Registration or Approval of Facilities to Export Blood and Blood Products Not Intended for Human Consumption for Use Outside the Feed Chain to the European Union

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TAHD-DSAT-IE-2004-5-6
March 2013

Amendment: This directive has been extensively revised according to the European Parliament and the Council of the European Union's new Animal By-Product (ABP) Regulations (EC) No. 1069/2009 and (EU) No. 142/2011 replacing Regulation (EC) No. 1774/2002. It completely replaces any previous versions.

I. Purpose

The purpose of this document is to:

  • explain the European Union (EU) import requirements for Canadian blood products to be used outside the feed chain. The document concerns the following products:
    • blood and blood products of equidae to be used outside the feed chain,
    • untreated blood products, excluding equidae, for the manufacture of derived products for purposes outside the feed chain for farmed animals, and
    • treated blood products, excluding equidae, for the manufacture of derived products for purposes outside the feed chain for farmed animals; and
  • standardize Canadian Food Inspection Agency (CFIA) field inspections of processing facilities for these products.

This document does not cover:

  • blood products for use as raw material for the manufacturing of animal feed for farmed animals (Refer to Directive TAHD-DSAT-IE-2010-4-2.);
  • blood from animals used for experimental and other scientific purposes;
  • facilities approved by the Canadian Centre for Veterinary Biologics; and
  • products exported in final packaged form (materials ready for distribution to the end user are exempt from Regulation (EU) No. 1069-2009 and No. 142/2011).

II. Background

See Directive TAHD-DSAT-IE-2009-8-2.

Regulation (EU) No. 142/2011 establishes the requirements for the importation of animal by-products not intended for human consumption into the EU.

These requirements are set in the following:

  • Annex XIII, Chapter IV and Annex XIV, Chapter II, Section 3 of Regulation (EU) No. 142/2011 for the blood and blood products of equidae to be used outside the feed chain; and
  • Annex XIV, Chapter II, Section 2 of of Regulation (EU) No. 142/2011 for treated and untreated blood and blood products, excluding equidae, for purposes outside the feed chain for farmed animals.

III. Definitions

See “Definitions” in Directive TAHD-DSAT-IE-2009-8-2.

Blood: Fresh whole blood.

Blood products: This term applies to products derived from blood or fractions of blood, excluding blood meal; they include dried, frozen, and liquid plasma; dried whole blood; and dried, frozen, and liquid red cells or fractions thereof, and mixtures.

IV. Import Requirements for Blood and Blood Products to be used Outside the Feed Chain

IV.a Equidae (Chapter 4[A])

1. The placing on the market of blood and blood products from equidae for purposes, other than in feed, shall be subject to the following conditions:

(a) from equidae which

  1. at inspection on the date of blood collection do not show clinical signs of any of the following reportable diseases: dourine, glanders, equine encephalomyelitis (all forms, including Venezuelan equine encephalomyelitis [VEE]), infectious equine anemia, anthrax, African horse sickness, and vesicular stomatitis (Annex I to Directive 2009/156/EC), as well as equine influenza, equine piroplasmosis, equine rhinopneumonitis, and equine viral arteritis, listed in point 4 of Article 1.2.3. of the World Organisation for Animal Health's (OIE) Terrestrial Animal Health Code 2010;
  2. have been kept for a period of at least 30 days prior to the date of, and during, blood collection on holdings under veterinary supervision which were not subject to a prohibition order or restrictions;
  3. for the following periods (laid down in Article 4[5] of Directive 2009/156/EC), had no contact with equidae from holdings which were subject to a prohibition order for animal health reasons:
    • six months in the case of glanders (Burkholderia mallei), equine encephalomyelitis of any type, including VEE, and beginning on the date on which the equidae infected with the disease are slaughtered,
    • in the case of equine infectious anemia, until the date on which the infected animals having been slaughtered, and the remaining animals have shown a negative reaction to two Coggins tests carried out three months apart,
    • six months from the date of the last recorded case of vesicular stomatitis,
    • one month from the date of the last recorded case of rabies, and
    • during 15 days from the date of the last recorded case of anthrax;
  4. for a period of at least 40 days prior to the date of, and during, blood collection, and had no contact with equidae from a Member State or third country not considered free of African horse sickness.

(b) blood must be collected under veterinary supervision either:

  1. in slaughterhouses registered or approved in accordance with Regulation (EU) No. 853/2004; or
  2. in slaughterhouses approved and supervised by the competent authority of the third country; or
  3. in facilities approved, furnished with a veterinary approval number, and supervised by the competent authority for the purpose of collecting blood from equidae for the production of blood products for purposes other than feeding.

2. Blood products may be placed on the market for such purposes provided that:

(a) all precautions have been taken to avoid contamination of the blood products with pathogenic agents during production, handling, and packaging;

(b) the blood products have been produced from blood that

  1. either fulfills the conditions set out in point 1(a), and that has been produced from blood collected from equidae which have been kept for a period of at least three months, or since birth if less than three months old, prior to the date of collection on holdings under veterinary supervision in the country of collection which during that period and the period of blood collection has been free of
    • African horse sickness for two years;
    • Venezuelan equine encephalomyelitis (VEE) for a period of at least two years; and
    • glanders;
      1. for a period of three years; or
      2. for a period of six months in which the animals have passed the post-mortem inspection for glanders in the slaughterhouse referred to in 1(a), including a careful examination of mucous membranes from the trachea, larynx, nasal cavities, and sinuses, and their ramifications, after splitting the head in the median plane and excising the nasal septum;

(c) in the case of blood products, other than serum, vesicular stomatitis for six months, or

  1. has been subjected to at least one of the following treatments, followed by an effectiveness check, for the inactivation of possible causative pathogens for African horse sickness, equine encephalomyelitis of all types, including VEE, equine infectious anemia, vesicular stomatitis, and glanders (Burkholderia mallei):
    • heat treatment at a temperature of 65°C for at least 3 hours, or
    • irradiation at 25 kGy by gamma rays, or
    • change in pH to pH 5 for 2 hours, or
    • heat treatment of at least 80°C throughout their substance.

3. Blood and blood products from equidae must be packed in sealed impermeable containers which, in the case of blood from equidae, bear the approval number of the slaughterhouse or facilities of collection referred to in point 1(b).

IV.b Species other than equidae (Chapter 4(C) and 4(D)).

The following requirements shall apply to the import of blood and blood products, excluding those from equidae, for the manufacture of derived products for uses outside the feed chain for farmed animals:

  • The blood products must originate from a plant for the production of derived products for uses outside the feed chain for farmed animals that meets the specific conditions laid down in this Regulation or from the establishment of collection.
  • The blood from which blood products for the manufacture of derived products for uses outside the feed chain for farmed animals are produced must have been collected:
    • in slaughterhouses, approved in accordance with Union legislation;
    • in slaughterhouses approved and supervised by the competent authority of the third country; or
    • from live animals in facilities approved and supervised by the competent authority of the third country.

1. Blood products from ruminants (bovidae, camelidae, and cervidae)

For blood products for the manufacture of derived products for uses outside the feed chain for farmed animals that have been derived from animals belonging to the taxa Artiodactyla, Perissodactyla, and Proboscidea, including their crossbreeds, they must comply with the following conditions:

(a) the products must have undergone one of the following treatments, guaranteeing the absence of pathogens of the diseases referred to in point (b):

  1. heat treatment at a temperature of 65°C for at least 3 hours, followed by an effectiveness checkFootnote *;
  2. irradiation at 25 kGy by gamma rays, followed by an effectiveness checkFootnote *;
  3. heat treatment of at least 80°C throughout their substance, followed by an effectiveness checkFootnote *;
  4. for animals, other than Suidae and Tayassuidae only: change in pH to pH 5 for 2 hours, followed by an effectiveness checkFootnote *;

Or

(b) in the case of blood products not treated in accordance with point (a), the products must originate from a third country or region:

  1. where no case of rinderpest, peste des petits ruminants, and Rift Valley fever has been recorded for a period of at least 12 months and in which vaccination has not been carried out against those diseases for a period of at least 12 months;
  2. where no case of foot-and-mouth disease has been recorded for a period of at least 12 months; and
    • in which vaccination has not been carried out against this disease for a period of at least 12 months, or
    • in which vaccination programs against foot-and-mouth disease are being officially carried out and controlled in domestic ruminant animals for a period of at least 12 months; in this case, following the veterinary checks provided for in Directive 97/78/EC, and in accordance with the conditions laid down in Article 8(4) of that Directive, the products must be transported directly to the registered establishment or plant of destination, and all precautions, including safe disposal of waste, unused or surplus material, must be taken to avoid risks of spreading diseases to animals or humans.

In addition to points IV.b 1.(b)(i) and IV.b 1.(b)(ii) cited above, in the case of animals, other than Suidae and Tayassuidae, there must be compliance with one of the following conditions:

(c) in the third country or region of origin, no case of vesicular stomatitis and bluetongue (including the presence of seropositive animals) has been recorded for a period of at least 12 months and vaccination has not been carried out against those diseases for a period of at least 12 months in the susceptible species;

Or

(d) following the veterinary checks provided for in Directive 97/78/EC, and in accordance with the conditions laid down in Article 8(4) of that Directive, the products must be transported directly to the plant of destination, and all precautions, including safe disposal of waste, unused or surplus material, must be taken to avoid risks of spreading diseases to animals or humans.

2. Blood products of porcine origin

In addition to points IV.b 1.(b)(i) and IV.b 1.(b)(ii), in the case of Suidae and Tayassuidae, in the third country or region of origin, no case of swine vesicular disease, classical swine fever, and African swine fever has been recorded for a period of at least 12 months; vaccination has not been carried out against those diseases for a period of at least 12 months, and there is compliance with one of the following conditions:

(a) in the country or region of origin, no case of vesicular stomatitis (including the presence of seropositive animals) has been recorded for a period of 12 months and vaccination has not been carried out against this disease for a period of at least 12 months in the susceptible species;

Or

(b) following the veterinary checks, the products must be transported directly to the registered establishment or plant of destination, and all precautions, including safe disposal of waste, unused or surplus material, must be taken to avoid risks of spreading diseases to animals or humans.

3. Blood products of avian origin

Blood products for the manufacture of derived products for uses outside the feed chain for farmed animals which have been derived from poultry and other avian species must comply with the following conditions:

(a) the products must have undergone one of the following treatments, guaranteeing the absence of pathogens of the diseases referred to in point (b):

  1. heat treatment at a temperature of 65°C for at least 3 hours, followed by an effectiveness checkFootnote *;
  2. irradiation at 25 kGy by gamma rays, followed by an effectiveness checkFootnote *; or
  3. heat treatment of at least 70°C throughout their substance, followed by an effectiveness checkFootnote *;

Or

(b) Blood products not treated in accordance with point (a) must originate from a third country or region

  1. which has been free from Newcastle disease and highly pathogenic avian influenza;
  2. which during the last 12 months has not carried out vaccination against avian influenza;
  3. where the poultry or other avian species from which the products derive have not been vaccinated against Newcastle disease, with vaccines prepared from a Newcastle disease master strain showing a higher pathogenicity than that in lentogenic virus strains.

For suppliers, other than approved slaughterhouses, district offices should ensure that all suppliers have been granted approval by the CFIA and are included in the list of approved facilities.

For facilities using imported materials, an import document must show the origin of the products and must provide all warranties with respect to the import conditions mentioned in point IV of this document. It must also indicate the address and approval number of slaughterhouses or technical plants where the materials originate from; if this information is unavailable, the blood products must be treated according to section 4.B.1.a of this directive.

* The effectiveness check should guarantee the absence of the diseases mentioned in IV.a and IV.b.

Note: The EU does not have in place a mechanism where producing companies can request special approval of other treatment processes.

V. Export Certification of Blood and Blood Products for purposes outside the feed chain for farmed animals, to the European Union

Prior to endorsing export certificates to the EU, district offices should ensure that:

  • the products originate from processing facilities that have been granted approval by the CFIA and are included in the list of facilities approved for export to the EU; and
  • they have been provided with the traceability certificate (This document is intended for internal use. CFIA staff can access this document using RDIMS number 1406482) that corresponds to the products for export and is signed by the appropriate veterinarian of the abattoirs.

For products that are being exported to the EU and that have been legally imported into Canada, district offices should ensure that

  • the products originate from processing facilities that have been granted approval by the competent authority or the country of origin and are included in the list of facilities approved for export to the EU; and
  • they have been provided with the sanitary certificate, issued by the competent authority of the country of origin of the products.

VI. Plant approval for export to the European Union

Refer to Directive TAHD-DSAT-IE-2009-8-2.

VI.a General Hygiene Requirements for the Approval of Category 3 Intermediate Plants

Refer to Directive TAHD-DSAT-IE-2009-8-2 IV.a.

VI.b General Hygiene Requirements for the Approval of Category 3 Storage Plants

Refer to Directive TAHD-DSAT-IE-2009-8-2 IV.b.

VI.c General Hygiene Requirements for the Approval of Category 3 Processing Plants

Refer to Directive TAHD-DSAT-IE-2009-8-2 IV.c abd IV.d.

VI.d Supervision of Production

Refer to Directive TAHD-DSAT-IE-2009-8-2 IV.e.

VI.e Validation Procedures

Refer to Directive TAHD-DSAT-IE-2009-8-2 IV.f.

VI.f Self-Inspection and Hazard Analysis and Critical Control Points

For the processing plants, the EU legislation requires that a self-inspection program, similar to the Hazard Analysis and Critical Control Point (HACCP) be in place.

Refer to Directive TAHD-DSAT-IE-2009-8-2 IV.g.

Required CCPs and Critical Limits for Plants Processing Treated Blood or Treated Blood Fractions
Processing method Footnote *
(one of the following)
Critical Control Points Critical Limits
Heat to 65°C for 3 hoursFootnote 1& Footnote 3 Minimum temperature, AND 65°C
Minimum time at minimum temperature 3 hours
IrradiationFootnote 1& Footnote 3 Minimum irradiation 25 kGy by gamma rays
pH alteringFootnote 1 pH value AND 5
Minimum time at pH 5.0 2 hours
Heat to 80°CFootnote 1& Footnote 2 Minimum internal temperature 80°C
Heat to 70°CFootnote 3 Minimum internal temperature 70°C

VII Plant Registration

Refer to Directive TAHD-DSAT-IE-2009-8-2 VI.

VIII Plant Approval

Refer to Directive TAHD-DSAT-IE-2009-8-2 VII.a.

IX Official Control

Refer to Directive TAHD-DSAT-IE-2009-8-2 VII.b.

X Hygiene Requirements for Collecting and Transporting Animal By-products and Processed Products

Refer to Directive TAHD-DSAT-IE-2009-8-2 V.

XI Pre-Inspection Procedures

Refer to Directive TAHD-DSAT-IE-2009-8-2 VIII.

XII Notarized Form for Approved Suppliers of Blood and Blood Products

The facility must provide a notarized form, declaring that the facility only receives materials of category 3 (Intended for internal use. CFIA staff can access this document using RDIMS number 2096149: Certificate of Traceability of Blood Products), either from approved slaughter facilities or blood-processing facilities that CFIA has approved as meeting the requirements of Regulation (EU) No. 142/2011. The forms must identify the supplying facilities. Appendix A includes this form.

XIII Notarized Processing Method Form for Blood-Processing Facilities

The form (Appendix B) also requires the facility to certify that it has a self-inspection program in place with the required critical limits.

XIV Inspection Procedures

Prior to arriving at the plant for the inspection, the inspector should review the forms already sent to the district office and the inspection checklist.

The inspection should begin in the plant management office. The required forms and the plant “self-inspection” program should be reviewed with plant management at this time.

The inspector may then wish to go over the checklist, included in this document as Appendix C (CFIA Plant Inspection Checklist for Approval of Facilities to Export Blood and Blood Products outside the feed chain for farmed animals to the European Union) with a plant tour guide to establish all questions that should be addressed during the tour. The guide should then take the inspector through the facility, addressing each item on the checklist. At the end of the tour, the inspector should ask the guide to return to any areas that require revisiting or to show the evidence for any unanswered questions.

During the inspection, inspectors should keep in mind the information they have reviewed in the supplied notarized forms and the self-inspection plan, and diligently observe for any indications of inaccuracies.

XV Billing for Inspections

Refer to Directive TAHD-DSAT-IE-2009-8-2 X.

XVI Completing Inspection Reports

Refer to Directive TAHD-DSAT-IE-2009-8-2 XI.

XVII Approval Numbers

Refer to Directive TAHD-DSAT-IE-2009-8-2 XII.

XVIII Facility Name or Address Changes

Refer to Directive TAHD-DSAT-IE-2009-8-2 XIII.

Appendix A - Notarized Form for Approved Suppliers of Blood and Blood Products

This serves to inform officials of the Canadian Food Inspection Agency (CFIA) that (complete name and address of facility)

receives for eventual export to the EU or for transit through the EU:

  • Check blood collected under the supervision of a veterinarian, from equidae, which on inspection at the time of collection, were free from clinical signs of infectious disease;
  • Check blood of slaughtered animals, which is fit for human consumption in accordance with Union legislation, but is not intended for human consumption for commercial reasons;
  • Check blood of slaughtered animals, which is rejected as unfit for human consumption in accordance with Union legislation, but which did not show any signs of diseases communicable to humans or animals, derived from carcasses that have been slaughtered in a slaughterhouse and were considered fit for human consumption following an ante-mortem inspection in accordance with Union legislation;
  • Check blood of slaughtered animals, which did not show any signs of diseases communicable to humans or animals, obtained from animals, other than ruminants, that have been slaughtered in a slaughterhouse after having been considered fit for human consumption, following an ante-mortem inspection in accordance with Union legislation;
  • Check blood and blood products derived from the production of products intended for human consumption
  • Check blood and blood products originating from live animals that did not show signs of any disease communicable through those products to humans or animals;
  • Check material from animals that have been treated with certain substances which are prohibited pursuant to Directive 96/22/EC, the import of the material being permitted in accordance with Article 35(a) (ii) of Regulation (EC) No. 1069/2009;

from the following species:

Facility name and address City, province, country CFIA approval number

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

Signed by:

space

Date:

space

Position:

space

Company name:

space

Notary signature:

space

Date:

space

Appendix B - Notarized Processing Method Form for Blood-Processing Facilities

This serves to inform officials of the Canadian Food Inspection Agency (CFIA) that (complete name and address of facility):

processes equine, ruminant, avian, or porcine blood, or blood products, using the following processing method according to the parameters noted below (check appropriate selection), and has in place a self-inspection program with the critical limits referenced.

Required Critical Control Points and Critical Limits for Plants
Processing Treated Blood or Treated Blood Fractions
Processing methodFootnote * (one of the following) Critical Control Points Critical Limits
checkboxHeat to 65°C for 3 hours Footnote 1&Footnote 2&Footnote 3 Minimum temperature, AND 65°C
Minimum time at minimum temperature 3 hours
checkboxIrradiation Footnote 1&Footnote 2&Footnote 3 Irradiation minimale 25 kGy by gamma rays
checkboxModification du pH Footnote 1 Valeur de pH, ET 5
Durée minimale à un pH de 5,0 2 hours
checkboxHeat to 80°C Footnote 1&Footnote 2 Minimum internal temperature 80°C
checkboxHeat to 70°C Footnote 2 Minimum internal temperature 70°C
checkboxUntreated

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

Signed by:

space

Date:

space

Position:

space

Company name:

space

Notary signature:

space

Date:

space

Appendix C - Canadian Food Inspection Agency Plant Inspection Checklist for Approval of Facilities to Export Blood and Blood Products for use outside the feed chain of farmed animals) to the European Union

1. Canadian Food Inspection Agency (CFIA) Approval Number: (Leave blank for newly inspected facilities.)

2. Plant/company name:

3. Address of location being inspected:

4. Address of headquarters if different:

5. Name of contact person at plant:

Telephone:

space

Facsimile:

space

6. List blood products produced at this plant for export to the EU:

7. Comments:

8. Recommendation for approval to export to the EU (Check all that apply.):
Equine blood products and derivatives checkbox Yes checkbox No
Ruminant blood products and derivatives checkbox Yes checkbox No
Avian blood products and derivatives checkbox Yes checkbox No
Porcine blood products and derivatives checkbox Yes checkbox No
Other checkbox Yes checkbox No
Approval Recommended: checkbox Yes checkbox No

Name of inspector (printed)

space

Signature of Inspector
space

Inspection Date
space

Signature of Area Export Specialist approving the recommendation
space

Date:

space

9. Approval valid until (date):

space

Please forward a copy of the completed form and all required notarized forms to the CFIA Area Export Specialist.

Note: To maintain approval, facilities must be inspected at least once every 12 months.

Preamble
1. Has the plant provided you with a current Notarized Form for Approval Suppliers of Blood and Blood Products (Appendix A)?
(Please attach to this checklist, and forward to the Area Export Specialist.)
checkbox Yes checkbox No
2. Has the plant provided you with a current Notarized Processing Method Form for Animal By-Products Processing Facilities (Appendix B)?
(Please attach to this checklist, and forward to the Area Export Specialist.)
checkbox Yes checkbox No
Checklist for Intermediate Plants
1. The premises are adequately separated from other premises, such as slaughterhouses. checkbox Yes checkbox No
2. The layout of plants ensures the total separation of Category 1 and 2 materials from Category 3 material, from reception until dispatch. checkbox Yes checkbox No
3. 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. checkbox Yes checkbox No
4. 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. checkbox Yes checkbox no
5. The plant has adequate lavatories, change rooms, and wash basins for staff. checkbox Yes checkbox no
6. The plant has appropriate arrangements for protection against pests, such as insects, rodents, and birds. checkbox yes checkbox No
7. Where it is necessary for the purpose of achieving the objectives of Regulation (EU) No. 142/2011, 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. checkbox Yes checkbox No
8. 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. checkbox Yes checkbox No
9. The sorting of materials shall be carried out in such a way that avoids any risk of the propagation of animal diseases. checkbox Yes checkbox no
10. 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. checkbox Yes checkbox No
11. Category 3 material is stored properly, including under appropriate temperature conditions, until re-dispatched. checkbox Yes checkbox no
Checklist for Storage Plants
1. Premises and facilities storing derived products from Category 3 material must not be at the same site as premises that store 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. checkbox Yes checkbox No
2. The plant must have a covered space to receive and dispatch the derived products, unless the derived products are:
(i) being discharged through installations that prevent the spreading of risks to public and animal health, such as through closed tubes for liquid products; or
(ii) received in packaging, such as in tote bags, or in covered leak-proof containers or means of transport.
checkbox Yes checkbox No
3. 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. checkbox Yes checkbox No
4. The plant has adequate lavatories, change rooms, and wash basins for staff. checkbox Yes checkbox No
5. The plant has appropriate arrangements for protection against pests, such as insects, rodents, and birds. checkbox Yes checkbox No
6. 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. checkbox Yes checkbox No
7. Derived products are stored properly until re-dispatched. checkbox Yes checkbox No
Checklist for Processing Plants
1. The processing plant is not situated on the same site as slaughterhouses or other establishments that have been approved or registered in accordance with Regulation (EC) No. 852/2004 or Regulation (EC) No. 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 or a room that is completely separated from the slaughterhouse or other establishment.
  2. The following is installed and operated in the processing plant:
    • Check a conveyer system which links the processing plant to the slaughterhouse or other establishment and which may not be bypassed; and
    • Check 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. Unauthorized persons and animals have no 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) No. 852/2004 or Regulation (EC) No. 853/2004.
checkbox Yes checkbox No
2. The processing plant has a clean and unclean sector, 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. checkbox Yes checkbox No
3. The processing plant has adequate lavatories, change rooms, and wash basins for staff. checkbox Yes checkbox No
4. The processing plant has sufficient production capacity for hot water and steam for the processing of animal by-products. checkbox Yes checkboxNo
5. 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. checkbox Yes checkbox No
6. Where heat treatment is required, all installations are equipped with the following:
  1. measuring equipment to monitor temperature against time and – if applicable, for the processing method used – pressure at critical points;
  2. recording devices to permanently record the results of these measurements in a way that retains accessibility for the purpose of checks and official controls; and
  3. an adequate safety system to prevent insufficient heating.
checkbox Yes checkbox No
7. To prevent recontamination of the derived product by introducing 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. checkbox Yes checkbox No
8. 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. checkbox Yes checkbox No
9. Adequate facilities are provided for disinfecting vehicle wheels, when departing the unclean sector of the processing plant. checkbox Yes checkbox No
10. The processing plant has a waste-water disposal system that meets the competent authority's requirements. checkbox Yes checkbox No
11. Preventative measures against birds, rodents, insects, or other vermin are taken systematically. A documented pest control program is used for that purpose. checkbox Yes checkbox No
12. Animal by-products are processed as quickly as possible. After processing, derived products are handled and stored in a way that avoids risks of contamination. checkbox Yes checkbox No
13. 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 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. checkbox Yes checkbox No
14. Any person who works 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 who work in the unclean sector do not enter the clean sector without first changing or disinfecting their work clothes and shoes;
  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.
checkbox Yes checkbox No
15. Cleaning procedures are established and documented for all parts of the premises. Suitable equipment and cleaning agents are provided for cleaning. checkbox Yes checkbox No
16. Records shall be maintained for at least two years to show that the minimum process values for each critical control point (CCP) are applied. checkbox Yes checkbox No
Checklist for Collection and Transport
Identification
1. 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. checkbox Yes checkbox No
2. 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. checkbox Yes checkbox No
Vehicles and Containers
1. Animal by-products and processed products are collected and transported in sealed new packaging or covered leak-proof containers or vehicles. checkbox Yes checkbox No
2. 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.
checkbox Yes checkbox No
3. Reusable containers are dedicated to the carriage of Category 3 material or derived product to the extent necessary to avoid cross-contamination. checkbox Yes checkbox No
Temperature Conditions
1. The design of vehicles used for refrigerated transport ensures the maintenance of an appropriate temperature throughout transport, and allows for temperature to be monitored. checkbox Yes checkbox No
Traceability and Records
1. Operators consigning, transporting, or receiving animal by-products or derived products keep a record of consignments and related commercial documents or sanitary certificates. checkbox Yes checkbox No
2. The operators referred to in point 1 have systems and procedures in place 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.
checkbox Yes checkbox No
Checklist for Self-Inspection Plants
1. Did the plant show you a written “Self Inspection” program that meets the requirements outlined in Appendix D? checkbox Yes checkbox No
2. Has the facility established CCPs for each of the critical limits noted at point 6.f of this document (main) for the appropriate processing method? checkbox yes checkbox No
3. Is the plant maintaining records for two years (or since the beginning of the CCP implementation if less than two years)? checkbox Yes checkbox No
4. An effectiveness check is performed after the processing of the raw material. checkbox Yes checkbox No
5. Does the plant have in place a written plan of action to implement if one of the critical limits is not reached during the treatment of the product, if applicable, and does this plan specify that the CFIA will be contacted if the product is produced without meeting the critical limit? checkbox Yes checkbox No

Signature of Inspector:

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Inspection date:

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Name of Inspector (printed):

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Appendix D: Self inspection and Hazard Analysis and Critical Control Points

1. Operators ensure that no animal by-products or derived products that are suspected or discovered not to comply with Regulation (EC) No. 1069/2009 are exported to the EU. checkbox Yes checkbox No
Hazard Analysis and Critical Control Points
1. 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:
  • Check processing of animal by-products;
  • Check transformation of animal by-products into biogas and compost; and
  • Check handling and storage of more than one category of animal by-product or derived products in the same establishment or plant.
checkbox Yes checkbox No
2. Operators as specified in point 1 act as follows
  • Check identify any hazards that must be prevented, eliminated, or reduced to acceptable levels;
  • Check identify the CCPs 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 CCPs that separate acceptability from unacceptability for the prevention, elimination, or reduction of identified hazards;
  • Check establish and implement effective monitoring procedures at CCPs;
  • Check establish corrective action when monitoring indicates that a CCP is not under control;
  • Check 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
  • Check 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.
checkbox Yes checkbox No
3. 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 checkbox Yes checkbox No

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