European Union (EU) - Export requirements for raw materials and treated raw materials for the production 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).
- Example HS codes listed on the EU certificates
- Raw materials: 0206, 0207, 0208, 0302, 0303, 0305, 0505, 0506, 0511 91, 0511 99, 4101, 4102 or 4103
- Treated raw materials: 0210, 0305, 0505, 0506, 0511 99, 1602, 1604, 4101, 4102 or 4103
- Information not available.
2. Pre-export approvals by competent authority of importing country
Raw materials and treated raw martials for the production 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/XV : Treated raw material for the production of gelatine and collagen (TCG)
- Section XIV/XVbis : Raw materials for the production of gelatine and collagen (to be developed as required)
To request inclusion on any of the EU approval lists, please submit the following information to your local CFIA office:
- unique establishment identifier
- Safe Food for Canadians licence number
- full legal name as it appears on the Safe Food for Canadians licence
- physical site address associated with the unique establishment identifier as it appears on the Safe Food for Canadians licence
- indicate the type of activity (gelatine and/or collagen) the establishment
- indicate the animal species (bovine, porcine, ovine, fish, etc.) if necessary
- describe the type of material, for example: bone or skin
- any other relevant information.
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 (appendices A and B) that were already sent to the district office and familiarize themselves with the checklist (appendix C) for the inspection.
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.
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.
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 raw materials and treated raw material for the production of gelatine and collagen for human consumption to be exported to the EU. RDIMS: 9007543 (internal use only).
A copy of the completed checklist (appendix C) and of all the required forms (appendices 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.
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.
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.
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
- 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
- hides and skins of farmed ruminant animals
- pig skins
- poultry skin
- tendons and sinews
- wild game hides and skins; and
- 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.
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
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.
- Official certificate for the entry into the Union for placing on the market of raw materials for the production of gelatine and collagen intended for human consumption. CFIA/ACIA 5891.
- 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 5892.
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:
- that the products are from facilities approved by the country of origin for export to EU and that they are listed in the facilities authorized to export to the EU
- that they have on hand an additional certificate issued by a competent authority in the country of origin, attesting that the products meet the EU requirements
6. Additional information
- Export of samples (personal or commercial) 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 control post where the products will be shipped.
- Exported products transiting through a third country may require transit documentation. It is the responsibility of the exporter to ensure that the shipment will be accompanied by all the necessary certificates. Please work closely with your importer.
- Link to the list of the Member countries of the European Union (EU). Please note that the EU has international agreements with some countries (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.
- 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.
- 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 including gelatin, collagen, raw material and treated raw material for the production of gelatin and collagen.
- Regulation (EU) no 999/2001 of the European Parliament and of the Council of 22 May 2001 lays down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies.
- Commission Decision 2007/453/EC establishing the Bovine Spongiform Encephalopathy (BSE) status of countries according to their BSE risk.
- Regulation (EU) no 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs.
- 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.
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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