requirements

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 the following DAFF document: Understanding water testing requirements for the EU 

2.3. Microbial and residue sampling, and maximum acceptable limits

Microbial testing of milk

This country adopts EU importing country requirements, including EU certification.

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:

Type of productTestStandard
Raw cows’ milkPlate count at 30 °C (per ml)= 100,000
Somatic cell count (per ml)= 400,000
Raw milk collected from other speciesPlate 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 the Milk and Milk Products section.

For information on how to meet these requirements, refer to the DAFF document: TPC & BMCC - Understanding & complying with EU requirements

Residue sampling, and maximum acceptable limits

This country adopts EU importing country requirements, including EU certification.

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: The EU does not allow for testing to involve heating of samples as this may remove the presence of antibiotic residues.

For more information, refer to the DAFF document: Antibiotics - Complying with EU requirements

3. Processing

3.1. Raw milk

This country adopts EU importing country requirements, including EU certification.

The EU’s raw milk processing requirements in Regulation 853/2004 can be met by complying with Schedule 5 of the Export Control (Milk and Milk Products) Orders 2005 .

3.2. Pasteurisation and heat treatment

This country adopts EU importing country requirements, including EU certification.

The raw milk must be subjected to pasteurisation that is equivalent to that specified for milk for human consumption in Schedule 5 of the Export Control (Milk and Milk Products) Orders 2005 or recognised in Australia as equivalent to 72 °C for 15 seconds (i.e. batch pasteurisation at 60 °C for 30 minutes).

3.3. HACCP

This country adopts EU importing country requirements, including EU certification.

The EU’s HACCP compliance requirements in Regulation 852/2004 can be met by complying with Schedule 2 of the Export Control (Milk and Milk Products) Orders 2005.

3.4. Refrigeration, transfer and loadout

This country adopts EU importing country requirements, including EU certification.

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 of Agriculture (the department) to verify the effectiveness of the establishment checks and accuracy of information on health certificates provided by the department by undertaking random inspections of container loadouts. This means exporters must lodge requests to process Requests for Permits (RFPs) with the Department of Agriculture 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. 

4. Production of edible products

4.1. Milk, milk products and composite foods containing dairy products

This country adopts EU importing country requirements, including EU certification.

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 the following composite products:
    • composite products that contain any meat
    • composite products with a fish or egg content of 50% or more
    • shelf-stable composite products with a dairy content of 50% or more and
    • composite products that require refrigeration or freezing (i.e. are not shelf-stable) that contain any dairy products.

Note: Composite foods are 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).

There are several options that apply for composite foods that contain processed dairy products that are sent to the EU. These options depend on the how the product is described, the customs tariff code applied to the product, what type of ingredient is in the product, and the quantity of these ingredients in the product.

For information about which option applies to specific products, click on the content linked to the following options:

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.

Micro-organism

Type of final product

EU food safety criteria (See note 1)

Listeria monocytogenes

Ready-to-eat products intended for infants and special medical purposes (See note 2)

n = 10, absence in 25g

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

Milk powder and whey powder that is not intended for further processing prior to consumption (See note 6)

n = 5, absence in 25g

Notes

  1. Where n = number of samples, and M = maximum number of bacteria allowed in a sample.
  2. 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 (i.e.  products with pH 4.4 or aw = 0.92, or pH 5.0 and aw = 0.94).
  3. 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.
  4. This testing is not required for products where the aw = 0.95.
  5. Testing is not required for products where the manufacturing process or composition of product will eliminate the risk of Salmonella in the product.
  6. 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.
  7. For information on how to meet these requirements, refer to the DAFF document: Understanding microbiological testing requirements for the EU.

5. Production of inedible products

5.1. Manufacturing Grade (Dm) milk and milk products

Manufacturing Grade (Dm) milk, milk products, colostrum and colostrum products

This country adopts EU importing country requirements, including EU certification.

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 Schedule 5 of the Export Control (Milk and Milk Products) Orders 2005 or recognised in Australia as equivalent to 72 °C for 15 seconds (i.e. 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.

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.

5.2. Animal food

Pet milk and milk-based petfood

This country adopts EU importing country requirements, including EU certification.

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

The processing establishment must be on the EU list of approved animal by-product establishments, in particular for petfood processing and export registered to export dairy petfood. These establishments do not need to be approved to process milk for human consumption.

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

  • a random sample must be taken from processed petfood during or after storage from each batch and found to comply with the standards in the following standards.
Type of final productMicro-organismStandard
Processed pet milk or milk-based ingredients in petfood Salmonellan = 5, c = 0, absence in 25g
Enterobacteriaceae in 1gn = 5, c = 2, m = 10, M = 300

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

Animal food

This country adopts EU importing country requirements, including EU certification.

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 e.g. 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 Schedule 5 of the Export Control (Milk and Milk Products) Orders 2005 or recognised in Australia as equivalent to 72 °C for 15 seconds (i.e. 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 registered to produce stockfeed. 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,(e.g. 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 (e.g. 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 audited by an AQIS 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.

5.3. Technical products and pharmaceutical material

Technical products (including pharmaceuticals)

This country adopts EU importing country requirements, including EU certification.

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 e.g. 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 Schedule 5 of the Export Control (Milk and Milk Products) Orders 2005 or recognised in Australia as equivalent to 72 °C for 15 seconds (i.e. 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, but these establishments do not need to be export registered, or 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:

  • 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,(e.g. 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 (e.g. 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 audited by an AQIS 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.

6. Labelling, shelf life, and shipping marks (port marks)

6.1. Labelling and packaging

Labels on finished foodstuffs

This country adopts EU importing country requirements, including EU certification.

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 (e.g. listing eggs, milk and/or gluten in the list of ingredients);
  • ensuring that labels are legible (e.g. having a minimum size of text);
  • having labels in languages understood by consumers (i.e. 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 of Agriculture’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 (i.e. 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. This is available online at

http://ec.europa.eu/food/food/labellingnutrition/foodlabelling/proposed_legislation_en.htm and http://ec.europa.eu/food/food/labellingnutrition/foodlabelling/docs/qanda_application_reg1169-2011_en.pdf

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.

Table 1: 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 2);
  • 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 2).
  • 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.

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 2: Substances used as ingredients or food manufacture identified in EU Regulation 1169/2011 as causing food allergies and intolerances

  • 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 3: 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

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

* No official confirmation has been provided to the Department of Agriculture. Exporters should clarify language requirements through commercial channels.

Labels on inedible by-products

This country adopts EU importing country requirements, including EU certification.

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 and
  • 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

6.2. Use-by date

Use-by date and/or shelf life restrictions

This country adopts EU importing country requirements, including EU certification.

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.

6.3. Shelf life restrictions

This country adopts EU importing country requirements, including EU certification.

The European Union has no known specific requirements for shelf life restrictions other than those provided in the Export Control (Milk and Milk Products) Orders 2005, with particular reference to Schedule 5 and 7.

6.4. Shipping marks (port marks)

This country adopts EU importing country requirements, including EU certification.

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

7. Documentation requirements for edible products

7.1. Milk, milk products and composite foods containing dairy products

Certificates for milk, milk products and composite foods containing dairy products

This country adopts EU importing country requirements, including EU certification.

Milk and milk products

For export of the following milk and milk products from cows or buffaloes, use the use ZDENH1or bilingual templates with the same endorsements as the ZDENH1. Select the 'H’ product use indicator so that the commodity is certified 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).

Note: Templates currently available are the ZDENH1 (English export), ZDDKH1 (Danish/English export), ZDDEH1 (German/English export), ZDDUH1 (Dutch/English export), ZDESH1 (Spanish/English export), ZDFRH1 (French/English export), ZDITH1(Italian/English export), and ZDMTH1(Maltese/English export). If this country does not accept the languages used in these templates, exporters should contact DAFF to initiate the development of another bilingual certificate template.

ZDENH1, ZDDKH1, ZDDEH1, ZDDUH1, ZDESH1, ZDFRH1, ZDITH1, and ZDMTH1

These templates have the following attestations:

I, the undersigned official veterinarian, declare that I am aware of the relevant provisions of Directive 2002/99/EC and of Regulation (EC) No 853/2004 and hereby certify that the dairy product described above:

(a) has been obtained from animals:

(i) under the control of the official veterinary service,

(ii) which were in a country or part thereof that has been free of foot-and-mouth disease and of rinderpest for a period of at least 12 months prior to the date of this certificate, and where vaccination against foot-and-mouth disease has not been carried out during that period,

(iii) belonging to holdings which were not under restrictions due to foot-and-mouth disease or rinderpest, and,

(iv) subject to regular veterinary inspections to ensure that they satisfy the animal health conditions laid down in Chapter I of Section IX of Annex III to Regulation (EC) No 853/2004 and in Directive 2002/99/EC,

(b) has undergone or been produced from raw milk which has been submitted to a pasteurisation treatment involving a single heat treatment with a heating effect at least equivalent to that achieved by a pasteurisation process of at least 72°C for 15 seconds and where applicable, sufficient to ensure a negative reaction to an alkaline phosphatase test applied immediately after the heat treatment.

II.2. Public Health attestation

I, the undersigned official veterinarian, declare that I am aware of the relevant provisions of Regulations (EC) No 178/2002, (EC) No 852/2004, (EC) No 853/2004 and (EC) No 854/2004 and hereby certify that the dairy product described above was produced in accordance with those provisions, in particular that:

(a) it was manufactured from raw milk:

(i) which comes from holdings registered in accordance with Regulation (EC) No 852/2004 and checked in accordance with Annex IV to Regulation (EC) No 854/2004,

(ii) which was produced, collected, cooled, stored and transported in accordance with the hygiene conditions laid down in Chapter I of Section IX of Annex III to Regulation (EC) No 853/2004,

(iii) which meets the plate and somatic cell count criteria laid down in Chapter I of Section IX of Annex III to Regulation (EC) No 853/2004,

(iv) which complies with the guarantees on the residues status of raw milk provided by the monitoring plans for the detection of residues or substances submitted in accordance with Council Directive 96/23/EC, and in particular, Article 29 thereof,

(v) which, pursuant to testing for residues of antibacterial drugs carried out by the food business operator in accordance with the requirements of Annex III, Section IX, Chapter I, Part III, point 4 of Regulation (EC) No 853/2004, it complies with the maximum residue limits for residues of antibacterial veterinary medicinal products laid down in the Annex to Regulation (EU) No 37/2010,

(vi) which has been produced under conditions guaranteeing compliance with the maximum residue levels for pesticides laid down in Regulation (EC) No 396/2005, and maximum levels for contaminants laid down in Regulation (EC) No 1881/2006.

(b) it comes from an establishment implementing a programme based on the HACCP principles in accordance with Regulation (EC) No 852/2004,

(c) it has been processed, stored, wrapped, packaged and transported in accordance with the relevant hygiene conditions laid down in Annex II to Regulation (EC) No 852/2004 and Chapter II of Section IX of Annex III to Regulation (EC) No 853/2004,

(d) it meets the relevant criteria laid down in Chapter II of Section IX of Annex III to Regulation (EC) No 853/2004 and the relevant microbiological criteria laid down in Regulation (EC) No 2073/2005 on microbiological criteria for foodstuffs,

(e) the guarantees covering live animals and products thereof provided by the residue plans submitted in accordance with Directive 96/23/EC, and in particular Article 29 thereof, are fulfilled.

Transit of milk and milk products from cows and buffaloes

Austria adopts EU importing country requirements, including EU certification.

For the transit of the following milk and milk products from cows or buffaloes, use the use ZDENHT or bilingual templates with the same endorsements as the ZDENHT. Select the 'H’ product use indicator so that the commodity is certified 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).

Note: Templates currently available are the ZDENHT (English transit), ZDITHT (Italian/English transit) and ZDMTHT (Maltese/English transit). If Austria does not accept the languages used in these templates, exporters should contact AQIS to initiate the development of another bilingual certificate template.

ZDENHT, ZDITHT, and ZDMTHT

These templates have the following attestations:

I, the undersigned official veterinarian, hereby certify

that the [dairy products] for [transit] / [storage] in the European Union described above:

(a) come from a country or part thereof authorised for imports to the European Union of raw milk or dairy products as laid down in Annex I to Regulation (EU) No 605/2010,

(b) comply with the relevant animal health conditions for the products concerned as laid down in the animal health attestation in Part II.1 of the model certificates [Milk-HTB] in Part 2 of Annex II to Regulation (EU) No 605/2010;

(c) was produced on … or between … and ….

Milk and milk products from sheep or goats

This country adopts EU importing country requirements, including EU certification.

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 AQIS to request that a certificate template be developed.

Composite foods containing processed dairy products

The template currently available for composite foods that contain processed dairy products and meat, or contain 50% or more, in total, of other processed animal products is the M492(English export). 

Templates are being developed in German/English , Dutch/English French/English. If this country does not accept the languages used in these templates, exporters should contact DAFF to initiate the development of another bilingual certificate template.

Note: These certificates are only available in a manual format as it is difficult for EXDOC to automatically incorporate information from several export programs. The manual certificates will be issued from DAFF 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. DAFF will provide exporters with instructions on how to complete this certificate on request.

M492

This template has the following attestations:

I, the undersigned official veterinarian/official inspector hereby certify that

II.1. I am aware of the relevant provisions of Regulations (EC) No 178/2002, (EC) No 852/2004 and (EC) No 853/2004, in particular Article 6.1(b) on the origin of the products of animal origin used in the production of the composite products described above and certify that the composite products described above were produced in accordance with those requirements, in particular that they come from (an) establishment(s) implementing a programme based on the HACCP principles in accordance with Regulation (EC) No 852/2004;

II.2. the composite products described above contain:

either

II.2.A Meat products, treated stomachs, bladders and intestines

 in any quantity which meet the animal health requirements in Commission Decision 2007/777/EC and contain the following meat constituents which meet the criteria indicated below:

Species (A) Treatment (B) Origin (C) Approved Establishment(s) (D)

(A) Insert the code for the relevant species of meat product, treated stomachs, bladders and intestines where BOV = domestic bovine animals (Bos taurus, Bison bison, Bubalus bubalis and their crossbreds); OVI = domestic sheep (Ovis aries) and goats (Capra hircus); EQI = domestic equine animals (Equus caballus, Equus asinus and their crossbreds), POR = domestic porcine animals (Sus scrofa); RM = domestic rabbits, PFG = domestic poultry and farmed feathered game, RUF farmed non-domestic animals other than suidae and solipeds; RUW = wild non-domestic animals other than suidae and solipeds; SUW = wild non-domestic suidae: EQW = wild non-domestic solipeds, WL = wild lagomorphs, WGB = wild game birds.

(B) Insert A, B, C, D, E or F for the required treatment as specified and defined in Parts 2, 3 and 4 of Annex II to Decision 2007/777/EC.

(C) Insert the ISO code of the country of origin of the meat product, treated stomachs, bladders and intestines as listed in Annex II, Part 2 to Decision 2007/777/EC and, in the case of regionalization by Union legislation for the relevant meat constituents, the region as indicated in Part 1 of Annex II to Decision 2007/777/EC or a Member State of the European Union.

The country of origin of the meat products must be one the following: the same as the country of export in box I.7, a Member State of the European Union, a third country or parts thereof authorised to export to the Union meat products treated with treatment A as set out in Annex II to Decision 2007/777/EC, where the third country where the composite product is produced is also authorised to export to the Union meat products treated with that treatment.

(D) Insert EU approval number of the establishments of origin of the meat products, treated stomachs, bladders and intestines contained in the composite product.

(E) If containing material from bovine, ovine or caprine animals, the fresh meat and/or intestines used in the preparation of the meat products and/or treated intestines shall be subject to the following conditions depending on the BSE risk category of the country of origin:

(E.1) for imports from a country or a region with a negligible BSE risk as listed in Annex to Commission Decision 2007/453/EC as amended:

(1) the country or region is classified in accordance with Article 5(2) of Regulation (EC) No 999/2001 of the European Parliament and of the Council as a country or region posing a negligible BSE risk;

(2) the animals from which the products of bovine, ovine and caprine animal origin were derived were born, continuously reared and slaughtered in the country with negligible BSE risk and passed ante-mortem and post-mortem inspections;

and/or II.2.B Processed dairy products

in an amount of half or more of the substance of the composite product or not shelf stable dairy products in any quantity that:

(a) have been produced in the country … in the establishment …(approval number of the establishments of origin of the dairy products contained in the composite product authorised at the time of production for export of dairy products to the EU). The country of origin of the dairy products must be one of the following: the same as the country of export in box I.7, a Member State of the European Union, a third country authorised to export to the Union milk and dairy products in Column A or B of Annex I to Regulation (EU) No 605/2010, where the third country where the composite product is produced is also authorised, under the same conditions, to export to the Union milk and dairy products.

The country of origin indicated in box I.7 must be listed in Annex I to Regulation (EU) No 605/2010 and the treatment applied must be conform to the treatment provided for in that list for the relevant country;

(b) have been produced from milk obtained from animals:

(i) under the control of the official veterinary service;

(ii) belonging to holdings which were not under restrictions due to foot-and-mouth disease or rinderpest; and

(iii) subject to regular veterinary inspections to ensure that they satisfy the animal health conditions laid down in Chapter I of Section IX of Annex III to Regulation (EC) No 853/2004 and in Directive 2002/99/EC;

(c) are dairy products made from raw milk obtained from: cows, ewes, goats or buffaloes and prior to import into the territory of the European Union have undergone or been produced from raw milk which has undergone a pasteurisation treatment involving a single heat treatment with a heating effect at least equivalent to that achieved by a pasteurisation process of at least 72 °C for 15 seconds and where applicable, sufficient to ensure a negative reaction to an alkaline phosphatase test applied immediately after the heat treatment;

 (d) were produced on … or between … and ….

and/or II.2.C Processed fishery products

that originate from the approved establishment No … situated in the country …]

and/or II.2.D Processed egg products

that originate from the approved country …

were produced from eggs coming from an establishment which satisfies the requirements of Section X of Annex III to Regulation (EC) No 853/2004 which at the date of issue of the certificate is free from highly pathogenic avian influenza as defined in Regulation (EC) No 798/2008 and

II.2.D.2 the egg products were processed:

either [liquid egg white was treated:

either [with 55,6 °C for 870 seconds.]

or [with 56,7 °C for 232 seconds.]

or [10 % salted yolk was treated with 62,2 °C for 138 seconds.]

or [dried egg white was treated:

either [with 67 °C for 20 hours.]

or [with 54,4 °C for 513 hours.]

or [whole eggs were at least treated:

either [with 60 °C for 188 seconds.]

or [completely cooked.]

[whole egg blends were at least treated]:

either [with 60 °C for 188 seconds.]

or [with 61,1 °C for 94 seconds.]

Transit of composite products

The template currently available for the transit of composite foods that contain processed dairy products and meat, or contain 50% or more, in total, of other processed animal products is the M492A (English transit). 

Templates are being developed in German/English , Dutch/English French/English. If this country does not accept the languages used in these templates, exporters should contact DAFF to initiate the development of another bilingual certificate template.

Note: These certificates are only available in a manual format as it is difficult for EXDOC to automatically incorporate information from several export programs. The manual certificates will be issued from DAFF 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. DAFF will provide exporters with instructions on how to complete this certificate on request.

M492A

This template has the following attestations:

I, the undersigned official veterinarian/official inspector hereby certify that the composite products described above contain:

(1) either II.1.A Meat products, treated stomachs, bladders and intestines (2) in any quantity and such meat products, treated stomachs, bladders and intestines have been produced according to Commission Decision 2007/777/EC and contain the following meat constituents and meet the criteria indicated below:

Species (A) Treatment (B) Origin (C)

(A) Insert the code for the relevant species of meat product, treated stomachs, bladders and intestines where BOV = domestic bovine animals (Bos taurus, Bison bison, Bubalus bubalis and their crossbreds); OVI = domestic sheep (Ovis aries) and goats (Capra hircus); EQI = domestic equine animals (Equus caballus, Equus asinus and their crossbreds), POR = domestic porcine animals (Sus scrofa); RM = domestic rabbits, PFG = domestic poultry and farmed feathered game, RUF farmed non-domestic animals other than suidae and solipeds; RUW = wild non-domestic animals other than suidae and solipeds; SUW = wild non-domestic suidae: EQW = wild non-domestic solipeds, WL = wild lagomorphs, WGB = wild game birds.

(B) Insert A, B, C, D, E or F for the required treatment as specified and defined in Parts 2, 3 and 4 of Annex II to Decision 2007/777/EC.

(C) Insert the ISO code of the country of origin of the meat product, treated stomachs, bladders and intestines as listed in Annex II, Part 2 to Decision 2007/777/EC and, in the case of regionalization by Union legislation for the relevant meat constituents, the region as indicated in Part 1 of Annex II to Decision 2007/777/EC or a Member State of the European Union. The country of origin of the meat products must be one the following:

- the same as the country of export in box I.7,

- a Member State of the European Union,

- a third country or parts thereof authorised to export to the Union meat products treated with treatment A as set out in Annex II to Decision 2007/777/EC, where the third country where the composite product is produced is also authorised to export to the Union meat products treated with that treatment.

(1) and/or [II.1.B Processed dairy products (3) in an amount of half or more of the substance of the composite product or not shelf stable dairy products in any quantity that

(a) have been produced in the country … The country of origin of the dairy products must be one of the following:

- the same as the country of export in box I.7,

- a Member State of the European Union,

- a third country or parts thereof authorised to export to the Union meat products treated with treatment A as set out in Annex II to Decision 2007/777/EC, where the third country where the composite product is produced is also authorised to export to the Union meat products treated with that treatment.

The country of origin indicated in box I.7 must be listed in Annex I to Regulation (EU) No 605/2010 and the treatment applied must be conform to the treatment provided for in that list for the relevant country;

(b) have been produced from milk obtained from animals:

(i) under the control of the official veterinary service;

(ii) belonging to holdings which were not under restrictions due to foot-and-mouth disease or rinderpest; and

(iii) subject to regular veterinary inspections to ensure that they satisfy the animal health conditions laid down in Chapter I of Section IX of Annex III to Regulation (EC) No 853/2004 and in Directive 2002/99/EC;

(c) are dairy products made from raw milk obtained from

cows, ewes, goats or buffaloes and prior to import into the territory of the European Union have undergone or been produced from raw milk which has undergone

a pasteurisation treatment involving a single heat treatment with a heating effect at least equivalent to that achieved by a pasteurisation process of at least 72 °C for 15 seconds and where applicable, sufficient to ensure a negative reaction to an alkaline phosphatase test applied immediately after the heat treatment.

(d) were produced on … or between … and …(4).

and/or [II.1.C Processed egg products that originate from the approved country (5)

Were produced from eggs coming from an establishment which satisfies the requirements of Section X of Annex III to Regulation (EC) No 853/2004 which at the date of issue of the certificate is free from highly pathogenic avian influenza as defined in Regulation (EC) No 798/2008 and

 (1) [II.1.C.2 [the egg products were processed:

(1) either [liquid egg white was treated:

(1) either [with 55,6 °C for 870 seconds.]

(1) or [with 56,7 °C for 232 seconds.]

(1) or [10 % salted yolk was treated with 62,2 °C for 138 seconds.]

(1) or [dried egg white was treated:

(1) either [with 67 °C for 20 hours.]

(1) or [with 54,4 °C for 513 hours.]

(1) or [whole eggs were at least treated:

(1) either [with 60 °C for 188 seconds.]

(1) or [completely cooked.]

[whole egg blends were at least treated]:

(1) either [with 60 °C for 188 seconds.]

(1) or [with 61,1 °C for 94 seconds.]

Provision of certificates for milk and milk products

This country adopts EU importing country requirements, including EU certification.

Details of Establishments

Export and transit certificates for milk, milk products and composite foods containing processed dairy products must include approval number of the manufacturing establishment where the product was manufactured and the establishment from where it was dispatched. Both of these establishments must be included on the lists on the EU list of approved food establishments.

Date of certificate

EU export and transit certificates must be signed on, or before, the nominated date of departure of the vessel. If the certificate is not submitted in sufficient time to allow printing and signing on, or before the date of departure, the Department of Agriculture will not issue an export certificate or transit certificate for any EU destination. In this situation, the product must be diverted to a non-EU country or returned to Australia.

Container and Seal Numbers for Sea Freight Consignments

Health certificates for milk and milk products exported in containers must include container and seal numbers.

Container and Seal Numbers for Air Freight Consignments

The word ‘Airfreight’ in the container number field.

Number of Containers on RFPs

If more than 10 containers are added to certificates, pages will print that do not include a signature of an official veterinarian. This means that there is a maximum of 10 shipping containers per RFP.

Batch codes

Export and transit certificates for milk, milk products and composite foods include a field for batch codes, (i.e. the identifying marks on the goods indicating the specific batch). These codes must be no more than 16 characters long.

Species

Export and transit certificates for milk and milk products must include the name of species of animal from which the milk was collected (i.e Bos taurus/Bos indicus/Bos taurus indicus cross for dairy products containing cows’ milk, Bubalus bubalus for dairy products containing buffalo milk, Capra hircus for dairy products containing goats’ milk, and Ovis aries for dairy products containing sheeps’ milk). This is automatically included on all certificates. Export, transit and storage certificates for composite foods containing processed dairy products do not require the species of animal from which the milk was collected.

Temperature of product

Export and transit certificates for milk, milk products include a field for the temperature of the product, and only one value (ambient, chilled, or frozen) can be used for each RFP.

Commodity Codes

Export and transit  certificates for milk and milk products must include commodity codes. Only one code can be used per RFP. Australia refers to these codes as AHECC codes, whereas the EU refers to codes as harmonised system (HS) codes. The only codes permitted on EU export, transit and storage certificates for milk and milk products for human consumption are 04.01, 04.02, 04.03, 04.04, 04.05, 04.06, 17.02, 21.05, 22.02, 35.01, 35.02, and 35.02. The only codes permitted on EU export, transit and storage certificates for composite foods containing processed dairy products are 16.01, 16.02, 16.03, 16.04, 16.05, 19.01, 19.02, 19.05, 20.04, 20.05, 21.03, 21.04, 21.05, and 21.06.

Imported ingredients

If the Request for Permit (RFP) contains imported dairy product, exporters are required to advise the nature of the imported dairy ingredient including the percentage in the product and the country of origin.

Exporter EU Checklist

The EU exporter checklist (DEP401) is required to be completed and provided to the Department of Agriculture before export certification can be provided.

Test Results

Exporters must state that the product described in the RFP complies with EU requirements for raw milk testing of somatic cells, antibiotics and end product testing and is eligible for entry into the European Union.

  • Refer to section on microbial and residue sampling, and maximum acceptable limits for testing of raw milk, and section on milk and milk products for testing of final products.
Certificates for composite foods containing processed milk products

Veterinary checks on arrival at an EU border inspection post are required for composite foods that contain any amount of meat, or contain 50% or more, in total, of other processed animal products. These composite foods will need an EU composite product certificate that attests to the compliance of specific ingredients with EU requirements, such as having been produced in a country approved for EU import, processed in accordance with EU treatments, and produced in an EU-listed establishment.

Use of transit certificates

Transit certificates are required for the following products that transit the EU or are stored in the EU:

  • all milk and milk products (including those made from non-bovine milk)
  • composite foods containing processed dairy products and any meat
  • composite foods containing 50% processed dairy products and
  • composite foods containing any processed dairy products that require refrigeration or freezing (i.e. are not shelf-stable).
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 (i.e. diseases present in Australia).

7.2. Ships stores

Provision of certificates for ships stores

This country adopts EU importing country requirements, including EU certification.

Ships stores

This country adopts EU importing country requirements, including EU certification.

Export certification is not issued for ships stores as the Export Control (Milk and Milk Products) Orders 2005 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.

7.3. Consignments under 10 kilograms and trade samples

Carry-on packs, personal consignments and trade samples

This country adopts EU importing country requirements, including EU certification.

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.

7.4. Additional certificates available

This country adopts EU importing country requirements, including EU certification.

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).

8. Documentation requirements for inedible products

8.1. Manufacturing Grade (Dm) milk and milk products

This country adopts EU importing country requirements, including EU certification.

The Department of Agriculture is working with European border authorities and the European Commission to determine what certificate should be used for this product. Exporters should contact the Department of Agriculture if they intend to send this type of product to EU destinations.

Provision of certificates for manufacturing grade (dm) milk, milk products, colostrum and colostrum products

Austria adopts EU importing country requirements, including EU certification.

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.

8.2. Animal food

Provision of certificates for animal food

This country adopts EU importing country requirements, including EU certification.

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 petfood

This country adopts EU importing country requirements, including EU certification.

For export of pet milk and processed milk-based petfood, use the following templates for processed petfood certificate (other than canned):

  • For export, Z725 (English) or bilingual templates with the same endorsements as Z725.
  • For transit, use the Z725A (English) or bilingual templates with the same endorsements as Z725A.

Note: Templates currently available are the M292 (Czech/English export), Z543 (Dutch/English export), Z725 (English export), Z539 (French/English export),Z548 (German/English export), 562 (Swedish/English export), and the Z725A (English transit).

If this country does not accept the languages used in these templates, exporters should contact DAFF to initiate the development of an another bilingual certificate template.

These templates have the following attestations. Attestations that refer to ingredients other than dairy ingredients should be crossed out where appropriate:

I, the undersigned official veterinarian, declare that I have read and understood Regulation (EC) No 1069/2009 of the European Parliament and of the Council (1a) and in particular Articles 8 and 10 thereof, and Commission Regulation (EU) No 142/2011 (1b), and in particular Annex XIII, Chapter II and Annex XIV, Chapter II, thereof and certify that the petfood described above:

II.1. has been prepared and stored in an establishment or plant approved and supervised by the competent authority in accordance with Article 24 of Regulation (EC) No 1069/2009;

II.2. has been prepared exclusively with the following animal by-products:

(2) either [- carcases and the following parts originating either from animals that have been slaughtered in a slaughterhouse and were considered fit for slaughter for human consumption following an ante-mortem inspection or bodies and the following parts of animals from game killed for human consumption in accordance with Union legislation:(i) carcases or bodies and parts of animals which are rejected as unfit for human consumption in accordance with Union legislation, but which did not show any signs of disease communicable to humans or animals;

(2) and/or [- blood, placenta, wool, feathers, hair, horns, hoof cuts and raw milk originating from live animals that did not show signs of any disease communicable through that product to humans or animals;]

(2) and/or [- aquatic animals, and parts of such animals, except sea mammals, which did not show any signs of diseases communicable to humans or animals;]

(2) and/or [- animal by-products from aquatic animals originating from plants or establishments manufacturing products for human consumption

(2) and/or [- the following material originating from animals which did not show any signs of disease communicable through that material to humans or animals:

(i) shells from shellfish with soft tissue or flesh;

(ii) the following originating from terrestrial animals: eggs, egg by-products, including egg shells;

(2) and/or [- material from animals which have been treated with certain substances which are prohibited pursuant to Directive 96/22/EC, the import of the material being permitted in accordance with Article 35(a)(ii) of Regulation (EC) No 1069/2009;]

II.3. (2) either [was subjected to a heat treatment of at least 90 °C throughout its substance;]

(2) or [was produced as regards ingredients of animal origin using exclusively products which had been:

(a) in the case of animal by-products or derived products from meat or meat products subjected to a heat treatment of at least 90 °C throughout its substance;

(b) in the case of milk and milk based products,

(i) if they are from third countries or parts of third countries listed in column B of Annex I to Commission Regulation (EU) No 605/2010 (3) submitted to a pasteurisation treatment sufficient to produce a negative phosphatase test;

(c) in the case of gelatine, produced using a process that ensures that unprocessed Category 3 material is subjected to a treatment with acid or alkali, followed by one or more rinses with subsequent adjustment of the pH and subsequent, if necessary repeated, extraction by heat, followed by purification by means of filtration and sterilisation;

(d) in the case of hydrolysed protein produced using a production process involving appropriate measures to minimise contamination of raw Category 3 material, and, in the case of hydrolysed protein entirely or partly derived from ruminant hides and skins produced in a processing plant dedicated only to hydrolysed protein production, using only material with a molecular weight below 10000 Dalton and a process involving the preparation of raw Category 3 material by brining, liming and intensive washing followed by:

(i) exposure of the material to a pH of more than 11 for more than three hours at a temperature of more than 80 °C and subsequently by heat treatment at more than 140 °C for 30 minutes at more than 3,6 bar; or

(ii) exposure of the material to a pH of 1 to 2, followed by a pH of more than 11, followed by heat treatment at 140 °C for 30 minutes at 3 bar;

(e) in the case of egg products submitted to any of the processing methods 1 to 5 or 7, as referred to in Chapter III of Annex IV to Regulation (EU) No 142/2011; or treated in accordance with Chapter II of Section X of Annex III to Regulation (EC) No 853/2004 of the European Parliament and of the Council (4)

(f) in the case of collagen submitted to a process ensuring that unprocessed Category 3 material is subjected to a treatment involving washing, pH adjustment using acid or alkali followed by one or more rinses, filtration and extrusion, the use of preservatives other than those permitted by Union legislation being prohibited;

(g) in the case of blood products, produced using any of the processing methods 1 to 5 or 7, as referred to in Chapter III of Annex IV to Regulation (EU) No 142/2011;

(h) in the case of mammalian processed animal protein submitted to any of the processing methods 1 to 5 or 7 and, in the case of porcine blood, submitted to any of the processing methods 1 to 5 or 7 provided that in the case of method 7 a heat treatment throughout its substance at a minimum temperature of 80 °C has been applied;

(i) in the case of non-mammalian processed protein with the exclusion of fishmeal submitted to any of the processing methods 1 to 5 or 7 as referred to in Chapter III of Annex IV to Regulation (EU) No 142/2011;

(k) in the case of fishmeal submitted to any of the processing methods or to a method and parameters which ensure that the products complies with the microbiological standards for derived products set out in Chapter I of Annex X to Regulation (EU) No 142/2011;

(l) in the case of rendered fat, including fish oils, submitted to any of the processing methods 1 to 5 or 7 (and method 6 in the case of fish oil) as referred to in Chapter III of Annex IV to Regulation (EU) No 142/2011 or produced in accordance with Chapter II of Section XII of Annex III to Regulation (EC) No 853/2004; rendered fats from ruminant animals must be purified in such a way that the maximum level of remaining total insoluble impurities does not excess 0,15 % in weight;

(2) or [was subject to a treatment such as drying or fermentation, which has been authorised by the competent authority;]

II.4. was analysed by a random sampling of at least five samples from each processed batch taken during or after storage at the processing plant and complies with the following standards (5):

Salmonella: absence in 25 g: n = 5, c = 0, m = 0, M = 0,

Enterobacteriaceae: n = 5, c = 2, m = 10, M = 300 in 1 gram;

II.5. has undergone all precautions to avoid contamination with pathogenic agents after treatment.

II.6. was packed in new packaging, which, if the petfood is not dispatched in ready-to-sell packages on which it is clearly indicated that the content is destined for feeding to pets only, bear labels indicating ‘NOT FOR HUMAN CONSUMPTION’;

II.7. the product does not contain and is not derived from bovine, ovine or caprine materials other than those derived from animals born, continuously reared and slaughtered in a country or region classified as posing a negligible BSE risk by a decision in accordance with Article 5(2) of Regulation (EC) No 999/2001.

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

This country adopts EU importing country requirements, including EU certification.

For export of milk and milk products from cows or buffaloes for use in animal food, use the following templates and select the 'A’ product use indicator so that the commodity is certified for animal food:

  • For export, ZDENS1 (English) or bilingual templates with the same endorsements as the ZDENS1.
  • For transit, use ZDENST (English) or bilingual templates with the same endorsements as the ZDENST.

Note: Templates currently available are the ZDENS1 (English export), ZDCZS1 (Czech/English export), ZDENST (English transit) and the ZDCZST(Czech/English transit). If this country does not accept the languages used in these templates, exporters should contact DAFF to initiate the development of an another bilingual certificate template.

These templates have the following attestations:

I, the undersigned official veterinarian, declare that I have read and understood Regulation (EC) No 1069/2009 of the European Parliament and of the Council (1a), and in particular Article 10 thereof, and Commission Regulation (EU) No 142/2011 (1b), and in particular Annex X, Chapter II, Section 4 and Annex XIV, Chapter I thereto, and certify that the milk (2), the milk-based products (2) and milk-derived products (2) referred to in box I.28 comply with the following conditions:

II.1. they were produced and derived in AUSTRALIA which is listed in the Annex to Commission Regulation (EU) No 605/2010, and which has been free from foot-and-mouth disease (FMD) and rinderpest for 12 months immediately prior to export and has not practised vaccination against rinderpest during that period;

II.2. they were produced from raw milk derived from animals which at the time of milking did not show clinical signs of any disease transmissible through milk to humans or animals, and which had been kept for at least 30 days prior to production on holdings that were not subject to official restrictions due to foot-and-mouth disease or rinderpest;

II.3. they are milk or milk products that have undergone one of the treatments or combinations thereof described in point II.4;

II.4. they have been subject to one of the following treatments: [High Temperature Short Time pasteurisation at 72 °C for at least 15 seconds, or an equivalent pasteurisation achieving a negative reaction to a phosphatase test in bovine milk, in combination with [the condition that the milk/milk product has been produced at least 21 days before the shipping and during that period no cases of FMD have been detected in the exporting country;]

II.5. every precaution was taken to avoid contamination of the milk/milk-based product/milk-derived product after processing;

II.6. the milk/milk-based product/milk-derived product was packed:either [in new containers;] or [in vehicles or bulk containers disinfected prior to loading using a product approved by the competent authority;] and the containers are marked so as to indicate the nature of the milk/milk-based product/milk-derived product and bear labels indicating that the product is Category 3 material and not intended for human consumption;

II.7. the product does not contain and is not derived from bovine, ovine or caprine materials other than those derived from animals born, continuously reared and slaughtered in a country or region classified as posing a negligible BSE risk by a decision in accordance with Article 5(2) of Regulation (EC) No 999/2001.

Trade samples of animal food

This country adopts EU importing country requirements, including EU certification.

For export of trade samples, use the M448 (English) or bilingual templates with the same endorsements as M448. Trade samples exported on these certificate templates are those that are intended for particular studies or analyses with a view to carrying out a production process or developing animal food.

Notes: 

  • Templates currently available are the M448 (English), M449 (French) and the M447(German). If this country does not accept the languages used in these templates, exporters should contact AQIS to initiate the development of an another bilingual certificate template.
  • Certificate templates are not available for transit of trade samples. If exporters wish to transit trade samples through the EU, they may contact DAFF to request that a certificate template be developed.

These templates have the following attestations:

I, the undersigned official veterinarian, declare that I have read and understood Regulation (EC) No 1069/2009 of the European Parliament and of the Council (1a) and Commission Regulation (EU) No 142/2011 (1b), and in particular Annex XIV, Chapter II thereof, and certify that the animal by-products described above:

II.1. are trade samples which consist of animal by-products intended for particular studies or analyses as referred to in definition No 39 of Annex I to Commission Regulation (EU) No 142/2011, that are bearing the label ‘TRADE SAMPLE NOT FOR HUMAN CONSUMPTION’.

Colostrum and colostrum-based products for use in animal food

This country adopts EU importing country requirements, including EU certification.

For export of colostrum and colostrum products from cows or buffaloes intended for animal food, use the following templates and select the 'A’ product use indicator so that the commodity is certified for animal food:

  • For export, ZDENC1 (English) or bilingual templates with the same endorsements as the ZDENC1.
  • For transit, use ZDENCT (English) or bilingual templates with the same endorsements as the ZDENCT.

Note: Templates currently available are the ZDENC1 (English export), ZDCZC1 (Czech/English export) and the ZDENCT (English transit). If this country does not accept the languages used in these templates, exporters should contact DAFF to initiate the development of an another bilingual certificate template.

These templates have the following attestations:

I, the undersigned official veterinarian, declare that I have read and understood Regulation (EC) No 1069/2009 of the European Parliament and of the Council (1a), and in particular Article 10 thereof, and Commission Regulation (EU) No 142/2011 (1b), and in particular Annex X, Chapter II, Section 4 and Annex XIV, Chapter I thereto, and certify that the colostrum (2) or the colostrum products (2) referred to in box I.28 comply with the following conditions:

II.1. they were produced and derived in AUSTRALIA which is listed in the Annex to Commission Regulation (EU) No 605/2010, and which has been free from foot-and-mouth disease (FMD) and rinderpest for 12 months immediately prior to export and has not practised vaccination against rinderpest during that period;

II.2. they were produced from colostrum derived from animals which at the time of milking did not show clinical signs of any disease transmissible through colostrum to humans or animals, and which had been kept for at least 30 days prior to production on holdings that were not subject to official restrictions due to foot-and-mouth disease or rinderpest;

II.3. they are colostrum or colostrum products of bovine animals that have been subject to High Temperature Short Time pasteurisation at 72 °C for at least 15 seconds, or an equivalent pasteurisation achieving a negative reaction to a phosphatase test in bovine milk, in combination with:[the condition that the colostrum or colostrum products have been produced at least 21 days before the shipping and in this period no cases of FMD have been detected in the exporting country;] and have been obtained from animals subject to regular veterinary inspections to ensure that they come from holdings on which all bovine herds are: [recognised as officially tuberculosis and brucellosis free] and [recognised as official enzootic-bovine-leukosis free]

II.4. every precaution was taken to avoid contamination of the colostrum/colostrum product after processing;

II.5. the colostrum/colostrum product was packed: either [in new containers,] or [in vehicles or bulk containers disinfected prior to loading using a product approved by the competent authority,] and the containers are marked so as to indicate the nature of the colostrum/colostrum product and bear labels indicating that the product is Category 3 material and not intended for human consumption

II.6.the product does not contain and is not derived from bovine, ovine or caprine materials other than those derived from animals born, continuously reared and slaughtered in a country or region classified as posing a negligible BSE risk by a decision in accordance with Article 5(2) of Regulation (EC) No 999/2001.

8.3. Technical products and pharmaceutical material

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

This country adopts EU importing country requirements, including EU certification.

For export of colostrum and colostrum products from cows or buffaloes intended for technical use, use the following templates and select the 'T’ product use indicator so that the commodity is certified for technical use:

  • For export, ZDENC1 (English) or bilingual templates with the same endorsements as the ZDENC1.
  • For transit,use ZDENCT (English) or bilingual templates with the same endorsements as the ZDENCT.

Note: Templates currently available are the ZDENC1 (English export), ZDCZC1 (Czech/English export) and the ZDENCT (English transit). If this country does not accept the languages used in these templates, exporters should contact DAFF to initiate the development of an another bilingual certificate template.

These templates have the following attestations:

I, the undersigned official veterinarian, declare that I have read and understood Regulation (EC) No 1069/2009 of the European Parliament and of the Council (1a), and in particular Article 10 thereof, and Commission Regulation (EU) No 142/2011 (1b), and in particular Annex X, Chapter II, Section 4 and Annex XIV, Chapter I thereto, and certify that the colostrum (2) or the colostrum products (2) referred to in box I.28 comply with the following conditions:

II.1. they were produced and derived in AUSTRALIA which is listed in the Annex to Commission Regulation (EU) No 605/2010, and which has been free from foot-and-mouth disease (FMD) and rinderpest for 12 months immediately prior to export and has not practised vaccination against rinderpest during that period;

II.2. they were produced from colostrum derived from animals which at the time of milking did not show clinical signs of any disease transmissible through colostrum to humans or animals, and which had been kept for at least 30 days prior to production on holdings that were not subject to official restrictions due to foot-and-mouth disease or rinderpest;

II.3. they are colostrum or colostrum products of bovine animals that have been subject to High Temperature Short Time pasteurisation at 72 °C for at least 15 seconds, or an equivalent pasteurisation achieving a negative reaction to a phosphatase test in bovine milk, in combination with:[the condition that the colostrum or colostrum products have been produced at least 21 days before the shipping and in this period no cases of FMD have been detected in the exporting country;] and have been obtained from animals subject to regular veterinary inspections to ensure that they come from holdings on which all bovine herds are: [recognised as officially tuberculosis and brucellosis free] and [recognised as official enzootic-bovine-leukosis free]

II.4. every precaution was taken to avoid contamination of the colostrum/colostrum product after processing;

II.5. the colostrum/colostrum product was packed: either [in new containers,] or [in vehicles or bulk containers disinfected prior to loading using a product approved by the competent authority,] and the containers are marked so as to indicate the nature of the colostrum/colostrum product and bear labels indicating that the product is Category 3 material and not intended for human consumption

II.6.the product does not contain and is not derived from bovine, ovine or caprine materials other than those derived from animals born, continuously reared and slaughtered in a country or region classified as posing a negligible BSE risk by a decision in accordance with Article 5(2) of Regulation (EC) No 999/2001.

Products used for research, education, diagnostic or museum purposes

This country adopts EU importing country requirements, including EU certification.

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

This country adopts EU importing country requirements, including EU certification.

For export of milk and milk products from cows or buffaloes intended for technical use, use the following templates and select the ‘T’ product use indicator so that the commodity is certified for technical use:

  • For export, ZDENS1 (English) or bilingual templates with the same endorsements as the ZDENS1.
  • For transit, use ZDENST (English) or bilingual templates with the same endorsements as the ZDENST.

Note: Templates currently available are the ZDENS1 (English export), ZDCZS1 (Czech/English export), ZDENST (English transit) and the ZDCZST (Czech/English transit). If this country does not accept the languages used in these templates, exporters should contact DAFF to initiate the development of an another bilingual certificate template.

These templates have the following attestations:

I, the undersigned official veterinarian, declare that I have read and understood Regulation (EC) No 1069/2009 of the European Parliament and of the Council (1a), and in particular Article 10 thereof, and Commission Regulation (EU) No 142/2011 (1b), and in particular Annex X, Chapter II, Section 4 and Annex XIV, Chapter I thereto, and certify that the milk (2), the milk-based products (2) and milk-derived products (2) referred to in box I.28 comply with the following conditions:

II.1. they were produced and derived in AUSTRALIA which is listed in the Annex to Commission Regulation (EU) No 605/2010, and which has been free from foot-and-mouth disease (FMD) and rinderpest for 12 months immediately prior to export and has not practised vaccination against rinderpest during that period;

II.2. they were produced from raw milk derived from animals which at the time of milking did not show clinical signs of any disease transmissible through milk to humans or animals, and which had been kept for at least 30 days prior to production on holdings that were not subject to official restrictions due to foot-and-mouth disease or rinderpest;

II.3. they are milk or milk products that have undergone one of the treatments or combinations thereof described in point II.4;

II.4. they have been subject to one of the following treatments: [High Temperature Short Time pasteurisation at 72 °C for at least 15 seconds, or an equivalent pasteurisation achieving a negative reaction to a phosphatase test in bovine milk, in combination with [the condition that the milk/milk product has been produced at least 21 days before the shipping and during that period no cases of FMD have been detected in the exporting country;]

II.5. every precaution was taken to avoid contamination of the milk/milk-based product/milk-derived product after processing;

II.6. the milk/milk-based product/milk-derived product was packed:either [in new containers;] or [in vehicles or bulk containers disinfected prior to loading using a product approved by the competent authority;] and the containers are marked so as to indicate the nature of the milk/milk-based product/milk-derived product and bear labels indicating that the product is Category 3 material and not intended for human consumption;

II.7. the product does not contain and is not derived from bovine, ovine or caprine materials other than those derived from animals born, continuously reared and slaughtered in a country or region classified as posing a negligible BSE risk by a decision in accordance with Article 5(2) of Regulation (EC) No 999/2001.

Trade samples of technical products (including pharmaceuticals)

This country adopts EU importing country requirements, including EU certification.

For export of trade samples, use the M448 (English) or bilingual templates with the same endorsements as M448. Trade samples exported on these certificate templates are those that are intended for particular studies or analyses with a view to carrying out a production process or developing technical products.

Notes: 

  • Templates currently available are the M448 (English), M449 (French) and the M447(German). If this country does not accept the languages used in these templates, exporters should contact AQIS to initiate the development of an another bilingual certificate template.
  • Certificate templates are not available for transit of trade samples. If exporters wish to transit trade samples through the EU, they may contact DAFF to request that a certificate template be developed.

These templates have the following attestations:

I, the undersigned official veterinarian, declare that I have read and understood Regulation (EC) No 1069/2009 of the European Parliament and of the Council (1a) and Commission Regulation (EU) No 142/2011 (1b), and in particular Annex XIV, Chapter II thereof, and certify that the animal by-products described above:

II.1. are trade samples which consist of animal by-products intended for particular studies or analyses as referred to in definition No 39 of Annex I to Commission Regulation (EU) No 142/2011, that are bearing the label ‘TRADE SAMPLE NOT FOR HUMAN CONSUMPTION’.

9. Shipping and airfreight requirements

This country adopts EU importing country requirements, including EU certification.

The EU has no known specific requirements for shipping and airfreight.

10. Port-of-entry checks

This country adopts EU importing country requirements, including EU certification.

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

Type of productFrequency of documentary and identity checksFrequency of physical checks
Milk and milk products for human consumption100%Not less than 50% of consignments
Milk and milk products not for human consumption100%Not less than 1% and not more than 10% of consignments

Note:

11. Definitions

This country adopts EU importing country requirements, including EU certification.

TermDefinitions
Export to the EUThe movement of goods from Australia to the EU.
Import into the EU

The movement of goods on arrival at an EU Border Inspection Post.

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.
Transit through the EUMovement 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.
ClearanceThe 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.
Documentary checkThe examination of commercial documents and, where appropriate, of documents required under EU law that are accompanying the consignment at a BIP.
Identity checkA visual inspection at a BIP to ensure certificates or other documents accompanying the consignment tally with the labelling and the content of the consignment.
Physical checkA 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.
EU member stateA country that has signed the treaties of the EU and is subject to the privileges and obligations of EU membership, including EU legislation.
EU dependency or dependent stateA 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).

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.

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).

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.

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.
Research and diagnostic samples of animal by-productsBy-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
Trade samples of animal by-productsBy-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
Composite productsFoods 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).
Pasteurisation

High Temperature Short Time pasteurisation at 72 °C for at least 15 seconds or equivalent pasteurisation effect.

Somatic cell countThe 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 of the udder when an infection occurs.
Total plate countThe 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.
BatchA 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.
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.

IngredientAny substance, including additives, used in the manufacture or preparation of a foodstuff and still present in the finished product, even if in altered form.

Latest updates

Last updated: 25/03/2021 8:44 AMCreated: 15/01/2015 11:06 AM