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European Union (EU) - Export requirements for highly refined products

This directive applies to food business operators manufacturing highly refined products (HRPs) such as chondroitin sulphate, hyaluronic acid, other hydrolysed cartilage products, chitosan, glucosamine, rennet, isinglass and amino acids. These HRPs are derived from bovine, sheep, goats pigs, poultry, equine and fishery products.

Eligible/ineligible product

EU certificate for highly refined products (HRPs) refers 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).



Pre-export approvals by competent authority of importing country


The highly refined products must come from an establishment licensed under the Safe Food for Canadian Regulations (SFCR).

The EU requires that HRPs originate from an establishment operating under HACCP principles (see Preventive control plan (PCP)) as stipulated in Commission Regulation (EC) No 852/2004 of the European Parliament and of the Council.

If applicable, the raw animal material used in the HRP must come from an establishment (such as: meat or fish, etc.) which is approved to export to the EU and on the list administered by the Directorate-General of Health and Food Safety (DG-SANTE). The third country lists are available on the EU website, Third Country Establishments - List per Country. Please select "Canada" to see the associated documents.

Production controls and inspection requirements

The HRPs must meet the requirements as described on the EU model certificate. The manufacturer must implement an auditable specific procedure which demonstrates that the final product meets among others the following:

Imported ingredients of animal origin

If imported ingredients of animal origin are used in the HRP, the competent authority of the exporting foreign country must provide support documentation attesting that the imported ingredients comply with the EU requirements.

Labelling, packaging and marking requirements

Products need to satisfy EU labelling requirements.

Export documents available upon request

The certificate model is 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.


Information required to complete EU health certificate

Part I: Details of dispatched consignments of the EU certificate should be completed by the applicant. It is strongly recommended that the exporter works closely with the importer. Please refer also to annex II in the link below regarding how to complete export certificates.

Commission implementing regulation (EU) 2019/628 of 8 April 2019 concerning model official certificates for certain animals and goods and amending Regulation (EC) No 2074/2005 and Implementing Regulation (EU) 2016/759 as regards these model certificates

Part II: Certification, must be completed by the CFIA. Each page of the certificate should be signed and stamped. The name of the certifying officer must be in capital letters.


Boxes I.21 and I.22 of the EU certificate should be left empty. This was discussed with DG-SANTE, and it was confirmed that Canada and DG-SANTE has the same understanding that boxes I.21 and I.22 should be left empty when the certificates are not generated in the Integrated Management System for Official Controls (IMSOC). According to the information we have, the Commission specifically sent a message on January 28, 2020, to all EU member states how empty boxes should be treated.

Additional information

Samples (personal or commercial) of highly refined products may be subject to the same requirements as 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.


Regarding the links above related to EU regulations, please ensure that you are using the most up-to-date / consolidated version. See: EUR-Lex.

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