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

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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.

1. Eligible/ineligible product

EU certificate for highly refined products (HRPs) refers 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 competent authority of importing country

Establishments

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 the Hazard Analysis Critical Control Point (HACCP) principles (see Preventive control plan (PCP)) as stipulated in Commission Regulation (EC) No 852/2004 of the European Parliament and of the Council. In addition, these establishments must be regularly audited by the competent authorities (CA), and be listed as an EU approved establishment in accordance with Regulation (EC) 853/2004 which applies to processed and unprocessed products of animal origin.

The establishments producing HRP must appear on the appropriate establishment list administered by the Directorate-General of Health and Food Safety (DG-SANTE).

Note: TRACES should be used to consult the lists of authorized establishments. The list of the HRP  is under the "Publications" tab, consult the lists of authorized establishments.

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).

To request inclusion on any of the EU approval lists, please submit the following information to your local CFIA office:

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 also has the obligation to inform the CFIA changes are made to the information provided above.

3. 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:

Part II of the certificate is completed by a certifying officer, however some information will have to be provided by the applicant. The applicant should provide a manufacturer's declaration on company letterhead, which confirms:

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.

4. Labelling, packaging and marking requirements

Products need to satisfy EU labelling requirements.

5. Export documents available upon request

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 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 a certifying officer (official veterinarian or official inspector). However, some information will have to be provided by the applicant in order for Part II to be completed, if applicable. This information should be provided in the form of a manufacturer's declaration when applying for an export certificate. See 3 above.

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

Certificate

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 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.

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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