Approval of facilities to export gelatine and collagen or raw material and treated raw material for the production of gelatine and collagen for human consumption to the European Union (EU)

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TAHD-DSAT-IE-2017-2-1

I. Purpose

The purpose of this document is to:

  • Explain the requirements of the European Union (EU) regarding the importation of raw materials and treated raw materials for use in the production of gelatine and collagen for human consumption.
  • Explain the requirements of the European Union (EU) regarding the importation of gelatine and collagen for human consumption.
  • Standardize the inspections made on site by the Canadian Food Inspection Agency (CFIA) staff in order to register or to provide an approval to the facilities that process such products.

This document does not concern:

  • Approval of facilities that produce gelatine and collagen not intended for human consumption, to be used as feed material or for purposes outside the feed chain, intended for dispatch to or for transit through the EU (see directive TAHD-DSAT-IE-2017-1-1).

II. Background and Regulations

The production of gelatine and collagen is not regulated in Canada. However, the export of these products is controlled by the CFIA. Gelatine and collagen can be produced from the skins and bones of different species (bovines, swine, fish, etc.).

Animal products for human consumption must come from animals that have passed an ante and post-mortem examinations by a veterinarian in slaughterhouses under full-time inspection. The gelatine processing plant must have a HACCP program in place.

The European Commission's Regulation (EU) no 2016/759 establishes a list of third countries authorized to export, among other things, gelatine and collagen or raw materials and treated raw materials for the production of gelatine and collagen for human consumption to the EU and sets the certification requirements.

This regulation which came into effect on April 28, 2016, modifies Regulation 2074/2005 and repeals decision 2003/812.

The certificate models related to the importation into the EU are set out in Regulation (EU) no 2016-759:

  • For gelatine: Annex II, part III.
  • For collagen: Annex II, part IV.
  • For raw material for the production of gelatine and collagen: Annex II, part V.
  • For treated raw material for the production of gelatine and collagen: Annex II, part VI

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 854/2004 of the European Parliament and of the Council of 29 April 2004 lays down specific rules for the organization of official controls on products of animal origin intended for human consumption (Guidelines for slaughter and inspection in slaughterhouses).

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 Regulation (EU) no 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs.

III. Definitions

Collagen:
The protein-based product derived from animal bones, hides, skins and tendons.
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.
Approved facility:
A facility that has received authorization from the CFIA to collect and/or process and/or store one or more animal by-products destined for export to the EU.
Specified risk material (as defined in Annex V of Regulation no 999-2001):

1. Definition of specified risk material

The following tissues shall be designated as specified risk material if they come from animals whose origin is in a Member State or third country or of one of their region with a controlled or undetermined BSE risk:

  1. as regards bovine animals:
    1. the skull excluding the mandible and including the brain and eyes, and the spinal cord of animals aged over 12 months;
    2. the vertebral column excluding the vertebrae of the tail, the spinous and transverse processes of the cervical, thoracic and lumbar vertebrae and the median sacral crest and wings of the sacrum, but including the dorsal root ganglia, of animals aged over 30 months; and
    3. the tonsils, the last four meters of the small intestine, the caecum and the mesentery of animals of all ages.
  2. as regards ovine and caprine animals
    1. the skull including the brain and eyes, the tonsils and the spinal cord of animals aged over 12 months or which have a permanent incisor erupted through the gum, and
    2. the spleen and ileum of animals of all ages.
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 1(a) to (e) must derive from animals which have been slaughtered in a slaughterhouse and whose carcases 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.

Treated raw material:
Raw materials which have undergone a transformation process as specified in the corresponding export certificate (HA2938).

IV. Import conditions

A. Sanitary requirements for gelatine for human consumption (HA2816):

  • it comes from (an) establishment(s) implementing a program based on the HACCP principles in accordance with Article 5 of Regulation (EC) no 852/2004;
  • it has been produced from raw materials that met the requirements of Chapters I and II of Section XIV of Annex III to Regulation (EC) no 853/2004;
  • it has been manufactured in compliance with the conditions set out in Chapter III of Section XIV of Annex III to Regulation (EC) no 853/2004
    See Appendix C, 10.1.a
  • it satisfies the criteria of Chapter IV of Section XIV of Annex III to Regulation (EC) no 853/2004 and of Commission Regulation (EC) no 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs (OJ L 338, 22.12.2005, p. 1)
    See Appendix C, 13.1.d

and if from ruminant origin, except for gelatine derived from hides and skins of ruminants,

either

  • it comes from a country or a region classified in accordance with Article 5(2) of Regulation (EC) no 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies (OJ L 147, 31.5.2001, p. 1) as a country or region posing a negligible BSE risk;
  • the animals from which the gelatine was derived were born, continuously reared and slaughtered in the country with negligible BSE risk and passed ante-mortem and post-mortem inspections;
  • if in the country or region there have been BSE indigenous cases:
    1. it comes from animals which were born after the date from which the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants had been enforced; or
    2. the products of bovine, ovine and caprine animal origin do not contain and are not derived from specified risk material as defined in Annex V to Regulation (EC) no 999/2001, or mechanically separated meat obtained from bones of bovine, ovine or caprine animals.

or

  • it comes from a country or a region classified in accordance with Article 5(2) of Regulation (EC) no 999/2001 as a country or region posing a controlled BSE risk;
  • the animals from which the gelatine was derived passed ante-mortem and post-mortem inspections;
  • the animals from which the gelatine destined for export was derived have not been slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity;
  • the gelatine does not contain and is not derived from specified risk material as defined in Annex V to Regulation (EC) no 999/2001, or mechanically separated meat obtained from bones of bovine, ovine or caprine animals.

or

  • it comes from a country or a region classified in accordance with Article 5(2) of Regulation (EC) no 999/2001 as a country or region with an undetermined BSE risk;
  • the animals from which the gelatine was derived have not been fed meat-and-bone meal or greaves derived from ruminants and passed ante-mortem and post-mortem inspections;
  • the animals from which the gelatine was derived have not been slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity;
  • the gelatine is not derived from
    1. specified risk material as defined in Annex V to Regulation (EC) no 999/2001;
    2. nervous and lymphatic tissues exposed during the deboning process;
    3. mechanically separated meat obtained from bones of bovine, ovine or caprine animals.

B. Sanitary requirements for collagen for human consumption (HA2939)

  • it comes from (an) establishment(s) implementing a programme based on the HACCP principles in accordance with Article 5 of Regulation (EC) no 852/2004;
  • it has been produced from raw materials that met the requirements of Chapters I and II of Section XV of Annex III to Regulation (EC) no 853/2004;
  • it has been manufactured in compliance with the conditions set out in Chapter III of Section XV of Annex III to Regulation (EC) no 853/2004
    See Appendix C. 10.1.b
  • it satisfies the criteria of Chapter IV of Section XV of Annex III to Regulation (EC) no 853/2004 and of Commission Regulation (EC) no 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs (OJ L 338, 22.12.2005, p. 1)
    See Apprendix C, 13.1.d

and if from ruminant origin, except for collagen derived from hides and skins of ruminants,

either

  • it comes from a country or a region classified in accordance with Article 5(2) of Regulation (EC) no 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies (OJ L 147, 31.5.2001, p. 1) as a country or region posing a negligible BSE risk;
  • the animals from which the collagen was derived were born, continuously reared and slaughtered in the country with negligible BSE risk and passed ante-mortem and post-mortem inspections;
  • if in the country or region there have been BSE indigenous cases:
    1. it comes from animals which were born after the date from which the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants had been enforced; or
    2. the products of bovine, ovine and caprine animal origin do not contain and are not derived from specified risk material as defined in Annex V to Regulation (EC) no 999/2001, or mechanically separated meat obtained from bones of bovine, ovine or caprine animals.

or

  • it comes from a country or a region classified in accordance with Article 5(2) of Regulation (EC) no 999/2001 as a country or region posing a controlled BSE risk;
  • the animals from which the collagen was derived passed ante-mortem and post-mortem inspections;
  • the animals from which the collagen destined for export were derived have not been slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity;
  • the collagen does not contain and is not derived from specified risk material as defined in Annex V to Regulation (EC) no 999/2001, or mechanically separated meat obtained from bones of bovine, ovine or caprine animals.

or

  • it comes from a country or a region classified in accordance with Article 5(2) of Regulation (EC) no 999/2001 as a country or region with an undetermined BSE risk;
  • the animals from which the collagen was derived have not been fed meat-and-bone meal or greaves derived from ruminants and passed ante-mortem and post-mortem inspections;
  • the animals from which the collagen was derived have not been slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity;
  • the collagen was not derived from:
    1. specified risk material as defined in Annex V of Regulation (EC) no 999/2001;
    2. nervous and lymphatic tissues exposed during the deboning process;
    3. mechanically separated meat obtained from bones of bovine, ovine or caprine animals.

C. Sanitary requirements for treated raw material for the production of gelatine and collagen for human consumption (HA2938):

  • they have been derived from establishments under the control of and listed by the competent authority

and;

  • bones, hides and skins of domestic and farmed ruminant animals, pigs and poultry described above are derived from animals which have been slaughtered in a slaughterhouse and the carcasses of which have been found fit for human consumption following ante- and post-mortem inspection,

and/or

  • wild game hides, skins and bones described above are derived from killed animals whose carcasses have been found fit for human consumption following post-mortem inspection,

and/or

  • fish skins and bones described above are derived from plants manufacturing fishery products for human consumption authorised for export,

and;

either

they are dried bones of species from bovine, ovine, caprine, porcine and equine animals, including farmed and wild animals, poultry including ratites and feathered game for the production of collagen or gelatine, they derived from healthy animals slaughtered in a slaughterhouse, and they have been treated as follows:

either

  • crushed to pieces of approximately 15 mm and degreased with hot water at a temperature of minimum 70°C for at least 30 minutes, minimum 80°C for at least 15 minutes, or minimum 90°C for at least 10 minutes, and then separated and subsequently washed and dried for at least 20 minutes in a stream of hot air with an initial temperature of minimum 350°C, or for 15 minutes in a stream of hot air with an initial temperature of more than 700°C.

or

  • sun-dried for a minimum of 42 days at an average temperature of at least 20°C.

or

  • acid treatment such that the pH is maintained at less than 6 to the core for at least one hour before drying.

Or they are hides and skins of farmed ruminant animals, pig skins, poultry skins or wild game hides and skins, they derived from healthy animals and they:

either

  • have undergone an alkali treatment which ensures a pH>12 to the core followed by salting for at least seven days.

or

  • were dried for at least 42 days at a temperature of at least 20°C.

or

  • have undergone an acid treatment that provides at least a pH of less than 5 to the core for a minimum of one hour.

or

  • have undergone an alkali treatment which ensures a pH>12 to the core for at least 8 hours.

Or they are bones, hides or skins of farmed ruminant animals, pig skins, poultry skins, fish skins and wild game hides and skins from third countries, parts of third countries and territories referred to in Part IV of Annex I to this Regulation that have undergone any other treatment than those listed above, and that come from establishments registered or approved pursuant to Regulation (EU) no 852/2004 or in accordance with Regulation (EU) no 853/2004

And if from ruminant origin, except for hides and skins of ruminants,

either:

  • they come from a country or a region classified in accordance with Article 5(2) of Regulation (EU) no 999/2001 as a country or region posing a negligible BSE risk;
  • the animals from which the treated raw materials of bovine, ovine and caprine animal origin were derived were born, continuously reared and slaughtered in the country with negligible BSE risk and passed ante-mortem and post-mortem inspections;
  • if in the country or region there have been BSE indigenous cases:
    1. the animals were born after the date from which the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants had been enforced; or
    2. the treated raw materials of bovine, ovine and caprine animal origin do not contain and are not derived from specified risk material as defined in Annex V of Regulation (EC) no 999/2001 or mechanically separated meat obtained from bones of bovine, ovine or caprine animals;

or

  • they come from a country or a region classified in accordance with Article 5(2) of Regulation (EC) no 999/2001 as a country or region posing a controlled BSE risk;
  • the animals from which the treated raw materials of bovine, ovine and caprine animal origin were derived passed ante-mortem and post-mortem inspections;
  • animals from which the treated raw materials of bovine, ovine and caprine animal origin destined for export were derived have not been slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity;
  • the treated raw materials of bovine, ovine and caprine animal origin do not contain and are not derived from specified risk material as defined in Annex V to Regulation (EC) no 999/2001, or mechanically separated meat obtained from bones of bovine, ovine or caprine animals;

or

  • they come from a country or a region classified in accordance with Article 5(2) of Regulation (EC) no 999/2001 as a country or region with an undetermined BSE risk;
  • the animals from which the treated raw materials of bovine, ovine and caprine animal origin were derived have not been fed meat-and-bone meal or greaves derived from ruminants and passed ante-mortem and post-mortem inspections;
  • the animals from which the treated raw materials of bovine, ovine and caprine animal origin were derived have not been slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity;
  • the treated raw materials of bovine, ovine and caprine animal origin are not derived from:
    1. specified risk material as defined in Annex V of Regulation (EC) no 999/2001;
    2. nervous and lymphatic tissues exposed during the de-boning process;
    3. mechanically separated meat obtained from bones of bovine, ovine or caprine animals.

The treated raw materials:

  • Have been obtained in a country eligible to export to the EU
  • have been obtained and prepared without contact with other materials not complying with the conditions required above, and have been handled so as to avoid contamination with pathogenic agents;
  • have been transported in clean and sealed containers or lorries.

D. Sanitary requirements for untreated raw material for the production of gelatine and collagen for human consumption(HA2116):

  • bones, hides and skins of domestic and farmed ruminant animals, pigs and poultry and tendons and sinews described above derived from animals which have been slaughtered in a slaughterhouse and the carcasses of which have been found fit for human consumption following ante- and post-mortem inspection,

and/or

  • wild game hides, skins and bones described above derived from killed animals whose carcasses have been found fit for human consumption following post-mortem inspection,

and/or

  • fish skins and bones described above derived from plants manufacturing fishery products for human consumption authorised for export,

And if from ruminant origin, except for hides and skins of ruminants,

either:

  • they come from a country or a region classified in accordance with Article 5(2) of Regulation (EC) no 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies (OJ L 147, 31.5.2001, p. 1) as a country or region posing a negligible BSE risk;
  • the animals from which the raw materials of bovine, ovine and caprine animal origin were derived were born, continuously reared and slaughtered in the country with negligible BSE risk and passed ante-mortem and post-mortem inspections;
  • if in the country or region there have been BSE indigenous cases:
    1. the animals were born after the date from which the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants had been enforced; or
    2. the raw materials of bovine, ovine and caprine animal origin do not contain and are not derived from specified risk material as defined in Annex V to Regulation (EC) no 999/2001, or mechanically separated meat obtained from bones of bovine, ovine or caprine animals;

or

  • they come from a country or a region classified in accordance with Article 5(2) of Regulation (EC) no 999/2001 as a country or region posing a controlled BSE risk;
  • the animals from which the raw materials of bovine, ovine and caprine animal origin were derived passed ante-mortem and post-mortem inspections;
  • animals from which the raw materials of bovine, ovine and caprine animal origin intended for export were derived have not been slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity;
  • the raw materials of bovine, ovine and caprine animal origin do not contain and are not derived from specified risk material as defined in Annex V to Regulation (EC) no 999/2001, or mechanically separated meat obtained from bones of bovine, ovine or caprine animals;

or

  • they come from a country or a region classified in accordance with Article 5(2) of Regulation (EC) no 999/2001 as a country or region with an undetermined BSE risk;
  • the animals from which the raw materials of bovine, ovine and caprine animal origin were derived have not been fed meat-and-bone meal or greaves derived from ruminants and passed ante-mortem and post-mortem inspections;
  • the animals from which the raw materials of bovine, ovine and caprine animal origin were derived have not been slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity;
  • the raw materials of bovine, ovine and caprine animal origin are not derived from:
    1. specified risk material as defined in Annex V to Regulation (EC) no 999/2001;
    2. nervous and lymphatic tissues exposed during the de-boning process;
    3. mechanically separated meat obtained from bones of bovine, ovine or caprine animals.

The raw materials have been obtained from:

  • Have been obtained in a country eligible to export to the EU

Either

  • animals that come from holdings and have remained in that territory since birth or for at least the last three months before slaughter;

and;

  1. either that are of the species referred to in Commission Regulation (EU) no 206/2010 of 12 March 2010 laying down lists of third countries, territories or parts thereof authorised for the introduction into the European Union of certain animals and fresh meat and the veterinary certification requirements (OJ L 73, 20.3.2010, p. 1), fulfilling all the relevant animal health import requirements laid down in that Regulation, and that were slaughtered for human consumption on a date for which import into the European Union of fresh meat from animals of those species was authorised from the country or territory thereof in accordance with Column  8 of Part 1 of Annex II to that Regulation;
  2. or that are of the species referred to in Commission Regulation (EC) no 119/2009 of 9 February 2009 laying down a list of third countries or parts thereof, for import into, or transit through, the Community of meat of wild leporidae, of certain wild land mammals and of farmed rabbits and the veterinary certification requirements (OJ L 39, 10.2.2009, p. 12), fulfilling all the relevant animal health import requirements laid down in that Regulation.

or

  • poultry that have remained in that territory since hatching or have been imported as day-old chicks or slaughter poultry from (a) third country(ies) listed for that commodity in Part 1 of Annex I to Commission Regulation (EC) no 798/2008 of 8 August 2008 laying down a list of third countries, territories, zones or compartments from which poultry and poultry products may be imported into and transit through the Community and the veterinary certification requirements (OJ L 226, 23.8.2008, p. 1) under conditions at least equivalent to those in that Regulation, and consist of species referred to in that Regulation, fulfilling all the relevant animal health import requirements laid down in that Regulation, and were slaughtered for human consumption on a date for which import into the European Union of meat from animals of those species was authorised from the country or territory thereof in accordance with Column 6 B of Part 1 to Annex I to that Regulation.

or

  • animals that have been killed in the wild in that territory; and captured and killed in an area:
    1. in which within 25 km there has been no case/outbreak of any of the following diseases for which the animals are susceptible: foot and mouth disease, rinderpest, Newcastle disease or highly pathogenic avian influenza during the prior 30 days, nor of classical or African swine fever during the prior 40 days and
    2. that is situated at a distance that exceeds 20 km from the borders separating another territory of a country or part thereof, which is not authorised at these dates for exporting these raw materials to the European Union, and
    3. in which after killing they were transported within 12 hours for chilling either to a collection centre and immediately afterwards to a game establishment, or directly to a game establishment;
  • have been obtained in an establishment around which, within a radius of 10 km, there has been no case/outbreak of the following diseases for which the animals are susceptible: foot and mouth disease, rinderpest, Newcastle disease or highly pathogenic avian influenza, classical or African swine fever during the prior 30 days or, in the event of a case of one of those diseases, the preparation of raw materials for exportation to the European Union has been authorised only after the removal of all meat and the total cleaning and disinfection of the establishment under the control of an official veterinarian;

and;

  • have been obtained and prepared without contact with other materials not complying with the conditions required above, and it has been handled so as to avoid contamination with pathogenic agents;

and;

  • have been transported in clean and sealed containers or lorries.

V. Approval process for facilities that export to EU.

Refer to the applicable checklist (Appendix C) and regulations mentioned in section II "Background and Regulations" of this Directive.

1. Pre-Inspection Procedures

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 familiarise themselves with the checklist (Appendix C) for the inspection.

Validation of the processing method:

In the case of treated raw material for the production of gelatine and collagen, the raw material processing method will need to be validated by the CFIA before or during the initial approval of the facility. To become familiar with the process for validating the processing method, the inspector must contact the veterinary specialist for the export of animal by-products in Ottawa.

2. Inspection Procedures

a) Notarized Approved Supplier Form for raw material and treated raw material for the production of gelatine and collagen for human consumption (Appendix A).

Terrestrial animals:

The raw material must come from animals that were slaughtered and passed ante and post mortem inspections.

Aquatic animals:

The raw material must come from federally inspected fish plants intended for human consumption.

b) Notarized 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 (Appendix B).

The processing method must be documented and monitored. A production diagram must be provided, including CCPs. The CFIA inspector must ensure that what happens on location corresponds to the production diagram.

c) Checklists (Appendix C)

  1. Checklist for the inspection and the approval of facilities of raw material and treated raw material for the production of gelatine and collagen for human consumption to be exported to EU.
  2. Checklist for the inspection and the approval of facilities that produce gelatine and collagen for human consumption to be exported to EU.
  3. Own checks and hazard analysis and critical control points

    Under Section 5 of the Regulation (EU) no 852/2004, EU legislation requires that processing facilities apply a self-regulation program for the Hazard Analysis Critical Control Points (HACCP) system.

  4. Inspection Report Package

    Approval recommendation:
    A copy of the completed checklist (Appendix C) and of all the required forms certified by a Commissioner of Oaths (Appendix A and B) must be sent to the designated contact in the CFIA region for recommendations 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 need to send the documentation by email to the Administrative Coordinator for the Animal Import/Export Division (Janet Goodall) from the Policy and Programs Branch in Ottawa.

    Where an item of the checklist 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 in the CFIA region for the recommendation of approval 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 TRACES (when applicable).

  5. Billing for Inspections

    Facility approval inspections for export of animal by-products to the EU will be billed according to the CFIA Fees Notice, Part II, item 27: $30 for each inspection (code 1483).

  6. Approval Numbers

    Facility approval numbers are issued by the Policy and Program Branch in Ottawa. The designated contact in the CFIA region responsible for the recommendation of approval will send the appropriate information (name, address of facility, and approval date) by email to the Administrative Coordinator of the Animal Import/Export Division (Janet Goodall). A list of approved facilities will be maintained and made available by the Policy and Program Branch.

  7. Facility Name or Address Changes

    Facilities must notify the district office of changes to names or mailing addresses. A written notification should be sent to the designated contact in the CFIA region responsible for the recommendation of approval, whom will send the information by email to the Administrative Coordinator for the Animal Import/Export Division (Janet Goodall) for an amendment to the list of approved establishments. If a facility's physical address changes, the new facility will require a new inspection.

VI. Certification

HA2116: sanitary certificate for raw material for the production of gelatine and collagen for human consumption
HA2938: sanitary certificate for treated raw material for the production of gelatine and collagen for human consumption
HA2816: sanitary certificate for the production of gelatine for human consumption
HA2939: sanitary certificate for the production of collagen for human consumption

The certificate has to be signed by a veterinarian.

A) Before signing the export certificate to the EU, certifying veterinarians must ensure the following:

  • they have the appropriate and valid export certificate in hand (most recent version) for the exported product:
  • that the facility was approved by the CFIA for export to the EU:
  • that the facility appears on the list of facilities authorized to export to the EU:
    - TRACES (Trade Control and Expert System)

    Notes:

    A facility that directly exports gelatine and collagen to the EU must be listed in TRACES.

    For raw materials or treated raw materials, the facility must be approved, but does not need to be listed in TRACES.

and

  • that the provided traceability certificate corresponding to the products for export (when applicable) has been signed by the slaughterhouse CFIA veterinarian:

    Note: During the initial approval and the renewal of the annual approval, the traceability certificates must be reviewed. They must be kept in the facility for a period of 2 years.

B) In addition to what must be checked in point A), 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 (if applicable): TRACES

and

  • 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.

VII. Appendix

  • Appendix A: Notarized 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: Notarized 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
  • Appendix C:
    1. Checklist for the inspection and the approval of facilities of raw material and treated raw material for the production of gelatine and collagen for human consumption to be exported to EU
      RDIMS 9010722 (internal use only)
    2. Checklist for the inspection and the approval of facilities that produce gelatine and collagen for human consumption to be exported to EU
      RDIMS 9007543 (internal use only)

Appendix A: Notarized 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):

space space space

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: space

Position: space

Notary Seal and Signature: space

Date: space

Appendix B: Notarized 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:

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space

from the following animal species:

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

  • Box The gelatine has been produced as per annex III, part XIV, of EU Regulation no 853/2004,
  • Box The collagen has been produced as per annex III, part XV, of EU Regulation no 8853/2004,
  • Box The raw materials have been processed as per the processing methods stated in certificate HA2938.

Comments:

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

Signature space
Date: space

Name and title: space

Name of Company: space

Notary Seal and Signature: space

Date: space

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