European Union (EU) - Export requirements for milk and dairy products
1. Eligible/ineligible product
EU export certificates for milk and dairy products refer to a list of Harmonized System (HS) code(s). This list is non exhaustive. 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).
- Examples of 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
- Information not available.
2. Pre-export approvals by the competent authority of the importing country
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 the Regulation (EU) No 852/2004, EU legislation requires that processing facilities apply a self-regulated program for the Hazard Analysis Critical Control Point (HACCP) system.
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. Please click on "Canada" to see the following associated documents under "Food":
Section IX: raw milk, dairy products, colostrum and colostrum-based products
If products requiring temperature control are being exported from a storage warehouse outside the registered facility, the storage warehouse must be registered by the (CFIA) and 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, please contact your to your local CFIA office to complete the Request for Addition to the list of Canadian Dairy Establishment Approved for Export to the European Union. Also, please ensure that you have a unique identifier for your establishment before you submit your request.
All additions, amendments and deletions 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 manufacturing and export of the dairy products can start once the establishment in on the EU list.
- Note: DG-SANTE has added the letter "D" as a suffix to the unique identifier (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 unique identifier 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.
3. Production controls and inspection requirements
The inspector must verify during a preventive control inspection that the establishment is aware of the standards and requirements of the EU and has a specific export procedure in place.
- All final export requests for milk and dairy products 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 (for example modified milk ingredients or milk ingredients) is not acceptable on the Manufacturer's certificate.
- Original signed Manufacturer's certificates are to be kept on file at the plant. These files may be verified during preventive control inspection (PCI)
- 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) 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.
Imported dairy ingredients
- Manufacturers producing milk and dairy products 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.
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. Please refer also to regulation (EC) 853/2004. The labelling activity must be conducted in the EU approved establishment.
5. Export documents available upon request
The certificate models are not available in all the languages of the member states of the Union. The CFIA may add other certificate models in additional languages of the Union as required. A reasonable delay is to be expected. However, a member state could accept a certificate which is not issued in its official language. It is the responsibility of the exporter to ensure that the certificate issued meets the requirements of the border control post (BCP)/member state of destination in terms of official language.
- 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. CFIA/ACIA 5816.
- 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. CFIA/ACIA 5817.
- Model Milk-T/S: Animal health certificate for raw milk or dairy products for human consumption, for [transit] / [storage] in the European Union. CFIA/ACIA 5818.
6. Additional information
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 his importer and / or at the EU border inspection post where the products will be shipped.
- Link to the list of the Member countries of the European Union (EU). Please note that the EU has international agreements with some countries (for example Switzerland, Norway, Iceland and Liechtenstein), which means that they implement EU veterinary legislation with regard to movement of animal products.
- Link to the list of the EU Veterinary border control.
- Link to the EU models of health certificates list of third countries or part thereof authorised for the introduction into the EU of consignments of raw milk and dairy products and indicating the type of heat treatment required for such commodities, see Commission Regulation (EU) No 605/2010.
- Link to the relevant microbiological criteria for foodstuffs, see Commission Regulation (EC) No 2073/2005 of November 2005 with amendments.
- Regulation (EU) 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 (EU) no 852/2004 of the European parliament and of the council of 29 April 2004 on the hygiene of foodstuffs (HACCP principles).
- Regulation (EU) no 853/2004 of the European Parliament and of the Council of 29 April 2004 lays down specific hygiene rules for food of animal origin.
- Regulation (EU) no 2017/625 of 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 (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.
- Links to the EU regulation. Please ensure that you are using the most up-to-date/consolidated version. See EUR-Lex
- Date modified: