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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

Ineligible

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

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 the EU website for Third Country Establishments - List per Country. Click on "Canada" to see the following associated document under "Food":

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:

All additions, amendments and deletions to the EU approval list will be forwarded to the EU for approval. The approval process takes approximately 40 days, but time frames may vary 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.

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 should clearly refer to the relevant EU regulations (see 6 below) and demonstrate that the exported dairy product meets EU requirements.

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 plate count and somatic cells. 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 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.

Manufacturer's declaration

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

Microbiological requirements

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.

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. Export documents available upon request

Certificate

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.

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

Certificates for milk and dairy products

Note: The certificate 2021/1471 (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

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 certificate).

As per the OIE's 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 statements on this document will be taken from the model dairy certificates that are in Regulation (EU) 2020/2235. This support documentation cannot be issued through TRACES. Contact your local CFIA office.

Export certificates cannot be issued after the products have left Canada.

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.

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

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.

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