Approval of facilities that produce gelatin 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 European Union (EU)

TAHD-DSAT-IE-2017-1-2

March 2018

Amendments: This directive was revised following the CFIA's decision to mandate the approval of establishments for the export of animal by-products not intended for human consumption to the EU, to veterinarians who have compulsorily completed the course (I6T228 or I6D320): Inspection and approval of animal by-products and pet food establishments for export to the EU or the US

On this page

1. Purposes
2. Background and regulations
3. Definitions
4. Import conditions
5. Approval process for facilities that export to EU
6. Export certification (HA2380)
7. Appendix

I. Purposes

The purposes of this document are as follows:

• Explain the requirements of the European Union (EU) regarding gelatin and collagen imports not intended for human consumption, to be used as feed material for pets or outside the feed chain (technical use)
• Standardize inspections conducted by Canadian Food Inspection Agency (CFIA) staff for the approval of establishments that process such products for export to the EU

This document does not deal with the following:

• Approval of facilities to export gelatin and collagen or raw material and treated raw material for the production of gelatin and collagen for human consumption to the European Union (see directive TAHD-DSAT-IE-2017-2)

II. Background and regulations

Gelatin and collagen production is not regulated in Canada. However, the export of these products is controlled by the CFIA. Gelatin and collagen can be produced from the skin and bones of various species (bovine, pork, fish, etc.).

Animal by-products intended for animal consumption must be from animals for which have passed an ante-mortem examination and that have undergone a post-mortem examination by a veterinarian in an abattoir under permanent inspection.

CFIA directive number TAHD-DSAT-IE-2009-8 (Registration or Approval of Facilities to Export Animal By-Products Not Intended for Human Consumption to the European Union (EU)) lists the general principles for registering or approving establishments for exports to the EU.

Regulation (EU) n^o 1069/2009 of the European Parliament and of the Council lays down health rules as regards animal by-products and derived products not intended for human consumption.

Regulation (EU) n^o 142/2011 implements Regulation (EU) n^o 1069/2009 of the European Parliament and of the Council laying down health rules as regards animal by-products and derived products not intended for human consumption.

Regulation (EU) n^o 853/2004 of the European Parliament and of the Council of 29 April 2004 lays down specific hygiene rules for food of animal origin.

Regulation (EU) n^o 999/2001 of the European Parliament and of the Council of 22 May 2001 is laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies.

III. Definitions

Collagen:

Protein-based products derived from hides, skins, bones, and tendons of animals.

Gelatin:

Natural soluble protein, gelling or non-gelling, obtained by the partial hydrolysis of collagen produced from bones, hides and skins, tendons and sinews of animals.

Approved facilities:

Applies to facilities that have 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. Refer to directive TAHD-DSAT-IE-2009-8 for the definition of the types of establishments.

Category 3 raw materials:

Refer to directive TAHD-DSAT-IE-2009-9 (Definition of Categories 1, 2, and 3 Animal Products and By-Products) and European Legislation N^o 1069/2009.

Specified risk material (as defined in annex V of Regulation n^o 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

Other definitions:

See definitions in directive TAHD-DSAT-IE-2009-8.

IV. Import conditions

Not intended for human consumption

• consist exclusively of gelatin/collagen not intended for human consumption

From an approved plant

• has been prepared and stored in a plant approved, validated and supervised by the competent authority in accordance with Article 24 of Regulation (EU) n^o 1069/2009, in order to kill pathogenic agents

Nature of animal by-products

• has been prepared exclusively with the following animal by-products:

either

• carcases and parts of animals slaughtered or, in the case of game, bodies or parts of animals killed, and which are fit for human consumption in accordance with Union legislation, but are not intended for human consumption for commercial reasons

and/or

• carcases and the following parts originating either from animals that have been slaughtered in a slaughterhouse and were considered fit for slaughter for human consumption following an ante-mortem inspection or bodies and the following parts of animals from game killed for human consumption in accordance with Union legislation:
  1. carcases or bodies and parts of animals which are rejected as unfit for human consumption in accordance with Union legislation, but which did not show any signs of disease communicable to humans or animals
  2. heads of poultry
  3. hides and skins, including trimmings and splitting thereof, horns and feet, including the phalanges and the carpus and metacarpus bones, tarsus and metatarsus bones
  4. pig bristles
  5. feathers

and/or

• animal by-products arising from the production of products intended for human consumption, including degreased bone, greaves and centrifuge or separator sludge from milk processing

and/or

• products of animal origin, or foodstuffs containing products of animal origin, which are no longer intended for human consumption for commercial reasons or due to problems of manufacturing or packaging defects or other defects from which no risk to public or animal health arises

and/or

• petfood and feedingstuffs of animal origin, or feedingstuffs containing animal by-products or derived products, which are no longer intended for feeding for commercial reasons or due to problems of manufacturing or packaging defects or other defects from which no risk to public or animal health arises

and/or

• aquatic animals, and parts of such animals, except sea mammals, which did not show any signs of diseases communicable to humans or animals

and/or

• animal by-products from aquatic animals originating from plants or establishments manufacturing products for human consumption

Packaging and processing

• the gelatin/collagen:

(a) was wrapped, packaged, stored and transported under satisfactory hygiene conditions, and in particular wrapping and packaging took place in a dedicated room, and only preservatives permitted under Union legislation were used

Wrappings and packages containing gelatin/collagen carry the words "gelatin/collagen suitable for animal consumption"; and

either

(b) the gelatin was produced in accordance with Annex III, Section XIV, of Regulation (EU) N^o 853/2004

or

(b) the gelatin, has been produced by a process that is ensuring that unprocessed Category 3 material is subjected to a treatment with acid or alkali, followed by one or more rinses, involving pH adjustment, extraction by heating one or several times in succession, followed by purification by means of filtration and sterilization, in order to kill pathogenic agents

either

(b) the collagen was produced in accordance with Annex III, Section XV, of Regulation (EU) N^o 853/2004

or

(b) the collagen, has been produced by a process that ensuring that unprocessed Category 3 material is subjected to a treatment involving washing, pH adjustment using acid or alkali followed by one or more rinses, filtration and extrusion, in order to kill pathogenic agents

Sanitary attestations

In the case of gelatin/collagen from materials other than hides and skins:

either

• the product does not contain and is not derived from specified risk material as defined in Annex V to Regulation (EC) N^o 999/2001 of the European Parliament and of the Council(3) or mechanically separated meat obtained from bones of bovine, ovine or caprine animals; and the animals from which this product is 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 of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity

or

• the product does not contain and is not derived from bovine, ovine or caprine materials other than those derived from animals born, continuously reared and slaughtered in a country or region classified as posing a negligible BSE risk by a decision in accordance with Article 5(2) of Regulation (EC) N^o 999/2001

in the case of gelatin/collagen from materials other than hides and skins:
in addition as regards TSE (Transmissible Spongiform Encephalopathy):

either

• in case of animal by-products intended for feeding ruminants and containing milk or milk products of ovine or caprine origin, the ovine and caprine animals from which these products are derived have been kept continuously since birth or for the last three years on a holding where no official movement restriction is imposed due to a suspicion of TSE and which has satisfied the following requirements for the last three years:
  1. it has been subject to regular official veterinary checks
  2. no classical scrapie case, as defined in point 2(g) of Annex I to Regulation (EC) N^o 999/2001, has been diagnosed or, following the confirmation of a classical scrapie case:
     • all animals in which classical scrapie was confirmed have been killed and destroyed, and
     • all goats and sheep on the holding have been killed and destroyed, except for breeding rams of the ARR/ARR genotype and breeding ewes carrying at least one ARR allele and no VRQ allele,
  3. ovine and caprine animals, with the exception of sheep of the ARR/ARR prion genotype, are introduced into the holding only if they come from a holding which complies with the requirements set out in points (i) and (ii)

or

• in case of animal by-products intended for feeding ruminants and containing milk or milk products of ovine or caprine origin, and destined to a Member State listed in the Annex to Commission Regulation (EC) N^o 546/2006, the ovine and caprine animals from which these products are derived have been kept continuously since birth or for the last seven years on a holding where no official movement restriction is imposed due to a suspicion of TSE and which has satisfied the following requirements for the last seven years:
  1. it has been subject to regular official veterinary checks
  2. no classical scrapie case, as defined in point 2(g) of Annex I to Regulation (EC) N^o 999/2001, has been diagnosed or, following the confirmation of a classical scrapie case:
     • all animals in which classical scrapie was confirmed have been killed and destroyed, and
     • all goats and sheep on the holding have been killed and destroyed, except for breeding rams of the ARR/ARR genotype and breeding ewes carrying at least one ARR allele and no VRQ allele
  3. ovine and caprine animals, with the exception of sheep of the ARR/ARR prion genotype, are introduced into the holding only if they come from a holding which complies with the requirements set out in points (i) and (ii)

V. Approval process for facilities that export to EU

Please refer to directive TAHD-DSAT-IE-2009-8.

1. General hygiene requirements

Refer to section IV of directive TAHD-DSAT-IE-2009-8.

2. Requirements for intermediate plants

Refer to section IV a of directive TAHD-DSAT-IE-2009-8.

3. Requirements for storage plants

Refer to section IV b of directive TAHD-DSAT-IE-2009-8.

4. Requirements for processing plants

Refer to section IV c of directive TAHD-DSAT-IE-2009-8.

5. Hygiene and processing requirements

Refer to section IV d of directive TAHD-DSAT-IE-2009-8.

6. Supervision of production

Refer to section IV e of directive TAHD-DSAT-IE-2009-8.

7. Validation procedures

Refer to section IV f of directive TAHD-DSAT-IE-2009-8.

8. Own checks and Hazard Analysis and Critical Control Points

Refer to section IV g of directive TAHD-DSAT-IE-2009-8.

For processing establishments, EU legislation requires that such establishments apply an own check program similar to the Hazard Analysis and Critical Control Points (HACCP).

9. Hygiene requirements for the collection and transport of animal by-products and derived products

Refer to section V of directive TAHD-DSAT-IE-2009-8.

10. Procedure for approval

Refer to section VII a of directive TAHD-DSAT-IE-2009-8.

11. Official control

Refer to section VII b of directive TAHD-DSAT-IE-2009-8.

12. Suspension, withdrawals and prohibitions on operations

Refer to section VII c of directive TAHD-DSAT-IE-2009-8.

13. Pre-inspection procedures

Refer to section VIII of directive TAHD-DSAT-IE-2009-8.

Before going to the establishment for an approval inspection, the inspector must examine the forms (appendices A, B and D) previously sent to the district office and become familiar with the checklist (Appendix C) for the inspection.

a) Appendix A: Approved Supplier Form of raw material for facilities that produce gelatin 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 European Union (EU)

The raw material must be of category 3 materials and must come from establishments or suppliers eligible for export to EU. The supplier establishments must be indicated on the form. Traceability certificates (TCs) must specify that raw material come from animals that have passed ante mortem inspection and went through post-mortem inspection by a veterinarian. During the annual inspection, TCs must be verified.

b) Appendix B: Processing Method Form for facilities that produce gelatin 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 European Union (EU)

A flow chart must be provided. Verify that the processing method form (Appendix B) is consistent with the processing taking place on the premises and with processing records such as time-temperature graphs etc.

c) Appendix D: Own checks

On this form, the establishment certifies that it has adopted an own check program that includes the necessary critical limits, how they will be monitored, and what precautionary measures will be implemented if these CCPs are not met.

14. Inspection procedure (checklist-appendix C)

Refer to section IX of directive TAHD-DSAT-IE-2009-8.

Appendix C: Checklist for the inspection to approve facilities that produce gelatin 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 European Union (EU)

Complete the applicable checklist (Appendix C) for the commodity being exported to the EU.

15. Billing for inspections

Refer to section X of directive TAHD-DSAT-IE-2009-8.

16. Inspection reports

Refer to section XI of directive TAHD-DSAT-IE-2009-8.

The inspection report and the appendices must be sent to the designated contact in the CFIA region for recommendations of approval before being sent to the Policy and Program Branch (janet.goodall@inspection.gc.ca). A copy of the documents must be kept in the district.

17. Approval numbers

Refer to section XII of directive TAHD-DSAT-IE-2009-8.

18. Facility name or address changes

Refer to section XIII of directive TAHD-DSAT-IE-2009-8.

VI. Export certification (HA2380)

A) The certificate has to be signed by a veterinarian.

• Before signing export certificates for the EU, certifying veterinarians must ensure that:
  • they have the appropriate and valid (most recent version) export certificate for the exported product;
  • the establishment has been approved by the CFIA for export to the EU;
  • the establishment is on the list of establishments authorized to export to the EU:
    TRACES (TRAde Control and Expert System)

Note: An establishment that exports gelatin and collagen directly to the EU must be listed in TRACES.

and

• the traceability certificate is provided for the products to be exported and signed by the veterinarian in charge of the abattoir

Note: At the time of the initial approval and the renewal of the annual approval, the traceability certificates must be verified. They must be kept at the establishment for a period of two years.

B) In addition to what must be checked under point A), in cases where products to be exported to the EU were legally imported to Canada, the certifying veterinarians must ensure that:

• the products are from establishments approved by the competent authority in the country of origin and that they are on the list of establishments authorized to export to the EU (as applicable): TRACES

and

• they have an additional certificate issued by the competent authority in the country of origin certifying that the product meets EU requirements

VII. Appendix

• Appendix A: Approved Supplier Form of raw material for facilities that produce gelatin 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 European Union (EU).
• Appendix B: Processing Method Form for facilities that produce gelatin 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 European Union (EU).
• Appendix C: Checklist for the inspection to approve facilities that produce gelatin 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 European Union (EU).
• Appendix D: Own checks and Hazard Analysis and Critical Control Points

Appendix A: Approved Supplier Form of raw material for facilities that produce gelatin 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 European Union (EU)

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

Receives only animal products of:

category 3

not intended for human consumption according to the European Union legislation (EU), of the following species

And come from the following facilities:

Name of facilities	City(Country)	Approval number of facility

Origin of Category 3 Raw Animal By-Products: federally inspected abattoirs; provincially inspected abattoirs with a full-time veterinarian; or an EU-eligible plant from a third country.^Footnote 1

I certify that I understand the European Union definition of "Category 1, 2, and 3 materials" as defined in Regulation (EC) N^o 1069/2009, and 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: Processing Method Form for facilities that produce gelatin 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 European Union (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 species

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

the gelatin was produced in accordance with Annex III, Section XIV, of Regulation (EU) N^o 853/2004,

in the case of gelatin, has been produced by a process that is ensuring that unprocessed Category 3 material is subjected to a treatment with acid or alkali, followed by one or more rinses, involving pH adjustment, extraction by heating one or several times in succession, followed by purification by means of filtration and sterilization, in order to kill pathogenic agents

the collagen was produced in accordance with Annex III, Section XV, of Regulation (EU) N^o 853/2004,

in the case of collagen, has been produced by a process that ensuring that unprocessed Category 3 material is subjected to a treatment involving washing, pH adjustment using acid or alkali followed by one or more rinses, filtration and extrusion, in order to kill pathogenic agents;

Comments:

I certify that the statements above are true to the best of my knowledge and belief. I agree to notify the CFIA immediately if the above information changes or if the critical limits for processing material destined to the European Union (EU) are not met. I am aware that to maintain my EU approval status, I must be re-inspected at least once per year by the CFIA and that I am responsible for arranging this inspection prior to the expiration of my one-year validity period.

Signature: Date:

Position:

Date:

Appendix C: Checklist for the inspection to approve facilities that produce gelatin 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 European Union (EU)

1. Canadian Food Inspection Agency (CFIA) Approval Number:
(For newly inspected facilities, leave blank.)

2. Plant/Company name:

3. Address of location being inspected:

4. Address of headquarters, if different from above:

5. Contact name at plant:

Telephone: Facsimile:

6. Please list animal by-products, species of origin produced at this plant for export to the EU, and their intended end use.

Animal by-products	Species of origin	Intended end use

7. Comments:

8. Recommendation for approval to export to the EU: Approve Disapprove

Signature of Veterinarian

Inspection date

Name of Veterinarian (printed)

Signature of the Area Approving Veterinarian

Date

9. Approval valid until (date): (1 year from date of inspection)

Please forward a copy of the completed form and all required forms to the designated contact in the CFIA region for recommendations of approval.

Note: To maintain approval, facilities must be inspected at least once every 12 months or each time that changes are made to the procedures, documents, facilities, etc.

Preamble

1. Yes No

Has the plant provided you with a current Approved Supplier Form of raw material (Appendix A) for facilities that produce gelatin 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 European Union (EU)? (Please attach to this checklist, and forward to the designated contact in the CFIA region for recommendations of approval.)

2. Yes No

Has the plant provided you with a current Processing Method Form (Appendix B) for facilities that produce gelatin 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 European Union (EU)? (Please attach to this checklist, and forward to the designated contact in the CFIA region for recommendations of approval.

Checklist for intermediate plants

1. Yes No

The premises are adequately separated from other premises, such as slaughterhouses.

2. Yes No

The layout of plants ensures the total separation of Category 1 and 2 materials from Category 3 material, from reception until dispatch.

3. Yes No

The plant has a covered space to receive and dispatch animal by-products, unless the animal by-products are being discharged through installations which prevent the spreading of risks to public and animal health, such as through closed tubes for liquid animal by-products.

4. Yes No

The plant is constructed in a way that eases cleaning and disinfection. Floors are laid down in a way that facilitates the draining of liquids.

5. Yes No

The plant has adequate lavatories, change rooms, and wash basins for staff.

6. Yes No

The plant has appropriate arrangements for protection against pests, such as insects, rodents, and birds.

7. Yes No

Where it is necessary for the purpose of achieving the objectives of Regulation (EC) n^o 142/201, plants must have suitable temperature-controlled storage facilities of sufficient capacity for maintaining animal by-products at appropriate temperatures and designed to allow the monitoring and recording of those temperatures.

8. Yes No

The plant has adequate facilities for cleaning and disinfecting the containers or receptacles in which Category 3 material is received, as well as the vehicles in which they are transported. Adequate facilities must be provided for disinfecting vehicle wheels.

9. Yes No

The sorting of materials shall be carried out in such a way that avoids any risk of the propagation of animal diseases.

10. Yes No

At all times during sorting or storage, materials of different categories are handled and stored separately, and in a way that prevents any propagation of pathogens.

11. Yes No

Category 3 material is stored properly, including under appropriate temperature conditions, until re-dispatched.

Checklist for storage plants

1. Yes No

Premises and facilities storing derived products from Category 3 material must not be at the same site as premises storing derived products from Category 1 or Category 2 material, unless cross-contamination is prevented due to the layout and management of the premises, such as by means of storage in completely separate buildings.

2. Yes No

The plant must have a covered space to receive and dispatch the derived products, unless the derived products are:

1. being discharged through installations which prevent the spreading of risks to public and animal health, such as through closed tubes for liquid products; or
2. received in packaging, such as in tote bags, or in covered leak-proof containers or means of transport.

3. Yes No

The plant is constructed in a way that eases cleaning and disinfection. Floors are laid down in a way that facilitates the draining of liquids.

4. Yes No

The plant has adequate lavatories, change rooms, and wash basins for staff.

 5. Yes No

The plant has appropriate arrangements for protection against pests such as insects, rodents, and birds.

6. Yes No

The plant has adequate facilities for cleaning and disinfecting the containers or receptacles in which the products are received, as well as the vehicles, other than ships, in which they are transported. Adequate facilities are provided for disinfecting vehicle wheels.

7. Yes No

Derived products are stored properly until re-dispatched.

8. Yes No

The gelatin or collagen is wrapped, packaged, stored and transported under satisfactory hygienic conditions.

9. Yes No

Wrapping and packaging takes place in a dedicated room.

10. Yes No

Only preservatives permitted under European Union legislation are used.

11. Yes No

Wrappings and packages containing gelatin/collagen carry the words "gelatin/collagen suitable for animal consumption".

Checklist for processing plants

1. Yes No

The processing plant is not situated on the same site as slaughterhouses or other establishments which have been approved or registered in accordance with Regulation (EC) n^o 852/2004 or Regulation (EC) n^o 853/2004, unless the risks to public and animal health resulting from the processing of animal by-products, which originate from such slaughterhouses or other establishments, are mitigated by compliance with at least the following conditions:

1. The processing plant is physically separated from the slaughterhouse or other establishment, where appropriate by locating the processing plant in a building that is completely separated from the slaughterhouse or other establishment
2. The following is installed and operated in the processing plant:
   • a conveyer system which links the processing plant to the slaughterhouse or other establishment and which may not be by-passed; and
   • separate entrances, reception bays, equipment and exits for both the processing plant and the slaughterhouse or establishment
3. Measures are taken to prevent the spreading of risks through the operation of personnel which is employed in the processing plant and in the slaughterhouse or other establishment
4. Unauthorised persons and animals do not have access to the processing plant

By way of derogation from points (i) to (iv), in the case of processing plant processing Category 3 material, the competent authority may authorize other conditions instead of those set out in those points, aimed at mitigating the risks to public and animal health, including the risks arising from the processing of Category 3 material, which originates from off-site establishments approved or registered in accordance with Regulation (EC) n^o 852/2004 or Regulation (EC) n^o 853/2004.

2. Yes No

The processing plant has clean and unclean sectors, adequately separated. The unclean sector has a covered place to receive animal by-products and is constructed in a way that eases cleaning and disinfection. Floors are laid in a way that facilitates the draining of liquids. The processing plant has adequate lavatories, change rooms, and wash basins for staff.

3. Yes No

The processing plant has adequate lavatories, change rooms, and wash basins for staff.

4. Yes No

The processing plant has sufficient production capacity for hot water and steam for the processing of animal by-products;

5. Yes No

If appropriate, the unclean sector contains equipment to reduce the size of animal by-products and equipment for loading the crushed animal by-products into the processing unit;

6. Yes No

Where heat treatment is required, all installations are equipped with:

1. measuring equipment to monitor temperature against time and, if applicable for the processing method used, pressure at critical points
2. recording devices to record continuously the results of these measurements in a way so that they remain accessible for the purpose of checks and official controls
3. an adequate safety system to prevent insufficient heating

7. Yes No

To prevent recontamination of the derived product by the introduction of animal by-products, a clear separation exists between the area of the plant where incoming material for processing is unloaded and the areas set aside for the processing of that product and the storage of the derived product.

8. Yes No

The processing plant has adequate facilities for cleaning and disinfecting the containers or receptacles in which animal by-products are received, as well as the vehicles, other than ships, in which they are transported.

9. Yes No

Adequate facilities are provided for disinfecting vehicle wheels, when departing the unclean sector of the processing plant.

10. Yes No

The processing plant has a waste water disposal system that meets the competent authority's requirements.

11. Yes No

Preventative measures against birds, rodents, insects, or other vermin are taken systematically. A documented pest control program is used for that purpose.

12. Yes No

Animal by-products are processed as soon as possible. After processing, derived products are handled and stored in such a way as to avoid risks of contamination.

13. Yes No

The processing plant has its own laboratory or makes use of the services of an external laboratory. The laboratory is equipped to carry out necessary analyses and is approved by the competent authority on the basis of an assessment of the capacity of the laboratory to carry out those analyses, is accredited according to internationally recognized standards or is subject to regular controls by the competent authority, to assess the capacity of the laboratory to carry out those analyses.

14. Yes No

Any person working in the establishment or plant referred to in this directive shall wear suitable, clean and, where necessary, protective clothing. Where appropriate in a particular establishment or plant:

1. persons working in the unclean sector do not enter the clean sector without first changing their work clothes and shoes or without having disinfected them
2. equipment and machinery are not moved from the unclean to the clean sector without first being cleaned and disinfected; and
3. the operator has established a procedure relating to the movements of persons in order to monitor their movements and describe the correct use of footbaths and wheel baths

15. Yes No

Cleaning procedures are established and documented for all parts of the premises. Suitable equipment and cleaning agents are provided for cleaning.

16. Yes No

Processing plants processing Category 3 material have in place an installation to check the presence of foreign bodies, such as packaging material or metallic pieces, in the animal by-products or derived products, if they are processing materials which are destined for feeding. Such foreign bodies are removed before or during processing.

17. Yes No

Accurately calibrated gauges/recorders are used to monitor continuously the processing conditions. Records are kept to show the date of calibration of gauges/recorders.

18. Yes No

Material that has not received the specified heat treatment, such as material discharged at start up or leakage from cookers, is recirculated through the heat treatment or collected and reprocessed or disposed of.

19. Yes No

Category 1 and Category 2 materials are processed in accordance with processing methods 1, 2, 3, 4 or 5 as referred to in Chapter III of Annex IV of Regulation (EU) n^o 142/2011.

20. Yes No

Category 3 material is processed in accordance with any of the processing methods 1 to 5 or processing method 7, or, in the case of material originating from aquatic animals, with any of the processing methods 1 to 7, as referred to in Chapter III of Annex IV of Regulation (EU) n^o 142/2011.

21. Yes No

The critical control points that determine the extent of the heat treatments applied in processing include, for the processing method as specified in Chapter III of Annex IV of Regulation (EC) n^o 142/2011, the following:

1. raw material particle size
2. temperature achieved in the heat treatment process
3. pressure, if applied to the raw material; and
4. duration of the heat treatment process or feed rate to a continuous system. Minimum processing standards are specified for each applicable critical control point

22. Yes No

Records shall be maintained for at least two years to show that the minimum process values for each critical control point are applied.

23. Yes No

The gelatin is produced in accordance with Annex III, Section XIV, of Regulation (EU) N^o 853/2004, or is produced by a process that is ensuring that unprocessed Category 3 material is subjected to a treatment with acid or alkali, followed by one or more rinses, involving pH adjustment, extraction by heating one or several times in succession, followed by purification by means of filtration and sterilization, in order to kill pathogenic agents.

24. Yes No

The collagen is produced in accordance with Annex III, Section XV, of Regulation (EU) N^o 853/2004, or is produced by a process that is ensuring that unprocessed Category 3 material is subjected to a treatment involving washing, pH adjustment using acid or alkali followed by one or more rinses, filtration and extrusion, in order to kill pathogenic agents.

25. Yes No

Document retention: 2 years

Checklist for collection and transport

Identification

1. Yes No

All necessary measures are taken to ensure that consignments of animal by-products and derived products are identifiable and kept separate and identifiable during collection where the animal by-products originate and during transportation.

2. Yes No

During transport and storage, a label attached to the container or vehicle clearly indicates the category of the animal by-products or of the derived products.

Vehicles and containers

1. Yes No

Animal by-products and processed products are collected and transported in sealed new packaging or covered leak-proof containers or vehicles.

2. Yes No

Vehicles and reusable containers, and all reusable items of equipment or appliances that come into contact with animal by-products or processed products are:

1. cleaned and dried before use; and
2. cleaned, washed, and/or disinfected after each use to the extent necessary to avoid cross-contamination

3. Yes No

Reusable containers must be dedicated to the carriage of Category 3 material or derived products to the extent necessary to avoid cross-contamination.

Temperature conditions

1. Yes No

The transport of animal by-products destined for the production of feed material takes place at an appropriate temperature, in the case of animal by-products from meat and meat products which have been destined for purposes other than human consumption, at a maximum of 7°C, in order to avoid any risk to public or animal health.

2. Yes No

Unprocessed Category 3 material destined for the production of feed material or pet food are stored and transported chilled, frozen or ensiled, unless:

1. it is processed within 24 hours after collection or after the end of storage in chilled or frozen form, if the subsequent transport takes place in means of transport in which the storage temperature is maintained; and

3. Yes No

The design of vehicles used for refrigerated transport ensures the maintenance of an appropriate temperature throughout transport, and allows that temperature to be monitored.

Traceability and records

1. Yes No

Operators consigning, transporting or receiving animal by-products or derived products keep a record of consignments and related commercial documents or sanitary certificates.

2. Yes No

The operators referred to in point 1 have in place systems and procedures to identify:

1. the other operators to which their animal by-products or derived products have been supplied; and
2. the operators from whom they have been supplied

This information is available to the competent authorities upon request.

Checklist for self-inspection plan

1. Yes No

Did the plant show you a written "Self Inspection" program that meets the requirements outlined in section IV.g of this document (Appendix D)?

2. Yes No

Has the facility established Critical Control Points (CCPs) for each of the critical limits noted in section IV of this document (for the appropriate processing method)?

3. Yes No

Is the plant maintaining records for two years (or since the beginning of the CCP implementation if less than two years)?

4. Yes No

An effectiveness check is performed after the processing of the raw material.

5. Yes No

Does the plant have in place a written plan of action to implement if one of the critical limits is not reached during the processing of the product, and does this plan specify that the CFIA will be contacted if the product is produced without meeting the critical limit?

Signature of Veterinarian

Inspection date

Name of Veterinarian (printed)

Appendix D: Own checks and Hazard Analysis and Critical Control Points

1. Yes No

Operators ensure that no animal by-products or derived products suspected or discovered not to comply with Regulation (EC) n^o 1069/2009 are exported to the EU.

Hazard Analysis and Critical Control Points

1. Yes No

Operators carrying out one of the following activities put in place and maintain a permanent written procedure or procedures based on the Hazard Analysis and Critical Control Points (HACCP) principles for the:

processing of animal by-products

transformation of animal by-products into biogas and compost; and

handling and storage of more than one category of animal by-products or derived products in the same establishment or plant

2. Yes No

Operators as specified in point 1 act as follows:

identify any hazards that must be prevented, eliminated or reduced to acceptable levels

identify the critical control points at the step or steps at which control is essential to prevent or eliminate a hazard or reduce it to acceptable levels

establish critical limits at critical control points which separate acceptability from unacceptability, for the prevention, elimination or reduction of identified hazards

establish critical limits at critical control points which separate acceptability from unacceptability, for the prevention, elimination or reduction of identified hazards

establish corrective action when monitoring indicates that a critical control point is not under control

establish procedures to verify that the measures outlined in the points above are complete and working effectively, and that these verification procedures are carried out regularly; and

establish documents and records commensurate with the nature and size of the business to demonstrate the effective application of the measures set out in the above-mentioned points

3. Yes No

When any modification is made to a product, process or any stage of production, processing, storage or distribution, operators immediately notify the CFIA, review their procedures and make the necessary changes.

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