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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AHPD-DSAE-IE-2009-7-2

Amendments: 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 (EC) No 142/2011, replacing Regulation (EC) No 1774/2002. It completely replaces any previous versions.

I. Purpose

The purpose of this directive is as follows:

  • to explain the import requirements of the European Union (EU) for the following products:
    • 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;
    • animal by-products for the manufacture of pet food; and
  • to standardize Canadian Food Inspection Agency (CFIA) field inspections of processing facilities for these products.

This directive does not cover articles for exhibition purposes: see Annex XIV, Chapter III, section 3 of Regulation (EC) No 142/2011.

II. Context

The European Parliament and the Council of the European Union Regulation (EC) No 1069/2009 lays down the health rules regarding animal by-products and derived products not intended for human consumption and repeals Regulation (EC) No 1774/2002.

The European Parliament and the Council of the European Union Regulation (EC) No 142/2011 is implementing European Parliament and the Council of the European Union Regulation (EC) No 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) No 1069/2009. Refer to the directive AHPD-DSAE-IE-2009-8-2 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 (e.g. 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) No 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 (AHPD-DSAE-IE-2009-9-1) and the European Legislation (EC) No 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) No. 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.
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) No 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) No 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) No 999/2001 referring to TSE (transmissible spongiform encephalopathies).

1.2 Processed pet food (Chapter 3B of Regulation (EC) No 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) No 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) No 999/2001 referring to TSE (transmissible spongiform encephalopathies).

1.3 Chewing articles (Chapter 3C of Regulation (EC) No 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) No 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) No 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) No 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) No 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) No 999/2001 referring to TSE (transmissible spongiform encephalopathies).

1.5 Flavouring innards for use in the manufacture of pet food (Chapter3E of Regulation (EC) No 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) No 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) No 999/2001 referring to TSE (transmissible spongiform encephalopathies).

1.6 Animal by-products for the manufacture of pet food (Chapter 3F to Regulation (EC) No 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) No 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) No 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) No 142/2011)

No requirement referring to origin.

2.1.2 Processed pet food (Chapter 3B of Regulation (EC) No 142/2011)

No requirement referring to origin.

2.1.3 Chewing articles (Chapter 3C of Regulation (EC) No 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) No 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) No142/2011: the animals from which the meat is derived come from the third countries, territories or parts thereof identified by an ISO 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) No 142/2011)

No requirement referring to origin.

2.1.6 Animal by-products for the manufacture of pet food (Chapter 3F of Regulation (EC) No 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) No 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) No 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 three 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 centre 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) No 142/2011)

Canned pet food has been subjected to heat treatment to a minimum Fc value of 3 in hermetically sealed containers. Fc3 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:

  • 110° Celsius for 40 minutes; or
  • 111 °Celsius for 32 minutes; or
  • 112 °Celsius for 25 minutes; or
  • 113 °Celsius for 20 minutes; or
  • 114° Celsius for 16 minutes; or
  • 115° Celsius for 13 minutes; or
  • 116° Celsius for 11 minutes; or
  • 117° Celsius for 9 minutes; or
  • 118° Celsius for 7 minutes; or
  • 119° Celsius for 6 minutes; or
  • 120° Celsius for 5 minutes; or
  • 121° Celsius for 3 minutes; or
  • 122° Celsius for 3 minutes; or
  • 123° Celsius for 3 minutes; or
  • 124° Celsius for 3 minutes; or
  • 125° Celsius for 2 minutes; or
  • 126° Celsius for 1 minute; or
  • 127° Celsius for 46 seconds; or
  • 128° Celsius for 37 seconds; or
  • 129° Celsius for 29 seconds; or
  • 130° Celsius for 23 seconds; or
  • 131° Celsius for 18 seconds; or
  • 132° Celsius for 15 seconds; or
  • 133° Celsius for 12 seconds; or
  • 134° Celsius for 9 seconds; or
  • 135° Celsius for 7 seconds; or
  • 136° Celsius for 6 seconds.

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 operational export specialist.

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) No 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 five 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:

  • n = number of samples to be tested
  • m = threshold value for the number of bacteria (The result is considered satisfactory if the number of bacteria in all samples does not exceed m.)
  • M = maximum value for the number of bacteria (The result is considered unsatisfactory if the number of bacteria in one or more samples is M or more.)
  • c = number of samples the bacterial count of which may be between m and M(the sample still being considered acceptable if the bacterial count of the other samples is m or less).
2.3.3 Chewing articles (Chapter 3C of Regulation (EC) No 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 five 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:

  • n = number of samples to be tested
  • m = threshold value for the number of bacteria (The result is considered satisfactory if the number of bacteria in all samples does not exceed m.)
  • M = maximum value for the number of bacteria (The result is considered unsatisfactory if the number of bacteria in one or more samples is M or more.)
  • c = number of samples the bacterial count of which may be between m and M(the sample still being considered acceptable if the bacterial count of the other samples is m or less).
2.3.4Raw pet food for direct sale or animal by-products to be fed to fur animals (Chapter 3D of Regulation (EC) No 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 five 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:

  • n = number of samples to be tested
  • m = threshold value for the number of bacteria (The result is considered satisfactory if the number of bacteria in all samples does not exceed m.)
  • M = maximum value for the number of bacteria (The result is considered unsatisfactory if the number of bacteria in one or more samples is M or more.)
  • c = number of samples the bacterial count of which may be between m and M(the sample still being considered acceptable if the bacterial count of the other samples is m or less).
2.3.5 Flavouring innards for use in the manufacture of pet food (Chapter 3E of Regulation (EC) No 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 five 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:

  • n = number of samples to be tested
  • m = threshold value for the number of bacteria (The result is considered satisfactory if the number of bacteria in all samples does not exceed m.)
  • M = maximum value for the number of bacteria (The result is considered unsatisfactory if the number of bacteria in one or more samples is M or more.)
  • c = number of samples the bacterial count of which may be between m and M(the sample still being considered acceptable if the bacterial count of the other samples is m or less).
2.3.6 Animal by-products for the manufacture of pet food (Chapter 3F of Regulation (EC) No 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) No 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) No 1069/2009.

The general hygiene requirements are set out in Chapters I, II and III of Annex IV of Regulation (EC) No 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) (AHPD-DSAE-2009-8-2), which deal with the hygiene requirements for intermediate, storage and processing plants.

2. Supervision of production

Refer to section IV. d., e., of directive AHPD-DSAE-2009-8-2.

3. Validation procedures

Refer to section IV. f., of directive AHPD-DSAE-2009-8-2.

4. Plant self-inspection (HACCP type)

Refer to section IV. g., of directive AHPD-DSAE-2009-8-2.

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) No 142/2011), for chewing articles (Chapter 3C of Regulation (EC) No 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) No 142/2011), and for flavouring innards for use in the manufacture of pet food (Chapter 3E of Regulation (EC) No 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 AHPD-DSAE-2009-8-2.

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

Refer to section V of directive AHPD-DSAE-2009-8-2, 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) No 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

Prior to scheduling the facility's inspection, the district office must forward these documents to the plant management:

  • Approved Supplier form (Appendix A)
  • Processing Method form (Appendix B)

Prior to CFIA inspection of the facility, the facility management must complete and forward the documents listed above to the district office.

Prior to facility inspection, the district office should confirm that the required forms have been provided and meet all requirements. All forms should be on oath and list the title of the signatory in the company. The title should indicate that the individual could be expected to have knowledge of the information included in the on oath form. These on oath documents should be updated (signed and provided to the district office) annually.

See section VIII of directive AHPD-DSAE-IE-2009-8-2.

8. Approved Supplier form (Appendix A)

The owner of the facility must provide an on oath form declaring that the facility will use only materials that have been subjected to checks in a federal or provincial slaughter plant that has a full-time veterinary inspection system or storage and processing system approved by the country's competent authority as being in compliance with the requirements of Regulation (EC) No 142/2011. The form must identify the supplying facilities.

9. Processing Method form (Appendix B)

This form requires the facility management to certify that it has in place a self-inspection program that ensures compliance with the standards described in section VI.4.

10. Inspection

Prior to arriving at the facility 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 facility management office. The required forms and the plant "self-inspection" program should be reviewed with facility management at this time.

The inspector may then review the checklist (Appendix C), along with the facility's guide, in order to inform the facility management of all the questions that they will be required to answer during the visit. 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 requiring revisiting or to show the evidence for any unanswered questions.

During the inspection, the inspector should keep in mind the information he or she has reviewed in the on oath forms and the self-inspection plan and diligently observe for any indications of inaccuracies.

See section 9 of directive AHPD-DSAE-IE-2009-8-2.

11. Billing for inspections

See section X of directive AHPD-DSAE-IE-2009-8-2.

12. Inspection reports

See section XI of directive AHPD-DSAE-IE-2009-8-2.

13. Approval numbers

See section XII of directive AHPD-DSAE-IE-2009-8-2.

14. Facility name or address changes

See section XIII of directive AHPD-DSAE-IE-2009-8-2.

Appendices

  • Appendix A: Approved Supplier form
  • Appendix B: Processing Method form
  • Appendix C: CFIA Plant Inspection Checklist for Approval of Facilities
  • Appendix D: List of Prohibited Substances Pursuant to Directive (EC) No 96/22

Appendix A: Approved Supplier Form

This serves to inform officials of the Canadian Food Inspection Agency (CFIA) that

space (Name of plant), located at:

space
(Street address, including city, province and postal code)

receives by-products that:

checkbox are of Canadian origin, or checkbox were legally imported from:space
(Country)

and come from the following:

checkbox Federal or provincial slaughter plants that have a full-time veterinary inspection system and were derived from animals that were not condemned at the ante-mortem stage

checkbox Federally inspected cutting plants

checkbox Farming operations and were derived from animals showing no clinical signs of a disease communicable through that product to humans or animals

checkbox Offshore fishing (excluding marine mammals) or plants that manufacture fish products for human consumption

checkbox Other

Animal By-Products Origin
Type of Source Facility Name and Address CFIA Approval Number (if applicable)

Description of by-products received by the plant:space
space

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

Commissary of oath signature:space

Appendix B: Processing Method Form

This serves to inform officials of the Canadian Food Inspection Agency (CFIA)

thatspace( Name of plant) located at

space
(Street address, including city, province and postal code)

receives animal by-products intended for export to the EU and:

checkbox has a self-inspection plan in place, and/or

checkbox processes the said by-products using the methods/processes described below:
space
space

and

checkbox in the case of processed pet foods, chewing articles, flavouring innards for use in the manufacture of pet food it should ensure that the products comply with the microbiological standards set out in section IV.2.3 of the directive, Approval of facilities to export to the European Union canned pet food, processed pet food other than canned pet food, chewing articles for pets, raw pet food, 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 (AHPD-DSAE-IE-2009-7-2) and given below:

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:

  • n = number of samples to be tested
  • m = threshold value for the number of bacteria (The result is considered satisfactory if the number of bacteria in all samples does not exceed m.)
  • M = maximum value for the number of bacteria (The result is considered unsatisfactory if the number of bacteria in one or more samples is M or more.)
  • c = number of samples the bacterial count of which may be between m and M( the sample still being considered acceptable if the bacterial count of the other samples is m or less).

and

checkbox in the case of raw pet food for direct sale or animal by-products to be fed to fur animals it should ensure that the products comply with the microbiological standards set out in section IV.2.3 of the directive, Approval of facilities to export to the European Union canned pet food, processed pet food other than canned pet food, chewing articles for pets, raw pet food, 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 (AHPD-DSAE-IE-2009-7-2) and given below:

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:

  • n = number of samples to be tested
  • m = threshold value for the number of bacteria (The result is considered satisfactory if the number of bacteria in all samples does not exceed m.)
  • M = maximum value for the number of bacteria (The result is considered unsatisfactory if the number of bacteria in one or more samples is M or more.)
  • c = number of samples the bacterial count of which may be between m and M( the sample still being considered acceptable if the bacterial count of the other samples is m or less).

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

Commissary of oath signature:space

Appendix C: CFIA Facility Inspection Checklist for Approval of Facilities

1. Canadian Food Inspection Agency (CFIA) Approval Number: space
(This should be left blank for newly inspected facilities.)

2. Plant/company name: space

3. Address of location being inspected: space
space

4. Address of headquarters if different from above: space
space

5. Contact at plant: space

Telephone:space
Facsimile:space

E. mail address: space

6. List animal by-products produced at this plant for export to the EU:space
space

7. Comments: space
space

8. Recommendation for approval to export to the EU (check all that apply):

checkbox for canned pet food (Chapter 3A)

checkbox for processed pet food (Chapter 3 B)

checkbox for chewing articles (Chapter 3C)

checkbox for raw pet food for direct sale or animal by-products to be fed to fur animals (Chapter 3D)

checkbox for flavouring innards used in the manufacture of pet food (Chapter 3E)

checkbox for animal by-products for the manufacture of pet food (Chapter 3F)

space
Approve

space
Disapprove

space
Inspection Date:

space
Name of inspector (printed)

space
Signature of area network export specialist concurring with recommendation in number 8.

space
Date

Approval valid until (date):space

Please forward a copy of the completed form and all required on oath forms to the CFIA area network export specialist.

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

Checklist

1. checkbox Yes checkbox No
Has the plant provided you with a current Approved Supplier Form? (Please attach to this checklist, and forward to area network export specialist.)
2. checkbox Yes checkbox No
Has the plant provided you with a current Processing Method Form? (Please attach to this checklist, and forward to area network export specialist.)

Checklist for Intermediate Plants

3. checkbox Yes checkbox No
The premises are adequately separated from other premises such as slaughterhouses.
4. checkbox Yes checkbox No
The layout of plants ensures the total separation of Category 1 and 2 from Category 3 material, from reception until dispatch.
5. checkbox Yes checkbox No
The plant has a covered space to receive animal by-products.
6. checkbox Yes checkbox No
The plant is constructed in a way that facilitates cleaning and disinfection. Floors are laid down in a way that facilitates the draining of liquids.
7. checkbox Yes checkbox No
The plant has adequate lavatories, change rooms, and wash basins for staff.
8. checkbox Yes checkbox No
The plant has appropriate arrangements for protection against pests such as insects, rodents, and birds.
9. checkbox Yes checkbox No
The plant has a waste water disposal system that meets hygiene requirements.
10. checkbox Yes checkbox No
The plant has 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.
11. checkbox Yes checkbox No
The plant has adequate facilities for cleaning and disinfecting the containers or receptacles in which by-products are received, as well as the vehicles in which they are transported. Adequate facilities are provided for disinfecting vehicle wheels departing unclean sector of the facility.
12. checkbox Yes checkbox No
The sorting of Category 3 material is carried out in a way that avoids any risk of the propagation of animal diseases.
13. checkbox Yes checkbox No
During sorting or storage, Category 3 material is handled and stored separately from goods, other than other Category 3 material, and in a way that prevents any propagation of pathogens.
14. checkbox Yes checkbox No
Category 3 material is stored properly, and where appropriate chilled or frozen until re-dispatched.

Checklist for Storage Plants

15. checkbox Yes checkbox No
Premises that store processed products derived from Category 3 material are not at the same site as premises storing processes products derived from Category 1 or Category 2 material, unless in a completely separate building.
16. checkbox Yes checkbox No
The plant has a covered space for receiving and storing animal by-products.
17. checkbox Yes checkbox No
The plant is constructed in a way that facilitates cleaning and disinfection. Floors are laid down in a way that facilitates the draining of liquids.
18. checkbox Yes checkbox No
The plant has adequate lavatories, change rooms, and wash basins for staff.
19. checkbox Yes checkbox No
The plant has appropriate arrangements for protection against pests such as insects, rodents, and birds.
20. checkbox Yes checkbox 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 departing unclean sector of processing facility.
21. checkbox Yes checkbox No
Products are stored properly until re-dispatched.
22. checkbox Yes checkbox No
In order to preserve the animal by-products at appropriate temperatures (refrigerated or frozen), the plant has 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.

Checklist for Processing Plants

23. checkbox Yes checkbox No
Premises for the processing of animal by-products are not at the same site as slaughterhouses, unless located in a completely separate building. However, a conveyer system may link an individual processing plant to a slaughterhouse on the same site, provided the following conditions are met:
  1. there are separate entrances, reception bays, equipment, exits, and personnel for the processing plant and the slaughterhouse;
  2. the animal by-products to be processed originate on the same premises; and
  3. unauthorized persons and animals do not have access to the processing plant.
24. checkbox Yes checkbox 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 facilitates 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.
25. checkbox Yes checkbox No
To prevent recontamination of the finished product, clear separation exists between the area of the plant that unloads incoming material for processing and those areas set aside for the processing of that product and the storage of the processed product.
26. checkbox Yes checkbox 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.
27. checkbox Yes checkbox No
Adequate facilities are provided for disinfecting vehicle wheels, when departing the unclean sector of the processing plant.
28. checkbox Yes checkbox No
The processing plants have a waste water disposal system that meets the competent authority's requirements.
29. checkbox Yes checkbox No
Animal by-products are processed as soon as possible upon arrival. They are stored properly until processed.
30. checkbox Yes checkbox No
Containers, receptacles, and vehicles used for transporting unprocessed material are cleaned in a designated area. That area is situated or designed to prevent the risk of contamination of processed products.
31. checkbox Yes No checkbox
Persons who work in the unclean sector do not enter the clean sector without changing or disinfecting work clothes and footwear. Equipment is not taken from the unclean sector into the clean sector, unless first cleaned and disinfected. Personnel movement procedures are in place to control movement of personnel between areas and to prescribe the proper use of foot baths and wheel baths.
32. checkbox Yes checkbox No
Preventative measures against birds, rodents, insects, or other vermin are taken systematically, with a documented program.
33. checkbox Yes checkbox No
Cleaning procedures are established and documented for all parts of the premises. Suitable equipment and cleaning agents are provided.
34. checkbox Yes checkbox No
Hygiene control includes regular inspection of the environment and equipment. Inspection schedules and results are documented and maintained for at least two years.
35. checkbox Yes checkbox No
Installations and equipment are kept in a good state of repair, and measuring equipment is calibrated at regular intervals.
36. checkbox Yes checkbox No
Processed products are handled and stored at the processing plant in a way that precludes recontamination.

Checklist for Collection and Transport of Animal By-Products

Identification
37. checkbox Yes checkbox No
Products are kept separate from any other animal by-product and identifiable during collection and transportation.
38. checkbox Yes checkbox No
Processed products are kept separate and identifiable during transportation.
39. checkbox Yes checkbox No
A marking substance for the identification of animal by-products or processed products of a specific category is used only for the category for which its use is required.
40. checkbox Yes checkbox No
Animal by-products and processed products are dispatched from one location to another in packaging, containers, or vehicles that are prominently and, at least for the period of transport, indelibly colour-coded or well identified.
41. checkbox Yes checkbox No
During transport, a label attached to the packaging, container, or vehicle must clearly indicate the category of the animal by-products or, for processed products, the category of animal by-products from which the processed products were derived.
Vehicles and Containers
42. checkbox Yes checkbox No
The following is true, for collection and transport:
  1. new packaging preventing any leakage is used for raw pet food for direct sale and animal by-products to be fed to fur animals; and
  2. new or sterilised packaging, or if transported in bulk, thoroughly cleaned and disinfected containers are used for flavouring innards for use in the manufacture of pet food;
  3. new or thoroughly cleaned and disinfected packaging is used for animal by-products for the manufacture of pet food for pets.
43. checkbox Yes checkbox 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 treated as follows:
  1. cleaned, washed and disinfected after each use; and
  2. maintained in a clean condition.
44. checkbox Yes checkbox No
Reusable containers must be dedicated to the carriage of Category 3 products to the extent necessary to avoid cross-contamination.
Temperature Conditions
45. checkbox Yes checkbox No
The transport of animal by-products takes place at an appropriate temperature to avoid any risk to animal or public health.
46. checkbox Yes checkbox No
The design of vehicles used for refrigerated transport ensures the maintenance of an appropriate temperature throughout transport.

Checklist for Self-Inspection Plan

47. checkbox Yes checkbox No
Did the plant show you a written "Self Inspection" program that meets the requirements outlined in section VI.4 of this document?
48. checkbox Yes checkbox No
Has the facility established Critical Control Points (CCPs) for each of the critical limits (for the appropriate processing method) noted in section VI.5 of this document?
49. checkbox Yes checkbox No
Is the plant maintaining records for two years (or since the beginning of the CCP implementation if less than two years)?
50. checkbox Yes checkbox 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? Does this plan specify that the CFIA will be contacted if the product is produced without meeting the critical limit?

space
Name of Inspector (printed)

space
Inspection Date

Appendix D: List of Prohibited Substances Pursuant to Directive 96/22/EC

List A: Prohibited Substances

  • thyrostatic substances
  • stilbenes, stilbene derivatives, and their salts and esters
  • oestradiol 17β and its ester-like derivatives

List B: Prohibited Substances With Derogations

  • β-agonists substances

Provisionally Prohibited Substances

  • substances with oestrogenic (other than oestradiol 17β and its ester-like derivatives), androgenic or teratogenic effects.
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