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) of animal origin such as chondroitin sulphate, hyaluronic acid, other hydrolysed cartilage products, chitosan, glucosamine, rennet, isinglass, amino acids that are authorized as food additives in accordance to EC No 1333/2008, food flavourings that are authorized in accordance to EC No 1333/2008 and fat derivatives. These HRPs are derived from bovine, sheep, goats pigs, poultry, equine and fishery products.

1. Eligible/ineligible product

EU certificate for 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

  • As per the list of HS codes which can be found on the model of health certificate available in the TRACES system.

Ineligible

  • Information not available.

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).

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).

Products

This information is not available.

3. Production controls and inspection requirements

The HRPs must meet the requirements as described on the EU model certificate. 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 must contains the following elements in particular:

  • reference to relevant EU regulations (see 6 below)
  • how the manufacturer follows changes in the European legislation
  • comparison of EU regulations/standards/parameters with those of Canada
  • the procedure to be followed in the event of a difference between the regulations/standards/parameters of the EU and those of Canada in order to ensure that the product meets the requirements of the EU
  • the corrective and preventive actions to be considered in the event of non-compliance

Manufacturer's Declaration

All export requests must be accompanied by a Manufacturer's declaration that has been completed on a company letterhead and signed by an authorized person of the food manufacturing establishment/facility. The following information must be included:

  • product name on label
  • establishment ID number/establishment registration number
  • lot number
  • names and origin (Canadian and/or imported) of ingredients of animal origin
  • animal species (bovine, porcine, apiculture)
  • if applicable, description of the heat and/or chemical treatments used
  • any other relevant information

Note: Inspectors will verify that the manufacturer's declaration is completed appropriately and reserve the right to request any other information that they think is necessary for the final certification of the product.

Certification requirements

The export certificate contains public health requirements.

  • the raw material used to manufacture the HRP must be food grade
  • the raw material of animal origin must be from animals, including feathers thereof, which have been slaughtered in a slaughterhouse and whose carcasses have been found fit for human consumption following ante-mortem and post-mortem inspection or from approved fishery products establishments
  • the raw material of animal origin must come from a meat or fish establishment approved for export to the EU
  • human hair must not be used as a source for the manufacture of amino acids

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:

  • the manufacturer has an SFC licence with preventive controls and a traceability system in place.

    Reference: Article 5 of Regulation (EC) No 852/2004

  • the product is manufactured as per Regulation (EC) No 852/2004

    Reference: Annex II of Regulation (EC) No 852/2004

  • the product complies with Section XVI of Annex III to Regulation (EC) No 853/2004. Indicate:
    • animals, including feathers thereof, which have been slaughtered in a slaughterhouse and whose carcasses have been found fit for human consumption following ante-mortem and post-mortem inspection as per Section XVI of Annex III to Regulation (EC) No 853/2004.
    • if raw materials of animal origin are used, they must come from an EU listed establishment. Indicate which establishment (establishment identification number)
  • if statement is applicable, confirm that human hair was not used as a source for production of amino acids and that the amino acids comply with Regulation (EC) No 1333/2008
  • if statement is applicable, fat derivatives comply with Regulation (EC) No 1333/2008 and are subjected to appropriate heat and/or chemical treatment
  • if the statement is applicable, food flavourings comply with Regulation (EC) No 1333/2008

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. Required documents

Canada does not have a bilateral certificate negotiated with the EU. The certificate issued for HRPs comes from EU regulations.

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.

In order to facilitate the certification process, it is important that the manufacturer/ exporter is familiar with the content of parts I and II of the EU model certificate.

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

  • (2020/2235) Official certificate for the entry into the Union of highly refined products as described in Annex III, Section XVI of Regulation (EC) No 853/2004, intended for human consumption (Model HRP)

    Note:

    • The health certificate is to be signed by an official veterinarian or official inspector.
    • Export certificates cannot be issued after the products have left Canada.

6. Other 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 their 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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