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

Eligible/ineligible product

Eligible

• All dairy products
• Example dairy products with associated Harmonized System (HS) codes:
  • 0401 - Milk and cream, no sweetening
  • 0402 - Milk and cream with sweetening
  • 0403 - Fermented products
  • 0404 - Whey and whey products
  • 0405 - Butter
  • 0406 - Cheese
  • 1517 - Margarine
  • 1702 - Lactose
  • 2105 - Ice cream (standardized)
  • 2202 - Beverages containing milk
  • 2835 - Phosphates
  • 3501 - Casein
  • 3502 - Milk albumin
  • 3504 - Milk protein substances
• Example dairy composite products (CPs) with associated HS codes:
  • 1901 - Food preparations containing dairy ingredients
  • 1902 - Pasta stuffed with dairy ingredients
  • 1905 - Patisseries (cake, cookies, pizza, quiche)
  • 2004 - Vegetables (frozen) with dairy based sauce
  • 2103 - Sauces with dairy ingredients
  • 2104 - Soups with dairy ingredients
  • 2105 - Ice cream (cakes, desserts)
  • 2106 - Protein concentrates (cheese fondue, dairy substitutes)

Ineligible

• No known ineligible products

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

Establishments

• Milk, dairy product, and composite products (CPs) manufacturing establishments must operate using HACCP principles (see Preventive control plan (PCP) for domestic guidance) as stipulated in Commission Regulation (EC) No 852/2004 of the European Parliament and of the Council.
• Milk and dairy product establishments must appear on the list of establishments approved to export dairy products to the European Union – PDF (77.1 kb).
  • If products requiring temperature control are being exported from a storage warehouse outside the registered facility, the storage warehouse must be registered by the Canadian Food Inspection Agency (CFIA) and must also be on the list of establishments approved to export dairy products to the European Union.
  • Note: Composite products (CPs) manufacturing establishments are not required to be on a list of establishments approved to export to the European Union.
• All Canadian establishments approved for export to the EU can be found on the EU website for Third Country Establishments List per Country.
• Establishments wishing to be on the EU list must contact CFIA regional office and complete the following forms:
  • Request for Addition to the List of Canadian Dairy Establishments Approved for Export to the European Union
  • HACCP plan compliance checklist for dairy establishments that are listed for export to the EU should also be filled (if necessary)
• Please note that after all documents are completed by the manufacturer and reviewed by the CFIA, it may take 40 days or more for the request to amend the list to be processed by the European Union.
• Note: DG-SANTE has added the letter "D" as a suffix to the registration number of certain registered dairy establishments appearing on the list of Canadian exporters approved for the EU. This was necessary because these dairy establishments shared the same registration number with other Canadian establishments appearing on lists of establishments approved to export other commodities, such as fish and seafood products, to the EU. 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.

Product

• Milk and dairy product samples are subjected to regular requirements. For animal health reasons, the EU does not have provisions for personal exemptions or other type of exemptions (i.e. trade samples).

Product specifications

Microbiological requirements

• Milk, dairy products, and composite products (CPs) 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) before issuing a health certificate.
• Compositing of samples for analysis is not acceptable in the case of a multi-lot shipment.

Maximum levels for therapeutants and antibiotics

• Dairy products must comply with the EU maximum residue limits (MRLs), for residues of pharmacologically active substances in food, as found in the Annex of 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.

Production Controls and Inspection Requirements

Manufacturer's certificate

• All final export requests for milk, dairy products and composite products (CPs) must be accompanied by a Manufacturer's certificate issued and signed by an authorized person of the registered establishment where the product was manufactured or prepared.
• The product(s) must be clearly identified on the Manufacturer's certificate 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 certificate if it contains all the required information.
• In cases where the list of ingredients of a dairy blend consists of milk ingredients or modified milk ingredients, each dairy ingredient in the blend must be listed separately on the Manufacturer's certificate. An ingredient with a single class name (e.g. modified milk ingredients or milk ingredients) is not acceptable on the Manufacturer's certificate.
• Electronic signatures are not accepted. Scanned and faxed copies of the Manufacturer's certificate are acceptable to CFIA.
• Original signed Manufacturer's certificates are to be kept on file at the plant. These files may be verified during export verifications or inspections.

Imported dairy ingredients

• Manufacturers producing milk, dairy products and composite products (CPs) needing certification, containing imported dairy ingredients must be able to show that the ingredients: were sourced from EU approved establishments in exporting countries authorized to export to the EU (Appendix I, of Commission Regulation (EU) No 605/2010); and, comply with the animal health requirements of EU Council Directive 2002/99/EC and of Commission Regulation (EC) No 853/2004.
• If foreign dairy ingredients are used, the Imported ingredients section of the Manufacturer's Certificate must be completed.

Documentation requirements

Certificate

Note: Model certificates must be in the language acceptable to the border entry point.

• Model Milk-HTB: Health certificate for dairy products derived from milk of cows, ewes, goats and buffaloes for human consumption from third countries or parts thereof authorised in column B of Annex I to Regulation (EU) No 605/2010 intended for importation into the European Union
• Model Milk-HTC: Health certificate for dairy products for human consumption from third countries or parts thereof authorised in column C of Annex I to Regulation (EU) No 605/2010 intended for importation into the European Union
• Model Milk-T/S: Animal health certificate for raw milk or dairy products for human consumption, for [transit] / [storage] in the European Union
• Model health certificate for import into the European Union of composite products intended for human consumption
  • For composite products containing 50% or more ingredients of animal origin (i.e. dairy and/or egg), and when composite products containing less than 50% of ingredients of animal origin (i.e. dairy and/or egg) do not meet specified conditions.
• Model health certificate for transit through or storage in the European Union of composite products intended for human consumption
  • Note: Composite products containing ingredients of animal origin (i.e. dairy and/or egg) which are not intended for importation into the EU but destined for a third country either by immediate transit through or after storage in the EU must come from a country authorized to export to the EU and be accompanied by a transit certificate

Other information

Composite products (CPs) for human consumption

• European Commission (EC) Decision 2007/275/EC and Commission Regulation (EU) No 28/2012 define a composite product (CP) as a foodstuff intended for human consumption that contains both processed products of animal origin and products of plant origin and include those where the processing of primary product is an integral part of the production of the final product.
• CPs containing ingredients of animal origin include those containing meat products, processed dairy product, processed fishery products and processed egg products.
• The certificates described above pertain only to CPs containing: dairy ingredients; or, dairy and egg ingredients.
• For CPs containing 50% or more ingredients of animal origin (i.e. dairy and/or egg):
  1. Export certification is required and the CP manufacturing establishment must follow the dairy requirements listed in the sections above.
  2. The manufacturing establishment of the dairy ingredients must follow the requirements listed in the sections above.

  3. The manufacturer of the shell egg or processed egg product ingredients contained in the CP must be on the Section X: Eggs and egg products – PDF (53 kb) list found on the Third Country Establishments List per Country website.

     Note: Egg products imported into Canada for the manufacture of CPs must be sourced from EU approved establishments of countries authorized to export to the European Union. Refer to the Commission Regulation (EC) No 798/2008 to verify if the exporting third country is on the list approved to export to the EU.

  4. If imported ingredients of animal origin (i.e. dairy and/or eggs) are used in the CP, the competent authority of the exporting foreign country must provide a certificate attesting to the statements as written on the CP.
• CPs containing less than 50% of ingredients of animal origin (i.e. dairy and/or egg):
  • According to Article 6 of Commission Decision 2007/275/EC, export certification is not required if the CP meets the following conditions:
    • Dairy ingredients in CP are from an approved country as listed in Appendix I, of Commission Regulation (EU) No 605/2010.
      • Note: Manufacturer of dairy ingredient is not required to be on a list of establishments approved to export dairy products to the European Union.
    • CP is shelf-stable at ambient temperature, or has clearly undergone in its manufacture a complete cooking or heat treatment process throughout their substance, so that any raw product is denatured.
    • CP is clearly identified as intended for human consumption.
    • CP is securely packaged or sealed in clean containers.
    • CP is accompanied by a commercial document and labelled in an official language of a member state, so that that document and labelling together give information on the nature, quantity and number of packages of the composite products, the country of origin, the manufacturer, and the ingredients.
    • CP is listed in Annex II of Commission Decision 2007/275/EC.
      • Note: Under Annex II, food supplements (HS Code 2106 10; HS Code 2106 90) packaged for the final consumer, containing small amounts (in total less than 20%) of processed animal products (including glucosamine, chondroitin and/or chitosan) other than meat products, do not require certification.
  • If the above conditions are not met export certification is required as per CPs containing 50% or more ingredients of animal origin.

Member countries of the European Union (EU)