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Approval of Facilities to Export to the European Union Canned Pet Food, Processed Pet Food Other Than Canned Pet Food, Chewing Articles, Raw Pet Food for Direct Sale or Animal By-Products to be Fed to Fur Animals, Flavouring Innards for Use in the Manufacture of Pet Food, and Animal By-Products for the Manufacture of Pet Food

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TAHD-DSAT-IE-2009-7-5

May 2021

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implementation of the new generic checklist and its annexes A to G, annexes A, B, C and D of this directive have been withdrawn.

I. Purpose

The purpose of this directive is as follows:

This directive does not cover articles for exhibition purposes: see annex XIV, chapter III, section 3 of Regulation (EC) 142/2011.

II. Context

The European Parliament and the Council of the European Union Regulation (EC) 1069/2009 lays down the health rules regarding animal by-products and derived products not intended for human consumption and repeals Regulation (EC) 1774/2002.

The European Parliament and the Council of the European Union Regulation (EC) 142/2011 is implementing European Parliament and the Council of the European Union Regulation (EC) 1069/2009 laying down health rules regarding animal by-products and derived products not intended for human consumption.

These regulations require facilities exporting animal by-products not intended for human consumption to the EU to be approved by the CFIA according to article 24 of Regulation (EC) 1069/2009. Refer to the directive TAHD-DSAT-IE-2009-8 for approval of facilities exporting pet food and by-products intended for the manufacture of pet food to the European Union.

Member States must authorize imports of the products mentioned in section I. above if those products meet the following criteria:

  1. come from third countries eligible to export such products to the EU (list available at the district offices)
  2. were obtained, prepared and stored in establishments approved by the CFIA in accordance with the present directive. District offices must ensure that all facilities (other than registered slaughter plants) through which product transits (for example intermediate establishments, storage facilities, or processing facilities) have been approved by the CFIA; in deciding whether facilities should be approved for that purpose, the CFIA must consider various factors, such as the processing methods, the existence of self-inspection programs, the materials processed, and the conditions of hygiene and storage
  3. were produced in accordance with Regulation (EC) 142/2011
  4. are accompanied as follows:
    1. for canned pet food, by a health certificate that conforms to the model set out in chapter 3(A), annex XV in the above-mentioned regulation
    2. for processed pet food, by a health certificate that conforms to the model set out in chapter 3(B), annex XV in the above-mentioned regulation;
    3. for chewing articles for pets, by a health certificate that conforms to the model set out in chapter 3(c), annex XV in the above-mentioned regulation
    4. for raw pet food for direct sale or animal by-products to be fed to fur animals, by a health certificate that conforms to the model set out in chapter 3(D), annex XV in the above-mentioned regulation
    5. for flavouring innards for use in the manufacture of pet food, by a health certificate that conforms to the model set out in chapter 3(E) of annex XV in the above-mentioned regulation
    6. for animal by-products for the manufacture of pet food, by a health certificate that conforms to the model set out in chapter 3(F) of annex XV in the above-mentioned regulation

Requirements referring to canned pet food, processed pet food, chewing articles and raw pet food (including animal by-products to be fed to fur animals) can be found in annex XIII, chapter II of the regulation. Requirements referring to flavouring innards can be found in annex XIII, chapter III of the regulation. Requirements referring to animal by-products for the manufacture of pet food can be found in annex XIII, chapter IV of the regulation.

Prior to inspection of facilities by the CFIA, owners are required to submit to the CFIA for review certain forms attesting that the plant meets the minimum requirements. Following the pre-inspection review of these forms by the district office, an inspection of the facilities is scheduled.

III. Definitions

Pets:
any animal belonging to species normally nourished and kept but not consumed, by humans for purposes other than farming.
Fur animals:
animals kept or reared for the production of fur and not used for human consumption.
Category 3 material:
refer to the directive, Definition of Categories 1, 2, and 3 Animal Products and By-Products (TAHD-DSAT-IE-2009-8) and the European Legislation (EC) 1069/2009.
Canned pet food:
heat-processed pet food contained within a hermetically sealed container.
Processed pet food:
pet food, other than raw pet food, which has been processed in accordance with point 3 of chapter II of annex XIII.
Chewing articles:
products for pet animals to chew, produced from untanned hides and skins of ungulates or from other material of animal origin.
Raw pet food or animal by-products intended for the feeding of farmed fur animals:
pet food containing certain Category 3 material which has not undergone any preserving process other than chilling or freezing.
Flavouring innards:
a liquid or dehydrated derived product of animal origin used to enhance the palatability values of pet food.
Animal by-products for the manufacture of pet food:
Category 3 material, according to article 10 a), b), e), f), i), j), k), l) and Category 1 material, according to article 8 c) of Regulation (EC) . 1069/2009. Blood, placenta, wool, feathers, hairs, horns, hooves and raw milk are excluded.
Approved facilities:

establishments that have received CFIA approval to manufacture, process and store pet food.

Refer to Directive TAHD-DSAT-IE-2009-8 for the definition of the approval and types of establishments.

Lot:
a unit of production produced in a single plant using uniform production parameters, such as the origin of the materials, or a number of such units, when produced in continuous order in a single plant and stored together as a shipping unit.

IV. Import conditions

1. Nature of products

1.1 Canned pet food (chapter 3A of regulation (EC) 142/2011)

Canned pet food must consist only of the following animal by-products: Category 3 material, according to article 10 a), b), d) (blood other than ruminant), e), f), g), h), i), j), k), l) and Category 1 material according to article 8 c) of Regulation (EC) 1069/2009. Milk and milk products of ovine or caprine origin are excluded because they do not meet European Union import requirements of chapter 3, paragraph 1 a) of Regulation (EC) 999/2001 referring to TSE (transmissible spongiform encephalopathies).

1.2 Processed pet food (chapter 3B of Regulation (EC) 142/2011)

Processed pet food must consist only of the following animal by-products: Category 3 material, according to article 10 a), b), c), d) (blood other than ruminant), e), f), g), h), i), j), k), l), m) and Category 1 material according to article 8 c) of Regulation (EC) 1069/2009. Milk and milk products of ovine or caprine origin are excluded because they do not meet European Union import requirements of chapter 3, paragraph 1 a) of Regulation (EC) 999/2001 referring to TSE (transmissible spongiform encephalopathies).

1.3 Chewing articles (chapter 3C of Regulation (EC) 142/2011)

Chewing articles must consist only of the following animal by-products: Category 3 material, according to article 10 a), b), d) (blood other than ruminant), e), j), and Category 1 material according to article 8 c) of Regulation (EC) 1069/2009. Milk and milk products of ovine or caprine origin are excluded because they do not meet European Union import requirements of chapter 3, paragraph 1 a) of Regulation (EC) 999/2001 referring to TSE (transmissible spongiform encephalopathies).

1.4 Raw pet food for direct sale or animal by-products to be fed to farmed fur animals (chapter 3D of Regulation (EC) 142/2011)

Raw pet food must consist only of the following animal by-products: Category 3 material, according to article 10 a), b i).

Animal by-products to be fed to farmed fur animals must consist only of the following animal by-products:

Category 3 material, according to article 10 a), b i), c), d) (blood other than ruminant), e), f), g), h), i), j), k), l), m) and Category 1 material according to article 8 c) of Regulation (EC) 1069/2009. Milk and milk products of ovine or caprine origin are excluded because they do not meet European Union import requirements of chapter 3, paragraph 1 a) of Regulation (EC) 999/2001 referring to TSE (transmissible spongiform encephalopathies).

1.5 Flavouring innards for use in the manufacture of pet food (chapter3E of Regulation (EC) 142/2011)

Flavouring innards for use in the manufacture of pet food must consist only of the following animal by-products: Category 3 material, according to article 10 a), b), d) (blood other than ruminant), e), f), g), i), j), k), l) and Category 1 material according to article 8 c) of Regulation (EC) 1069/2009. Milk and milk products of ovine or caprine origin are excluded because they do not meet European Union import requirements of chapter 3, paragraph 1 a) of Regulation (EC) 999/2001 referring to TSE (transmissible spongiform encephalopathies).

1.6 Animal by-products for the manufacture of pet food (chapter 3F to Regulation (EC) 142/2011)

Animal by-products the manufacture of pet food must consist only of the following animal by-products: Category 3 material, according to article 10 a), b), e), f), i), j), k), l) and Category 1 material according to article 8 c) of Regulation (EC) 1069/2009. Milk and milk products of ovine or caprine origin are excluded because they do not meet European Union import requirements of chapter 3, paragraph 1 a) of Regulation (EC) 999/2001 referring to TSE (transmissible spongiform encephalopathies).

2. European Union animal health requirements for material used in the manufacture of pet food

2.1 Origin of products

2.1.1 Canned pet food (chapter 3A of Regulation (EC) 142/2011)

No requirement referring to origin.

2.1.2 Processed pet food (chapter 3B of Regulation (EC) 142/2011)

No requirement referring to origin.

2.1.3 Chewing articles (chapter 3C of Regulation (EC) 142/2011)

No requirement referring to origin.

2.1.4 Raw pet food for direct sale or animal by-products to be fed to farmed fur animals (chapter 3D of Regulation (EC) 142/2011)

Raw pet food or animal by-products to be fed to farmed fur animals must:

  1. be derived from meat satisfying the specific requirements of annex XV, chapter 3(D), II.2 of the Regulation (EC) 142/2011: the animals from which the meat is derived come from the third countries, territories or parts thereof identified by an ISO (International Organization for Standardization) code. ISO code of Canada is CA. The third country or the part of third country must be free of foot-and-mouth disease, rinderpest, classical swine fever, African swine fever, swine vesicular disease, Newcastle disease and avian influenza for the last 12 months and were no vaccination has taken place during that time for the susceptible species. Low pathogenic avian influenza is not considered here
  2. be derived from animals that were not condemned at the ante-mortem stage, done within the 24 hours prior to slaughter, and that exhibit no signs of the diseases mentioned (IV.2.1.4.a)
  3. in the case of feed for fur animals derived from aquatic animals which satisfies the relevant animal and public health requirements, they come from a country or part of territory identified by an ISO code
2.1.5 Flavouring innards for use in the manufacture of pet food (chapter 3E of Regulation (EC) 142/2011)

No requirement referring to origin.

2.1.6 Animal by-products for the manufacture of pet food (chapter 3F of Regulation (EC) 142/2011)
  1. The by-products must originate from Canada or be legally imported
  2. Where the products have been imported, it is necessary to ensure that they meet all the specific requirements of Annex XV, Chapter 3(F) of the Regulation (EC) 142/2011. To this end, a health certificate from the exporting country confirming all the specific requirements of annex XV, chapter 3(F) of the Regulation (EC) 142/2011 must be provided to the CFIA to allow the certification of animal by-products for the manufacture of pet food for from Canada to European Union
  3. The animal by-products have been derived from the following:

    Either

    1. animals that have remained in the territory where they have been slaughtered since their birth or during at least the 3 months preceding their slaughter, and that:
      1. they come from holdings where, for the following diseases for which the animals are susceptible, there has been no case or outbreak of rinderpest, swine vesicular disease, Newcastle disease or highly pathogenic avian influenza during the prior 30 days, nor of classical or African swine fever during the prior 40 days, and there has been none in the holdings situated in their vicinity within 10km, during the prior 30 days; and
      2. they come from holdings where there has been no case or outbreak of foot-and-mouth disease during the prior 60 days, and there has been none in the holdings situated in their vicinity within 25km, during the prior 30 days; and
      3. they were not killed to eradicate any epizootic disease; and
      4. they have remained in their holdings of origin for at least 40 days before departure and have been transported directly to the slaughterhouse without contact with other animals which did not comply with the same health conditions; and
      5. at the slaughter house, they have passed the ante-mortem health inspection during the 24 hours before the slaughter and have shown no evidence of the diseases referred to in IV.2.1.6.c.i above.

        Or

    2. animals that were captured and killed in an area eligible to export game meat intended for human consumption to the EU, that were captured and killed in the wild, and
      1. for the following diseases for which the animals are susceptible, within 25 km of the area in which the animals were captured and killed, there has been no case or outbreak of foot-and-mouth disease, rinderpest, Newcastle disease, or highly pathogenic avian influenza during the prior 30 days, nor of classical or African swine fever during the prior 40 days; and
      2. the area in which they were captured and killed is situated at a distance greater than 20 km from the borders separating another territory of a country or part thereof, which is not authorized at this time for exporting this material to the European Community; and
      3. which after killing were transported within 12 hours for chilling, either to a collection center and immediately afterwards to a game establishment, or directly to a game establishment
    3. These by-products must have been obtained in an establishment around which, within a radius of 10 km, there has been no case or outbreak of diseases referred to in IV.2.1.6.c.i for which the animals are susceptible during the prior 30 days or, in the event of a case of disease, the preparation of raw material for exportation to the European Community has been authorized only after removal of all meat, and the total cleaning and disinfection of the establishment under the control of an official veterinarian

2.2 Contamination

Effective measures must be taken to ensure that all products covered by this directive are protected from contamination at all stages in the production chain and right through to the point of sale.

2.3 Processing and monitoring standards

2.3.1 Canned pet food (chapter 3A of Regulation (EC) 142/2011)

Canned pet food has been subjected to heat treatment to a minimum Fo value of 3 in hermetically sealed containers. Fo of 3 is a processing standard that specifies that the core temperature of the product has reached 121° Celsius for 3 minutes. Equivalent time/ temperature parameters are also acceptable:

Information referring to heat treatment required by chapter 3A is collected in annex B and reviewed during the inspection for the approval of the facility. Should doubts exist with regard to the protocol used to reach the required temperature, please consult the Area Approving Veterinarian.

For each exported lot, tests were conducted on 5 randomly collected samples. Manufacturers must ensure exported products were incubated at least 10 days at 37°C ± 1°C. This requirement is confirmed by exporters to the CFIA in the document "Exporter declaration".

2.3.2 Processed pet food (chapter 3B of Regulation (EC) 142/2011)

They were subjected to a heat treatment of at least 90°C throughout its substance.

If the above mentioned heat condition is met, verification of other conditions of Chapter 3B, II.3 a) to m) is not required.

If the above mentioned heat condition is not met, then the confirmation of specific conditions for each ingredient included in the processed pet food is required. Written confirmation of either heat treatment or the processing method or sanitary conditions must be provided before issuance of an export certificate for processed pet food to the European Union. A link between the lots of ingredients and the exported processed pet food should exist.

If flavouring innards are added to processed pet food after heat treatment, these flavouring innards must be produced and tested according to the requirements of chapter 3B, II.4. In addition to microbiologic tests on processed pet food, microbiologic tests on flavouring innards are also required. A copy of microbiologic test results must be provided before issuance of an export certificate for processed pet food to the European Union. A link between the lots of flavouring innards and the processed pet food should exist.

The microbiologic standards of chapter 3 B, II. 4 are: random sampling of at least 5 samples from each processed batch taken during or after storage (before shipping) at the processing plant and complies with the following:

Salmonella: absence in 25 g, n = 5, c = 0, m = 0, M= 0

Enterobacteriaceae: n = 5, c = 2, m = 10, M= 300 in 1 g

Where:

2.3.3 Chewing articles (chapter 3C of Regulation (EC) 142/2011)

In the case of chewing articles made from hides and skins of ungulates or from fish and dry, they are subjected to a heat treatment sufficient to destroy pathogenic organisms (including salmonella). (Vg. 70°C for 30 minutes or other equivalent parameters are acceptable)

In the case of chewing articles made from animal by-products other than hides and skins of ungulates or from fish, they are subjected to a heat treatment of at least 90°C throughout their substance.

The microbiologic standards of chapter 3 C, II.3 are: random sampling of at least 5 samples from each processed batch taken during or after storage (before shipping) at the processing plant and complies with the following:

Salmonella: absence in 25 g, n = 5, c = 0, m = 0, M= 0

Enterobacteriaceae: n = 5, c = 2, m = 10, M= 300 in 1 g

Where:

2.3.4 Raw pet food for direct sale or animal by-products to be fed to fur animals (chapter 3D of Regulation (EC) 142/2011)

No heat treatment is required. Raw pet food for pets for direct sale or animal by-products to be fed to fur animals have been obtained and prepared without contact with other material not complying with the conditions laid down in Chapter 3D.

The microbiologic standards of chapter 3D, II.6 are: random sampling of at least 5 samples from each processed batch taken during or after storage (before shipping) at the processing plant and complies with the following:

Salmonella: absence in 25 g, n = 5, c = 0, m = 0, M= 0

Enterobacteriaceae: n = 5, c = 2, m = 10, M= 5000 in 1 g

Where:

2.3.5 Flavouring innards for use in the manufacture of pet food (chapter 3E of Regulation (EC) 142/2011)

Flavouring innards must be subjected to processing and parameters which guarantee the products meet the following microbiologic standards (annex XIII, Chapter III, article 2 does not indicate which treatment is required but the microbiologic standards to meet).

Microbiologic standards of Chapter 3 E, II. 4 are: random sampling of at least 5 samples from each processed batch taken during or after storage (before shipping) at the processing plant and complies with the following:

Salmonella: absence in 25 g, n = 5, c = 0, m = 0, M= 0

Enterobacteriaceae: n = 5, c = 2, m = 10, M= 5000 in 1 g

Where:

2.3.6 Animal by-products for the manufacture of pet food (chapter 3F of Regulation (EC) 142/2011)

Chapter 3F does not indicate microbiologic standards to meet for animal by-products for the manufacture of pet food for pets, but the products have been deep-frozen at the plant of origin and preserved in such a way that they will not spoil during the shipping.

If the by-products are derived from animals treated with prohibited substances, ensure conditions of chapter 3F, II.1.9 are met. The importation should be permitted in accordance with the Regulation (EC) 1069/2009.

2.4 Approved suppliers

Veterinary offices must ensure, based on the appropriate traceability certificate (available from CFIA district offices or federal slaughter plants), that suppliers other than federally inspected slaughter plants have been approved by the CFIA.

V. Certification for export to the EU of canned pet food, processed pet food, chewing articles, raw pet food for direct sale or animal by-products to be fed to farmed fur animals, flavouring innards for use in the manufacture of pet food, and other animal by-products for the manufacture of pet food

Prior to endorsing export certificates to the EU, district offices should ensure that the processing facilities have been granted final approval by the CFIA and are included in the list of facilities approved for export to the EU. They must also determine, based on the appropriate traceability certificate, whether the product meets the requirements of the certificates chapter 3.

VI. Approval of facilities to export to the EU

1. General hygiene requirements for the approval of facilities

The approval of facilities is in accordance with Section 2, articles 24, 25, 26, 27 of Regulation (EC) 1069/2009.

The general hygiene requirements are set out in chapters I, II and III of annex IV of Regulation (EC) 142/2011.

Refer to sections IV. a., b., c., in the directive, Approval of Facilities to Export Animal By-Products Not Intended for Human Consumption to the European Union (EU) (TAHD-DSAT-IE-2009-8), which deal with the hygiene requirements for intermediate, storage and processing plants.

2. Supervision of production

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

3. Validation procedures

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

4. Plant self-inspection (HACCP type)

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

The EU requires that establishments that manufacture or process animal by-products not intended for human consumption have a self-inspection program in place, similar to the Hazard Analysis and Critical Control Point (HACCP) system.

In addition, for processed pet food (chapter 3B of Regulation (EC) 142/2011), for chewing articles (chapter 3C of Regulation (EC) 142/2011), for raw pet food for direct sale or for animal by-products to be fed to farmed fur animals (chapter 3D of Regulation (EC) 142/2011), and for flavouring innards for use in the manufacture of pet food (chapter 3E of Regulation (EC) 142/2011), random samples must be taken during production and/or during storage (before dispatch) to verify compliance with the standards of respective chapters.

5. Official control and list of approved plants

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

6.1 Hygiene requirements for the collection and transport of animal by-products and processed products

Refer to section V of directive TAHD-DSAT-IE-2009-8, which deals with identification, vehicles and containers, records, and temperature conditions.

6.2 Specific requirements related to transport of the animal by-products covered by this directive (annex XIV, Chapter II, section 8 of Regulation (EC) 142/2011) are as follows:

  1. Animal by-products for the manufacture of feed for fur animals, for pet food other than raw pet food, and for derived products other than for farmed animals may be imported into the EU if following conditions are met:
    1. the animal by-products have been deep-frozen at the plant of origin or have been preserved in such a way to prevent spoiling between dispatch and delivery to the establishment or plant of destination
    2. the animal by-products have undergone all precautions to avoid contamination with pathogenic agents
    3. the animal by-products were packed in new packaging preventing any leakage or in packaging which has been cleaned and disinfected before use
  2. In the case of raw material for pet food production derived from animals which have been treated with certain substances prohibited in accordance with Directive 96/22/EC, (see annex D), Category 1 by-products must meet the following criteria:
    1. they must be marked in the third country before entry into the territory of the Community by a cross of liquefied charcoal or activated carbon, on each outer side of each frozen block, in such a way that the marking covers at least 70 % of the diagonal length of the side of the frozen block and is at least 10 cm in width
    2. in the case of material which is not frozen, they must be marked in the third country before entry into the territory of the Community by spraying it with liquefied charcoal or by applying charcoal powder in such a way that the charcoal is clearly visible on the material

    Note: The raw materials mentioned in VI. 6.2 b are considered to be Category 1 products. Their export to the EU is permitted since they are intended solely for use in pet food. They will not enter the human food supply.

  3. Where a consignment is made up of raw material of Category 1, derived from animals which have been treated with certain substances prohibited in accordance with Directive 96/22/EC (see annex E) and other raw material of Category 3, all the raw materials in the consignment are considered to be Category 1 and must be marked as laid down in VI.6.2.b of above
  4. The markings provided for in sections VI.6.2.b shall remain visible from the dispatch and until the delivery to the pet food plant of destination

7. Pre-inspection

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)

8. Inspection

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)

9. Billing for inspections

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)

10. Inspection reports

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)

11. Approval numbers

See section XII of directive TAHD-DSAT-IE-2009-8.

12. Facility name or address changes

See section XIII of directive TAHD-DSAT-IE-2009-8.

Appendix

List of Prohibited Substances Pursuant to Directive 96/22/EC

List A: prohibited substances

List B: prohibited substances with derogations

Provisionally prohibited substances

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