Approval of Facilities to Export to the European Union Raw Pet Food, Animal By-Products to Be Fed to Farmed Fur Animals*, Flavouring Innards for Use in the Manufacture of Pet Food, and Animal By-Products for the Manufacture of Pet Food

TAHD-DSAT-IE-2009-7-1
March 31, 2011

I. Purpose

The purpose of this directive is as follows:

• to explain the import requirements of the European Union (EU) for the following products:
  • raw pet food for direct sale or animal by-products to be fed to farmed fur animals (referred to hereinafter as "raw pet food"), and
  • flavouring innards for use in the manufacture of pet food (referred to hereinafter as "flavouring innards"), and
  • animal by-products for the manufacture of pet food excluding raw blood, raw milk, skins, hooves and horns, pig bristles and feathers (referred to hereinafter as "animal by-products"); and
• to standardize Canadian Food Inspection Agency (CFIA) field inspections of processing facilities for these products.

This directive does not cover the following items, which fall under the Pet Food Program:

• processed food for pets;
• canned pet food; or
• chewing articles for pets.

*. Fur animals, means animals kept or reared for the production of fur and not for human consumption.

II. Context

Regulation (EC) No. 1774/2002 establishes the requirements for the importation of animal by-products not intended for human consumption into the EU.

Chapter II of Annex VIII of the Regulation sets out the requirements for raw pet food and animal by-products to be fed to farmed fur animals, whereas Chapter XIV of the same Annex sets out the requirements for flavouring innards.

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

1. They come from third countries eligible to export such products to the EU (list available from the district offices).
2. They were obtained, prepared and stored in establishments approved by the CFIA in accordance with the present directive.
3. They were produced in accordance with Regulation (EC) No. 1774/2002.
4. They are accompanied as follows:
   1. for raw pet food for direct sale, by a health certificate that conforms to the model set out in Chapter 3D, Annex X in the above-mentioned Regulation;
   2. for flavouring innards, by a health certificate that conforms to the model set out in Chapter 3(E) of Annex X in the above-mentioned Regulation; and
   3. 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 the same Annex in the said Regulation.

The Regulation requires that the CFIA approve facilities to export the products to the EU. 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.

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, in the case of flavouring innards only) have been approved by the CFIA.

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

Approved facilities: establishments that have received CFIA approval to manufacture, process and store raw pet food, animal by-products to be fed to farmed fur animals, flavouring innards for the manufacture of pet food, and other animal by-products for the manufacture of pet food.

Category 3 material: See the directive, Definition of Categories 1, 2, and 3 Animal Products and By-Products According to the European Legislation 1774-2002 (AHPD-DSAE-IE-2009-9-1).

Flavouring innards: a liquid or dehydrated processed product of animal origin used to enhance the palatability values of pet food.

Other animal by-products for the manufacture of pet food: raw blood, raw milk, hides and skins, hooves and horn, pig bristles and feathers are excluded.

Raw material for pet food or for farmed fur animals: pet food which has not undergone any preserving process other than chilling, freezing or quick freezing to ensure preservation.

IV. Import conditions

1. Nature of products

1.1 Raw pet food (Chapter 3D of Regulation [EC] No. 1774/2002)

Raw pet food must consist only of the following animal by-products:

1. parts of slaughtered animals, which are fit for human consumption in accordance with Community legislation, but are not intended for human consumption for commercial reasons; or
2. parts of slaughtered animals, which are rejected as unfit for human consumption but are not affected by any signs of diseases communicable to humans or animals and derive from carcases that are fit for human consumption in accordance with Community legislation.

1.2 Flavouring innards (Chapter 3E of Regulation [EC] No. 1774/2002) and animal by-products for the manufacture of pet food (Chapter 3F of Regulation [EC] No. 1774/2002)

These products must have been prepared using the following animal by-products only:

1. parts of slaughtered animals, which are fit for human consumption in accordance with Community legislation, but are not intended for human consumption for commercial reasons;
2. parts of slaughtered animals, which are rejected as unfit for human consumption but are not affected by any signs of diseases communicable to humans or animals and derive from carcases that are fit for human consumption in accordance with Community legislation;
3. animal by-products derived from the production of products intended for human consumption, including degreased bones and greaves;
4. former foodstuffs of animal origin, or former foodstuffs containing products of animal origin, other than catering waste, which are no longer intended for human consumption for commercial reasons or due to problems of manufacturing or packaging defects or other defects which do not present any risk to humans or animals;
5. fish or other sea animals, except sea mammals, caught in the open sea for the purposes of fishmeal production;
6. fresh by-products from fish from plants manufacturing fish products for human consumption;
7. shells, hatchery by-products and cracked egg by-products originating from animals which did not show clinical signs of any disease communicable through that product to humans or animals; and

8. materials from animals which have been treated with certain substances which are prohibited pursuant to Directive 96/22/EC, the import of the material being permitted in accordance with Article 28 of Regulation (EC) 1774/2002. (See Annex E.)

   Flavouring innards (Chapter 3E of Regulation [EC] No. 1774/2002) may also be derived from the following animal by-products:

9. hides and skins, hooves and horns, pig bristles and feathers originating from animals that are slaughtered in a slaughterhouse, after undergoing ante-mortem inspection, and were fit, as a result of such inspection, for slaughter for human consumption in accordance with Community legislation;
10. blood obtained from animals other than ruminants that are slaughtered in a slaughterhouse, after undergoing ante-mortem inspection, and were fit, as a result of such inspection, for slaughter for human consumption in accordance with Community legislation; and
11. raw milk originating from animals that do not show clinical signs of any disease communicable through that product to humans or animals.

2. European hygiene requirements

2.1 Origin of products

2.1.1 Raw pet food (Chapter 3D of Regulation [EC] No.1774/2002)

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

1. It must be derived from meat satisfying the specific requirements of Chapter 3D (II.2) of Regulation (EC) No. 1774/2002, Annex X.
2. It must 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 above (IV.2.1.1.a).

2.1.2 Flavouring innards (Chapter 3E of Regulation [EC] No. 1774/2002)

No requirement.

2.1.3 Animal by-products for the manufacture of pet food (Chapter 3F of Regulation [EC] No. 1774/2002)

1. The by-products must originate from Canada. Or, where the products have been imported, it is necessary to ensure that they meet the specific requirements of Chapter 3F (II.1.2, II.2.1 and II.2.2) of Regulation (EC) No. 1774/2002, Annex X.

2. The animal by-products have been derived from the following:

   Either

   1. animals that have remained in an area satisfying the requirements of the preceding point since their birth or during at least the three months preceding their slaughter, and of which the following is true:

      1. they come from holdings where, for the following diseases for which the animals are susceptible, there has been no case/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 10 km, during the prior 30 days;

         and

      2. they come from holdings where there has been no case/outbreak of foot-and-mouth disease during the prior 60 days, and there has been none in the holdings situated in their vicinity within 25 km, 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.2.1.3.b.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 of which the following is true:

      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/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. after killing, they 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/outbreak of diseases referred to in IV.2.1.3 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 (including the period after treatment, in the case of flavouring innards).

2.3 Processing and monitoring standards

Raw pet food (Chapter 3D) and flavouring innards (Chapter 3E) must comply (in the case of flavouring innards, after undergoing an appropriate treatment) with the microbiological standards set forth in Annex VIII, Chapter II, paragraph 6 of Regulation (EC) No. 1774/2002 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

This compliance must be verified through random sampling performed as follows:

• In the case of raw pet food, by random sampling of at least five samples from each batch taken during storage (before dispatch).
• In the case of flavouring innards, on the basis of a random sample, immediately prior to dispatch.

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 raw pet food, animal by-products for the manufacture of pet food 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 certificate.

VI. Facility approval to export to the EU

1. General hygiene requirements for the approval of facilities

The general hygiene requirements are set out in Chapter I, II and III of Annex III of Regulation (EC) No. 1774/2002.

Refer to sections IV.a, b and c in the directive, Approval of Facilities to Export Animal By-Products Not Intended for Human Consumption to the European Union (EU) (AHPD-DSAE-2009-8-1), which deal with the hygiene requirements for intermediate, storage and processing plants.

2. Supervision of production

Refer to section IV.d of directive AHPD-DSAE-2009-8-1.

3. Validation procedures

Refer to section IV.e of directive AHPD-DSAE-2009-8-1.

4. Plant self-inspection (HACCP type)

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.

Refer to section IV.f of directive AHPD-DSAE-2009-8-1.

In addition, for raw pet food (Chapter 3D of Regulation (EC) No. 1774/2002) and flavouring innards (Chapter 3E of Regulation (EC) No. 1774/2002), random samples must be taken during production and/or during storage (before dispatch) to verify compliance with the following standards:

• 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

Flavouring innards must have been submitted to a treatment method and parameters which ensure that the product complies with the microbiological standards above.

5. Official control and list of approved plants

Refer to section V of directive AHPD-DSAE-2009-8-1.

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

Refer to section VI of directive AHPD-DSAE-2009-8-1, which deals with identification, vehicles and containers, records, and temperature conditions.

Specific requirements related to transport of the animal by-products covered by this directive (Annex VIII, Chapter XI of Regulation (EC) No. 1774/2002) are as follows:

1. Category 3 material, unprocessed and intended for the manufacture of raw materials for use in animal feed or pet food, must be transported in refrigerated or frozen form.

   The raw materials shall have been quick-frozen in the source plant or preserved in a way that prevents spoilage between the time they are shipped and the time they reach the destination facility.

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 (see note below) 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 this point 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 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 V.1.6.2.b above.
4. The markings provided for in sections V.1.6.2.b and V.1.6.2.c 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:

• Notarized Approved Supplier Form (Appendix A)
• Notarized Processing Method of Animal Proteins Form (Appendix B)

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

Prior to plant inspection, the district office should confirm that the required forms have been provided and meet all requirements. All forms should be notarized. The notarized forms should also list the position 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 notarized form. These notarized documents should be updated (signed and provided to the district office) annually.

See section VII of directive AHPD-DSAE-IE-2009-8-1.

8. Notarized Approved Supplier Form (Appendix A)

The owner of the facility must provide a notarized 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/processing system approved by the country's competent authority as being in compliance with the requirements of Regulation (EC) No. 1774/2002. The form must identify the supplying facilities.

9. Notarized Processing Method Form (Appendix B)

This form requires the facility 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 plant for the inspection, the inspector should review the forms already sent to the district office and the inspection checklist.

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

The inspector may then 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 supplied notarized forms and the self-inspection plan and diligently observe for any indications of inaccuracies.

See section VIII of directive AHPD-DSAE-IE-2009-8-1.

11. Billing for inspections

See section IX of directive AHPD-DSAE-IE-2009-8-1.

12. Inspection reports

See section X of directive AHPD-DSAE-IE-2009-8-1.

13. Approval numbers

See section XI of directive AHPD-DSAE-IE-2009-8-1.

14. Facility name or address changes

See section XII of directive AHPD-DSAE-IE-2009-8-1.

Appendices

• Appendix A: Notarized Approved Supplier Form
• Appendix B: Notarized Processing Method Form
• Appendix C: CFIA Plant Inspection Checklist for Approval of Facilities
• Appendix D: List of Prohibited Substances Pursuant to Directive 96/22/EC

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Appendix A: Notarized Approved Supplier Form

This serves to inform officials of the Canadian Food Inspection Agency (CFIA) that
(Name of plant), located at:

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

receives by-products that:

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

and come from the following:

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

Federally inspected cutting plants

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

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

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:

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

Position:

Company name:

Notary signature:

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Appendix B: Notarized Processing Method Form

This serves to inform officials of the Canadian Food Inspection Agency (CFIA) that
(Name of plant), located at:

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

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

has a self-inspection plan in place; and/or

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

and/or

in the case of flavouring innards and raw food for pets or for farmed fur animals, ensures that the products comply with the microbiological standards set out in section IV.2.3 of the directive, Approval of Facilities to Export Animal By-Products Not Intended for Human Consumption to the European Union (EU) (AHPD-DSAE-IE-2009-8-1) 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

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

Position:

Company name:

Notary signature:

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Appendix C: CFIA Plant Inspection Checklist for Approval of Facilities

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

2. Plant/Company name:

3. Address of location being inspected:

4. Address of headquarters if different from above:

5. Contact person at plant:

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

7. Comments :

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

for use in the manufacture of pet food (Chapter 3F)

for use in raw pet food or in food for fur animals (Chapter 3D)

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

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

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

Checklist

Checklist for Intermediate Plants

Checklist for Storage Plants

Checklist for Processing Plants

Checklist for Collection and Transport of Animal By-Products

Identification

Vehicles and Containers

Temperature Conditions

Checklist for Self-Inspection Plan

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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

Provisionally Prohibited Substances

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