European Union (EU) – Export requirements for milk and dairy products

The information presented below is under review.

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1. Eligible/ineligible product

EU export certificates for milk and dairy products including colostrum and colostrum based products refer to a list of Harmonized System (HS) code(s). It is the responsibility of the exporter to ensure that the product being exported will be covered by the certificates issued by the Canadian Food Inspection Agency (CFIA).

Eligible

  • The list of Harmonized System codes can be found on the model health certificates available in the TRACES system.

Ineligible

  • Information not available.

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

Country

To export raw milk, dairy products, colostrum and colostrum-based products to the EU, the exporting country must be on the list of authorized third countries.

Establishments

Milk, colostrum, dairy products, and colostrum based-products must come from an establishment licensed under the Safe Food for Canadian Regulations (SFCR). Under Section 5 of Regulation (EC) no 852/2004, EU legislation requires that processing facilities apply a self-regulated program for the Hazard Analysis Critical Control Point (HACCP) system. In addition, these establishments must be regularly audited by the competent authorities (CA), and be listed as an EU approved establishment.

The establishments must appear on the appropriate establishment list administered by the Directorate-General of Health and Food Safety (DG-SANTE). The third countries lists are available on TRACES under the section: Food, MMP Raw milk, dairy products, colostrum and colostrum-based products.

If products requiring temperature control are being exported from a storage warehouse outside the licensed facility, the storage warehouse must be licensed by the CFIA. It must also be on the list of establishments approved to export dairy products to the EU.

To request inclusion on any of the EU approval lists, contact your local CFIA office to complete the Request for Addition to the list of Canadian Dairy Establishment Approved for Export to the European Union (RDIMS 8164839 – internal access only). Ensure that you have an establishment identification (ID) number for your establishment before you submit your request.

As part of the application the inspector will provide a recent CFIA inspection report to demonstrate that an inspection based on HACCP principles has been carried out before submitting the request for approval to DG-SANTE. To complete this task, the inspector responsible for the establishment should be familiar with relevant EU regulations related to HACCP. See 6 below.

Element 1: Process and product controls will be prioritized in order to assess the operator's preventive control plan on the following sub-elements:

  • 1.1a Incoming inputs
  • 1.1bc Product formulation, specifications and processing
  • 1.2 Product controls
  • 1.3 Import controls
  • 1.4 Export controls

Note: Particular attention will be given to critical control points (CCPs), for example, compliance with temperature control requirements for foodstuffs as well as the corrective actions that will be taken in the event of a non-conformity.

All additions, amendments and deletions to the EU approval list will be forwarded to the EU for approval. The approval process can take time depending upon circumstances beyond the control of the CFIA. The inspector will submit the request following the Operational procedure: Procedure for maintaining food export eligibility lists.

The manufacture and export of the dairy products to the EU can start once the establishment in on the EU list.

The CFIA is responsible to keep the lists of establishments up to date and to inform the commission of any changes necessary. However, the manufacturer has the obligation to inform the CFIA if changes are made to the following:

  • approval number (establishment identification number)
  • establishment name
  • address, city and region
  • activity code (Processing plant (PP), Cold stores (CS))
  • any other relevant information

Note: DG-SANTE has added the letter "D" as a suffix to the establishment identification (ID) number (former registration number) of certain dairy establishments appearing on the list of Canadian establishments approved for the EU. This was necessary because these dairy establishments shared the same establishment identification (ID) number with other Canadian establishments appearing on lists of establishments approved to export other commodities to the EU, such as fish and seafood products. This suffix was added only for the purpose of maintaining the list. Exporters can maintain their label as is and do not need to add the "D" to the information recorded on the certificate.

Products

This information is not available.

3. Production controls and inspection requirements

In general, the food manufacturer must comply with the relevant provisions on Annexes II and III of Regulation (EC) no 853/2004. The requirements for raw milk, colostrum, dairy products and colostrum based-products are set out in Section IX, Annex III of Regulation (EC) no 853/2004.

The inspector must verify during a preventive control inspection that the manufacturer is aware of the standards and requirements of the EU and has a specific export procedure in place. This procedure must contains the following elements in particular:

  • reference to relevant EU regulations (see 6 below)
  • how the manufacturer follows changes in the European legislation
  • comparison of EU regulations/standards/parameters with those of Canada
  • the procedure to be followed in the event of a difference between the regulations/standards/parameters of the EU and those of Canada in order to ensure that the product meets the requirements of the EU
  • the corrective and preventive actions to be considered in the event of non-compliance

Primary production – raw milk and colostrum

In Canada, raw milk production and transportation is within the constitutional jurisdiction of each province. Each province sets out the requirements for farms and milk production in their provincial legislation. This legislation is based on the National Dairy Code.

Regulation (EC) No 853/2004 and Canada's National Dairy Code lay down the health requirements for raw milk and colostrum. EU has specific requirements for milking, collection, and the transport of raw milk as well as criteria regarding the levels of bacteria count (PC) and somatic cells count (SCC). Canada's requirements are slightly different from those of the EU; however, these differences were determined not to be significant during the equivalency exercise that took place between the two parties.

Section III, Chapter I of Annex III of Regulation (EC) no 853/2004 sets out criteria for raw milk and colostrum.

In case of raw milk exceeding the parameters on BC and/or SCC, the farmer needs to take the necessary actions to improve the quality of raw milk within the deadline requested by the control authority.

In Canada, the monthly somatic cell and bacteria counts for milk quality by province is available at the following link: Somatic cell and bacteria counts.

As a Safe Food for Canadians licence holder, a preventive control plan must be in place which includes an assessment of the biological, chemical and physical hazards associated with raw milk and colostrum (SFCR 47, 86, 88).

For raw milk quality, refer to the sections on raw product acceptability and monitoring at this link: Good manufacturing practices: Dairy processors.

When milk fails to meet the appropriate criteria, the manufacturer must inform the competent authority and take measures to correct the situation. The presence of antibiotics shall result in rejection of the milk.

Only milk and colostrum produced on a dairy farm approved by the regulatory agency is received at the dairy plant. These farms shall undergo official controls to verify that the applicable hygiene requirements are being complied with. In terms of animal health management, no farmer shall sell or offer for sale milk that is obtained from an animal that shows evidence or visible signs of disease transmissible to humans by milk or that adversely affects the quality or flavour of the milk. Dairy farmers must have an Animal Health Declaration signed by a veterinarian annually and the most recent version kept on file. See Regulation (EU) 2020/692.

Note: The animal health declaration must be presented during the official controls. The provincial inspector must ensure that this information is documented in its inspection report.

Manufacturer's declaration

To request a template of the EU manufacturer's declaration, contact your local CFIA office.

  • All final export requests for milk and dairy products must be accompanied by a Manufacturer's declaration (accessible only on the Government of Canada network – RDIMS 15559018 – internal access only) issued and signed by an authorized person of the registered establishment where the product was manufactured or prepared.

    The information below are requested in the manufacturer's declaration:

    • confirmation that the establishment is on the EU list. See 2 above
    • that a specific EU export procedure is in place demonstrating that the product meet the EU requirements. See 2 above
    • confirmation that the raw milk comes from farms that are under the control of the competent authority
    • the origin of the raw milk (Canadian and/or imported). The province and/or foreign country must be indicated
    • confirmation that the raw milk has been evaluated for its acceptability
    • the heat treatment applied to the dairy product according to EU requirements/Model export certificate
    • If applicable, the microbiological analysis required by Regulation (EC) 2073/2005
    • the origin of the dairy ingredient (Canadian and/or imported). If imported, indicate among other things, the country, the name and the number of the establishment. Supporting documentation must be attached to the request
    • If applicable the name and the registration number of the cold storage warehouse. The cold storage must be on the EU list in TRACES
    • indicate if this is the first time these products are exported to the EU
    • the animal species
    • model of certificate for the shipment as per TRACES
    • the final destination
    • any other relevant information

    Note: The inspector reserves the right to request any other information that he thinks is necessary for the final certification of the product.

  • The product(s) must be clearly identified on the manufacturer's declaration and match exactly the product(s) that are part of the export shipment. In the case where a large number of different products are being shipped, a computerized printout containing all the required information may be attached to the manufacturer's declaration if it contains all the required information.
  • Original signed manufacturer's declarations are to be kept on file at the plant. These files may be verified during a preventive control inspection (PCI).

Microbiological requirements

  • Milk and dairy products needing certification, intended for human consumption must meet the relevant microbiological criteria stipulated in Commission Regulation (EC) no 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs with amendments.
  • CFIA must be provided with a signed copy of a laboratory report indicating that each lot of the shipment was analysed by a laboratory officially accredited by the Standard Council of Canada (SCC) or Canadian Association for Laboratory Accreditation (CALA) before issuing a health certificate.
  • Compositing of samples for analysis is not acceptable in the case of a multi-lot shipment.

Traceability

The manufacturer must develop and implement control programs to demonstrate that products produced for the EU market meet applicable requirements and to assure complete segregation when both eligible and ineligible products are present on the premises.

Maximum levels for therapeutants and antibiotics

Imported dairy ingredients

The use of imported dairy ingredients from certain countries may limit the ability to export to the EU. The list of countries eligible to export dairy products are listed in Regulation (EU) 2021/404.

  • The use of imported dairy ingredients is acceptable; however, the operator must demonstrate through official documentation (for example, a model health certificate as per Regulation (EU) 2020/2235 issued by the competent authority of the country of origin) that the imported ingredients meet EU requirements. This also applies to imported ingredients from EU member states and countries maintaining international agreements with the EU.
  • The manufacturer of the imported dairy ingredients must be on the EU eligibility list.
  • The manufacturer must have a procedure in place for the segregation of imported dairy ingredients that are eligible for export to the EU.
  • If foreign dairy ingredients are used, the "Imported ingredients" section of the manufacturer's declaration must be completed.
  • A copy of the documentation establishing the eligibility of the imported product must be kept on file in order to meet the traceability requirements in place.

4. Labelling, packaging, and marking requirements

Exported products, depending on their final destination, must meet certain packaging and labelling requirements. The exporter must work closely with the importer to ensure the compliance of their products. Refer also to Regulation (EC) 853/2004. The labelling activity must be conducted in the EU approved establishment.

5. Required documents

Canada does not have a bilateral certificate negotiated with the EU. The certificates issued for dairy products come from EU regulations.

It is the responsibility of the exporter to ensure that the issued certificate meets the requirements of the entry border control post (BCP)/member state of destination in terms of official language.

As a manufacturer/exporter and in order to facilitate the certification process, it is important that you are familiar with the content of parts I and II of the EU model certificates.

The export certificate will be issued through TRACES. The applicant must select the EU model certificate that corresponds to the product intended for export and to complete Part I. Note that the applicant is responsible for the details entered in Part I of the certificate. In addition, the applicant will need to include the EU reference IMSOC number (Box I.2.a of Part I of the certificate) with their export request in order for the CFIA to retrieve the certificate in TRACES.

Part II must be completed by an official veterinarian or an official inspector, depending on the case. However, some information will have to be provided by the applicant in order for Part II to be completed, if applicable. This information (for example: the origin of dairy products, the heat treatment of dairy products, the origin of raw milk, animal species, the date of production) should be provided in the form of a manufacturer's declaration when applying for an export certificate.

These animal health/official certificates shall be completed according to the notes for the completion of certificates provided for in Chapter 4 of Annex I to Implementing Regulation (EU) 2020/2235 as well as the notes on the export certificates.

If a container is used to ship the products, it is mandatory that the exporter provide the container and seal number in Part I: Details of dispatched consignment in TRACES.

For more information about TRACES, refer to the CFIA web page Exporting food and animal products to the European Union.

Certificate

Certificates for milk and dairy products

  • (2020/2235) Dairy products intended for human consumption that are required to undergo a pasteurization treatment – Model DAIRY-PRODUCTS-PT.
  • (2020/2235) Dairy products intended for human consumption that are required to undergo a specific risk-mitigating treatment other than pasteurisation – Model DAIRY-PRODUCTS-ST.
  • (2020/2235) Dairy products intended for human consumption derived from raw milk or that are not required to undergo a specific risk-mitigating treatment – Model MILK-RMP/NT.
  • (2020/2235) Dairy products destined for human consumption – Model Milk-RM.

Note:

The certificate (2020-2235) Model DAIRY-PRODUCTS-PT should replace the certificate Model MILK-HTB which was the certificate issued the most by the CFIA.

Certificates for colostrum and colostrum-based products

  • (2020/2235) Colostrum destined for human consumption – Model COLOSTRUM.
  • (2020/2235) Colostrum based products destined for human consumption – COLOSTRUM-BP.

Note:

The EU requires that the certificate applicable to the specific type of product also be presented with exported products intended for a market other than the EU, to permit its transit or storage into the Union. In such case, Section II.1. Public health attestation of Part II: Certification is to be deleted (as indicated on the EU certificate). The certificate of the final destination must always accompany the transit health certificate.

As per the World Organisation for Animal Health (WOAH) export certification procedures, the certifying officer should only certify matters that are within their own knowledge at the time of signing the certificate, or that have been separately attested by another CA, and sign only at the appropriate times certificates that have been completed fully and correctly. Where a certificate is signed on the basis of supporting documentation, the certifying officer should have verified or be in possession of that documentation before signing. This is in line with articles 88 and 89 of Regulation (EU) 2017/625 that sets out, among other things, rules to be observed in issuing certificates.

In the case where Canadian dairy ingredients are used to manufacture products in a foreign country and these will be subsequently shipped to the EU, the foreign country operator may request Canadian documentation to support export certification. The model "Health certificate for dairy products manufactured in Canada and used in foreign countries for export to the European Union" (accessible only on the Government of Canada network – RDIMS 15883053). The statements on this document are taken from the model dairy certificates that are in Regulation (EU) 2020/2235. This support documentation cannot be issued through TRACES. Please contact your local CFIA office to obtain this certificate. Some countries may require that this certificate be accompanied by the export dairy certificate negotiated with Canada.

Export certificates cannot be issued after the products have left Canada. The health certificate is to be signed by an official veterinarian or official inspector.

6. Additional information

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

Samples (personal or commercial) of dairy products may be subject to the same requirements as a regular shipment. It is strongly recommended that the exporter verify these requirements with their importer and/or at the EU border inspection post where the products will be shipped.

Article 6 of Regulation (EU) 2020/2235 establishes rules regarding the replacement of certificates required for entry into the Union. The replacement certificate is issued in TRACES.

EU inspectors at the border control will check, among others, the following:

  • if the product comes from an approved country
  • if the product comes from an EU approved establishment
  • if an export certificate is available and accurate.
  • if the shipments match to the certificate issued by the CFIA
  • if the labelling meets the EU requirements
  • if there is any chemical/microbiological contamination

Relevant links

Links to the EU regulation

Ensure that you are using the most up-to-date/consolidated version. See EUR-Lex, the official and most comprehensive online access point to the EU legal documents.

  • Link to the relevant microbiological criteria for foodstuffs, see Commission Regulation (EC) no 2073/2005 of November 2005 with amendments.
  • Regulation (EC) no 178/2002 of the European Parliament and of the Council of 28 January 2002 lays down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety.
  • Regulation (EC) no 852/2004 of the European parliament and of the council of 29 April 2004 on the hygiene of foodstuffs (HACCP principles).
  • Regulation (EC) no 853/2004of the European Parliament and of the Council of 29 April 2004 lays down specific hygiene rules for food of animal origin.
  • Regulation (EU) no 2017/625of the European Parliament and the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products.
  • Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption.
  • Regulation (EU) 2019/627 of 15 March 2019 laying down uniform practical arrangements for the performance of official controls on products of animal origin intended for human consumption.
  • Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2016 on transmissible animal diseases.
  • Regulation (EC) no 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives.
  • Regulation (EU) 2019/625 of 4 March 2019 supplementing Regulation (EU) 2017/625 of the European Parliament and of the Council with regard to requirements for the entry into the Union of consignments of certain animals and goods intended for human consumption.
  • Regulation (EU) 2020/2235 of 16 December 2020 laying down rules for the application of Regulations (EU) 2016/429 and (EU) 2017/625 of the European Parliament and of the Council as regards model animal health certificates, model official certificates and model animal health/official certificates, for the entry into the Union.
  • Regulation (EU) 2021/405 of 24 March 2021 laying down the lists of third countries or regions thereof authorised for the entry into the Union of certain animals and goods intended for human consumption in accordance with Regulation (EU) 2017/625.
  • Commission Implementing Regulation (EU) 2021/404 of 24 March 2021 laying down the lists of third countries, territories or zones thereof from which the entry into the Union of animals, germinal products and products of animal origin is permitted in accordance with Regulation (EU) 2016/429 of the European Parliament and the Council.
  • Commission Regulation (EU) no 37/2010 of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin.
  • Commission Delegated Regulation (EU) 2020/692 of 30 January 2020 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards rules for entry into the Union, and the movement and handling after entry of consignments of certain animals, germinal products and products of animal origin.
  • Commission Implementing Regulation (EU) 2021/1471 of 18 August 2021 amending and correcting Implementing Regulations (EU) 2020/2235 and (EU) 2020/2236 as regards references to national measures designed to limit the impact of certain diseases of aquatic animals and to lists of third countries, territories or zones thereof from which entry into the Union of animals and goods is permitted.
  • 2011/163/EU: Commission Decision of 16 March 2011 on the approval of plans submitted by third countries in accordance with Article 29 of Council Directive 96/23/EC.
  • Regulation (EC) no 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC.
  • Commission Regulation (EC) no 1881/2006 of 19 December 2006 setting maximum levels for certain contaminants in foodstuffs.
  • Commission Implementing Regulation (EU) 2022/36 of 11 January 2022 amending Annex III to Implementing Regulation (EU) 2020/2235 as regards model certificates for the entry into the Union of consignments of certain live aquatic animals and products of animal origin.
  • Commission Delegated Regulation (EU) 2023/905 of 27 February 2023 supplementing Regulation (EU) 2019/6 of the European Parliament and of the Council as regards the application of the prohibition of use of certain antimicrobial medicinal products in animals or products of animal origin exported from third countries into the Union.
  • Commission Implementing Regulation (EU) 2024/399 of 29 January 2024 amending Annex III to Implementing Regulation (EU) 2020/2235 and Annex II to Implementing Regulation (EU) 2021/403 as regards model certificates for the entry into the Union of consignments of certain products of animal origin and certain categories of animals.
  • Commission Implementing Regulation (EU) 2023/2744 of 20 November 2023 amending Implementing Regulation (EU) 2020/2235 as regards model animal health certificates, model official certificates, model animal health/official certificates and private attestation, for the entry into the Union or transit through the Union of consignments of certain categories of animals and goods, and official certification regarding such certificates.
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