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

This page is part of the Guidance Document Repository (GDR).

Looking for related documents?
Search for related documents in the Guidance Document Repository

TAHD-DSAT-IE-2004-5-8
Avril 2021

Amendment: following the implementation of the new generic checklist and its annexes A to G, annexes A, B, C and D of this directive have been withdrawn.

Purpose
Background
Definitions
Import requirements for blood and blood products to be used outside the feed chain
Export certification of blood and blood products for purposes outside the feed chain for farmed animals, to the European Union
Plant approval for export to the European Union
Plant registration
Plant approval
Official control
Hygiene requirements for collecting and transporting animal by-products and processed products
Pre-inspection procedures
Inspection procedures
Billing for inspections
Completing inspection reports
Approval numbers
Facility name or address changes

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.)
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-2010-4.

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 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.

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

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 (WOAH; founded as Office International des Épizooties (OIE)) Terrestrial Animal Health Code 2010
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
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:
- 6 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 2 Coggins tests carried out 3 months apart
- 6 months from the date of the last recorded case of vesicular stomatitis
- 1 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
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:

in slaughterhouses registered or approved in accordance with regulation (EU) No. 853/2004; or
in slaughterhouses approved and supervised by the competent authority of the third country; or
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

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 3 months, or since birth if less than 3 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 2 years
- Venezuelan equine encephalomyelitis (VEE) for a period of at least two years; and
- glanders
  1. for a period of 3 years; or
  2. for a period of 6 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

has been subjected to at least 1 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 1 of the following treatments, guaranteeing the absence of pathogens of the diseases referred to in point (b):

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

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

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
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 1 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

(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 1 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

(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 1 of the following treatments, guaranteeing the absence of pathogens of the diseases referred to in point (b):

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

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

which has been free from Newcastle disease and highly pathogenic avian influenza
which during the last 12 months has not carried out vaccination against avian influenza
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.

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.

VI.a General hygiene requirements for the approval of category 3 intermediate plants

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

VI.b General hygiene requirements for the approval of category 3 storage plants

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

VI.c General hygiene requirements for the approval of category 3 processing plants

Refer to directive TAHD-DSAT-IE-2009-8 IV.c and IV.d.

VI.d Supervision of production

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

VI.e Validation procedures

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

**Required Critical Control Points and critical limits for plants processing treated blood or treated blood fractions**
Processing method required^{Table Note a}	Critical Control Points	Critical limits
Heat to 65°C for 3 hours^{Table Note b}, ^{Table Note c}, ^{Table Note d}	Minimum temperature, and	65°C
	Minimum time at minimum temperature	3 hours
Irradiation^{Table Note b}, ^{Table Note c}, ^{Table Note d}	Minimum irradiation	25 kGy by gamma rays
pH altering^{Table Note b}	pH value and	5
	Minimum time at pH 5.0	2 hours
Heat to 80°C^{Table Note b}, ^{Table Note c}	Minimum internal temperature	80°C
Heat to 70°C^{Table Note d}	Minimum internal temperature	70°C

Table Notes

Table Note a

Self-inspection program must specify that material will be safety-tested after the treatment for any disease agent of concern that was present in the regions where the source animals originated.

Return to Table Note a referrer

Table Note b

Method authorized for ruminant origin blood products

Return to Table Note b referrer

Table Note c

Method authorized for porcine origin blood products.

Return to Table Note c referrer

Table Note d

Method authorized for avian origin blood products.

Return to Table Note d referrer

VII. Plant registration

Refer to directive TAHD-DSAT-IE-2009-8 VI.

VIII. Plant approval

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

IX. Official control

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

X. Hygiene requirements for collecting and transporting animal by-products and processed products

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

XI. Pre-inspection procedures

Refer to OP-31410 Use of the inspection checklist to export animal products and by-products not intended for human consumption, including pet food, to all countries except the United States (internal access only – RDIMS 14156149)

Language selection

Search