European Union (EU) – Requirements for the export of gelatin and collagen intended for human consumption

1. Eligible/ineligible product

Gelatin 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). 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 Harmonized System (HS) codes which can be found on the models of health certificates available in the TRACES system.

Ineligible

Information not available.

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

Establishments

Gelatin and collagen products must come from an establishment licensed under the Safe Food for Canadian Regulations (SFCR). Under Section 5 of the Regulation (EC) No 852/2004, EU legislation requires that processing facilities apply a self-regulated program for the Hazard Analysis Critical Control Point (HACCP) system. In addition, these establishments must be regularly audited by the competent authorities (CA), and be listed as an EU approved establishment.

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 in TRACES.

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 (gelatin 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 (Annexes A SGDDI 15717338 and B SGDDI 15717366) that were already sent by the manufacturer to the district office and familiarize themselves with the checklist (Annex C) for the inspection.

Refer to the applicable checklist (Annex C) and the appropriate EU Regulations mentioned below in section 6 additional information.

The inspector must use the Annex C, checklist for the inspection and the approval of facilities that produce gelatin and collagen for human consumption to be exported to the EU – RDIMS 9007543.

A copy of the completed checklist (Annex 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.

Annex A

Approved supplier form for raw material and treated raw material for the production of gelatin and collagen for human consumption to be exported to EU.

This serves to inform Canadian Food Inspection Agency (CFIA) officials that the establishment:

Name:

Address:

Registration No:

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
List by-products.	List animal species.

And come from the following facilities:

Name of facility	City (country)	Approval number of facility
List facility name.	Insert city and country.	Insert approval number of the 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:

Annex B

Processing method form for the production of gelatin and collagen or for treated raw material for the production of gelatin and collagen for human consumption to be exported to EU.

This serves to inform Canadian Food Inspection Agency (CFIA) officials that the establishment:

Name:
Address:
Registration No:

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 gelatin 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 animal health/official certificate for the entry into the Union of treated raw materials for the production of gelatin and collagen intended for human consumption available in TRACES or in the implementing Regulation (EU) 2020/2235.

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. This procedure should clearly refer to the relevant EU regulations (see 6 below) and demonstrate that the exported product meets EU requirements.

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

Gelatin

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

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.

Import conditions

Please refer to the specific health attestation on the respective certificates available in TRACES or in the implementing Regulation (EU) 2020/2235 as well as the corrected version (EU) 2021/1471.

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

Canada does not have a bilateral certificate negotiated with the EU. The certificate issued for gelatin and collagen come 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.

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. Please 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.

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 and its amendments.

For more information about TRACES, please refer to the CFIA web page Exporting food and animal products to the European Union

Certificates

(2020/2235) Gelatin intended for human consumption – Model GEL.
(2020/2235) Collagen intended for human consumption – Model COL.

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

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

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.

Links to the EU regulation:

Please 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.

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 - (English only).
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 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.
Regulation (EU) 2020/2235 of 16 December 2020 laying down rules for the application of Regulations (EU) 2016/429 and (EU) 2017/625 of the European Parliament and of the Council as regards model animal health certificates, model official certificates and model animal health/official certificates, for the entry into the Union.
Regulation (EU) 2021/405 of 24 March 2021 laying down the lists of third countries or regions thereof authorised for the entry into the Union of certain animals and goods intended for human consumption in accordance with Regulation (EU) 2017/625.
Commission Implementing Regulation (EU) 2021/1471 of 18 August 2021 amending and correcting Implementing Regulations (EU) 2020/2235 and (EU) 2020/2236 as regards references to national measures designed to limit the impact of certain diseases of aquatic animals and to lists of third countries, territories or zones thereof from which entry into the Union of animals and goods is permitted.
Commission Implementing Regulation (EU) 2023/2744 of 20 November 2023 amending Implementing Regulation (EU) 2020/2235 as regards model animal health certificates, model official certificates, model animal health/official certificates and private attestation, for the entry into the Union or transit through the Union of consignments of certain categories of animals and goods, and official certification regarding such certificates.

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