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European Union (EU) - Requirements for the export of gelatine and collagen intended for human consumption

1. Eligible/Ineligible product

Gelatine and collagen can be produced from the skins and bones of different animal species (bovines, swine, fish, etc.).

EU certificates 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).

Eligible

Ineligible

2. Pre-export approvals by competent authority of importing country

Establishments

Gelatine and collagen 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 XIV: Gelatine

Section XV: Collagen

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

Note: All additions, amendments and deletions will be forwarded to the EU for approval. The approval process takes approximately 3 months, 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.

Procedure for approval and recommendation

Before going to the facility for the inspection approval, inspectors must examine the forms (Annexes A and B) that were already sent to the district office and familiarize themselves with the checklist (Annexe C) for the inspection.

Refer to the applicable checklist (Appendix C) and the appropriate EU regulations mentioned below in section 6 Additional information.

The inspector must use the Appendix C - Checklist for the inspection and the approval of facilities that produce gelatine and collagen for human consumption to be exported to the EU. RDIMS: 9007543 (internal use only).

A copy of the completed checklist (Annexe C) and of all the required forms (Annexes A and B) must be sent to the designated contact in the CFIA regional office for recommendation of approval. This person will need to review all the provided documentation to ensure that the facility's approval is in accordance with the EU regulations. They will then send the documentation to the Food Import/Export Division in Ottawa.

Where a checklist item is not applicable, please provide an explanation. The form must be completed legibly.

Copies of the inspection documents must be kept at the district office.

The facility will not be approved to export to the EU until the designated contact for the recommendation of approval in the CFIA regional office has reviewed the inspection results and provided approval.

Once the approval is given, the EU export eligibility begins on the date of recommendation of approval and when the establishment is on the EU list.

Appendix A
Appendix A
Approved Supplier Form for raw material and treated raw material for the production of gelatine and collagen for human consumption to be exported to EU.

This serves to inform Canadian Food Inspection Agency (CFIA) officials that the establishment (name and full address):
________________________________________
________________________________________
________________________________________
receives only animal by-products that were slaughtered in a slaughterhouse under full-time inspection by a veterinarian and that were subject to ante-mortem and post-mortem examinations, under the provisions of the European Union (EU), of the following species:

By-products Animal species
   
   
   
   
And come from the following facilities:
Name of facility City (country) Approval number of facility
     
     
     
     
     

I certify that the statements above are true. I agree to inform the CFIA immediately if any changes are made to the above information.

Signed by:
________________________________________

Position:
________________________________________

Date:
________________________________________

Appendix B
Appendix B
Processing Method Form for the production of gelatine and collagen or for treated raw material for the production of gelatine and collagen for human consumption to be exported to EU.
This serves to inform Canadian Food Inspection Agency (CFIA) officials that the establishment (name and full address):
________________________________________
________________________________________
Processes the following animal by-products:
________________________________________
________________________________________
From the following animal species:
________________________________________
________________________________________

Using the processing method noted below or attached, and has in place a self-inspection program with the critical limits referenced:

  •  The gelatine has been produced as per annex III, part XIV, of EU Regulation No 853/2004,
  •  The collagen has been produced as per annex III, part XV, of EU Regulation No 853/2004,
  •  The raw materials have been processed as per the processing method stated in the model official certificate for the entry into the union for placing on the market of treated raw materials for the production of gelatine and collagen intended for human consumption CFIA/ACIA 5982 (internal use) or Part IX of the Regulation (EU) no 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.

Comments:
________________________________________
________________________________________
________________________________________
________________________________________
________________________________________

I certify that the statements above are true to the best of my knowledge and belief.

Signature:
________________________________________

Date:
________________________________________

Name and title:
________________________________________

Name of company:
________________________________________

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.

The processing method must be documented and monitored. A production diagram must be provided, including Critical Control Points (CCPs). The CFIA inspector must ensure that what occurs on location corresponds to the production diagram.

Animal products for human consumption must come from animals that have passed an ante- and post-mortem examinations by a veterinarian in slaughterhouses which are under full-time inspection.

Definitions

Gelatine
The natural, soluble protein, gelling or non-gelling, obtained by the partial hydrolysis of collagen produced from animal bones, hides and skins, tendons and sinews.
Collagen
The protein-based product derived from animal bones, hides, skins and tendons.
Treated raw material
Raw materials which have undergone a transformation process as specified in the corresponding export certificate (CFIA/ACIA 5892).
Raw material
  1. bones, other than specified risk materials as defined in Article 3(1)(g) of Regulation (EC) No 999/2001 of the European Parliament and of the Council
  2. hides and skins of farmed ruminant animals
  3. pig skins
  4. poultry skin
  5. tendons and sinews
  6. wild game hides and skins; and
  7. fish skin and bones

The use of hides and skins is prohibited if they have undergone any tanning process, regardless of whether this process was completed.

Raw materials listed in point (a) to (e) must be derived from animals 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, in the case of hides and skins from wild game, found fit for human consumption.

Raw material from aquatic animals intended for human consumption must come from federally inspected fish establishments.

Specific risk material
As defined in annex V of EU Regulation No 999-2001.

Import conditions

Please refer to the specific health attestation on the respective certificates as per Regulation (EU) no 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.

4. Labelling, packaging and marking requirements

It is the exporter's responsibility to meet all the requirements for labelling, packaging and marking requirements as per the importing country.

5. Export documents available upon request

Certificates

The certificate models are not available in all the languages of the member states of the Union. The CFIA may add other 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.

Note: Before signing the export certificate to the EU, the provided traceability certificate corresponding to the products for export (when applicable) has been signed by the slaughterhouse CFIA veterinarian.

When the products for export to the EU were legally imported into Canada, the certifying veterinarians must ensure:

6. Additional information

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

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